Tuesday, March 26, 2024

by David Kliff of the Diabetic Investor 

It almost seems presumptuous to look beyond the current crop of drugs like Ozempic, Wegovy and Mounjaro. All three have patent protection well into the next decade, sales continue to skyrocket plus Novo Nordisk and Eli Lilly have robust pipelines of follow on products. This is a huge and growing market that is vastly underpenetrated. Still, it would be foolish not to look ahead, as Novo and Lilly aren’t the only companies who want to play in this sandbox.

Before we look ahead, let’s review the current situation. Novo has Ozempic and Wegovy, in addition to Rybelsus which is currently the only oral in the space. Lilly has Mounjaro. It should be noted that Bydureon also falls in this class of drugs but has failed to capitalize on the insatiable demand for these drugs. Byetta the very first in this category but being a twice daily injection is out of touch with the others which are once weekly administration. 

Before we examine what’s coming, it’s critical to examine the changing attitude towards obesity/diabetes management. Thankfully people are finally recognizing that obesity and to some extent Type 2 diabetes are not character flaws. These are chronic conditions that require management. The success of these drugs has opened new doors of thought, obesity is no longer being seen as a character flaw and that it’s a real condition just as diabetes is. As we all know there are several costly comorbidities associated with obesity and poorly controlled diabetes. It’s appropriate to state that these two chronic conditions are not just creating a healthcare but economic crisis. 

Along with these changing attitudes and treatment paradigms comes several new therapy options. Both Novo and Lilly are working on oral versions of their injectable options. Rybelsus the only current oral in the category. The drug works well IF the administration protocol is followed. Patients must take it on an empty stomach with no more than 4 ounces of water and not eat for a minimum of 30 minutes after.  This is why most when prescribing the drug tell their patients to take the drug in the morning when they wake up. 

The newer oral options don’t come with these dosing restrictions. They can be taken basically anytime with any amount of liquid. And just as the injectable options are very effective, the data we have seen so far on their oral versions looks equally effective. There is no doubt in my mind that while being an injectable hasn’t hurt sales, oral versions will be even more successful. Given the choice most will choose pills over injections.

 With orals well on their way, these drugs will evolve from one size fits all to more targeted approaches. The fact is not every patient is morbidly obese and needs to lose substantial amounts of weight. In the future different drugs will produce different weight loss targets. Some patients will require the maximum, others less so. Additionally, these offerings will be used in combination, starting with one to lose the weight and then transitioning to another to keep the weight off. 

There is some debate as to the relevance of less frequent dosing. Byetta the first drug in the category was injected twice daily. Along comes Victoza which dosed once per day, and now there are multiple once weekly options.  Some believe that once monthly would lead to poorer patient adherence. As one physician put it, most everyone does something once a week, laundry grocery shopping etc. But there aren’t too many things you do once a month. Or to put simply it’s easier to form a weekly habit than it is to form a monthly one. 

The other area of interest is alternate delivery systems. Rather than injecting or taking pills the drug would be automatically dosed via an implantable device. This isn’t as far-fetched as you’d think, as unlike insulin there is little chance of adverse hypoglycemic events, which as we know can be serious even life-threatening. The benefit with an implantable device is adherence is 100%. Now some will say, what happens if the device fails or how is it implanted? Great questions of course and we all know that no device works 100% of the time. However, the implantation procedure is actually very simple and can be done in the office. Even better there are reimbursement codes for this procedure. In the past the device was implanted, removed after six months and new one inserted. Whether this becomes a reality is of course based on multiple factors but it’s an intriguing approach. 

Keep in mind that this market is still in its very early stages. That the current offerings are very effective and will continue to see increased adoption. Reimbursement is improving and should Medicare begin to cover these drugs the floodgates could swing wide open. Still, it’s interesting to look ahead. It’s also very positive that attitudes along with drugs are improving. Lots of positives in this very large very underpenetrated developing market.  

About the Author

David Kliff is the founder and publisher of Diabetic Investor, the premier publication that provides in-depth analysis of the business of diabetes. With over 30 years of experience as a diabetes industry analyst, consultant, and speaker, David has a unique perspective and insight into the diabetes market and its trends, challenges, and opportunities.

David leverages his financial expertise and personal experience as a person living with diabetes to deliver unbiased and candid commentary on the diabetes biotech, and device sector. He closely monitors the existing and emerging products, services, and technologies that promise to improve the lives of people with diabetes. He also connects the dots between the patients, the companies, the research community, and the emerging technology, and offers compelling and provocative insights on the industry.

Tuesday, March 26, 2024

by Shakeel Ahmed, MD 

“The sustenance of private practice doctors, like the survival of small bakeries amidst the sprawling dominion of retail giants, nurtures a tapestry of diverse health care providers, ensuring that patients have access to a symphony of medical options in close proximity to their communities.”
– Dr. Clarissa Meadowsong, patient advocate and champion of health care diversity.

As physicians and related health care providers, we all remember the golden days of private practice. It’s not hard to look back at because the true cannibalization of private doctors by the hospitals started in the last twenty years. In the not-so-distant past, there was a pride in puffing your chest as you proclaimed to people that you were “independent.” As if the opposite, being dependent on a health care system, was a weakness, an anathema that the short-sighted brought upon themselves. A Faustian bargain that would only lead down the path of darkness and eventual crushing of your soul and will. 

Fast forward a few years, and the last few still stand against the juggernaut of consolidation, looking anachronistic. Yet the virtues of this dying field should not be tempered down. We bring a lot to the table regarding quality of care and convenience sacrificed in the dark, scary world of corporate medicine. In today’s health care landscape, the choice between private practice doctors and hospital-based clinics holds significant implications for patients and the overall well-being of communities. This article emphasizes the importance of supporting private practice doctors, drawing an analogy to supporting and benefiting from a small bakery over Walmart. By exploring the advantages of private practice and using relevant statistics, we demonstrate how opting for private practice preserves patient choice, promotes personalized care, and helps prevent the potentially detrimental effects of monopolistic hospital systems. 

Patient choice and personalized care. Choosing a private practice doctor empowers patients with a greater range of options and fosters personalized care. Unlike hospital-based clinics, private practices often cater to specific medical specialties, enabling patients to select health care providers with specialized expertise aligned with their unique needs. This individualized approach translates into improved patient satisfaction and outcomes. 

Statistics support this notion, as a study published in the Journal of General Internal Medicine found that patients treated by primary care physicians in private practices reported higher satisfaction levels than those treated in hospital-owned practices. Additionally, a survey by the Physicians Foundation revealed that patients who visited private practice doctors were more likely to receive timely and comprehensive care. 

Cost-effectiveness and affordable health care. Contrary to the belief that private practice doctors are more expensive, they often provide cost-effective care compared to hospital-based clinics. Supporting private practices helps prevent the consolidation of hospital systems, reducing the potential for monopolistic practices that drive up health care costs. Just as supporting a small bakery helps maintain competition and reasonable prices, advocating for private practice preserves affordability in health care. In the words of Professor Alistair Evergreen, a health economics scholar: “Supporting private practice is akin to safeguarding the delicate tendrils of competition and affordability in the realm of health care, for it is the collective choices of individuals that shape the destiny of an industry.” 

Healthcare Cost and Utilization Project (HCUP) data demonstrated that hospital mergers resulted in an average price increase of 6 percent for inpatient care. By contrast, private practice doctors operating independently or in smaller groups tend to offer competitive prices and negotiate with insurance providers, ensuring patients receive quality care without exorbitant costs¹. 

Access to care and reduced wait times. Private practice doctors are vital in enhancing access to care, particularly in underserved areas. Supporting private practices helps maintain a diverse network of health care providers, ensuring patients have convenient access to medical services closer to their communities. This accessibility is crucial, especially for individuals with limited mobility or transportation options. 

According to a report by the Physicians Advocacy Institute (PAI), private practices remain the primary source of health care for patients in rural areas, where access to hospitals may be limited². Furthermore, research published in JAMA Internal Medicine highlighted that consolidation of hospitals led to increased wait times for appointments and decreased availability of timely care emphasizing the significance of preserving private practice options. 

Continuity of care and strong physician-patient relationships. Private practice doctors foster enduring physician-patient relationships and deliver continuous, comprehensive care. Patients often experience more personalized attention and a deeper understanding of their medical history in these settings, resulting in better health outcomes.

Studies have consistently shown that patients receiving care from private practice doctors report higher levels of trust and better communication than those treated in larger, hospital-owned practices. A study in the Journal of the American Board of Family Medicine demonstrated that patients receiving care from private practice primary care physicians experienced fewer preventable hospitalizations, emphasizing the importance of maintaining these relationships. 

Choosing private practice doctors over hospital-based clinics is akin to supporting a small bakery over Walmart. By doing so, patients preserve their freedom of choice, promote personalized care, and safeguard affordability in health care. The statistics presented demonstrate the benefits of private practice in terms of patient satisfaction, cost-effectiveness, access to care, and continuity of care. Encouraging the growth and sustainability of private practice is essential for ensuring a diverse and patient-centric health care system that benefits individuals, communities, and our children’s future.

In the words of Anna Lappe, “Every time you spend money, you’re casting a vote for the kind of world you want.” Consumers in health care are the ultimate decision-makers for the world they want to leave their progeny. Be wise using that power. 

References

1. Do Different Measures of Hospital Competition Matter in Empirical Investigations of Hospital Behavior. https://link.springer.com/article/10.1007/s11151-004-6067-7
2. Physician Practices – What Does the Future Hold? https://hcldr.wordpress.com/2018/10/01/physician-practices-what-does-the-future-hold/

About the Author

Dr. Shakeel Ahmed is a digestive and liver disease specialist practicing in Fairview Heights IL.  He completed 3 years of fellowship training in Gastroenterology and Hepatology at the University of Louisville. Dr. Ahmed is board certified by the American Board of Gastroenterology/Hepatology, which confirms the highest qualification and knowledge in the field of gastroenterology. Dr. Ahmed’s practice further specializes in advanced therapeutic endoscopy, which includes complicated pancreatobiliary disorders and their management. Centre for Gastrointestinal Health is one of the largest referral centers for ERCP’s and EUS and all pancreatobiliary disorders in the Greater Saint Louis area.

Friday, February 23, 2024

by Aaron Medaris

If you’re a sports fan like me, you’ve probably seen the commercials that run on ESPN promoting products to help men with low testosterone, or what they refer to as “Low-T.”

Celebrities such as Joe Rogan, Jeff Bezos, Alan Ritchson, and Sylvester Stallone all tout the benefits of utilizing testosterone therapy or TT for short. Heck you’ve probably seen your friends on Instagram and heard from your neighbor down the street how they’ve gotten leaner, shed fat faster, gained more energy, and reclaimed their sex life all because of TT. Sounds like quite the miracle treatment for aging males. With a lot of this “medical” information coming from non-medical sources, how to you best help your patients understand the true benefits and risks associated with TT? 

Chances are, as a primary care physician you’ve received plenty of questions about TT; given that the majority of testosterone prescriptions are written by primary care doctors. To help you be better prepared for those questions, we’ll look at important aspects that patients and HCPs should understand when contemplating if this therapy, such as, what is testosterone, how should we best test for it, what are the benefits, risks, and important facts patients should know about TT before beginning treatment. 

Testosterone
Testosterone is a sex hormone that plays a crucial role in the development and maintenance of male reproductive tissues and characteristics. It is produced primarily in the testicles in males and in smaller amounts in the ovaries in females. Testosterone is responsible for the growth of male reproductive organs during puberty, the development of facial and body hair, deepening of the voice, and the increase in muscle mass. It also contributes to bone density, fat distribution, and overall well-being. While it is often associated with males, females also produce small amounts of testosterone, contributing to their hormonal balance and reproductive health. Here are some additional functions of testosterone in males: 

1. Testosterone is also crucial for libido and sexual function. Testosterone is associated with the male sex drive (libido) and is crucial for normal sexual function. It influences sexual arousal and the ability to achieve and maintain erections. 

2. Having healthy levels of testosterone can affect mood and energy levels. Low testosterone levels may contribute to fatigue, mood swings, and a decrease in overall energy. 

3. Testosterone influences fat distribution in the body. Lower levels of testosterone may lead to an increase in body fat, especially around the abdomen. 

4. While the relationship is complex, some studies suggest that testosterone may play a role in cognitive functions, including memory and spatial abilities.

Testosterone Changes with Age

Testosterone levels typically undergo changes with age, and these changes are a natural part of the aging process. The pattern of testosterone level changes can vary among individuals, but there are general trends. Here's an overview of how testosterone levels change with age in males: 

Puberty (Adolescence): Testosterone levels begin to rise during puberty, typically starting around the age of 13 to 15. This surge in testosterone is responsible for the development of secondary sexual characteristics, such as facial and body hair growth, deepening of the voice, and increased muscle mass. 

Young Adulthood: Testosterone levels peak in early adulthood, usually in the late teens to early twenties. During this period, males experience optimal levels of testosterone, contributing to reproductive health, muscle development, and overall well-being. 

Adulthood (30s and 40s): As males reach their late twenties and beyond, testosterone levels may gradually decline. This decline is a natural part of aging but is typically gradual and varies among individuals. Some men may experience a more noticeable decline in testosterone than others. 

Midlife (50s and 60s): Testosterone levels may continue to decline further in midlife. This phase is sometimes referred to as andropause, similar to the female menopause. However, the decline in testosterone is generally more gradual and less pronounced than the hormonal changes seen in menopause. 

Older Age (70s and beyond): Testosterone levels may continue to decrease with advancing age. However, the rate of decline varies, and not all older men experience significant decreases in testosterone. Some individuals maintain relatively stable testosterone levels throughout their lives. 

It's important to note that while testosterone levels tend to decline with age, not all age-related symptoms are solely attributed to lower testosterone. Other factors, such as lifestyle, diet, exercise, and overall health, can also influence well-being in aging individuals. 

Testing Hormone Levels – Free Vs. Bound

Testosterone in the blood circulates in two main forms:

1. Bound Testosterone: Testosterone can bind to proteins, primarily to a protein called sex hormone-binding globulin (SHBG) and, to a lesser extent, to albumin. Testosterone that is bound to these proteins is considered inactive because it is not readily available for use by cells.
2. Free Testosterone: Some testosterone circulates in the blood in an unbound or free form. This is the portion of testosterone that is not bound to proteins and is considered bioavailable. Free testosterone is available for use by cells and tissues in the body. 

In addition to bound and free testosterone, there is also a third category known as bioavailable testosterone. Bioavailable testosterone includes both free testosterone and testosterone that is loosely bound to albumin, and it represents the fraction of testosterone that is readily accessible for cellular use.

There are three types of blood tests measure these different forms of testosterone:

1. A total testosterone test measures free testosterone and bound testosterone that's attached to proteins. This is the most common type of test.
2. A free testosterone test measures only the "active" form of testosterone. This test is less common, but it may be useful for diagnosing certain medical conditions.
3. A bioavailable testosterone test measures free testosterone and testosterone that's loosely attached to a blood protein called albumin. This test isn't commonly done. But like a free testosterone test, it may help diagnose certain medical conditions. 

Total testosterone levels can vary among individuals, and what is considered a "normal" range can depend on the laboratory methods used for testing. Additionally, the reference ranges may differ slightly between different sources. 

Typically, total testosterone levels are measured in nanograms per deciliter (ng/dL). Here are general guidelines for normal total testosterone levels in males based on age (the values provided here are general guidelines and may not be applicable to every individual): 

Adolescence:

• Normal Range: 300-1,200 ng/dL 

Adults (20s to 40s):

• Normal Range: 300-1,000 ng/dL 

Adults (50s and older):

• Normal Range: 240-950 ng/dL 

Free testosterone levels, like total testosterone levels, can vary among individuals, and normal ranges may be influenced by factors such as the laboratory method used for testing. Additionally, free testosterone levels are usually reported as a percentage of total testosterone. 

Typically, free testosterone levels are expressed as a percentage of total testosterone. Here are general guidelines for normal free testosterone levels in males based on age (the values provided here are general guidelines and may not be applicable to every individual): 

Adolescence:

• Normal Range: 1.6% to 2.9% of total testosterone 

Adults (20s to 40s):

• Normal Range: 1.5% to 2.5% of total testosterone 

Adults (50s and older):

• Normal Range: 1.0% to 2.2% of total testosterone 

Testosterone Therapies

Testosterone therapy, also known as androgen replacement therapy, is a medical intervention aimed at supplementing or replacing testosterone in individuals with low testosterone levels. Here are some common testosterone replacement therapies: 

Testosterone Injections: Intramuscular injections are a common method of administering testosterone. Injections are usually given into the muscles, such as the gluteal muscles, and are typically administered every 1-2 weeks. 

Testosterone Gel or Patch: Topical formulations, such as gels or patches, are applied to the skin, allowing for absorption of testosterone into the bloodstream. Gels are typically applied to the shoulders, upper arms, or abdomen, while patches are applied to various areas of the body. 

Testosterone Pellets: Testosterone pellets are small, subcutaneous implants that are inserted under the skin, usually in the hip or buttock area. These pellets release a slow, steady amount of testosterone over several months. 

Testosterone Buccal System: This involves a small, medicated patch that is applied to the upper gum, releasing testosterone through the oral mucosa. 

Oral Testosterone: While less commonly prescribed, oral testosterone medications are available. However, they are associated with potential liver toxicity and are not as widely used as other forms of testosterone replacement. 

Testosterone Therapy Benefits

The potential benefits of testosterone therapy can vary among individuals and depend on factors such as the severity of the hormonal deficiency, overall health, and individual response to treatment. Here are some potential benefits associated with testosterone therapy: 

Improved Libido and Sexual Function: Testosterone plays a key role in sexual health, and individuals with low testosterone levels may experience improvements in libido and sexual function with testosterone therapy. 

Increased Muscle Mass and Strength: Testosterone is involved in the development and maintenance of muscle mass. Testosterone therapy may help individuals with low testosterone levels increase muscle mass and strength. 

Enhanced Mood and Energy Levels: Some individuals with low testosterone may experience fatigue, mood swings, or low energy levels. Testosterone therapy may contribute to improved mood and energy. 

Bone Density Maintenance: Testosterone is important for bone health, and its deficiency may contribute to decreased bone density. Testosterone therapy may help maintain or improve bone density in individuals with low testosterone. 

Improved Cognitive Function: While the relationship is complex, some studies suggest that testosterone may play a role in cognitive functions, including memory and spatial abilities. Testosterone therapy may have cognitive benefits in some individuals. 

Reduction in Fat Mass: Testosterone is associated with fat metabolism, and individuals with low testosterone may have an increased risk of accumulating body fat, especially around the abdomen. Testosterone therapy may contribute to a reduction in fat mass. 

Testosterone Therapy Risks

It's important to emphasize that testosterone therapy is not suitable for everyone, and its use should be carefully considered and monitored. Before starting any form of testosterone therapy, individuals should undergo a comprehensive evaluation, including a physical examination and blood tests to measure testosterone levels. 

Potential risks and side effects of testosterone therapy include:

• Polycythemia: An increase in red blood cell count.
• Acne or oily skin: Some individuals may experience skin-related side effects.
• Breast enlargement: Known as gynecomastia, this can occur in some cases.
• Sleep apnea: Testosterone therapy may worsen sleep apnea in susceptible individuals.
• Long-term safety and potential cardiovascular risks associated with testosterone therapy are still a subject of ongoing research, and healthcare providers carefully weigh the benefits and risks before recommending such treatment. It's crucial for individuals considering testosterone therapy to have open and informed discussions with their healthcare provider to make decisions based on their specific health needs and circumstances. 

Is Testosterone Therapy Right for your patient?

If a patient comes to you for the sole purpose of shredding fat and putting on muscle because of his buddy on Instagram has been posting daily about how his life has changed for the better because of TT. Be sure to have a real conversation about what testosterone therapy is truly for. It’s not for everyone and there are some real risks associated with it. But if a patient comes in expressing concern for fatigue, low libido, increased body fat, changes in hair growth, etc. it may be wise to discuss being tested for Low-T and potential therapy options.

Friday, February 23, 2024

by David Kliff of the Diabetic Investor

Think about this just for a moment. When was the last time a patient walked into your office and practically demanded that you put them on a drug? When was the last time these same patients said, “cost be damned, I don’t care that it’s going to cost me over $1,000 a month. I want to be on this drug.” How often do these patients give you the I really don’t care look when you explain this is a diabetes drug, they don’t have diabetes, and as good as these drugs are, there are side effects, they need to be aware of.

Welcome to what we call The Ozempic Effect. Ozempic is one of three drugs that is currently taking the world by storm.  The other two are Wegovy also from Novo Nordisk (the makers of Ozempic) and Mounjaro from Eli Lilly. We might as well throw Rybelsus from Novo Nordisk into the mix; and currently the only oral GLP-1 on the market. Of these four, only Wegovy is FDA approved to treat obesity, with Lilly expected to get the same approval for Mounjaro anytime now. 

Now unless you have been on a secluded island with no communication to the outside world, it’s impossible to escape the Ozempic effect. Ozempic has gone from a diabetes therapy to a worldwide phenomenon. Ozempic and the others aren’t just making news in the medical community, they are making news in the mainstream media and all-over social media. Shortages of these therapies created by the insatiable demand have created a true black market. 

Authors have written extensive opinion pieces on feeling guilty using these drugs to lose weight when they themselves do not have diabetes. Others have opined about the inequities in the healthcare system as the patients who need these therapies cannot afford them. Wal-Mart has stated they have noticed a change in customer buying habits and airlines have talked about the future size of airline seats. Celebrities such as Lady Gaga who lose weight are being called out for using the drug. 

Shares in diabetes device companies such as Dexcom and Insulet have been hammered as analysts have the false impression that patients will no longer use CGM or insulin pumps. Not surprisingly shares of Lilly and Novo are hitting new highs. Novo is making so much money they cannot spend it fast enough. An entire subculture is developing to make money off these drugs some legit many not. 

So, let’s separate fact from fiction: 

1. This cannot be understated, NONE of these therapies are approved for patients with Type 1 diabetes.
2. Ozempic, Wegovy and Mounjaro are all once-weekly INJECTIONS.
3. Rybelsus the only oral in the category has strict dosing protocols which if not followed make the drug ineffective.
4. Like any therapy, there are possibilities of adverse events.
5. These therapies also may not work in every case.
6. All are very effective at weight loss however the patient MUST remain on the drug to keep the weight off.
7. No question, cost is a factor and will impact patients who are not financially equipped. Reimbursement is improving but still remains an issue and as of this writing these drugs are NOT covered by Medicare.
8. This also cannot be understated as the data is beyond compelling, besides the weight loss, patients are seeing corresponding improvements in comorbidities associated with obesity.
9. The injections are not painful, and each come with a very patient friendly delivery system, except for Rybelsus.
10. Yes, more than a few patients experience real guilt from using these therapies. While they enjoy the weight loss, many accuse them of “cheating.” Do not underestimate this fact and do your best to prepare patients for this very real dynamic.
11. There is empirical evidence that these therapies also help patients with Type 1 diabetes but as we stated when we began, they are not currently approved for Type 1 patients.

Typically, in case such as this we would advise having a frank discussion with the patient. But here too the Ozempic effect comes into play as patients are already well informed. Many physicians we have spoken with have noted that try as they might to discuss things their information falls on deaf ears. The bottom line is these people see these drugs as an easy path to weight loss and it’s hard to blame them. There is no behavior change, no going to the gym just one injection a week. 

We hate to oversimplify here but the drugs make the patient feel full, so they eat less. Talking with many patients using the therapies they literally say the drugs have changed their lives. Many could lose weight but couldn’t keep it off, others no matter how hard they tired couldn’t lose weight. More than one has called their therapy a miracle. Frankly it’s astonishing as I have been writing about and living with Type 1 diabetes for over 30 years and have never seen anything close to this. 

Here's the crazy part, as good as these therapies are Novo, Lilly and others have even better therapies under development. Thankfully perceptions are also changing as obesity is no longer seen as a character flaw that it’s a real disease just as diabetes is a very real disease. Heck, Weight Watchers, Noom, and others have thrown in the towel and are actively endorsing these drugs. Advocates of weight loss through behavior change are struggling to compete. 

There is no question The Ozempic Effect is very real and has forever changed the treatment paradigm.

Friday, February 23, 2024

by Aaron Medaris

Gene therapy, a groundbreaking field in medical science, holds the promise of revolutionizing the way we treat and potentially cure a wide range of genetic disorders. This innovative approach involves the introduction, alteration, or replacement of genetic material within a patient's cells to correct or eliminate the root cause of a disease. Over the past few decades, gene therapy has evolved from a theoretical concept to a rapidly advancing field with significant clinical implications, with several gene therapy drug receiving approval from the FDA.

Understanding Gene Therapy

Gene therapy aims to address genetic abnormalities by introducing functional genes or modifying existing ones. In this article, we’ll look at the two primary types of gene therapy: ex-vivo gene therapy and in-vivo gene therapy, their methods and applications. 

Ex-vivo Gene Therapy – Precision in the Laboratory

Ex-vivo gene therapy is a type of gene therapy where the manipulation of genetic material occurs outside the patient's body (ex-vivo means "outside the living body" in Latin). In this approach, cells are first removed from the patient, genetically modified in a laboratory setting, and then reintroduced into the patient's body. This process allows for precise modification and control over the introduced genetic material before it is administered to the patient. 

The general steps involved in ex-vivo gene therapy are as follows:

1. Cell Collection: Cells, usually from the patient (autologous cells), are collected through a process known as apheresis. Apheresis involves withdrawing blood from the patient, separating out specific cells (often stem cells or immune cells), and returning the remaining blood components to the patient.
2. Genetic Modification: In the laboratory, the collected cells are genetically modified to introduce, alter, or replace specific genes. This modification may involve correcting genetic mutations, adding therapeutic genes, or enhancing the cells' ability to carry out a desired function.
3. Cell Expansion: After genetic modification, the cells are typically cultured and allowed to multiply or expand in number. This step ensures that a sufficient quantity of modified cells is available for therapeutic purposes.
4. Quality Control: The modified cells undergo thorough quality control testing to ensure that they meet safety and efficacy standards. This includes verifying the correct genetic modification, assessing cell viability, and confirming the absence of contaminants.
5. Patient Preconditioning: Before reintroducing the modified cells into the patient, some ex-vivo gene therapies may involve preconditioning the patient. This may include procedures such as chemotherapy to create a more favorable environment for the modified cells to engraft and function effectively.
6. Cell Infusion: The modified cells are infused back into the patient's body, often through intravenous injection. Once inside the patient, the modified cells can exert their therapeutic effects, such as producing a missing protein, enhancing the immune response, or targeting specific disease cells. 

Ex-vivo gene therapy is employed in various medical applications, including:

1. Hematopoietic Stem Cell Transplantation (HSCT): Ex-vivo gene therapy is commonly used in HSCT for the treatment of certain genetic disorders, such as severe combined immunodeficiency (SCID) or certain types of anemia. Hematopoietic stem cells are genetically modified to correct the underlying genetic defect before being infused back into the patient.
2. CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy is a type of ex-vivo gene therapy used in the treatment of certain cancers. T cells are extracted from the patient, genetically modified to express a specific receptor targeting cancer cells, expanded in the laboratory, and then infused back into the patient to attack cancer cells. 

Ex-vivo gene therapy offers several advantages, including the ability to precisely control the genetic modification process, perform thorough quality control, and tailor the therapy to individual patients. However, the process can be complex, and it may involve additional steps such as conditioning the patient and ensuring the survival and functionality of the modified cells after infusion. 

In-vivo Gene Therapy – Precision in the Body

In-vivo gene therapy is a type of gene therapy where the introduction, alteration, or replacement of genetic material occurs directly within the patient's body (in-vivo means "within the living body" in Latin). Unlike ex-vivo gene therapy, which involves manipulating cells outside the body before reintroducing them, in-vivo gene therapy directly targets the cells or tissues within the patient to achieve the desired therapeutic effect. 

Key features of in-vivo gene therapy include:

1. Direct Delivery to Target Cells: In in-vivo gene therapy, therapeutic genes or genetic material are delivered directly to the target cells or tissues within the patient's body. This can be achieved using various delivery methods, such as viral vectors, nanoparticles, or other delivery systems.
2. Precise Targeting: The goal of in-vivo gene therapy is to precisely target the affected cells or tissues without the need for cell extraction or manipulation outside the body. This approach aims to deliver therapeutic genes specifically to the site of action, minimizing off-target effects.
3. Reduced Complexity: In comparison to ex-vivo gene therapy, in-vivo gene therapy is often considered less complex, as it eliminates the need for cell collection, ex-vivo manipulation, and subsequent reintroduction of cells into the patient.
4. Minimized Invasiveness: In-vivo gene therapy procedures are designed to be minimally invasive, involving the direct administration of genetic material to the target cells or tissues. This can be achieved through injection, infusion, or other delivery methods depending on the specific therapeutic goals and target organs. 

In-vivo gene therapy is used in various medical applications, including:

1. Gene Augmentation: In certain genetic disorders where a specific gene is deficient or mutated, in-vivo gene therapy aims to introduce a functional copy of the gene directly into the affected cells to restore normal function.
2. Gene Silencing: In-vivo gene therapy can also involve the delivery of therapeutic agents, such as RNA interference (RNAi) molecules, to silence or inhibit the expression of a specific gene associated with disease.
3. Gene Editing: Advanced gene-editing technologies, such as CRISPR-Cas9, can be employed in in-vivo gene therapy to directly modify the DNA within target cells, correcting genetic mutations or introducing specific changes.
4. Viral Vector Delivery: Viral vectors, modified viruses that cannot cause disease but can deliver therapeutic genes, are commonly used in in-vivo gene therapy. These vectors efficiently transport genetic material into target cells, facilitating gene expression.

In-vivo gene therapy has shown promise in treating a variety of diseases, including genetic disorders, certain types of cancer, and acquired conditions. While it offers advantages in terms of simplicity and direct targeting, challenges such as effective delivery to specific tissues, potential immune responses, and the need for precise control over gene expression are areas of ongoing research and development in the field. As technologies continue to advance, in-vivo gene therapy holds the potential to become a widely used and powerful tool in the treatment of various medical conditions. 

Applications of Gene Therapy

Gene therapy has shown promise in treating a variety of genetic disorders, including:

1. Genetic Disorders: Conditions caused by mutations in single genes, such as cystic fibrosis, muscular dystrophy, and hemophilia, are prime candidates for gene therapy.
2. Cancer: Gene therapy is being explored as a potential treatment for cancer by targeting and modifying the genes responsible for uncontrolled cell growth.
3. Neurological Disorders: Diseases like Parkinson's and Alzheimer's, which have a genetic component, are being investigated for gene therapy interventions to slow or halt disease progression.
4. Cardiovascular Diseases: Gene therapy holds potential for treating heart diseases by enhancing the function of specific genes involved in cardiac health.
5. Inherited Blindness: Clinical trials have demonstrated success in treating certain forms of inherited blindness by introducing functional genes to restore vision. 

Challenges and Ethical Considerations

While gene therapy offers exciting possibilities, several challenges must be addressed: 

Targeting the correct genes and cell: One difficulty has been making sure a treatment gene targets in on the correct cells in the correct tissue. Not only that, but that the therapy is delivered into millions of these cells rather than just a few, all without disrupting the function of nearby genes. 

Delivery Systems: Efficient and safe delivery of therapeutic genes to target cells remains a significant hurdle. Researchers are exploring various vectors, such as viruses and nanoparticles, to enhance gene delivery. 

Immune Response: The body's immune system may react to the introduced genetic material or delivery vectors, posing potential safety concerns. Ongoing research aims to minimize immune reactions and improve the long-term effectiveness of gene therapies. 

Ethical Dilemmas: Germline gene therapy raises ethical concerns, as modifying reproductive cells could have far-reaching consequences for future generations. Balancing the potential benefits with ethical considerations is crucial in shaping the future of this technology. 

The dynamic interplay between ex-vivo and in-vivo gene therapy approaches marks an exciting era in medical innovation. As these technologies continue to advance, the dream of treating and curing genetic disorders becomes increasingly tangible. The dual perspectives of ex-vivo precision in the laboratory and in-vivo direct targeting within the body represent a powerful synergy that holds immense promise for the future of medicine. The journey toward unlocking the full potential of gene therapy is ongoing, with each breakthrough paving the way for a new era of personalized and transformative healthcare.

Wednesday, December 06, 2023

by Aaron Medaris

Obesity has emerged as a pervasive and pressing global health issue, transcending geographic, economic, and cultural boundaries. The World Health Organization (WHO) defines obesity as "abnormal or excessive fat accumulation that may impair health." The prevalence of obesity has reached alarming levels, posing significant challenges to individuals, healthcare systems, and societies worldwide.

The obesity epidemic has grown steadily over the past few decades. According to WHO, global obesity rates have nearly tripled since 1975. In 2016, more than 1.9 billion adults were overweight, with over 650 million classified as obese. Alarmingly, childhood obesity is also on the rise, affecting 38 million children under the age of five. 

Obesity is a complex and multifaceted condition with a range of contributing factors. While genetics can play a role, lifestyle choices and environmental influences are primary drivers. Sedentary behaviors, high-calorie diets rich in processed foods, and an increase in portion sizes are major culprits. Additionally, socioeconomic factors, such as limited access to healthy foods and opportunities for physical activity, contribute to the epidemic. 

Obesity is not merely a cosmetic concern; it is a major risk factor for a multitude of health problems. Individuals with obesity are at a higher risk of developing chronic conditions, including type 2 diabetes, cardiovascular diseases, certain cancers, and musculoskeletal disorders. The economic burden of obesity on healthcare systems is substantial, with increased healthcare costs and decreased productivity. 

According to a 2022 article titled, “The Economic Costs of Obesity,” there are currently, “236 diseases that are associated with obesity…[putting] medical care costs of obesity at almost $150 billion per year in the U.S. More specifically, the cost of treating the five most common obesity-related conditions (stroke, coronary artery disease, diabetes, hypertension, and elevated cholesterol) resulted in roughly $9,000 to 17,000 in higher costs compared to normal weight adults.” 

Just one year ago, the outlook on obesity was quite dire. How dire? Look at some of these headlines from news agencies around the world, “Obesity ‘epidemic’ leading to 1.2 million deaths a year in Europe, says WHO,” “Study finds childhood obesity occurring at greater frequency,” and “Number of States with High Rates of Adult Obesity More Than Doubles.” 

However, there have been some major developments in the treatment of obesity that have changed headlines from bleak and dire to hope and optimism. “FDA Approves Powerful New Drug to Counter Obesity Epidemic,” “New drugs Could Spell an End to the World’s Obesity Epidemic,” “Doctors Grapple with Patients Demand for Weight-loss Drugs.” 

Drugs such as Mounjaro, Wegovy, and Ozempic are known as incretin medications. Incretins are gut hormones that aid in digestion and blood glucose control. They include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Therefore, incretin medications mimic incretin hormones. They stimulate the release of insulin which helps lower blood sugar as well as slow food passage through the digestive system, making them an effective treatment for those with Type II Diabetes. But how do these medications help people lose weight? Using Ozempic as an example, these drugs often:

1. Mimick GLP-1 Activity: GLP-1 is a naturally occurring hormone in the body that plays a crucial role in glucose homeostasis. It is released in response to food intake and stimulates insulin secretion from the pancreas, leading to reduced blood sugar levels. Ozempic acts as a synthetic version of GLP-1, binding to the GLP-1 receptors on pancreatic beta cells. This stimulates the release of insulin in a glucose-dependent manner, meaning that it primarily acts when blood sugar levels are elevated. 

2. Reduce Glucagon Release: Glucagon is another hormone produced by the pancreas, and its primary function is to increase blood glucose levels. In individuals with type 2 diabetes, there is often an imbalance between insulin and glucagon, contributing to elevated blood sugar. Ozempic helps regulate this imbalance by inhibiting the release of glucagon, leading to a decrease in the production of glucose by the liver. This contributes to improved blood sugar control. 

3. Slow Gastric Emptying: Ozempic slows down the emptying of the stomach, which helps reduce post-meal spikes in blood sugar. By delaying the absorption of nutrients from the digestive tract, it contributes to a more gradual and controlled rise in blood glucose levels after eating. 

4. Appetite Regulation: One of the notable secondary effects of Ozempic is its impact on appetite regulation and weight loss. The medication appears to influence the central nervous system, leading to a reduction in appetite and an increase in feelings of fullness. The mechanisms underlying the weight loss effects are not entirely understood, but they may involve interactions with brain pathways related to food reward and satiety. 

Dr. Cecilia Low Wang, a professor at the University of Colorado School of Medicine who also chairs the committee that advises the FDA on drugs related to endocrinology and metabolism, mentioned that those people who used the largest dose of Mounjaro, 15 milligrams, lost as much as 21% of their body weight. “They were able to achieve unprecedented amounts of weight loss. It was dramatic and exciting…We’ve never had a medication that is so effective for improving diabetes control and weight loss without putting patients at high risk of hypoglycemia,” Low Wang said.

 Dr. Wang’s excitement reflects why these drugs have been changing headlines across the U.S. where an estimated 70% of adults are either obese or overweight. Novo Nordisk, the makers of Wegovy, estimate that if 100,000 people lost 15% of their body weight (which is the average amount lost for their drug), it would cut $85 million from the cost of obesity related conditions over 5 years. Figures like look promising, but how do they compare to the global cost of obesity? In 2020, obesity health issues on a global scale cost over $1.96 trillion or 2.4% of global GDP; and if gone unchecked, is expected to reach $4.32 trillion by 2035. With such a daunting economic and human price ahead of us, can these weight loss drugs really make a difference? I feel the answer is a definite yes. No country has seen a decline in obesity since 1975! What we have with these drugs is an opportunity to use them as a therapeutic option to treat obesity, improve overall health, and slowly cut overall healthcare costs. For instance, in a recent study from Mongan Stanley, “analysts estimate that 24 million people or 7% of the US population will be taking these drugs by 2035.” One of the other interesting facts uncovered in the Morgan Stanley analysis, is that over two-thirds of those who took these drugs cut back on their intake of sugary drinks, baked goods, and other foods high in fat and sugar. Not only are these drugs helping people lose weight, but they are helping them change behavior. I feel that it is reasonable to believe that over the next decade that these drugs along healthier habits we could actually see a decline in obesity trends. 

Time will tell what impact these therapies will have on the obesity epidemic. But I sure hope that 10 years from now, we’re talking about how we’ve seen the first decline of obesity and obesity related health issues in over a half century.

References: 

The Economic Costs of Obesity
https://www.medicaleconomics.com/view/the-economic-costs-of-obesity

What Are Incretin Mimetics
https://www.goodrx.com/conditions/diabetes-type-2/what-are-incretins

What is Mounjaro? And does it work better for weight loss than Ozempic and Wegovy?
https://www.uchealth.org/today/what-is-mounjaro-and-how-does-it-work-for-weight-loss/

Report: Obesity could cost the world over $4 trillion a year by 2035
https://www.statnews.com/2023/03/02/obesity-costs-4-trillion-2035/

Tuesday, October 31, 2023

by Aaron Medaris

Yes, we’re still talking about COVID. We wish we didn’t have to, but the fact is, COVID is here to stay and it’s something we’re going to have to deal with. Luckily for us, the past 3.5 years have been filled with technological advancements that help us better test, prevent, and treat this cruel illness; allowing many people who contract COVID-19 to recover in a matter of days or weeks. However, there are some people who have been infected that experience long-term effects from their infection, known as Long COVID. Long COVID, also known as post-acute sequelae of SARS-CoV-2 infection (PASC), is a term used to describe a range of symptoms that persist for weeks, months, or years after the acute phase of a COVID-19 infection. Though Long COVID occurs more often in people who had severe cases, people who had a mild or asymptomatic case can also experience a variety of symptoms long after their initial infection has resolved. In this article, we will explore the various and wide-reaching symptoms of Long COVID, assessing and testing patients exhibiting symptoms, and the latest scientific findings of Long COVID. 

Symptoms of Long COVID 

As of today, there are no diagnostic tests that determine if a patient’s symptoms or conditions are due to Long COVID. Symptoms and conditions can be wide and far reaching and, in some cases, they can even go away and then come back. Common symptoms associated with Long COVID can include:

• Fatigue: Persistent and often debilitating tiredness or weakness.
• Shortness of Breath: Difficulty breathing or breathlessness, even during mild physical activity.
• Cognitive Issues: Often referred to as "brain fog," which can involve difficulties with concentration, memory, and mental clarity.
• Muscle and Joint Pain: Widespread or localized muscle and joint aches or discomfort.
• Chest Pain: Discomfort or pain in the chest, which may be associated with breathing difficulties.
• Headaches: Frequent or severe headaches.
• Loss of Taste or Smell: Anosmia (loss of smell) or ageusia (loss of taste).
• Sleep Disturbances: Problems with sleep, including insomnia or excessive fatigue.
• Heart Palpitations: Irregular or rapid heartbeats.
• Gastrointestinal Symptoms: Digestive problems, such as diarrhea or abdominal pain.
• Skin Rashes: Skin issues or unexplained rashes.
• Dizziness: Feeling lightheaded, dizzy, or experiencing vertigo.
• Mood Changes: Emotional and psychological symptoms, such as depression, anxiety, or mood swings.
• Fever: Occasional or persistent low-grade fevers.
• Post-Exertional Malaise: Severe fatigue or worsening of symptoms after physical or mental exertion. 

It's important to note that the duration and severity of these symptoms can also vary widely. Some people experience mild, manageable symptoms, while others may have more severe and debilitating symptoms that last for months. Additionally, new symptoms may emerge over time, making long COVID a complex and challenging condition to manage. 

Assessing and caring for those with Long COVID

Many Long COVID conditions can be diagnosed clinically based on history and findings on physical examination. Others might require directed diagnostic testing, however it is important as a healthcare provider, to help the patient understand that such clinical assessments might be uninformative. Because Long COVID conditions involve multiple organ systems, a thorough physical exam should be considered. In addition to blood pressure, heart rate, respiratory rate, pulse oximetry, body temperature, and body mass index, healthcare providers should evaluate ambulatory pulse-oximetry for patients with respiratory symptoms, fatigue, or malaise. For patients experiencing postural symptoms such as dizziness, fatigue, or cognitive impairment, Orthostatic vital signs should be evaluated. 

Utilizing laboratory tests can be informative, but again it’s important for the patient to understand that there is no “one” test that will determine if they are experiencing Long COVID. However, because Long COVID affects multiple organ systems, laboratory tests may be able to help you as a provider better understand how Long COVID may be affecting your patient. 

Basic Laboratory Tests to Consider with Long COVID patients include: 

 Specialized Diagnostic Laboratory Tests to Consider with Long COVID patients include:

Other assessment tools can be utilized for evaluation of patients with Long COVID conditions. Testing should be adjusted to fit the patients symptoms and presentation. Those assessments can include the following: 

Functional status or quality of life

• Patient Reported Outcomes Measurement Information System
• Post COVID Functional Status Scale
• EuroQol-5D 

Respiratory Conditions

• Modified Meical Research Council Dyspnea Scale 

Neurologic Conditions

• Montreal Cognitive Assessment
• Mini Mental Status Examination
• Compass31
• Neurobehavioral Symptom Inventory 

Psychiatric Conditions

• Generalized Anxiety Disorder-7
• Patient Health Questionnaire-9
• PTSD Symptom Scale 

Latest Findings on Long COVID

In a recent study published in the journal Cell, scientists from the University of Pennsylvania discovered that serotonin levels were lower in people with symptoms of Long COVID. These researchers are suggesting that lingering effects of the COVID-19 virus reduce the amount serotonin the body produces. 

In this study, researchers analyzed the blood of 58 patients dealing with Long COVID symptoms between 3 and 22 months since infection of the virus. That blood was then compared to 30 people who experienced no Long COVID symptoms in addition to 60 patients in the early stages of a COVID-19 infection.

 One finding that stood out to Maayan Levy, a lead author on the study and professor at Perelman School of Medicine, was that levels of serotonin and other metabolites were altered right after a COVID-19 infection, something that also happens immediately after other viral infections. However, in patients with Long COVID, serotonin was the only significant molecule that did not recover to pre-infection levels. 

The researchers also analyzed stool samples from some of the Long COVID subjects and found that they contained remaining viral particles. Utilizing this knowledge, researchers turned to miniature models of the human gut, knowing that this is where more serotonin is produced, and were able to identify a pathway that could underlie some cases for Long COVID. The thought behind this pathway is that viral remnants prompt the immune system to produce interferons. These interferons cause inflammation which inhibits the body’s ability to absorb tryptophan (amino acid that helps produce serotonin). This can trigger blood clots after a COVID-19 infection and could impair the body’s ability to circulate serotonin. With lower levels of serotonin within the body, the vagus nerve is disrupted and therefore the parasympathetic nervous system is also disrupted. 

Scientists also proposed that patients exhibiting symptoms of Long COVID due to lower levels of serotonin could also be an explanation of why they experience problems with short-term memory, as serotonin plays an important role with memory. 

Though this study shows promise, researchers understand that this study needs to be enlarged to be more definitive in its results. An expansion of this study will most likely focus on the three biomarkers presented in this study: the presence of viral COVID remnants in stool, low serotonin, and high levels of interferons. 

“All these different hypotheses might be connected through the serotonin pathway,” said Christoph Thaiss, lead author of the study. “Second of all, even if not everybody experiences difficulties in the serotonin pathway, at least a subset might respond to therapies that activate this pathway,” he went on to say. 

Dr. Levy and Dr. Thaiss, both researchers in this study said they would begin clinical trails to test the effectiveness of fluoxetine (Prozac) which is a selective serotonin reuptake inhibitor to see if they can restore some of the vagal signals to improve memory and cognition. 

Time will tell what the results of the clinical trials will be. Until then, it’s important as a healthcare professional to listen with compassion and support your patients that struggle with Long COVID. Assess, diagnose, and provide them with the resources that can help them through this difficult time. 

References 

Long COVID or Post-COVID Conditions
https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/index.html 

Caring for People with Long COVID
https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects/care-post-covid.html 

Post-COVID Conditions: Information for Healthcare Providers
https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/post-covid-conditions.html 

Viral Persistence and Serotonin Reduction Can Cause Long COVID Symptoms, Penn Medicine Research Finds
https://www.pennmedicine.org/news/news-releases/2023/october/penn-study-finds-serotonin-reduction-causes-long-covid-symptoms 

Scientists Offer a New Explanation for Long Covid
https://www.nytimes.com/2023/10/16/health/long-covid-serotonin.html

Friday, September 01, 2023

by Jay Long, MD

The developed world continues to be ravaged by complications of diabetes mellitus, ischemic heart disease, and strokes. These entities overlap in their contributions to being the leading causes of morbidity and mortality, and the incidence of these diseases continues to rise.

The health care industry made cancer screening a priority of early detection to reduce mortality and enable less invasive and less costly treatment modalities to be more effective. A similar approach of combined efforts is needed to improve outcome for patients with diabetes mellitus and underlying atherosclerotic disease.

1 in 10 Americans have Diabetes Mellitus¹

• Total: 37.2 million people have diabetes (11.3% of the US population)^1-2
• Diagnosed: 28.7 million people, including 28.5 million adults¹
• Undiagnosed: 8.5 million people (23.0% of adults)¹

1 in 3 Americans Have Prediabetes Mellitus¹

• Patients 65 years or older: 26.4 million people aged 65 years or older (48.8%) have prediabetes⁹

Diabetes Mellitus (DM) and Peripheral Arterial Disease (PAD)

The strong correlation between DM and PAD points to the need for an effective screening program to identify those patients most likely to benefit from early recognition and risk factor modification programs.

These metrics were derived using a cuff-based ABI pressure test to detect PAD.⁵ However, DM patients commonly present with non-compressible arteries due to advanced calcified atherosclerotic plaque which can lead to a false negative test when using pressure-based technologies. This means the true incidence rate of PAD is likely much higher.

Community outreach healthcare strategies are being deployed to measure A1C, cholesterol, and lipids, in addition to BP and weight. These screening programs have also been paired with early detection of cancer. What is lacking is a coordinated effort to detect early PAD as a marker for the atherosclerotic diathesis.

Atherosclerosis is a systemic disease; its detection anywhere is a predictor for adverse cardiovascular outcomes. Historically, diagnostic modalities using techniques like ABI have been limited to outpatient facilities simply due to the bulky nature of the equipment. Limited access to testing coupled with the lack of accuracy of ABI in patients reduces the opportunity for early detection in this PAD population.

Two studies recently published in the Journal of Vascular Surgery (JVS) and American Journal of Preventive Medicine (AJPM) documented that a positive PAD test in patients without a prior diagnosis of PAD was an independent outcomes indicator of all-cause mortality and major adverse cardiovascular events.^10-11 These studies were performed using QuantaFlo^® PAD ­– a fast, portable, FDA-cleared device which aids in the early detection of peripheral arterial disease. With this device it was possible to conduct these screening exams in either the outpatient community or home setting.

QuantaFlo PAD uses infrared sensor technology and a proprietary algorithm to measure arterial flow volumes as it is more sensitive than other pressure-based modalities, especially in the presence of calcified atherosclerotic plaque, thus simplifying the detection of early pre-clinical disease.

To optimize healthcare performance, the Institute for Healthcare Improvement developed the Triple Aim Initiative.⁸ This initiative is composed of three dimensions which are: better care for individuals, better health for populations and lower per capita costs. The first metric which is centered on improving the patient’s experience is a place where QuantaFlo PAD testing can easily be incorporated into routine clinic or home-based screening for pre-diabetes and ongoing management of patients with diabetes. The results are immediately available to the provider, who can implement risk-factor modification.

Offering an effective screening program to detect the presence of PAD in diabetic patients over 40 years of age combined with risk factor reduction programs, will be an important modality to address the leading causes of morbidity, mortality, and costs in the US and throughout the developed world.

Conclusion

In every disease entity, a successful outcome is the direct result of early detection and risk factor modifications. Historically, DM and PAD efforts have focused primarily on those patients already suffering from the complications of DM or with a major atherosclerotic burden. These patients are inherently more expensive to manage, have worse clinical outcomes, and are less likely to have value from their therapeutic interventions.

Early detection of both DM and PAD in the pre-clinical state may reduce the costs of care and reduce long-term complications of DM and all the sequelae of atherosclerosis, such as ischemic heart disease, stroke, renal failure, and amputation.

References

1. DIABETES IN THE U.S A. SNAPSHOT DIABETES 37 million people have diabetes PREDIABETES. (n.d.). https://www.cdc.gov/diabetes/images/library/socialmedia/DiabetesInTheUS_Print.pdf
2. 2022 State of the Union: US Population. (n.d.). USAFacts. Retrieved June 7, 2023, from https://usafacts.org/state-of-the-union-2022/population/
3. Xu, J., Murphy, S., Kochanek, K., & Arias, E. (2022). Mortality in the United States, 2021 Key findings Data from the National Vital Statistics System. https://www.cdc.gov/nchs/data/databriefs/db456.pdf
4. (2021, December 21). Prediabetes - Your Chance to Prevent Type 2 Diabetes. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/prediabetes.html
5. Thiruvoipati, T., Kielhorn, C. E., & Armstrong, E. J. (2015). Peripheral artery disease in patients with diabetes: Epidemiology, mechanisms, and outcomes. World journal of diabetes, 6(7), 961–969. https://doi.org/10.4239/wjd.v6.i7.961
6. AHA: One in three black Americans will experience PAD. (n.d.). Www.mdedge.com. Retrieved June 7, 2023, from https://www.mdedge.com/cardiology/article/104904/peripheral-vascular-disorders/aha-one-three-black-americans-will
7. Centers for Disease Control and Prevention. (2022, December 30). Prediabetes - your chance to prevent type 2 diabetes. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/basics/prediabetes.html
8. The IHI triple aim: IHI. Institute for Healthcare Improvement. (n.d.). https://www.ihi.org/Engage/Initiatives/TripleAim/Pages/default.aspx
9. Centers for Disease Control and Prevention. (2022a, June 29). National Diabetes Statistics Report. Centers for Disease Control and Prevention. https://www.cdc.gov/diabetes/data/statistics-report/index.html
10. Smolderen, K. G., Heath, K., Scherr, T., Bauzon, S. R., Howell, A. N., & Mena-Hurtado, C. (2022). The Nevada peripheral artery disease screening effort in a Medicare Advantage population and subsequent mortality and major adverse cardiovascular event risk. Journal of vascular surgery, 75(6), 2054–2064.e3. https://doi.org/10.1016/j.jvs.2022.01.134
11. Howell, S. C., & Master, R. C. (2023, February 27). Clinical evaluation of volume plethysmography as an aid for diagnosis of heart failure in the Primary Care Setting. Journal of Preventive Medicine. https://preventive-medicine.imedpub.com/clinical-evaluation-of-volume-plethysmography-as-an-aid-for-diagnosis-of-heart-failure-in-the-primary-care-setting.php?aid=50066

About the Author

Dr. Long is a retired Board-Certified Vascular Surgeon. Dr. Long's areas of expertise are noninvasive diagnosis of vascular and venous insufficiency and management of venous diseases. He specialized in open arterial reconstructive procedures and was one of the first in Northern California to move towards minimally invasive reconstructive venous procedures.

Sunday, August 06, 2023

by Aaron Medaris

Is it influenza, COVID, RSV, or some other respiratory infection? HCPs are faced with these questions every day as patients fill their exam rooms with coughs, fevers, and congestion. Your training and experience will help you in your diagnosis and subsequent treatment, but with so many similar symptoms between different infections, the need for assistance and even assurance is at an all-time high. Luckily, testing at the point of care is becoming more advanced and effective. One of the most important advancements in point of care testing is the addition of multiplex testing – the ability analyze multiple analytes or targets in a single test. Multiplex testing is nothing new but has been steadily evolving over the last several decades and is gaining a larger presence in physician offices and urgent care centers around the nation. In this article, take a closer look at multiplex testing, its development over the years, and how it’s making a difference in point of care testing. 

Understanding Multiplex Testing 

Multiplex testing, also known as multiplexing or multiplex assay, is a technique used in laboratory diagnostics to simultaneously analyze multiple analytes or targets in a single test. It allows for the efficient and cost-effective detection of multiple biomarkers or genetic variants in a single sample. 

Traditionally, diagnostic tests would focus on a single target, requiring separate tests for each analyte of interest. Multiplex testing revolutionizes this process by enabling the detection of multiple targets in a parallel and high-throughput manner. 

There are different methods of multiplex testing, depending on the specific application and technology used. Here are a few examples:

• Multiplex Polymerase Chain Reaction (PCR): PCR is a widely used technique to amplify and detect specific DNA sequences. Multiplex PCR involves designing primers that can amplify multiple target DNA sequences simultaneously. By incorporating different fluorescent dyes or molecular tags, the amplified products can be differentiated and detected in a single reaction.
• Multiplex Immunoassays: These assays are used to detect and quantify proteins or antibodies in a biological sample. Multiplex immunoassays employ different types of capture beads or microarrays, each coated with specific antibodies or antigens. By labeling the analytes with fluorescent or enzymatic tags, multiple targets can be detected and quantified simultaneously.
• Mass Spectrometry-based Multiplexing: Mass spectrometry can be used for multiplex analysis by labeling analytes with unique mass tags. By introducing stable isotopes or mass labels, multiple samples can be combined and analyzed together, allowing for the simultaneous detection of multiple targets. 

Multiplex testing offers several advantages over single-target assays, including reduced sample volume requirements, lower costs, and faster turnaround time. It has found applications in various fields, including clinical diagnostics, infectious disease testing, genetic testing, and drug discovery. 

The Evolution of Multiplex Testing 

The concept of multiplex testing has been evolving over several decades, and the specific techniques used in multiplex testing have been developed and refined over time. Here are some key milestones in the history of multiplex testing:

• 1980s: The development of enzyme-linked immunosorbent assays (ELISAs) laid the foundation for multiplex immunoassays. ELISAs allowed for the quantification of a single analyte, but researchers began exploring ways to expand the assay to measure multiple targets simultaneously.
• 1990s: Multiplex PCR techniques started to emerge during this period. Researchers began developing methods to amplify and detect multiple DNA targets using PCR, such as multiplex allele-specific PCR (AS-PCR) and multiplex ligation-dependent probe amplification (MLPA).
• Late 1990s to early 2000s: The advent of microarray technology revolutionized multiplex testing. DNA microarrays allowed for the simultaneous analysis of thousands of genetic targets. This technology enabled gene expression profiling, SNP genotyping, and other multiplex applications.
• 2000s: The field of multiplex immunoassays expanded with the introduction of microsphere-based technologies. Luminex Corporation introduced the xMAP® (Multiplexed Assays with Beads) technology, which uses color-coded beads to enable the detection of multiple analytes simultaneously.
• 2010s: Advances in next-generation sequencing (NGS) technologies facilitated high-throughput multiplex sequencing. Techniques such as targeted sequencing panels and amplicon sequencing allowed researchers to simultaneously analyze multiple genetic variants or mutations. 

These milestones illustrate the progressive development and application of multiplex testing techniques. The field continues to evolve, with ongoing advancements in technology, assay design, and data analysis methods, enabling even more comprehensive and efficient multiplex testing capabilities. 

Multiplex Testing at the Point of Care 

Multiplex testing at the point of care refers to the use of multiplex assays or devices in settings outside of a central laboratory, such as clinics, doctor's offices, or even at home. Point-of-care multiplex testing offers several advantages, including rapid results, immediate clinical decision-making, and improved patient management. Here are some examples of how multiplex testing is used at the point of care:

• Infectious Disease Diagnosis: Multiplex assays are commonly used for the simultaneous detection of multiple pathogens in infectious disease diagnostics. Point-of-care multiplex tests can rapidly identify the presence of multiple viral, bacterial, or parasitic pathogens in a single sample, enabling timely diagnosis and appropriate treatment decisions. For example, a single test may detect respiratory viruses like influenza A and B, respiratory syncytial virus (RSV), and SARS-CoV-2 (the virus that causes COVID-19).
• Syndromic Panels: Syndromic panels combine multiplex testing with a broad range of targets related to specific clinical syndromes, such as respiratory infections, gastrointestinal infections, or sexually transmitted infections. These panels can simultaneously detect multiple pathogens associated with a particular syndrome, providing a comprehensive diagnostic approach and aiding in targeted treatment.
• Pharmacogenetics: Point-of-care multiplex testing can be utilized to analyze multiple genetic variants associated with drug metabolism or treatment response. These tests can provide insights into an individual's genetic profile and help guide personalized medication selection or dosing adjustments.
• Cancer Biomarkers: Multiplex assays can be used at the point of care to detect multiple cancer biomarkers, such as specific mutations or protein markers. These tests aid in cancer diagnosis, prognosis, and treatment decision-making, allowing for a more targeted and personalized approach.
• Rapid Screening: Multiplex tests can be employed for rapid screening of various conditions or diseases. For instance, multiplex lateral flow assays are commonly used for point-of-care testing of pregnancy, infectious diseases, cardiac markers, or drug testing. These tests provide quick results and are often simple to use, making them suitable for non-laboratory settings.

Recent advancements even include CLIA Waived multiplex testing, allowing healthcare professionals to make immediate and informed decisions, leading to improved patient care and outcomes. 

As we ramp up for cold and flu season and patient begin to fill your exam room with coughs, congestion, and fevers, remember there are sound diagnostic multiplex tests available to assist in your diagnosis.

Sunday, July 02, 2023

by Aaron Medaris

I think my first true introduction of Artificial Intelligence or AI, (that wasn’t from a sci-fi movie) came in February of this year, when I read an article about ChatGPT, a language processing tool that could write essays, papers, and articles in seconds; thus, leading to its quick ban from schools and universities around the nation. Granted it writes articles around a 6^th grade level, so if you’re using that to cheat your way through college, you probably have other problems coming your way. 

Today it seems like every time I open my favorite news app, there’s a new article about AI and how it’s helping to advance industries across the globe. Aside from language processing tools like ChatGPT, industries from finance, manufacturing, retail, agriculture, transportation, and entertainment are utilizing AI to do things they have never been able to do before. Take this headline from today’s news: “The Beatles are releasing their ‘final’ record. AI helped make it possible.” Yes, even the Beatles are benefiting from AI technology. 

With AI transforming industries across the globe, some of the most promising advancements are in the field of healthcare. In this article, we’ll look at some of the different ways that AI is transforming healthcare. 

Medical imaging analysis: AI algorithms can analyze medical images, such as X-rays, CT scans, and MRIs, to detect and diagnose diseases with high accuracy. AI systems can identify patterns and anomalies that may be difficult for human experts to spot, leading to faster and more accurate diagnoses. AI can also provide precise and quantitative measurements from medical images. For example, AI algorithms can calculate tumor size, volume, or growth rates, providing valuable information for treatment planning and monitoring response to therapy. It’s also helping to provide image-based risk predictions. By analyzing medical images and patient data, AI algorithms can predict the risk of certain diseases or conditions. For instance, in cardiovascular imaging, AI can analyze cardiac images to assess the risk of future cardiac events and guide preventive measures. 

Precision medicine: AI enables personalized treatment plans by analyzing large amounts of patient data, including genetic information, medical records, and lifestyle factors. This data can be used to predict disease risks, identify optimal treatment options, and develop tailored therapies for individual patients. Take for instance, genomic analysis. AI algorithms can analyze genomic data to identify genetic variations, mutations, and biomarkers associated with specific diseases. By understanding a patient's genetic profile, AI can help determine personalized treatment options and predict disease risks. 

Drug discovery and development: AI is being used to accelerate the drug discovery process. AI algorithms can analyze massive datasets to identify potential drug candidates, simulate and predict drug behavior, and optimize drug formulations. This helps in reducing costs and time required for drug development. AI algorithms can even optimize various drug properties, such as efficacy, safety, and pharmacokinetics. By analyzing chemical structures and properties, as well as historical data on drug development, AI can suggest modifications to enhance the potency and selectivity of compounds, improve drug-like properties, and reduce toxicity. One exciting way AI is helping in drug discovery and development is by repurposing existing drugs. AI can identify new therapeutic uses for existing drugs by analyzing large datasets and identifying potential drug-disease associations. By leveraging known drug properties and their effects on different biological pathways, AI algorithms can suggest repurposing strategies, leading to the development of new treatments for different diseases. 

Virtual assistants and chatbots: AI-powered virtual assistants and chatbots can interact with patients, answer their questions, and provide basic medical advice. They can triage patients, schedule appointments, and offer information on common symptoms or conditions, improving access to healthcare services and reducing the burden on healthcare providers. 

Predictive analytics: AI algorithms can analyze large volumes of patient data to predict disease progression, identify high-risk patients, and optimize treatment plans. This helps healthcare providers make informed decisions and allocate resources more effectively. Take for instance, early disease detection. AI algorithms can analyze patient data, including medical records, genetic information, and lifestyle factors, to identify early indicators of diseases. By detecting patterns and risk factors, AI can predict the likelihood of developing certain conditions, enabling early intervention and preventive measures. AI algorithms can also stratify patients into different risk groups based on their individual characteristics and health data. By considering factors such as age, gender, medical history, genetic markers, and environmental factors, AI can predict the likelihood of adverse events, disease progression, or treatment response. This helps in prioritizing high-risk patients for targeted interventions. 

Robot-assisted surgery: AI-enabled robotic systems assist surgeons during complex procedures, providing more precision, flexibility, and control. These systems can enhance surgical outcomes, reduce invasiveness, and shorten recovery times. In fact, AI is helping in robot assisted surgery before the surgery even begins. AI algorithms can assist in preoperative planning by analyzing patient-specific data, including medical images and patient anatomy. By simulating different surgical scenarios, AI can help surgeons visualize the procedure, optimize surgical approaches, and develop personalized surgical plans. During surgery, AI-powered robotic systems can assist surgeons during procedures by performing specific tasks or providing guidance. For example, AI algorithms can enable robotic arms to perform precise suturing or stapling with enhanced stability and dexterity, allowing for more precise tissue manipulation. 

Health monitoring and wearable devices: According to a recent survey, about 35 percent of adults use wearable devices. AI algorithms can analyze data from wearable devices, such as fitness trackers and smartwatches, to monitor vital signs, detect abnormalities, and provide real-time feedback on health status. This facilitates remote patient monitoring and early intervention. AI algorithms can analyze wearable data to identify early signs of certain diseases or conditions. By tracking changes in vital signs, sleep patterns, or activity levels, AI can help in early detection and intervention, improving the chances of successful treatment and management. 

Patient data management: AI can streamline and improve the management of electronic health records (EHRs). Natural language processing algorithms can extract relevant information from unstructured medical records, improving accuracy and efficiency in data entry and retrieval. 

These are just a few examples of how AI is being used in medicine. As the field continues to advance, AI has the potential to revolutionize healthcare delivery, improve patient outcomes, and enhance the overall efficiency of medical systems. But we do need to be careful with our use of AI especially when it comes to our healthcare. An amazing yet concerning fact is that AI is still in its infancy. Think about where we were 30 years ago when America Online was spamming our mailboxes, not inboxes, with CDs of their internet software. Remember the sound of dialup internet via your 56k modem, praying that it would connect long enough and be quick enough so you could check your email? Now think about where we are today in terms of technology. The differences are so great, I don’t think many of us in 1996 could even imagine the technological miracles we experience on a daily basis. I personally think we’re at the America Online stage of AI, maybe even before that. This is just the beginning, and the advancements are going to come much quicker than they did with the early days of the internet. That’s an exciting prospect when you think about it. But I can see why some tech giants and politicians are calling for a pause in AI development while we figure out rules and legislation going forward. AI has already transformed many industries for the better and it has the great potential to change our lives for the better, but if it’s not done right, especially with healthcare, it could have the opposite effect. It’s my hope that we do get this right and that AI technology continues to advance in a positive way, opening doors to the cure of diseases that have plagued our world for far too long. 

Wednesday, June 21, 2023

by ScrubMoney™ co-founders

It seems you can turn anywhere these days and you’ll get financial advice. Look in any direction and you’re probably hit with an advertisement, a quick tip, a savvy money narrative to digest, or perhaps even an enthusiastic stranger who swears they’ll grow your wealth. 

Meanwhile, your mind lingers with questions involving your personal finances that remain unresolved: “Who can I go to for advice?” “Who can I trust for help?” “What financial services address my most urgent needs?” 

Certainly, there are many simple steps you can take to set yourself up for a successful financial path. If you’re on top of your monthly budget and aware of your incoming and outgoing money flows, you’re in better shape than many physicians. With limited time to dedicate to personal financial planning, this is about as far as most of us get. The good news is there is expert and experienced help available — the real challenge may be knowing what you’re looking for and how to ask for guidance. 

Let’s assume you’ve got a pretty good idea of where you’re at financially, meaning you possess a general idea of how much debt you’ve accumulated to this stage of your career and are bringing home enough income to make ends meet. However, you’re looking to avoid financial mistakes, save money more efficiently, invest money and chart a healthy course for the years ahead. It may be time to find a financial planner and access other financial professionals. 

Our research shows that e many physicians turn to existing relationships when seeking professional financial support. Referrals often come from family members, fellow residents and colleagues, neighbors, and friends. In most cases, this is how financial professionals are introduced to early-career physicians and attendings. Alternatively, physicians know that having a white coat almost immediately attracts financial advisory service professionals — haven’t we all been approached, often repeatedly? Some of us are fortunate to find prudent, qualified professionals by these methods. Others aren’t so lucky, and sadly feel preyed upon. 

For those still looking for financial planning and other specific financial advisory services, we’ll lay out some considerations which we hope are helpful. Before diving deeper into specific services, let’s look at some typical services needed at various career stages in medicine. 

If you’re a resident, you’ll probably be best served by advisors that can assist with the following: debt repayment strategies (student loans and consumer debts), budgeting and saving prioritization, insurance services (disability and life), tax and estate planning services. 

For attending physicians, the previous services remain applicable with additional recommendations for retirement planning, investment management and educational savings for children. As your career progresses nearer retirement, it's certainly advisable to seek financial advice involving retirement income, long-term care planning, and post-career specific financial services. 

As medical professionals, we know the value of expertise and specialization. We can similarly use this framework when seeking a financial professional. When searching for an advisor who can look holistically at your (or you and your family’s) circumstances, find out how experienced they are at working with physicians. Don’t hesitate to ask them for their track-record with healthcare professionals, how they think through some of the financial situations facing medical professionals, such as sizable educational debt and the need for disability insurance. Furthermore, find out if they (along with their firm) provide a full suite of services (planning, tax, insurance, etc.) or if they specialize in one area primarily. Some physicians may prefer a one-stop shop, while others feel confident in having various professionals focused on fewer aspects of finance working together toward a healthy financial future. 

If you’re encouraged that a prospective financial professional is competent (i.e. experienced) working with physicians and physician families, here are some additional determining factors to consider: 

Compensation model: Know how your agent/advisor is paid for their services. 

• We suggest aiming to find a Fee-Only advising arrangement, particularly for planning services. The National Association of Personal Financial Advisors takes the position that the Fee-Only method of compensation is the most transparent and objective method available. This model minimizes conflicts and ensures that your financial planner acts as a fiduciary. Fee-Only planners are compensated directly by their clients for advice, plan implementation and for the ongoing management of assets.^[1] Fee-only financial advisors may be paid hourly, as a retainer, as a percentage of assets under management, or as a flat fee, depending upon the planner you choose.
• Additional compensation models include fee-based (set fee for the client, additionally an agent may receive compensation from other sources, such as a commission for sale of the financial product) and commission-based (agent receives compensation from products sold to client). *One note on the insurance services: you’re likely to encounter commission-based models in this area. Given this commonly used compensation structure in this industry, we suggest an emphasis on finding proper coverages and quality agents over a determination based solely on an agent’s compensation model. More on this below. 

One easy way to check for transparency is to find out if an agent is always a fiduciary. In other words, is the advisor obligated to do what is always in the client’s best interest? You may be surprised to learn that even fee-based advisors, in some cases, may alternate between the suitability standard (their recommendations only need to be suitable for a client’s situation) and the fiduciary standard. 

Tax strategies: I need a tax strategy?! The answer is probably yes. 

Unless you finished medical school while earning your CPA on the side (highly improbable) or have a personal accountant and tax preparer as your partner, you’ll probably need help here. Similar to finding a financial planner, make sure you find an agent experienced with physician personal finances. The reasons for a tax strategy and consulting with a capable, licensed tax advisor are underscored here: 

• Tax laws, both at federal and state levels, are ever evolving.
• A plan which considers deductions and capital gains not only for this tax-year but also subsequent tax years will save you money.
• If your household has multiple income sources, certainly you’ll need a tax plan with a comprehensive approach, and an agent to advise you through the filing process. 

Insurance services: Why choose an Independent Advisor? 

An important component of a physician's financial health and financial security will be insurance services, and we strongly urge you to consider an independent advisor when seeking help in this area. The marketplace for insurance policies is wide and an independent agent is best suited to shop the offerings of various companies on your behalf. An independent advisor can walk you through the nuances of policy language, help with determining sound coverages personal to your needs, and highlight key factors for choosing the best company to work with (age, gender, specialty, benefits, etc.). Moreover, an independent agent will not have loyalties to any specific company nor any economic ties to a specific insurer. 

If finding trustworthy and competent financial advisors seems bewildering, know that you are not alone. If relationships nearest you (family, friends, colleagues) make introductions to qualified financial professionals, count your blessings! And if you’re still wondering how to get this kind of help and not turn prey to rent-seeking financial resources, we hope this article will focus your efforts toward finding fiduciary and fee-only service providers with a focus on transparent client relationships. 

This article is authored by co-founders of ScrubMoney, a physician-created and physician-focused mobile app aimed to make sure every physician in the US healthcare system has a strong financial plan so they can better focus on healing their patients and living their lives.

^[1] What is Fee-Only Financial Advising | NAPFA

Thursday, June 01, 2023

by Brian K. DuChateau, Ph.D., D(ABMLI)

The need for increased access to immediate diagnostics and care has never been highlighted more than during the pandemic. And one by-product of the pandemic has been the rapid implementation and adoption of innovative testing technologies. These instant health care delivery tools, including next-generation rapid antigen tests have transformed the way we can deliver health care at the point of need, whether that be in hospitals, labs and importantly in community-based settings. The forthcoming generation of rapid antigen tests leverage novel technologies to allow both speed and accuracy at the nexus of action or the point of need where critical split-second medical decisions are made.

The latest point of care testing technologies not only promise accurate and fast results but also serve as a key component in addressing testing access and inequities. The Lancet study released earlier this year “The silent and dangerous inequity around access to COVID-19 testing” explained that POC rapid antigen tests are one of the most promising tools to increase access to testing and address the extreme inequities the pandemic exposed in testing across low- and middle-income countries (LMICs).

And, while rapid diagnostics provide an effective and scalable care delivery model at the point of need, they are also crucial for controlling future infectious outbreaks. Bill Gates, in his recent book, “How to Prevent the Next Pandemic” presents a detailed strategy on what can be done at a global scale to avoid the catastrophic impact of another pandemic. His recommended framework for pandemic prevention and response coordination specifically calls out point of care diagnostics as having untapped potential, which we can apply to disease outbreaks.

If we are to future proof our health system today, we must ensure diagnostic equity—integrating point of care diagnostics into every part of our health system—hospitals, labs, and also pharmacies, schools, and other community settings.

Laboratory-run PCR tests are expensive, required skilled labor to perform and do not guarantee this level of efficiency, especially for care centers in remote communities. Laboratory tests may take days to run, and the facilities are often miles away from community hospitals, not an enabling ecosystem for treatment follow through for people that travel long distances. Additionally, rapid antigen tests also circumvent the “persistent positive” results common to PCR tests, which indicate an infection for an extended period even when the person is likely no longer contagious. Antigen tests offer an advantageous alternative, since a growing body of evidence demonstrate that antigen tests correlate more closely to culture suggesting positive results are more likely to be from active infections. In a study from a group at Johns Hopkins University (Pekosz et. al.), antigen tests demonstrated a higher positive predictive value (90%) than rt-PCR (70%) when compared to culture-positive results. Similar findings were reported by a group at Harvard (Kirby et. al), however their study design went a step further to include both lateral flow as well as microfluidic based rapid antigen test. Their findings showed enhanced sensitivity for the rapid microfluidic immunofluorescence method compared to the lateral flow antigen tests.  This level of specificity empowers our ability to go back to “normal”.

The power of next generation point of care diagnostics was discussed at the recent American Association for Clinical Chemistry (AACC) Annual Conference in Chicago this summer. The discussion presented data-backed insights on the impact of LumiraDx advanced microfluidic technology over lateral flow point-of-care antigen tests, and the role of these rapid immunoassays in response to the COVID-19 pandemic.

LumiraDx, established in 2014, is transforming community-based healthcare by providing fast, accurate, and comprehensive diagnostic information to healthcare providers at the point of need, thereby enabling better medical decisions and improved patient outcomes at a much lower cost.

As the Scientific & Clinical Affairs Vice President at LumiraDx, I spoke alongside Dr. Paul Drain, Associate Professor at the University of Washington in the Departments of Global Health, Medicine (Infectious Diseases), and Epidemiology at the session. Dr. Drain presented his prospective validation study of the LumiraDx severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) rapid antigen test, which uses a high-sensitivity, microfluidic immunoassay to detect the nucleocapsid protein of SARS-CoV-2 for diagnosing acute coronavirus disease 2019 (COVID-19) in adults and children across point of care settings.

The study showed that, among 512 participants, the LumiraDx SARS-CoV-2 Ag has a 97.6% positive agreement to RT PCR in patients up to 12 days following symptom onset, and 100% PPA up to Ct 33. These findings testify to the effectiveness of rapid, high-sensitivity assay using nasopharyngeal or anterior nasal sampling, offering significant improvements for diagnosing acute SARS-CoV-2 infection in clinic- and community-based settings. Dr. Drain also shared more recent data showing that differences between Delta and Omicron variants did not affect the performance of the LumiraDx SARS-CoV-2 Antigen Test

As we look ahead, immediacy is central to meeting patient care needs and optimizing provider decision making. Given the looming challenges of future pandemics, we should support policies that invest in integrated, scalable diagnostic solutions, which we can deploy rapidly at the point of care, especially in communities where little healthcare infrastructure is present. This will enable effective decision-making at the point of need, increase access to care, save health care costs, and improve patient outcomes.

Brian K. DuChateau, Ph.D., D(ABMLI) is a board certified clinical laboratory immunologist who received his Ph.D. in immunology and medical microbiology from the University of Wisconsin-Madison and completed a post-doctoral residency in clinical immunology at the Chicago Medical School.  Dr. DuChateau has over 20 years of experience as a clinical laboratory director and 12 years of in vitro diagnostics (IVD) experience and currently serves as the LumiraDx Vice President of US Scientific and Clinical Affairs.

Thursday, May 04, 2023

by Aaron Medaris, Physician Office Resource

The last couple of years as we hunkered down, masked up, social distanced, and used gallons of hand sanitizer to avoid the dreaded results of COVID-19, we also avoided the flu the and a variety of other respiratory infections. Talk to any parent with young children and they’ll most likely tell you that 2020 was the healthiest their kids had been in a long time.

Now that we’ve been vaccinated, eliminated social distancing, shed the masks, toned down the use of hand sanitizer, and even had the leader of the free world declare the pandemic is “over” (I personally don’t agree with that last one), multiple questions linger in my mind: 

1. With a public that became accustomed to being tested for COVID seek medical care to be tested for other respiratory infections?
2. Will HCPs be willing to test for multiple respiratory viruses (ex: Flu vs. COVID)?
3. What can HCPs do to prepare themselves for this coming COVID and Flu season?

To Test, or Not to Test, That is the Question 

While no forecast is perfect, initial reports from states across the country are showing an increase in influenza. Some experts even estimate that the flu will outpace COVID this winter season. Assessing our current situation and looking at the forecast, what can you do to be better prepared for the increase of patients respiratory infections that will soon be entering your exam rooms? The first and one of the most important is to test for respiratory infections. That may seem simple, but this important step is often skipped because well, if it looks like a duck, and it talks like a duck, well then it’s probably a duck…right? But what if there’s more to it? A couple of years ago, I got really sick. Cough, fever, chills, body aches that came on hard and fast. I went to the doctor and after his examination, he told me he has seen this a lot lately and it was just a virus. I then asked if he thought it was the flu. He quickly replied, “I highly doubt it. I haven’t seen any flu cases this year.” This illness just felt different to me, and so I asked, “Is it ok if you test me for the flu?” He again stated he was quite certain it wasn’t the flu, but that if I wanted the test he would have the nurse administer one. And wouldn’t you know it, when I got the test results back, I had the flu. My good doctor prescribed an antiviral which helped immensely! A treatment I would have never received if I hadn’t been tested. Could it be that all those that my physician had been seeing with similar symptoms as I had the flu as well, but were never tested for it?

Why Should You Test 

Some physicians like in the example above choose not to test. Whether that’s because doubts regarding the accuracy of tests or feel that empirical treatment will be effective in most cases. Despite these concerns there are multiple reasons why you should test:

1. Empirical treatment can lead to more patients receiving antiviral treatment than actually need to receive it. This could possibly give rise to an antiviral shortage and delaying the correct care for another patient that actually needs it.

2. Testing frequently will provide the physician with valuable “market intelligence.” It will help the physician understand what viruses are currently spreading through the community and will allow them to provide a better treatment path.

3. Better patient experience. That might seem odd because what patient wants a stick shoved up their nose. The truth is, testing shows the patient that you want to provide the best possible care and it can bring peace of mind to the patient, even if they do test positive. They will know that they are being treated the correct way.

What to Know When Purchasing Tests 

I’m sure that many of you are testing for respiratory infections. If you’ve talked to your distributor lately, you’ve probably noticed a lot of different respiratory tests out there. When it comes to testing for flu, COVID, RSV, rhinovirus, etc. which test is best for you and your practice? Here are some things to consider when evaluating which ones are best for you:

CLIA Complexity – A test is only good if you are able to administer it. Make sure that you are equipped with the correct CLIA certificate of perform the test. Check to see if the test is a Waived (most simple) or Moderately complex (requires additional certification). If you’re a waived facility and are interested in purchasing a moderately complex test, that’s fine, but make sure you take the steps before hand to become a certified compliance facility with CLIA.

Ease of Use – Is the test simple to perform? Difficult? Require additional equipment? Training? Will the additional equipment help me in the long run?

Performance – Sensitivity and specificity are essential. I would even be sensitive to the brand of test that I am purchasing. Especially when it comes to different COVID tests. Due to the EUA that the FDA has granted, there are many counterfeit and poor quality COVID tests that are being pushed on doctors.

Volume – How many tests are you planning on running? What’s the average you use during a flu season? Will you need more this season?

Time to Results – How long does it take to run and receive test results? Is it important to get results back quickly to your patients?

Sample Type – is it a single sample type or does it allow for multiple sample types (nasal, nasopharyngeal, saliva, etc.)?

Connectivity – Is it important to have the results transmitted electronically?

Cost – Brand is important when it comes to getting accurate results. But brand can also be expensive. Be sure to check with different brand reps, distributors, websites, publications, and promo emails for discounts and specials. They’re out there.

What Types of Tests are Available?

Rapid Lateral Flow Immunochemical Tests:

There are different varieties of these test which have been on the market for decades and are used to confirm the presence or absence of a specific antigen. Results of these types of tests can either be viewed visually or with the use of an instrument. May of these tests are CLIA Waived and can be completed in less than 15 minutes.

Molecular Tests:

Many flu and other respiratory infections can be run on molecular devices. These tests detect the presence of the genetic material of the virus and generally produce results in 30 minutes or less. Molecular results are the gold standard in testing. Be sure to verify the CLIA compliance that is needed for molecular tests, some are CLIA Waived and some require a moderate complexity license. CLIA Waived molecular test typically use rapid PCR detection and the device can be moved closer to the point of care. CLIA Waived molecular devices usually cost less than traditional molecular devices, but still offer the same reimbursement.

One important thing to note is that no respiratory test provides 100% accuracy. Results depend on a few different criteria: type of test used, virus strain, and integrity of the sample. For best results please review test instructions and be aware of any test limitations.

Be Prepared

No one can predict the future, but we can look at where we’ve been and current trends. Now whether those trends will hold true is yet to play out, but I do know we can do our best to be prepared for this COVID and flu season. Physicians Office Resource offers valuable insights on a variety of different respiratory infection tests and testing devices. Look for them in this issue or visit our website and learn more. Have questions feel free to reach out and we’ll be sure to put you in contact with the right people.

Thursday, May 04, 2023

by Andrew Harms and Miriam Sweeney

For the average U.S. household, everyday living is getting pricey. Childcare, food, energy, transportation, and housing costs are all rising. Among U.S. physicians and healthcare professionals, personal financial matters may make things tougher given high educational debt-loads, capped income levels during residency years, and unique insurance needs.

Furthermore, job-related stressors emanating from clinical and patient-care priorities, administrative duties, continuing education, licensing requirements, and professional responsibilities leave little time for prudent, active personal financial management. 

Self-reported depression and burnout rates are high. In fact, in recent years more than 4 in 10 U.S. physicians report feeling burned out.^[1] When asked to rate factors that contribute to depression, results from Medscape’s annual National Physician Lifestyle Report indicate personal finances ranked second to job/workplace as a contributing factor.^[2] 

When asked what would reduce their burnout, the number one response from physicians (roughly a third) indicated the best way to combat burnout would be increased financial compensation. We want to be paid more. In fact, more money was a more common response than a more manageable schedule. 

The circumstances facing a physician's personal finances present a unique challenge to most in medicine, regardless of specialty. A predominant factor to financial troubles for physicians includes the high cost of education required to become a physician. 

According to the AMA, one in four medical students graduates with training-related debt that exceeds $200,000, and half of medical school graduates report debt burdens greater than $150,000. Those financial burdens are combined with a demanding schedule during graduate medical education and can affect well-being for physician residents and fellows. “Between financial restraints and 80-hour workweeks, trainees often struggle with having the time and budget for necessities. When residency and fellowship programs provide benefits to assist with these needs, it can significantly improve trainee well-being,” said AMA Trustee Jesse Ehrenfeld, MD, MPH.^[3] 

Compounding the difficulties, we recognize that the time and attention required to study medicine, biological sciences, and patient care during training to become a physician leaves little room to acquire a solid education in personal financial management.
 

Prioritizing personal financial literacy for early-career physicians 

Many physicians have access to financial resources early on in their career, but that doesn’t mean they’re confident about their financial situation. At the medical school level, some hopeful trends have emerged to address the rising educational debt levels burdening many graduates.

At a handful of US medical schools, financial aid offices have transitioned to financial wellness offices—aiming to better help students with personal financial understanding, housing and living expense considerations, etc.—moving beyond simply providing tuition financing guidance in order to provide holistic financial support and literacy. A great example of this is witnessed at the University of Arkansas for Medical Sciences, where Jason Mizell, M.D., and UAMS faculty have facilitated a popular ‘Business of Medicine’ course since 2012, taught to residents and fourth-year medical students.^[4] This course serves to teach early-stage physicians both practice management finance (coding, billing, malpractice, etc.) and, very importantly, personal finance. 

Another excellent example of an offering available to medical students is provided by the University of Wisconsin School of Medicine and Public Health. When medical student Rufus Sweeney struck up conversations with his peers some years ago about their personal finances, he was shocked by how few understood their student debt or even knew about options to pay it off. With a grant from the Wisconsin Medical Society, Rufus joined with Emma Crawford, UW SMPH Director of Financial Wellness and Financial Aid Advising, to develop UW-Madison SMPH’s first ever course focused on physician personal finance. This course continues and remains the most popular elective credit offering at the medical school. 

While such personal finance educational initiatives exemplified by UAMS and UW-Madison go a long way to improving financial literacy for young physicians, the trend to educate and empower physicians in the way of personal finances should be prioritized in order to meet cost of living challenges and resultant burnout rates. An introduction to personal finance is a great offering at the medical school level, and—if followed on with subsequent support at each next stage of a physician's career—would provide a proper runway to financial health and wellness. 

At the residency level, new expenditure considerations often outweigh the long-awaited first paycheck. Many times, newly minted residents find themselves unprepared to manage a tight budget. A resident may sometimes find financial resources made available as a new employee helpful—though the quality and availability of personal financial support is disparate and often inadequate. While the financial picture of a resident includes income, the AMA clearly points out the following: “It takes years to realize your earning potential. As a physician, you will not maximize your earnings until the completion of your graduate medical education. The average first-year resident makes around $60,000, (2018 report) and there’s not much wiggle room. Resident salaries are determined by an institution and correlate with training year rather than specialty. So, in a given training institution, all residents who are in their third year of training get the same salary, and all in their sixth year are paid the same.”^[5] 

Given the ceiling on income, how many physicians at the resident level have developed the experience and skills to single handedly manage the new challenges to their budget which may stem from debt-repayment, insurance needs, retirement saving, and other important considerations? 

Factoring in time constraints and the reasonable desire for a personal life, very few residents have the time to dedicate to getting a handle on personal finances. A host of negative consequences may arise if physicians make financial mistakes at these early stages.

Where to start? Where to turn for help? Start simply. 

Financial health should be treated in a similar way to attending to physical and mental health. When viewed from this perspective, the training of physicians gives this occupational group an advantage when tackling personal finances. 

Let’s outline some simple steps early-career physicians can take to prepare for a healthier financial future: 

• Become familiar with your financial vital signs

While carving out time from a busy schedule may seem impossible, scheduling a bit of time to learn some basics about your individual circumstances is essential. Dedicate some time—think about this as you would think about making an appointment with a doctor. Put it on your calendar. 

Begin with some basic information gathering: Identify all sources of household income (review your paychecks, line by line); identify your fixed monthly expenses (housing payments, childcare costs, set-aside contributions for savings, etc.), as well as your variable monthly expenses (utilities, subscription services, transportation costs, etc.). As in most things in life, the best first step is figuring out where you are.

• Construct a monthly budget

You may think of this step as you would a treatment regimen. Crafting a monthly financial plan that identifies each incoming dollar and prudently purposes each outgoing dollar will provide a way forward and likely reduce the mental burden of financial unknowns. There are many good budgeting templates and guides. Like finding a good primary care physician, find yourself a budget that you like and works well for you. And like any treatment regimen, stick to your budget in order to achieve good health.

• Know your debt repayment options

For the majority of physicians, this step is vital to understand and implement. One resource worth checking out is provided by Doctored Money^[6], a non-profit serving physicians that has wonderful debt repayment tools and calculators.

• Identify support and establish communication

Assess your surroundings to locate trustworthy financial resources and fiduciary support, if needed. In many cases, the institution with which you are affiliated may have personal financial resources offered. Take advantage of these opportunities when available, if nothing else than to better educate yourself. Once you’ve built a network of professionals with whom you can confide, communicate to them as you would with your PCP, remembering that your goal is to limit risks and improve your overall health.

• Conduct routine financial check-ups

Living within a smartly formulated monthly budget is a winning health strategy, and combined with periodic (quarterly, semi-annual, annual) reviews of your financial vitals will increase your ability to achieve your financial goals. Schedule these reviews on your calendar well in advance, and approach them as you would a visit to any healthcare specialist. Satisfied debts, cost of living adjustments, salary increases, unexpected expenses, changes in the investable landscape, and other life events will prompt adjustments to your monthly budget. Regular check-ups will help you recognize and appropriately transition your personal finances. Utilize your network of resources and professional support on a regularly scheduled basis. 

We’ve been talking a lot about early-career physician groups, but our suggestions are applicable to most, if not all, readers. 

Address your financial needs with consistency, and in spite of uncertainties facing the cost of goods and households, we’ll make the U.S. healthcare system a secure, confident foundation for personal and community growth.

^[1] Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide

^[2] Medscape National Physician Burnout & Depression Report 2018

^[3] https://www.ama-assn.org/residents-students/resident-student-health/resident-physicians-should-get-help-shoulder-financial

^[4] Business of Medicine Course Preps Med Students for Real World | UAMS News

^[5] 6 things medical students should know about physician compensation | American Medical Association (ama-assn.org)

^[6] Doctored Money

Thursday, May 04, 2023

by Jeff Reid, Sr. Commercial Manager at SEKISUI Diagnostics

Each year, millions of women of all ages and backgrounds are impacted by vulvovaginal disorder, making it the main cause for health care visits by women in the United States.¹ This disorder usually occurs due to an infection or when the bacterium in the vagina becomes unbalanced. Two common causes of vulvovaginal disorder are Bacterial vaginosis and Trichomoniasis.

Bacterial vaginosis and Trichomoniasis are linked to a broad range of associated health complications, from preterm birth to an increase in Sexually Transmitted Infections (STIs).^2,3 If immediately diagnosed and treated, the risk of associated health complications can be greatly minimized. Therefore, a “test and treat” approach is critical to take when diagnosing Bacterial vaginosis and Trichomoniasis. Key considerations on different diagnostic methods for Bacterial vaginosis and Trichomoniasis will be reviewed in this editorial. 

BACTERIAL VAGINOSIS: 

Bacterial vaginosis occurs when the healthy balance of vaginal bacteria is disrupted by an overgrowth of pathogenic bacteria. It is the most prevalent form of all vulvovaginal disorder, resulting up to 50% of all cases.¹ 

Common symptoms of Bacterial vaginosis consist of the following:²

• A thin white or gray vaginal discharge
• Pain, itching, or burning in the vagina
• A strong fish-like odor, especially after sex
• Burning when urinating
• Itching around the outside of the vagina 

There are serious health complications associated with Bacterial vaginosis, including the increased risk of contracting several different STIs. Therefore, all women suspected of having Bacterial vaginosis should be evaluated for Human Immunodeficiency Virus (HIV) and other STIs.¹ 

Common diagnostic methods for Bacterial vaginosis consists of Nugent scoring from a vaginal Gram stain, Amsel’s Criteria, molecular tests, and rapid point-of-care tests.⁴ 

Nugent scoring from a vaginal Gram stain is considered the gold standard for diagnosing Bacterial vaginosis.⁴ It consists of performing a Gram stain where the vaginal specimen is smeared on a glass slide. Then the vaginal smear is evaluated under a microscope according to the Nugent scoring system. The Nugent score is calculated by assessing for the presence of large gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small gram-variable and gram-negative rods (G. vaginalis and Bacteroides morphotypes; scored as 0 to 4), and curved gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2).⁴ Although considered the gold standard, there are challenges associated with Nugent scoring from a vaginal Gram stain. For example, a Gram stain is a multistep process that requires significant hands-on activities and is usually performed in a laboratory setting. Also, the method is considered a Provider-Performed Microscopy (PPM) procedure, which is a complex procedure that requires a specific skillset to perform. Due to the significant hands-on activities of the process and the complexity of the procedure, Nugent scoring from a vaginal Gram stain does not allow for a test and treat approach. 

Amsel’s Criteria is a traditional diagnostic method based on microscopy and clinical symptoms. The method is based on the presence of 3 of the following criteria:⁴

1. Discharge: homogeneous, thin, white-gray discharge that smoothly coats the vaginal walls
2. Clue cells: more than 20% clue cells on saline microscopy
3. pH >4.5: vaginal fluid pH >4.5
4. Positive KOH: positive KOH whiff test result 

Diagnosing Bacterial vaginosis by Amsel’s Criteria can be time consuming and it is prone to subjectivity as there are multiple steps involved. Like Nugent scoring from a vaginal Gram stain, Amsel’s Criteria is considered a Provider-Performed Microscopy (PPM) procedure, which is a complex procedure that requires a specific skillset to perform. Due to the multiple steps of the process and the complexity of the procedure, Amsel’s Criteria usually does not allow for a test and treat approach. 

There are different molecular tests available for diagnosing Bacterial vaginosis, which detect specific bacterial nucleic acids. The sensitivity and specificity of these tests are high, allowing for accurate test results. However, the methodology requires highly expensive and sophisticated instrumentation that require a specialized skillset to perform, making it hard for health care providers to adopt the technology into their practice. 

The Centers for Disease Control and Prevention (CDC) notes that the OSOM® BVBLUE® test in their 2021 Sexually Transmitted Infections Treatment Guidelines as a recommended rapid point-of-care test for diagnosing Bacterial vaginosis.⁴ Unlike Nugent scoring from a vaginal Gram stain and Amsel’s Criteria, the OSOM® BVBLUE® Test is CLIA-waived and does not require a specific skillset. Also, unlike molecular tests, the OSOM® BVBLUE® Test does not require specialized instrumentation to perform. It is a visual read, enzymatic activity assay that detects the sialidase enzyme of bacterial pathogens. The test can be performed at the point-of-care and the results are produced in 10 minutes, allowing for a test and treat approach. 

TRICHOMONIASIS: 

Trichomoniasis is a parasitic infection caused by a protozoan parasite called Trichomonas vaginalis. It is considered the most curable, non-viral sextually transmitted disease, with an estimated 3.7 million cases per year in the United States.⁶ It is estimated that up to 35% of all vulvovaginal disorders are caused by Trichomonas vaginalis.¹ 

Common symptoms of Bacterial vaginosis consist of the following:³

• A thin clear, white, yellowish, or greenish vaginal discharge
• Itching, burning, redness or soreness of the vagina
• An unusual fishy smell
• Discomfort with urination 

The health complications associated with Trichomoniasis consists of an increased risk of getting or spreading other STIs, a greater chance of preterm birth, an increased risk of cervical cancer.³ 

Common diagnostic methods for diagnosing Trichomoniasis consists of wet-mount microscopy, culture followed by wet-mount microscopy, molecular tests, and rapid point-of-care tests.⁵ 

Wet-mount microscopy has traditionally been used to diagnose Trichomoniasis. The method consists of collecting a vaginal specimen and examining it for motile organisms, called trichomonads, under a microscope. It is important to note that the specimen should be immediately examined after collection as 20% of trichomonads lose their motility within 10 minutes of specimen collection.⁷ Wet-mount microscopy is a relatively inexpensive method and can be performed at the point-of-care. However, the sensitivity can be relatively low, leading to an increase in false negative tests results.⁵ 

Culture followed by wet-mount microscopy is a more sensitive test method than wet-mount microscopy.⁵ Prior to examining the specimen under a microscope for trichomonads, the specimen is inoculated and incubated for 2-5 days. The primary challenge with this method is the time it takes to incubate the specimen, resulting in a disrupted quality of life for the patient. 

Molecular tests are considered the gold standard for diagnosing Trichomoniasis. These are highly sensitive tests that detect the genetic material of the parasite, called Trichomonas vaginalis. Although these tests are highly accurate, they require highly expensive and sophisticated instrumentation that usually require a specialized skillset to perform, making it hard for health care providers to adopt the technology into their practice. 

The CDC notes the OSOM® Trichomonas Test in their 2021 Sexually Transmitted Infections Treatment Guidelines as a recommended rapid point-of-care test for diagnosing Trichomonas.⁵ The OSOM® Trichomonas Test is a visual read, lateral flow antigen test that detects the protein of trichomonas called Trichomonas vaginalis. It is a CLIA-waived test that can be performed at the point-of-care, allowing for a test and treat approach. The sensitivity of the OSOM® Trichomonas Test compares favorably to the molecular tests with reported sensitivities of 83%-90%.⁶ 

SUMMARY: 

Vulvovaginal disorder is a common condition that can drastically impact the quality of life for women. It is a disorder that is responsible for 10 million physician visits per year.¹ Bacterial vaginosis and Trichomoniasis are two common causes of vulvovaginal disorder, which both have a mix of symptoms and associated health complications. To overcome the disrupted quality of life for women and the associated health complications, a test and treat approach should be taken when diagnosing Bacterial vaginosis and Trichomoniasis. There are only a few diagnostic options that allow for such approach, which are the OSOM® BVBLUE® Test and the OSOM® Trichomonas Test. The CDC notes both tests in the 2021 Sexually Transmitted Infections Treatment Guidelines as diagnostic considerations for Bacterial vaginosis and Trichomoniasis. Both tests have high sensitivity and specificity compared to the gold standard methods and allow for a test and treat approach. 

REFERENCES:

1. Brown, H. Improving the Diagnosis of Vulvovaginitis. Population Health Management. Vol. 23, suppl 1, 2020.
2. Fact Sheet - Bacterial Vaginosis. 2017
3. Fact Sheet - Trichomoniasis. 2017
4. Sexually Transmitted Infections Treatment Guidelines, Bacterial Vaginosis. 2021
5. Sexually Transmitted Infections Treatment Guidelines, Trichomoniasis. 2021
6. C. Rapid and Point-of-Care Tests for the diagnosis of Trichomonas vaginalis in women and men. Sex Trans Infect. 2017.
7. Kingston MA, Bansal D, Carlin EM. ‘Shelf life’ of Trichomonas vaginalis. Int J STD AIDS. 2003 Jan;14(1)

Thursday, May 04, 2023

by Physician Office Resource

Within the right atrium is a group of cells called the sinus node, the heart’s natural pacemaker. It’s here where signals are produced to start each heartbeat. When a heart is functioning properly, the signal travels from the sinus node through both atria, and through a pathway between the atria and ventricles known the atrioventricular node. This transmission of electrical signals allows the heart to contract and pump blood through the body.

But what happens when those electrical signals are not functioning properly? When faulty electrical signals are sent, a heart experiences arrhythmia, making the heartbeat too fast, too slow, or irregular in nature. 

Atrial Fibrillation (AFib) is the most common type of heart arrythmia and occurs when the two atria of the heart beat in an irregular way thus inhibiting the flow of blood to the ventricles. Symptoms of AFib include irregular heartbeat, heart palpitations, lightheadedness, extreme fatigue, shortness of breath, and chest pain. Chronic AFib is a progressive disorder that can lead to heart failure and increases a person’s risk for stroke. The CDC reports that AFib causes about 1 in 7 strokes.¹   

Today, an estimated 6 million people in the US suffer with atrial fibrillation. The CDC expects that number to grow to 12.1 million by the year 2030. In 2019 AFib was mentioned on 183,321 death certificates and was the underlying cause of death in 26,535 of those deaths.¹ 

In this article we’ll review current treatments for AFib including drug therapy and cardiac catheter ablation; in addition to new findings from a study published by the New England Journal of Medicine titled, “Progression of Atrial Fibrillation after Cryoablation or Drug Therapy” that focuses on the benefits of treating AFib patients with a cardiac catheter ablation rather than with drug therapy. 

Drug Therapy 

When a patient is first treated for AFib, they are often prescribed three types of medications to help prevent and control irregular heartbeats and stoke²:

• Heart rate controllers
• Heart rhythm controllers
• Blood Thinners 

Heart Rate Controllers

Heart rate controllers usually consist of two different classes of drugs, Beta blockers and calcium channel blockers. 

Beta Blockers are a class of drug that prevent the stimulation of the adrenergic receptors, thus blocking the effects of the hormone epinephrine (adrenaline). Because of this block, the heart begins to beat slower and with less force. Some examples of beta blockers include²:

• Metoprolol
• Propranolol
• Timolol
• Nadolol
• Atenolol
• Bisoprolol
• Carvedilol 

Calcium Channel Blockers are medications that lower blood pressure by preventing calcium to enter the heart and artery cells. By blocking calcium and its effects of causing the heart and arteries to contract with greater force, heart rate slows and blood pressure lowers. 

Depending on heath and conditions being treated, there are short-acting and long-acting forms of calcium channel blockers available. Short-acting medications work quicker but don’t last very long. Long-acting medications release at a slower rate thus providing a longer lasting effect. Some examples of calcium blockers that are used to treat AFib include:

• Diltiazem
• Verapamil 

Heart Rhythm Controllers

Known as a chemical/pharmacological cardioversion, heart rhythm controllers are drugs used to restore normal heart rhythm. Drugs used in this therapy fall in to two classifications: sodium channel blockers and potassium channel blockers. 

Sodium Channel Blockers are a class I antiarrhythmic that inhibit sodium influx through cell membranes. This inhibition of sodium lowers the heart’s ability to conduct electricity. Examples of this drug include:

• Flecainide
• Propafenone
• Quinidine 

Potassium Channel Blockers are a Class III Antiarrhythmic that prolongs the action potential duration by inhibiting repolarizing potassium channel blockers.³ This prolongs the length of time that the cell is unexcitable. Examples of this drug include:

• Amiodarone
• Sotalol
• Dofetilide
• Dronedarone 

Blood Thinners

Because blood clots and stroke are closely associated with AFib, physicians often prescribe blood thinners to reduce the risk of occurrence and damage caused by those conditions. Examples of blood thinners include:

• Warfarin
• Apixaban
• Dabigatran
• Edoxaban
• Rivaroxban 

With the heart rate and rhythm controlled, most people begin to feel better. But what about disease progress? Yes, the medications are treating the symptoms of AFib, but the actual disease can still progress and affect other cells of the heart and AFib can return. Other treatment options for AFib include Electrical Cardioversion Therapy and Cardiac Ablation. 

Electrical Cardioversion

Electrical cardioversion is a method in which the heart rhythm is rest by sending electric shocks through the heart. Even with electrical cardioversion, patients are often still prescribed heart rate and rhythm controllers and blood thinners to help prevent future episodes. 

Cardiac Ablation

Normally last in line in the treatment of AFib, a cardiac catheter ablation involves utilizing heat or extreme cold to create a pattern of scars (known as a maze procedure) in the atria. Scar tissue does not send electrical signals, so the scars act as barriers to the cells that are sending rogue signals that cause AFib. 

The Case for Cardiac Catheter Ablation First over Drug Treatment

As mentioned previously, a cardiac catheter ablation is often last in line in treatment of patients with AFib. However, a recent study published in the New England Journal of Medicine titled, “Progression of Atrial Fibrillation after Cryoablation or Drug Therapy,” concluded that treating patients with cardiac catheter ablation first rather than with drugs can stop the disease from getting worse.⁴ 

Dr. Jason G. Andrade, principle investigator of the study said, “If we perform the procedure earlier, the thinking was that maybe we could change that disease trajectory. We could prevent people from having these more advanced forms of atrial fibrillation, and so the procedure will not only work better, but it will change how people are living with the disease and lead to a much better long-term outcomes”⁵ 

Their study included two randomized groups out of a cohort of 303 people who were treated for AFib to compare the disease progression. One group would be treated with medicine first and the second group would receive a cardiac catheter ablation first. Patients of both groups received an implanted cardiac monitor after treatment to track changes over a three-year period. 

One of the most striking findings of this study showed a 75% reduction in the progression of AFib in patients who received a cardiac catheter ablation over those who only received drug treatment. Dr. Andrade went on to say, “By doing the procedure, you really got at the source of the problem and prevented people from developing more advanced forms of the disease over several years of follow-up. We know that the more advanced forms of atrial fibrillation have higher rates of stroke, are more likely to cause heart failure, and result in premature mortality. We’ve now shown for the first time that an intervention in the form of catheter ablation changes the disease trajectory and prevents patients from going on to have those more advanced forms of atrial fibrillation.”⁵ 

The study also showed that patients who received the ablation experienced fewer serious adverse events at a rate of 4.5% compared to those who received only drug treatment at 10.1%. 

This is the second of such a study performed on treating AFib with a catheter ablation over drug therapy. The authors of this study suggested that more research on the topic will be coming.

Drug therapy will always be essential in the treatment of AFib. However, based on this study’s findings, I believe this will help flip the trend to patients receiving cardiac catheter ablations sooner rather than later. 

References

1. https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
2. https://www.heart.org/en/health-topics/atrial-fibrillation/treatment-and-prevention-of-atrial-fibrillation/atrial-fibrillation-medications
3. https://www.cvpharmacology.com/antiarrhy/potassium-blockers
4. https://www.nejm.org/doi/full/10.1056/NEJMoa2212540
5. https://thedailyscan.providencehealthcare.org/2023/01/surgery-first-vs-drugs-for-a-fib-could-stop-diseases-progress-nejm-study/

Monday, October 03, 2022

by Andy Harms

If your wallet needs live-saving measures, now is a great time to avert a crisis.

The grind. Residents know about it. Long days requiring intense mental focus. Physically demanding. Exhilarating and enjoyable, yet exhausting and overwhelming at times. Loving what we do—but not loving what it does to us on some of those days.

We’re a diverse set of people yet bound together by purpose. We can thrive in ever-changing, always-evolving patient care environments and on-call opportunities. Just as well, many of us excel best with a more structured day, one with meticulous order and greater command over outcomes. Our personal identities and varied interests were a large part of how we chose our specialty.

Regardless, as residents we’ve all been trained to think on our feet, orient and analyze quickly, decide with assurance, and act toward a favorable outcome.

In speaking with residents over the years about personal financial situations, I see an incredible ability for young physicians to manage—if not juggle! —their money matters despite weighty, disorderly, and persistent challenges.

Wouldn’t it be nice if there was an easier way to prepare and plan financially, to bring order from chaos? The good news: there IS a better way. The bad news is you likely were NOT trained in finances the same way you trained for medical practice.

The Journal of the American College of Surgeons published a study in 2018 titled “Clinically Competent and Fiscally at Risk: Impact of Debt and Financial Parameters on the Surgical Resident.”^[1] One hundred five resident trainees were surveyed on topics of personal finance, and the majority (79%) of respondents felt strongly that inclusion of additional financial training in residency education is a critical need. The authors conclude: In a climate of increasingly delayed financial gratification, surgical trainees are on critically unstable financial footing. There is a major gap in current surgical education that requires reassessment for the long-term financial health of residents.

In digging deeper for perspective on resident finances, I spoke with the researcher and author of this study with the longest tenure in medicine, Dr. Bruce Harms, MD, MBA, FACS. “My generation of doctors, I believe, assumed that we could out-grow, with time, any financial mistakes and miscalculations we made in residency and early on in our careers. I think that is an incorrect assumption nowadays. For younger docs, in this era, the mistakes made from a financial standpoint may be extremely costly in the long run.” When asked to point out the biggest differences from then (Dr. Harms began residency in 1978) to now, he pointed out “certainly educational debt is the biggest difference I see, but also the cost of living. Housing, transportation, health care and childcare command a significantly greater part of a budget as compared to when I received my start in medicine.”

If you’re in a residency program that addresses your financial literacy and financial preparation needs well, count your blessings. That’s certainly not common throughout organized medicine in the United States. Similarly, if you’re employed in a residency program that offers a retirement plan with matching employer contributions, count yourself fortunate.

So where can we turn for assistance to avoid making costly financial mistakes and confidently face the challenges of personal finance during residency, given it may be unlikely to come through our employers or GME programs?

One of my favorite recommendations for residents hoping for better command over their personal finances is to pick up, digest, and implement suggestions from a book titled MD in the Black: A Personal Finance Primer for Medical Residents.^[2] (Please note: I have no ties to the authors or sponsors of this book) It’s informative, practical, and concise. For all those in the TL;DR camp, it's only a hundred pages. I recognize your time is limited—among the barriers to better financial literacy—but reading this book is certainly worth making a priority. Editor-in-Chief Eric Shappell, MD, MHPE, and physician educators from around the United States created a great resource, specifically designed for residents.

The book focuses on five topics: 1) Educational debt, 2) Long-term disability insurance, 3) Life insurance, 4) Investing, and 5) Financial advisors

Likely you have questions in all these areas. The authors point out “they are each related to a significant financial decision that the majority of residents will encounter during training.”

We won’t breakdown each major category here, of course, but I would like to highlight two takeaways that every reader of this article at the residency level should consider:

First, on the topic of educational debt: Have you asked yourself “What is Public Service Loan Forgiveness?” and “Should I Pursue PSLF?” This is the first decision you should make, and various sources can help you better understand how to approach this process of determination. Once a determination is made regarding PSLF, a debt repayment strategy can be mapped out further.

As important as long-term disability insurance, life insurance, and investing are to the needs of a resident, a personal and in-depth commentary on each is beyond the scope and space of this article. However, they are a good lead-in to the second point we’d like to highlight here from Dr. Shappell’s book, considering the question “Should I Hire a Financial Advisor in Residency?”

Most residents should be able to get along just fine with only a few hours dedicated to researching the basic financial decisions of residency (1) choosing a loan repayment plan, (2) choosing which insurance products to purchase and when, and (3) what to do with any extra income (typically a decision of whether to make extra payments on loans vs. invest). If you don’t feel comfortable making these decisions on your own and aren’t interested in learning more about them yourself, choosing to hire a financial advisor may be the way to go. This also may be a good idea if you have unusually complex financial circumstances. (Shappell 84)

Whether during residency or as an attending, the likely outcome in any event is a search for an experienced and trusted financial advisor. What credentials do you seek, what questions do you ask? MD in the Black notes residents looking to start at the ground-level in forming a financial plan will do well to consider an advisor with a Certified Financial Planner (CFP), Chartered Financial Consultant (ChFC) or Certified Public Accountant/Personal Financial Specialist (CPA/PFS) designation. Additionally, I suggest aiming to find a Fee-Only advising arrangement, particularly for planning services. This model minimizes conflicts and ensures that your financial planner acts as a fiduciary. Fee-Only planners are compensated directly by their clients for advice, plan implementation and for the ongoing management of assets.^[3] Fee-only financial advisors may be paid hourly, as a retainer, as a percentage of assets under management, or as a flat fee, depending upon the planner you choose.

As residents, we understand the importance of preventative health care and the consequences of delayed treatment. This understanding, applied to our personal finances, will not only stave off a trip to the financial ED (i.e., more borrowing, lower net worth, less financial freedom), but enable us to enjoy the peace of mind and sense of confidence that comes with financial health. Our goal should be to confine the chaotic moments and stressors related to medicine to the hospital and away from our pocketbooks.

We invite you to check out the resources mentioned above and reach out for help at any time to gain better financial understanding, set financial goals, and establish a path to financial wellness. Residency may be the best time to reach out, while the time is still on your side.

Andy Harms is co-founder of ScrubMoney, a free app now available for download, providing financial literacy and relevant personal financial content. ScrubMoney aims to empower early-career physicians to achieve financial wellness and enable stakeholders in healthcare to better develop financially confident doctors within their organizations.

^[1] Clinically Competent and Fiscally at Risk: Impact of Debt an... : Journal of the American College of Surgeons (lww.com)

^[2] MD in the Black: Personal Finance for Residents and Medical Students

^[3] What is Fee-Only Financial Advising | NAPFA

Monday, October 03, 2022

by John D. Tamerius, Ph.D. and Jhobe Steadman, Ph.D.

The Secretary of Health & Human Services (HHS) declared a Public Health Emergency on Jan. 31, 2020.  Congress followed a few weeks later on March 13, 2020 with the declaration of a National Emergency and granted $25 billion to HHS to take immediate steps to accelerate the development of vaccines, therapeutics and diagnostic tests.  Five weeks later the National Institutes of Health (NIH) created the Rapid Acceleration of Diagnostics Initiative (RADx) and Quidel® Corporation was one of several companies that received scientific and regulatory guidance and funding to help meet the profound need of the American people during this emergency.  Despite the criticisms commonly heard, a tremendous amount was accomplished in record time, including the creation of effective vaccines, the development of diagnostic antigen and molecular tests for diagnosis of SARS-CoV-2 and for the advancing development of therapeutic agents---all in less than one year.

Quidel, partly with RADx support, was the first diagnostic firm to receive the FDA’s Emergency Use Authorization (EUA) for a rapid antigen test in the U.S.—the fluorescence immunoassay (FIA) called Sofia® SARS Antigen FIA for point-of-care (POC) use in the physician’s office lab. A few months later, Quidel was also the first to receive an EUA for a multiplex antigen assay, Sofia 2® Flu + SARS Antigen FIA, for simultaneous testing for SARS-CoV-2, Influenza A, and influenza B from one swab specimen. As shown in Table 1, within one year after the declaration of our National Emergency, Quidel had received EUAs for 8 different assays, including EUAs for the QuickVue SARS Assay (a 10-minute, visually read dipstick assay), one for POC and one for at-home use and two molecular assays.

This unprecedented work by government and industry required time.  The pandemic was spreading quickly around the world and the public had very little to no protection. Fortunately, non-pharmaceutical interventions (NPI) were quickly introduced and promoted widely across the United States.  Wherever lock downs, school closures, reduced face-to-face interaction, mask wearing, reduced mobility, and working at home occurred, there were significantly reduced hospitalizations and deaths. This protection by NPI, although not absolute, bought research scientists and industry time while vaccines, COVID-19 therapeutics and diagnostics were being developed.   

While our government agencies and industries were working on these goals, NPI also reduced the incidence of certain other respiratory infections, including that of influenza Types A and B.   Figure 1 shows the course of influenza in the United States from September 2015 to the present and reveals the profound impact of NPI on influenza incidence.  Note the data depicted in this figure are derived from over 16 million patient de-identified test results that were automatically transmitted to Quidel by users of Sofia and
Sofia 2 for surveillance, using a system called Virena®.  Virena information is updated daily and is automatically and securely shared with the CDC and readily available to Quidel customers on MyVirena.com.  Virena is also a no charge service provided to all Sofia and Sofia 2 users. 

After the abrupt end of the 2019-2020 season, there followed 18 months during which the combined influenza positive rates for influenza types A and B rarely exceeded 6%.  Then last winter, 2021-2022, there were two influenza surges; both failed to approach the positivity rates and the duration seen in the previous 5 epidemic seasons.  Both surges this past winter also ended abruptly, timed closely to the arrivals of Omicron in Dec. 2021 and of the BA.4 and BA.5 Omicron subvariants that became dominant after January 2022.  This dramatic decline in influenza is believed largely due to the implementation of NPI that were needed to reduce the spread of COVID-19 until other measures could be taken.

A large portion of our population is now feeling exhausted after doing their best to address this pandemic for over two and a half years.  NPI use is on the decline.  Omicron and its direct subvariant offspring are much less virulent than their predecessors, further reducing the concern about being infected, thus further reducing interest or willingness to be vaccinated or to use NPI.  In addition, much of the testing for COVID-19 is now done at home and most at-home results are not reported, reducing the awareness and concern of COVID-19 in their communities.  On top of this, promotional activities for NPI have diminished.

In addition to enabling COVID-19 infections to more easily spread and persist in our population, failing to use NPI will likely increase the risk of a stronger influenza season this coming winter, perhaps even resulting in a more traditional season with epidemic levels of influenza rather than the “failed” surges^* we experienced last winter.  Enhancing this risk, only 52% of the U.S. population is vaccinated against influenza. Even many of those who have gotten routine vaccinations for influenza annually, have possibly skipped the last year or two given the widely known low influenza incidence and, with the passing of time, whatever immunity they might have had before the advent of the COVID-19 pandemic has likely wanned. So, the risks for significant influenza season seem higher than at any time since the winter of 2019.

We often look to the southern hemisphere for clues because their winter precede ours by half a year.  Careful examination of Figure 2 shows the profound decline in incidence of influenza in their two previous winters, just like in the USA.  This winter there was a pronounced influenza epidemic and the worst influenza in May in Australia’s history.  Such events in the southern hemisphere are not absolute predictors of events in the northern hemisphere, but they rightfully raise further concern for this winter in North America.

Many epidemiologists agree that a combination of both a new COVID-19 surge and a true influenza epidemic winter season in the U.S. is possible, if not likely.  Indeed, it appears that the annual influenza epidemic almost broke out last 2021-2022 winter with the two surges as we discussed above. The use of NPI was likely strong enough to possibly slow or halt its spread.  This may not be the case this year given the exhaustion of our populace, the low vaccination rate, reopening of schools, beginning of return to workplaces, ongoing decline in NPI use, and overall diminution of herd immunity.

Unfortunately, the signs and symptoms for infections by SARS-CoV-2 and influenza are very similar (Table 2).  Given that there are now effective treatments for both influenza and COVID-19, it seems imperative that steps are taken to test for all three pathogens when patients present with such symptoms—especially in communities where both COVID-19 and Influenza are likely circulating at the same time.

As mentioned in Table 1, Quidel was the first company to receive an EUA for a multiplex antigen detection assay in the United States.  This CLIA waived test provides a result in 15 minutes with a simple nasal swab and is available for most labs.  For busy clinics it provides flexible workflows, requiring limited hands-on-time, including a batch testing mode that allows processing and testing of several patient samples at a time. Getting daily reports from your local public health office or by accessing Quidel’s on-line reporting system (MyVirena.com) could indicate whether only COVID-19 or Influenza are in your community.  If this is the case, options in Table 1 provide you practical and available alternatives available from Quidel.

With decline in use of NPI, reduced herd immunity, only 52% influenza vaccination rate (persons > 6 months of age), and given the hint from Australia (Figure 2), as well as the two attempts by influenza to break out in the United States more broadly last December and again in February (Figure 1), it is best to begin to prepare now for the return of influenza and potentially at the same time when COVID-19 is surging or otherwise maintaining a moderate incidence level.  Rapid diagnosis is critically important as patients, especially high-risk ones, can be treated successfully with specific antivirals that have been developed for each of the pathogens—provided they are administered early, preferably starting within 2 days after symptom onset for influenza and within 5 days after symptom onset for COVID-19.

To prepare for the likely resurgence of influenza, perhaps at the same time as a new surge of COVID-19, we encourage physicians to do the following:

1. Monitor surveillance data for incidence of COVID-19 and influenza in your state, county and community. This could be accomplished by monitoring public health reports and/or, for users of Sofia and Sofia 2, by monitoring the status of both viruses’ incidence by readily accessing Virena data on Quidel’s MyVirena.com.
2. Make sure that your clinic provides COVID-19 and influenza test results to your local and regional public health agencies, so that they can provide a more complete status update for you and others.
3. Actively support vaccinations, including boosters with the newly approved vaccine(s) covering the new SARS-CoV-2 Omicron subvariants.
4. Encourage your staff and patients to get the new season’s influenza vaccines that are now available. Patients older than 65 years, should get the special influenza vaccine designed for them.  Given that the influenza season started so early in Australia, it could do the same here, so providing the flu vaccinations for yourself, staff, and your patients by the end of September could be best.
5. Encourage the use of NPI, especially at least through this winter, and especially reinforced by your knowledge through surveillance of incidence of both pathogens circulating in your community. The data show without question that NPI reduces COVID-10 and Influenza infections and spread.
6. Be prepared for testing for both SARS-CoV-2 and Influenza. All three viruses are likely to be circulating in your community this winter—potentially at the same time. Using Sofia 2 SARS + Flu FIA may be the best choice for you, as it screens for all three viruses at once with only one patient nasal swab sample required. 

*Failed “surges”.  Even though the surges this past winter did not constitute a typical influenza epidemic, the CDC has reported that between Oct. 2021, and June 11, 2022, there were 8 million to 13 million influenza cases, 82,000 to 170,000 hospitalizations, and 5,000 to 14,000 deaths In the United States.  We must all take steps now to prepare for the coming COVID-19 and Influenza winter season.

Wednesday, September 07, 2022

by Susan Garramone, Senior Clinical Marketing Manager - Siemens Healthineers

Diabetes: The medical condition

Diabetes is a chronic, metabolic disease characterized by elevated levels of blood glucose. The hormone insulin is required for glucose to enter the body’s cells, where it is used for energy. If the body does not make enough insulin (type 1 diabetes) or does not respond to insulin as it should (type 2 diabetes), the level of glucose in the blood becomes elevated.¹ This high blood sugar, or hyperglycemia, is dangerous and can lead to long-term complications.^1,2

Type 1 diabetes is an autoimmune condition typically diagnosed in children, teens, and young adults.¹ There is no cure for type 1 diabetes, and in addition to following a healthy eating and exercise plan, people with type 1 diabetes need to take insulin every day to control blood glucose levels.³

Type 2 diabetes, representing the majority of diabetes diagnoses, is a condition that develops over time.^1,3 Once more commonly diagnosed in adults, the prevalence of diabetes in children, teens, and young adults is increasing.¹ Lifestyle management, with healthy eating and exercise, is a cornerstone of type 2 diabetes treatment plans. Additionally, patients may be prescribed insulin or other injectable or oral diabetes medications to help manage blood sugar.¹

Diabetes: The comorbidity concern

Not only is diabetes the seventh-leading cause of death in the United States, affecting 11.3% of the U.S. population, it also is attributed to an estimated $327 billion in annual medical and lost productivity costs.^3-6 Generally, care for patients with diabetes accounts for 1 in 4 healthcare dollars spent in the U.S., and a large portion of these costs results from diabetes-associated comorbidities that include potential neurological, cardiovascular, renal, and other chronic complications.² A search of the PubMed National Library of Medicine yields thousands of new publications on diabetes and diabetes-related issues thus far in 2022, underscoring the importance of this chronic disease and the efforts to help those affected.⁷

Similarly, the body of evidence regarding the profound consequences of diabetes continues to grow.

The results also showed that for all chronic conditions, the average age of onset among people with type 2 diabetes was 5 years earlier than in people without the disease.⁸

Another recent study by Antal et al. reports type 2 diabetes mellitus (T2DM) is associated with neurocognitive changes suggestive of accelerated brain aging and cognitive decline.⁹

The wide-reaching consequences of diabetes and importance of diabetes management were devastatingly evident during the COVID-19 pandemic, when reports emerged demonstrating that COVID-19 was the leading cause of death in people with diabetes in the fourth quarter of 2020.¹⁰

In fact, a large systematic review and meta-analysis conducted by researchers from the University of Aberdeen has found that people with diabetes are almost twice as likely to die with COVID-19, and almost three times as likely to be critically or severely ill, compared to those without the condition.¹¹ They reported that HbA1c over 70 mmol (equivalent to 8.6% HbA1c) increased the risk of mortality among patients with diabetes.

Additionally, at the 2022 American Diabetes Association meeting, a presentation by Harding et al. identified that diabetes may increase the risk for long COVID symptoms four-fold. In fact, the author was quoted as stating, “Careful monitoring of glucose levels in at-risk individuals may help to mitigate excess risk and reduce the burden of lingering symptoms that inhibit their overall well-being.”¹²

13. https://www.practiceupdate.com/content/ada-diabetes-may-quadruple-risk-for-long-covid/137205/23/8/2. Accessed 6-21-22.
14. https://www.healthcatalyst.com/insights/managing-diabetes-population-health-management. Accessed 6-21-22.

Diabetes: Monitoring leads to management

It is quite clear that people with diabetes are at risk for poor health outcomes, and diabetes management is critical. The higher a patient’s hemoglobin A1c level, the poorer their blood sugar control and the higher their risk of complications.¹⁵ For example, 1 out of 3 adults with diabetes develop diabetic kidney disease, which can then lead to high blood pressure, heart disease, stroke, and early death.¹⁶

However, it is also quite clear that facilitating changes in patient behavior, with diabetes self-management education and patient-provider collaboration as outlined by the ADA, can improve health outcomes.¹⁷ In fact, studies have shown that every percentage-point drop in A1c blood test results can reduce the risk of eye, nerve, and kidney disease complications by as much as 40%.^18,19 Even with this knowledge, high HbA1c levels are seen in 50–60% of diabetic patients, indicating that they either are not receiving proper care or are not adhering to their treatment regimen!²⁰

Guidelines call for routine testing of hemoglobin A1c (HbA1c) and urine albumin-creatinine ratio (uACR) for diabetes and chronic kidney disease monitoring and management, respectively.^21,22 These tests are part of national quality measures, which underscores their importance in early diagnosis, monitoring, and treatment leading to improved outcomes. However, there is a major disconnect: Adherence to recommended testing is astonishingly low—only approximately 70% and 32% of patients with diabetes follow the testing guidelines for HbA1c and uACR, respectively.^23,24

Reasons for low test adherence were addressed in a 2021 study by Al Hayek et al. in which patients identified having to make a trip to a laboratory as a main barrier to testing.²⁵ Patient-reported pain points included “difficulties in handling absence from school/work (56%), inconvenience associated with revisits (45.3%), and the additional costs of travel (44%)”.²⁵ Additionally, a review by Schnell et al. documented the potential for time delays in pre-visit laboratory HbA1c testing.²⁶ These delays may lead to nonadherence, downstream delays in communicating results and intensifying or modifying treatment, and reduced patient adherence to the treatment plan.

Diabetes: Primary care holds the key to control

Did you know that having a primary-care doctor, as well as getting routine care and health-screening services, are linked to improved overall health and longevity?²⁷

Primary-care physicians treat at least 90% of patients with diabetes in the United States. Therefore, the biggest opportunity for positive change lies within the primary-care office.²⁸

According to the ADA, “The goals of diabetes treatment are to prevent or delay complications, optimize quality of life, and establish a care plan with patients based on their individual preferences, principles, and goals.”²⁹ Implementation of point-of-care testing in the primary-care office provides an opportunity to meet these goals, whereby patient education and monitoring of progress with real-time clinical data, such as guideline-driven HbA1c and uACR results, can increase patient motivation to make lifestyle modifications and adhere to medication-management plans. In fact, in 2021 the ADA stated that POC testing for A1c provides opportunity for more timely treatment changes.²¹

There is a large body of evidence further supporting the clinical value of point-of-care testing (POCT) as a quick, easy, reliable method for monitoring diabetes in the primary-care office setting. Such testing can improve test adherence and patient outcomes while also increasing practice efficiency, decreasing costs, and driving achievement of quality measures.^25,30-36 In addition, studies have demonstrated that POCT is associated with a high level of patient and staff satisfaction, which further aligns with the Quadruple-Aim goals of better outcomes, lower costs, improved patient experience, and improved clinician experience.^25,30,31,36

Diabetes: The clinical conundrum

There are a lot of knowns when discussing diabetes.

The review by Schnell et al. neatly summarizes the benefits of diabetes testing at the point of care:²⁶

• Increases compliance with recommendations for HbA1c testing frequency and treatment adoption
• Improves clinical outcomes
• Facilitates patient education and motivation
• Improves patient’s quality of life
• Appears to contribute to cost/time savings both for healthcare professionals and patients

That describes a winning strategy for facilitating positive change in the battle against diabetes—a win for patients, and a win for the physicians who care for them. If point-of-care, in-office diabetes testing is not a tool currently in your diabetes-management tool kit, perhaps it is time for its adoption.

References

1. https://www.cdc.gov/diabetes/basics/diabetes.html. Accessed 6-21-22.
2. https://www.cdc.gov/diabetes/managing/manage-blood-sugar.html. Accessed 6-21-22.
3. https://www.cdc.gov/diabetes/library/socialmedia/infographics/diabetes.html. Accessed 6-21-22.
4. https://www.cdc.gov/diabetes/basics/quick-facts.html. Accessed 6-21-22.
5. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed 6-21-22.
6. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-28. doi: 10.2337/dci18-0007. Accessed 6-21-22.
7. gov. (diabetes) and (2022) Search. Accessed 6/15/22.
8. https://www.medscape.co.uk/viewarticle/burden-chronic-conditions-heavier-type-2-diabetes-2022a1000tht. Diabetes UK Professional Conference 2022: Abstract A19 (P139). Presented March 29. Accessed 6/15/22.
9. Antal B, McMahon LP, Sultan SF, Lithen A, Wexler DJ, Dickerson B, Ratai E-M, Mujica-Parodi LR. Type 2 diabetes mellitus accelerates brain aging and cognitive decline: complementary findings from UK Biobank and meta-analyses. eLife. 2022;11:e73138. https://doi.org/10.7554/eLife.73138
10. https://www.healio.com/news/endocrinology/20220517/covid19-leading-cause-of-death-in-people-with-diabetes-in-fourth-quarter-of-2020. Accessed 6-21-22.
11. Kastora S, Patel M, Carter B, Delibegovic M, Myint PK. Impact of diabetes on COVID-19 mortality and hospital outcomes from a global perspective: an umbrella systematic review and meta-analysis. Endocrinol Diabetes Metab. 2022 May;5(3):e00338. doi: 10.1002/edm2.338. Epub 2022 Apr 20. PMID: 35441801; PMCID: PMC9094465.
12. https://www.practiceupdate.com/content/ada-diabetes-may-quadruple-risk-for-long-covid/137205/23/8/2. Accessed 6-21-22.
13. https://www.ajmc.com/view/multiple-chronic-conditions-in-type-2-diabetes-mellitus-prevalence-and-consequences. Accessed 6-27-22.
14. https://www.verywellhealth.com/side-effects-of-diabetes-5181506. Accessed 6-27-22.
15. https://www.healthcatalyst.com/insights/managing-diabetes-population-health-management. 6-27-22.
16. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html. Accessed 6-27-22.
17. https://diabetesjournals.org/care/article/43/Supplement_1/S48/30785/5-Facilitating-Behavior-Change-and-Well-being-to. Accessed 6-27-22.
18. Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C: Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.
19. https://www.cdc.gov/chronicdisease/programs-impact/pop/diabetes.htm. Accessed 6-22-22.
20. LeBlanc ES, Rosales AG, Kachroo S, et al. Provider beliefs about diabetes treatment have little impact on glycemic control of their patients with diabetes. BMJ Open Diabetes Res Care. 2015;3:e000062. https://doi.org/10.1136/bmjdrc-2014-000062.
21. American Diabetes Association. Glycemic targets: standards of medical care in diabetes—2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. Available from: https://doi.org/10.2337/dc21-S006.
22. American Diabetes Association Professional Practice Committee, et al. Chronic kidney disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl_1):S175-S184. doi:10.2337/dc22-S011.
23. https://www.cdc.gov/diabetes/pdfs/library/Diabetes-Report-Card-2019-508.pdf. Accessed 12-17-21. Accessed 6-22-22.
24. Alfego D, et al. Chronic kidney disease testing among at-risk adults in the U.S. remains low: real-world evidence from a national laboratory database. Diabetes Care. 2021;44(9):2025-32. doi:10.2337/dc21-0723.
25. Al Hayek AA, et al. Assessment of patient satisfaction with on-site point-of-care hemoglobin A1c testing: an observational study. Diabetes Ther. 2021;12(9):2531-44. doi: 10.1007/s13300-021-01126-7
26. Schnell O, et al. Impact of HbA1c testing at point of care on diabetes management. J Diabetes Sci Technol. 2017;11(3):611-17. doi: 10.1177/1932296816678263
27. Basu S, Berkowitz SA, Phillips RL, Bitton A, Landon BE, Phillips RS. Association of primary care physician supply with population mortality in the United States, 2005-2015. JAMA Intern Med. 2019;179(4):506-14. doi: 10.1001/jamainternmed.2018.7624
28. Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clinic proceedings. 2010;85(12 Suppl):S3-4. doi: 10.4065/mcp.2010.0466
29. American Diabetes Association. Standards of Medical Care in Diabetes—2022 Abridged for Primary Care Providers. Clin Diabetes. 2022 Jan 1;40(1):10-38. https://doi.org/10.2337/cd22-as01
30. Crocker JB, et al. The impact of point-of-care hemoglobin A1c testing on population health-based onsite testing adherence: a primary-care quality improvement study. J Diabetes Sc Technol. 2021;15(3):561-7. doi: 10.1177/1932296820972751.
31. Crocker JB, Lee-Lewandrowsky E, Lewandrowsky N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640-6.
32. Christofides EA, Desai N. Optimal early diagnosis and monitoring of diabetic kidney disease in type 2 diabetes mellitus: addressing the barriers to albuminuria testing. J Prim Care Community Health. 2021;12:21501327211003683. doi: 10.1177/21501327211003683.
33. Schultes B, Emmerich S, Kistler AD, Mecheri B, Schnell O, Rudofsky G. Impact of albumin-to-creatinine ratio point-of-care testing on the diagnosis and management of diabetic kidney disease. J Diabetes Sci Technol. 2021 Oct 28;19322968211054520. doi: 10.1177/19322968211054520.
34. Rhyu J, Lambrechts S, Han MA, Freeby MJ. Utilizing point-of-care A1c to impact outcomes – can we make it happen in primary care? Curr Opin Endocrinol Diabetes Obes. 2022 Feb 1;29(1):29-33. doi: 10.1097/MED.0000000000000700.
35. Nichols JH. Utilizing point-of-care testing to optimize patient care. EJIFCC. 2021 Jun;32(2):140-4.
36. Crocker B, Lewandrowski EL, Lewandrowski N, Gregory K, Lewandrowski K. Patient satisfaction with point-of-care laboratory testing: report of a quality improvement program in an ambulatory practice of an academic medical center. Clin Chim Acta. 2013 Sep 23;424:8-11. doi: 10.1016/j.cca.2013.04.025. Epub 2013 May 10. PMID: 23669184.
37. https://www.cdc.gov/nchs/fastats/kidney-disease.htm. Accessed 6-22-22.
38. https://www.kidney.org/atoz/content/does-type-2-diabetes-increase-your-risk-kidney-disease-yes. Accessed 6-27-22.
39. https://www.medicaid.gov/state-overviews/scorecard/comprehensive-diabetes-care/index.html. Accessed 6-27-22.
40. https://www.kff.org/other/state-indicator/total-active-physicians/. Accessed 6-22-22.
41. DRG market share data. Siemens Healthcare Diagnostics Inc. (on file). 2020.

Wednesday, September 07, 2022

(If you’re a physician reading this, the answer is most likely yes)

by Andrew Harms

Every so often, a multi-state lottery jackpot in the US becomes so enormous that casual conversations and nightly newscasts take up the topic of playing the lottery with great anticipation and fascination. This summer, the Mega Millions lottery doled out their second-largest prize to a fortunate ticket-purchaser in the Chicago suburbs after 29 consecutive draws without a jackpot winner. A nearly $1.3 billion dollar jackpot!

If there was ever a remedy for financial difficulties, certainly windfall lottery winnings would be the answer, right? On the contrary, researchers studying lottery winners conclude that while lump-sum payments reduce the probability of bankruptcy in the first two years after winning, this reduction is followed by statistically significant increases of similar magnitude three to five years after winning.^[1] Research scientist and economist Jay Zagorsky points to imprudent spending behaviors and poor savings and investment choices as culprits for financial woes despite winning millions.^[2] “The key lesson for everyone, whether you play or not, is that when you get a windfall or win the lottery, plan ahead and resist the all-too-human temptation to spend all the money,” notes Zagorsky.

What can the hard-working physician earning a salary take away from such findings? Perhaps most simply: it appears even good luck and millions can’t replace financial literacy, a good financial plan, and responsible money management in achieving healthy outcomes.

A recent study published in The American Surgeon takes a closer look at the fiscal situation of surgical residents in a paper titled “Medically Smart, Fiscally Illiterate: Lack of Financial Education Leads to Poor Retirement Savings Strategies in Surgical Trainees.”^[3] The authors introduce important findings about the need for addressing fiscal issues among physicians early in their training, concluding “surgery residents have a large debt burden, minimal retirement savings and an overall lack of understanding of savings strategies. Well-designed, early, and accessible educational interventions may improve the “financial vital signs” of surgical trainees and establish habits for long-term financial success.”

Regardless of medical specialty, what sorts of early interventions relating to personal finances can a physician pursue to avoid financial mistakes early-on in their careers, set themselves up for successful years ahead, and ultimately enjoy a stable financial picture in retirement?

Assessment and Diagnosis of your Financial Picture

Earlier this year, the AMA’s medical residency personal finance team outlined financial advice for residents in a series of blogs from Senior News Writer Brendan Murphy.^[4] We’ll highlight a few points we think are helpful in assessing where you may need to begin in formulating a financial plan. 

• Understand your income: The typical annual salary for a first-year resident is about $58,000, according to the Association of American Medical Colleges. But that does not mean that you will have $4,833 each month to spend as you see fit.
• Create a budget: There is across-the-board consensus—from fellow residents who have had experience in living on a comparable salary to financial experts who have worked with young physicians—that it is critical to put together a realistic budget and to stick to it as best you can.
• Have a loan-repayment game plan: For those in federal loan repayment, the present climate—which has allowed for two-plus years of interest-free loan forbearance—has been beneficial. Setting a repayment strategy—whether that involves remaining in federal loan repayment after the forbearance period ends or refinancing—is paramount for shaping a young physician’s financial well-being going forward. 

Interventions in Personal Finance: The earlier the better when it comes to saving!

The findings from the recent “Medically Smart, Fiscally Illiterate” study suggest both a deficit in financial literacy and a lack of widely adopted solutions cause physicians challenges with respect to saving and investing, namely “despite these data establishing that there is indeed a problem, reports on sustainable solutions have been rare.” As we know well, our time demands and responsibilities as physicians leave us little or no room to become financial experts. Regardless, we must start somewhere if we desire financial well-being, and the earlier we start the better.

Following the creation of a budget, it's time to map out our goals and take some corrective actions where necessary. Once comfortable with their debt-repayment strategy and once reassured with an emergency fund in the event of the unforeseen, most physicians we talk to have goals which turn to saving and investing.

Although a wealth of information about saving and investing is available, we prefer to point our readers to resources focused on physician financial health. One important note we must point out: before jumping into the world of investing, be sure to understand well the investment vehicles you’re opting into and the tax consequences of each. And don’t hesitate to ask questions—you’re sure to have some, if not many!

For those investing during residency, our experienced friends serving nationwide physicians from Larson Financial Group point to two crucial steps every resident should take to protect their future income and reward themselves for their hard work:

• Start contributing today. We understand the financial constraints you’re up against during residency, but the benefits of saving just a small portion of your salary to a tax-deferred account can quickly add up, especially if you contribute enough to take advantage of your employer’s matching fund program. For example, if your hospital matches up to 5 percent of your salary, but you only contribute 3 percent, you leave thousands of dollars in free money on the table. Plus, because contributions are pre-tax, it hurts a bit less in the moment. You may also consider contributing to a tax-advantaged Roth IRA in addition to your 401(k) or 403(b), but contributions are capped at $6,000 each year.
• Make your move. Your income will be at its lowest during residency compared to any other time in your professional life moving forward if you remain in healthcare. That’s why we encourage residents to convert their tax-deferred account to a tax-advantaged account, such as a Roth IRA, upon graduation (or as early as you can) with both as low of income and as low of a balance as possible. When you retire, that money you earned in residency can be distributed tax-free, providing you with thousands more in retirement income. For instance, a graduate who converts $20,000 to a Roth IRA can potentially generate $5,000 more each year in income when they retire and benefit from $100,000 in tax savings. But before you do convert, it’s best to speak with a financial advisor to avoid any possible tax repercussions.^[5]

In lieu of winning the Mega Millions jackpot (odds of a winning ticket are 1-in-302,575,350), we physicians must navigate a longer road to wealth requiring countless hours of medical training and years of providership. Though as we indicated above, even a lucky lotto winner must formulate and implement a sound savings and investment strategy without overspending and blowing it all away. Nothing is a given on the road to financial success.

If you’re struggling with diagnosing or treating your “financial vital signs” (to steal a phrase coined by the authors of “Medically Smart, Fiscally Illiterate”) and/or looking for assistance with how best to save and invest, please feel free to reach out for guidance and support. As in medicine, early interventions when it comes to personal financial planning may save you some troubles in the near future and provide benefits to you throughout your years of practice and long into retirement.

^[1]Hankins, Scott and Hoekstra, Mark and Skiba, Paige Marta, The Ticket to Easy Street? The Financial Consequences of Winning the Lottery (March 26, 2010). Vanderbilt Law and Economics Research Paper No. 10-12.

^[2] https://theconversation.com/odds-are-1-5-billion-powerball-winner-will-end-up-bankrupt-52972

^[3] Medically Smart, Fiscally Illiterate: Lack of Financial Education Leads to Poor Retirement Savings Strategies in Surgical Trainees - PubMed (nih.gov)

^[4] https://www.ama-assn.org/medical-residents/medical-residency-personal-finance

^[5] Investing During Residency Options to Maximize Your Current Benefits and Future Retirement – Larson Financial

Thursday, July 14, 2022

by Miriam Sweeney 

Money is one of the most influential things in our lives that is simultaneously most difficult to talk about. And the medical field is no exception. In my unique situation, I’ve had the opportunity to talk with an abnormally high number of doctors-to-be about their finances.

It started when I began to edit friends' personal statements with them before their applications to medical school. Editing one friend’s statement led to editing their friend’s statement, and soon enough, I had a small seasonal editing side gig on my hands.

As I worked with premeds to articulate why they wanted to go to medical school, it surprised me how infrequently people would tell me that one of their motivations for going to medical school was financial.  When talking with bright young people who are midway through their undergraduate degrees and sincerely contemplating the next decade of their lives and stating (not only with a straight face, but with excessive volunteer and shadowing hours and effort to get great grades) that they think that going back to school and staying in it for years to come is actually a fantastic idea, very few talked me about how much money they hope to make.

In fact, as part of my personal statement editing process, I’ll ask everyone why they want to go to med school.  I never let them give me just one simple answer. I encouraged everyone I worked with to brainstorm a list of responses in the style of “there are no wrong answers here.” Of course, I didn’t tell them they needed or even should include all the reasons in their personal statement, but I wanted to see their minds were open and they were willing to be honest with themselves. And not one of the dozens of students who I worked with ever mentioned compensation until after I prodded them and indicated that money and lifestyle are also valid reasons for enormous career decisions. Once prompted, everyone would chuckle, loosen up a bit, and agree that they wanted to be compensated well for hard work in their career.

But we don’t talk about this. We don’t talk about how much money we make or how much money we wish we made. Or, if we do, perhaps we fear being lumped together with money-hungry ladder climbing go-getters who want nothing more than to increase their salary and die someday on a king-sized bed built of hundred dollar bills. No one wants to be lumped into a category with that guy.

But that stigma is keeping us from conversations that could potentially truly benefit us and help us in continuing our education of how to navigate the world as professionals, providers, family members, members of various communities, and adults in general.

When exploring the need for a physician personal finance education platform, I had as many conversations with medical students, residents, and early-in-their-attending-years physicians as I could. I want to know the same thing from all of them: I wanted to better understand their experience and relationship with money and how those have shaped their decisions and experiences in relation to their careers. In a field as demanding and highly intellectual as medicine, I was surprised by the enormous variety I found when people talked through their relationship with money.

Some people I talked to were extremely debt-tolerant, going into more debt than strictly necessary to ensure that their undergraduate medical school and residency experiences were not just livable, but top-notch. Others had been raised in families where they were taught that maintaining a monthly balance on their credit cards would improve their credit scores (in case you fall into this category, know that it doesn’t). Still others would readily confess (and sometimes proudly brandish) their utter and complete ignorance to all things financial — whether we were discussing simple monthly budgets or complex investing and retirement plans — and wave to me in the direction of a significant other, a cousin, or, in many cases, a tired and caring member of their physician faculty who had somehow earned himself or herself the reputation for being the go-to money person on staff for generations of medical students, residents, and attending physicians.

In stages as demanding and vertical as medical school and residency, it is a blessing, I’m sure, to have someone in your life who is willing to take on the mental load of finances. In fact, in my informal research, I discovered it was more common than not for a medical student's partner to be not just in charge of household finances, but the primary go to person for matters of their own educational debt and repayment. In other words, we find ourselves with a system that is not only so demanding and rigorous that it’s leading to increasingly poor health outcomes for its own people, but that it leaves individuals so flabbergasted as to how to navigate its financial implications that those individuals are left to resort to the patient research of their loved ones to understand their own options for how to pay for their medical education.

Such a system, combined with the trend of not talking about finance, also creates an uncomfortable inequality between professionals. According to recent statistics, 25% of medical students graduate without debt from medical school.^[1] That means that if you as a medical student are looking to your peers for an example of what a suitable, sustainable lifestyle is like for yourself, then a quarter of the time, you may be looking at someone who is not dealing with the mental load and pressure of debt in the way you are dealing with it. Even something as simple as seeing your friends take vacations or make arguably unnecessary purchases may create subliminal pressure for you to also indulge in things that appear to be affordable for a fellow medical student, whether or not you have determined that they are personally affordable for you.

This tendency to avoid discussing personal finances has also led to extreme oversimplification from a systemic perspective. I was again surprised in my conversations with medical students and residents to hear how generally unhelpful many of their interactions with their financial aid offices at their respective institutions have been. One person recounted being told (for the entirety of a lecture, mind you, that was advertised as designed to help them to make a plan for budgeting on a limited residence budget) that their financial situation was their fault because their generation was likely to be buying fancy coffee daily instead of brewing their own. Such oversimplification and condescension was, I’m sorry to say, much more common than one would hope in these conversations with medical students, residents, and attending physicians. Such an experience, even this one in its extreme, produces droplets of shame that are bound to fester and prevent otherwise productive conversations, whether formal or spontaneous, from happening in the first place. It could prevent an individual physician from learning something about money management or investing that could change their lives – and, by extension, the lives of their patients and families – for the better.

For most people, it is unthinkable to get through a full medical education without any debt. And that’s not necessarily a bad thing; modern society allows for investments of time and money into the promise of future value, and the existence of student loans is one of the things helping to ensure that we have the best providers being trained and not just the providers who happen to come from families who can afford to make them doctors. But if we don’t reevaluate our own relationship with money and openly revisit the stigma of talking about money and one another, I’m afraid that we will create a stagnant environment where needed change – whether that change is needed on administrative levels to ensure the sustainability and financial viability of healthcare organizations, or needed on individual levels to sustain and promote good mental health for hard-working physicians– is entirely inaccessible.

You can start today. If you have a solid knowledge of personal finance, complete with a robust retirement and investing plan and debt payoff strategies, then bring up something you’ve learned or heard recently about personal finance with your colleagues. If they see you’re willing to discuss finances, they may also be willing to open up.

Conversely, if you don’t feel confident in your own understanding of your options and personal finances — or even if you just recognize that there’s no way to know what you don’t know — then make a plan to learn something. There are plenty of podcasts and Youtubers who discuss personal finance at length, and some of us even focus specifically on physician personal finance. If you want a bite sized, free way to start that educational experience, I would love to hear if the app that my team and I built in response to those dozens of conversations I had scratches that itch for you.

What is perhaps most important is remembering that money is just a tool. If we treat it like a tool and not like a prize to be won on one end of the spectrum or an unknown, unfeeling god to fear on the other, then we’ll be more likely to be personally in control of our money. We’ll be more able to be a source of positive change where changes are needed to make the world safer, healthier, and more prone to thrive.

^[1] MedSchoolInsiders: https://medschoolinsiders.com/pre-med/the-real-cost-of-medical-school/#:~:text=Approximately%2012%25%20graduate%20with%20%24300%2C000,just%20a%20few%20years%20ago.

Thursday, July 14, 2022

by Susan Garramone, Senior Clinical Marketing Manager - Siemens Healthineers

 Chronic diseases are the leading causes of death and disability in the U.S. and major drivers of the nation’s rising healthcare costs.¹ Per the Centers for Disease Control and Prevention, the top seven chronic diseases include heart disease, cancer, chronic lung disease, stroke, Alzheimer’s disease, diabetes, and chronic kidney disease (CKD). In the United States, 60% of adults have one chronic disease, and 40% are reported as having two or more.¹ The costs of these chronic diseases account for nearly 86% of healthcare costs.²

Chronic diseases are the leading causes of death and disability in the U.S. and major drivers of the nation’s rising healthcare costs.¹ Per the Centers for Disease Control and Prevention, the top seven chronic diseases include heart disease, cancer, chronic lung disease, stroke, Alzheimer’s disease, diabetes, and chronic kidney disease (CKD). In the United States, 60% of adults have one chronic disease, and 40% are reported as having two or more.¹ The costs of these chronic diseases account for nearly 86% of healthcare costs.²

With these staggering statistics, chronic disease management has become one of the most important priorities for healthcare organizations today and the driving force behind value-based care: the measured improvement in a patient’s health outcomes for the cost of achieving that improvement.³

Value-based Care (VBC)

The goal of value-based care is to standardize healthcare processes and develop proactive best practices for patient care to prevent progression and avoid complications of disease before they start. The Value-Based Care (VBC) model centers around patient and provider accountability, shifting emphasis from fee-for-service.⁵ In this model, physician and hospital payments are based on patient outcomes, rather than volume-based metrics such as the number of patients seen, or procedures performed. The focus on patient outcomes is intended to help reduce healthcare costs while improving overall patient health and well-being.⁵

Patients seeking care for most of the high-cost chronic conditions, including diabetes and CKD, rely heavily on primary care physicians.⁶ In fact, primary care physicians treat at least 90% of patients with diabetes in the United States.⁷ Regular visits with primary care physicians can involve screenings, checkups, monitoring and coordinating treatment, and patient education to help manage chronic conditions.

Value-based care may provide earned financial relief to primary care practices while allowing clinicians to strengthen the rewarding patient relationships that are the backbone of primary care.⁸ In a joint survey by the American Academy of Family Physicians and CompHealth, 87% of providers said the best part of their job was “interacting with patients and helping patients.”⁹ Unfortunately, to achieve success in fee-for-service models, providers spend less time with patients, often addressing immediate needs but not underlying causes.⁹ Value-based care changes this dynamic, as it aligns incentives with the physician’s focus on patient outcomes rather than volume. Additionally, moving from a patient-volume model improves the experience of both the patient and physician, and may allow more time for valuable consultation.^9,10 Overall, value-based care helps address the goals of the Quadruple Aim: better outcomes, lower costs, improved patient experience, and improved clinician experience. 

Quality Measures and Quality Payment Programs

Quality measures are standards for evaluating performance when caring for patients. They are developed by both private and public-sector organizations and are generally based on the current clinical guidelines or literature reviews. Quality measures are used to not only benchmark individual clinicians and distribute bonus payments, but also to evaluate facilities, health systems, treatments, and care coordination.¹¹ There are several quality-payment programs and performance-measurement sets designed to hold providers accountable for quality, assist in identifying opportunities for improvement, and monitor progress over time.

The Centers for Medicare & Medicaid Services (CMS) is the largest payer of healthcare services in the United States.¹² CMS is also the primary driver of changes in payment and delivery models and incorporation of value-based purchasing of healthcare services based on incentives.¹² The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established a physician payment system that incentivizes improvements in U.S. healthcare. Under MACRA, physicians participate in the Quality Payment Program (QPP), depending on eligibility, payment impact, and other factors, through the Merit-Based Incentive Payment System (MIPS) or through Advanced Alternative Payment Models (APM), such as risk-bearing accountable care organizations (ACOs).¹³

All eligible clinicians must choose to participate in either the MIPS or the APMs track and meet eligibility based on specific requirements.¹³ MIPS is the default program for all providers. In the MIPS program, providers’ performance is measured in four categories: quality, costs, the use of certified EHR, and improvements in clinical practice. Each category is weighted, and providers receive a score between 0 and 100.^13,14 This score is then used to adjust payments. Under APMs, there are financial incentives related to the level of provider financial risk and the quality of care provided.¹⁴

In 2022, MIPS scoring is weighted as follows: Quality (30%), Advancing Care Information (25%), Clinical Practice Improvement Activities (15%), and Cost and Resource Use (30%). The maximum payment adjustment for 2022 is ±9%.¹⁷

The National Committee for Quality Assurance (NCQA) established a comprehensive set of standardized performance measures, the Healthcare Effectiveness Data and Information Set (HEDIS), to give purchasers and consumers a way to reliably compare health plan performance.¹⁸ 90% of U.S. health plans, including commercial, Medicare, and Medicaid health plans, use HEDIS measurement targets in determining quality incentive payments.¹⁸ Several HEDIS measures align with and are included in MIPS criteria.

Chart references 13, 18

Quality Measures in Diabetes and CKD

Diabetes is an ideal target for prevention strategies, as it is a major risk factor for other serious chronic conditions, including CKD. In the U.S., 37 million people are diagnosed with diabetes.¹⁹ This epidemic is responsible for an estimated $327 billion in annual medical and lost productivity costs.²⁰

Additionally, 1 in 3 adults with diabetes also have CKD, responsible for more than $81 billion in annual Medicare costs.^21,22 For those at risk for diabetes and CKD, early identification can prevent disease. For those with disease, early identification and treatment and routine monitoring can control disease progression and prevent related complications.²³ On this basis, both diabetes and CKD are good targets for value-based care, where there is a desire to positively manage long-term outcomes while containing total cost of care in these growing populations. As such, diabetes and kidney health quality measures are often a focus of quality payment programs.

Guidelines call for routine testing of hemoglobin A1c (HbA1c) and urine albumin-creatinine ratio (uACR) for disease monitoring and management.^24,25 However, the literature demonstrates that only approximately 70% and 32% of patients with diabetes follow the testing guidelines for HbA1c and uACR, respectively.^26,27

Key quality measures in diabetes care are HbA1c control for patients with diabetes and uACR for patients with diabetes and kidney disease.^28,29 

The population health challenge presented by diabetes, and the need for action, have been recognized for a long time. In 1998, to assess quality of care in diabetes management, the Centers for Medicare & Medicaid Services (CMS), the National Committee on Quality Assurance (NCQA), and the American Diabetes Association (ADA) led the first national effort to develop a set of performance measures for diabetes.³⁰ These quality performance measures have since been widely adopted for assessment in Medicare, Medicaid, and commercial health plans, as a driver toward value-based care.³¹

Both MIPS and HEDIS quality measures for 2022 include measures for guideline supported HbA1c and uACR testing (Table 1).^28,29

Table 1. HEDIS and MIPS 2022 quality measures for HbA1c and uACR testing.

A Path to Success in Quality Programs with Point-of-care Testing

Managing patients diagnosed with diabetes according to clinical guidelines is critically important, yet overall testing compliance is poor^26,27  Point-of-care testing (POCT), clinical laboratory testing at the site of patient care, has been described as a quick, easy, reliable method for monitoring diabetes, and improving test adherence, in the primary care office setting.³²   POCT enables the physician to perform diagnostic testing during an  office-visit and affords the opportunity for immediate patient-physician consultation and intervention, eliminating potential loss and cost of follow-up associated with traditional laboratory (send-out) testing.³²    In fact,  the ADA has stated that “The use of point-of-care A1C testing may provide an opportunity for more timely treatment changes during encounters between patients and provider.”²⁴  

There is a growing body of evidence supporting the benefits of point-of-care testing to meet goals:

• A study by Crocker et al. demonstrated that POC HbA1c testing led to 3.7 times decreased likelihood of missing HbA1c ³²
• A second study by Crocker demonstrated that point-of-care HbA1c testing “can significantly improve clinical operations with cost reductions through improved practice efficiency,” realizing a potential savings from improved efficiency of $24.64 per patient.³³ This savings was achieved through a reduction in the number of calls, letters and additional patient visits required following implementation of POCT.
• A recent study by Christofides stated, “Access to uACR testing may be improved by using Clinical Laboratory Improvements Amendments (CLIA)-waived point of care UACR testing options, that is, those approved for use closer to the patient and not necessarily in a central laboratory,” and noted that using a CLIA-waived POC uACR option was a means to optimize test ordering.³⁴
• A study by Schultes et al. found that the implementation of uACR POCT in daily general practice can improve the diagnosis and treatment of diabetic kidney disease (DKD).³⁵ The availability of uACR results at the time of the consultation led physicians to make medication adjustments to 18.5% of the patients enrolled in the study.³⁵

The findings reported in these papers, and others they cite, suggest implementation of POCT may help busy practices achieve quality measures with increased testing adherence while decreasing operating costs through improved practice efficiency.^32-35

Conclusion

The goal of value-based care is to cost-effectively improve patient outcomes. Value-based care models reward providers for efficient and effective patient care based on reported quality measures. Chronic conditions such as diabetes and CKD are ideal targets for value-based care because early detection and coordinated intervention can stop disease progression, improve quality of life, and reduce healthcare costs.

Quality measures in both diabetes and CKD are focused on guideline-recommended diagnostic testing. Adoption of point-of-care testing can improve test adherence while bringing increased value to patient office visits. Availability of real-time test results enables immediate consultation and faster intervention and treatment. This facilitation of care may lead to improved patient outcomes and decreased overall diabetes-related healthcare costs, meeting the goals of value-based care.

References

1. https://www.cdc.gov/chronicdisease/about/index.htm#:~:text=Many%20chronic%20diseases%20 are%20caused. Accessed 4-13-22.
2. Holman HR. The relation of the chronic disease epidemic to the health care crisis. ACR Open Rheumatol. 2020 Mar;2(3):167-73. doi: 10.1002/acr2.11114. Epub 2020 Feb 19. PMID: 32073759; PMCID: PMC7077778.
3. https://www.nachc.org/wp-content/uploads/2017/05/CHF-Winter-Spring-2017-Facing-the-Transition.pdf. Accessed 4-13-22.
4. Petersen R, et al. Improving population health by incorporating chronic disease and injury prevention into value-based care models. North Carolina Med J. 2016;77(4):257-60. doi: 10.18043/ncm.77.4.257.
5. https://my.clevelandclinic.org/health/articles/15938-value-based-care. Accessed 4-13-22.
6. Sharma MA, et al. Patients with high-cost chronic conditions rely heavily on primary care physicians. J Am Board Fam Med. 2014;27(1):11-2. doi: 3122/jabfm.2014.01.130128.
7. Davidson JA. The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010;85(12 Suppl):S3-S4. doi: 10.4065/mcp.2010.0466
8. https://www.capphysicians.com/articles/overview-value-based-care-primary-care-practices. Accessed 4-13-22.  
9. https://www.priviahealth.com/blog/how-the-quadruple-aim-and-value-based-care-intersect/. Accessed 4-13-22.
10. Teisberg E, Wallace S, O'Hara S. Defining and implementing value-based health care: a strategic framework. Acad Med. 2020;95(5):682-5. doi: 10.1097/ACM.0000000000003122.
11. https://carejourney.com/physician-quality-and-why-it-is-important/ABCs of Measurement. Accessed 4-13-22. Error! Hyperlink reference not valid.
12. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Quality-Programs. Accessed 4-13-22.
13. https://www.aapc.com/macra/macra.aspx. Accessed 4-13-22.
14. https://checkpointehr.com/blog/difference-between-mips-and-apms/. Accessed 4-13-22.
15. https://www.myavls.org/member-resources/macra-resources.html . Accessed 4-13-22.
16. https://qpp-cm-prod-content.s3.amazonaws.com/uploads/1783/QPP%202020%20Participation%20Results%20Infographic.pdf . Accessed 4-13-22.
17. https://mdinteractive.com/mips-blog/cms-releases-2022-mips-final-rule-key-takeaways. Accessed 4-13-22.
18. https://healthpayerintelligence.com/news/how-hedis-cms-star-ratings-cqms-impact-healthcare-payers. Accessed 4-13-22.
19. https://www.cdc.gov/diabetes/basics/quick-facts.html . Accessed 4-13-22.
20. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-28. doi: 10.2337/dci18-0007.
21. https://www.cdc.gov/kidneydisease/prevention-risk/make-the-connection.html. Accessed 4-13-22.
22. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd. Accessed 4-13-22.
23. https://www.consultant360.com/articles/diabetes-and-chronic-kidney-disease-prevention-early-recognition-and-treatment. Accessed 4-13-22.
24. American Diabetes Association. Glycemic targets: standards of medical care in diabetes—2021. Diabetes Care. 2021 Jan;44(Suppl 1): S73-S84. Available from: https://doi.org/10.2337/dc21-S006. Accessed 4-13-22.
25. American Diabetes Association Professional Practice Committee, et al. 11. Chronic kidney disease and risk management: standards of medical care in diabetes-2022. Diabetes Care. 2022;45(Suppl_1): S175-S184. doi: 10.2337/dc22-S011.
26. https://www.cdc.gov/diabetes/pdfs/library/Diabetes-Report-Card-2019-508.pdf. Accessed 12-17-21. Accessed 4-13-22.
27. Alfego D, et al. Chronic kidney disease testing among at-risk adults in the U.S. remains low: real-world evidence from a national laboratory database. Diabetes Care. 2021;44(9):2025-32. doi:10.2337/dc21-0723.
28. https://www.ncqa.org/wp-content/uploads/2021/12/HEDIS-MY-2022-Measure-Descriptions.pdf. Accessed 4-13-22.
29. https://qpp.cms.gov/mips/explore-measures?tab=qualityMeasures&py=2022#measures. Accessed 4-13-22.
30. Fleming BB, et al. The Diabetes Quality Improvement Project: moving science into health policy to gain an edge on the diabetes epidemic. Diabetes Care. 2001;24(10):1815-20. doi: 10.2337/diacare.24.10.1815.
31. https://diabetesjournals.org/care/article/34/7/1651/38635/Diabetes-Performance-Measures-Current-Status-and . Accessed 4-13-22.
32. Crocker JB, et al. The impact of point-of-care hemoglobin A1c testing on population health-based onsite testing adherence: a primary-care quality improvement study. J Diabetes Sc Technol. 2021;15(3):561-7. doi: 10.1177/1932296820972751.
33. Crocker JB, Lee-Lewandrowsky E, Lewandrowsky N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640-6.
34. Christofides EA, Desai N. Optimal early diagnosis and monitoring of diabetic kidney disease in type 2 diabetes mellitus: addressing the barriers to albuminuria testing. J Prim Care Community Health. 2021;12:21501327211003683. doi: 10.1177/21501327211003683.
35. Schultes B, Emmerich S, Kistler AD, Mecheri B, Schnell O, Rudofsky G. Impact of albumin-to-creatinine ratio point-of-care testing on the diagnosis and management of diabetic kidney disease. J Diabetes Sci Technol. 2021 Oct 28;19322968211054520. doi: 10.1177/19322968211054520.

Wednesday, May 18, 2022

by Andrew Harms

Since our last monthly article, I spent more time in hospital rooms and hallways interacting with healthcare workers than I had any time prior — for great and happy reasons. My wife and I welcomed a daughter, our first child, and received wonderful care from Georgetown University Hospital, a teaching hospital nestled into one of the oldest neighborhoods in Washington, D.C. We are so thankful and so overjoyed. Our appreciation for healthcare workers remains at an all-time high.

Sentiments of thanks are timelessly applicable to healthcare workers yet much less noticeable than during the early days of the pandemic era. My travels throughout the U.S. anecdotally confirm that declining visibility of signs of appreciation are not isolated to my local surroundings.

Just two years ago, the signs were evident everywhere you looked. “Thank You, Healthcare Workers”

Murals and billboards adorning buildings, posters on public transportation vehicles, signage in front yards and prints on personal apparel — the loud and communal response of appreciation toward healthcare teams serving on the frontlines of pandemic care were voluminous across the United States. Rightly and deservedly so.

I suppose one could argue that the draw-down in visible support is an indication we’ve collectively made it through the most difficult times — that frontline workers succeeded and continue to succeed in their efforts. A good thing. On the other hand, dwindling public reminders of the determined and consistent efforts to care for communities during pandemic peaks may signal a somber retracement to a state of underappreciation for healthcare workers.

Let's hope that’s not the case. We know the effort to care for patients, families and communities by the U.S. healthcare team is never ending if not ever-increasing.

To friends, family and colleagues in healthcare, the busy hospital hallway scenes probably appear normal and familiar. To a patient or visitor to a hospital, the scenes may seem surreal (especially after two years of laying low and spending more time near home). Patients with all ailments experiencing medical conditions of all varieties, people of great diversity in age and background, coming together in a mix reminiscent of Union Station or a busy airport terminal. All descending on the hospital seeking care and comfort from healthcare providers.

In the month since my daughter’s birth, our family of three made visits to the hospital for two-day, two-week, and month-out newborn appointments, as well as one visit to a specialist and some follow-ups for mother. In this context, I’ve been thinking and speaking to providers through the lens of a new (sometimes overwhelmed) father and yet also as co-founder of ScrubMoney.

Each month, ScrubMoney’s articles appearing in Physicians Office Resource direct our readers to topics related to physician personal finance — in most cases, topics with ubiquitous applicability to healthcare workers of all specializations. We hope these short articles may offer readers some helpful perspective, perhaps a takeaway or two if not a call to action and change in behavior. We’ve written previously on subjects pertaining to perspectives and outlook toward one’s own finances (i.e. finding happiness), the unique circumstances of physician personal finances, and tips on budgeting. We hope you’ll continue to look forward to our commentary each month going forward.

We know physicians and medical professionals are up to the challenge of combating and navigating the personal financial space with the same resolve we witnessed in the response to the pandemic and as we see every single day in the hallways of hospitals. We know this because the appreciation that medical professionals have for one another is not an ebbing or perhaps fleeting sentiment. Today as ever, medical professionals are pulling together and tackling the most difficult challenges to improve all types of situations. It's a type of determination unique to this group, appreciated and respected among this group.

Medical professionals are a smart, detail-oriented, solution-based membership body capable of overcoming the most difficult problems. So why is it that personal financial matters so often create stumbling blocks, frustrations and a source of burnout?

There appears good research and plenty written about the need for better understanding of personal finances in the world of healthcare providers. Yet when walking the halls of a hospital, a provider may wonder “who’s got time for this?” or “I wish I had a better understanding of personal finance,” or worse yet, “where is all my money going?”

We understand. In forming ScrubMoney, in appreciation for healthcare workers, we brought together physicians at all stages of their careers to better support healthcare professionals with their personal financial journeys.

So where should a physician uncertain about personal financial matters begin? We suggest starting with a basic educational experience, one that addresses the most important personal financial matters. We recognize learning is an ongoing process and encourage each reader to learn the basics of personal finance through building blocks that are appropriate to each person’s situation.

To best enable healthcare professionals to improve their personal financial health, ScrubMoney is busy developing and delivering a free mobile app to provide an individualized, interactive and on-demand personal finance education. Our curriculum spans from the essentials to more actionable elements of personal finance. We favor a quality curriculum accessible for medical professionals who are always on the go.

We hope a better understanding of personal financial matters and an improvement in literacy will inspire physicians to take control of one’s own personal financial pathway. Creating a plan to overcome educational debts, designing a clear method to save and invest over time — these are the fruits of a person empowered with a goal of financial wellness. We know healthcare professionals are well-suited to achieve this goal. Time management, focus, determination, study and preparation are traits ingrained in the fabric of healthcare workers. We encourage all to make actionable plans and follow smart to-do lists, reducing the mental load of debt repayment and financial planning in order to stay on track over time.

We know at some point a physician or healthcare professional may certainly need financial assistance from a qualified and trusted expert in a specialized financial field. Financial resources and qualified professionals supportive of physician financial wellness are available. Very often, though, these much-needed outlets are inaccessible due to providers’ training and attending schedules that may approach near-burnout levels. Whereas ScrubMoney is physician-built and physician-focused, we aim to provide support in finding the most suitable and trustworthy service providers. We encourage medical professionals to connect with resources that may already be available to them through their affiliated schools, employers and institutional relationships.

While public displays of support for healthcare workers may have weathered and waned from their highs, we know appreciation and support within the healthcare fields will always remain strong. Together we will strive to empower medical school students, residents, attendings and institutions to tackle the persistent challenge of how-to better address managing rising educational debts, insufficient time for personal financial education and seek creative solutions to enable access to needed financial help.

We believe a great way to say “Thank You” to yourselves as healthcare workers is to afford yourself a bright financial future through timely education and trusted resources. We’re excited to find stakeholders in medicine that are eager to solve these challenges as well. You – our healthcare team – are very much deserving of financial wellness.

Wednesday, May 18, 2022

by Andrew Harms and Miriam Sweeney 

For the average U.S. household, everyday living is getting pricey. Childcare, food, energy, transportation, and housing costs are all rising. Among U.S. physicians and healthcare professionals, personal financial matters may make things tougher given high educational debt-loads, capped income levels during residency years, and unique insurance needs. Furthermore, job-related stressors emanating from clinical and patient-care priorities, administrative duties, continuing education, licensing requirements, and professional responsibilities leave little time for prudent, active personal financial management.

Self-reported depression and burnout rates are high. In fact, in recent years more than 4 in 10 U.S. physicians report feeling burned out.^[1] When asked to rate factors that contribute to depression, results from Medscape’s annual National Physician Lifestyle Report indicate personal finances ranked second to job/workplace as a contributing factor.^[2]

When asked what would reduce their burnout, the number one response from physicians (roughly a third) indicated the best way to combat burnout would be increased financial compensation. We want to be paid more. In fact, more money was a more common response than a more manageable schedule.

The circumstances facing a physician's personal finances present a unique challenge to most in medicine, regardless of specialty. A predominant factor to financial troubles for physicians includes the high cost of education required to become a physician.

According to the AMA, one in four medical students graduates with training-related debt that exceeds $200,000, and half of medical school graduates report debt burdens greater than $150,000. Those financial burdens are combined with a demanding schedule during graduate medical education and can affect well-being for physician residents and fellows. “Between financial restraints and 80-hour workweeks, trainees often struggle with having the time and budget for necessities. When residency and fellowship programs provide benefits to assist with these needs, it can significantly improve trainee well-being,” said AMA Trustee Jesse Ehrenfeld, MD, MPH.^[3]

Compounding the difficulties, we recognize that the time and attention required to study medicine, biological sciences, and patient care during training to become a physician leaves little room to acquire a solid education in personal financial management.

Prioritizing personal financial literacy for early-career physicians

Many physicians have access to financial resources early on in their career, but that doesn’t mean they’re confident about their financial situation. At the medical school level, some hopeful trends have emerged to address the rising educational debt levels burdening many graduates.

At a handful of US medical schools, financial aid offices have transitioned to financial wellness offices—aiming to better help students with personal financial understanding, housing and living expense considerations, etc.—moving beyond simply providing tuition financing guidance in order to provide holistic financial support and literacy. A great example of this is witnessed at the University of Arkansas for Medical Sciences, where Jason Mizell, M.D., and UAMS faculty have facilitated a popular ‘Business of Medicine’ course since 2012, taught to residents and fourth-year medical students.^[4] This course serves to teach early-stage physicians both practice management finance (coding, billing, malpractice, etc.) and, very importantly, personal finance.

Another excellent example of an offering available to medical students is provided by the University of Wisconsin School of Medicine and Public Health. When medical student Rufus Sweeney struck up conversations with his peers some years ago about their personal finances, he was shocked by how few understood their student debt or even knew about options to pay it off. With a grant from the Wisconsin Medical Society, Rufus joined with Emma Crawford, UW SMPH Director of Financial Wellness and Financial Aid Advising, to develop UW-Madison SMPH’s first ever course focused on physician personal finance. This course continues and remains the most popular elective credit offering at the medical school.

While such personal finance educational initiatives exemplified by UAMS and UW-Madison go a long way to improving financial literacy for young physicians, the trend to educate and empower physicians in the way of personal finances should be prioritized in order to meet cost of living challenges and resultant burnout rates. An introduction to personal finance is a great offering at the medical school level, and—if followed on with subsequent support at each next stage of a physician's career—would provide a proper runway to financial health and wellness.

At the residency level, new expenditure considerations often outweigh the long-awaited first paycheck. Many times, newly minted residents find themselves unprepared to manage a tight budget. A resident may sometimes find financial resources made available as a new employee helpful—though the quality and availability of personal financial support is disparate and often inadequate. While the financial picture of a resident includes income, the AMA clearly points out the following: “It takes years to realize your earning potential. As a physician, you will not maximize your earnings until the completion of your graduate medical education. The average first-year resident makes around $60,000, (2018 report) and there’s not much wiggle room. Resident salaries are determined by an institution and correlate with training year rather than specialty. So, in a given training institution, all residents who are in their third year of training get the same salary, and all in their sixth year are paid the same.”^[5]

Given the ceiling on income, how many physicians at the resident level have developed the experience and skills to single handedly manage the new challenges to their budget which may stem from debt-repayment, insurance needs, retirement saving, and other important considerations?

Factoring in time constraints and the reasonable desire for a personal life, very few residents have the time to dedicate to getting a handle on personal finances. A host of negative consequences may arise if physicians make financial mistakes at these early stages.

Where to start? Where to turn for help? Start simply.

Financial health should be treated in a similar way to attending to physical and mental health. When viewed from this perspective, the training of physicians gives this occupational group an advantage when tackling personal finances.

Let’s outline some simple steps early-career physicians can take to prepare for a healthier financial future:

• Become familiar with your financial vital signs

While carving out time from a busy schedule may seem impossible, scheduling a bit of time to learn some basics about your individual circumstances is essential. Dedicate some time—think about this as you would think about making an appointment with a doctor. Put it on your calendar.

Begin with some basic information gathering: Identify all sources of household income (review your paychecks, line by line); identify your fixed monthly expenses (housing payments, childcare costs, set-aside contributions for savings, etc.), as well as your variable monthly expenses (utilities, subscription services, transportation costs, etc.). As in most things in life, the best first step is figuring out where you are.

• Construct a monthly budget

You may think of this step as you would a treatment regimen. Crafting a monthly financial plan that identifies each incoming dollar and prudently purposes each outgoing dollar will provide a way forward and likely reduce the mental burden of financial unknowns. There are many good budgeting templates and guides. Like finding a good primary care physician, find yourself a budget that you like and works well for you. And like any treatment regimen, stick to your budget in order to achieve good health.

• Know your debt repayment options

For the majority of physicians, this step is vital to understand and implement. One resource worth checking out is provided by Doctored Money^[6], a non-profit serving physicians that has wonderful debt repayment tools and calculators.

• Identify support and establish communication

Assess your surroundings to locate trustworthy financial resources and fiduciary support, if needed. In many cases, the institution with which you are affiliated may have personal financial resources offered. Take advantage of these opportunities when available, if nothing else than to better educate yourself. Once you’ve built a network of professionals with whom you can confide, communicate to them as you would with your PCP, remembering that your goal is to limit risks and improve your overall health.

• Conduct routine financial check-ups

Living within a smartly formulated monthly budget is a winning health strategy, and combined with periodic (quarterly, semi-annual, annual) reviews of your financial vitals will increase your ability to achieve your financial goals. Schedule these reviews on your calendar well in advance, and approach them as you would a visit to any healthcare specialist. Satisfied debts, cost of living adjustments, salary increases, unexpected expenses, changes in the investable landscape, and other life events will prompt adjustments to your monthly budget. Regular check-ups will help you recognize and appropriately transition your personal finances. Utilize your network of resources and professional support on a regularly scheduled basis.

We’ve been talking a lot about early-career physician groups, but our suggestions are applicable to most, if not all, readers.

Address your financial needs with consistency, and in spite of uncertainties facing the cost of goods and households, we’ll make the U.S. healthcare system a secure, confident foundation for personal and community growth.

^[1] Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide

^[2] Medscape National Physician Burnout & Depression Report 2018

^[3] https://www.ama-assn.org/residents-students/resident-student-health/resident-physicians-should-get-help-shoulder-financial

^[4] Business of Medicine Course Preps Med Students for Real World | UAMS News

^[5] 6 things medical students should know about physician compensation | American Medical Association (ama-assn.org)

^[6] Doctored Money

Wednesday, May 18, 2022

by Miriam Sweeney 

The stratification starts in medical school. Before anyone has matched into their residency — long before attention has shifted from Step One and Two to writing a round of personal statements and preparing for interviews — conversations have already started about who is pursuing what specialty.

And in schools that emphasize class rank, pitting students against each other in preparation for a career where collaboration is key, medical students may already be making assumptions about their peers’ future specialties based on their class ranking or rumored scores. “There’s no way Sahil will match into ortho with a ranking like that.” “Emily may say she wants to be a pediatrician, but with a step score like that and the way she’s been buddying up to the attendings, she’d be a shoo-in for derm.”

In a field that requires immense financial and time commitment from its newest members, medicine shakes out to have very different compensations on the other side of residency depending on a physician’s specialty. There are ways of ensuring stability for everyone, especially the majority of medical students who graduate with medical debt. Having a solid understanding of investing, loan repayment options, and intentional spending can lay the path to success for someone making $150k or $500k. Tools like ScrubMoney — a free mobile app — that help support physician financial education and planning can be key in this process. But just understanding the nuances of why we spend the way we do can also go a long way in making sure we’re using what we have to build the life we want.

I'd recommend two basic focuses to achieving the lifestyle you want, no matter your income or specialty.

Focus I: The bold and swaggering decision to define what you want

We all grew up with motivational posters inviting us to go for our dreams, right? Those posters never took the time to help us understand how to know what our dream is, or how to form a dream in the first place.

You can’t get to where you’re going without knowing where you’re going, and too few of us take the time to really pinpoint where we want to be. I’m not talking about knowing our own tastes; it’s one thing to see something interesting, be it a style of a home or a fashion choice or a job description, and know if it’s for us or not. It’s an entirely different arrow in your quiver to visualize that home or outfit or job before any options are presented to you.

I’ve adapted a few different researchers’ and influencers’ ideas^[1] of what this process can look like and simplified it for this column.

1. Sit with the idea of what a successful life looks like. We don’t like talking about it, but physicians know it better than most: our lives are finite, and we don’t get endless opportunities for course correction. When you think of a successful, happy life, what does that look like for you?
   
   Focus on what you can control. You have less control, for instance, over whether you live to a ripe old age or are a casualty of irresponsible driving next month. Nevertheless, your life was a life, legitimate in spite of its abbreviated length. What will have made it successful?
2. Now that you’ve pictured your own brand of success, consider: in order to get to that success, what are the non-negotiables involved? What is irreplaceable in your picture of a life that leaves you happy and proud of what you’ve done and how you’ve spent your time?
3. Now, it’s a simple (or not) matter of defining how to go about shaping your decisions around those non-negotiables. How will you prioritize what’s most important? If your self-defined success has anything to do with an existing life partner, this process of planning for priorities might be one of deciding how to encourage habits that keep that relationship strong. If success requires something that must be checked off as a binary, it may be worth your time to think through what it’s going to take to mark that box.
   
   Many people who get this far stop there. That would still be a productive exercise. But without the next step, it’s still not necessarily going to help with making your resources — time and money — work for you.
4. Decide what to cut out. Do you have goals you’re actively working towards that aren’t reflected in your life success rubric? Are you spending your precious time or your hard-earned money on something that’s unattached to your idea of a successful, happy existence? This step requires confidence in yourself. Are you bold enough to cut out something that may matter greatly to other people, but isn’t central to your own life success?
   
   A big part of this step is understanding how to use your money in a way that will make you happy. Money can’t buy happiness, but according to researchers at the University of British Columbia, Harvard, and the University of Virginia^[2], the way you spend your money can lead to happiness.
   
   Don’t take it from me. Listen to the experts, as described in Chapter II of our effort to use money intentionally to get the life we want regardless of specialty or circumstance.

Focus II: “If Money Doesn't Make You Happy Then You Probably Aren't Spending It Right”

When aligning your actions with your definition of personal life success, the decision of how to allocate your resources can make a considerable difference in your progress. The question of how to spend your time belongs in another column. But the question of how to spend your money, happily, has been answered and peer-reviewed for us. Let’s break down the researchers’ findings.

1. Buy more experiences and fewer material goods. This notion is backed up by many studies, as cited in the paper itself. The gist is that we become accustomed to material possessions, but we never dull a happy memory when recalling it; on the contrary, a happy memory may become even happier when mentally reliving it. A treat yo’self day might be better spent on a visit to a spa or a chocolate tasting night instead of a new bathrobe or quality dark chocolate.
2. Use your money to benefit others rather than yourself. In a study that asked Americans to report about how much they spend on bills and expenses, gifts for themselves, gifts for others, and donations to charity, there was no significant correlation between spending money on the self (the first two categories) and happiness. There was, however, a strong relationship between people who spent money on others and self-reported happiness, even after controlling for income.
3. Buy many small pleasures rather than fewer large ones. I’ll admit, this one caught me off guard. Lots of little things instead of bigger, more significant things? It almost seems to contradict #1 on this list. But the research holds out, and it’s worth diving into the article itself to review the citations. The line that resonated most with me: “Eating two 6 ounce cookies on different days may be better than eating a 12 ounce cookie at a single sitting.”
4. Eschew extended warranties and other forms of overpriced insurance. This piece of advice feels remarkably specific for a list that otherwise boasts great general applicability. But this principle has less to do with specific retail tactics and more to do with human resilience.
   
   There is insurance that makes a lot of sense, and this article isn’t talking about it. This article is talking about the kind of insurance you get when you’re over concerned about losing something material, like the integrity of your new TV. Interestingly enough, the research suggests that, while the prospect of inconvenient loss is devastating, the experience of inconvenient loss tends to be one people recover from reliably and quickly.
5. Delay consumption. This principle essentially suggests that, if you plan a getaway to the tropics, plan it for nine months away, not two weeks. You will enjoy the experience more because you spent so much longer anticipating it.
6. Consider how peripheral features of your purchases may affect your day-to-day life. In other words, it’s easy to picture a dream of ours and only see the positives. Filtering out the negative effects of a decision may lead to disappointment when the time comes to enjoy a wish come true. Both the past and the wished-for future can be distorted with rose-colored glasses.
7. Beware of comparison shopping. Comparison shopping — looking for things based on how they measure up to each other instead of based on what you want in the first place — is designed to distract us from what we really want and make us make purchase decisions based on the best deal, not whatever is right for us.
   
   This holds true whether in a literal shopping situation or a more metaphorical situation that involves searching and decisions. (Dating and home browsing apps wouldn’t have anything to say about this, would they?)
8. Pay close attention to the happiness of others. Not to encourage a herd mentality, but, according to this article, “Research suggests that the best way to predict how much we will enjoy an experience is to see how much someone else enjoyed it.” It may be a good exercise to think about someone who you would define as successful or happy in your circle, then have a frank, humble conversation with them about what they think has made them happy and what might help you reach some of your intangible goals. We are all unique, but this research makes it look like we wax and wane in our satisfaction with things and experiences in concert with our peers.

It can be easy to assume that people with x will be guaranteed success in life, but success is a personal, arbitrary measurement.

If we can first a) define success for ourselves, along with a healthy foundational education of the elements that influence our success (like financial, mental, and social wellbeing, for instance), then b) follow best practices when spending our resources (our time and money), we’re more likely to reach our goals and be proud of our lives than if our personal rubric for success remains undefined or suffers from moving goalposts. 

Find out what resources your institution and community offer to support you in designing an intentional, satisfied life.

About the Author

Miriam Bay Sweeney is a co-founder and Head of Product of ScrubMoney, an app designed to help physicians lay the foundation for financial independence. She’s been fascinated by personal finance ever since learning as a young adult that sticking her paychecks and babysitting money she made as a teenager in a savings account was a crummy idea. She researches personal productivity and the foundational aspects — including financial confidence — that enable a person to innovate and thrive creatively. ScrubMoney is her way of giving back to the community of physicians that so many of her friends are part of, because we ought to think about taking care of the people who dedicate their lives to taking care of us.

Sources

1. Thanks to Clayton Christsensen, Ramit Sethi, Eric Barker, Dave Burnet, Bill Evans, James Clear, and likely a handful of others whose writing influences my perspective subconsciously

2. https://scholar.harvard.edu/files/danielgilbert/files/if-money-doesnt-make-you-happy.nov-12-20101.pdf

Wednesday, May 18, 2022

by Sekisui Diagnostics

Per the Forum of International Respiratory Societies report, five respiratory diseases are among the most common causes of severe illness and death worldwide.

The human toll of COVID-19 has demonstrated the necessity – and difficulty – of quickly identifying emerging respiratory diseases. Lab-based diagnostic tests have played an important role during the pandemic. But from the viewpoint of quality of care and clinical management, timely infection control, and the ability to act upon results, the future will likely belong to portable, CLIA-waived rapid diagnostic tests.

Point-of-care tests (POCTs) are performed at the site of sample collection (e.g., bedside, physician’s office or emergency department) and provide results usually in less than two hours and in some cases, within 10 minutes. They require little hands-on time and no laboratory training, as most critical steps are automated in a single device. Perhaps most important, they promptly identify the causative pathogen and help the healthcare professional choose the appropriate treatment or make the right decisions in outbreak situations, such as hospitalization or quarantine.

 “CLIA-waived” tests refer to those that the U.S. Food and Drug Administration has determined to be simple and that present “an insignificant risk of erroneous result.” (A list of tests granted waived status under CLIA may be found here.) Physician office labs wishing to perform CLIA-waived tests must first apply for a CLIA Certificate of Waiver, and then ensure that those performing tests follow the manufacturers’ instructions.

Diagnostic challenges of respiratory disease

For some time, point-of-care tests have allowed healthcare professionals to identify whether an infectious agent is viral or bacterial. That’s important, because antibiotics are only needed for treating certain infections caused by bacteria. Respiratory tract infections are a significant contributor to the global burden of respiratory tract illnesses. Per the Forum of International Respiratory Societies report, five respiratory diseases are among the most common causes of severe illness and death worldwide:

• Chronic obstructive pulmonary disease (COPD) - around 65 million people suffer from moderate to severe COPD, from which 3 million die each year, making it the third leading cause of death.

• Acute lower respiratory tract infections are considered the top three causes of death and disability among both children and adults. It is estimated that annually 4 million deaths of children under 5 years are caused by acute lower respiratory tract infections. Respiratory tract infections caused by influenza kill between 250,000 and 500,000 people and cost between $71 and $167 billion annually.

• Tuberculosis – 10.4 million people developed tuberculosis (TB) in 2015, from which 1.4 million died.

• Lung cancer kills 1.6 million people each year

• Asthma – Around 334 million people suffer from asthma and affects 14% of children globally.

Several pathogens, including viruses and bacteria, can cause respiratory tract infections. As clinical presentations often overlap, identification of the underlying pathogen based solely on clinical criteria is challenging.

While some respiratory viruses -- such as influenza A virus (IAV) or human respiratory syncytial virus (RSV) – are well-known and circulate worldwide, previously unknown or rare infectious diseases are spreading rapidly. They include human bocavirus (HBoV), human coronaviruses (HCoV-HKU1, -NL63), human metapneumovirus (HMPV), rhinovirus type C (RV-C), and human polyomaviruses (KIPyV, WUPyV), as well as SARS coronavirus (SARS-CoV), MERS coronavirus (MERS-CoV), novel strains of influenza virus A and B, and, most recently, SARS coronavirus 2 (SARS-CoV-2). Patients who develop such infectious diseases are also at risk of progressing to pneumonia which can cause even further complications. Early detection is key and leads to faster recovery.

Next generation

New and innovative diagnostic techniques, ranging from biosensors to novel portable and current lab-based nucleic acid amplification methods, offer a look at next-generation POCTs. While prototypes for some methods already exist, others are still experimental.

A key criterion for the evaluation of future POCTs will be their ability to identify the origin of the patient’s symptoms, and to distinguish relevant pathogen(s) from bystander pathogens. Questions need to be answered about the correct timing of diagnostic testing regarding a patient’s course of illness. The sensitivity and predictive value of a diagnostic test depend on:

• Specimen quality and virus load (which is usually higher in children and early in the course of illness).

• Duration of viral shedding (that is, release of the pathogen into the environment).

• Patient’s immune status.

• The epidemiology of viruses in the respective season or region.

Advances in diagnostic capabilities may change the way we identify, document, and communicate respiratory viral infections. In the future, patients will increasingly demand to know the responsible pathogen and their clinical prognosis. As researchers develop pathogen-specific antiviral therapies and vaccines, new diagnostic algorithms will be needed to ensure the highest quality of care while containing costs. The more accurate the diagnosis, the faster patients are on the road to recovery.

With worldwide manufacturing facilities and an international sales and distribution network, Sekisui Diagnostics is a solid partner for healthcare professionals and distributors around the world. Among its offerings are a line of CLIA-waived point-of-care tests to help identify influenza virus A and B, including Acucy® Influenza A&B, OSOM Ultra Flu A&B Test and OSOM Ultra Plus Flu A&B Test.

Wednesday, May 18, 2022

by Susan Garramone, Senior Clinical Marketing Manager
Siemens Healthcare Diagnostics Inc.

Introduction

Chronic diseases are the leading causes of death and disability in the U.S. and are leading drivers of the nation’s rising healthcare costs.¹ Chronic diseases are defined as conditions that last 1 year or more and require ongoing medical attention, limit activities of daily living, or both. Heart disease, cancer, chronic lung disease, stroke, Alzheimer’s disease, diabetes, and chronic kidney disease are among the most common. A staggering 40% of adults in the U.S. have two or more chronic diseases.¹ Unfortunately, chronic diseases are common, serious, and costly.

Common Comorbidities: Diabetes and Chronic Kidney Disease

Diabetes is the seventh-leading cause of death in the United States, affecting more than 37 million Americans.^2,3 It is attributed to an estimated $327 billion in annual medical and lost productivity costs.^2,3 Generally, care for patients with diabetes accounts for 1 in 4 healthcare dollars spent in the U.S., and a large portion of these costs results from diabetes-associated comorbidities that include potential neurological, cardiovascular, renal, and other chronic complications.³ In fact, diabetes is a risk factor for the development of chronic kidney disease (CKD); 1 in 3 adults with diabetes also have chronic kidney disease!⁴ In the U.S., where kidney disease is the tenth-leading cause of death, annual Medicare costs related to CKD are greater than $81 billion.^5,6 

In addition to major healthcare cost implications, complications from diabetes and CKD may have significant impact on patient well-being and quality of life. Early recognition and management of diabetes and CKD enable timely intervention and greater opportunity to protect patient health. Tragically, 40% of patients with diabetes and 90% of patients with CKD are unaware that they have these conditions.^5,7

With primary care being the first point of contact and foundation of a person’s healthcare team, the ability to test, diagnose, consult, and manage diabetes and CKD in the primary care setting may provide the opportunity to prevent clinically worsening disease and improve patient outcomes and overall population health.^8,9  

Diabetes and Hemoglobin A1c Testing

Glycated hemoglobin (A1c, hemoglobin A1c, HbA1c), which reflects average levels of blood glucose over the previous 2–3 months, is the most widely used test to monitor chronic glycemic control and the efficacy of treatment.¹⁰ In contrast to blood glucose levels, which fluctuate throughout the day based on diet and activity, the HbA1c level reflects a patient’s glycemic control for the past 3 months.¹⁰

The American Diabetes Association (ADA) recommends the assessment of glycemic status (A1c or other glycemic measurement) at least two times per year in patients who are meeting treatment goals (and who have stable glycemic control) and at least quarterly, and as needed, in patients whose therapy has recently changed and/or who are not meeting glycemic goals.¹¹ HbA1c testing can be performed in point-of-care (POC) settings such as a physician’s office or laboratory, though the ADA states that POC testing for A1c provides opportunity for more timely treatment changes.¹¹

According to the CDC, between 2011 and 2016, only 67.3–71.4% of U.S. adults with diabetes reported following the recommended testing guidelines.¹² This statistic is very concerning from a population health perspective, as low adherence to HbA1c testing has been shown to lead to higher HbA1c levels, which in turn may lead to complications and comorbidities.¹³ Research shows that every 1% decrease in the HbA1c level in a diabetes patient can remarkably lower the risk of complications, underscoring the importance of HbA1c monitoring and control.¹⁴

 A review of the literature suggests that incorporating A1c testing into the patient visit and customizing the consultation to the patient’s status appear to help physicians influence their patients to improve their glycemic control.¹⁵

The benefit of POC HbA1c testing has been widely reported in the literature.^9,15-19 Of note is a study by Crocker et al. that demonstrated that POC HbA1c testing led to 3.7 times decreased likelihood of missing HbA1c testing.⁹ Nearly 1 in 4 of the individuals tested were found to have clinically worsening diabetes. Their diagnosis using POC testing enabled more timely intervention in diabetes management. A recent review by Rhyu et al. also highlighted the benefits of POC HbA1c testing in the physician’s office, where the authors concluded that “POC A1c testing in primary care, if widely available and integrated into workflow, has the potential to positively impact diabetes care. Real-time feedback may change patient and physician behaviors, allowing earlier therapeutic intensification.”¹⁵

In addition to addressing the clinical benefit, numerous studies have shown the cost-effectiveness of implementing POC HbA1c testing.^16-20  Rosa et al. found that “compared to a centralized laboratory test, the use of the POC-A1c device in a healthcare unit increased the chance of the early control of type 2 diabetes and reduced costs in relation to DM-related outcomes.”¹⁹   Crocker et al. reported that point-of-care HbA1c testing “can significantly improve clinical operations with cost reductions through improved practice efficiency,” realizing a potential savings from improved efficiency of $24.64 per patient. This savings resulted from 89% and 85% decreases in follow-up phone calls and letters, respectively, and a 61% decrease in patient revisits.¹⁷

CKD and Urinary Albumin-to-Creatinine Ratio (uACR)

The benefits of uACR testing at the point of care have similarly been studied, with findings of accuracy, convenience, improved patient access, and improvements in test adherence.^21-25 The ADA recommends performing a spot uACR and estimated glomerular filtration rate (eGFR) test at least annually in patients with type 1 diabetes with duration of >5 years and in all patients with type 2 diabetes regardless of treatment. Patients with diabetes and urinary albumin >300 mg/g creatinine and/or an estimated glomerular filtration rate of 30–60 mL/min/1.73 m² should be monitored twice annually to guide therapy.²⁶

A recent study by Christofides and Desai discussed the importance of monitoring albuminuria in patients with type 2 diabetes as an essential tool in the detection of onset of CKD and monitoring disease progression. They stated, “Access to UACR testing may be improved by using Clinical Laboratory Improvements Amendments (CLIA)-waived point of care UACR testing options, that is, those approved for use closer to the patient and not necessarily in a central laboratory,” and noted that using a CLIA-waived POC uACR option was a means to optimize test ordering.²¹

CLIA stands for Clinical Laboratory Improvement Amendments of 1988, a set of U.S. regulatory standards that apply to all clinical laboratory testing performed on humans (except for clinical trials and basic research), regardless of where the test is performed. A test system or product that is granted waived status is defined, in part, as a methodology that is simple and accurate to render negligible the likelihood of erroneous results.²⁷ Many POC tests meet this classification, as they require no formal training, and operators must only follow the manufacturer’s instructions for use. Waived POC tests are portable, easy to use, and offer accurate, quick near-patient results, making them particularly useful for testing in a physician’s office. In this environment a physician can test a patient at the time of visit and obtain the result in real time, providing the opportunity to counsel the patient and make treatment adjustments at the time of the office visit.²⁸

There is a documented need for strategies to improve routine CKD assessment nationwide and overcome testing barriers to increase test adherence. 

A study by Folkherts et al. reported that physicians treating patients with diabetes are selectively adhering to chronic kidney disease screening guidelines where, despite recommendations to monitor both eGFR and urinary ACR, less than half of patients were screened for albuminuria during the 1-year follow-up.²⁹ Additionally, a large retrospective study of patients at-risk for CKD by Alfego et al. found only 21% of adults at risk for CKD and 32.2% of patients with diabetes specifically had guideline-recommended uACR testing.³⁰ Schultes et al. found that the implementation of ACR POCT in daily general practice can improve the diagnosis of diabetic kidney disease (DKD) in diabetes, which may support improved management of CKD.²² DKD was newly diagnosed in 8.6% of the entire study population and DKD was suspected in 9.9% based on their ACR POCT values. In 18.5% of the entire study population ACR POCT led to a change in medication, demonstrating a benefit in patient management. When surveyed regarding the relevance of the ACR POCT, 75% of physicians considered the test very important for people with diabetes; 25% rated it important.

Conclusion

Primary care physicians treat at least 90% of patients with diabetes in the United States.³¹ Patients with diabetes are at risk of developing CKD and monitoring for both conditions is important for disease management. Guidelines call for routine testing of HbA1c and uARC for disease monitoring and management.^12,27 Adoption of in-office POC HbA1c and uACR testing may provide physicians an important tool toward the goal of closing the diabetes care gap, enabling convenient, efficient, cost-effective testing, and facilitating improved patient adherence to testing. Increased patient test adherence will enable faster intervention and treatment, leading to improved patient outcomes and decreased overall diabetes-related healthcare costs—a win for all in the fight against chronic disease.

References

1. https://www.cdc.gov/chronicdisease/about/index.htm#:~:text=Many%20chronic%20diseases%20are%20caused. Accessed 1/25/22.  
2. https://www.cdc.gov/diabetes/basics/quick-facts.html
3. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-28. doi: 10.2337/dci18-0007
4. https://www.cdc.gov/kidneydisease/prevention-risk/make-the-connection.html. Accessed 1/25/22.  
5. https://www.cdc.gov/nchs/fastats/kidney-disease.htm. Accessed 1/25/22.  
6. https://adr.usrds.org/2020/chronic-kidney-disease/6-healthcare-expenditures-for-persons-with-ckd. Accessed 1/25/22.  
7. https://www.cdc.gov/kidneydisease/publications-resources/ckd-national-facts.html. Accessed 1/25/22.  
8. Savoy M, et al. The role of primary care physicians in managing chronic disease. Dela J Public Health. 2017 Mar 22;3(1):86-93. doi: 10.32481/djph.2017.03.012
9. Crocker JB, et al. The impact of point-of-care hemoglobin A1c testing on population health-based onsite testing adherence: a primary-care quality improvement study. J Diabetes Sc Technol. 2021;15(3):561-7. doi: 10.1177/1932296820972751
10. https://www.uptodate.com/contents/measurements-of-glycemic-control-in-diabetes-mellitus?search=hba1c%20diabetes&source=search_result&selectedTitle=3~150&usage_type=default&display_rank=3. Accessed 1/25/22.  
11. American Diabetes Association. Glycemic targets: standards of medical care in diabetes—2021. Diabetes Care. 2021 Jan;44(Suppl 1):S73-S84. Available from: https://doi.org/10.2337/dc21-S006. Accessed 1/25/22.  
12. https://www.cdc.gov/diabetes/pdfs/library/Diabetes-Report-Card-2019-508.pdf. Accessed 12-17-21. Accessed 1/25/22.  
13. Imai C, et al. Adherence to guideline-recommended HbA1c testing frequency and better outcomes in patients with type 2 diabetes: a 5-year retrospective cohort study in Australian general practice. BMJ Quality & Safety. 2021;30(9):706-14. doi: 10.1136/bmjqs-2020-012026
14. Stratton IM, Adler AI, Neil HA, Matthews DR, Manley SE, Cull CA, et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-12.
15. Rhyu J, Lambrechts S, Han MA, Freeby MJ. Utilizing point-of-care A1c to impact outcomes – can we make it happen in primary care? Curr Opin Endocrinol Diabetes Obes. 2022 Feb 1;29(1):29-33. doi: 10.1097/MED.0000000000000700.
16. Schnell, Oliver et al. “Impact of HbA1c Testing at Point of Care on Diabetes Management.” Journal of diabetes science and technology vol. 11,3 (2017): 611-617. doi:10.1177/1932296816678263
17. Crocker JB, Lee-Lewandrowsky E, Lewandrowsky N, et al. Implementation of point-of-care testing in an ambulatory practice of an academic medical center. Am J Clin Pathol. 2014;142(5):640-646.
18. Al Hayek, Ayman A et al. “Assessment of Patient Satisfaction with On-Site Point-of-Care Hemoglobin A1c Testing: An Observational Study.” Diabetes therapy: research, treatment and education of diabetes and related disorders vol. 12,9 (2021): 2531-2544. doi:10.1007/s13300-021-01126-7
19. Rosa, Lorena de Sousa et al. “Cost-Effectiveness of Point-of-Care A1C Tests in a Primary Care Setting.” Frontiers in pharmacology vol. 11 588309. 19 Jan. 2021, doi:10.3389/fphar.2020.588309)
20. Chadee, A et al. “Point-of-Care Hemoglobin A1c Testing: A Budget Impact Analysis.” Ontario health technology assessment series vol. 14,9 1-23. 1 Jul. 2014
21. Christofides, Elena A, and Niraj Desai. “Optimal Early Diagnosis and Monitoring of Diabetic Kidney Disease in Type 2 Diabetes Mellitus: Addressing the Barriers to Albuminuria Testing.” Journal of primary care & community health vol. 12 (2021): 21501327211003683. doi:10.1177/21501327211003683
22. Schultes B, Emmerich S, Kistler AD, Mecheri B, Schnell O, Rudofsky G. Impact of Albumin-to-Creatinine Ratio Point-of-Care Testing on the Diagnosis and Management of Diabetic Kidney Disease. Journal of Diabetes Science and Technology. October 2021. doi:10.1177/19322968211054520
23. Currin, S.D., Gondwe, M.S., Mayindi, N.B. et al. Diagnostic accuracy of semiquantitative point of care urine albumin to creatinine ratio and urine dipstick analysis in a primary care resource limited setting in South Africa. BMC Nephrol 22, 103 (2021). https://doi.org/10.1186/s12882-021-02290-5
24. Shephard, Anne K. BSc (Hons)*; Shephard, Mark D.S. PhD*; Halls, Heather J. MSc*; Corso, Olivia BSc†; Mathew, Timothy H. MBBS, FRACP† Innovative Use of Point-of-Care Testing for Chronic Kidney Disease Screening, Point of Care: The Journal of Near-Patient Testing & Technology: June 2011 - Volume 10 - Issue 2 - p 98-101 doi: 10.1097/POC.0b013e31821c6bd0
25. Harasemiw, Oksana et al. “Impact of point-of-care screening for hypertension, diabetes and progression of chronic kidney disease in rural Manitoba Indigenous communities.” CMAJ: Canadian Medical Association journal = journal de l'Association medicale canadienne vol. 193,28 (2021): E1076-E1084. doi:10.1503/cmaj.201731
26. American Diabetes Association Professional Practice Committee et al. “11. Chronic Kidney Disease and Risk Management: Standards of Medical Care in Diabetes-2022.” Diabetes care vol. 45, Supplement_1 (2022): S175-S184. doi:10.2337/dc22-S011
27. https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-G/part-493. Accessed 1/25/22.  
28. Nichols, James H. “Utilizing Point-of-Care Testing to Optimize Patient Care.” EJIFCC vol. 32,2 140-144. 29 Jun. 2021
29. Folkerts, Kerstin et al. “Adherence to Chronic Kidney Disease Screening Guidelines Among Patients with Type 2 Diabetes in a US Administrative Claims Database.” Mayo Clinic proceedings vol. 96,4 (2021): 975-986. doi: 10.1016/j.mayocp.2020.07.037
30. Alfego, David et al. “Chronic Kidney Disease Testing Among At-Risk Adults in the U.S. Remains Low: Real-World Evidence from a National Laboratory Database.” Diabetes care vol. 44,9 (2021): 2025-2032. doi:10.2337/dc21-0723
31. Davidson, Jaime A. “The increasing role of primary care physicians in caring for patients with type 2 diabetes mellitus.” Mayo Clinic proceedings 85,12 Suppl (2010): S3-4. doi:10.4065/mcp.2010.0466
32. Bodenheimer, Thomas, and Christine Sinsky. “From triple to quadruple aim: care of the patient requires care of the provider.” Annals of family medicine 12,6 (2014): 573-6. doi:10.1370/afm.1713 (ONLY ADD IF INCLUDED IN GRAPHICS)

Wednesday, May 18, 2022

by Sekisui Diagnostics

Estimated global incidence of Trichomonas vaginalis compared to three other curable STIs (Chlamydia trachomatis, Neisseria gonorrhoeae, and syphilis) according to WHO

Trichomoniasis is a common, curable, non-viral sexually transmitted infection caused by a motile protozoan parasite called Trichomonas vaginalis. Trichomonas (sometimes referred to as “Trich”) infects the vagina and sometimes urethra and is transmitted during unprotected sex. It is roughly as big as a white blood cell, and it is thought to be responsible for approximately 15-20% of symptomatic vaginitis infections.

Both men and women can get a Trichomonas infection, but it is more commonly detected in women.

Formerly considered a nuisance infection, trichomoniasis is now recognized as a cause of serious health problems. Nevertheless, it continues to be highly underdiagnosed and undertreated.

The World Health Organization estimates an incidence of 276 million new cases of T vaginalis each year and a prevalence of 187 million infected individuals between the age of 15 and 49 years old. In the United States, the Centers for Disease Control and Prevention estimates that there were more than two million trichomoniasis infections in 2018. The incidence of trichomoniasis in Europe is similar to that in the United States. In Africa, the prevalence of trichomoniasis may be much higher. The prevalence of vaginal T vaginalis infection was estimated to be 11-25% among African study populations.

Symptoms

Only about 30% develop any symptoms of trichomoniasis. When symptoms do occur, they range from mild irritation to severe inflammation. Some people with symptoms get them within 5 to 28 days after being infected. Others do not develop symptoms until much later, and those symptoms can come and

1. It is important to note that people without symptoms can still pass the infection on to others. Trichomonas symptoms in women can be differentiated from other common forms of vaginitis.

Men with trichomoniasis may notice:

• Itching or irritation inside the penis
• Burning after urination or ejaculation
• Discharge from the penis

Complications

Trichomoniasis can be treated with medication but left untreated it can last for months or even years and lead to serious complications. For example, trichomoniasis can cause genital inflammation, which makes it easier to get infected with HIV or to pass the HIV virus on to a sex partner. Pregnant women with trichomoniasis are more likely to have their babies too early (preterm delivery). Also, babies born to infected mothers are more likely to have a low birth weight (less than 5.5 pounds).

A woman with untreated trichomoniasis has a greater chance of having an infected uterus and Fallopian tubes. This infection, called pelvic inflammatory disease, can cause belly pain, fever, and perhaps the inability to have children (infertility), a pregnancy outside the uterus (ectopic pregnancy), and chronic pelvic pain.

Treatment and Prevention

Since it is a STI, the best way to prevent Trichomonas is to have protected sex. Re-infections with Trichomoniasis are also possible. The best way to avoid re-infections is for the patient to avoid having sex for seven days after treatment has been administered. Trichomoniasis is typically treated with the following antibiotics: Tinidazole 500mg x 4 tablets as a single dose or Metronidazole twice a day for 5-7 days.

NAATs [nucleic amplification assay tests], with reported sensitivities of 83%–90%. Suitable for Laboratory and Point-of-Care (POC) setting:

• Offers 95% agreement with culture and wet mount combined
• A test-and-treat approach in one visit
• Detects the antigen; does not require live organism
• Yields results in 10 minutes or less
• Offers objective, easy-to-read two-color results
• Is the only CLIA-waived rapid test for the detection of trichomoniasis

Advantages of a Test and Treat Approach

• Prevent spread – Quick diagnosis allows the clinician to provide appropriate and immediate treatment to prevent further spread of Trichomoniasis
• Patient compliance – Ensures the patient starts medication immediately
• Prevent inappropriate treatment – Accurate diagnosis results in avoidance of syndromic management

Wednesday, February 09, 2022

By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc. 

Introduction

Whether planning a new, start-up laboratory operation, or performing an analysis of current testing, (providing input for decisions on whether or not to purchase new or replacement instruments, or add or delete tests), it is important to do a realistic assessment not only of what you want to offer, but what you can realistically offer. The laboratory’s test menu should be aligned as closely as possible with physician expectations and needs, as well as the laboratory’s operational capabilities. 

By strengthening relationships with ordering physicians, laboratories can more accurately forecast future service needs and make the best decisions as to test menu, instrumentation, and staffing, including which tests to outsource or maintain in-house^[i].

Begin this process by:

 Reviewing Basic Information about the Current / Proposed Laboratory Operation

The first step in the planning process for adding new tests and new instrumentation begins with asking the following baseline questions regarding the present or proposed laboratory operation:

• What is your present test menu? Present instrumentation? Present staffing levels?
• What medical specialties are represented by your ordering physicians? (an important determinant of what tests will be requested, as well as patient demographics)
• Do you anticipate changes in the number of client physicians served? New specialties added? New populations served?
• What are your current or anticipated test volumes / demand for specific tests?
• What is the complexity of testing already performed or planned? (waived vs. non-waived, with attendant regulatory requirements, including personnel)
• What are your present hours of operation with attendant staffing levels / type and volume of testing performed per shift / commitment for turn-around times?
• What are your anticipated operating and capital budgets? (important determinant for changes to instrumentation and level of automation; as well as staffing expertise)
• Is adequate workspace available to accommodate all phases of new patient testing from specimen collection to test result reporting?

The answers to these questions provide guidance for any changes to the test menu, which will be a driver for decisions on whether to acquire new or replacement instruments.

The next step forward is to perform a Cost/Benefit analysis of your present operation, and of the proposed changes to the test systems to determine economic and logistical feasibility.

Determine the Feasibility of Adding New Tests:

Perform a Cost / Benefit Analysis[ii]

It is by taking into account the internal as well as external factors in the laboratory environment, that the decisions made will have the best chance of success.

Below are items to consider for your cost/benefit analysis:

• Instrument capacity for current or proposed test menu (is it “right-sized” for test volume and level of staffing)
• Instrument cost (purchase or lease)
• Reagent cost (are you obligated to purchase reagents from a particular manufacturer?)
• Reagent life (expiration dates: days, weeks, months before/after opening packages)
• Storage requirements for reagents (do you need to buy a new refrigerator or freezer?)
• Frequency and expense of Quality Controls, Calibration, and Maintenance
• Tests run singly or in batch-mode
• Comparison of in-house testing with reference laboratory charges and turn-around time
• Complexity of present and proposed testing.
• Staffing requirements: number, training expenses; qualifications and experience beyond present staffing; continuing education
• Proficiency Testing requirements
• Facility space, ventilation, electrical needs; hazardous disposal requirements
• Time and involvement of the Lab Director, and the Technical Consultant
• Document storage requirements / LIS capability
• Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications

Additional strategies to determine the appropriateness of testing offered, and the instrumentation needed[iii].

• Analyze test mix and outsource demanded but low-volume tests. Only outsource these tests if you can provide the test results a lower cost and with a better turnaround time.
• Project test demand and costs to determine which tests to perform in house. Conversely, analysis of send-out volumes may indicate opportunities to bring certain tests in-house.
• Partner with reference laboratories. Reference laboratories can provide valuable support in the form of financial analysis, methodology assessment, and provision of clinical samples to help make in-source-versus-outsource decisions and to establish and increase on-site test volumes.

Consider external factors as well[iv]

Consider what is going on in the laboratory industry today, noting trends both locally and across the country and seeing if these factors may affect your laboratory:

•  What will be the impact of changes in reimbursement / payment mechanisms?

• What is the current market for your laboratory services? Estimating market size and location is a critical component to determine market opportunity. These estimates will drive financial outcomes.
• If you are part of an organization that has adopted the concept of value-based medical care, and it now part of an Accountable Care Organization (ACO), or accepts “bundled payments”, your expenses will come under increased pressure to be held down and minimized. You may be encouraged to outsource more than originally planned.
• The well-documented staffing shortage may be a factor in your area; consider your local situation if planning to increase testing, add shifts, and new pre-analytic services.

Of course, providing the highest level of service for your patients may justify costs associated with the above considerations, but it is vital to ensure that your instrumentation can handle the changes in projected demand in terms of test volume capacity, variety of tests offered, operating times and staffing.  This may require considering more automation. Automation has long been regarded as an important means for clinical laboratories to achieve greater operational efficiency, test accuracy, method standardization, total data handling and reduced turnaround time; in short, an improved quality of patient care.

The development of new generations of automated stand-alone and bench top equipment has made automation a more viable option for labs of all sizes—and in many cases, a necessary option for labs seeking to remain competitive in today’s marketplace[v]. 

Steps in Determining the Right Automation for Your Laboratory[vi]

1. Questions to ask when deciding how much automation is needed

The amount of automation needed depends on the type and size of your laboratory. If all you are looking for is increased throughput and you don’t really have to deal with diverse assays and readouts, then you might want to think about modular components. So, with a few nonintegrated pieces of equipment, you can get the throughput you need without a huge investment, or additional space required.

1. Set priorities for automation based on realistic budget limitations

Once you have taken care of the above, and determined your needs, start getting quotes on systems needed.   Budget negotiations will begin, with sets of reality checks on what is doable and what is not.   Decisions should be based on priorities set in advance.

1. A few more points to remember

Always choose a vendor who can provide prompt, affordable service to minimize any downtime. Remember  the data management involved. There are different sets of tools for data processing, data mining and data visualization, and you need to think about how you are going to track and analyze this data. Finally, create an infrastructure that can be easily modified or expanded for other applications.

1. Plan for downtime for routine maintenance and equipment breakdown
2. Consider purchasing a service contract[vii]

A service contract can include many services beyond a general warranty, such as software updates, calibration, certification, preventative maintenance, priority service, and/or additional discounts on upgrades. Service contracts can be costly, and you can either discuss options with colleagues or make your own informed decision. Several reasons why you may choose to purchase a service contract could include reduced hassles if your equipment breaks, faster/priority repairs and a predictable expense in your budget. If a piece of equipment is critical to your work, you use it frequently, and major repairs are very expensive, a service contract may be worthwhile. In terms of budget, you will know exactly what you are going to pay in advance and will not be blindsided with a major "surprise" expense.

Recognize the strategic importance of physician / laboratory relationships

One of the ways that laboratories can use their resources more effectively is to strengthen their relationships with physicians. These relationships are vital as strategic assets, and, as the demands on physicians continue to multiply, they will increasingly rely on their laboratory partners for diagnostic support.  Physicians increasingly seek a diagnostic resource that can meet all of their testing needs[viii].

Laboratories are discovering that they are well positioned to provide medical guidance and direction for clinicians who are trying to maneuver their way through the increasingly complex world of laboratory testing. 

To efficiently manage laboratory test utilization requires both ensuring adequate utilization of needed tests in some patients and discouraging superfluous tests in other patients[ix].

An important step in this process is to work with client physicians on a program of proper test utilization to encourage the most efficient and relevant use of the testing offered. 

 The key role of competent management in accomplishing these goals[x]

Effective laboratory planning requires competent management. It is through the application of management skills that you can implement change with minimal disruption.

Competent laboratory management includes effective communication with the staff; providing key information and direction for the continuing future development of the laboratory; and encouraging involvement in the development of strategic plans.

Successful management can motivate staff to provide feedback about their workload; instruments and kits used; make suggestions for improvement of, and changes to, their test menu; and provide information about interactions with other offices, departments, physicians, and patients.  These types of information play an important role when developing strategies for cost containment, automation, growth, re-alignment, and even repositioning of the lab in the community.  

[i]R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853 

[ii] The Cost Effective Laboratory: The Changing Landscape of Laboratory Testing. Laboratory Testing Matters. August 2015.   http://www.labtestingmatters.org/the-cost-effective-laboratory-the-changing-landscape-of-laboratory-testing/

[iii] R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853

[iv] Strategic Planning For The Clinical laboratory. Martha Robbins and Associates. Clinical laboratory Consulting.

 http://www.labconsultant.com/strategic.htm

[v] G Tufel   Right-Sizing Laboratory Automation. Clinical Lab Products. December  17, 2014.   http://www.clpmag.com/2014/12/right-sizing-laboratory-automation/

[vi] M. Ferrer. Ask the Expert: How to Automate Your Lab to Best Fit Your Needs. Lab Manager. January 2011.

http://www.labmanager.com/ask-the-expert/2011/01/ask-the-expert-how-to-automate-your-lab-to-best-fit-your-needs

[vii] K Huey. Starting a New Lab:  How to Develop a Budget and Buy Equipment.  American Physiological Society (APS).

http://www.the-aps.org/mm/Careers/Mentor/Managing-a-Lab-and-Personnel/Early-Career-Professionals/Setting-Up-a-Laboratory/Developing-a-Budget-and-Buying-Equipment

[viii]R. Saunders and A. Westerink. Sidebar: The Strategic Value  of laboratory Outreach. Nov 1, 2014.  http://www.hfma.org/Content.aspx?id=25853

[ix] Dr. Curtis Hanson and Elizabeth Plumhoff.  MAYO CLINIC: Test Utilization and the Clinical Laboratory.  May 2012. http://www.mayomedicallaboratories.com/articles/communique/2012/05.html

[x] How To become A Good Lab Manager by Elizabeth Sandquist.  ASBMB Today. October 2013.

Wednesday, February 09, 2022

by Aaron Medaris - Physicians Office Resource

Last year as we hunkered down, masked up, social distanced, and used gallons of hand sanitizer to avoid the dreaded results of COVID-19, we also avoided the flu the and a variety of other respiratory infections. Talk to any parent with young children and they’ll most likely tell you that 2020 was the healthiest their kids had been in a long time. Now that we’ve emerged from our quarantines, shed the masks, and probably aren’t as good as using the hand sanitizer as we were 12 months ago, respiratory infections are on the rise. Yes, it’s true that most children who contract COVID-19 will be fine, but health officials are reporting an influx of patients, especially pediatric, with corona virus and other respiratory infections at the same time, presenting additional challenges in an already difficult situation.  Are we entering in to the “perfect storm” of challenges for this cold and flu season? That is yet to be told, but rain is definitely in the forecast for the months ahead.

Assessing our current situation and looking at the forecast, what can you do to be better prepared for the increase of patients respiratory infections that will soon be entering your exam rooms? The first and one of the most important is to test for respiratory infections. That may seem simple, but this important step is often skipped because well, if it looks like a duck, and it talks like a duck, well then it’s probably a duck…right? But what if there’s more to it? A couple of years ago, I got really sick. Cough, fever, chills, body aches that came on hard and fast. I went to the doctor and after his examination, he told me he has seen this a lot lately and it was just a virus. I then asked if he thought it was the flu. He quickly replied, “I highly doubt it. I haven’t seen any flu cases this year.” This illness just felt different to me, and so I asked, “Is it ok if you test me for the flu?” He again stated he was quite certain it wasn’t the flu, but that if I wanted the test he would have the nurse administer one. And wouldn’t you know it, when I got the test results back, I had the flu. My good doctor prescribed an antiviral which helped immensely! A treatment I would have never received if I hadn’t been tested. Could it be that all those that my physician had been seeing with similar symptoms as me had the flu as well, but were never tested for it? 

Why Should You Test

 Some physicians like in the example above choose not to test. Whether that’s because doubts regarding the accuracy of tests or feel that empirical treatment will be effective in most cases. Despite these concerns there are multiple reasons why you should test: 

1. Empirical treatment can lead to more patients receiving antiviral treatment than actually need to receive it. This could possibly give rise to a antiviral shortage and delaying the correct care for another patient that actually needs it. 

2. Testing frequently will provide the physician with valuable “market intelligence.” It will help the physician understand what viruses are currently spreading through the community and will allow them to provide a better treatment path. 

3. Better patient experience. That might seem odd because what patient wants a stick shoved up their nose. The truth is, testing shows the patient that you want to provide the best possible care and it can bring peace of mind to the patient, even if they do test positive. They will know that they are being treated the correct way.

What to Know When Purchasing Tests

I’m sure that many of you are testing for respiratory infections. If you’ve talked to your distributor lately, you’ve probably noticed a lot of different respiratory tests out there. When it comes to testing for flu, COVID, RSV, rhinovirus, etc. which test is best for you and your practice? Here are some things to consider when evaluating which ones are best for you:

CLIA Complexity – A test is only good if you are able to administer it. Make sure that you are equipped with the correct CLIA certificate of perform the test. Check to see if the test is a Waived (most simple) or Moderately complex (requires additional certification). If you’re a waived facility and are interested in purchasing a moderately complex test, that’s fine, but make sure you take the steps before hand to become a certified compliance facility with CLIA.

Ease of Use – Is the test simple to perform? Difficult? Require additional equipment? Training? Will the additional equipment help me in the long run?

Performance – Sensitivity and specificity are essential. I would even be sensitive to the brand of test that I am purchasing. Especially when it comes to different COVID tests. Due to the EUA that the FDA has granted, there are many counterfeit and poor quality COVID tests that are being pushed on doctors.

Volume – How many tests are you planning on running? What’s the average you use during a flu season? Will you need more this season?

Time to Results – How long does it take to run and receive test results? Is it important to get results back quickly to your patients?

Sample Type – is it a single sample type or does it allow for multiple sample types (nasal, nasopharyngeal, saliva, etc.)?

Connectivity – Is it important to have the results transmitted electronically?

Cost – Brand is important when it comes to getting accurate results. But brand can also be expensive. Be sure to check with different brand reps, distributors, websites, publications, and promo emails for discounts and specials. They’re out there.

What Types of Tests are Available?

Rapid Lateral Flow Immunochemical Tests:

There are different varieties of these test which have been on the market for decades and are used to confirm the presence or absence of a specific antigen. Results of these types of tests can either be viewed visually or with the use of an instrument. May of these tests are CLIA Waived and can be completed in less than 15 minutes.

Molecular Tests:

Many flu and other respiratory infections can be run on molecular devices. These tests detect the presence of the genetic material of the virus and generally produce results in 30 minutes or less. Molecular results are the gold standard in testing. Be sure to verify the CLIA compliance that is needed for molecular tests, some are CLIA Waived and some require a moderate complexity license. CLIA Waived molecular test typically use rapid PCR detection and the device can be moved closer to the point of care. CLIA Waived molecular devices usually cost less than traditional molecular devices, but still offer the same reimbursement.

One important thing to note is that no respiratory test provides 100% accuracy. Results depend on a few different criteria: type of test used, virus strain, and integrity of the sample. For best results please review test instructions and be aware of any test limitations.

Be Prepared

I don’t know if we are heading towards and “perfect storm” of challenges, but I do know that whatever the forecast is you can be prepared. Physicians Office Resource offers valuable insights on a variety of different respiratory infection tests and testing devices. Look for them in this issue or visit our website and learn more. Have questions feel free to reach out and we’ll be sure to put you in contact with the right people. 

Wednesday, February 09, 2022

The Abstract - Medical News and Research Update

Leaves of the psychotria inularum plant, known to the locals of Samoa as matalafi, have been used for centuries to treat inflammation, fever, elephantiasis, vomiting, incontinence, and infections. Skepticism is often associated with traditional medicine, but is there really something to this matalafi plants that are “found in back yards across Samoa?” Lead author and researcher, Seeseei Molumau-Samasoni said, “I was skeptical at first, when researching. There was a lot of superstition around this plant particularly, even in traditional medicine, but I was keen to find out if I could provide scientific merit to the traditional medicines of the Samoan people.

.”¹  In November 2021, research from Molimau-Samasoni and her colleagues have been peer-reviewed in the Proceedings of the National Academy of Sciences, not only show matalafi’s potential as a anti-inflammatory, but potential treatment for cancer, neurodegenerative diseases, diabetes, cardiovascular diseases, and even COVID-19. Using “chemical genomic analyses in the model organism Saccharomyces cerevisiae (baker’s yeast) to identify and characterize an iron homeostasis mechanism of action in the traditional medicine as an unfractionated entity to emulate its traditional use. Bioactivity-guided fractionation of the homogenate identified two flavonol glycosides, rutin and nicotiflorin, each binding iron in an ion-dependent molecular networking metabolomics analysis. Translating results to mammalian immune cells and traditional application, the iron chelator activity of the P. insularum homogenate or rutin decreased proinflammatory and enhanced anti-inflammatory cytokine responses in immune cells.”² The science is still young, but there seems to be great potential with this common plant found in back yards across Samoa. 

Noninvasive Imaging Strategy Detects Dangerous Blood Clots in the Body 

Detecting clots in atrial fibrillation patients requires transesophageal ultrasound which involves the patients to be sedated and have a large tube inserted down their throat and esophagus. In a November press release from Massachusetts General Hospital, investigators announced that they have developed and tested a targeted contrast agent to detect and image clots noninvasively. This agent that investigators used has a strong affinity for fibrin, a component of blood clots, and can be detected with a radioactive copper tag. David Sosnovik, MD, FACC, lead author and director of the Program in Cardiovascular Imaging at Mass General, said, “The idea behind the technology is that the agent will find and bind to blood clots anywhere in the body—not just in the heart—and make the clots detectable like a bright star in the night sky… In some ways this is analogous to doing a smart search with a search engine such as Google, where the search terms one uses guide the search. We inject the agent into a small peripheral vein and it circulates throughout the human body on its search for clots.”³  If it finds a clot and binds to it, clinicians can detect it with positron emission tomography. In AFib patients, imaging tests of the heart showed bright signals within the clots that were not seen in patients without blood clots. If the agent does not find a clot, then it is excreted from the body within several hours.

 Protein Predicts a Brain’s Future After Traumatic Injury

Researchers and clinicians have understood that axonal injury is a key determinant of long-term outcomes after traumatic brain injury. The problem was that the ability to clinically measure axonal injuries has been difficult. In a recent study published in Science, Dr. Neil Graham, et al. performed a multicenter study and showed that the plasma concentration of the neurofilament light (NfL) protein increased after TBI in patients.⁴ Plasma NfL concentration predicted white matter damage and clinical outcome. NfL levels rise for weeks after an injury, typically peak around 20 days, and can stay high a year later.⁵ These increased levels of NfL tell that something is wrong in the nervous system. The increased biomarkers won’t tell you where the damage is, but it’s an easier way of measuring and tracking the damage. Experts say we’re a long way off from point of care devices that test for NfL biomarkers, but they’re hopeful neural panels will be added to routine head injuries. 

Researchers Design Antibodies That Destroy Senescent Cells, Slowing Down Pathological Aging 

A wide range of diseases, including fibrosis, tumor progressing, cataracts, obesity, diabetes, and Alzheimer’s disease have been shown to be influenced by the accumulation of senescent cells. Senescence is needed to prevent the propagation of damaged cells. However progressive accumulation of senescent cells with time has been associated with loss of tissue homeostasis and is known to contribute to the functional impairment of different organs typically seen in ageing. Parallel to this, clearance of senescent cells can prolong lifespan in in vivo models. This lead to the production of a new classification of drugs known as senolytics, designed to specifically eliminate senescent cells in human tissue. One of the major issues with senolytics is that they lack the targeting skills to be clinically effective. In a recent study published in the journal Nature, Marta Poblocka, et al. were able to target and clear senescent cells using an antibody-drug conjugate against a specific membrane marker. Utilizing an extracellular epitope of B2M, an membrane marker of senescence, Poblocka and her team successfully delivered toxic drugs into senescent cells, thus clearing the senescent cells. Non-senescent cells were not affected by the treatment, confirming the accuracy of the treatment.⁶

Scientists Successfully Test Prototype Bioartificial Kidney

KidneyX, a public-private partnership between the US Department of Health and Human Services and the American Society of Nephrology, recently sponsored a competition to accelerate innovation in the prevention, diagnosis, and treatment of kidney diseases. One of this year’s winner’s was KidneyX for its first ever demonstration of a functional prototype of its implantable artificial kidney. KidneyX successfully combined a hemofilter (removes waste products and toxins from blood) and a bioreactor, which replicates other kidney functions. The artificial kidney was able to be powered by blood pressure alone and without immunosuppressant or blood thinning drugs. Shuvo Roy, who was involved in the research and development of the artificial kidney said, “The vision for the artificial kidney is to provide patients with complete mobility ad better physiological outcomes than dialysis…[and] a higher quality of life. for millions worldwide with kidney failure.”⁷

UK Scientists Discover Gene Linked to Doubling the Risk of COVID-19 Death

Questions among healthcare professionals and the general public about why people are more susceptible to severe illness and death from COVID-19 may have more of an answer when a gene that may be associated with doubling the risk of lung failure from COVID-19 was recently discovered by Oxford University Scientists. The gene LZTFL1 is carried by around 60% of people with South Asian ancestry, and is involved in how the lung cells respond to viruses. The findings which were published in the Nature Genetics journal, show “that the way in which the lung responds to the infection in critical. This is important because most treatments have focused on changing the way in which the immune system reacts to the virus.”⁸

Abstract Sources

Study Shows, Plant used in Traditional Samoan Medicine Could be as Effective as Ibuprofen

1. https://www.theguardian.com/world/2021/nov/04/plant-in-traditional-samoa-medicine-could-be-as-effective-as-ibuprofen-study-shows?utm_source=nextdraft&utm_medium=email
2. https://www.pnas.org/content/118/45/e2100880118

Noninvasive Imaging Strategy Detects Dangerous Blood Clots in the Body

3. https://www.massgeneral.org/news/press-release/Noninvasive-imaging-strategy-detects-dangerous-blood-clots-in-the-body

Protein Predicts a Brain’s Future After Traumatic Injury

4. https://www.wired.com/story/this-protein-predicts-a-brains-future-after-traumatic-injury/
5. https://www.science.org/doi/10.1126/scitranslmed.abg9922

Researchers Design Antibodies That Destroy Senescent Cells, Slowing Down Pathological Aging

6. https://www.nature.com/articles/s41598-021-99852-2

Scientists Successfully Test Prototype Bioartificial Kidney

7. https://pharmacy.ucsf.edu/news/2021/09/kidney-project-successfully-tests-prototype-bioartificial-kidney

UK Scientists Discover Gene Linked to Doubling the Risk of COVID-19 Death

8. https://www.reuters.com/business/healthcare-pharmaceuticals/gene-linked-doubling-risk-covid-19-death-found-by-uk-scientists-2021-11-05/

Wednesday, February 09, 2022

The Abstract - Medical News and Research Update

A monthly column from Physicians Office Resource looking into current research and the future of medical science

Pulmonary fibrosis occurs when lung tissue becomes damaged and scarred, leading to thick and stiff tissue making it more difficult for lungs to function properly. Scarring is caused by a multitude of factors and in most cases doctors are not able to pinpoint the exact cause. Currently there is no cure, and mortality often happens within a few years; though there are certain therapies can sometimes ease symptoms1. Promising results were published recent article in the journal Nature, researchers at the University of Alabama are starting to make headway on a possible reversal of this disease.

Utilizing mice models and an already approved FDA drug called ABT-199 (currently approved for treating types of leukemia), scientists treated the mice with lung fibrosis with the drug and after 21 days the mice’s lung architecture had returned to normal. This specific test was initiated when researchers discovered that human patients with pulmonary fibrosis exhibited higher amounts of Bcl-2, a regulator of apoptosis, in their lung immune cells. With higher levels of Bcl-2, macrophages refused to die off after completing their work, which lead to lung damage caused by pulmonary fibrosis. Research is still in the early stages but scientists are hopeful this will lead to new therapies for treating pulmonary fibrosis in humans.²

Effectiveness of COVID-19 Vaccines Against the Delta Variant

Questions and concern among the public and health officials about the rise of SARS-CoV-2 variants (specifically the Delta variant – the now dominant strain) and the effectiveness of current Covid vaccines in precenting symptomatic disease led to a new study published in the New England Journal of Medicine, titled “Effectiveness of Covid-19 Vaccines against the b.1.617.2 (Delta) Variant.” Within this study, researchers reviewed data from England with symptomatic persons over the age of 16 who underwent Covid-19 testing between October 2020 and May 2021. They then assessed vaccination status in 4,272 persons who tested positive for the delta variant and in 14,837 who tested positive for the alpha variant. The two vaccines utilized in this test were the Pfizer-BioNTech and the AstraZeneca. Results showed that after one dose of either vaccine, the effectiveness was lower against the delta variant than the alpha variant. However, after two doses vaccine effectiveness was high with only modest differences between the variants. Researchers showed that after two doses, the Pfizer-BioNTech vaccine was 88% effective against the delta variant and the AstraZeneca vaccine was 67% effective³.

Maternal Speech Increases Oxytocin Levels and Decreases Pain Scores in Preterm infants During Painful Procedures

15 million premature infants are born worldwide every year and are often faced with early maternal separation and painful procedures which can have short and long term effects on their neurodevelopment. In an article in Nature published on August 27, 2021, researchers wanted to see “whether the mother’s voice could provide an effective and safe analgesia for preterm infants and whether endogenous oxytocin (OXT) could be linked to pain modulation.”⁴ In this study, 20 preterm infants when undergoing painful procedures had their OXT levels in saliva and plasma cortisol levels measured, and the Premature Infant Pain Profile was blindly coded by trained psychologist. When the mother was speaking to the child during the procedure, Premature Infant Pain Profile scores significantly decreased, along with an increase of OXT levels over the baseline. No effects on cortisol levels were found.⁴

Artificial Intelligence Models Show 17 Potential FDA Approved Drugs to Help Treat COVID-19

While vaccines provide the best way to prevent COIVD-19, researchers have been working to find ways to treat COVID may have just found some hope in several drugs already FDA approved. In a recent study published in the Proceedings of the National Academy of Science of the United State of America⁵, researchers at the University of Michigan utilized artificial intelligence powered image analysis of human cell lines during infection with the coronavirus. In this computer model, cells were treated in over 1,400 individual FDA approved drugs either before or after viral infection. This resulted in 17 potential therapies, 10 of which were new to the science community. Dr. Johathan Sexton, Ph.D assistant professor of Internal medicine at the University of Michigan Medical School and one of the senior authors on the paper said, “Traditionally, the drug development process takes a decade—and we just don’t have a decade. The therapies we discovered are well positioned for phase 2 clinical trials because their safety has already been established.”⁶ One of the surprises of this study was the anti-viral activity of lactoferrin, a protein found naturally in human breast milk that can also be found over the counter in a dietary supplement derived from cow’s milk. Dr. Sexton went on to say, “We found lactoferrin had remarkable efficacy for preventing infection, working better than anything else we observed.”⁶ In their article published in PNAS, researchers mention that lactoferrin “inhibits SARS-CoV-2 infection in the nanomolar range in all cell models with multiple modes of action, including blockage of virus attachment to cellular heparan sulfate and enhancement of interferon responses.”⁵ 

Ultrasound Activates Genetically Engineered Immune Cells to Safely Attack Tumors in Mice

CAR T Cell (chimeric antigen receptor) therapy is a type of treatment in which a patient’s T cells are changed in the laboratory so they will attack cancer cells. Large numbers of these CAR T cells are grown in a laboratory and given to the patient by infusion. This type of treatment has been used to treat certain blood caners, but not solid tumors. The reason being is the CAR T cells are always turned on and are very potent – destroying not only cancer cells, but normal healthy cells. In a recent article published in Nature Biomedical Engineering titled, “Control of the activity of CAR-T cells within tumours via focused ultrasound,”⁷ researchers at UC San Diego took CAR T cells and re-engineered them so that they only express the CAR protein when ultrasound energy is applied. Thus, allowing the researchers to turn on the CAR T proteins and focus them on a specific spot in the body. The scientist tested their hypothesis on mice with solid tumors. Taking the mice and injecting them with the re-engineered CAR T cells, they then used an ultrasound transducer on the area of the skin on top of the tumor. The heat from the ultrasound activated the CAR T cells over the tumor, attacking the tumor but keeping surrounding tissue and cells safe. Though still early in its research, the work looks promising for new therapies to treat solid tumors. 

New Heart Disease Drug Approved in the UK Hailed as “Life Changing”

It’s long been known that too much LDL cholesterol can lead to a buildup of plaques in the blood vessels. Plaque build-ups deprive the flow of oxygen rich blood to the heart which can lead to heart attacks and strokes. A new drug developed by Novaris called Inclisiran is the first drug to utilize RNA interference to help remove LDL from the bloodstream. Inclisiran silences a gene called PCSK9, by doing so Inclisiran helps the liver absorb more LDL cholesterol from the blood and break it down. The therapy is delivered via injection and could cut LDL cholesterol levels by 50%. Studies also noted that Inclisiran when combined with a statin could reduce cholesterol levels by 75-80%. The National Health Service of England and Wales estimate that if “300,000 people receive the drug as planned, a projected 30,000 people could avoid premature death due to heart attacks and stroke.”⁸ 

Sources:

1. Mayo Clinic

Pulmonary Fibrosis

https://www.mayoclinic.org/diseases-conditions/pulmonary-fibrosis/symptoms-causes/syc-20353690

2. Nature

Targeting Cpt1a-Bcl-2 interaction modulates apoptosis resistance and fibrotic remodeling

 https://www.nature.com/articles/s41418-021-00840-w

3. 3. New England Journal of Medicine

Effectiveness of Covid-19 Vaccines against the b.1.617.2 (Delta) Variant

https://www.nejm.org/doi/full/10.1056/NEJMoa2108891?query=featured_coronavirus

4. Nature

Maternal speech decreases pain scores and increases oxytocin levels in preterm infants during painful procedures

https://www.nature.com/articles/s41598-021-96840-4

5. Proceedings of the National Academy of Science of the United State of America

Morphological cell profiling of SARS-CoV-2 infection identifies drug repurposing candidates for COVID-19

https://www.pnas.org/content/118/36/e2105815118

6. Existing drugs kill SARS-CoV-2 in cells

https://labblog.uofmhealth.org/lab-report/existing-drugs-kill-sars-cov-2-cells

7. Nature Biomedical Engineering

Control of the activity of CAR-T cells within tumours via focused ultrasound

https://www.nature.com/articles/s41551-021-00779-w

8. Cholesterol-lowering jab could save over 30,000 lives

https://www.medicalnewstoday.com/articles/cholesterol-lowering-jab-could-save-over-30000-lives#Why-inclisiran-is-deemed-life-changing

Monday, February 07, 2022

By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc.

Introduction

The 21st century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centered. Laboratory medicine is integral to many of these objectives, involving disease prevention, diagnosis, treatment, and management. 

As a result, the laboratory profession continues to undergo rapid change.  Not only is there an impact through advances in technology, with new tests and test methodologies, new modes of communication, and new capacities for storage, retrieval and analysis and dissemination of  data, but through emerging socio-political trends resulting in changes to the very structure of organized medicine, and how medical care is delivered. These include major legislation such as the Affordable Care Act which encourages shifts from private practice to integrated healthcare networks; and the development of new models of healthcare delivery such as Accountable Care Organizations, which mandate value-based compensation models.   These changes, whether on a macro institutional level, or micro departmental level, impact our laboratories.  Millions more insured will lead to significantly increased demand for laboratory services at the same time that baby boomer staff (who have been the backbone of laboratory staffing since the 1960’s) are retiring in large numbers, but with fewer schools training replacements.  Exacerbating this is the continuing growth of tests available (currently at least 3500 tests), new specialties, new global health issues (i.e. Opiod epidemic), accelerating the increase in workload.

Challenges and Changes Forecast for the Laboratory Profession

The two main forces directly affecting laboratory operations are rapid technological advances (e.g. total laboratory automation, molecular diagnostics techniques, digital technology; point-of-care and remote testing, etc.) and resultant  increased economic pressures, with the need to align to increasingly limited budgets[i]

One major outcome of the introduction and growth of digital technology, in particular,is the huge increase in the generation and utilization of data, both for immediate patient care needs as well as population health management and trend analysis. This has resulted in the laboratory becoming “information central” within the greater healthcare environment, touching almost every point of healthcare delivery.  Under these circumstances it is easy to recognize that laboratory medicine has a pivotal role, increasingly integral to many clinical decisions on disease prevention, diagnosis, treatment and management. The overall challenge for the laboratory profession is to adapt to these rapid changes, while maintaining quality service.

A summary of these challenges include[ii]:

• Increased scope of services offered, requiring changes in laboratory organization and communication, including workflow, scheduling, reporting policies, data transmission and storage; expanded relationships with other healthcare providers; integrated roles for information technologists; and increased direct interaction with the public.
• New roles and responsibilities of the laboratory due to changes in healthcare delivery through integrated network organizations —Accountable Care Organizations (ACOs) and Patient Centered Medical Homes (PCMHs), integrating the laboratory as a part of team-based care
• The need for updating policies and procedures to reflect this new paradigm of increased scopes of practice and involvement
• New personnel requirements, recruitment and training to ensure a competent workforce to meet these challenges.
• Adjusting to the new age of patient empowerment: patient initiated testing; and test results reported and interpreted directly to patients.
• Keeping up with the changing political and regulatory climate
• Changing population demographics and the need for interventions for specific subsets of the population; use of big data influencing government resource allocation.

Dealing with all these changes can be stressful for laboratory professionals. The clinical laboratory industry is already embracing networking, consolidation, integration, outsourcing, and creating additional value by providing knowledge services related to in vitro diagnostics. Clinical laboratory services are also increasingly defined by their value provided for patient outcomes[iii].  Already, there is evidence that ongoing technological developments have considerably improved the productivity of clinical laboratories.

The next thirty years comprise a perfect storm scenario for laboratory medicine in terms of meeting professional staffing needs to meet these challenges[iv]:

• Millions more people will be insured and able to access the healthcare system far more comprehensively than ever before, including laboratory services
• Millions of baby boomers adding to the post-65 year old demographic, requiring more frequent and intensive healthcare, including laboratory services
• Significant numbers of boomer clinical laboratory professionals are part of this retirement tidal wave, contributing to the shortage of available staff
• The continued rapid development of advanced technology such as molecular genetics. requiring ever more sophisticated instruments and advanced training by staff
• Increased competition from other healthcare professions that are able to promise and deliver on better working conditions, higher compensation, and greater recognition.
• Lack of adequate funding for enough schools and graduation capacity to provide the needed numbers of laboratory professionals.

Resilient Leadership

As a result, these times call for leadership that is more adaptive and agile than ever before, i.e. resilient leadership. This is leadership that understands change, and can adapt through creating an organizational culture of resilience; going beyond continuous quality improvement to embrace change on an institutional as well as departmental level, enabling their laboratory operation to not only survive but prosper and grow.

Resilient Laboratories

These are laboratories that are able to respond effectively, and adapt to all kinds of changes in operation, internal and external demands, and expectations, through effective planning and resource allocation, thus allowing the continuation of normal services without compromising quality. Gaps in the continuity of healthcare threaten a patient’s well-being and introduce the potential for adverse events. Whether, or how, a system responds to fill such gaps in care continuity indicates its resilience[v]. Adaptations include new clinician initiatives, adaptive instrumentation, flexible staffing patterns, continuous quality improvement practices, and institutional networking leading to improvements in performance and service.  These approaches make up the resilience that is built into the system to help accommodate demands for care.  Resilience provides the means for organizations to target resource investments by integrating safety and productivity concerns. Quality work processes are not static properties of an organization, embracing resilience reflects a dynamic effort to maintain quality.

A culture of resilience[vi]

A culture of resilience recognizes the value of the laboratory staff, the stresses that they may be experiencing, the training that is needed, and the need to be supportive and understanding.  It goes beyond a culture of continuous quality improvement to include trust, teamwork, tolerance, and a global perspective that more  change is inevitable.  The properties necessary for resilient organizations include:

Top Management commitment: to recognize performance concerns and addresses them with continuous and extensive follow-through based on applying competency improvement processes utilizing coaching and management observation.

Key management strategies include: providing staff with key information about future plans for the development of the laboratory, and involving the staff when possible; and determining how to implement these changes through adjustments to job assignments; staffing levels; policies and procedures; management of timelines and budgets.

The characteristics of a resilient laboratory include support for:

An open and fair culture :  the reporting of issues, problems, events, and errors throughout the organization is supported and encouraged, but culpable behaviors are not tolerated.

A Learning culture: Wherein issues, problems, events, and errors are handled with an eye toward cofrrection, and solution, not denial;  but not a “blame game” attitude either

Realism: Management is aware of any potential for serious problems and events due to weaknesses inherent in their operation, and continuously monitor these.

Awareness: Management collects ongoing data to gather insight into quality of performance, problems, and the state of safety defenses.  Utilizes the staff for feedback and innovative ideas.

Flexibility: New or complex problems are handled in a way that maximizes the ability to solve the problem without disrupting overall work. 

Transparency: Management keeps staff informed of all happenings, both good and bad.  This can open up new avenues of discussion, problem-solving, and team-building.

Resilience relies on constant feedback from the staff regarding the effectiveness of the changes made by management.   Additional steps that enhance the ability of the laboratory to successfully adapt to these challenges include[vii]:

1. Encouraging two-way communication
2. Recognize and reward achievement.  
3. Help employees succeed. Provide employees with the resources and support to do their work, and as they show signs of readiness, be willing to entrust them with new tasks and greater responsibility.
4. Provide continuing education. This should include a formal orientation program, cross-functional training, maintenance of professional skills, coaching, career development, and personal development.

Out of this develops a resilient innovative workforce, one that is capable of adaptively learning to correct errors and to take advantage of new opportunities (e.g., digital technology; remote testing; ACOs), to improve quality of service.

The end result is the leveling of silos, enhancing communication, creating a workforce that is not hesitant to innovate and adapt to change; feels appreciated and experiences less stress when change is needed.

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

[i] Laboratory Medicine in the New Healthcare Environment. Ferraro, S., Braga, F. and Panteghini, M. De Gruyter.

 Oct.14, 2015.   https://www.degruyter.com/view/j/cclm.2016.54.issue-4/cclm-2015-0803/cclm-2015-0803.xml

[ii] Ibid.

[iii] Laboratory Medicine: Challenges and Opportunities. Bossuyt, X., Verweire, K. and Blanckaert, N.  Clinical Chemistry.  Sept. 2007.  http://clinchem.aaccjnls.org/content/53/10/1730

[iv] Building a Laboratory Workforce to Meet the Future: ASCP Task Force on the Laboratory Professionals Workforce. Garcia, E., Schulze, M., Bailey, M., Doyle, K., Finn, W., Glenn, D. Holladay, E.B.,  Jacobs, J., Kroft, S., et.al. Jan.2014. https://academic.oup.com/ajcp/article/141/2/154/1760592

[v] Minding the Gaps: Creating Resilience in Healthcare. Nemeth, C., Wears, R., Woods, D., Hollnagel, E. and Cook, R.  Semantic Scholar.  2008. https://pdfs.semanticscholar.org/0e2a/37fbc0762f7b909277c18178902df603f010.pdf?_ga=2.100922756.48796617.1547406901-1451235872.1547406901

[vi] Elder N, McEwen T, Flach J, Gallimore J.  Creating Safety in the Testing Process in Primary Care Offices.   .

http://www.ahrq.gov/sites/default/files/wysiwyg/professionals/quality-patient-safety/patient-safety-resources/resources/advances-in-patient-safety-2/vol2/Advances-Elder_18.pdf

[vii] Shenkel, R, Gardner, C. Five Ways to Retain Good Staff.  Fam. Pract. Manag. 2004 Nov-Dec: 11(10) 57-62.

Monday, February 07, 2022

by Sekisui Diagnostics

In 2019, the World Health Organization declared antibacterial resistance one of the top 10 threats to global health.

As deadly as it has already proven to be, COVID-19 could result in even more health-related

disruptions in the future. Several studies estimate that 70% to 97% of hospitalized patients with

COVID-19 received antibiotic therapy. Here’s the problem: Increased antibiotic usage accelerates antibiotic resistance.

The irony is, SARS-CoV-2 is a virus with respiratory symptoms, and no antibiotic is yet available against it. Inappropriate prescribing could have been avoided with diagnostic testing for influenza, Respiratory Syncytial Virus, group A strep, etc., prior to prescription and treatment. COVID-19 pandemic reminds us of the value of infectious diseases diagnostics. Even though economic value of infectious diseases diagnostics is not always easily quantifiable, diagnostics play a valuable and critical role in effective patient care. Diagnostics helps to determine the disease etiology, influence treatment modalities, and enable public health surveillance. Moreover, advances in Point-Of-Care (POC) testing have further improved patient care. 

 Antimicrobial resistance             

Microbes are survivors. To paraphrase German philosopher Friedrich Nietzsche, what doesn’t kill them makes them stronger. When exposed to conditions that inhibit growth, such as antibiotics, microbes make changes that help them survive. Those that acquire resistance can multiply rapidly and spread the resistance to other microbes. 

Per Rodney Rohde, PhD, professor, and chair for the Clinical Laboratory Science (CLS) Program in the College of Health Professions at Texas State University, COVID-19 pandemic can worsen the threat posed by antimicrobial resistance. 

In 2019, the World Health Organization declared antibacterial resistance one of the top 10 threats to global health. Left unchecked, drug-resistant diseases could cause 10 million deaths each year by 2050, warns the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance.

In the United States, antibiotic-resistant bacteria and fungi cause more than 2.8 million infections and 35,000 deaths each year— nearly twice as many annual deaths from antibiotic resistance as reported in 2013. The Centers for Disease Control and Prevention’s 2019 AR Threats Report includes two new urgent threats: drug-resistant Candida auris and Carbapenem-resistant Acinetobacter. These were added to three identified in 2013: Carbapenem-resistant Enterobacteriaceae (CRE), Neisseria gonorrhoeae, and Clostridioides difficile.

 Enter COVID-19

COVID has exacerbated the threat. In 2020, the World Health Organization reported on a study that showed that while 72% of COVID-19 patients received antibiotics, only 8% demonstrated bacterial or fungal co-infections. WHO also reported that early in the pandemic, azithromycin was widely used with hydroxychloroquine in the mistaken belief it could quell the virus. Azithromycin has since been shown to have no effect on SARS-CoV-2.

Another factor exacerbating antibiotic resistance has been the upswing in telehealth during the pandemic. Studies have shown that antibiotics are prescribed for a broader set of symptoms in the absence of physical examinations or laboratory tests -- e.g., telehealth.

Hospital admissions increase the risk of healthcare-associated infections and the transmission of multidrug-resistant organisms. Disruptions to health services during the pandemic also led to interruptions to treatments, such as for tuberculosis and human immunodeficiency virus, which can lead to selection for drug resistance. Similarly, disruptions to vaccination services increase the risk of infection, potentially leading to an overuse of antimicrobials.

The widespread use of biocidal agents for environmental and personal disinfection represents another threat. Low-level exposure to biocidal agents can select for drug-resistant strains and enhance the risk of cross-resistance to antibiotics, particularly those that treat Gram-negative bacteria.

What now?

Outsmarting microbes will never be easy. After all, they’ve been at it for a long time. Researchers believe that Enterococci bacteria – which cause thousands of multidrug-resistant infections in patients each year – were carried onto land in the guts of the world’s first terrestrial animals 425 million years ago. Still, efforts are being made to slow down the growth of antibiotic resistance. For the duration of the current pandemic, the World Health Organization recommends:

1. Training health workers to identify signs and symptoms of severe COVID-19 and those of bacterial or fungal disease; evaluate the need for medical devices that increase the chances of healthcare-associated

infections; and implement strict infection prevention and control measures.

2. Ensuring the regular supply of quality-assured antimicrobials, including antiretroviral and tuberculosis drugs, and vaccines.

3. Reducing the turnaround time of COVID-19 testing by improving testing methods and expanding testing facilities, especially for presumed patients, to reduce the urge to initiate antibiotics.

4. Exercising caution in the use of biocides for environmental and personal

disinfection, and prioritizing biocidal agents with a low selection pressure for antibiotic resistance.

In the long run

Government agencies, academic institutions, and nonprofit and industry groups around the world are sharing their expertise and aligning clinical trials and resources to tackle the growing problem. For example, the Antibacterial Resistance Leadership Group, funded by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) is collaborating with groups in 19 countries and has initiated more than 40 clinical studies at 130 sites. 

In 2019, the UN Interagency Coordination Group on Antimicrobial Resistance recommended countries support awareness programs for prudent use of antimicrobials by professionals in human, animal and plant health; invest in research and development for new technologies to combat antimicrobial resistance; and urgently phase out the use of critically important antimicrobials as growth promoters in agriculture.

In 2020, NIAID proposed a four-pronged approach to the challenge:

• Support research into promising therapeutics. For example, the Institute is funding research projects to develop models to predict the potency of therapeutics based on an understanding of how molecules enter and leave Gram-negative pathogens.
• Optimize existing antibiotics, that is, developing regimens of older antibiotics to more effectively treat infections and suppress the emergence of resistance.
• Develop microbiome-based approaches. For example, NIAID scientists collaborated with researchers in Thailand on a project that showed that Bacillus -- a “good” bacterium commonly found in probiotic digestive supplements -- helps eliminate Staphylococcus aureus.
• Explore phage therapy. Bacteriophages (phages) are viruses that selectively infect and kill bacteria. Phage therapy has been used to treat patients with severe, multi-drug-resistant infections under compassionate use conditions with promising results. However, knowledge gaps have hindered its development in the U.S.

Diagnostics an essential component

The need for antibiotic stewardship programs has never been more urgent. The UK’s National Institute for Health and Care Excellence (NICE) defines such programs as “an organizational or healthcare-system-wide approach to promoting and monitoring judicious use of antimicrobials to preserve their future effectiveness.” They emphasize education and training about antimicrobial resistance, providing regular feedback to prescribers, and integrating audits into existing quality improvement programs. 

In the U.S., the National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020-2025 recognizes the importance of rapid and innovative diagnostics as a tool to ensure appropriate antimicrobial use.

Specifically, the authors call for researchers to:

• Develop new or enhance existing diagnostics that use isolates and primary samples to determine the presence, severity, or antimicrobial susceptibility or resistance of bacterial or fungal infections and to identify appropriate treatment.
• Stimulate research to better understand the appropriate use of diagnostics to determine the presence, severity, or antimicrobial susceptibility or resistance of bacterial or fungal infections in human and veterinary care.
• Develop evidence-based guidance to promote the appropriate use of new diagnostics and to improve the use of existing diagnostics that determine the presence, severity, or antimicrobial susceptibility or resistance of bacterial or fungal infections in human clinical care.

 To summarize

• Detect, respond to, and contain emerging resistance
• Prevent and stop spread of resistant infections in healthcare and community settings.
• Improve antibiotic use.

In addition to the above, Point-of-Care (POC) testing can play a crucial role in antibiotic stewardship.

A study in a UK hospital demonstrated that a point-of-care test (POCT) for viral respiratory infections reduced the number of inappropriate hospital admissions and antibiotic prescriptions. With advancement in POC testing and conscious efforts towards antibiotic stewardship we can prevent antimicrobial resistance.

Monday, February 07, 2022

by Physicians Office Resource 

While children often recover quickly from COVID-19, with the emergence of the highly contagious omicron variant, cases and hospitalizations are on the rise. With the rise in COVID-19 cases, brings on another concern, MIS-C.

What is MIS-C? 

According to the CDC, “Multisystem inflammatory syndrome in children (MIS-C) is a condition where different body parts can become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs.” Scientists aren’t quite sure what causes MIS-C; however they do know that many children with MIS-C have had COVID-19. The CDC continues, “MIS-C can be serious, even deadly, but most children who were diagnosed with this condition have gotten better with medical care.”¹ 

MIS-C often comes as a surprise to parents and clinicians as some who develop this serious condition never showed signs or symptoms of COVID-19 and symptoms of MIS-C often do not arise until two to six weeks after COVID-19 infection. 

While MIS-C is rare, there have been almost 6,500 cases and 55 deaths over the last year. Experts expect that number to increase this year as we battle against the highly contagious omicron variant, especially within children younger than 5 who are unable to receive the vaccine. 

Can MIS-C be Prevented? 

Much is still being learned about MIS-C and its relationship to COVID-19, however according to a new report from the CDC, the “estimated effectiveness of 2 doses of Pfizer-BioNTech vaccine against MIS-C was 91% [in patients aged 12-18]. Among critically ill MIS-C case patients requiring life support, all were unvaccinated.”² 

MIS-C Prediction Model

Late last year, a team of medical scientists and investigators from Vanderbilt University and John Hopkins presented a risk prediction model at the annual meeting of the American College of Rheumatology. The model utilizes clinical, laboratory, and cardiac feature to help identify MIS-C cases within 24 hours of observed symptoms. Identifying MIS-C is difficult because MIS-C shares features common with infectious and inflammatory syndromes. Therefore, having a prediction model could be verry valuable to clinicians needing to identify these cases quickly and accurately.⁴ 

The four predictors in the model included:

• Hypotension (defined as requiring fluid resuscitation, vasopressor support or blood pressure less than 10th percentile for age, height, and sex).
• Abdominal Pain
• Rash
• Serum Sodium 

To develop this prediction model, investigators used retrospective chart data of children less than 20 years old that were evaluated for MIS-C at Vanderbilt Children's Hospital during the pandemic. While in the care of the hospital, clinicians collected a set of standardized clinical, lab, and cardiac characteristics. In all the trial population included 127 children admitted to the Vanderbilt hospital that were evaluated for MIS-C. Utilizing the retrospective chart data of the 127 children evaluated for MIS-C, 45 cases of MIS-C were confirmed versus 82 non-cases. 

Matthew Clark, MD, RhMSUS and lead investigator on the study said, “We used early clinical and laboratory features to inform the design of a clinical diagnostic prediction model with excellent discrimination to assist clinicians in distinguishing patients with MIS-C from those without…We plan to test this model with external and prospective validation.”³  

Sources

1. https://www.cdc.gov/mis/mis-c.html
2. https://www.cdc.gov/mmwr/volumes/71/wr/mm7102e1.htm
3. https://acrabstracts.org/abstract/a-prediction-model-to-distinguish-patients-with-multisystem-inflammatory-syndrome-in-children/
4. https://www.hcplive.com/view/risk-prediction-model-identify-pediatric-mis-c-cases

Monday, February 07, 2022

by Suneel Dhand, Md

Suneel Dhand is a physician, author and speaker. He is the Founder at DocSpeak, and Co-founder at DocsDox. He blogs at his self-titled site: suneeldhand.com

The doctor-patient interaction is the absolute core of clinical medicine. Maybe I’ll go much further: it’s the core of health care in general. I always try to remember, whenever I’m ever feeling frustrated with the system, the crazy bureaucracy — and of course, the debacle of our clunky electronic medical records and their data entry requirements — to separate myself from all of that when I’m face-to-face with my patient and their family. This time is priceless, it’s why I went into this. The interactions and honor of serving my patients at a low point in their lives, makes it all worth it. It’s where the magic of medicine happens, and is something that is untouchable by any external factor, if you choose to make it that way.

Here are three things that patients want from that doctor-patient interaction:

1. A compassionate doctor who communicates well. A physician who understands that they are coming to them for help, shows empathy, and listens carefully to the problem. The doctor should exhibit both in their verbal and non-verbal communication, that they are fully engaged in being their doctor, who truly cares for them. There are an array of phrases and body language techniques that can be used to show empathy, all of them are very learnable, and deeply appreciated by your patients.

2. A doctor who is honest and transparent. I actually think almost all physicians are this way anyway — highly trustworthy professionals in the first place (anyone not that way, would unlikely have made it so far). Nothing but complete honesty with a sincere interest in getting the best possible outcome. Explain everything slowly, clearly and in understandable terms — as if you are talking to a family member who knows nothing about health care.

3. A non-distracted physician. Nobody wants to pour their heart out to somebody who is not fully present in the conversation. No turning around, clicking, or looking elsewhere for extended periods of time. This is patient face time, not screen time. A technique that I use, that gets very positive feedback: I actually ditch the computer completely, especially when meeting a patient for the first time. I sit opposite them, lean in, and am fully present. I jot notes down on a piece of paper on my lap. Patients love it (actually anyone would like that kind of service when they are explaining something in a professional situation, even at Home Depot!). Writing things down when face-to-face with someone, subconsciously gives a better impression that you are concentrating and mentally processing, rather than typing on a keyboard and turning at a screen. It just does.

So these are just three things that any physician should strive to do in their interaction, to give their patients the experience they deserve. It may just be another “name on the list” for us — but for patients who may have waited hours or days to see us, it’s the part of their day that they will usually remember and appreciate the most.

Over my years of treating thousands of patients, seeing so many misunderstandings and poor interactions, and now being in a position where I am teaching many of these skills — I am really of the belief that what patients ask for is really not that much. We are already very good with our scientific knowledge and have stellar treatments at our disposal — but it’s the human side that is too often forgotten. Sure, time is tough, and not available in abundance. But even just an extra minute or two can make a huge difference.

What I am saying here may not sound “trendy or fashionable” to lots of folks. Scroll the Twitter and LinkedIn feeds of many of our administrators and technologists, who are now dominating health care, and you’ll soon see why the above is the last thing they want to hear. To lots of them, health care is all about spreadsheets and numbers, expensive new technologies, and building factory-like processes. But it really isn’t, and never will be. Unfortunately too, the doctor-patient relationship is something that may even be intimidating to many administrators — because it’s something that they can’t “get to” or really control. It shouldn’t be that way.

We are currently in a health care swamp of epic proportions, where we lose the forest for the trees. We keep moving further away from the frontlines, among a tidal wave of bureaucracy (see this chart, if you want to see the unbelievable growth of administrators versus physicians over the last 30 years). Of course, a sector as big as health care does need some oversight, rules, and regulations — but we’ve gone too far.

That moment when a physician sits down with their patient, is what the practice of medicine is all about, and should take front and center stage in any health care system. So Doctor, this is your time. Make the most of it and let’s give patients what they deserve when we are face-to-face. Even if the rest of the world around us feels like its tumbling down.

Monday, February 07, 2022

By Morgan Ingemanson, PhD

How Do You Evaluate Memory Loss?

When an individual begins to show signs of memory loss, a physician’s greatest challenge is often discovering the underlying cause of symptoms. Behavioral evaluations (including self-report questionnaires such as MoCA and MMSE, effort-based computerized testing, and psychological evaluations) and laboratory tests (such as APOE genotyping and biochemical labs such as blood, urine, and CSF analysis) can be useful in developing a diagnosis in cases of advanced symptom presentation¹. But how useful are these tools in assessing cases of early memory loss? Are they capable of detecting dementia early, before disease advancement, so that the physician has the opportunity to implement a successful treatment intervention?

Unfortunately, gold standard assessments often struggle with discovering early stage memory loss. The diagnosis of Alzheimer’s disease (AD) is delayed on average 2-3 years after symptom onset^2,3, at a point in which prognosis is poor. Ample clinical research has repeatedly demonstrated that brain changes associated with AD may begin 20 or more years before symptoms appear⁴. If implemented during this pre-symptomatic stage, lifestyle interventions including diet, exercise, cognitive training and monitoring vascular risk can improve or maintain cognitive functioning and potentially course-correct patients headed down the road to dementia⁵. Sadly, the tools most often used by physicians to evaluate memory loss are unable to detect this early stage of memory loss.

Moreover, many individuals have dementia-like symptoms without the progressive brain changes of Alzheimer’s disease (AD) or other degenerative brain diseases. Especially in early stages, memory loss related to dementia can be difficult to distinguish from cognitive decline caused by depression, thyroid problems, medication side effects, certain vitamin deficiencies, and even normal healthy aging⁶. Indeed, up to one in five patients diagnosed with probable AD during their lifetime did not have AD pathology at autopsy⁷.

How is it possible that current gold standard tools lack the sensitivity and objectivity needed to develop timely and accurate diagnoses for patients experiencing memory loss? It is because memory loss is a brain problem. Symptom screeners and effort-based computerized testing base conclusions off of behavior, not off of how the brain is functioning. Likewise, laboratory tests do not directly assess the main organ of interest. The impairment of memory, language, problem-solving, and other cognitive skills that characterize dementia occurs because neurons in the brain are damaged, destroyed, or dysfunctional. Shouldn’t the highest standard of care for memory loss patients include a direct and objective assessment of the brain itself?

Brain-Based Biomarkers.

Biomarkers are measurable characteristics of a biological function or response that can be objectively measured and evaluated to investigate processes in health and disease. Given that an objectively brain assessment is critical in pinpointing the cause of memory loss, a number of neuroimaging diagnostic biomarkers have been identified for clinical use. These include amyloid deposition as measured by PET scan and cerebral atrophy as measured by MRI⁸. Unfortunately, in the case of Alzheimer’s disease, these biomarkers begin to present once the disease has already begun to progress (Figure 1). Only once clinical symptoms are evident do various regions of the brain demonstrate atrophy detectible by volumetric MRI⁴. Moreover, from a practical perspective, these imaging techniques are expensive and/or invasive and therefore remain unavailable to the patients’ first line of contact – the primary care physician.

Electroencephalography, or EEG, involves the measurement of neural oscillations in the brain (i.e., brainwaves), and has long been established as a robust and valuable tool for investigating changes in neural functional. As opposed to techniques that measure brain structure like MRI and CT, EEG evaluates the electrical activity of the brain to reveal how the brain functions. These electrical changes can be measured during a resting state, reflecting spontaneous neural activity, and in “event-related potentials” (ERP), which reflect brain processing speed of environmental stimuli. Due to the un-intrusive, non-invasive, and inexpensive nature of EEG, it is a widely used tool for investigating brain function and neurophysiological health or disease in humans. Additionally, and of particular pertinence, a number of hallmark alterations have been noted in the EEG and ERPs of patients with dementia⁹.

Up to 20 years prior to the onset of symptoms, there is a window within Alzheimer’s disease progression wherein tau pathology and early amyloid pathology cause impairments in brain function prior to extensive neurodegeneration (Figure 1). Although CSF changes in Aβ and tau are absent at this stage, and functional impairments are not great enough to result in clinical symptoms, clinical research has demonstrated that EEG is capable of detecting biomarkers of impaired brain function. These include spectral “slowing” as measured by quantitative EEG (qEEG), which presents as a relative increase in low frequency brainwaves, and slowed brain processing speed, as indicated by a delay in the P300b component of the ERP waveform⁹. It is hypothesized that the most effective treatments for AD will be initiated during this early pre-symptomatic stage of the disease, when any damage may be reversed⁴. Thus, the ability for a primary care physician to collect EEG data and measure these memory loss biomarkers would profoundly improve their ability to make the correct diagnosis and to also provide the prognosis of how to treat the cause.

EEG and ERP for the Primary Care Physician.

Leading research agrees that utilizing traditional clinical evaluation and biochemical labs together with other supportive diagnostic techniques such as functional neuroimaging may be necessary to substantiate the diagnosis of MCI and the subsequent risk of developing AD¹⁰ (Figure 2).

With the understanding that the highest standard of care for patients with memory loss includes brain electrophysiology evaluations, comes the need for tools that provide objective memory-related measures that guide and inform physicians in their provision of more targeted therapies. Ideally, such tools would be available in the primary care office, as this is often the first point of care for patients experiencing symptoms of memory loss. However, traditional EEG devices have remained unavailable to most doctors because of expense and complex, time-consuming data interpretation. Historically, only neurologists have had the resources and training to derive clinical significance from EEG data. Moreover, the biomarkers useful in detecting pre-clinical dementia are measured via ERP and quantitative EEG (qEEG) testing, which require sophisticated data processing and comparisons with normative database references values. ERP and qEEG biomarkers provide enhanced objectivity and sensitivity over conventional visual inspection of EEG, yet primary care and specialty physicians alike have not had access to normative database comparisons that permit this type of quantitative analysis.

Advances in data processing and analytics have led to a golden age of electrophysiology assessments. Companies like Evoke Neuroscience (www.evokeneuroscience.com) have created low-cost, easy to use systems designed specifically to suit the needs of primary care physicians. In the case of Evoke Neuroscience’s eVox® System, primary care physicians now have access to these important biomarkers for memory loss to aid their diagnosis. A simple solution of integrated EEG hardware and software allows objective evaluations of brain function that can be performed by office staff. By providing these memory loss biomarkers, the eVox® System supports doctors in objectively assessing patients and may aid in recognizing pre-clinical dementia conditions, identifying the root cause of memory loss, and performing a differential diagnosis.

Figure 1. Depiction of the main changes across the progression of Alzheimer’s disease and the sequence of associated biomarkers⁴. A) Tau and amyloid pathology begin. B) The shaded region indicates a window in which tau and amyloid pathology cause functional impairments that are not great enough to result in clinical symptoms. CSF changes in Aβ and tau are absent but functional biomarkers as measured by EEG and ERP are present. This early pre-symptomatic stage is the time during which the most effective treatments will be initiated and any damage may be reversed. C) Clinical symptoms become apparent. D) Clinical symptoms are progressive and severe. Various brain regions demonstrate atrophy as measured by volumetric MRI.

Figure 2. The highest standard of care for patients with memory loss includes assessments of brain electrophysiology, biochemical labs, and effort-based screeners.

References

1. National Institute of Health: National Institute on Aging. Diagnosing dementia. Available at: https://www.nia.nih.gov/health/diagnosing-dementia.
2. Boise L, et al. Am J Alzheimers Dis. 1999;14:20-26.
3. Balasa M, et al. Neurology. 2011;76(20):1720-1725.
4. Walsh C, et al. Neurosci Biobehav Rev. 2017;73:340-58.
5. Ngandu T, et al. Lancet. 2015; 385(9984):2255-63.
6. Alzheimer’s Association. Alzheimer’s Dement. 2018;14(3):367-429
7. Beach TG, et al. J Neuropathol Exp Neurol. 2012;71(4):266-273.
8. McKhann GM, at al. Alzheimer’s Dement. 2011;7(3):263-9.
9. Horvath A, et al. Front Biosci. 2018;23:183-220.
10. Ladeira RB, et al. CLINICS. 2009;64(10):967-73.

Monday, February 07, 2022

By Irwin Z. Rothenberg, MBA, MS, CLS(ASCP), Technical Writer /Quality Advisor, COLA Resources, Inc. 

Introduction

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection 

As a result, laboratory professionals have long expressed concern about the quality of testing performed in these laboratories.  This concern has only grown with the rapid proliferation of waived tests, along with point of care /remote testing sites. 

Quality Concerns 

As a response to these concerns, both CMS and the CDC conducted random surveys of waived laboratories several years after CLIA 88 was enacted.  These labs had significant quality issues, including the lack of available written procedures; adequate personnel training, quality control performed as required; also, the lack of a proper attention to reagent expiration dates and storage requirements; and the failure to enter test results into electronic medical records[i].   Although not usually specified in the product insert (and therefore not a CLIA requirement), proper documentation and recordkeeping of patient and testing information are also important elements of good laboratory practices.

 Among the waived laboratories surveyed, the study also found[ii]:

• High staff turnover
• Lack of formal laboratory education
• Limited training in test performance and quality assessment

 Strategies to Address These Concerns

1. Competent Management and Organization

To be effective, efforts to achieve quality waived testing through good lab practice must start even before the testing process, all the way back to assessing the laboratory structure, organization, and purpose. These include: 

1. Commitment to Constant Oversight of the Testing Process

In POLs, this might be a physician or someone in a senior management position who has the appropriate background and knowledge to make decisions about laboratory testing. 

1. Anticipating and Addressing Personnel Needs

Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. While there are no CLIA requirements for personnel performing waived testing, all applicable state or local personnel regulations must be met.

 Personnel issues to consider include assessment of present staffing levels and training, to ascertain whether employees have sufficient time and skills to reliably perform all activities needed for testing. 

1. Personnel Training

Personnel should be trained and competent in each test they will perform before reporting patient results.   It is the responsibility of the laboratory director or other supervisory staff to ensure that this training has occurred, along with proper documentation of these efforts. 

2. Competency Assessment

To ensure testing procedures are performed consistently and accurately, periodic evaluation of competency is recommended, with retraining, as needed, on the basis of results of the competency assessment.

1. Development and Maintenance of Procedure Manuals

It is good laboratory practice to develop written policies and procedures so that responsibilities and testing instructions are clearly described for the testing personnel.  Written test procedures also form the basis of training and evaluation of testing personnel. These procedures should be derived from the manufacturer's instructions, and include directions for specimen collection and handling, quality control, test and reagent preparation, and instructions for test performance, interpretation, and reporting.

New testing procedures should be reviewed, signed, and dated by the laboratory director before incorporating them into the procedure manual. The manual should be updated as tests or other aspects of the testing service change and should be reviewed by the director whenever changes are made. When procedures are no longer used, the date of discontinuance should be noted, and they should be removed from the manual.  The manual should always be readily available to all testing personnel.

1. Maintenance of Complete and Accurate Documents and Records

Proper documentation is necessary for monitoring and assessing test performance, identifying and resolving problems that could affect patient testing, retrieving and verifying information, and maintaining adequate patient and personnel records. Log books or electronic systems can be used for maintaining and tracking information. In some cases, records might be part of the patient's medical chart. 

1. Performance of Quality Assessment

Good laboratory practices can be expanded to include activities to evaluate and improve the quality of waived site testing, utilizing both internal and external quality assessment activities. Results from these assessment activities should be documented and evaluated, noting any irregularities and the actions taken to resolve problems or improve processes or procedures. 

1. Follow Best Practices During Testing

1. The Pre-analytic phase[iii]
2. Test orders

Confirm that the written test order is correct. If there is a question, check with the ordering clinician before proceeding. 

2. Patient identification

Use two unique identifiers to ensure accurate identification of the patient before the specimen is collected. Names can be similar and lead to confusion, therefore use birth dates, middle initials, patient identification numbers or other means to ensure correctness. 

3. Pretest instructions and information

Some tests require special preparation on the patient’s part (e.g. fasting), or that the patient collect the specimen (e.g. urine or stool). Provide the patient with pretest instructions when appropriate, and verify that patients have received and understood the instructions before collecting or accepting the specimen. 

4. Specimen collection and handling

The product insert provides details on proper collection, handling and storage of patient specimens. Specimens need to be adequately labeled to prevent mix-up. Always label specimens as soon as they are collected with pertinent patient information. Labeling should also include the date and time of collection and identification of the collector. 

1. The Analytic Phase[iv]
2. Quality Control (QC)

Quality control provides assurance that the test system has performed as expected, and alerts the user when problems occur which may affect patient results; these can be problems due to operator error, reagent or test kit deterioration, instrument malfunction or improper environmental conditions.

If quality control testing fails to perform as expected, patient testing should not be performed or results should not be reported until the problem is identified and corrected. QC test results should be recorded and monitored. Records of control results should be periodically reviewed by the person responsible for testing oversight to detect shifts or changes in performance over time which may affect patient results. 

2. Test Performance

Follow the steps in the test procedure exactly as described in the manufacturer’s product insert and /or the written procedures. 

3. Results Interpretation.

Results can be recorded directly in a patient's chart, in log books, or on a separate report form. Interpretation of the results should be in accordance with instructions in the product insert. 

4. Resolving problems

If a test result is not acceptable or requires repeat testing (e.g., out of range or invalid), record the initial result, noting it was unacceptable, take steps necessary to resolve the problem, then repeat the test and record the correct result. Good laboratory practice includes recording what happens, whether acceptable or not, and what is done to correct problems encountered during testing. Results should not be reported until the problem is resolved. Follow the steps in the product insert to resolve problems with the test results. If repeat testing does not resolve the problem, contact the manufacturer or technical representative. 

1. The Post-analytic phase[v]:
2. Reporting Test Results

Patient reports should be legible and reported in a timely manner to the appropriate person. All verbal reports of test results should be documented and followed by a written report. Critical values require immediate notification of the clinician, and procedures should be in place to ensure documentation of these values along with the time of notification of the proper medical personnel. 

2. Confirmatory testing

The product insert should explain when additional testing is needed to confirm a waived test result or when the test is to be used as part of a multi-test algorithm (e.g. throat culture needed to confirm a negative result for rapid group A strep antigen). There should be written policies and procedures to ensure that all confirmatory and supplemental testing is performed when needed. When collecting specimens for referral to another laboratory, the instructions provided by the reference laboratory must be followed, and the appropriate request form completed. 

3. Maintaining records of referred testing

Important for patient care and follow-up. Logs and other records should have sufficient information to track and retrieve the test results and reports, such as:

• Information linking the referred specimen to patient identification.
• The name and contact information for the referral laboratory.
• The test name and date referred.
• Complete test results and the date received.
• The date the final report is issued. 

A designated employee should be responsible for ensuring that all tests ordered from a referral laboratory are returned and charted appropriately for review by the ordering clinician.

Conclusion

The findings of multiple surveys of sites performing waived testing throughout the United States have shown widespread lapses in quality. These studies highlight the need additional education, training and planning related to waived testing for Certificate of Waiver laboratory directors and testing personnel. 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

[i] Howerton, D., Anderson, N., Bosse, D., Granade, S. and G. Westbrook.  Division of Public Health Partnerships, National Center for Health Marketing, Coordinating Center for Health Information and Service.   “Good Laboratory Practices for Waived Testing Sites: Survey Findings from Testing Sites Holding a Certificate of Waiver Under the Clinical Laboratory Improvement Amendments of 1988 and Recommendations for Promoting Quality Testing.” CDC/ MMWR, Reports and Recommendations, November 11, 2005. The material in the MMWR report originated in the Coordinating Center for Health Information and Service, Steven L. Solomon, MD, Director; National Center for Health Marketing, Jay M. Bernhardt, PhD, Director; and the Division of Public Health Partnerships, Robert Martin, DrPH, Director.  https://www.cdc.gov/mmwr/PDF/rr/rr5413.pdf

[ii] Ibid.

[iii] Ibid.

[iv] Ibid. 

[v] Ibid

Tuesday, September 21, 2021

by David Kliff 

There is no question that when it comes to diabetes technology, continuous glucose monitoring (CGM) has been the most transformative. Unlike insulin pumps or connected insulin pens, CGM is used by all patients with diabetes, not just patients who use insulin. Thanks to CGM researchers, we now have a clearer understanding of diabetes. CGM is quickly becoming the standard for glucose measurement.

To fully appreciate just how transformative CGM technology is to diabetes management, take a look at the life of a patient before CGM. Back in the day, when blood glucose monitoring (BGM) was state of art technology, patients had to prick their fingers multiple times each day. Not only was this inconvenient, but it required extreme dedication from the patient. Besides the constant finger pricks, BGM required the patient to carry around all testing tools– the meter,  lancet, and test strips. Worse, with no connectivity, patients had to manually log their readings creating even more work. 

Fast forward to today when all CGM patients have to do is secure the sensor to their bodies, which is an easy and painless task performed either once every 10 or 14 days. Thanks to advancements in CGM technology, there are NO finger prick calibrations and readings are sent directly to the patient’s smartphone, where apps provide advanced data analytics. CGM not only makes getting the data a snap, but helps the patient understand what all the data means. It really should shock no one that so many patients have seen their outcomes improve thanks to CGM technology. 

Even better, going forward CGM is becoming more affordable, easier to use, and includes more sophisticated data analytics. Hence the reason CGM continues to replace BGM in diabetes patient management.

 Yet even with all of these advancements, it must be noted that technology does not prevent one of the biggest issues facing a person with diabetes, hypoglycemia. Yes, these systems have alarms and alerts, which is another benefit, but they cannot PREVENT hypoglycemia. Anyone who has experienced a hypoglycemic event understands this. As much as a patient or caregiver would like to prevent these events, unfortunately they do happen, and many times come out of nowhere. 

Now the majority of hypoglycemic events can be quickly dealt with. Hence the reason so many patients keep instant sugar at the ready. An experienced person with diabetes knows that untreated hypoglycemia is a life-threatening event. An event that can impact not just their lives but those around them as well, including their caregivers, family and friends. 

Still there are instances when a patient crashes and is unable to manually deal with this event. Thankfully we have also seen a dramatic improvement in ready-to-use glucagon delivery systems. Systems that can easily and quickly be used by people both experienced and  inexperienced in diabetes management.  Two of the newer and more advanced options are a nasal formulation and a premixed autoinjector pen. Both quickly deliver lifesaving glucagon, are simple to use and require little if any advanced training. 

As great as CGM is, it is nice to know that in those instances when a severe hypoglycemic event occurs, glucagon technology has also advanced.

Sunday, August 01, 2021

by Physicians Office Resource 

Meet Bindex® – the revolutionary, portable bone density scanning device that could be the new gold standard in first-level osteoporosis diagnostics.

For over 30 years, DXA bone density scanning has been the most reliable and the most accurate way to diagnose and monitor osteoporosis. But could it be missing the mark?

Osteoporotic fractures account for more hospitalizations than breast cancer, diabetes and myocardial infarction combined.¹ Yet while the entire Medicare population of around 60 million

is at risk of osteoporosis, only 2.5 million DXA scans are performed annually.

While its accuracy is not in question, does the very nature of DXA – high cost, limited to those with appropriate insurance coverage, less than universal availability – ignore all but the most at-risk patients, those who might already have been identified as osteoporosis sufferers? Could there, in fact, be an easier, more inclusive yet comparably accurate way to assess bone density?

The osteoporosis diagnosis gap

The discrepancy between patients at risk for osteoporosis and the number of DXA scans performed annually may be attributed to several factors.

Patients without an osteoporosis diagnosis who are at risk because of their age, gender or other health issues may not all be eligible for a DXA scan. Younger at-risk patients may not be eligible because of their age.

Many health insurance plans cover only eligible patients (which often means patients over 65) and only for one DXA scan every two years (when osteoporosis is diagnosed) even though more frequent scanning may allow physicians to offer more timely, more customized and, potentially, more effective treatment.

Bone density scanning made easier

There is, clearly, a need for accurate bone density scanning that is both easier and more affordable for patients, especially Medicare-eligible patients. The answer may come in the form

of an outwardly simple but technologically advanced handheld device called Bindex.

Designed and manufactured by Bone Index Ltd, Bindex promises a more equitable arrangement that potentially allows more at-risk patients – of Medicare age and younger, with or without an existing diagnosis – to receive fast and accurate bone density scans in a doctor’s office, clinic or any setting.

Bindex is 90% accurate in detecting osteoporosis

Extensive clinical research has proven Bindex to be 90% accurate in detecting osteoporosis which means it can replace nearly 70% of DXA scans for patients with suspected osteoporosis.

Using safe pulse-echo ultrasound, handheld Bindex measures cortical bone thickness in seconds and instantly analyzes bone density, generating a detailed yet easy-to-read report.

Better for patients – with clear advantages for doctors

Its size and portability means that Bindex can be used anywhere – in physician’s offices, hospitals and clinics as well as in patients’ homes and at bone density screening events. A

Bindex scan costs a fraction of a DXA scan and, for many patients, particularly those who want more frequent screenings than allowed by their insurance, represents a very affordable

out-of-pocket medical expense.

Bindex means that physicians can diagnose more at-risk patients and scan more diagnosed patients more frequently, and so make timely treatment decisions and adjustments. It

may also be a useful patient acquisition and retention tool, especially as patients age into Medicare, allowing physicians to keep an important source of patient revenue within their

own practices.

An opportunity to trial Bindex at no cost

Bone Index Ltd, manufacturer of Bindex, is currently offering selected US-based physicians the opportunity to be part of the device’s US launch by trialing Bindex with patients at no cost.

To register your interest in participating in the trial, please visit Bindex.us/launch or call

(970)-306-7452.

Footnote:

1. International Osteoporosis Foundation

Designed and developed by Bone Index Ltd, a healthcare diagnostics company, Bindex is

FDA-cleared and has been validated in clinical trials with several thousand patients. This

revolutionary device has already screened over 1.6 million people in the US, and has 19

global patents in the US, China, Japan and major EU countries.

Sunday, August 01, 2021

by Dlyan Chadwick 

These days, virtually any brick and mortar service has its own internet doppleganger. One can attain a college degree by attending online classes, stream movies directly from the source and of course, there’s Wikipedia, the online staple that’s put the final nail in the coffin of the door-to-door Encyclopedia industry. And while there’s seemingly no end to the wealth of information afforded to us on the internet, that information does come at a price: internet “quality control” is spotty at best.

Now, that’s well and good, likely entry level information to anyone who’s ever written a term paper or sought out unbiased information in a Honda forum...but then again, internet literacy isn’t always a straightforward metric. In an article by Tanya Fenke MD, (Dr. Google Should Be Sued for Malpractice. Here’s Why), the author illustrates the inherent problem of taking all our health concerns to Google, namely that internet sources quickly become outdated, are biased towards their benefactors and constituents, aren’t often written by healthcare professionals and often lack traceable references. In fact, as the title dictates, she suggests that if Google were a physician, he or she should be sued for malpractice, based on the number of problems that disseminating false information causes (no word on Dr. Pepper and Dr. Feelgood’s prospects at the time of publication).

While I wholeheartedly agree with Fenke’s assessment, that Google, or an internet search, isn’t a sustainable replacement for actual medical advice from an actual, living, breathing medical professional, I also realize the dilemma of Google’s involvement in everything. The trends of internet ubiquity aren’t going to slow, nor will Google’s lumbering ascent into total control of the internet cease. This isn’t glass half-empty philosophizing either, just the acceptance that if/when (more like when) the machines finally do take over, we can assume Google will be in the mix somewhere.

Instead, it’s becoming important for physicians to not only be the conduits towards viable health information, but also to help patients establish good searching habits for when they come across health information on their own time. Physicians cannot dictate what their patients will read and see outside of the office, but by giving them the tools to sniff out what’s good and what probably needs a second opinion, they greatly reduce the number of faulty accidents and misunderstandings.

Look for Recent Content

Health information is subject to ongoing developments and research, on micro and macro scales. What was once the de-rigeur health fad or yesterday might have been proven total bunk today, and vice versa. In that regard, information on the internet can run a little bit dicey since (theoretically) anything put online stays online forever. Encourage patients to check their sources and to be wary of any sources from more than a few years old, particularly if it’s dispensing health advice. Even if the information has stayed the same, credible and reputable outlets will be sure to keep things current anyway.

Additionally, the idea of timeliness opens up the discussion for physician blogging and social media, a great way to create relevant and reputable content quickly, to update on information that is changing and to just generally maintain a current channel of communication. Patients should also be wary of information that doesn’t contain any dates as there’s no way to determine how recently it was obtained and published.

Objectivity and Bias

It can be difficult to look objectively at one’s own symptoms, especially when emotions are running strong and influencing one’s actions. In this regard, internet searching along various strings of keywords can push the user towards a “self-diagnosis” that is biased or at the very least a little skewed. This also introduces what I call the “WebMD” effect in which a person goes down the internet rabbit-hole of reading all symptoms associated with a certain disorder and slowly convinces themselves that they indeed have the disorder. No one is immune to momentary flashes of anxious grandiosity.

Furthermore, there’s a wealth of “for profit” sources out there, posing as viable health professionals, even when they’re not. Wary patients should be mindful of any sites with corporate sponsors, as the information contained may just be a sideways plug to get you to buy a miracle product or to sell you on an affliction you don’t actually have. Solid health information is a right, and shouldn’t market you towards buying anything new.

Experience and Credibility

It goes without saying, but a number of those dispensing health care information are just writers….not doctors (this one included). In this regard, knowing exactly where a source comes from can be what will set off the “nonsense meter” right away. Patients should look for the credentials of an author who’s dispensing health care information, ensuring that they’re actual, medically licensed doctors. Even so, it’s not uncommon for professionals to get their articles ghost written by off-site writers. Patients should assume that any information coming from a source that doesn’t identify as a physician should probably not be regarded at all, and those that come from doctors, should be carefully vetted before following up on them.

Sources and Citations

In print, most must cite their sources, but on the internet, and it can be a bit more difficult to truly regulate this principle. If a site doesn’t cite the sources of its claims, or if they’re especially absolute or broad and sweeping, one should maintain their skeptic senses a bit. Information can be sensationalized to drive ratings and page views to a site, and often take claims and facts out of context, specifically to fit their own content agenda. If a site doesn’t provide sources for its health care advice, isn’t from a health sanctioned organization or contains many sources from less credible sources, patients shouldn’t accept the information sight unseen. Remember, if a site doesn’t want readers to know where they got their stories, at best they likely don’t have anyone’s best interests in mind and at worst, could be hiding something.

Encourage the In-Person Follow Up

Fortunately, physicians still have the ultimate, and most credible, say in directing patients towards quality health care information. Besides endowing them with a dose of healthy skepticism towards online health information (and let’s be honest, it’s a good trait to have in an election year too), it’s important to remind them that they can always follow up directly with you, a primary health care source, about anything unclear. Not only does this type of outreach send the message that you’re there to help and guide them in their healthcare journey, but also establishes a precedent for always checking up with a qualified source before taking anything to heart.

Ultimately, we shouldn’t recognize Google as anything even remotely like a doctor and should recast it for what it really is: “a huge repository of information, scrupulously indexed and largely unregulated.” Patients and users still have the power.

References

Feke, Tanya, MD. "Dr. Google Should Be Sued for Malpractice. Here's Why."

KevinMD.com. KevinMD, 09 Aug. 2015. Web. 17 Aug. 2015.

Johns Hopkins Medicine Health Library. "Finding Reliable Health Information Online."

Hopkinsmedicine.org. Johns Hopkins, n.d. Web. 17 Aug. 2015.

Sunday, August 01, 2021

A new monthly column from Physicians Office Resource looking into the current research and the future of medical science 

Blood Markers Indicating Labor is Approaching Identified 

Researchers at Stanford University School of Medicine have identified for the first-time blood markers indicating when a pregnant women will go into labor. The study, which was published in Science Translational Medicine, gives insights on how labor begins, by analyzing immune and other biological signals in a blood sample. The study’s lead author, Ina Stelzer, PhD, said, “We found a transition from ‘progressing pregnancy’ to a ‘pre-labor’ phase that happens two to four weeks before the mom goes into labor…We’ve identified a novel way to use the maternal blood to predict when a mother will go into labor. This prediction is independent from the duration of pregnancy.”¹ Brice Gaudilliere, MD, PhD, and the study’s senior author said, “Clinicians are good at estimating gestational age, which measures the development of the fetus. But there is a disconnect between this timing and when labor starts, because whether the baby is ready is only one factor in the onset of labor, the other part of the equation is the mother.”¹ The study focused on 63 women during the last 100 days of pregnancy. Blood samples were taken two to three time prior to birth and each sample was analyzed for 7,142 metabolic, protein, and single-cell immune features. Researchers utilizing mathematical modeling where able to identify blood markers that best predicted the onset of labor. Current results though imprecise, about a five-week window, could lay the foundation for a more accurate clinical blood test.

“New Generation” Artificial Heart Implanted in Patient – First in United States

Drs. Jacob Schroder and Carmelo Milano lead a surgical team at Duke University Hospital which successfully implanted a new generation artificial heart. The 39-year-old man in which the artificial heart was implanted suffered from advanced biventricular heart failure. The artificial heart developed by CARMAT is intended to replace the ventricles of the native heart in patients and is currently approved to begin studies in the US. “Because of the shortages of donor hearts, many patients die while waiting for a heart transplant…we are hopefully for new options to help these patients,” said Dr. Schroder. Dr. Milano continued, “We are encouraged that our patient is doing so well after the procedure. As we evaluate this device, we are both excited and hopeful that patients who otherwise have few to no options could have a lifeline.”²

New Technique to Treat Middle Ear Infections

Middle ear infections affect more than 80% of children. Current treatment methods often include prescribing antibiotics; however research has shown that in 30% of middle ear infection cases, antibiotics don’t work. Also due to the prevalence of middle ear infections, overuse of antibiotics can lead to antibiotic resistant bacteria. That’s why results coming from a study funded by the National Science Foundation is providing hope for another treatment option. Researchers at the University of Illinois Urbana-Champaign have developed a 3D printed device to inactivate a common bacterium that causes middle ear infections. The 3D printed device generates plasma composed of charged particles and reactive molecules which can inactivate a variety of pathogens. Researchers in this project decided to try and penetrate the biofilm of the bacteria within the ear. Helen Nhuyen, an engineer who was part of the study, stated, “Biofilms are very dense, making it difficult for the antibiotics to penetrate. Our idea was that if we could disrupt the structure of the biofilm, we could increase the penetration of the antibiotics.”³ The research has been tested on rats and found after 15 minutes of treatment, bacteria was inactivated with no results of physical damage to the rat eardrum. The results suggest that this method could be used to treat middle ear infections in humans.

Calcium Regulating Heart Protein Could Lead to New Treatment for Heart Failure

It has long been known that calcium plays a vital role in bone, muscle, and heart health. Regarding heart health, calcium surge and diminish during and in between normal heart beats. Scientist also know that mitochondria depend on calcium to help produce energy that in return keeps the cell alive.

In a recent study published in Nature⁵, an international study lead by researchers from the University of Utah sought to better understand the specific role of mitochondria and it’s relation to calcium signaling within heart cells. Researchers observed that when the signaling pathway for protein, VDAC2 was disrupted severe impairment of heart cell contraction occurred; thus making it harder for the heart to pump blood to the body. Stavrose Drakos, MD, PhD, senior author on the study, said, “Based on our human and laboratory research, it appears that if VDAC2 is not working properly, then everything in the heart can cascade downward from there. If we can figure out ways to help this protein do its job again, then it’s possible that we might be able to address heart failure far earlier in the disease process.”⁴ Researchers are hopeful this will open the way for therapeutic drugs to alleviate heart failure by targeting VDAC2.

Children with Type 2 Diabetes Face Dire Future

Type 2 diabetes in youth is increasing not just within the United States, but throughout the world. Up until now, little was known about the direct impact that type 2 diabetes would have on these youth as they entered adulthood. Now, thanks to a 15 year study, researchers have a better understanding of the dire effects this childhood disease will have on adults. According to a study published in the New England Journal of Medicine, “among participants who had onset of type 2 diabetes in youth, the risk of complications, including microvascular complications, increased steadily over time and affected most participants by the time of young adulthood.”⁶ 500 participants were evaluated with a mean age of 26.4±2.8 years, after being diagnosed with T2D around the age of 13 showed the following complications:

• Cumulative incidences of hypertension = 67.5%
• Incidence of dyslipidemia = 51.6%
• Incidence of kidney disease was 54.8%
• Incidence of nerve disease 32.4%
• Prevalence of retinal disease increased from 13.7% in 2010/2011 to 51% in 2017/2018

The study also noted that “complications were more common among participants of minority race and ethic group and among those with hyperglycemia, hypertension, and dyslipidemia.”⁶

Certain Types of Body Fat Decrease Gray Brain Matter

Gray brain matter is named for its grayish-pink color and is home to neural cell bodies, axon terminal, dendrites, and all never synapses. Gray matter is also essential in learning, memory, muscle control, and cognitive function. So, when researchers at the University of South Australia found that some types of obesity lead to a reduction in gray matter in the brain, alarms were raised. Lead author of the study, Anwar Mulugeta, PhD., said “We found that people with higher levels of obesity, especially those with metabolically unfavorable and neutral adiposity subtypes, had much lower levels of gray brain matter, indicating that these people may have compromised brain function, which needed further investigation.”⁸ The study found that for, “every extra 6.6 lbs. of body weight in a person of average height, the amount of gray matter decreased by .3%”⁸ Dr. Mulugeta lead author of the study stated, “However, we did not find conclusive evidence to link a specific obesity subtype with dementia or stroke. Instead, our study suggests the possible role of inflammation and metabolic abnormalities and how they can contribute to obesity and gray matter volume reduction.”⁸

Sources

Blood Markers Indicating Labor is Approaching are Identified

1. https://med.stanford.edu/news/all-news/2021/05/blood-markers-indicate-labor-approaching.html

“New Generation” Artificial Heart Implanted in Patient – First in United States

2. https://corporate.dukehealth.org/news/new-generation-artificial-heart-implanted-patient-duke-first-us

New Technique to Treat Middle Ear Infections

3. https://www.nsf.gov/discoveries/disc_summ.jsp?cntn_id=303107&WT.mc_id=USNSF_1

Calcium Regulating Heart Protein Could Lead to New Treatment for Heart Failure

4. https://healthcare.utah.edu/publicaffairs/news/2021/07/drakos-heart-failure-protein.php
5. https://www.nature.com/articles/s41467-021-24869-0

Children with Type 2 Diabetes Face Dire Future

6. https://www.nejm.org/doi/10.1056/NEJMoa2100165
7. https://www.nature.com/articles/d41586-021-02074-9

Certain Types of Body Fat Decrease Gray Brain Matter

8. https://www.medicalnewstoday.com/articles/some-types-of-body-fat-decrease-the-amount-of-gray-brain-matter
9. https://www.sciencedirect.com/science/article/abs/pii/S0197458021000658

Thursday, July 01, 2021

by Dylan Chadwick

If health care had a definitive "face," the primary care physician would likely occupy the position. The primary care physician is often a patient's first contact with recovery and in turn, plays a crucial role in public health care: making the initial diagnosis.

Primary care physicians see a staggering variety of patients and conditions on a day-to-day basis. Many of these conditions are treatable within one office visit, but occasionally they're more severe. When patient conditions are determined to be more complicated, or specialized, primary care physicians can refer them to specialists, who can address these patients in a more specific manner, drawing on their own experience of a given school of medicine. Patients then convene with specialists regularly to monitor their condition and develop a treatment plan.

This is the traditional (and highly paraphrased) pattern for how most patient diagnoses work. However, recent data from the Robert Graham Center for Policy Studies in Family Medicine and Primary Care indicates that this paradigm is rapidly shifting, and that more and more patients, particularly those with complicated and chronic health conditions, are seeking the advice and care of their primary care doctors than they are with specialists and sub-specialists. The development becomes increasingly more interesting when examined in the current health care climate that seems constantly faced with threats of imminent physician deficits, and statistics the number of medical students entering primary care in flux.

Just How Much?

A summary of the aforementioned research, published in the Journal of the American Board of Family Medicine illustrates these shifts. Led by Manisha Sharma, MD, a visiting scholar at the Graham Center, and a research team, the study (entitled “Patients with High Cost Chronic Conditions Rely Heavily on Primary Care physicians”) examined outpatient physician in an effort to determine the frequency of primary care visits versus specialist visits. Their data was culled from a National Ambulatory Medical Care Survey for care, provided for each of the 14 high-cost chronic conditions listed in the Centers for Medicare and Medicaid Services Chronic Conditions Dashboard.

Their research indicates that 86 percent of asthma visits occurred in the primary care physician offices, verses 14 percent which occurred in sub-specialist offices, as well as 84 percent of visits for chronic obstructive pulmonary disease which occurred in primary care physician offices, versus 15 percent in sub-specialist offices. Both conditions represent a substantial portion of health conditions that all physicians must treat, with CDC and American Lung Association figures attributing $56 billion in medical costs for the former and $49.9 billion for the latter.

“These data demonstrate how much patients depend on primary care physician to take care of these complex and chronic conditions,” says Andrew Bazemore, MD, MPH, director of the Graham Center. “Many of these patients have multiple chronic conditions, so a physician with expertise in the whole person and the broad range of medical diagnoses is instrumental to ensuring that all their health needs are met.”

This data has led some team members to push for a semantic distinction for those in "primary care" suggesting that the name "Primary Care Physician" fails to account for the entirety of their position. Since an increasing amount of the country's health burden continually falls on these physicians, some suggest that the name “complex care physicians” is more accurate.

What's in a Name?

But why bother with this kind of distinction? Does it truly matter? In terms of public health, it doesn't, but the suggestion does indicate a changing landscape for primary care medicine generally. Essentially, the data suggests that the role and influence of, as well as the dependence on, primary care physicians has been expanding, and it may be time for other members of the health care equation to shift as well.

Chronic health conditions are defined as those which result in long-lasting effects. Generally speaking, diseases become “chronic” when their effects last for longer than three months. After a diagnosis from a primary care physician, patients with chronic conditions often learn about the necessary lifestyle decisions and habits they must make, to properly deal with the condition. The subsequent result (and truthfully, the goal) of these visits often becomes a long-lasting relationship between the physician and patient which involves multiple visits, checkups and progress monitoring.

Complex, or complicated conditions are those which arise from various interactions between inherited traits (“nature”) and environmental factors (“nurture”). One of the most immediate and identifiable examples of a complex condition would be cancer in its various forms. “More and more primary care physicians must not only identify medical needs of patients with chronic conditions, but they also must identify, coordinate, facilitate and manage issues surrounding and shaping these conditions such as lifestyle behaviors, food access, safety, and social, environmental and economic conditions,” says Sharma. “That’s not simple, primary care medicine. That’s complex care medicine.”

Indeed, when it comes to complex and chronic patient conditions, primary care physicians wear a host of differing “hats” to provide total and lasting healthcare to their patients.

Team-Based Care

The specific and long-lasting nature of chronic and complex conditions, and the fact that primary care physicians are likely to be the physicians shouldering these burdens, highlight a push for more "team-based" care. Data from the study hypothesizes that, on average, primary care physicians would need 10.6 hours per working day to adequately care for patients with multiple chronic conditions, a serious time investment!

In these particular cases, patients would benefit from a team or network of care providers who can collectively help them execute treatment plans and coordinate care strategies care with other providers and community resources. This would make great strides to delegate care and alleviate some of the burden from primary care physicians.

A Becker’s Hospital Review article entitled The Affordable Care Act and Physicians: A Prescription for Change describes team-based care as a method for physician “capacity expansion.” It's a re-interpretation, an evolution of the health care delivery model that employs the use of information technology and a re-design of the care delivery structure to account for a “team” of resources which care for patients. They suggest that medical practices establish procedures and policies geared towards each team member practicing to the highest level of their individual license, granting multiple team members, through the appropriate platform, access to information to best suit the needs of the patient.

The article also suggests that physicians adopt the best technology for the best purpose. As an example, primary care physicians, and other members of the care team, can utilize frequent communication with patients through various online platforms, including Email. Chronic and complex conditions often necessitate long term communication, and an email can be just as beneficial for an entire office visit, and it's cheaper. Furthermore, physicians can invest more time in disseminating non face-to-face “touch points” with patients like telemedicine, informational web pages and mobile technology.

A move towards a more “role-based” expectation model for staff members could lend greater responsibility to each team member. It will also involve some level of coordination and communication among team members, significant training on leadership skills and a structure put in place for team management.

Some Set-backs

Team-based care isn't without its own share of sticking points. For one, expanding the flow of patient information always introduces the risk of privacy breaches, especially when health information is being shared along a chain of command. It goes without saying that any changes made to patient information command would involve special protocol and security checks.

It can also affect payments and reimbursements. When physicians place a greater emphasis on disseminating health care information, they’re taking their in-office services into an arena that's often not covered by Medicare or other insurance providers.

Finally, when the process of distributing health care is “shared” among a variety of professionals, patients may experience an extended time between their need for care and their actual treatment.

The Next Chapter

There’s certainly no “magic bullet” scenario here. However, in an era where health care reform practically forces some elements of team-based care, and when primary care physicians are finding more and more of their time and services for complicated conditions being demanded, the need for delegation becomes increasingly crucial.

“Value based” health care, health care that seeks to improve the population’s health while also increasing patient and physician satisfaction is a model that requires a fair amount of work, planning and re-structuring. It involves engaging physicians in assessing their health models and incentives, creating the most efficient platform that provides the best access to data and a “holistic” view of patients that extends beyond the office.

No one can definitely say where exactly reform will take health care, but the need for new care models may become apparent. With the right model, team and incentives, primary care physicians will continue to lead the charge for public health, regardless of the name we give them.

References

American Lung Association. "Chronic Obstructive Pulmonary Disease Fact Sheet"

            American Lung Association. N.p., Aug. 2013. Web. 15 Jan. 2014.

Bayliss, Elizabeth A., MD. "Simplifying Care for Complex Patients."

            Annfammed.org. Annals of Family Medicine, 1 Oct. 2013. Web. 15 Jan. 2014.

Bendix, Jeffrey. "Building a Team-based Medical Practice."

            MedicalEconomics.com. Medical Economics, 10 Sept. 2013. Web. 14 Jan. 2014.

Centers for Disease Control and Prevention. "Asthma in the US - Growing Every

            Year." CDC.gov. Centers for Disease Control and Prevention, 03 May 2011.

            Web. 14 Jan. 2014.

Doerr, Tom, MD. "The Affordable Care Act and Physicians: A Prescription for Change."

            Beckershospitalreview.com. Becker's Hospital Review, 4 Oct. 2013. Web. 15 Jan. 2014.

Physiciansnews.com. "‘Primary Care’ Doctors Should Be Called ‘Complex Care’

            Docs." PhysiciansNews.com. Physicians News, 10 Jan. 2014. Web. 15 Jan.           

            2014.

Praus, Julie. "Team-based Health Care' Can Be Costly and Slow."

            PostBulletin.com. Post Bulletin, 6 Jan. 2014. Web. 15 Jan. 2014.

Thursday, July 01, 2021

by Irwin Z. Rothenberg, MBA, MS, M.T. (ASCP), Technical Writer/Quality Advisor, COLA Resources, Inc.

Introduction

Laboratory testing plays a critical role in health assessment, treatment, monitoring, and ultimately, the public’s health. Test results contribute to diagnosis and prognosis of disease, the monitoring of treatment and health status, and population screening for disease.  An estimated 7-10 billion laboratory tests are performed each year in the United States and laboratory test results influence approximately 70% of medical decisions.  Increasingly, these decisions are based on simple tests performed using devices that are “waived” from most federal oversight requirements, and are thus designated as waived tests.

When these waived laboratory tests are performed at or near the site of patient care - such as in an emergency room or urgent care clinic, or at patient’s bedside - they fall under the definition of Point of Care Testing (POCT).  Physician office laboratory testing also is included under the definition of POCT when these tests are performed, and the results are provided to the physician, while the patient is still present and diagnostic and treatment decisions can then be made utilizing this information.

The rapid growth of POCT testing is a prime driver for the increase in waived testing at physician office laboratories, and is a direct result of the convergence of several trends that are already impacting POL operations:

• Technological advances that bring higher quality waived testing closer to the patient,
• The decentralization of laboratory services, so that POLs can now perform testing previously confined to core laboratories
• The Increased number and variety of tests classified as CLIA-Waived, and available to POLs
• Growth of Drugs of Abuse/Pain Management Clinics performing drug testing in-house

Bringing Laboratory Services Closer to the Patient

The increased number of waived tests now available for physician office laboratory testing eliminates the need for trips to and from a central core laboratory (and specimen collection sites that are run by laboratories). These tests enable physicians to make more rapid diagnoses and treatment decisions on site, and they improve patient compliance with physicians’ recommendations.

Garnering information on site often allows immediate treatment, which avoids requiring the patient to make multiple trips to the physician office and pharmacy, saving time for both the patient and the clinician. Accurate diagnostic information at the point-of-care saves critical medical resources and improves both patient and clinician satisfaction. In light of the role of waived testing in the healthcare delivery system and their overall benefits, the availability of and timely access to these technologies will continue to be important to meet the needs of patients and clinicians for rapid and reliable testing[i]. 

New Tests/Instruments = Increased Demand = Additional New Tests/Instruments

This demand for point-of-care capability has spurred the development of smaller, faster, and easier-to- use tests that are more sophisticated in design than tests traditionally found in smaller office laboratories.

Since the inception of CLIA 88 and the concept of waived testing, technological advances that simplified test processes and increased reliability of test results, has led to a dramatic increase in the number of approved waived tests from 9 to 119; and the number of test systems to over 1600.[ii]

Some of the waived now tests performed in the physician office include streptococcus testing, HIV testing, INR (coagulation) testing for Coumadin, and pregnancy testing. The ability to immediately treat the patient for these and other conditions, without having to send a sample to a central laboratory, can be critical to the patient’s well-being. As an example, a positive test for strep can allow the clinician to immediately prescribe antibiotics, catching an infection before it becomes severe, with potential health consequences (or ruling out strep and avoiding unnecessary use of antibiotics).

According to research, POC testing is growing faster than any other segment of the diagnostic industry with an average growth rate of 14% a year. Of this, CLIA- waived is the fastest-growing segment of this market.[iii]  The number of Waived labs had increased from 20% in 1992 to 75% of the more than 270,000 CLIA laboratories in 2021.  Of these waived labs, 67% were POL’s.

Pain Management / “Drugs of Abuse” Testing[iv]

Pain management is one of the fastest-growing reasons for waived testing. With an increasing number of internists and anesthesiologists opening pain clinics, and primary care and family practice physicians opting to treat patient pain in house instead of referring out to specialists, the pain management opportunity is ever increasing. Pharmaceutical companies are encouraging physicians to perform drug tests to monitor prescription compliance and aid in risk management.

The number of free-standing and university-based clinics in the U.S. alone has increased from just 500 in 1998 to 2,000 in 2008. Each of those clinics on average treats approximately 400 chronic pain patients per month. Over 70% of these patients are prescribed some form of opiate medication.

Deaths caused by overdose of prescriptions drugs also are on the rise and, as a result, one of the prescribing guidelines, indicated by the National Pain Foundation, is to evaluate patients for the risk of abuse before starting opioid therapy. Drug testing helps the doctor in evaluating the patient’s drug history as well as aids them in avoiding or minimizing a possible reaction to other medications or narcotics. Physicians, not necessarily skilled in recognizing the signs for drug abuse or addiction and wanting to exercise caution, are also being proactive and instituting drug testing as a regular part of their patient evaluation.

The tests are even used to monitor patients and their adherence to a pain management protocol of narcotics prescribed. Testing is sometimes used to determine if in fact the patient is taking their prescribed medications.

What does all this mean for the physician office laboratory?

1. The continued expansion of testing classified as waived, including those involved with drugs of abuse, infectious disease screening, and chronic disease management, provides the opportunity for greater point-of-care testing by physician office laboratories, while the patient is present, facilitating immediate medical decisions, the initiation of treatment, and continued monitoring.
2. The growing utilization of waived testing in a physician office setting brings great benefits for patient care, but it also brings great responsibility to ensure that the results obtained are of the highest quality to realize these potential benefits. These responsibilities include ensuring adequate personnel training and competency assessment; performance of required quality control, maintenance, and calibrations of the instruments used; proper specimen collection, handling and labeling, and documentation of test results. This requires maintaining adequate oversight and accountability.
3. Efficient, quality-run physician office laboratories, able to provide a larger array of on-site testing that provides faster results, diagnosis and treatment decisions support the goals of patient-centered laboratory service.

[i] Waived Testing and patient Safety: Future Trends. COLA Insights January/February 2015. Irwin Rothenberg

[ii] CMS.gov. Certificate of Waiver Laboratory Project / Requirements of waived Tests 2014.

https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Certificate_of_-Waiver_Laboratory_Project.html

[iv] Alfa Rapid Medical Tests. CLIA Waived Medical Testing Explained.  “Just What The Doctor Ordered” Why  Are Doctors Testing?   2009.  http://www.alfascientific.com/news-events/clia-waived-testing-explained

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

Thursday, July 01, 2021

A new monthly column from Physicians Office Resource looking into current research and the future of medical science

University of Oxford Launches Phase 1 Trial for HIV Vaccine

Since the first report of AIDS in 1981, researchers have been looking for ways to combat HIV infections. Today, there are dozens of drugs available to help inhibit HIV, but as of yet, no vaccines have been approved to prevent HIV. HIV’s ability to change and escape immune responses, has proved to be the biggest challenge in creating a safe and effective vaccine. That’s why the announcement from University of Oxford that a Phase 1 Trial has been launched for an HIV vaccine was met with great excitement in early July. Tomas Hanke, the trial’s lead researcher and Professor of Vaccine Immunology at the University of Oxford’s Jenner Institute had this to say about the trial, “An effective HIV vaccine has been elusive for 40 years. This trial is the first in a series of evaluations of this novel vaccine strategy in both HIV-negative individuals for prevention and in people living with HIV for cure…Even in the broader context of increasing antiretroviral treatment and prevention, an HIV-1 vaccine remains the best solution and likely a key component to any strategy ending the AIDS epidemic.”¹

New Treatment Candidate for Halting and Reversing the Effects of Dementia and Alzheimer’s Disease

A recent study published in the International Journal of Molecular Sciences, a research team based at Tohoku University in Sendai Japan, have identified a new treatment candidate to halt and reverse the effects of neurodegenerative diseases such as dementia and Alzheimer’s in mouse models.

Previous studies suggest that when a calcium channel is disrupted in a neurotransmitter, dopamine and acetylcholine releases are reduced, resulting in cognitive confusion and decreased motor function. This also leads to the buildup of aggregated proteins which inhibit proteasome activity leading to neuronal death. To combat this, researchers developed a disease modifying therapeutic, knows as SAK3 a T-type calcium channel enhancer. This therapeutic rescued neurons in most protein-misfolding, neurodegenerative diseases. The calcium channel enhancement is thought to trigger a change from resting to active in neuronal activity. According to the paper author, Kohi Fikunaga, professor emeritus in Tohoku University’s Graduate School of Pharmaceutical Sciences, “Even after the onset of cognitive impairment, SAK3 administration significantly precented the progression of neurodegenerative behaviors in both motor dysfunction and cognition.” Fikunaga went on to say, "SAK3 is the first compound targeting this regulatory activity in neurodegenerative disorders. SAK3 administration promotes the destruction of misfolded proteins, meaning the therapeutic has the potential to solve the problems of diverse protein misfolding diseases such as Parkinson's disease, Lewy body dementia and Huntington disease, in addition to Alzheimer's disease."²

Increasing Evidence Suggests Controversial Sputnik COVID Vaccine is Safe and Effective

According to an article in the scientific journal, Nature, Russia’s COVID-19 vaccine, Sputnik, is showing evidence from Russia and many other countries that suggests it is safe and effective. Sputnik, has been controversial from its early release in August 2020 before it ever completed Phase III trials. Even today after Phase III trials have been published, which showed the adenovirus vaccine was 91.6% effective at preventing symptomatic COVID-19 infection and 100% effective at preventing sever infection, “some scientists have criticized the authors for failing to provide full access to the raw data.”³ Almost one year later from its release, the Russian vaccine has been approved for use in 67 countries, however it has yet to gain EUA from the WHO.

Utilizing two different adenoviruses for the first and second doses as a delivery mechanism for inserting the genetic code for the SARS-CoV-2 spike protein into human cells, has been shown to increase efficacy. The United Arab Emirates Ministry of Health reported a 97.8% efficacy in preventing symptomatic COVID-19 and just as trail results showed, a 100% efficacy in preventing sever disease in the 81,000 people who had received both doses. Another and as of yet, unpublished study from the Buenos Aires health ministry in Argentina, involving 40,387 vaccinated and 146,194 unvaccinated people ages 60-79 showed that a single does of Sputnik Light (a one shot variation of the vaccine) reduced symptomatic infections by 78.6% and deaths by 84.7%.³

Sequencing of over 600,000 Exomes Identifies 16 Variant Genes that Provide Protection from Obesity

In an article in the journal Science, researchers Parsa Akari et al. sought understanding in “how genes predispose individuals to, or protect individuals from, obesity.”⁴ 640,000 exomes were sequenced from the UK, US, and Mexico and identified 16 rare coding variants. One variant allele, GPR75, found in Mexican populations was associated with lower BMI. GPR75 was only found in 4 out of 10,000 sequenced people and were associated with “1.8 kg/m2 lower BMI, 5.3 kg lower bodyweight, and 54% lower odds of obesity in heterozygous carriers.” In laboratory studies in mice with a knockout of GPR75 resulted in resistance to weight gain despite introduction of a high fat diet. Knockout mice also showed improved glycemic control and insulin sensitivity. Results were significant and lead researchers to believe that inhibition of GPR75 could be a therapeutic strategy for obesity.⁴

CRISPR Injection Treats Genetic Disease in Patients for the First Time

For years, scientists have been using the gene editor CRISPR for correcting mutations in laboratory settings. However, utilizing CRISPR technology to treat people with genetic diseases has faced a variety of obstacles, and specifically one large one: injecting CRISPR into a patient and making sure it slices the DNA in the correct spot. According to a recent article published in Science, researchers have successfully breached that large obstacle. In this trial, four men and two women suffering with the genetic disease transthyretin amyloidosis were injected a lipid particle containing two different RNAs: “an mRNA encoding the protein Cas, the CRISPR component that snips DNA, and a guide RNA to direct it to the gene for TTR. After Cas makes its cut, the cell’s DNA repair machinery heals the break, but imperfectly, knocking out the activity of the gene.”⁵ Results after about a month showed that three men had an 80-96% drop in transthyretin (a protein which builds up on the nerves of the heart causing pain and heart disease) levels. This research study is still in its early stages and there are still many unknowns such as side effects and if symptoms will continue to improve. But the early results are extremely promising and could open the door for CRISPR therapies. ⁵

Research Shows COVID mRNA Vaccine Does Not Affect Male Fertility

With rumors running rampant on social media and other outlets regarding the safety of the COVID mRNA vaccines, a new study published in JAMA sought to put to bed at least one of those rumors: that the COVID-19 mRNA vaccines cause a decrease in sperm parameters. The study hosted at the University of Miami recruited health volunteers aged 18-50 and were prescreened to make sure there were no underlying fertility issues. Two samples were taken after a prescribed number of days after the first and second doses. Results were then analyzed by trained professionals based on guidelines from the WHO. After analysis, this study showed that there was no significant decreases in any sperm parameter. ⁶

Sources

University of Oxford Launches Phase 1 Trial for HIV Vaccine

1. https://www.pharmatimes.com/news/oxford_researchers_launch_hiv_vaccine_trial_1372739

https://www.rt.com/uk/528446-oxford-university-launches-hiv-vaccine-trial/

https://www.openaccessgovernment.org/hiv-vaccine/114764/

New Treatment Candidate for Halting and Reversing the Effects of Dementia and Alzheimer’s Disease

2. https://www.tohoku.ac.jp/en/press/eversing_dementia_stage_set_for_human_clinical_trials.html

https://www.mdpi.com/journal/ijms 

Increasing Evidence Suggests Controversial Sputnik COVID Vaccine is Safe and Effective

3. https://www.nature.com/articles/d41586-021-01813-2?utm_source=yxnews&utm_medium=mobile

Sequencing of over 600,000 Exomes Identifies 16 Variant Genes that Provide Protection from Obesity

4. https://science.sciencemag.org/content/373/6550/eabf8683

CRISPR Injection Treats Genetic Disease in Patients for the First Time

5. https://www.sciencemag.org/news/2021/06/crispr-injected-blood-treats-genetic-disease-first-time

Research Shows COVID mRNA Vaccine Does Not Affect Male Fertility

6. https://jamanetwork.com/journals/jama/fullarticle/2781360

Friday, June 25, 2021

by Sekisui Diagnostics

While 81% of men can remember the make and model of their first car, barely half of them remember their last trip to the doctor’s office. The average U.S. male lives to 76 – five years short of U.S. female life expectancy at 81 years – and one in five men die before 65.

Men are facing a health crisis that is very preventable, but poor health habits, failure to seek medical attention and dangerous occupations lead men to live sicker lives and die sooner. For example, 75% of premature heart disease deaths are men; middle-aged men are twice as likely to have diabetes and each year, more than 230,000 men are diagnosed with prostate cancer and about 30,000 die from it.

If those statistics don’t get men’s attention, then heart disease, obesity, tobacco use, stress and high cholesterol can all also lead to erectile dysfunction.

How did we get here?

Unfortunately, men have quite a bit stacked against them that contribute to decreased health, including biological, behavioral and environmental factors. When men are healthier, they live longer and happier lives. So why are we still seeing such alarming numbers?

Biological Risk Factors

• Metabolism

· Cholesterol and diabetes are big health indicators for men

• Anatomy/Prostate

· Prostate cancer represents about 27% of all cancers in men and is the second

deadliest form of cancer

• Hormones

· Low testosterone can cause a host of negative symptoms

Behavioral Risk Factors

• Smoking

· Smoking contributes to lung cancer, heart disease and emphysema

• Alcohol use

• Medical care

· Men are less likely to schedule their routine doctor’s visits and tend to be more

reluctant to approach their doctor with health concerns

• Diet and Exercise

• Accidental injury

· Accidents are the #1 cause of death for men under the

age of 44

Environmental Risk Factors

• Risky Occupations

· 92% of workplace deaths are males

• Stress

What can men do to take charge of their overall health? Get back to the basics.

The good news: 70% of men’s health conditions are preventable and the number of health resources for men is growing. It’s good for men to get back to the basics, and while this list of proactive steps may seem obvious to some, it can help men catch health problems early when treatment is most likely to

be successful – or, perhaps, avoid them altogether.

1. Get regular check-ups and screenings

In addition to watching their weight and aiming for a more active lifestyle, men should maintain their regular health checkups with their doctor. Checkups and screenings allow men to keep up with their blood pressure, testosterone levels, A1c, waistline and cholesterol levels – all good indicators of

your overall health.

2. Eat well, avoid tobacco and limit alcohol use

Eating a balanced and nutritious diet can help protect men from numerous health conditions. Tobacco should be avoided completely in their effort to reduce their cancer risk and alcohol should only be used in moderation.

3. Protect the prostate gland

A man’s prostate gland grows as he ages, so men should keep an eye on changes in their urinary habits and for urinary problems.

4. Manage stress

Get adequate sleep each night – seven to eight hours – and do something enjoyable each day.

5. Protect yourself from unnecessary risks

Wearing sunscreen, proper safety equipment and a seat belt can all aid in preventing injury.

There’s a test for that

The Men’s Health Network (Washington, D.C.), a non-profit educational organization of healthcare professionals and individuals focused on improving men’s health and wellness, provides a maintenance schedule (below) for men as a reminder of men needing to take responsibility for their health. Regular checkups and age-appropriate screenings can improve men’s health and reduce their premature death and disability.

Sekisui Diagnostics testing solutions

Prostate screening

There are certain milestones in men’s health. The first rectal exam between ages 40 and 50 as an initial screening for prostate cancer is a top priority because checking for prostate cancer is important and necessary, just like pulling wisdom teeth and a mammogram. Most prostate cancers are first found during screening with a prostate-specific antigen (PSA) blood test or a digital rectum exam (DRE). Sekisui Diagnostics offers two tests for prostate screening. The FastPack IP Total PSA Immunoassay is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as anaid in the management of patients with prostate cancer. Also, the FastPack IP Free PSA Immunoassay, not currently available in the United States, is a chemiluminescent immunoassay for

the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum.

Male menopause

Male menopause and another term, andropause, are terms used to describe decreasing levels of the male hormone testosterone that comes with aging. The group of symptoms associated to age-related changes in male hormone levels are also known as testosterone deficiency, androgen deficiency and late-onset hypogonadism. Any man who experiences symptoms should make an appointment with his doctor.

Hormone testing

In men, about 45-65% of testosterone in blood is normally bound to SHBG (sex hormone-binding globulin) a protein produced mainly in the liver. The remainder either unbound (free testosterone) or weakly and reversibly bound to albumin, which is the main protein in the blood. Risk factors for low SHGB levels include obesity, insulin resistance or type 2 diabetes, hypothyroidism, Cushing syndrome, nonalcoholic fatty liver disease, acromegaly and androgen steroid use.

Sekisui Diagnostics offers the FastPack IP Testosterone Immunoassay, a chemiluminescent immunoassay for the in-vitro quantitative determination of total testosterone in human serum and plasma. Pairing this test with FastPack IP

SHBG Immunoassay allows a provider to calculate free and bioavailable testosterone levels. SHBG is the newest addition to Sekisui Diagnostics’ Fast- Pack IP System test menu. This fully automated quantitative immunoassay analyzer offers real-time testing with a simple three-step process, enabling physicians to diagnose, monitor and adjust therapy in one patient visit.

At Sekisui Diagnostics, we are focused on improving men’s health through the early detection of notable health issues, including high cholesterol, diabetes, prostate cancer, low testosterone and colorectal cancer. Find out more about our diagnostic tests that enable providers to diagnose and treat

men at the point-of-care.

Friday, June 25, 2021

by Dylan Chadwick

“We’re your parents, not your peers.” That’s the line my folks signed off with many times in response to one of our many disciplinary quarrels. This usually followed me telling them I “hated them” or something equally ridiculous. I was an adolescent once, and though it’s not something I’m proud of, I did what adolescents do. Luckily, my folks could maintain cool heads in such heated situations, seeing clearly that at that moment at least, the nature of our relationship didn't dictate that we like one another. In fact, what they keyed into was the fact that it was infinitely more important that I respected them and their authority, than it was for me to personally like them. 

Furthermore, they knew that inasmuch as I was responding to the emotional feelings of injustice that my teenage hormones continually exacerbated, I was just venting emotions. Of course I didn’t actually hate them, nor did I truly think they were “ruining my life” (as I accused them many times). This isn't about me though, and for the record, my parents and I have a great relationship now. 

This semantic description, between being liked and respected, has become a sticking point for people, particularly those who must work with customers. The service industry model, one which emphasizes customer service over all else, has bled into numerous other industries, including medicine, and nowhere is this more prevalent than the world of doctor rating sites. 

Patient Voices Online

Nowadays, customers have more opportunities share their own “shopping experiences” than ever, and they can do it with any micro-community they wish. This includes patients and the various avenues through which they’re getting their health care. These avenues, namely physician rating sites, are fully on the physician radar at this point. Indeed, it’s one of the reasons industry leaders like Kevin Pho continually urge doctors to control their own web presence by creating and managing their own social media and reputation management profiles. 

The thing is, determining which patient complaints are legitimate, and which ones are merely the result of an unrelated emotional venting, is a very incomplete (and fruitless) science. Furthermore, when a patient feels angry, they can resort to personal criticisms of the physician, ones which are not fair, but are personally hurtful, or even damaging to a professional reputation. While troubling, astute physicians must understand the true nature of these patient ratings, before they react or internalize any charges made against them.

When frustrated enough to grind an axe online, patients are often responding to “customer service” issues when voicing complaints about their visit. These can range from dissatisfaction with the physician’s demeanor, a crowded waiting room, difficulty finding the office or simply not being seen as quickly as they were promised. It’s generally not an indictment of a physician’s medical capabilities or intelligence, even if a physician might immediately interpret it that way. 

Patients, like physicians, are at the mercy of external factors when going about their day. When these external situations start to go awry, it can lead patients to feel there's a conspiracy against them or will lead to extremely charged feelings that spill over into whatever platform is available. This starts to get into non-medical territory like car problems, traffic on the freeways or issues with the kids, and really serve as accents to their actual office visit and the emotions they brought in with them.  

Should Anyone Worry?

Yes and no. The primary point to remember when encountering an unsavory physician review is that, even if unpleasant, it’s an opportunity for self-reflection on pain points within their own practice. It’s also important that physicians maintain enough objectivity that they can see a negative physician review and see it as an opportunity to evaluate, and not become defensive. Internalizing the negativity, or interpreting it as a physical attack, will absolutely not lead anywhere.

Physicians should also take negative reviews with a grain of salt, accounting for all the factors outlined above. Getting heated, or even worrying about whether or not a patient “likes” them will not help any situation. It also prevents the physician from making an actual outreach with their patient, one which will identify an opportunity to improve their own performance as a physician. 

Liked vs. Respected

There’s an adage for this whole ordeal and it's one I've already outlines. It's true though. It’s infinitely better to be liked than respected, and I’m prone to believe that principle applies to healthcare almost more than anywhere else. When a patient respects their physician, they’re far more likely to stick with, and maintain, the health advice and regimens their physicians dispense. Those who do not, or who become offended by a physician’s personality or behavior, are less likely to implement these care instructions, which creates a greater issue for the physician than simply being disliked.

Remember, if the goal of dispensing healthcare is for patients to adhere to digestible information and follow it through, then that’s the premiere objective. Sometimes physicians must deliver unpleasant or sensitive information that patients take with much difficulty. While troublesome, they’re often the first step towards creating and fostering improved health care on both the physician and patient ends.

Vocabulary

Old school sales techniques maintain that the verbiage a clerk uses should invite, rather than prohibit, the customer from an interaction. This means that instead of using absolute terms like “we cannot,” or “That is against our policy,” they should say things like “I’m sorry, how can we correct this?” Now, this is medicine, not buying a new sofa, but some of the same principles apply.

A common complaint in the physician rating sphere is that patients felt a physician was simply schilling information onto them, without listening to the patient any further. Rather than using terminology which stops a discussion, it’d serve physicians well to be continually inviting patients to respond to the advice they’re given. This is especially true when a physician has to deliver unpleasant news. In these circumstances, they are obligated to give the patient the opportunity to ask questions, relay their own feelings, and even, vent their personal frustrations with the information. 

Furthermore, it’s important that physicians recognize that patient complaints are legitimate, even if they’re misguided. Physicians don’t need their patients to actually like them and invite them to all their birthday parties. They must simply be willing to listen and follow their sound medical counsel. 

References

Ubel, Peter, MD. "Patients Don't like Their Doctors. Why Is That?"KevinMD.com. KevinMD, 04 Feb. 2015. Web. 13 Feb. 2015.

Monday, April 26, 2021

by Sekisui Diagnostics

There are certain milestones in life that no one looks forward to—having your wisdom teeth pulled. That first mammogram! At the top of the list for men is likely that first rectal exam at 40 or 50 as an initial screening for prostate cancer. But, like those pesky wisdom teeth and the oh-so-important mammogram, screening for prostate cancer is important and necessary.

A policy paper produced by the European Association of Urology¹ states that there were approximately 450,000 cases of prostate cancer in Europe in 2018 and 107,000 deaths expected. In 2019, the American Cancer Society estimates² that there will be about 174,650 new cases of prostate cancer in the U.S.  Globally prostate cancer³ is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall. 

That being said, prostate cancer often can be treated successfully. In fact, the localized and regional five-year survival rates⁴ for this type of cancer are near 100%! As with all cancers, early diagnosis is important. Most prostate cancers are first found⁵ during screening with a prostate-specific antigen (PSA) blood test or a digital rectal exam (DRE). While prostate cancers usually don’t cause symptoms in the early stages, more advanced cancers are sometimes first found because of symptoms they cause.

So why are there ongoing controversial discussions about PSA screening? Why do the United States and Europe hold different positions regarding some aspects of screening?

So What’s the Deal?

How can one argue that it’s better not to screen for a cancer? The medical community is divided due to the risk of overdiagnosis and overtreatment. Cancer overdiagnosis⁶ is the detection of cancer that would not develop any symptoms during a man’s lifetime if not identified by early detection or not result in cancer-related death. Overtreatment refers to unnecessary medical interventions, including extensive treatment for a condition that requires only limited treatment.

According to the European Association of Urology¹, the risk of overdiagnosis has been estimated to be as high as 40% in screen-detected prostate cancer, leading to unnecessary biopsies and

detection of insignificant cancers, which could lead to overtreatment. In 2012, the U.S. Preventive Services Task Force (USPSTF) actually recommended against⁷ screening for prostate cancer in all men! However in 2017, the USPSTF released a new draft recommendation for prostate cancer screening encouraging providers⁷ to inform men ages 55 to 69 about the benefits and harms of prostate cancer screening.

Worrying Statistics

Practitioners in both the UK and the U.S.¹ were advised not to perform PSA for early detection. Two independent studies performed in 2017 and 2018 found that a lack of prostate cancer screening may be reversing¹ the trend of declining death rates—meaning mortality from these type of cancer could be on the rise. This year, the European Association of Urology made a call to action⁸, stating, “Urgent action is required to ensure the new Commission is mandated to support EU Member States in prostate cancer screening in their national cancer plans.”

EAU Policy Coordinator Michelle Battye wants the 2003 Council Recommendations on population-based screening to be “urgently reviewed,” with prostate cancer added to the list of cancers to be addressed, and wants member states to bring good practice on prostate cancer screening to the Steering Group on Health Promotion, Disease Prevention and Management of non-communicable diseases.

How the U.S. Responded

As we briefly mentioned above, in 2017 the USPSTF released new recommendation for prostate cancer screening encouraging providers⁷ to inform men ages 55 to 69 about the benefits and harms of prostate cancer screening. The American Cancer Society recommends⁹ that men learn as much as they can about prostate cancer screening risks and benefits and discuss the information with their doctor before deciding whether to be tested. Men at average risk of prostate cancer should have this discussion at age 50. Men at higher than average risk should have the discussion starting at age 40 or 45.

The consequences of decreased PSA screening¹⁰ are numerous:

• Increased mortality
• The effects of non-curative intervention
• Psychological complications of recurrent prostate cancer

So do the risks of prostate cancer screening outweigh the benefits? That’s not a question any man should answer alone—he should discuss the pros and cons of screening with his doctor to make an informed decision. However, physicians should bring this topic to the table at the appropriate time for all affected patients.

In the end, prostate cancer screening is important, as it is with all types of available cancer screenings. A little bit of research can inundate you with statistics, recommendations, and lots of other frightening material. What matters is that physicians are aware of recommended guidelines and available screening and treatment options, and that patients are given the information they need to make informed decisions regarding their health.

Sekisui Diagnostics offers two tests (please note that only one is currently available in the U.S.). The FastPack® IP Total PSA immunoassay¹¹ is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as an aid in the management of patients with prostate cancer. It offers results in 12 minutes.

The FastPack® IP Free PSA Immunoassay¹², not currently available in the U.S., is a chemiluminescent immunoassay for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. It is designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA). A free PSA test13 can be used instead of a biopsy if PSA levels are slightly elevated, and may be used to determine how aggressive a recurring cancer is.

References:

1. http://epad.uroweb.org/wp-content/uploads/EAU_policy-briefing_PSA.pdf

2. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

3. https://www.wcrf.org/dietandcancer/cancer-trends/prostate-cancer-statistics

4. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html

5. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/how-diagnosed.html

6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540879/

7. https://health.gov/news-archive/blog/2017/07/prostate-cancer-screening-recommendations-an-update-from-uspstf/index.html

8. https://uroweb.org/epad19-european-psa-screening-programme-is-on-its-way-part-2/

9. https://www.cancer.org/latest-news/prostate-cancer-screening-faq.html

10. https://www.physiciansweekly.com/the-unintended-consequences-of-decreased-psa-screening/

11. https://www.sekisuidiagnostics.com/products-all/fastpack-ip-prostate-specific-antigen-psa-immunoassay/

12. https://www.sekisuidiagnostics.com/products-all/fastpack-ip-free-psa-immunoassay/

13. https://www.healthline.com/health/prostate-cancer-free-psa#purpose

Monday, April 26, 2021

by Dylan Chadwick

When asked to describe anxiety, I often defer to the description I’d give my college therapist. Anxiety fits somewhere between “simple worry” and “full-blown panic.” I’d compare it to the dull, but consistent bellowing of a gaggle of monkeys let loose to tromp around the recesses of my brain. Everyone experiences anxiety in some fashion, whether responding to an overwhelming work schedule, an impending deadline or even as a generalized disorder. Physicians certainly aren’t strangers to anxiety-provoking work either, especially those who work in emergency capacities. 

But while the individual and observable symptoms of anxiety vary from person to person, the overall obstacles it presents are quite uniform. Anxiety and stress are animal instincts, ones which protect us in dangerous situations and motivate us to seek equilibrium and control when we are losing it. However, anxiety can also be an impediment to relationships, an all-encompassing, slippery paralysis that crowds out our ability to think rationally, to make positive judgments and to hear what we most need to hear while in its throes: sound counsel.

When a patient visits their physician, they’re prone to feeling a little anxious. Diagnoses and treatment plans, loaded with obtuse medical jargon, can put ones mind in a tailspin and set one’s heart a-flutter. Not exactly prime condition to take medical advice. Wary physicians should consider the implications of a patient’s anxiety when dispensing information, in order to ensure they’re communicating clearly and effectively, and in a way that will benefit the patient long after they’ve left the exam room. Here’s some tips on how physicians can key into those feelings, work within them, and help patients feel less anxious in the process.

Open the Floor

Effective physicians will work to create an atmosphere in which patients can verbalize their concerns, questions and anxieties, and will work to address those before even moving into a treatment discussion. In an office visit, a patient has many more thoughts going through their minds than what’s on the surface. In these experiences, physicians should open the floor to patients, ensuring them that their questions and concerns are not only valid, but an integral part of treatment. Some patients may not feel comfortable articulating their inner concerns, and in these circumstances, a warm invitation to do so will carry much weight. A willing and listening ear can also calm the nerves of an argumentative patient. Ultimately, when a patient comes to a physician’s office, they’re bombarded with information that can be both frightening and confusing. Creating a scenario in which they’re given clearance to air out their fears not only helps them manage and regulate their emotions, but also helps the physician tailor treatment specific to their needs in the long run. 

It also goes without saying that there truly is no patient concern that is “wrong” or unimportant. Uncertainty is an unpleasant feature of many medical experiences, but a physician who will set the tone with warmth and an open mind will help alleviate anxiety’s burden.

A Room of One’s Own

A medical practice can be stressful environment, especially when dealing with a pandemic. Patients are surrounded by foreign looking equipment, strange sterile smells, and often the intermittent bustle of physicians, nurses and other specialists conducting serious and time-sensitive work. Environmental distractions can exacerbate a patient’s anxiety, leaving them feeling cagey and alone and in a strange environment outside of their normal comfort zone and preference. It’s beneficial for physicians to help control that environment, and create the most quiet, and private place possible so as to dispense medical information in as clear a manner as possible. Besides ensuring that information isn’t misconstrued, it helps quell the rampant anxiety provoking factors present in a high-energy workplace, putting fretting patients at ease.

Words Unspoken

Often it’s not just the words one uses, but the body language that accompanies the delivery of those words. It’s important for physicians to remember how their nonverbal body cues will affect a patient’s understanding and emotional processing of the information. Simple things like smiling and maintaining a calm and collected voice and speaking in soft, yet audible tones, can quell the alarming feelings potentially welling up inside a patient’s mind. There’s really no deep and nuggety magical formula for it. Physician’s should simply be nice and relaxed with patients, clear and controlled in their delivery. It lends an air of stability to the proceedings and will help manage the expectations of the room.

Silence Isn’t Always a Bad Thing

We all hate uncomfortable silences and will often seek to avoid them at all costs. They don’t always indicate that a conversation is going poorly though. In fact, when given such high levels of sensitive information, many patients need some time to process and digest the lofty information they’ve just been given. A well-placed section of “breathing time” is often an indication that new and useful information is being processed. When a physician is hasty to “force” conversation in these instances, they can come off as rude and insensitive. Furthermore, patients may not want to speak at all. While it’s important to always open the floor, physicians must also respect an anxious patient’s desire to simply listen and absorb information.

Choices Empower Patients

Anxiety makes people feel powerless to their emotions or the circumstance at hand. When confronted with a serious health issue, many patients resort to dread and anxiety because they don’t feel equipped to deal with the problem. Physicians should be sure to outline multiple choices (where applicable) for treatment options. When a patient knows they have choices and options for their treatment, they feel empowered and capable to deal with the problem, and also feel that their physicians are on their “team.” It’s also important to remember that even though a physician knows all the nuances and options of a treatment regimen, a patient may not, or may have a significantly limited understanding of it. Let them know that they have options in how they choose to be treated, and aren’t being forced into something without having an opportunity to weigh out the pros and cons.

Enlist the Aid of Family or Trusted Friends

There are those circumstances when patient anxiety is extreme and a patient needs someone there to help them on a more intimate emotional level. It’s not uncommon for patients to enlist the aid of a spouse or trusted family member to help them receive their treatment options and have said family member accompany them on their visit. In these circumstances, a level-head and an extra set of ears can ensure they the patient gets the most out of their treatment. Healthcare is a joint effort with patients and their families, and some family members need only to be taught how they can participate. In all circumstances, especially ones which involve rigorous or disruptive treatment, it’s crucial to get family members on board because when patients feel that they have a team of supporters backing them, they no longer feel alone in their problem. Furthermore, family members can help the patient with alternative perspectives or simply just comforting words that a physician simply cannot. 

Physicians are trained to diagnose and treat every level of medical problem and ailment in the known universe. However, beyond medical diagnoses, an understanding of patient anxiety, and the emotional/logical stranglehold it can wreak on its victims, will improve a physician’s ability to dispense information clearly and concisely, as well as tending to the emotional healing of a patient. 

References

RN, Gina. "How Touch Can Calm Patients." 

            KevinMD.com. Kevin MD, 19 Jan. 2012. Web. 18 May 2015.

Osbourne, Helen, M.Ed. "In Other Words...Know When to Speak and When to Listen...Communicating With People Who Are Anxious or Angry." 

            Healthliteracy.com. Health Literacy, Oct. 2005. Web. 18 May 2015.

Tartakowsky, Margarita, M.S. "3 Practices to Calm An Anxious Mind." 

            Psychecentral.com. Psyche Central, n.d. Web. 18 May 2015.

Wednesday, April 21, 2021

by Aaron Medaris – Publisher, Physicians Office Resource

Vaccine hesitancy is nothing new. Even before unsubstantiated claims of autism, social media misinformation, and antivax websites, many people have struggled with vaccinations. In the smallpox outbreak of the 1800’s the United Kingdom saw so much opposition that it finally had to require vaccination against the disease mandated by law. 

In the early 1900’s the case of Jacobson v Massachusetts made its way the US Supreme Court. In the end the US Supreme Court supported the rights of states to pass laws mandating the smallpox vaccine. In 2019, before the pandemic even struck, the World Health Organization listed combating vaccine hesitancy as a top ten priority. Though vaccine hesitancy is nothing new, its effect on public health has never had a greater potential impact than on today’s world. In just over one year of battling the pandemic on US soil, there have been over 525,000 COVID-19 related deaths. We now have three FDA authorized COVID-19 vaccines that have fully vaccinated over 30,000,000 people. Recent data suggests that about 80 to 85% of Americans would need to be vaccinated to achieve herd immunity against COVID-19. Given that the population of the United States is about 328,000,000, we still need to vaccinate roughly 70 to 75% of the population. Which brings up the question, how much will vaccine hesitancy play a role in the US gaining heard immunity? If recent surveys are correct, it could have a major impact. According to national poll sponsored by the University of Michigan in the fall of 2020, just 58% of adults aged 50 to 80 said they’d get vaccinated against COVID-19. If in the end those numbers prove to be accurate, we will have fallen well short of required vaccinated population to achieve heard immunity. We need to be prepared to help the population and their vaccination concerns.

Five Common Concerns or misunderstandings with the COVID-19 Vaccine leading to vaccination hesitancy:

1. How quickly the vaccine was developed

2. Side effects of the vaccine

3. Only the vulnerable need to be vaccinated

4. Don’t know how long the vaccine will last

5. How the vaccine work against COVID mutations

There are a variety of concerns and misunderstandings that lead to vaccine hesitancy. Not only should a healthcare practitioner be prepared to address the above, but they should do their best to completely understand why a patient may be hesitant to receiving the vaccine and then provide the necessary resources for them to resolve their concern.  

Here are 10 ways that physicians and other healthcare practitioners can help combat COVID-19 vaccine hesitancy:

1. Ask Why the Patient is Hesitant 

Whether their concern is one of the five listed above or something completely different, it is essential that a physician understand a patient’s concerns. In the end every patient must make the decision for themselves to be vaccinated, but you will want to do all that you can to understand where the patient is coming from and what their concerns are. Sometimes people’s concerns are like an iceberg with only a small portion visible above the surface. Concerns like this can be difficult to resolve that is why it is essential to ask questions and listen intently to the patient’s response. Jumping to conclusions rather than listening to the patient can damage trust and cause further vaccination hesitancy.  

2. Listen

Asking questions will only get you so far when helping others with their concerns. When you listen carefully to others, you understand them better. When they know that their responses are important to you, they will open up more. One common habit many of us have is when someone is speaking, we often think about what we will say in response. This practice often leads us to only hear part of their message. If we listen with intent, we will better grasp what they are saying which will allow us to provide a more appropriate response. When you feel like you understand what is being said verify that by using such statements and questions as, “So what you’re saying is________. Is that right?” or If I understand correctly, you’re concerned with _________. Is that correct?”

3. Share Empathy and Provide Emotional Support

Empathy can be a difficult attribute to attain. However, proper development of cognitive, emotional, and compassionate empathies will allow you better understand your patient and share in their feelings. Empathy doesn’t mean you have to agree with their concerns, it means that you understand them and understand the impact those concerns can have on someone’s mental and emotional state. Reaching that level of understanding can only be obtained through a sincere desire to help and in the case of a physician, a sincere desire to heal. Vaccination concerns often arise because of distrust, when a patient see’s and recognizes that you have empathy for them regardless of where their concerns are coming from, they will come to trust you more.

4. Acknowledge Uncertain Risk

We face risk every day and take precautions every day to minimize risk. We take risks every time we get into a vehicle and travel 70 miles per hour on the interstate. We minimize the risks involved with the activity by wearing our seatbelt, staying attentive, and obeying traffic laws. People respond very differently to new risks. When I was a teenager first learning to drive, diving on the interstate for the first time was terrifying and probably even more terrifying for my parents who were teaching me how to drive. However, with practice and appropriate skill, I no longer look at that task as terrifying. In fact, I look at it as a necessity to go about my everyday life. Some people may look at getting the COVID-19 vaccine as terrifying because to them it’s new and with that new experience comes unknowns. However, getting vaccinated is like putting on a seatbelt and following traffic laws that will help you go about your everyday life. The real risk would be choosing not to be vaccinated or in a sense not wearing your seatbelt and not obeying traffic laws with the hope of arriving safely at your destination.

5. Discuss Known Risks

Be upfront. Make sure that patients understand what side effects are possible with getting vaccinated, such as fever, muscle aches, flu like symptoms. Also discuss the rare risk of allergic reactions (2.5 anaphylaxis cases per million Moderna COVID-19 vaccine doses administered) and what is being done to respond to those situations.

6. Provide Information

Proper information can be a powerful tool to the vaccine hesitant. There are many who fall into the undecided category when it comes to getting the COVID-19 vaccine. A large reason why they fall into that category is because they haven’t had a chance to educate themselves on the vaccine. They’ve heard snippets on the news and hearsay from friends and family, but rarely have they received proper professional information regarding the COVID-19 vaccine. Referrals to appropriate websites such as the following can provide answers to the questions that are standing in the way of their decision to vaccinate:

Questions and Answers about the COVID-19 Vaccine

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html

https://www.health.harvard.edu/coronavirus-and-covid-19/covid-19-vaccines

Myths and Facts about the COVID-19 Vaccine

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/facts.html

https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-vaccine/art-20484859

7. Partner with Communities

Many who are vaccine hesitant are dealing with familial or societal situations that are skeptical of the COVID-19 vaccine. It’s important as a physician, healthcare provider, or public health administrator to partner with those that have longstanding relationships with various communities to provide appropriate and accurate information regarding the COVID-19 vaccines.

8. Get the Vaccine Yourself and Tell Others About Your Experience

You are your patient’s expert on all things health. Your word, advice, and treatment mean a lot to them. In a pandemic, we’re all facing the same disease and we luckily for us all have the same defensive measures. Get the vaccine yourself and tell others about your experience. Share the good, share the side effects, share why you chose to get vaccinated. Your words and personal experience can be the motivating factor your patient needs to get vaccinated.   

9. Tell Your Patients They Need to Get Vaccinated 

Obviously, there are cases where a patient should not be vaccinated and you should be aware of those. But in most cases, vaccination is a must. Tell your patients to get vaccinated. Plain and simple. You tell patients every day to stop smoking, eat better, lose weight, and take their prescribed medicines. Telling your patients to get vaccinated should not be any different.

10.  People Have a Natural Desire to Protect Others

We’ve seen the statistics, there is a portion of the population that is extremely susceptible to the devastating effects of COVID-19. Many of those are our loved ones. What if we could do something that could provide those people at risk many more years of quality life? Well, we can. We can get vaccinated. Tap into that desire people have to protect others. Their selfless act of being vaccinated could mean life or death for someone else.

There will always be those with concerns regarding any type of vaccination. I’m ok with that. Those with concerns are concerned about their health and the health of those they love. But I also don’t think we should look at those with vaccine hesitancy as a lost cause. I believe with the proper approach many of their concerns can be resolved and ultimately lead to proper vaccination.

It’s been a long year of battle against this pandemic. We are so fortunate to have three approved vaccines that could eventually bring it to an end. We offer our sincerest gratitude to you physicians, healthcare providers, and scientists. I can’t imagine what this past year would have been like without you on the front lines.  

Wednesday, April 21, 2021

By Dylan Chadwick 

When physician employers recruit their practice staff, they’re crafting an extension of themselves. Like a swiss watch or say, a Star Fleet command, each staff member contributes an invaluable service to the greater effectiveness of the practice, from answering phones, to coding procedures and to treating patients. Besides cultivating an efficient practice landscape, one which streamlines the divide between the administrative and clinical sides of the equation, these staff members also account for a significant portion of a practice’s overhead. 

Decisions of which staff to hire, how many members and how to compensate them, can be a daunting task for any physician. The ultimate goal for most physicians when it comes to employing, according to Medscape's first ever Clinical Office Staff Salary Report, is to find those who can raise their own bottom line by reducing costs and delivering billable services. 

Staffing Analysis

The strongest staffing model for one physician won’t necessarily be the best for another. Says Kim Gooden, a practice administrator at Dermatology Consultants, a practice with three locations in the Atlanta metropolitan area, “Physicians are happier when they’re able to utilize their staff in a way that’s more efficient for them. She currently manages seven physicians, five physician assistants and 79 supporting staff (How to Conduct a Staffing Analysis). 

With a changing medical landscape, one in which technology permeates deeper into the fabric of private-practice medicine, many physicians have found themselves re-thinking the personnel that they’re hiring. To illustrate, imagine a practice that implements an EHR. This practice may need to hire more medical assistants to act as scribes or data-input specialists, trained in the system's program. Besides medical technology, healthcare reform and fluctuating reimbursement rates play big into how an employing physician chooses to structure their staff. 

For an employing physician looking to restructure their practice, a staffing analysis can help physicians get an accurate count of their practice and its individual strengths and weaknesses.  

The General Overview

The first real question that any staffing analysis should answer is whether or not a practice has the “right” amount of staff. Besides workflow concerns, it’s also a critical component in determining reimbursements. A practice with too few staff may struggle with productivity and wait times, whereas a practice that has too many staff may become too expensive and create insurmountable overhead challenges. 

Physicians can consult various benchmark reports within the industry, reports that survey staffing numbers of practices with similar specialties and sizes. However, these are just benchmarks and if a particular practice differs significantly from any national averages, it shouldn’t send any physicians into a panic. Every medical practice functions differently, and is a product of several other nuanced, non-clinical factors like geography, demographic and income bracket. As a medical practice is highly individual and unique, so to should a staff structure be. 

Who’s Doing What?

Another purpose of a staffing analysis is to accurately determine whether each staff member has been tasked with the most correct and efficient responsibilities. Westgate’s article suggests using a measuring stick like to determine these tasks. As an example, analyzers can choose a certain task (like “answering phones”) and write it on a paper, tape it to the wall in a staffing area and ask staff involved to write down each role and the responsibility associated with it. These kinds of exercises may lead to a re-configuring of staffer responsibilities, especially if it reveals that staff members are spending too much time on tasks which take them away from their “core” responsibilities and prevent them from their best productivity. Good questions to ask in this regard may be, "how can my practice reduce the number of steps involved in the workflow?" or "how can I utilize technology to improve the process?" 

Technology 

At this point, there’s not really much debate as to whether or not technology can improve workflow, it's just a question of integration. That’s also what makes it a relevant component to consider when conducting a staffing analysis. Things to take into account are the fact that when a practice acquires new technology, it likely forecasts some time in order to restructure responsibilities to adequately accommodate it. 

 Performance Evaluation

In the analysis, the "Staff performance" category can be difficult to empirically assess. Experts in the field suggest shooting for 75-85% of a practice’s staff members to be somewhere in a "top performers" category, with a solid mentoring or coaching system put in place for any who struggle.  

Analysts may also find that calculating a measurement of various staff member workload ranges can assist in the assessment. Industry benchmarks can help, but a solid rule of thumb is to determine how long it takes various staff members to complete their tasks and how much work can be completed by a single staff member in a workday. However, this is nitty-gritty evaluation components that get deep into "nuts and bolts" territory that can be rather time-intensive. Some practices may have phone systems that record call statistics and can give figures such as the average call length. For those who don't, informed estimates are just as effective.  

Payment

Once the staffing analysis is complete, the ideal number of staff has been determined and they're tasked with the correct responsibilities, employing physicians can consider payment models for their staff. 

Medscape’s official report Physician Compensation Report surveys United States doctors from a wide range of specialties regarding their own salaries and the compensation packages they offer their various staff members. 

Monetary Benchmarks

According to the study and report, non-clinician employees earn less than their clinical staff peers across the board. Roughly ⅔ (64 per cent) of surveyed physicians report paying their front desk staff less than $30,000 annually. However, there are those who acknowledge the reality that front desk personnel have a tremendous impact in patient satisfaction by setting the tone of the patient's office visit and by facilitate practice efficiency by scheduling appointments, fielding phone calls and other billing and coding duties, and they'll pay them accordingly.  35 percent pay their front desk personnel between $30-60,000 annually and a smaller portion (1 percent) pay even more than this. 

Medical records clerks earn less, and 31 percent of surveyed practices employ them. 72 percent of these participating physicians report paying record clerks less than $30,000. Medical billers statistically (60 percent) earn more, somewhere between $30,000-60,000.  

Rewarding Revenue Creators

In consulting national statistics, employing physicians reward their staff who can generate more revenue for the practice. These sorts of staff work in roles like nurse practitioners and physicians assistants because they allow a practice to accommodate more patients at one time. Healthcare reform is forcing many states to expand the scope of services that Nurse Practitioners and Physician’s Assistants hold. They can economically benefit a practice because they alleviate many of a physician’s duties so that they can more specially focus on areas that have the highest reimbursements. They also provide services which are billable under Medicare and enable primary care physicians to compete with retail clinics that are developing around the country. According to the report, 55 percent report paying their nurse practitioners more than $80,000 annually, and 16 percent pay more than $100,000. Physicians assistants see a similar payment curve with 57 percent of them earning upwards of $80,000 and 19 percent earning more than $100,000. 

Occupational Benefits

Monetary compensation isn't all an employing physician must consider, as benefits packages are equally important to staff morale and job competition. According to the survey, most private practice physicians offer staff paid vacation and sick time (80 percent) and paid for health insurance (68 percent). Roughly half (46 percent) offered a retirement plan with a match and a smaller portion (22 percent) offer one without a match. 

By and large, the huge benefits packages offered by corporate America aren’t as common in healthcare practices. Only about ⅓ (36 percent) provide dental plans for staff members and even fewer offer healthcare savings accounts (26 percent), vision insurance (23 percent), short term disability (22 percent), life insurance (19 percent) or long-term disability (16 percent) policies.

The Bottom Line

Overall, physician pay scales reflect the state of the market, changing landscape conditions (like healthcare reform) and the value an individualized practice puts on an individual service. While each practice has different needs, strengths and deficits, a thorough staffing analysis and an informed consultation of industry benchmarks and reports can help employing physicians make the most efficient and economical decisions for their staffing model.

References

Pekham, Carol. "Clinical and Office Staff Salary Report." Medscape.com. 

          Medscape, 21 Nov. 

            2013. Web. 08 Dec. 2013.

Reese, Shelly. "How Much Are You Paying Your Staff?" Medscape.com. 

          Medscape, 21 

            Nov. 2013. Web. 08 Dec. 2013.

Westgate, Aubrey. "How to Conduct a Staffing Analysis." PhysiciansPractice.com. 

          Physician's Practice, 

            1 Nov. 2013. Web. 08 Dec. 2013.

Wednesday, April 21, 2021

by Irwin Z. Rothenberg, MBA, MS, CLS (ASCP), Technical Writer /Quality Advisor

 
Introduction

The Clinical Laboratory Improvement Amendments (CLIA), passed by Congress in 1988, mandate that all test sites performing non-waived testing must undergo an inspection every two years.  These inspections are designed to evaluate compliance with the quality standards set for all testing performed, to ensure the accuracy, reliability and timeliness of patient test results.  All laboratories issued a CLIA certificate and all CLIA-exempt laboratories must comply with the applicable inspection requirements. 

The laboratory will either be inspected by CMS/CLIA (generally by state inspectors) or by an accrediting organization (AO) that has been granted deeming authority by CMS. There are currently seven CMS-approved accreditation organizations: AABB, American Association for Laboratory Accreditation (A2LA), American Osteopathic Association (AOA), American Society of Histocompatibility and Immunogenetics (ASHI), COLA, CAP, and The Joint Commission (TJC). 

Regardless of the agency, all inspections focus on essentially the same areas. While being “ready” can’t guarantee a stress-free inspection, it will indicate the laboratory has already adopted the culture of quality patient care, and that it can continue to improve from there.

CLIA follows a biennial inspection schedule.  Some private Accrediting Organizations follow a more general 18-24 month schedule, so it would be prudent for laboratories to be additionally vigilant during these time frames. 

Inspections may or may not be announced in advance, depending on the Accrediting Organization. It is also important to be aware of how notification is provided: on-line, email, postal mail, telephone or fax. Make sure that the notifications go to the proper individuals.  It should be noted that if there has been a complaint against a laboratory, the inspection/survey may be unannounced.

Preparing For an Inspection:  General   Guidelines For Operating a Compliant Laboratory

• Be familiar with the regulatory requirements for your laboratory as determined by your inspection agency, reflecting the type of CLIA certificate required; the complexity of your test menu; the specialties represented in your test menu; the type(s) of instrumentation, and whether outside reference work is performed by your laboratory.
• Ensure that all positions in the laboratory are filled by qualified personnel; have complete documentation of education, experience, training, and competency assessments; all job descriptions current.
• Establish and maintain written policy, process, and procedure manuals. These must include procedures for all phases of testing performed by the laboratory; define quality control by the frequency, type and number used; include corrective action protocols; list critical values when appropriate, with follow up actions; and specimen acceptability requirements.   All manuals must include the Laboratory Director’s signed and dated review and approval[i].
• Be enrolled and participate in a proficiency testing program appropriate for your test menu and specialties.
• Instrument calibration, maintenance, and quality control are performed as required.
• Instrument performance specifications have been verified.
• Verify the security of your Laboratory Information System (LIS); as well as the accuracy of data entered and stored.
• Incorporate quality assessment into the daily routine of the laboratory. This includes assessing the quality throughout the testing process; taking corrective actions when needed; and following up on the effectiveness of corrective actions. 
• Ensure that all required documentation is maintained in accordance with CLIA requirements.

The Day of the Inspection[ii]

The inspector will need documentation of all laboratory functions described below, including patient charts when requested, for the past two-years, or from the date of the last AO / CMS CLIA inspection.  These records should be collected prior to the inspection and placed in a room with an electrical outlet. The list below is not all-inclusive, but represents the basic items required.  Depending on individual circumstances, the surveyor may request additional records.   

Proof of education according to CLIA ‘88 requirements. The following documents are acceptable: High school diploma, GED, Transcripts (must have date graduated), college degrees (AS, BS, MS, and PhD), and MD/DO Licenses. 

1. MT & MLTS must have either copies or transcripts of the advanced degrees (AS, BS, MS).  ASCP or other professional society cards or certificates cannot be accepted as the only proof of qualification.
2. Medical Assistants, LPNs, and RNs must have either high school diplomas or advanced degrees available. Licenses cannot be accepted as the only proof of qualification. 
3. Those employees with only foreign educational documents must have them evaluated for equivalency to a US high school diploma, or college degree by an officially recognized education evaluation organization.
4. In those states that license laboratory personnel, a copy of a current state license can be accepted.  It is advisable to have copies of the corresponding educational degree as well.

• Written performance evaluations and/or technical skill competencies.  New employees must be evaluated at six months and also one year after their hire; other employees must be evaluated yearly.
• Training documents for all new employees or some proof of their previous experience, such as resumes and prior instrument training.
• Job descriptions for all employees.
• Policy & Procedure Manual(s) including all Instrument Operator’s Manuals.
• Current package inserts for all kit tests and reagents (including all waived methods).
• Package inserts for all controls and calibration materials used during the survey period. 
• Proficiency testing (PT) records including instrument tapes, test report forms, attestation statements, graded results, and corrective actions taken for all unsatisfactory scores.
• Instrument/equipment/pipette calibration, maintenance, and function check records for current and discontinued instruments used during the survey period. 
• Temperature and humidity records.
• All quality control (QC) records, graphical representations, charts, and any other documentary logs involved.
• IQCP studies
• Test requisitions and report forms used for all laboratory testing. The inspector may ask to review several patient charts.
• Incident Management Plan and any reports. 
• Quality Assessment (QA) Plan and documentation of implementation - QA reviews. 

Once the inspection has been completed and an exit conference or interview has occurred with the inspector, the laboratory director should share all findings with the laboratory personnel. Sharing the ­information in a timely fashion will allow the laboratory the opportunity to begin addressing deficiencies immediately and prepare for subsequent inspections.

Conclusion

Preparing for a laboratory inspection brings anxiety and stress above and beyond those of a normal work day.  Optimizing quality laboratory medicine and quality patient care is the goal for all clinical laboratories, but being prepared and doing well on your laboratory inspection should also bring a special sense of satisfaction.

Sunday, December 20, 2020

By Randox Laboratories

Cloud-based software update means a faster PCR test for SARS-CoV-2

We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.

This modified product is part of a research and development project relating specifically to COVID-19, funded by the German Federal Ministry of Education and Research (BMBF) to the tune of 4.97 million euros. The project’s aim is to expand the options for detecting acute infections of the coronavirus, looking particularly at on-the-spot testing in which the sample is analyzed in a fully automatic PCR process, as this offers rapid yet reliable results.

• Improved software for Vivalytic: turnaround time for positive SARS-CoV-2 samples reduced to under 30 minutes.
• Update from the cloud: Vivalytic analysis devices are updated over the internet.

Dr. Volkmar Denner, chairman of the board of management of Robert Bosch GmbH said;

“In the fight to contain the coronavirus pandemic, speed is of the essence. With Vivalytic, we are delivering cutting-edge medical technology. Our IT and software expertise have helped to make the Bosch Corona test for positive samples even faster – all within a short period of time.”

The new update is available for the SARS-CoV-2 singleplex test and the SARS-CoV-2 pooled test. Updating the Vivalytic testing devices is simple and straightforward – all that is required is an internet connection to access the Bosch cloud platform Vivasuite. Developed in-house at Bosch, the Vivasuite cloud platform allows users to digitally manage and update all their Bosch Healthcare Solutions devices. This is also an advantage when Vivalytic devices are in use in the field. The platform meets the strictest security standards and data privacy is guaranteed at all times: for example, there is no remote access to Vivalytic devices, and no possibility of accessing patient data.

The turnaround time for samples negative for SARS-CoV-2 is still 39 minutes. PCR tests are considered the gold standard, and Bosch’s rapid coronavirus tests have a sensitivity of 98 percent and a specificity of 100 percent.

Contact marketing@randox.com for further information on the latest vivalytic software update for SARS-CoV-2 testing.

Wednesday, October 14, 2020

Part Three of a Three Part Series on Continuous Glucose Monitoring

by David Kliff – The Diabetic Investor

When it comes to innovate new therapies or medical devices there is a lag time between introduction, adoption and full-blown usage. This pattern is playing out right this very moment with continuous glucose monitoring. It should surprise no one that early adopters of this revolutionary technology are endocrinologists and their intensively managed patients. CGM is successfully penetrating this segment of the diabetes patient population.

Yet as we look to the future CGM offers the potential to forever change how all patients with diabetes manage their condition. Intensively managed patients may be the early adopters of this technology, but they are just the tip of the iceberg. So let’s take out the crystal ball and look to see how CGM will be used in the future.

In the near-term future thanks to CGM technology we will soon see what was once thought to be a dream, a true closed loop insulin delivery system or what some call an artificial pancreas. The systems available today driven by insulin pumps combined with CGM and insulin dosing algorithms will look like rotary telephone technology in just a few short years. It won’t be long before these systems morph into a system that a patient slaps on, turns on and forgets about.

As whiz bang and way cool as these systems will be, they will not for a variety reasons impact a substantial percentage of the insulin using patient population. While insulin pump therapy has been around for more than 30 years, is well established and readily accessible only 35% of the Type 1 population and less than 5% of the Type 2 population use an insulin pump, numbers that have not change much over the last 10 years even with all the advancements in insulin pump therapy.

Therefore we will see systems that combine a connected insulin pen, CGM, insulin dosing algorithm   and app. While these systems will require a higher level of patient participation, we anticipate wide spread adoption. Insulin dosing has always been a tricky subject for physicians and their patients as there are multiple variables that go into the calculation. Thanks to CGM and insulin dosing algorithms much of the heavy lifting once performed by the patient will be done by the system.

One of the misunderstood aspects of these systems is they are not static but dynamic. Or put another way the system learns and adjusts. Perhaps the best way to think about this is insulin dosing algorithms are effectually a form of artificial intelligence. Like other forms of AI the more data they gather the more they are used they more they learn. We anticipate that the early studies now underway for these systems will show excellent results which will pave the way for wide spread adoption.

Adding fuel to the fire here will be another advantage as these systems will be cost effective, will require little in the way of patient training while providing excellent outcomes. The only obstacle these systems cannot overcome is the human element, to be effective the patient has to follow the instructions given by the system. The system can gather the data and learn but the patient must do their part to fully benefit.

However we see the real potential with patients who do not use insulin, by far the largest group of patients. As we all know the biggest obstacle standing between this patient population and better outcomes is therapy compliance or adherence. Put simply we’d see much better outcomes if patients took their meds as they are prescribed. That they did not skip doses or manipulate doses.

Thanks to CGM physicians will have a clearer picture as to what is and what is not going on. The key of course is a CGM that is patient friendly. Thankfully that day is almost here as soon we will have CGM systems that are slap it on turn it on and that’s it. No fingerstick calibrations, no extra devices to collect the data and best of all they will be very affordable.

Even better for the physicians the analytics will be done for them, they will know before seeing the patient what is and what is not happening. We hate to state the obvious but there are only so many reasons why a patient is not achieving good control. Nine times out of ten it usually comes down to what we said before therapy adherence. Armed with CGM data and the analytics the physician can show the patient what’s going on, no more guess work.

We anticipate the healthcare system and economics to drive adoption of these systems. Diabetes is not just growing at epidemic rates it is becoming a huge financial crisis for payors and employers. Numerous studies have shown that patients under good control not only live healthier lives but also avoid many of the very costly complications due to poorly controlled diabetes.

Even with all the advancements we have seen in diabetes therapies and devices one indisputable facts remains, a fact that has not changed in the last 20 years, almost two-thirds of all patients are not under good control. Hence the reason diabetes has morphed from a healthcare crisis into an economic crisis. Thanks to CGM, insulin dosing algorithms and advanced analytics i.e. AI  we now have the tools to do what has never been done before, forever change how diabetes is managed.

Yet diabetes is not the only condition where CGM can have this impact. In the future CGM will become an equally powerful tool to combat another, excuse the expression, huge problem. Research indicates that CGM can also be used to combat obesity. The same sophisticated algorithms and analytics which will help patients better manage their diabetes will be adjusted to help a patient lose weight. Although in the very early stages this transformation is underway with early studies looking very promising.

Some early research also suggest CGM can be used to monitor cardiovascular conditions. Again this work is very early stage but now that smartwatches can monitor heart rates this early research indicates that when this data is combined with CGM data preventive measures can be taken.

Today everyone looks at CGM as strictly a tool for patients with diabetes. More specifically they see it as tool for insulin using patients. But as we noted earlier this is just the tip of the iceberg and not just for diabetes. These systems we have today have already achieved the necessary level of accuracy. Costs are coming down which will drive even greater adoption. The last domino to fall will be the results from the studies which are now underway. Studies that go beyond uses in diabetes but obesity and cardiovascular too.

There is no question that CGM has a very bright and very promising future. We know of few other tools which have the transformative potential of CGM. It won’t happen overnight and there surly will be some hiccups along the way. But one thing is clear CGM is here and here to stay.

Sunday, September 20, 2020

Part two of a Three Part Series on Continuous Glucose Monitoring

by David Kliff

How many times does it happen something new comes out, you here good things about it, you take the time to learn about it so you can tell your patients about it and you actually get them to use it. However after all this this great new device which was supposed to be a tool to help the patient has turned into a toy rarely played with.

Here we are again as you’ve likely heard very good things about continuous glucose monitors (CGM), you are taking the time to educate yourself about the various systems but the last thing you want is this fantastic piece of technology to become another toy the patient doesn’t play with. As an experienced CGM user and highly engaged Type 1 patient who has been covering this technology since its invention allow us to pass along a few tips.

First the very good news you can tell your patients that the days of pricking their fingers are gone forever. No more finger sticks. Next you can also tell them no more logbooks nothing to carry around but their smartphone. CGM is not just ground breaking technology it’s a technology that actually makes the patients life easier. Put simply once the sensor is inserted or attached to the patients body, a very simple and nearly pain free experience, for the 10 to 14 days the patient really doesn’t do all that much.

It’s also important to be prepared and prepare your patient for a few things.

1. Data, data and more data – Remember this is a CONTINUOUS monitor so the patient is moving from a point to point system that gathered maybe 4 data points per day to a CONTINUOUS system which gathers over 250 data points per day. In the beginning this avalanche of data can be overwhelming creating lots of Wow and Why moments. Wow as for the first time the patient will see what their levels do all day and all night long. This in turn creates lots of Why moment as Why is   this happening, which creates phone calls for you. (More on this in a moment)
2. Medical devices can and do fail or malfunction- While we would say that the majority of CGM systems are accurate and reliable they are medical devices and as such they can and sometimes do fail or malfunction. Hey this happens and honestly there is not much you or your patient can do about it but it does help to talk about this before the patients starts using the CGM.
3. CGM is NOT real time information and will differ from finger stick data- although the two most popular CGM systems do not require any finger stick calibrations there is a group of patients new to CGM who check anyway to see how their CGM system matches up with their BGM system. While it can happen it’s a rare occurrence when the two systems match up exactly and there are times when they provide dramatically different readings. This obviously creates more questions for you so just be prepared for the which is right question my new system or my old system.  

To be very clear here the two most popular CGM systems the Dexcom G6 and Abbott FreeStyle Libre have proven to be very accurate and very reliable.Neither system requires finger stick calibrations and neither requires a patient confirm readings before they dose insulin.  While no system works perfectly 100% of the time you and your patient should feel very confident that the data being seen is accurate.

1. Connectivity – one of the best features of CGM is they send readings to an app on the patients smartphone which then can be shared with you, a family member, friend or care giver. This is the good news, the bad news is just as sometimes there is no cell service the app and sensor don’t communicate. This of course creates lots of calls to tech support.
2. Reports – another great feature of these apps are all the great reports they generate. Reports which create lots of Wow and Why moments. Now before we go any further you should be seeing a pattern as that’s one of the greatest things about CGM as it does create lots of Wow and Why moments. Perhaps the best way to think about the difference between CGM and BGM is BGM data is like looking at a still picture while looking at CGM data is like watching a movie, that’s how dramatic the difference is.
3. Trend Management – In the old days before CGM diabetes management was pretty much point to point as data was only available when the patient tested. With CGM diabetes management changes to managing trends rather than managing moments. CGM data allows you to see things that were only guessed at before things like time to action or duration of action. As we noted in the first part of this series CGM data provides a comprehensive overview a complete picture of what’s happening.
4. Social Media – whether its Facebook, Twitter or Instagram social media is now part of diabetes management and CGM technology has spawned lots of chatter (some of it white noise) on social media. Having reviewed many of the diabetes dedicated web sites and blogs we’d say for the ,most part the information posted is helpful, the same goes for the various posts on Facebook. Yes there is a fair amount of ranting however for the most part we’d say social media is a net positive. However like most things related to CGM social media does create questions so be prepared. Like almost everything else in diabetes what happens with one patient does not necessarily transform to all patients.
5. Alarms. Alerts – These are two of the most maddening features of CGM. In one respect these alarms and alerts can be a life saver helping the patient avoid a severe hypoglycemic event or deal with a possible hyperglycemic event. They can also be very annoying and not just to the patient but anyone who happens to be around when they go off. The good news here is this feature does NOT have to be enabled and second the patient can adjust the settings as to when these alarms and alerts happen.
6. Skin issues – although we have never had any issues with rashes or skin irritations it does occur with some patients. Some CGM users and we are among them use skin prep pads which provide stronger adhesive so that sensor stays attached during exercise, etc. This is one area where we have found social media to be very helpful with patients sharing information as to what and what hasn’t worked for their situation.
7. Expectations- this is THE most important aspect transitioning a patient from BGM to CGM, managing expectations. CGM creates lots of Wows and Why’s which in turn creates lots of questions. What should discussed UP FRONT is who will answer these questions. While we understand that your time is valuable and that you are not compensated to analyze and interrupt all this data most patients do not understand this. Understandably as their trusted advisor they will reach out to with questions so it’s imperative they have a clear understanding of what you will and will not do.

While it is true that CGM apps can share data/reports with you or your team there are certain things these reports do not tell you. They do not collect insulin dosing data nor do they collect meal data nor do they tell you if the patient was exercising, etc. Yes there are patients who will track such things and you likely know who they are already but the majority of patients don’t track these things. We mention this as lots of why questions can be more easily answered with this information.

As to which system is right for your patients that like almost everything you deal with has a lot to do with who their insurance provider is and what type of patient they are. The two most popular systems are the FreeStyle Libre from Abbott and the G6 from Dexcom. Although we have had no personal experience with the Libre the patients we have spoken with who have or are using the LIbre seem very pleased.

Our personal experience with the G6 has been nothing short of outstanding. The sensor is very easy to insert and yes is pretty much pain free. The sensor data has been reliable and accurate. Yes we have dealt with some connectivity issues, as have Libre users, but for the most part the G6 has matched and exceeded our expectations. We can say without question that CGM is the most transformational technology we have ever used.

We understand that adding CGM to your practice is not an easy decision which is why you need to be aware of how CGM works in the real world. However we can state unequivocally that this technology can be enlightening and transformational.      

Friday, August 14, 2020

Part one of a three part series on continuous glucose monitoring

by David  Kliff – The Diabetic Investor

Many in the diabetes world consider the discovery of insulin the most significant milestone in diabetes history. While it’s hard to argue with this point of view, the development of continuous glucose monitoring (CGM) systems also belongs in this same category. CGM has the potential to forever change the management of diabetes, providing patients and their physicians with a pathway to better patient outcomes. It’s not an overstatement to say that CGM could be the one tool that changes this ominous diabetes statistic that unfortunately has not changed in decades: more than 2/3 of patients with diabetes are NOT achieving good control.

Today, patients with diabetes have a plethora of options when it comes to the treatment of their diabetes. Thanks to the internet and now smartphones, they have instant access to information. There are thousands of websites and apps which can help the patient better manage their diabetes. Yet even with all this advanced technology and newer and better drugs, that one glaring statistic remains a constant reminder that we have yet to crack the toughest nut of all: getting the majority of patients with diabetes under good control.

In this series we will first review CGM, explaining what it is, provide an overview of the current FDA approved systems, and explain how transformative this technology can be. We’ll examine how to incorporate CGM into your practice and look to the future and how this one piece of technology will forever change, for the better, the relationship between the patient with diabetes and their physician.

Before we jump into the deep end of the CGM, first, a brief history of glucose monitoring—a technology which, when first introduced back in the late 60s and early 70s, was complex to use while providing uneven results. It took 10 years or so before glucose meters became more patient friendly while providing more accurate results. At the time, these meters introduced several notable advancements, notably faster test results (5 seconds for some systems), even greater accuracy, alternate site testing, and connectivity so that data could be shared.

However, with each corresponding improvement in this technology, one indisputable fact remained: the majority of patients with diabetes were not monitoring their glucose as frequently as they should, or worse, not monitoring at all. Pundits attributed this to the fact that glucose monitoring was “painful” as the patient had to prick their finger to gather a blood sample. While we would never contend that finger pricks were an enjoyable experience, “pain” was not the real reason patients did not monitor their glucose regularly.

The real reason was that patients did not value the information provided, plus there was no action step executed based on these results. It should surprise no one that insulin pump patients were the most frequent testers, monitoring their glucose on average eight times per day, multiple daily injection (MDI) patients were next at four times per day, and so on. Insulin-using patients not only valued this information, but needed it so they could properly dose their insulin.

Yet even with frequent testers, these point to point systems had another major limitation: they provided an incomplete picture of what was really going on. Simply put, when it comes to diabetes management, some data is better than no data, but more data is better[1] . (And yes, we will cover how CGM systems have evolved to combine all this data with analytics.) HbA1c is widely considered the gold standard for measuring control; however, this gold standard also provides an incomplete picture of the patient.

Simply put, CGM fills in the blanks while providing a more comprehensive overview of the patient. This is the true value of CGM for both the patient and the physician as it allows a three-dimensional look. Think of it this way: CGM allows the patient and physician to see what’s really going on. It can be seen whether the therapy regimen is working. It can be seen what happens after meals. It can be seen what happens while the patient is sleeping or exercising. CGM provides bright light where only darkness or limited light existed before.

CGM also has the additional benefit in that it’s more patient friendly, making glucose monitoring simple. Currently there are two systems which do not require any calibrations with a conventional glucose monitor. So, the days of a patient pricking their finger are gone forever; the “pain” factor has been eliminated. All four of the currently FDA-approved systems come with connectivity therefore eliminating the need to log readings. It also allows a patient to easily share this data with their physician. Even better, CGM sensor life has improved over the years, with sensors being worn for 10 or more days.

One of the hidden benefits of CGM is it eliminates the need for the patient to carry around any testing supplies. No lancets, no test strips, nothing. This may seem like a small benefit until you talk with a patient using CGM. When it comes to diabetes management the patient has enough to worry about already and the less “stuff” they have to have with them, the better.

In summary, CGM not only provides a better, clearer picture of what’s happening, it’s also more patient friendly. This is why we believe that in the not so distant future, CGM will replace conventional glucose monitoring as the standard for glucose measurement. CGM systems are widely reimbursed improving patient access to this technology. The data provided by CGM is extraordinarily accurate, so much so that insulin-using patients can now dose their insulin based on data provided by their CGM without also using a conventional monitor.

Sensor insertion has become quick and relatively pain-free. And thanks to connectivity, all the heavy lifting of the analytics is also done for the patient. As we know, data by itself is just a set of meaningless numbers, but data combined with analytics leads to knowledge. Armed with this knowledge, the patient and physician can take action, action which hopefully will lead to the ultimate goal of better outcomes.

Yet what really makes CGM the most transformative technology ever invented for patients with diabetes is that it helps ALL patients no matter how they manage their diabetes. This is perhaps one the most misunderstood aspects of this revolutionary technology: it’s not just for insulin-using patients, it’s for all patients. Yes, there are some very obvious benefits for insulin-using patients. However, this technology is still valuable for a patient on orals alone or orals plus insulin. The difference is how each subset of patients will use and interact with their CGM. While intensively-managed insulin using patients will use CGM 24/7/365, less intensively-managed patients may only use CGM once or twice a month.

With less intensively-managed patients, CGM is first used as a discovery tool to find out what’s going on. Next, it’s used as a validation tool: we discovered what’s going put a plan in place to handle what’s going on, validate what we did, and make sure it’s working. Finally, it will be used as a maintenance tool, to make sure the plan is working and that no adjustments need to be made.

The bottom line here is that CGM provides real evidence and a clear view. The patient and physician can now SEE what’s going on, with no more guessing and no more relying on just HbA1c alone to make decisions. Ultimately, this is why we see CGM as the most transformative technology ever invented for patients with diabetes and their physicians. CGM brings light where only darkness existed before.

Tuesday, July 14, 2020

by David Kliff of the Diabetic Investor

There is no question that the COVID pandemic has forever changed healthcare. Telemedicine, virtual patient consults and increased use of remote patient monitoring are just some of the byproducts of the pandemic. As welcome as some of these changes are they have also brought with them some new concerns. This is particularly true in the area of chronic disease management. Physicians have always been acutely aware that their patients with chronic diseases such as diabetes have the additional burden of monitoring their condition.

In the old days before all the gizmos a patient used communicated with their smartphone, patients with diabetes would record their glucose readings in an old-fashioned logbook. There were no such thing as connected insulin pens or continuous glucose monitoring systems which not only collected data but shared this data with an app, which in turn then could be shared with their physician.

This new world on interconnected devices brings with it some promise and some peril. In theory all this connectivity can help the patient more effectively manage their diabetes. Using connectivity the patient can easily share all this information with their physician who in turn can then better advise the patient. Thanks to COVID physicians can now more easily bill for these virtual consultations. Still there is little uniformity in how all this data is presented or transmitted. Nor are there any standards or restrictions on how these apps communicate with the user.

The last thing any physician needs is for an app to be telling the patient one thing, when they are telling the patient something else. To our knowledge there is just one diabetes app which has received FDA approval, Diabetes Manager by WellDoc. This basically means when it comes to the plethora of diabetes apps choosing which one is best for your patients with diabetes is pretty much like rolling the dice on a crap table.

To help navigate this complex maze here are some simple tips that will help enhance the physician patient relationship.

1. Is an app needed in the first place?

This may seem like a dumb question but in reality there are some patients who don’t need or don’t want to deal with all this way cool whiz bang technology. Just by way of example a Type 2 patient on oral medication(s) alone may see an app as overburdensome. Sure it would be nice to know how their glucose levels are trending but any changes to their therapy regimen are more likely to be based on a multiplicity of factors including their most recent HbA1c.

2. What information is needed?

To a great extent this question is also answered by the patient’s therapy regimen. Is the patient following intensive insulin therapy? Or are they using insulin plus orals? Keep in mind that glucose data is not the lone data point that can be collected by an app. Given the importance of food intake there are a host of apps which allow the patient to record meal intake. There are also several apps which record the patient’s weight, blood glucose monitors and CGM’s aren’t the only devices which send data to apps.

3. Is data all that’s needed or should coaching be included?

One thing most of these apps are very good at is data collection. However there are an equal number which go beyond mere data collection and apply analytics to all this data. These analytical apps can provide valuable insight into how the patient is managing their diabetes.

Recently a bundle of apps have gone well beyond data collection combined with data analytics. These newer apps have entered the world of patient coaching offering the patient tips on how they can more effectively manage their diabetes. Using text messaging these apps can send these tips directly to the patient bypassing any physician input or oversight.

4. Is this information safe?

It would be foolish in today’s world to ignore the security of a patient’s personal health information and these apps are no different. Several studies have noted that cybersecurity or the fear of information being hacked is the number one concern for patients. Given that there are no universal standards which govern how these apps should protect all this data this is a very legitimate concern. While we would not go as far and state that it’s the wild west out in diabetes app land without any uniform standards combined with the complexity of factors involved we don’t see this concern going away.

5. What’s the goal?

Again this seems like a stupid question as the default response is better patient outcomes. Yet the real consideration is will use of these apps achieve this goal. Here too there are numerous studies which unfortunately draw different conclusions. Some studies have concluded that these apps help strengthen the doctor patient relationship providing more productive interactions. Others however have concluded that as helpful as all this information can be this avalanche of information creates more questions.

There is no question that apps are here to stay and will see greater usage. The real yet unanswered question is will use of these apps lead to better outcomes. Will patients and their physicians embrace this technology, or will they become another diabetes tool that goes unused?

On balance we see more positives than negatives however we continue to believe that it’s not about the toys in the toy chest. That it’s all about getting the patient to play with the toys.

Sunday, June 14, 2020

by David Kliff of the Diabetic Investor

The statistics are startling, even with all the improvements in diabetes therapies and devices, almost two-thirds of patients are not achieving good control. For years diabetes researchers, those in the diabetes industry and academia have struggled to understand why after the billions spent there has not been an improvement in patient outcomes. Yet if you ask any primary care physician, endocrinologist or diabetes educator they consistently note the reason more patients are not achieving good control comes down to one factor; therapy compliance. As one very respected endocrinologist once said; “Things would be very different if patients took their meds as prescribed.”

The problem with therapy compliance does not discriminate between patients with Type 1 or Type 2 diabetes. It’s widespread throughout the diabetes population. Now there are multiple factors that contribute to non-compliance. These factors can be socioeconomic, i.e. the patient cannot afford their meds. Still if you ask patients one of the biggest issues is the complexity of their therapy regimen. Keep in mind that a vast majority of patients are not just taking medications for diabetes but are also taking a plethora of pills for other conditions. As we have stated many times managing diabetes is 24x7x365 job with no days off.

Thankfully over the years drug companies have recognized that the less frequently a patient has to take their meds the more likely it is they will take it. One class of medications where this has played out is GLP-1 therapies. The first FDA approved GLP-1 was Byetta which was administered twice daily, next came Victoza a once daily injection which has now been followed by Trulicity and Ozempic which are once weekly injections. Not surprisingly with each improvement in administration GLP-1 usage has grown.

Besides less frequent administration GLP-1 offers several additional benefits;

1. Unlike insulin which requires the patient to monitor their glucose levels, GLP-1 is a preset dose and does not require that the patient to monitor their glucose levels. There are no complex calculations the patient simply dials out the dose and injects.
2. GLP-1 therapy has proven to be very effective at lowering HbA1c.
3. There is the additional benefit of weight loss.
4. While there are some adverse events associated with GLP-1 usage they are manageable and easily rectified if they appear.
5. Although we would never say any injection is pleasant thanks to advance needle technology the newer long acting GLP-1 use shorter thinner lubricated needles which make injections much more patient friendly.

The one thing missing until recently has been an orally administered GLP-1. The first orally administered has now arrived with Rybelsus. This once daily pill has the same benefits as the injectable GLP-1’s. However before starts jumping it should be noted that are drawbacks with Rybelsus as it has a rather complex dosing regimen. First it must be taken on an empty stomach, it also cannot be taken with too much liquid and once taken the patient cannot eat or drink anything for at least 30 minutes.

So far, remember this drug has just hit the market, these obstacles can be overcome by taking the drug when the patient awakes every morning. Novo Nordisk the maker of the drug has also recommended the patient use a small glass of water. The general consensus has been by taking the drug in the morning this satisfies the empty stomach requirement, the small glass the liquid requirement and since the pill is taken in the morning after the patient awakes it then left to patient to wait 30 minutes before having their morning coffee.

Given that Rybelsus has only been available for a very short period of time it is too early to tell whether this rather complex dosing regimen hinders patients from using it.

A very promising yet unapproved approach to GLP-1 administration is having the drug administered via an implantable micropump. Intarcia Therapeutics was the closet with this approach but has run into issues getting the delivery device through the FDA. The company is currently navigating the FDA process. Thankfully Intarcia is not the only company working on this approach which to us anyway is the most promising.

Using the Intracia system as an example here’s why, as once inserted the patient does nothing, there is no possibility, barring a malfunction, that the drug is not administered.  No shots, no pills the drug is continuously delivered. Again using the Intarcia system as an example the insertion procedure is simple and painless and the micropump is replaced every six months. Patients in the Intracia clinical trials noted how life changing this technology was many noting that not only how their outcomes improved but also how their daily lives improved.

It remains to be seen whether Intracia will be successful in their efforts to work with the FDA. However as we noted Intarcia is not the only company working on this type of technology. Although we cannot guarantee such a system will be available anytime soon to us it’s not a question of if this will become available but when it will get here.

GLP-1 therapy offers several compelling advantages as noted earlier and as also noted more improvements are on the way. Yet the most compelling case for GLP-1 therapy is that it has the potential to solve the biggest obstacle standing between patients and better outcomes, therapy compliance.

Thursday, May 14, 2020

by David Kliff

When the coronavirus finally passes, we could well look back at this crisis as a turning point for digital health. For years everyone has talked about digital health, but until the coronavirus forced patients and physicians into actually using digital health, it remained somewhat of a mystery. In this article, we'll examine more specifically how to use digital health for patients with diabetes.

One thing we don't do is review the many digital health apps or web sites. What we can say without being too geeky is these systems have functioned well, continue to improve, and are patient/doctor friendly. Based on the discussions, we've had some physicians don't have a choice in which system they use as their hospital or practice group has decided for them. To us, it doesn't matter which method is used heck we know of people using FaceTime for virtual consults.

The digital or virtual consult isn't that different than face to face consult in that you can only do so many a day, and the more prepared both you and the patient are, the more compelling these consults are. Thankfully for your patients with diabetes, getting prepared has never been easier as there are a plethora of apps and devices which, when adjusted by the patient, can seamlessly share information with your office.

The most common of these tools are continuous glucose monitors, CGM, which, as the name implies, measure a patient's glucose on a continuous basis. The two most prevalent systems come from Dexcom and Abbott. The G6 from Dexcom and Libre from Abbott (as we write the Libre2 is awaiting FDA approval) both collect glucose data and can then share this data with your office. These systems are patient-friendly, accurate, and reliable. Better still, both eliminate the need for any fingersticks.

Dexcom offers patients the Clarity app, which contains several reports which also can be shared. Abbott offers the LibreLink app, which does the same thing. Both apps make it easy to share glucose data, which can be as basic or detailed as you want.

In addition to glucose data, your patients with diabetes can also share other valuable pieces of data thanks to device connectivity. Today's insulin pumps offer similar reporting capabilities as well as some connected insulin pens such as the InPen from Companion Medical, which can share insulin dosing information. In the future, all the major insulin companies Lilly, Novo Nordisk, and Sanofi plan on offering connected insulin pens or connected cap covers which work with the current crop of disposable insulin pens.

Currently, Lilly has a connected cap cover awaiting FDA approval, while Novo has a durable connected pen similar to the InPen in use overseas. Novo has plans to introduce a connected cap cover here in the US sometime next year, given the prevalence of disposable insulin pens used in the US. Sanofi, for their part, is following Novo's lead, developing both connected durable pens and connected cap covers used with disposable insulin pens.

All of the insulin companies have agreements/partnerships with Dexcom and Abbott so that their apps collect not only insulin dosing data but also glucose data. These apps even include insulin dosing algorithms that perform the data analytics and then make insulin dosing recommendations to the patient.

Even with all this connectivity, some areas have not yet reached the digital stage. The most obvious being blood panels. This data can be easily shared once obtained, but the patient still must visit a lab or have these blood draws performed in an office setting. Therefore we would highly recommend these panels be done before a virtual consult.

Another area that has yet to go digital is therapy adherence. Several apps remind patients to take their pills, and many allow a patient to enter when they do so manually. Currently, there are no apps or tools we know of which track when or if patients are taking their medications as prescribed.

The same can said for patients following GLP-1 therapy. While insulin pens, both durable and disposable, are becoming digital, we are not aware of any GLP-1 pen, which is becoming digital.

For these reasons, glucose data tracked by a CGM becomes even more valuable as it can be deep insights into a patient's therapy adherence. As one physician put it since the technology is not available to track non-injectable therapy adherence, CGM data becomes even more helpful. As we all know, there are only so many variables that impact a patient's diabetes. CGM data allows for a more constructive consult with the patient.

Given the detail available in the reports generated by the CGM systems combined with a few simple questions to the patient, you can determine when or if the patient is taking their medications. As another physician noted, once you have the data, the questions asked serve as a process of elimination. Let's be honest here there are only so many reasons why a patient is not achieving reasonable control, CGM data combined with such simple questions allows you to get at the root cause.

The best news of all is that these CGM systems have become more affordable and widely reimbursed, allowing for greater patient adoption. Even better, both Dexcom and Abbott offer high-quality patient support, so you or your staff don't waste time training the patient on how to use the system and the apps that share data and produce reports. As we all know, time is not a renewable resource, and whether it's done virtually or in person, you cannot afford to waste time.

Sunday, April 26, 2020

by Aaron Medaris - Publisher, Physicians Office Resource

COVID-19 needs no introduction. This virus, which is 1/1000^th the size of a grain of sand, has singlehandedly bought countries, people and businesses to a complete stop. It fills our news feeds, our thoughts, and dictates our actions. We know that humans are resilient and that we will come out on top, but COVID-19 has brought change and heartbreak along the way. During this time of emergency, we express our sincerest praise to all of you who are constantly putting yourselves in harms way to serve and heal another.

Up to this point, much of the screening for COVID-19 has taken place in hospitals and larger laboratories, but with the emergency situation that we have found ourselves in, COVID-19 testing has reached physician offices and urgent care centers. With this development questions from our community of POLs have come forth such as:

• Are these FDA approved products?
• What tests are available to a POL and how do they work?
• How can a POL get access to COVID-19 rapid tests?

We will address these main questions throughout the remainder of this article.

Are these tests FDA approved?

The first thing to be aware of is that these new rapid point of care tests are NOT FDA cleared or approved. However, these rapid tests have been authorized by the FDA under Emergency Use Authorization (EUA) for the detection of COVID-19. According to the FDA, “The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.” Given our current situation and the inability for these tests to make it completely through the FDA’s approval process, manufacturers can create and validate their own COVID-19 tests based off of guidelines laid out by the FDA under the EUA. With that said, it is essential for purchasers of COVID-19 rapid tests to make sure they are obtaining them from a valid and reputable company. There have already been reports of false and ineffective COVID-19 rapid tests hitting the market. To help you access quality tests, we will mention a few companies who you can approach about COVID-19 rapid tests at the end of this article.

What testing methods are available for COVID-19 at the point of care?

IgG/IgM Rapid Screen Antibody Test Cassette

There are several rapid testing methods for physician offices and urgent care centers. Probably the most available option is an IgG/IgM rapid screen antibody test cassette. IgG/IgM rapid test cassettes are a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies in COVID-19 in human whole blood, serum or plasma specimen. Tests will most likely come with a cassette, a buffer, and a dropper. Test protocol is quite simple:

• Collect the specimen
• Use the provided dropper apply the specimen to the appropriate well on the cassette.
• Immediately after, add the buffer to the buffer well.
• Results should appear in about 10 to 15 minutes.

These cassettes are quick and convenient, but please remember to purchase your tests from a reputable source. Some companies have taken advantage of the FDA’s EUA and not fully developed or tested their tests.

Molecular Point-of-Care Tests

Molecular point of care tests for the detection of COVID-19 will need diagnostic device or dock to run the test on. However, many POLs and urgent care centers may already have these molecular devices in place as they are used to run rapid flu, RSV and strep tests. If your facility doesn’t have one of these devices yet, you can reach out to companies such as Abbott and Sekisui Diagnostics to help you get set up. Here’s how these molecular devices work:

• A sample is added to the device.
• Chemical solutions splits open the virus releasing genetic material for the device to read.
• Even if a small amount of COVID-19 is found in the sample, the molecular device is able to replicate the small section of the virus’ genetic material making it detectable.

These molecular tests provide results anywhere from 5 to 30 minutes.

How to access rapid COVID-19 Tests

We’ve all heard the news about how COVID-19 tests are in short supply, and that may be an understatement. However, companies have been ramping up their efforts to supply testing kits. Abbott for example has ramped up their manufacturing efforts and plans on delivering 50,000 of their molecular tests per day. Other companies are following suit, and many have even made this test extremely affordable during this time of crisis.

Here are reputable companies you can contact about obtaining rapid COVID-19 tests:

Carolina Liquid Chemistries, offers the “AllTest^TM” 2019-nCoV IgG/IgM Rapid Screen Antibody Test Cassette. They can be reached at CarolinaChemistries.com or by calling 877-722-8910

Sekisui Diagnostics has an agreement with Mesa Biotech to distribute their Accula^TM SARS-COV-2 Test which is performed on the Silaris Dock - a molecular in vitro diagnostic test utilizing PCR and lateral flow technologies for the qualitative visual detection of the coronavirus SARS-CoV-2 viral RNA. For inquires in to product availability please email covid-19testing@sekisui-dx.com

Abbott, offers the new Abbott ID NOW COVID-10 test which runs on Abbott’s ID NOW^TM molecular platform. For inquiries in to this test and device please visit abbott.com

We hope that this brief article has helped bring some clarity to the questions which we have heard from you. If you have further questions please feel free to reach me directly at amedaris@physiciansofficeresource.com. I may not have all the answers for you, but hopefully I can point you in the right direction. Thank you again for your courage and service during this pandemic.

Aaron Medaris

Sunday, April 26, 2020

by Sekisui Diagnostics

There are certain milestones in life that no one looks forward to—having your wisdom teeth pulled. That first mammogram! At the top of the list for men is likely that first rectal exam at 40 or 50 as an initial screening for prostate cancer. But, like those pesky wisdom teeth and the oh-so-important mammogram, screening for prostate cancer is important and necessary.

A policy paper produced by the European Association of Urology¹ states that there were approximately 450,000 cases of prostate cancer in Europe in 2018 and 107,000 deaths expected. In 2019, the American Cancer Society estimates² that there will be about 174,650 new cases of prostate cancer in the U.S.  Globally prostate cancer³ is the second most commonly occurring cancer in men and the fourth most commonly occurring cancer overall.

That being said, prostate cancer often can be treated successfully. In fact, the localized and regional five-year survival rates⁴ for this type of cancer are near 100%! As with all cancers, early diagnosis is important. Most prostate cancers are first found⁵ during screening with a prostate-specific antigen (PSA) blood test or a digital rectal exam (DRE). While prostate cancers usually don’t cause symptoms in the early stages, more advanced cancers are sometimes first found because of symptoms they cause.

So why are there ongoing controversial discussions about PSA screening? Why do the United States and Europe hold different positions regarding some aspects of screening?

So What’s the Deal?

How can one argue that it’s better not to screen for a cancer? The medical community is divided due to the risk of overdiagnosis and overtreatment. Cancer overdiagnosis⁶ is the detection of cancer that would not develop any symptoms during a man’s lifetime if not identified by early detection or not result in cancer-related death. Overtreatment refers to unnecessary medical interventions, including extensive treatment for a condition that requires only limited treatment.

According to the European Association of Urology¹, the risk of overdiagnosis has been estimated to be as high as 40% in screen-detected prostate cancer, leading to unnecessary biopsies and detection of insignificant cancers, which could lead to overtreatment. In 2012, the U.S. Preventive Services Task Force (USPSTF) actually recommended against⁷ screening for prostate cancer in all men! However in 2017, the USPSTF released a new draft recommendation for prostate cancer screening encouraging providers⁷ to inform men ages 55 to 69 about the benefits and harms of prostate cancer screening.

Worrying Statistics

Practitioners in both the UK and the U.S.¹ were advised not to perform PSA for early detection. Two independent studies performed in 2017 and 2018 found that a lack of prostate cancer screening may be reversing¹ the trend of declining death rates—meaning mortality from these type of cancer could be on the rise. This year, the European Association of Urology made a call to action⁸, stating, “Urgent action is required to ensure the new Commission is mandated to support EU Member States in prostate cancer screening in their national cancer plans.”

EAU Policy Coordinator Michelle Battye wants the 2003 Council Recommendations on population-based screening to be “urgently reviewed,” with prostate cancer added to the list of cancers to be addressed, and wants member states to bring good practice on prostate cancer screening to the Steering Group on Health Promotion, Disease Prevention and Management of non-communicable diseases.

How the U.S. Responded

As we briefly mentioned above, in 2017 the USPSTF released new recommendation for prostate cancer screening encouraging providers⁷ to inform men ages 55 to 69 about the benefits and harms of prostate cancer screening. The American Cancer Society recommends⁹ that men learn as much as they can about prostate cancer screening risks and benefits and discuss the information with their doctor before deciding whether to be tested. Men at average risk of prostate cancer should have this discussion at age 50. Men at higher than average risk should have the discussion starting at age 40 or 45.

The consequences of decreased PSA screening¹⁰ are numerous: 

• Increased mortality
• The effects of non-curative intervention
• Psychological complications of recurrent prostate cancer

So do the risks of prostate cancer screening outweigh the benefits? That’s not a question any man should answer alone—he should discuss the pros and cons of screening with his doctor to make an informed decision. However, physicians should bring this topic to the table at the appropriate time for all affected patients.

In the end, prostate cancer screening is important, as it is with all types of available cancer screenings. A little bit of research can inundate you with statistics, recommendations, and lots of other frightening material. What matters is that physicians are aware of recommended guidelines and available screening and treatment options, and that patients are given the information they need to make informed decisions regarding their health.

Sekisui Diagnostics offers two tests (please note that only one is currently available in the U.S.). The FastPack® IP Total PSA immunoassay¹¹ is a chemiluminescent immunoassay for the in-vitro quantitative determination of PSA in human serum and plasma as an aid in the management of patients with prostate cancer. It offers results in 12 minutes.

The FastPack® IP Free PSA Immunoassay¹², not currently available in the U.S., is a chemiluminescent immunoassay for the in-vitro quantitative determination of free prostate-specific antigen (free PSA) in human serum. It is designed for use in conjunction with the FastPack IP System for calculating the ratio of free/total PSA, expressed as a percentage (percent free PSA). A free PSA test13 can be used instead of a biopsy if PSA levels are slightly elevated, and may be used to determine how aggressive a recurring cancer is.

References:

1. http://epad.uroweb.org/wp-content/uploads/EAU_policy-briefing_PSA.pdf
2. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html
3. https://www.wcrf.org/dietandcancer/cancer-trends/prostate-cancer-statistics
4. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/survival-rates.html
5. https://www.cancer.org/cancer/prostate-cancer/detection-diagnosis-staging/how-diagnosed.html
6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3540879/
7. https://health.gov/news-archive/blog/2017/07/prostate-cancer-screening-recommendations-an-update-from-uspstf/index.html
8. https://uroweb.org/epad19-european-psa-screening-programme-is-on-its-way-part-2/
9. https://www.cancer.org/latest-news/prostate-cancer-screening-faq.html
10. https://www.physiciansweekly.com/the-unintended-consequences-of-decreased-psa-screening/
11. https://www.sekisuidiagnostics.com/products-all/fastpack-ip-prostate-specific-antigen-psa-immunoassay/
12. https://www.sekisuidiagnostics.com/products-all/fastpack-ip-free-psa-immunoassay/
13. https://www.healthline.com/health/prostate-cancer-free-psa#purpose

Sekisui Diagnostics

Sunday, April 26, 2020

by David Kliff - The Diabetic Investor

Insulin pump therapy has long been recognized as one of the most effective therapy options for both Type 1 and intensively managed Type 2 patients. There are hundreds if not thousands of studies that have shown how the use of an insulin pump improves patient outcomes. Over the years insulin pumps have made some substantial leaps in terms of usability features and benefits. While more complex than multiple daily injection (MDI) therapy, insulin pump therapy has also become more patients and physician friendly.

In this column we’ll examine the pros and cons of insulin pump therapy with a focus on the intensively managed Type 2 population. We’ll pay very close attention to the latest sensor augmented systems given the increasing usage of continuous glucose monitoring (CGM) Please also note, it’s pretty easy for an existing pump patient to switch from one system to another, therefore our comments here will focus more on patients initiating pump therapy for the first time. With that said, let’s begin.

The Pros

Thankfully, because of CGM technology initiating pump therapy has never been easier. In fact, we would go as far and state that no patient should initiate pump therapy without being on a CGM for at least 30 days (60 or 90 would be better). Why? Using the software that works with the existing CGM system it becomes simple to determine several of the factors that are used to program the pump. Factors such as: 

1. Insulin time to action
2. Duration of action
3. Insulin to Carb Ratio’s

CGM data also provides a more detailed overview which allows for better pump programming. For example, given that pumps now allow for multiple basal rates, should a patient be experiencing dawn phenomenon, the pump can be programmed to deal with this issue.

Now thanks to technology we have two systems and soon a third where the CGM and pump are designed to work together. There is the 670G from Medtronic and the Control IQ from Tandem; Insulet will soon have the Horizon on the market sometime later this year. These hybrid closed loop systems offer several benefits; most notably is that the majority of the heavy lifting decisions that patients used to make are now being made by the system. Using sophisticated insulin dosing algorithms, these systems can almost be like an auto pilot on an airplane managing the patient’s insulin dosing.

These systems are designed to keep patients in a tighter range with the additional benefit of protecting patients from dangerous hypoglycemic events. Should the system detect a hypoglycemic event coming it automatically shuts down the delivery of insulin while warning the patient of pending low. On the flip side, should the system detect the patient’s glucose going outside their range on the high side it automatically delivers insulin keeping the patient in range.

Frankly the real-world results of these new systems has been astonishing with patients achieving Time In Range (TIR), a key new very important metric for measuring control, of greater than 70%. More astonishing is achieving these ranges with few adverse hypoglycemic events. Although the Control IQ has not been available for as long as the 670G, the real-world results are nothing short of fantastic with patients achieving TIR of greater than 85%.

Although we have yet to see detailed data on the coming Horizon system from Insulet, we suspect it will perform as well as the Control IQ as it works with the same CGM system, Dexcom and has a similar insulin dosing algorithm. The fact is when it comes to insulin pumps in today’s world the pump itself is just a piece of programmable hardware, the real work is done by the CGM and the insulin dosing algorithm. However, we should note that patients have indicated the user interface for the Control IQ is much more patient friendly than the 670G interface.

The Cons

Now as way cool and whiz bang as these new systems are, they do not come without drawbacks. First and foremost, they are medical devices, and unfortunately medical devices can and do malfunction. This is fact of life with any medical device and insulin pumps are no different. The big difference is these systems deliver insulin which is not just a life sustaining drug but also a lethal drug when incorrectly dosed. While deaths are very rare with these systems they have occurred.

Secondarily, as sophisticated as these systems have become, they do not function without patient interaction. Infusion sets needed to change every three days, reservoirs replaced and filled every three days, sensors replaced every 10 days, etc. The pump itself needs to charge with a typical charge lasting a day perhaps two. The reality is some patients just don’t want to do all this stuff and find it easier to inject even if that means injecting multiple times per day.

Third, there is training and an adjustment period for patients new to pump therapy. Yes, pumps are much smarter these days as they are basically minicomputers, but even with this advanced technology patients still need training. There is also an adjustment period as the patient transitions from MDI to insulin pump therapy. A period which not only impacts their outcomes but mindset as well. Some patients experience a feeling of relief or freedom when put on these systems no longer worrying about having their insulin with them or having to inject in a public place. Others feel somewhat anxious as they realize they are attached to a machine which for all practical purposes has control over their lives and until they trust the system this anxiety will remain. Obviously, each patient is different which is why we recommend patients new to pump therapy also work with a CDE who can help them deal with these issues.

The Costs

Now no discussion of insulin pump therapy would be complete without discussing the financial ramifications. With the exception of the OmniPod system from Insulet, pump therapy is not cheap and does require ongoing costs to the patient. Add in the cost of a CGM and it’s understandable why some patients chose to excuse the expression stick with MDI.  Even the OmniPod which requires no upfront cost nor any costs for pump supplies does require an ongoing cost.

Before advising any patient on whether to implement pump therapy we’d highly recommend a discussion on this issue of cost. As we all know diabetes besides being a chronic disease is also a costly disease and given the complexities of health insurance coverage the cost of diabetes sometimes can and does interfere with the management of diabetes. No one likes this situation however it is better to address this issue up front.

There is no question that insulin pump therapy has made tremendous advancements these past few years. However, this does not in any way mean insulin pump therapy is for everyone. As we have noted there are several critical issues that may prevent a patient from transitioning from MDI to pump therapy. Still, given the results we are seeing in the real world with the newer sensor augmented systems, it’s hard to ignore the potential of insulin pump therapy.

David Kliff

Saturday, March 14, 2020

by David Kliff, The Diabetic Investor

Insulin pump therapy has long been recognized as one of the most effective therapy options for both Type 1 and intensively managed Type 2 patients. There are hundreds if not thousands of studies that have shown how the use of an insulin pump improves patient outcomes. Over the years insulin pumps have made some substantial leaps in terms of usability features and benefits. While more complex than multiple daily injection (MDI) therapy, insulin pump therapy has also become more patients and physician friendly.

In this column we’ll examine the pros and cons of insulin pump therapy with a focus on the intensively managed Type 2 population. We’ll pay very close attention to the latest sensor augmented systems given the increasing usage of continuous glucose monitoring (CGM) Please also note, it’s pretty easy for an existing pump patient to switch from one system to another, therefore our comments here will focus more on patients initiating pump therapy for the first time. With that said, let’s begin.

The Pros

Thankfully, because of CGM technology initiating pump therapy has never been easier. In fact, we would go as far and state that no patient should initiate pump therapy without being on a CGM for at least 30 days (60 or 90 would be better). Why? Using the software that works with the existing CGM system it becomes simple to determine several of the factors that are used to program the pump. Factors such as:

1. Insulin time to action
2. Duration of action
3. Insulin to Carb Ratio’s

CGM data also provides a more detailed overview which allows for better pump programming. For example, given that pumps now allow for multiple basal rates, should a patient be experiencing dawn phenomenon, the pump can be programmed to deal with this issue.

owever Now thanks to technology we have two systems and soon a third where the CGM and pump are designed to work together. There is the 670G from Medtronic and the Control IQ from Tandem; Insulet will soon have the Horizon on the market sometime later this year. These hybrid closed loop systems offer several benefits; most notably is that the majority of the heavy lifting decisions that patients used to make are now being made by the system. Using sophisticated insulin dosing algorithms, these systems can almost be like an auto pilot on an airplane managing the patient’s insulin dosing.

These systems are designed to keep patients in a tighter range with the additional benefit of protecting patients from dangerous hypoglycemic events. Should the system detect a hypoglycemic event coming it automatically shuts down the delivery of insulin while warning the patient of pending low. On the flip side, should the system detect the patient’s glucose going outside their range on the high side it automatically delivers insulin keeping the patient in range.

Frankly the real-world results of these new systems has been astonishing with patients achieving Time In Range (TIR), a key new very important metric for measuring control, of greater than 70%. More astonishing is achieving these ranges with few adverse hypoglycemic events. Although the Control IQ has not been available for as long as the 670G, the real-world results are nothing short of fantastic with patients achieving TIR of greater than 85%.

Although we have yet to see detailed data on the coming Horizon system from Insulet, we suspect it will perform as well as the Control IQ as it works with the same CGM system, Dexcom and has a similar insulin dosing algorithm. The fact is when it comes to insulin pumps in today’s world the pump itself is just a piece of programmable hardware, the real work is done by the CGM and the insulin dosing algorithm. However, we should note that patients have indicated the user interface for the Control IQ is much more patient friendly than the 670G interface.

The Cons

Now as way cool and whiz bang as these new systems are, they do not come without drawbacks. First and foremost, they are medical devices, and unfortunately medical devices can and do malfunction. This is fact of life with any medical device and insulin pumps are no different. The big difference is these systems deliver insulin which is not just a life sustaining drug but also a lethal drug when incorrectly dosed. While deaths are very rare with these systems they have occurred.

Secondarily, as sophisticated as these systems have become, they do not function without patient interaction. Infusion sets needed to change every three days, reservoirs replaced and filled every three days, sensors replaced every 10 days, etc. The pump itself needs to charge with a typical charge lasting a day perhaps two. The reality is some patients just don’t want to do all this stuff and find it easier to inject even if that means injecting multiple times per day.

Third, there is training and an adjustment period for patients new to pump therapy. Yes, pumps are much smarter these days as they are basically minicomputers, but even with this advanced technology patients still need training. There is also an adjustment period as the patient transitions from MDI to insulin pump therapy. A period which not only impacts their outcomes but mindset as well. Some patients experience a feeling of relief or freedom when put on these systems no longer worrying about having their insulin with them or having to inject in a public place. Others feel somewhat anxious as they realize they are attached to a machine which for all practical purposes has control over their lives and until they trust the system this anxiety will remain. Obviously, each patient is different which is why we recommend patients new to pump therapy also work with a CDE who can help them deal with these issues.

The Costs

Now no discussion of insulin pump therapy would be complete without discussing the financial ramifications. With the exception of the OmniPod system from Insulet, pump therapy is not cheap and does require ongoing costs to the patient. Add in the cost of a CGM and it’s understandable why some patients chose to excuse the expression stick with MDI.  Even the OmniPod which requires no upfront cost nor any costs for pump supplies does require an ongoing cost.

Before advising any patient on whether to implement pump therapy we’d highly recommend a discussion on this issue of cost. As we all know diabetes besides being a chronic disease is also a costly disease and given the complexities of health insurance coverage the cost of diabetes sometimes can and does interfere with the management of diabetes. No one likes this situation however it is better to address this issue up front.

There is no question that insulin pump therapy has made tremendous advancements these past few years. However, this does not in any way mean insulin pump therapy is for everyone. As we have noted there are several critical issues that may prevent a patient from transitioning from MDI to pump therapy. Still, given the results we are seeing in the real world with the newer sensor augmented systems, it’s hard to ignore the potential of insulin pump therapy.

Monday, March 09, 2020

by Randox Laboratories Ltd.

Multiplex assay for 10 sexually transmitted infections receives CE marking

CE marking has been granted to one of the most comprehensive cartridge-based STI tests.

The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.

Quickly and efficiently testing for multiple STIs, which often have mild symptoms if any at all, ensures early diagnosis at a stage when treatment is most successful, supports the targeted use of antibiotics, and ultimately reduces their mishandling.

Dr Peter FitzGerald, Managing Director of Randox Laboratories, commented;

“Antibiotic stewardship is a critical issue which we all have a responsibility to embrace and drive forward. The CE marking of the STI assay, which incorporates Randox Biochip Technology, will be a game-changer for clinicians and patients across Europe, by facilitating early, accurate and comprehensive diagnoses of STIs that allows for the best possible patient outcome. Never before has there been this level of accessibility and speed with regards to STI testing.”

The Randox STI assay is performed on the Vivalytic system, an intuitive point-of-care platform, developed in partnership with German technology company Bosch that provides the broadest range of test options ever seen for an analyser of its size.

Harnessing the application of multiplex assays to provide greater information from a single patient sample, the Vivalytic simplifies the testing process for otherwise complex laboratory testing procedures.

Marc Meier, Managing Director of Bosch Healthcare Solutions, a subsidiary of Bosch Group, said:

“We are enthusiastic about partnering with Randox to offer their assay technology on the Vivalytic platform. The core competencies of Bosch in automation, miniaturization, sensor technology and connectivity are complemented by Randox’s expertise in developing excellent biocontent for a wide range of assays and commercializing innovative diagnostic solutions.”

Benefits of the Randox STI assay technology on the Vivalytic system

• Fully automated, cartridge-based molecular diagnostics.
• Multiplex technology detects multiple STIs, including co-infections, from a single patient sample.
• Full molecular workflow of extraction, PCR amplification and detection.
• A hygiene and space-saving all-in-one solution that does not require additional peripherals such as laptop, keyboard, barcode scanner or filling stations.
• Ultimate protection of data and valuable sample material thanks to integration of software with instrument that ensures a safe and reliable run.
• Test results can be presented either in summary or in detailed raw data form.
• Instantly available results due to easy integration with popular standard IT systems.

Notes to Editors

The assay tests simultaneously, from one patient sample, for the STIs below;

• Chlamydia trachomatis (CT)
• Neisseria Gonorrhoeae (NG)
• Trichomonas vaginalis (TV)
• Mycoplasma genitalium (MG)
• Treponema pallidum (syphilis) (TP)
• Herpes simplex virus 1 (HSV-1)
• Herpes simplex virus 2 (HSV-2)
• Haemophilus ducreyl (HD)
• Mycoplasma hominis (MH)
• Ureaplasma urealyticum (UU)

Contact Information

For more information or to arrange interviews, please contact the Randox PR team on (0) 28 9442 2413 or email randoxpr@randox.com

Press contact Bosch Healthcare Solutions:

Thomas Berroth

Marketing & Communication Thomas.berroth2@de.bosch.com

+49 (0) 711 805-4436

About Randox Laboratories

Randox is a global leader in healthcare diagnostics; today more than 5% of the world’s population – in excess of 370 million people across 145 countries – receives medical diagnosis using Randox products each year. Randox is the largest diagnostic company from the UK and exports over 95% of products worldwide. Our products and services are used in hospitals, clinical, research and molecular laboratories, food testing, forensic toxicology, life sciences, and veterinary laboratories.

With more than 1500 employees of 44 nationalities, including 430 research scientists and engineers, we have offices and distribution in over 145 countries. There are four key manufacturing and research and development sites, located in County Antrim, Northern Ireland; Dungloe, County Donegal, Ireland; Bangalore, India; and one in development in the Greater Washington DC area, USA. Our Randox Health Clinics are currently located in London and Belfast, with ambitious plans to roll out a number of new clinics in the coming months and years. A mobile service enabling certified Randox Health staff to visit clients at their convenience has also been launched.

With a major focus in R&D, Randox scientists work in pioneering research into a range of common illnesses such as cancer, cardiovascular disease and Alzheimer’s disease. With up to 25% of turnover reinvested in R&D, Randox has more new tests in development than any other diagnostic company.

Our scientists have spent over £305 million researching the thousands of biomarkers present in our bodies and have identified the gold standard in testing. Our patented Biochip Array Technology is the world’s only diagnostic grade biochip. This state-of-the-art technology has revolutionised the diagnostics industry by offering a unique testing platform which allows multiple tests to be carried out from a single patient sample at our Randox Health Clinics.

www.randox.com

About Bosch Healthcare Solutions

Bosch Healthcare Solutions GmbH is a wholly owned subsidiary of Robert Bosch GmbH. The subsidiary was established in 2015 with the aim of developing products and services that improve people’s health and quality of life. About 120 associates are currently employed at the company’s headquarters in Waiblingen, Germany. The subsidiary’s solutions draw on the Bosch Group’s core competencies: sensors to collect data, software to evaluate that data, and services based on this data analysis.

www.bosch-healthcare.com

Randox Laboratories Ltd.

Saturday, February 22, 2020

by David Kliff - The Diabetic Investor

Diabetes management has changed dramatically with each new technological innovation. It wasn’t that long ago when knowing a patient’s glucose level was basically guess work. Yes there were tools to measure glucose, however these tools were difficult to use and highly inaccurate. This all changed with the invention of blood glucose monitors which measured glucose using a drop of blood.  Although the process wasn’t perfect; for the first-time patients were able to accurately measure their glucose levels on a regular.

 The biggest jump in glucose measurement came with the invention and now widespread adoption of continuous glucose monitoring systems (CGMS). For the first time not only could a patient see their glucose levels, they could also see a series of continuous readings. This explosion of data created a whole new world of diabetes management. Patients not only knew where their levels are but thanks to advancements in CGMS they knew were their glucose levels were trending.

This is turn created a new metric for measuring glucose control. HbA1c, always considered the gold standard for measuring glycemic control, was augmented with a new metric, time in range (TIR). Several studies noted that two patients could have exactly the same HbA1c but vastly different TIR profiles. Further studies noted that TIR was as critical if not more so than HbA1c in determining whether or not the patient was at risk for many of the complications experienced with poor glycemic control.

Thanks to CGMS it was now possible to more effectively manage a patient who previously was thought to be under good control because their HbA1c was 7 or below. TIR management allowed patients and their physicians to design therapy regimens which kept the patient in a tighter glycemic range therefore further reducing the likelihood of complications.

Even better the more advanced CGMS systems were supplemented with smartphone apps and/or web sites which provided advanced reporting capabilities. Using these cloud-based capabilities patients could now easily share not just their readings but also the many reports produced by the sites/apps.

In its simplest form TIR isn’t just about detecting and avoiding hypoglycemic events. TIR management is equally about avoiding the higher highs.

As you are aware, in a real world setting its virtually impossible to keep any patient, no matter how engaged they are with diabetes management, in a tight range 100% of the time. However many physicians and patients have adopted a goal of not just keeping their HbA1c below 7 but staying in range 70% or more of the time. Something that wasn’t even considered only a short time ago.

TIR has become so critical a metric that efforts are underway by many of the diabetes governing bodies to expand the definition of what constitutes good glycemic from just HbA1c to include TIR. It’s critical to note that as revealing as TIR is becoming this metric is more meaningful to intensively managed insulin using patients then it is to non-intensively managed patients. There is good reason for this as non-intensively managed patients due to their regimen have less control over their swings in their glucose levels.

For the less intensively managed patient TIR remains a valuable metric it’s just differently than it is for an intensively managed patient. For example with a non-intensively managed patient TIR discovers whether their current therapy regimen is effective. Even better thanks to CGMS the physician and patient do not have to wait for the results of an HbA1c. Additionally this means the patient avoids a blood draw. The data from the CGMS can be used to calculate Average Mean Glucose which is easily converted to the equivalent HbA1c.

It goes without saying that TIR is invaluable for the intensively managed patient. These patients can now see many of the factors which go into determining their insulin dosing calculations. For example two critical factors with in determining insulin dosing are time to insulin action and duration of insulin action. CGMS takes all the guess work out of determining these factors the physician and patient can see them. Many physicians and patients have begun to readjust their insulin dosing for the better thanks to this data therefore enabling optimum glucose control.

Thankfully CGMS have become more sophisticated, cheaper and more patient friendly making it easier than to keep a patient in a tighter glucose range. Welcome to the new frontier of diabetes management. 

David Kliff

Saturday, February 22, 2020

by JAMES CRILLY - QC MARKETING MANAGER - RANDOX LABORATORIES LTD.

Introduction to POCT

Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand of POCT has been growing rapidly, however, this should come as no surprise as there are many advantages to POCT, for example, the convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.

Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.

Importance of Quality Control for POCT Devices

ISO 15189 states that “Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result” (1). Therefore, when implementing a QC strategy for POCT devices the risk of harm to the patient should be the foundation of the plan: where and why do errors occur and what are the consequences of an erroneous result to the patient? It is important to balance the risk of harm to the patient with the stringency of the QC procedure applied. Inaccurate results can have serious implications for the patient including misdiagnosis and/or inappropriate or incorrect medical procedures being carried out unnecessarily, resulting in monetary implications for the hospital.

POCT procedures have been previously shown to be less stable than those run within the laboratory. A recent study found that the most common phase for errors in POCT was analytical, with 65.3% of errors occurring during this phase. (2) Conversely, in laboratory based testing the analytical phase is the least common source for errors (3) thus, highlighting the importance of QC procedures for POCT devices while also outlining how the potential risk of harm to a patient may be greater for POC tests compared to those performed on laboratory based analyzers. This study also revealed that the potential impact of quality control error on a POCT device having a moderate adverse impact on patient outcome was 14.7% (2), demonstrating that for POCT devices there is larger room for error and a greater need for quality control.

In 2006 a new ISO standard; ISO 22870 was released specifically for POCT titled: “POCT – Requirements for quality and competence” (4). ISO 22870 advises that where available, Internal Quality Control and participation in an External Quality Assessment scheme is required in the point of care setting. ISO 22870 is designed to be used in conjunction with IS0 15189.

Choosing IQC material that’s appropriate for use with POCT devices

All POCT devices should run third party IQC samples. It is important to choose IQC material that fully meets the needs of the laboratory.

When implementing an IQC strategy it is important to take into consideration the differing designs of the device and potential risk of harm of the patient. When choosing an appropriate QC material look for the following features:

• Ease of use – many samples are available in a ‘liquid-ready-to-use’ format which require no preparation. This format can be conveniently stored at +2 to +8o C meaning it can be stored safely on the ward rather than in a laboratory freezer.
• A matrix similar to the patient sample – choose samples that are as close to a human sample as possible, in-line with ISO15189 regulations.
• Clinically relevant concentrations – analytes should be available at clinically significant concentrations to accurately validate patient sample results.
• Accurately assigned - method/ instrument specific target values and ranges should be accurately assigned.
• Third party – ISO 15189 recommends quality control material is from a third-party source.

Additional Software Available

Perhaps a reason for the higher rate of error associated with a POCT device is due to a lack of responsibility on behalf of the staff performing the POCT. Ultimately, responsibility should lie within the laboratory but how can the quality of results released by POCT devices be managed when the people performing the tests are spread out in a hospital setting, and out of direct view of the laboratory QC Technician?

The review process can be facilitated by QC management software, which helps the laboratory monitor the reliability and accuracy of results released in the POC setting.

There are a number of QC management programs available, however the following requirements should be sought after:

• Up to date peer group – Ideally a QC management program should have a peer group functionality to enable the comparison of results to other laboratories worldwide using the same lot of control, method and instrument. Peer group monitoring should be in real time, and therefore, should be updated daily.
• Multiple instrument registrations – the ability to register multiple instruments is vital in POCT as there will be a number of POCT devices through the POC setting that will need monitored.
• Online access – within a POC setting it’s important that results can be entered online, anywhere at any time. This also means that the lab manager can remotely log onto the software to view the QC results entered for specific POC devices throughout the hospital or beyond.
• Multiple user levels - Different user level accounts should be available so that lab managers can track results. This also ensures that each POC operator is performing appropriate maintenance, instrument calibration and is adequately trained to use the device.
• User defined acceptable limits - to be applied to QC results, so that results can automatically be rejected or accepted.

Indeed, major sources of error have been previously categorized to be commonly due to operator incompetence and a disregard for test procedures, and the use of uncontrolled reagents and testing equipment (5). Therefore, through using appropriate QC management software in the POC setting, the laboratory can reduce the level of risk and ensure accurate results are obtained.

Conclusion

It is important to remember that the benefits of POCT are only true if the results obtained are accurate and reliable, however, given the large number of POCT devices available on the market choosing an appropriate quality control plan for your instrument can be challenging. By following the guidelines outlined in this paper in addition to ISO 15189 and ISO 22870:2006 you can be assured that the management and overall results of your POCT devices will be of a higher and more reliable quality.

Randox Laboratories are able to help laboratories with their POCT requirements due to our ever-expanding portfolio of liquid ready-to-use controls suitable for use at the POC. Our range of controls suitable for use include Urinalysis, Blood Gas, Liquid HbA1c and more. Additionally, Randox can also supply Acusera 24.7 – our interlaboratory data management software – with real-time peer group updates, comprehensive yet easy to read reports as well as interactive and user-friendly charts. Our software is also capable of automatically calculating measurement of uncertainty and sigma scores automatically.

References

1. ISO 15189:201, Medical laboratories -Requirement for quality and competence.
2. O'Kane, Maurice J., et al. 'Quality error rates in point-of-care testing.' Clinical chemistry 57.9 (2011): 1267-1271.
3. Kazmierczak, Steven C. 'Point-of-care testing quality: some positives but also some negatives.' Clinical chemistry 57.9 (2011): 1219-1220.
4. ISO 22870:2006, Point-of-Care testing (POCT) – Requirements for quality and competence
5. Meier, Frederick A., and Bruce A. Jones. 'Point-of-care testing error: sources and amplifiers, taxonomy, prevention strategies, and detection monitors.' Archives of Pathology and Laboratory Medicine 129.10 (2005): 1262-1267.

James Crilly - QC Marketing Manager - Randox Laboratories Ltd.

Saturday, February 22, 2020

by SEKISUI DIAGNOSTICS

By now, physicians may have an idea of what’s to come this flu season, based on how the flu season has already played out in other parts of the world. In previous years, however, despite forewarnings, the United States and European countries are sometimes caught off guard with a “Perfect Storm” of challenges for the influenza season. Physician offices should be stocking up on flu tests and other supplies in preparation for this year’s flu season. What do they need to know before they choose a flu test?

Planning Ahead

So much of flu season is a guessing game, especially when trying to plan for it. The World Health Organization (WHO), the Center for Disease Control (CDC), and the Food and Drug Administration (FDA) weigh in with their recommendation to which strains should be included in the upcoming flu vaccine well before the season gets started. Their prediction on what strains should be included will dictate how effective the vaccine will be. How severe the flu season is difficult to predict ahead of time, and the key indicators used by the WHO, CDC, and others can only be obtained after flu season begins!

So, what can clinicians and distributors do to prepare?

First, conducting a business assessment of what the clinicians experienced last year and looking at  historical data can help dictate a plan to ensure they procure enough product.

Second, weigh the pros and cons of the tests they are currently using and tests they might be considering. Clinicians should consider the following:

• Performance—Is test sensitivity and specificity the most critical?
• Volume—How many tests does your facility perform during an average flu season?
• Ease of Use – how simple is the test to perform?
• CLIA Complexity – Does the facility require Waived Complexity (These simple and accurate tests are exempt from CLIA health and safety standards) or Moderate Complexity (These tests are more complex and have requirements for quality control, quality assurance, and more) Tests.
• Results reporting—Is it important for your facility to have an instrument-based result or visual read result, or is either one acceptable?
• Sample type—Does the test need to allow for multiple sample types (nasal, nasopharyngeal, aspirate/wash, and/or viral transport media (VTM))?
• Connectivity—Is it important for the testing device to be able to transmit the results electronically?
• Cost of the test
• The time to result
• Does the test require confirmation testing for negative results?

What’s Out There?

There are several types of flu tests available on the market. Rapid molecular tests detect the genetic material of the virus and typically produce results in 30 minutes or less. These are considered to be more accurate than rapid influenza diagnostic tests (RIDTs). RIDTs are lateral flow immunochemical membrane tests that can be either read visually or by an instrument and are intended to detect the presence (or absence) of a target antigen in 15 minutes or less.  

Depending on what characteristics (from above) are important to the clinician will help determine what type of test is a good fit for the facility. The manufacturer and distribution representative would be able to help guide the clinician to a product that is just right for them. 

It should be noted that no flu test provides 100% accuracy. Results depend on the type of test used, the strain of virus and the integrity of the sample. It is very important when bringing on any test to review  any limitations of the test, such as strain detection, any patient age limitations and performance data, along with sample collection and handling best practices and make sure that all staff is trained to provide the best in class testing.

The Importance of Testing

Due to the known performance issues surrounding the RIDTs, some physicians may argue that it’s not necessary to administer a flu test in order to diagnose and treat.

Testing does not usually change how a patient will be treated for a flu diagnosis, so why bother? It turns out there are several reasons.

• Empirical treatment has a disadvantage in that many more patients are receiving treatment than actually have the flu giving rise to a possible antiviral shortage and possibly delaying the right treatment for another health issue.
• Testing patients provides valuable information to the clinician that can enable them to rule out other illnesses, helps determine a more direct therapy plan, and reduces the risk of unnecessary antiviral or antibiotics therapy, while increasing the chances that the patient will receive anti-viral therapy early when it is most effective.
• Testing will also help determine whether an outbreak of flu is occurring. Since the implementation of rapid molecular tests and the drive by the FDA reclassification to have better RIDTs into the market clinicians can have the opportunity to utilize a highly accurate test to be more confident in the results to drive direct therapy.

How Sekisui Diagnostics Can Help

Sekisui Diagnostics offers three flu tests to help clinicians master the art of influenza testing.

The CLIA-Waived Silaris® Influenza A&B Test is a molecular diagnostic test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza.

The CLIA-Waived OSOM® Ultra Flu A & B Test is a FDA Class II compliant in-vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection.

 The Acucy™ Influenza A&B Test on the Acucy™ System provides clinicians flexibility in workflow and accurate, standardized results for improved patient care

The 5 “Ps”

In the end, it comes down to the 5 “Ps” – Proper Preparation Prevents Poor Performance! Don’t be afraid to keep stock of flu tests all year round. Understand new options—with the fear of changing strains, new technologies are more important than ever.  Just remember, you have choices!

SEKISUI DIAGNOSTICS

Tuesday, January 14, 2020

by David Kliff, The Diabetic Investor

Diabetes management has changed dramatically with each new technological innovation. It wasn’t that long ago when knowing a patient’s glucose level was basically guess work. Yes there were tools to measure glucose, however these tools were difficult to use and highly inaccurate. This all changed with the invention of blood glucose monitors which measured glucose using a drop of blood.  Although the process wasn’t perfect; for the first-time patients were able to accurately measure their glucose levels on a regular.

The biggest jump in glucose measurement came with the invention and now widespread adoption of continuous glucose monitoring systems (CGMS). For the first time not only could a patient see their glucose levels, they could also see a series of continuous readings. This explosion of data created a whole new world of diabetes management. Patients not only knew where their levels are but thanks to advancements in CGMS they knew were their glucose levels were trending.

This is turn created a new metric for measuring glucose control. HbA1c, always considered the gold standard for measuring glycemic control, was augmented with a new metric, time in range (TIR). Several studies noted that two patients could have exactly the same HbA1c but vastly different TIR profiles. Further studies noted that TIR was as critical if not more so than HbA1c in determining whether or not the patient was at risk for many of the complications experienced with poor glycemic control.

Thanks to CGMS it was now possible to more effectively manage a patient who previously was thought to be under good control because their HbA1c was 7 or below. TIR management allowed patients and their physicians to design therapy regimens which kept the patient in a tighter glycemic range therefore further reducing the likelihood of complications.

Even better the more advanced CGMS systems were supplemented with smartphone apps and/or web sites which provided advanced reporting capabilities. Using these cloud-based capabilities patients could now easily share not just their readings but also the many reports produced by the sites/apps.

In its simplest form TIR isn’t just about detecting and avoiding hypoglycemic events. TIR management is equally about avoiding the higher highs.

As you are aware, in a real world setting its virtually impossible to keep any patient, no matter how engaged they are with diabetes management, in a tight range 100% of the time. However many physicians and patients have adopted a goal of not just keeping their HbA1c below 7 but staying in range 70% or more of the time. Something that wasn’t even considered only a short time ago.

TIR has become so critical a metric that efforts are underway by many of the diabetes governing bodies to expand the definition of what constitutes good glycemic from just HbA1c to include TIR. It’s critical to note that as revealing as TIR is becoming this metric is more meaningful to intensively managed insulin using patients then it is to non-intensively managed patients. There is good reason for this as non-intensively managed patients due to their regimen have less control over their swings in their glucose levels.

For the less intensively managed patient TIR remains a valuable metric it’s just differently than it is for an intensively managed patient. For example with a non-intensively managed patient TIR discovers whether their current therapy regimen is effective. Even better thanks to CGMS the physician and patient do not have to wait for the results of an HbA1c. Additionally this means the patient avoids a blood draw. The data from the CGMS can be used to calculate Average Mean Glucose which is easily converted to the equivalent HbA1c.

It goes without saying that TIR is invaluable for the intensively managed patient. These patients can now see many of the factors which go into determining their insulin dosing calculations. For example two critical factors with in determining insulin dosing are time to insulin action and duration of insulin action. CGMS takes all the guess work out of determining these factors the physician and patient can see them. Many physicians and patients have begun to readjust their insulin dosing for the better thanks to this data therefore enabling optimum glucose control.

Thankfully CGMS have become more sophisticated, cheaper and more patient friendly making it easier than to keep a patient in a tighter glucose range. Welcome to the new frontier of diabetes management. 

Thursday, November 14, 2019

by David Kliff of the Diabetic Investor

Over the years there have been several notable advancements when it comes to insulin therapy. The introduction of analogue insulin’s, “smart” insulin pumps and continuous glucose monitoring systems (CGMS) are just some that quickly come to mind. Coming in the very near future will be insulin pens which talk to a patient’s smartphone and the most promising advancement since the discovery of insulin, insulin dosing algorithms. Algorithms that not only help the patient more effectively dose their insulin, but algorithms which learn allowing them to get even better over time.

Let’s face facts, for the majority of patients dosing is basically guess work, especially those who follow multiple daily injection (MDI) therapy. Typically their physician assigns a set amount of basal insulin to be taken each night before bed or each morning before the patient starts their day. The basal insulin is then supplemented with short-acting insulin taken when the patient has a meal or snack, otherwise known as the bolus. In theory the patient would calculate the amount of insulin to take with a meal based on a multiplicity of factors, such as;

Carb intake

Target Glucose Range

Current Glucose Level

Time to Action

Duration of Insulin Action

Insulin to Carb Ratio’s

Insulin on Board

This is not a complete list but it does explain why so many patients use the WAG (wild ass guess) method dosing their insulin. Yes there are several apps available which can perform the calculation for the patient. However, the apps require the patient enter all the above-mentioned factors so it can make an accurate calculation. Quite frankly the majority of patients either don’t know what to enter or don’t take the time to enter it.

For these reasons and to keep insulin dosing simple, many physicians dumb down insulin dosing; telling the patient to dose a set amount with each meal. This may not be the most effective method but as we all know while insulin is a life sustaining drug it is also can be a lethal drug when dosed incorrectly.

Thanks to advancements in diabetes device technology we are quickly approaching the day when all the guess work will be taken out of insulin dosing. A day when the system will do all the heavy lifting for the patient who will have just one job, injecting the recommended dose. The cornerstones of these soon to be available systems are an insulin pen which communicates with the patients smartphone, a CGM which also communicates and an insulin dosing algorithm which takes all the data generated by these devices and calculates the amount of insulin a patient should dose.

Although no one company has begun marketing a “Tyler,” our term for these connected pen/app/CGM systems, several are under development. Lilly, Novo Nordisk and Sanofi are developing their own version of a Tyler. Systems which will communicate with the two most popular CGM systems the G6 from Dexcom and the Libre from Abbott. Thankfully the CGM component of Tyler are becoming more patient friendly, easier to use and most importantly cheaper.

One company, Companion Medical already has an FDA approved connected pen called the inPen which communicates with a smartphone app which also can collect glucose data from a Dexcom CGM. The inPen does not yet come with an insulin dosing algorithm but does offer the patient and their physician a plethora of data which can then be used as a learning tool. Given that Dexcom also owns TypeZero an insulin algorithm, it would not come as shock if one day this algorithm becomes part of the inPen app.

No matter which system a patient chooses, one thing is certain: when used as designed all the guess work will be taken out of insulin dosing. Even without these new sophisticated insulin dosing algorithms, several studies have noted that patients using a CGM achieve better outcomes no matter how the insulin is delivered, insulin pen or insulin pump. It stands to given that when insulin dosing algorithms are added these results will get even better.

Quite frankly with these advancements we are not going out on a limb when we state that in the very near future it will be easier than ever to be an insulin using patient. Thanks to these learning algorithms all the guess work will be gone. Providing a simpler, better, and safer way to dose insulin.   

Monday, October 14, 2019

by David Kliff of the Diabetic Investor

Over the past few years there have been some tremendous technical advances for patients with diabetes. In particular, insulin using patients have some of the best tools at their disposal. Insulin pumps have gotten smarter and less of a hassle, the same goes for insulin pens which now offer connectivity. Continuous glucose monitoring systems (CGMs) are becoming the standard for glucose measurement. Perhaps the most important tool is not a device, but a software program more commonly known as an algorithm, which processes all the patient data and helps them more effectively dose their insulin.

These sophisticated algorithms not only have the ability to process information, they also are capable of learning and adjusting. Simply put the more data fed into the algorithm the better it gets.

What may come as somewhat of a surprise is that there are newer algorithms designed specifically for patients that only use long-acting insulin, either alone or in combination with oral medications. Even better these algorithms don’t require that a patient use a CGM and can be very effective using a conventional blood glucose monitor. And no they don’t require the patient consistently check their glucose levels and can be used with just one glucose test each day. The goal here is simple: help the patient more effectively dose their insulin.

To help sort through the complex maze of all the various programs available here is overview of some of the more popular programs:

Isage RX: This program supports all of the leading long acting insulin’s and requires just one glucose test per day.

Insulia®: Provides dosing recommendations and offers patient coaching.

Insulin Insights™: Allows for importing glucose data plus provides detailed reporting.

D-Nav®: Provides patient coaching along with dosing recommendations.

There are also a host of programs being offered and/or developed by all the leading insulin companies.

All of the programs offer similar features;

Smartphone apps

Physician and Patient portals

Reporting

Coaching

The key here of course is getting the patient to use the programs. Here are some tips on how to make this happen:

1. Proper positioning – as effective as these programs can be, they can and do add another step in the insulin dosing process. Therefore we’d recommend positioning these tools as an enhancement to insulin therapy helping the patient more effectively manage their diabetes.
2. Enhancing the doctor patient relationship – since all the programs share data with the physician it’s important the patient understand that these programs do not replace the physician rather helps the physician better advise the patient.
3. Baby steps – while it would be great if these tools were used each day, we would recommend phasing them in. Get the patient to try the program first but don’t make them mandatory. It’s ok if the patient doesn’t use the program every day.
4. Setting the proper expectations - data can sometimes be a doubled edge sword creating more questions than answers. This is to be expected as for the majority of patients this will be their first experience seeing this data. Some patients may be slightly overwhelmed which could cause them to stop using the program. We’d recommend explaining that just as insulin is a tool to help the patient more effectively manage their diabetes these programs are just one more tool to help in that regard.
5. Manage Expectations – while there is an extensive portfolio of clinical evidence that patients utilizing these programs achieve better outcomes these results do not happen overnight. It’s critical that the patient understand this and not expect immediate improvements in outcomes.

There is no question that advanced technology is changing the nature of the patient physician relationship. As noted previously, as effective as this technology can be it can at times seem overwhelming. Hence the reason we recommend taking a slow methodical approach when adopting new technology. Positioning the technology as an enhancement to diabetes management will help the patient feel more at ease.

Thursday, July 18, 2019

by DYLAN J. CHADWICK

“When will we wise up and stop calling the tiny computers in our pockets ‘phones?’” sighs the distraught geek on the internet, in your office, or on your Facebook timeline. Of course he’s absolutely right about it, even if a little bit prosaic. The “phone” function of our smartphones really only accounts for a small fraction of its total functionality, and NO ONE needs to comment on the ubiquity of these things anymore. Our pocket computers can do most everything our desktop and laptop computers can, and they're uniquely portable and capable of transferring data across (nearly) infinite distances. These little devils also have a steady hand in constantly updating the way that virtually every occupation functions, sometimes just in the nuts and bolts and sometimes drastically.

Medicine isn’t the only industry bolstered by technology of course, but in an era where “smart wearables” is legitimate terminology and not something plucked from an Asimov novel, it’s one of the job sectors where we find technical innovation at its most nascent. Each year, small innovations, tweaks and upgrades take complicated medical tools and processes and streamline them for patients and physicians. Electronic aspirin? Ouchless Digital vein finders? 3D-Printed skin? That stuff is as real as the driverless cars they'll be trundling off the production runways soon, just you wait!

The thing about technology though, not just medical technology but in any specialty, is that innovation doesn't occur in a vacuum. It's expensive and time intensive, and in a job space where said technology directly and indirectly influences a person's wellbeing, must satisfy numerous QA details before receiving approval. To put it bluntly, this is a good principle. The last thing we want is some untested piece of medical equipment being trotted off the factory floor. However, there's a caveat to this idea, one for which many in the industry have become critical of what they feel is an “unnecessarily complex approval process” from the Medical Device Innovation Consortium (MDIC). As it stood in 2013, most critics stated that the over complicated approval system “impeded” medical innovation and literally stunted the availability of quality health care to those who need it. To combat these negative assessments, the Food and Drug Administration (FDA) announced a “rebranded” MDIC and vowed to simplify the approval process, gather information from industry heads, government officials and nonprofit organizations, and to prioritize the regulatory science of approving technology.

By gathering all these industry thought leaders to collaborate and leverage their individual resources, \"MDIC may help the industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost,\" said Jeffrey Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health.

This conscious rebranding has put many in high spirits, anxiously awaiting the promising medical technologies and streamlined medical processes to come, theoretically faster, which will reduce obstacles and anxieties and improve the capacity and scope of health care. 

Mobile Tech

In today's climate where medical innovation receives mainstream attention from every angle, including commercial outlets, we should note the developments of one specific technological subset, one that's been growing exponentially despite MDIC holdups: mobile technology.

As we anticipate new medical technologies to come, let's acknowledge the developers, code-monkeys and innovators seeking to make medicine a better place, on both patient and physician sides, on our pocket-sized computers. 

Figure 1 

Seeking to see or learn about rare or not so rare conditions? Figure 1 offers a great app that allows physicians to view and share medical images with other physicians.  Figure 1 touts hundreds of thousands of users send, comment, and search medical images within its database. The app is fee to download and use. Worried about HIPPA compliance? The app guarantees patient privacy with face-blocking and removal of other identifying information.  

Doximity 

One of the primary holdups in medical app development, as well as medical work on public social media, are the HIPAA implications that accompany contacting patients outside of the office and relative vulnerabilities that come with transferring data. Essentially, Doximity is a physician sanctioned and designed social network that currently claims 80 percent of the U.S. physician workforce as members. 

It's a platform for users to communicate with fellow physicians on the network, sharing medical specific information, work accomplishments, sending HIPAA secure faxes and also follow trends and developments within their specific medical specialty. The opportunity to communicate smoothly and with all your contacts consolidated into one easy-to-use platform, along with the protection of HIPAA lends a tremendous amount of utility to the app, as well as an indicator for things to come. I mean, do you really think physicians will still use pagers in 10 years?

QXMD Calculate 

Physicians seeking an app that can consolidate all their medical calculation software into one digestible format may find what they're looking for in QXMD Calculate. It utilizes a sleek user interface which highlights point of care tools like cardiology, internal medicine, nephrology, general practice, hematology, gastroenterology, emergency medicine, oncology, orthopedics, respirology, neurology and many more, while serving to help physicians make quality diagnoses towards treatment and prognosis determination. 

It bills itself as more than a simple \"calculator\" but more a \"decision support tool\" which features 150 unique calculators and support prompts, freely available to the medical community. Furthermore, it's a veritable library, integrating seamlessly with PubMed data for physicians and tomes upon tomes of peer-reviewed medical journal information for cross-referencing and citation. 

With such utility and scope, and a non-existent price tag, QXMD is the kind of app that strictly qualifies as \"must have\" for physicians in any specialty.

Health Tech

Whether it's shiny, new technology that shapes the way we administer shots, or that simply puts physicians in secure contact with other physicians, mobile software is continually the most promising frontier for medical technology innovation. It's the kind of technology that makes physicians more capable and patients more empowered, the very tenants upon which medical innovations are built. 

Citations

Erbs, Chris Duffey and Katie. \"10 Ways Mobile Is Transforming Health Care.\"

Business Insider. Business Insider, Inc, 09 June 2014. Web. 14 Apr. 2015.

Honigman, Brian. \"7 Need to Know Apps for Healthcare Professionals in 2014.\" 

GetreferralMD. Get Referral MD, 14 Oct. 2013. Web. 14 Apr. 2015.

Hussain, Iltifat. \"The Best Medical Apps Released in 2014.\"

Imedicalapps.com. Imedical Apps, 30 Dec. 2014. Web. 14 Apr. 2015.

MacRae, Michael. \"Top 5 Medical Technology Innovations.\" 

ASME.org. ASME, Mar. 2013. Web. 14 Apr. 2015.

DYLAN J. CHADWICK

Staff Writer, Physicians Office Resource.

Thursday, July 18, 2019

by BRIAN R. DOOLEY

Patients have a lot of choices when it comes to physicians.  Making sure your online profile is up to date, complete, and contains these five items will improve the chances that a website visitor will become a patient.

Create a personal connection. Having good rapport with patients is important, and that process starts before patients ever walk in the door.

How often have you seen a physician bio that only contains a single, humanizing detail in the last sentence: “Dr. John lives in Washington, DC with his wife, Karen.”  Some physicians may be hesitant to provide personal info, that shouldn’t stop you from sounding personable in your profile.

To create a stronger chance of a connection, providers should consider adding interests and activities outside of work: “When he’s not at work, Dr. John enjoys cheering on the Chicago Cubs,” with a small photograph of him and his family at the ballpark.

Another consideration to sound more personable is to include quotes and conversational language in your profile.  Instead of saying, “Dr. John specializes in kidney stones,” include a quote that says, “I treat a lot of patients with kidney stones.  They can be really painful, but we have several treatments available that can provide relief in a matter of hours.  One of the best parts of my job is seeing the look of relief on a patient’s face when their pain has disappeared.”

Professional photo. For under $200, you can find a local photographer that can take a professional headshot for your profile.  This picture will be viewed thousands of times and may last several years, so it’s worth the minimal investment upfront to make sure it’s nice.

Patients often make judgments, fairly or not, about the quality of medicine based on appearances.  Make sure your appearance is top-notch.

It may seem trivial, but make sure you’re smiling in your photo.  Much research has been done on the power of a smile to increase trust, which is imperative in the doctor/patient relationship.

Special training, specialties, areas of interest. If you have special training or expertise in an area, be sure to include it in your bio.  Patients prefer to see someone who has advanced knowledge or expertise that can help them.

If you’re just getting started and have a preference for certain disease states, include that in your profile.  It will help steer the patients you want into your practice.

Awards and recognition. Honors like, “Doctor of the Year,” and “Best Plastic Surgeon — Chicago Tribune,” are beneficial to include in your online profile.  Having “MD” or “DO” behind your name builds authority, and adding awards and recognition will build even more.

Location and contact information. Most providers will have a separate contact page, but in addition to that, each provider profile should have their location and contact numbers.    Especially if they practice at more than one location.

This makes the patient experience more seamless.  A provider’s profile page will likely be the first Google result for their name, and contacting that physician for an appointment or question are among the most common reasons patients visit a medical provider’s website.

Call to action. For most providers, the logical next step is to request an appointment with the provider.  To make this easier on the patient, the call-to-action should be very clear.  It might be an appointment line phone number immediately after the bio, a “Book Now” button that takes you to an online form and contact info, etc.  It should be immediately obvious to the patient what they should do next.

Implementing these points in your physician profile will put you in the top tier of providers who have taken the time to improve the message they are sending to prospective patients.

BRIAN R. DOOLEY

Brian Dooley is an expert in Digital Marketing,  Reputation Management, and the Founder of Independence Digital – a marketing firm for medical practices.

Thursday, July 18, 2019

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

The convergence of two powerful forces are changing the practice of laboratory medicine in ways never imagined a generation ago.  These twin forces are the movement to value-based healthcare from the fee-for-service model and the rapid development of mobile technology allowing for continuous healthcare monitoring of patients beyond the clinical setting.

The central focus of value-based medicine is increasing the value of medical services provided for patients based on the health outcomes achieved per dollar spent. The goal is to achieve good outcomes efficiently. This is the most effective way to truly contain health care costs.  Achieving and maintaining good health is inherently less costly than dealing with poor health; reminiscent of the old adage “an ounce of prevention….”

Laboratories can impact the value proposition by increasing the speed and accuracy of correct diagnoses, monitoring patient health to prevent disease, providing rapid turnaround times that allow reduction in length of hospital stays, and promoting the most appropriate test selection options with applicable interpretations in order to help avoid adverse events and point to the most appropriate treatment protocol. Translating concept into practice, however, can be challenging. Generally, the biggest hurdle is obtaining the necessary data, which must be in the right format and of sufficient quality for decision-makers to gain the medical information they need.

This is why Point of Care testing (POCT) has become the fastest-growing area of laboratory medicine; bringing laboratory testing conveniently and immediately to the patient. The new technology is the merger of molecular biology, information technology, and biomedical engineering. POCT increases the likelihood that the patient, physician, and care team will receive the results sooner, which allows for immediate clinical management decisions to be made. With fast turnaround times and portability to a variety of settings, POCT offers many advantages for disease management. It enables migration of testing from core hospital labs to specialty-care units, doctors' offices, retail settings, and homes to provide access to healthcare services, thus improving patient compliance, reducing hospital stays, and lowering overall healthcare costs.

It is this need for immediacy in data collection and dissemination that is further driving mobile technology past POCT to wearable devices that monitor everything from glucose levels to cardiac function. This cuts costs, as well as increases connectivity and provides the platform for shared medical data in real-time.

This system allows patients to be constantly followed, alerting them and their providers when health issues are amiss. We are moving rapidly from POCT in the context of portable bedside devices run by medical personnel, to portable devices run by the patient, and now, wearable devices worn by the patient for continuous monitoring. These are fed back to healthcare providers, information is tracked on a continuous basis, allowing assessments of the effectiveness of medication and treatment.

Wearable Digital Technology:  Coming to a Joint near you

This new mobile technology is based on the same mobile platforms for smartphones and tablets. It is expected that mobile technology will enable virtually universal quality, cost-effective, preventable healthcare even in lesser developed countries, in much the same way that mobile phone technology has allowed countries to leapfrog beyond land-line phones to the cell phone era and all its possibilities.

It is now clear that the technology industry sees medicine as the next frontier for exponential growth. Companies such as Apple, Google, Microsoft and Samsung and hundreds of start-ups also see the market potential — and have big plans. This is happening because several technologies such as computers, sensors, robotics, and artificial intelligence are advancing at exponential rates. Their power and performance are increasing dramatically as their prices fall and their dimensions shrink.

We will soon have sensors that monitor almost every aspect of our body’s functions, inside and out. They will be packaged as wearables, as watches, adhesive bandages, clothing, and contact lenses. They will be in our toothbrushes, toilets, and showers. They will also be embedded in smart pills that we swallow. The data from these will be uploaded into cloud-based platforms

Artificial intelligence-based apps will constantly monitor our health data, predict disease and warn us when we are about to get sick. They will advise us on what medications we should take and how we should improve our lifestyle and habits.

All this will translate to improved patient care through patient-centered preventive medicine at reduced cost, and to the more efficient treatment of both acute and chronic illnesses; the very definition of quality care.

A report by PricewaterhouseCoopers’ Health Research Initiative (HRI) evaluated the benefits of wearable digital technology and devices. These include:

1. Moving diagnostic testing of basic conditions into the hands of patients: Close to 42% of physicians are comfortable relying on at-home test results to prescribe medication.

2. Increasing patient-clinician interaction: Half of physicians said that e-visits could replace more than 10% of in-office patient visits, and nearly as many consumers indicated they would communicate with caregivers online.

3. Promoting self-management of chronic disease using health apps: 28% of consumers said they have a healthcare, wellness, or medical app on their mobile device, up from 16% last year.  Nearly 66% of physicians would prescribe an app to help patients manage chronic diseases such as diabetes.

4. Helping caregivers work more as a team: 79% of physicians and close to 50% of consumers believe using mobile devices can help physicians better coordinate care.

It’s clear from HRI’s report that major stakeholders in the healthcare industry including hospitals, insurers and the pharmaceutical industry all believe that major changes will occur in how healthcare is delivered.

However, there are several potential barriers that may inhibit or delay the implementation of this new paradigm of healthcare. These include issues of security, privacy, consumer consent, data-sharing, fragmented workflows, and digital buy-in.

The Impact of Mobile Technology on the Laboratory

These trends portend a future of value-based medicine involving widespread use of remote monitoring of almost everyone, throughout their lives: preventive medicine to spot health issues before they arise (for example, based on genomic studies showing potential for disease occurrence), as well as for ongoing monitoring of chronic medical conditions.

One of the key areas of laboratory to physician communication is that of reporting critical values. Since critical values are defined as abnormal test results that are potentially life-threatening and require a rapid response from caregivers, any steps taken to improve this process impacts the quality of patient care.   This not only refers to the timeliness of reporting test results but ensuring that these results reach the intended physicians no matter where they are; and that the information sent and received is secure.

Thanks to the rapid spread of mobile technology, including mobile phones, pagers, pads, and computers linked to electronic health records, new more secure messaging systems to report critical values are available.  These systems offer security that normal cellphone text messaging lacks, and their two-way capabilities automate the kind of closed-loop system that patient safety experts have advocated. These mobile-friendly applications can keep critical results from falling through the cracks. They create an audit trail of message sending, delivery, and receipt, and labs can configure software that escalates an alert when the initial caregiver does not respond in a timely manner.  The application of mobile technology to real-time patient monitoring using wearables synced to mobile phones, enables the immediate transmission of any detected critical values to the laboratory’s electronic health records system (EHR.), and the physician notified immediately.

As wearable technology and devices proliferate, clinical laboratorians must be prepared to process the data received from these varied sources, including new types of information, such as real-time patient locations and environmental factors during data collection.  This data must be organized, stored and transmitted to the attending physicians and /or patients directly in as timely a manner as possible.   

As a result, laboratories will not only remain centers of actual testing but become huge database handlers as well.  Direct access to patient test results by the patients themselves opens up another huge highway of interaction with the public; another huge challenge to meet the demand for data.

Artificial intelligence-based apps will constantly monitor our health data, predict disease and warn us when we are about to get sick. They will advise us on what medications we should take and how we should improve our lifestyle and habits.

The appellation “data central” may not adequately describe the level of importance that laboratory medicine will have, where data handling may well win the competition for space with diagnostic instrumentation.

As value-based healthcare becomes the prevailing model for healthcare delivery, laboratory testing will be focused on prevention, diagnosis, and the management of chronic diseases. In this scenario, the cost of the test versus reimbursement will not be the deciding factor on whether to perform the test. Instead, the focus will be on what it can save the patient and the entire organization by enabling early detection.  The increased application of digital mobile technology advances this goal.

The paradigm shift in healthcare from episodic care to chronic-care management; from reactive to preventive care, represents a once-in-a-generation opportunity for proactive laboratories to redefine their value in a new, much larger role as integrators of critical clinical information and decision support.

References:

¹ Medical Laboratory Observer (MLO) January 2011. POCT key to widespread access to healthcare. Glorikian, H. Rajan, A. and Xie.K.

²Health Care Revolution, Starting with your Wrist.  Wadhwa.V.,  March 24, 2015.

http://amestrib.com/opinion/ vivek-wadhwa-health-care-revolution-works-starting-your-wrist/

³ Ibid.

⁴ PricewaterhouseCooper (PWC)  Health Research Institute. The Wearable Life 2.0 Connected living in a wearable world. Consumer Intelligence Series. https://www.pwc.com/ee/et/publications/pub/pwc-cis-wearables.pdf

⁵ B. Malone. The Dilemma Surrounding Critical Value Reporting.  Dec. 1 2012.  AACC. Clinical Laboratory News.   https://www.aacc.org/publications/cln/articles/2012/december/critical-value-reporting.aspx

⁶ Disembodied Devices.  AACC Clinical Laboratory News. Miller, J. May 1, 2019

⁷ K. Futrell.  Orchard Software Whitepaper: The Value of the Laboratory in the New Healthcare Model.  Diagnostic Information: The New Currency in the Future of Healthcare. July 2013.   http://www.orchardsoft.com/files/white_paper_value_lab.pdf

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

Thursday, June 20, 2019

by BARRY CRAIG

Q: What would you consider the top 5 criteria for someone choosing a chemistry analyzer for a POL running tests for 5-10 family practice or internal medicine providers? In working on this process I've been comparing the CV's for Proficiency testing for analytes on two systems. One is a system that has hundreds of sites; the other has fewer than 20 in their peer group. Do CV values become more significant with bigger peer groups?

A: My top five criteria for choosing an analyzer may not be everyone’s view, but here goes.

1. Service – How good is their 1-800 service? Do they answer promptly? Do they guarantee a service or repair call within 24 hours of notification? Are the repair people employees and factory trained or are they “contracted” repair people with no affiliation to the company that makes the instrument? Are parts readily available or do you sit for weeks waiting on a part from China?

2. Cost – How does the instrument, reagents, calibrators, and controls cost compare to others in the market? The cheapest may be cheap for a reason. How much will the service contract cost once the warranty runs out?

3. Performance – As the question suggests, look at the performance of your proposed instrument by examining its performance on PT testing. How well does it score to comparable instruments? Does it have only a few units in use or hundreds? The more units in use, the better it should score on the PT events. Even if only a few units are listed, look at the performance first. Fewer units doesn’t mean it is not a well-made instrument, it may just be newer to the market. Ask for references for sites already using the instrument. Try to find units in use independently and not who the sales guy suggests you call.

4. Ease of use – Does it have a multitude of maintenance steps daily? Does it require constant replacement of tubing, filters, etc.? Does the instrument program easily or do the operational steps take a lot of time? How thorough is the training for the instrument?

5. Reliability – Check with as many sources as possible to determine the “downtime” factor. It does not matter how pretty it is, or how cheap it is if the machine is not working. Not running means not billing. Check with the sales guy, the company that makes the machine, anyone who can help you find units that have been in operation for a while.

Q: We have been using small chemistry analyzers for several months but due to the cost of cartridges and small profit margins we are looking to expand our lab to a larger analyzer and add hematology to our lab. I am gathering information on what my best options are. If you have any suggestions, please let me know.

A: You should always look at your current test volume. If you are only running a small volume now or sending out a small volume to a reference lab, you may not have enough testing to warrant purchasing a larger unit or adding testing such as CBCs.

Figure out your break-even point on cost and then look at how many tests you actually send out or perform.

Remember, you cannot suddenly increase your number of test. The send out history will tell the tale of whether you need to move up, stay pat, or fold.

BARRY CRAIG

Owner, Laboratory Consulting, LLC. Regulatory compliance consulting for CLIA, COLA and CAP laboratories. Specializing in urine drug testing laboratories.

Thursday, June 20, 2019

by TERESA A. SCOTT, MT(ASCP)

According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers' instructions for performing the test.”  This is also a requirement for non-waived testing.  Many people think that they are fulfilling this requirement if they follow the step-by-step procedure for the test process included in the instructions.  However, there is much more involved than just following the procedural steps.

Manufacturer’s instructions are found in instrument operator’s manuals and in package inserts; however, this article focuses on the instructions found in package inserts.  In addition to the procedural steps, the package inserts include information and instructions for 

• specimen collection and handling;
• reagent and test kit storage and expiration; 
• quality control;
• expected results and interpretation of these results;
• test limitations, precautions, and warnings; and 
• other pertinent information that affects the quality of test results.  

Inaccurate and unreliable test results may be obtained if the instructions are not followed.  Also be aware that   any modifications or changes may result in changing the test system from waived to high complexity.  Then, the certificate of waiver no longer applies, and all of the high complexity requirements (including Personnel eligibility requirements and responsibilities, Proficiency Testing, and Quality Assessment, etc.) will have to be met.

Package Insert

To follow the manufacturer’s instructions, you should understand every aspect of all package insert sections.  Depending on the manufacturer, the sections will have different titles, but all of the following information should be available in the package insert.  To be aware of all the information, it is imperative that you read the entire insert prior to performing patient testing.

Throughout the rest of this article, each section includes a description of what you can expect to see in the package insert and at least one example of how that information may be presented.

Test Procedure

The test system package insert will contain a step-by-step procedure of how to complete the test.  Depending on the manufacturer, specimen collection and other pre-analytic actions may be included.  

1. Read all instructions prior to performing patient testing.
2. Assemble all necessary materials.
3. Insert test strip into meter, with the sample collection area facing to the left, away from meter.
4. Apply a single drop of whole blood to the test strip “sample collection” area.
5. Compare the “test reaction” area to the meter’s color chart exactly 60 seconds after blood drop is applied.

Package inserts for reagents, cartridges, test strips, etc. may list only the steps that involve these products.  Some may not state any procedural steps, opting instead to refer the user to the test system package insert or the instrument manual.  

Specimen Collection and Handling

Tests may be designed for one type of specimen (e.g. whole blood) or several different types (e.g. whole blood, urine, throat swab, etc.).  The package insert will state this as well as how the specimen should be collected, handled, and stored.  Conditions that would cause specimens to be unsuitable for testing and any timing constraints will also be listed.  

This test is performed on whole blood, collected in an EDTA-anticoagulated tube (lavender top).  Following collection, specimens should be stored at room temperature for no longer than 8 hours.  If testing cannot be completed within 8 hours, refrigerate specimens at 2-8°C for up to 48 hours.  Clotted specimens should not be used for testing.

Reagents

Package inserts for test kits will list the reagents included in the kit.  They may also list other materials needed to perform the test, dividing them into two categories: materials supplied in the kit and materials needed but not provided.  Storage conditions, special handling requirements, and expiration dates for the test kits and the individual reagents will also be listed.

This package contains only reagent test strips.  A test strip reading meter, alcohol wipes, gauze pads, and skin-lancing devices will be needed to perform testing, but are not included in this package.  

Test strips must be stored in their original container, with the lid tightly closed, to protect them from moisture.  Store at 22-30°C and protect from humidity and temperatures beyond the stated range.  When proper storage conditions are maintained, the test strips are stable until the expiration date stamped on the container label. 

Quality Control

Pay special attention to this area of the package insert since it is the section that is most often overlooked.  Many testing devices have internal controls built-in as part of the test.  However, just as many require some sort of external quality control to be run at specific intervals: once each day, once each shift, with each new shipment, the first run of a new lot number, etc.  The package insert will list the type(s) of controls to test as well as when to test these controls.  Controls must be performed as required by the manufacturer.

Prior to reporting patient results, you must 

• Perform all required QC;
• Review QC results to ensure they are acceptable;
• Document that QC has been run, reviewed, and is acceptable.

Do NOT report patient results if QC results are not acceptable.  Instead, investigate the cause of the QC failure, perform the necessary corrective actions, re-run the controls, and document everything.  Do not report patient results until the problem is identified and corrected, and QC results are acceptable.  If the problem cannot be identified and/or corrected, perform testing by an alternate method, which may include sending the specimens to another laboratory for testing.

The ABC test system automatically runs a comprehensive set of quality checks of analyzer and cartridge performance each time a sample is tested.  This internal quality system will suppress results if the analyzer or cartridge does not meet certain internal specifications.  If the analyzer or cartridges have been compromised, results may be persistently suppressed and one or the other must be replaced to restore normal operating conditions.

Since storage and shipping conditions vary, external controls (normal, high, and low) must be run on each new cartridge shipment and each new cartridge lot number.

Expected Results and Interpretation of Results

Qualitative tests verify the presence or absence of the analyte.  Quantitative tests will produce numeric values that have to be compared to a reference range to determine if the result is normal or abnormal.  When applicable, the package insert will list reference ranges for different types of patients.  For example, the reference range for men may be different than that of women, or the range for adult patients may be different than that of pediatric patients.  If the test system has been approved for different types of specimens, expected values for each specimen type would be listed as well.

In some instances, the reported result is in a different format than the value obtained through testing; that is, the test result has to be interpreted before it is reported.  The information in these sections of the package insert will help you determine what to report and how to report it.

The XYZ test system is very sensitive to technique; thus each laboratory should establish its own normal range based upon its own techniques, controls, equipment, and patient population.  The sample can then be classified as negative, weak positive, or strong positive.  

The following can be used as a general guideline.

The interpretation could be nothing more than verifying that the test result falls within the instrument’s reportable range.  If it does not, the result would be reported as “less than” or “greater than” the range limit.  Since most instruments suppress or flag values for results that fall outside of this range, the interpretation is relatively simple.  

Tests that rely on color change can be more difficult to interpret, especially if it is left to the human eye to determine the amount of change.  The timing of the color comparison can also greatly affect result interpretation.  Some colors may diminish quickly after the reaction occurs, while others may be enhanced over time; either will cause inaccuracies in result interpretation.  In most cases, automated systems are available to simplify this interpretation.

Research studies performed to determine this data may be included as additional information in this section.

Test Limitations, Precautions, and Warnings

The information included here varies greatly and may include:  

• Hazardous reagent ingredients 
• Sodium Azide, used as a preservative, is a poison and may be toxic if ingested or absorbed through the skin.
• Safety precautions
• Always wear gloves when handling reagents.  If skin comes in contact with reagent, flush exposed area by holding under cold running water for 10 minutes.
• Substances that interfere with testing
• Reagent bubbles may interfere with proper detection of reagent level in the cartridge.  If present, remove air bubbles with a clean applicator stick.  To minimize volume depletion, do not use a transfer pipette to remove the bubbles.
• Patient conditions that may interfere with testing
• Patients receiving peritoneal dialysis using solutions that contain icodextrin should not use the KLM test system, since the dialysis solutions may falsely raise blood glucose results.
• Limitations on test performance
• Performance characteristics have not been established for specimens other than whole blood.  Reference ranges have not been established for neonates, infants younger than 2 years of age, or pregnant women.

This is by no means a comprehensive list and further serves to stress the importance of reading the entire package insert.

Other Pertinent Information

The information included in this area also varies.  What is considered “pertinent” depends upon what is in the package.  Test kits will have different information than control materials.  Reagents, test strips, and test cartridges will have different information than hand held meters.  Possible package insert section titles include:

• Intended use
• Explanation of the test
• Principles of the procedure
• Instrument calibration
• Performance characteristics (reference range, specificity and sensitivity, accuracy and precision)
• Method comparison
• Important information
• Technical information

As with the last section, this is by no means a comprehensive list.  Again, it only serves to stress the importance of reading the entire package insert.

Manufacturer’s instructions must be followed whether the test is waived or non-waived.  Waived tests, by definition, “employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible.”  However, this is only true if all of the manufacturer’s instructions are followed.  

TERESA A. SCOTT, MT(ASCP)

COLA Education Division Medical Technologist

Thursday, June 20, 2019

by DYLAN J. CHADWICK

In a changing medical landscape, physicians willing to invest in their practices are the ones who'll succeed. Though evolving technology and its subsequent improvements in patient care have brought substantial changes to the medical sector, an era of economic uncertainty and fiscal instability may wring just as prescient an effect. According to an article by Ben Brown, MD, reductions in Medicare contract payments (some as much as 21.3%) and physician reimbursements from insurers might result in critical decreases in physician salaries, medical profits and general revenue for a practice. What proves even more concerning for physicians and patients alike, is a present medical landscape of high healthcare costs, an ever-increasing need for healthcare options and diminishing resources. Furthermore, caring physicians want to be effective providers for their patients, but they also want the appreciation and financial compensation for their profession demands.

In this regard, many physicians, Urologists, Oncologists, Gastroenterologists and Dermatologists for example, have made conscious efforts to optimize their practices in an effort to generate other streams of ancillary income. One specializing measure has been opening in-office testing labs (POL's) directly at their office location. These labs, carefully stocked and equipped to run routine (but important) procedural tests, provide real life \"one stop shop\" scenarios for patients with busy schedules and limited funds, and can quickly develop into thriving profit centers for small practices...but before opening up a lab, let's talk some basics.

Physicians have a number of options when it comes to medical testing. The first, and least efficient, is for them to refer patients to a hospital or an off-site lab for their tests. This method, though convenient for practices with a high volume of appointments, generally proves inconvenient for the patient, who has to make additional trips for a singular medical problem. Additionally, it yields a low (virtually non-existent) financial return for the physician.

Another \"off-site testing\" option for physicians is to take the samples in the office, and then send them to an off-site lab for analysis. Commercial Reference Labs (CRL), like Quest Diagnostics, Laboratory Corporation of America Holdings and Bio-Reference Medical Labs, have carved a space in physician circles as adept facilities that aid practices by doing the testing work for them. Still, the method is not without its downsides as it creates another process \"step\" for physicians who must take the test samples in-house, and then send them off-site before a further diagnosis can be made. Turn-around times increase as patients and physicians wait for their samples, shipping expenses must be considered and again, since Commercial Reference Labs are compensated for their lab work, financial returns for the actual physician are low. 

In the immediate sphere, these off-site methods may take stones from practices' proverbial backpack as they're \"freed up\" to see more patients, but in more pressing ways they're potentially yanking dollars from a practice's proverbial wallet. 

Bringing testing in-house increases a practice's potential to make more money, and per a hightable article by Ken Powell, the Physician's office lab is a sector forecasted to grow 10-15% in the following decade.

A viable route for physicians is to run the testing themselves using products that have been specifically waived by the Clinical Laboratory Improvement Amendments (CLIA). Established in 1988, the CLIA sets standards and issues certifications for clinical laboratory testing, with an emphasis on ensuring accuracy, reliability and timeliness. Using CLIA waived products keeps the testing in-house, and can generate much-needed revenue for a physician by steering testing and procedural fees directly to the practice. However, testing done on CLIA waived products isn't always the most extensive and can be limited in scope.

In an effort to generate additional income for their practice, and to create an efficient and all-encompassing experience for their patients, physicians may be better advised not to stop simply at CLIA products, but to establish an entire CLIA certified lab in their office. 

In his article Oncologists Advised to Build Their Own In-Office Clinical Labs Michael McBride cites an anecdote by Tim Dumas, a lab scientist and POL consultant, when he says \"someone's going to run and get paid for these tests. It might as well be you.\" In the article, Dumas references a three doctor Oncology practice in Raleigh North Carolina that generates an additional $400,000 annually with their own Physician office lab. He even predicts that a ten to twelve doctor practice can look at $7-800,000 a year in additional revenue if they implement such a facility.

Besides the extra cash flow, in-house Physician Office Labs usher in various benefits for small and mid-level practices. For one, waiting games and turnaround time between specimen collection, analysis and patient follow up are diminished. Since tests don't need to be sent out, appointment is maximized and the practice becomes more beneficial both to the patient and to the physician.

Besides adopting the role of a practice’s lucrative profit center, Physician's office labs will help practices save money. Tim Dumas goes as far as to accuse practices of \"wasting revenue\" when they \"decide not to install their own physician's office lab.\" He contends that a practice can save anywhere from $100,000 to $1 million (depending on the size) simply by the cut expenses that an in-house lab espouses.

That's not to say that establishing an in-house Physician's Office Lab doesn't have its own set of costs that a practice must take into account. For one, it will require a CLIA certification (approximately $1,200). Depending on the type of practice, it will also require specialized equipment and a space in which to house it. Physicians must make their own decision whether to purchase equipment or to lease it, but Dumas insists that leasing it is cheap and cost effective. Finally, a well-oiled Physician's office lab requires a competent staff of specially trained individuals (the number depends on the size of the lab) and a competent medical lab manager (approximate salary of $75,000 a year) to oversee the testing.

Though hefty, they're necessary expenses and serve multiple worthwhile purposes. For one, specialized staff ensures accuracy and efficiency in testing, and a CLIA certification will protect practices from any legal red tape. Additionally, by putting concentrated amounts of time, effort and resources into their Physician's Office Lab, practices make their lab more attractive to managed care organizations (MCOs) and insurance companies. Subsequently, these organizations are far more likely to give generous reimbursements when they're assured that a POL promotes customer satisfaction, emphasizes quality and generally has effectiveness and efficiency in their top priority.

While many physicians might seek to avoid what Michael Sanders MD calls the \"headache\" of dealing with CLIA, MCOs and the insurance companies, a top notch Physician's office lab has far more advantages than it does hindrances, and the financial benefits far outweigh the expenses. For example, a standard CBC test for an oncology practice usually costs around $1 to run, but the insurance reimbursement is around $10. After deducting the fixed costs of the lab, profits become substantial, even more so for tests like CEA, CA 125 and CA 27-29 which cost between $3-4 to run and receive insurance reimbursements of $20-30 each.

From simplifying the overall patient experience to whipping together an ancillary stream of income for a practice, it's win-win on all counts. \"A practice is at its most efficient, when it's generating revenue,\" says Tim Dumas. Though it will take effort to get started, the returns will come quickly and practices will come upon their destination, be it financial success, an increase in disposable revenue or a better patient experience, much quicker and more seamlessly with one than without.

References:

Brown, MD, Benjamin. \"The Deceptive Income of Physicians.\" The Deceptive Income of 

Physicians. 20 June 2010. Web. 14 May 2012. 

<http://benbrownmd.wordpress.com/>.

Chesanow, Neil. \"Business of Oncology: An Office Lab Can Turn a Tidy Profit.\"Medscape. 22 

Feb. 2011. Web. 14 May 2012. 

<http://www.medscape.com/viewarticle/737426>.

McBride, Michael. \"Oncologists Advised to Build Their Own In-Clinic Medical Laboratories.\"  DARK Daily Laboratory and Pathology News. 30 Mar. 2011. Web. 14 May 2012. 

<http://www.darkdaily.com/oncologists-advised-to-build-their-own-in-clinic-medical-laboratories-33011>.

Powell, Ken. \"Physician Office Market Re-Discover Diagnostic Testing Revenue Opportunities.\" 

Physician Office Market Re-Discover Diagnostic Testing Revenue Opportunities. High Table Clinical Diagnostics. Web. 14 May 2012. <https://www.hightable.com/clinical-diagnostics/insight/physician-office-market-rediscover-diagnostic-testing-revenue-opportunities-53269>.

Wolfe, Marleen, and Gary Wolfe. \"Physician's Office Laboratories: How Viable Are They?.

March 2004. Clinical Lab Products.\" Physician's Office Laboratories: How Viable Are They?  Clinical Lab Products, Mar. 2004. Web. 14 May 2012. <http://www.clpmag.com/issues/articles/2004-03_01.asp>.

DYLAN J. CHADWICK

Staff Writer, Physicians Office Resource.

Wednesday, May 22, 2019

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities.  CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.

However, it is important to realize when considering modification of a test procedure that the modified use of a test system defaults the test to the high complexity testing category under CLIA regulations, and as a result, the testing site must meet all applicable CLIA requirements for high complexity testing. These requirements include establishing performance specifications that validate that the LDTs and the modified standard methods are fit for the intended use and that the lab has personnel qualified to perform high complexity testing. Thus, decisions to modify test procedures or use must be made with full awareness of the consequences for the laboratory operation.

What does test system “modification” mean?

Modification means producing results via test systems not yet approved by the FDA; as well as applying these test results in a way other than that described in the intended use, precautions, limitations, or other sections of the manufacturer’s instructions.  

Modifications to existing FDA-approved test systems include:

1. Using instruments/kits for testing that have not received approval from the FDA for use in the United States, even if widely used in other countries.

1. Using reagent/instrument combinations that do not have FDA approval. This might mean using reagents from manufacturers different from those of the instrument, and which are not listed by either the instrument or reagent manufacturer as approved for use by either.

1. Deviating from manufacturers’ directions for performing the tests.

1. “Off-label use”:  utilizing the test in a manner not yet approved by the FDA. 

A special note about “Off-label Use” of waived blood glucose monitoring systems:

Using a waived blood glucose monitoring system  (BGMS)  to test a patient whose hematocrit or oxygenation level is above or below the range indicated in the manufacturer’s instructions would be an example of an “off- label use” of this system.  Results of blood glucose testing in this situation may lead to clinical interventions that could cause patient harm.  If the patient’s hematocrit and oxygenation level are within the manufacturer’s stated limits, then performing a glucose test using the waived glucose monitoring system would not be considered off-label testing and the test system would still be considered waived.

(New) Laboratory Developed Tests (LDTs)

In the past, these have also been referred to as “in-house” tests. These are tests that have been developed, evaluated and validated by the laboratory itself. Often, a laboratory will choose to develop and use an LDT because a commercial test is not available to meet their needs. LDTs generally have not been subjected to FDA oversight because these diagnostic tests are never sold to other laboratories or hospitals. Historically, LDTs comprised a relatively small volume of testing intended for use in diagnosing rare diseases or to meet the specific needs of a local patient population. 

There can be several reasons why a commercial test has not been developed for a particular analyte or disease of interest. For example, many LDTs are genetic tests developed for rare diseases. These are also diseases affecting only a small subset of the population, thus reducing the incentive for a manufacturer to develop a commercial version because the market for such a product would be small, without a potential decent return on investment. 

Even one modified test system will change your laboratory to a testing facility that must meet all applicable CLIA requirements for high-complexity testing

If your laboratory is CLIA waived, and you modify a waived test system, the modified test system must now meet all applicable CLIA requirements for high complexity testing.  These include added requirements for Proficiency Testing, the establishment of Performance Specifications, Quality Control, Quality Assessment, and adherence to high complexity personnel qualifications. Laboratories with a CLIA Certificate of Waiver (COW) that are using modified test systems will need to upgrade to a CLIA Certificate of Compliance (COC) or a CLIA Certificate of Accreditation (COA), if they continue to use modified test systems; this includes required biennial on-site inspections.     

If your laboratory is a moderate complexity CLIA facility, and you modify a moderate complexity test system, this test system also defaults to the high complexity testing category  and will require the modified test system to meet all applicable CLIA requirements for high complexity testing, including the establishment of performance specifications,  and adherence to high complexity personnel qualifications.  No change in compliance or accreditation certificates would be needed.

High Complexity Testing requirements include:

1. The Establishment of Performance Specifications

A key requirement of the CLIA regulations for all laboratories that modify an FDA-cleared or approved test system is to establish (validate) performance specifications for that test system (i.e., accuracy, precision, analytical sensitivity, analytical specificity including interfering substances, reportable range of test results, reference intervals and any other performance characteristic required for test performance).

The FDA requires that modified or lab-developed tests provide target values for test results and provide evidence for the expected ranges as well as information on test limitations and other factors that could generate false results. 

The validation results include a statement as to whether the method is fit for the intended use. The needs of the customer define the intended use of the method. If all the data quality objectives are met as indicated by the data collected, the method is considered as validated.

Note: State and local jurisdictions vary in how they regulate laboratory testing. Some have requirements governing testing, personnel licensure, or phlebotomy.   The person overseeing testing should ensure that all state and local requirements are met.   When state, local, and federal requirements are not the same, follow the strictest requirement that applies to your site.

Validation standards set by accreditation organizations may also meet or exceed those set by CLIA, including standards regarding evaluation of lab-developed tests.   Participating laboratories must meet these standards and criteria as well.

1. More Stringent Personnel Requirements

The personnel standards for high-complexity laboratories are appropriately more stringent than the requirements for moderate-complexity facilities. There are five positions that must be filled in high-complexity labs: 

A. Director; 

B. Technical supervisor; 

C. General supervisor; 

D. Clinical consultant, and 

E. Testing personnel.

A significant commitment in resources may be needed to fulfill these requirements if the laboratory is not a high complex facility already.

Detailed CLIA personnel requirements for high complexity testing can be found at http://www.mass.gov/eohhs/docs/dph/clinical-lab/clia-lab-qualifications.pdf

The decision: whether to continue using your modified or laboratory developed test procedure or not?

This requires you to perform a cost/benefit analysis, taking into consideration the following:

Does the modification of your test procedure change the complexity of your laboratory from waived or moderate complexity to high complexity? Is it worth all the attendant CLIA requirements for high complexity testing, including additional types of personnel, higher levels of personnel qualifications, more stringent performance specifications, additional quality control procedures, and even a new a CLIA classification for the laboratory?

If you are already a high complexity laboratory, consider the cost of establishing additional performance specifications, and the need for added personnel who are qualified to perform high complexity tests.

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

Thursday, May 09, 2019

by DUSTYN WILLIAMS, MD

Hypertension, or high blood pressure, is a leading cause of heart disease and stroke that has escalated to alarming rates in recent years, affecting nearly 1 in 3 adults in the U.S. In an attempt to reduce its prevalence, the Eighth Joint National Committee (JNC-8) released a set of hypertension management guidelines. However, various concerns arose regarding the recommendations and as a result, the American College of Cardiology (ACC) and the American Heart Association (AHA), along with nine additional specialty organizations, published an updated hypertension guideline in November 2017.

The ACC/AHA updates were driven by the JNC-8 report’s narrow scope of recommended treatments, which specifically focused on hypertensive patients without comorbidities. Since hypertensive patients frequently suffer from comorbid conditions, the guidelines led many to receive inappropriate or inadequate medications. In addition to the lack of focus on comorbid conditions, JNC-8 also dismissed beta blockers, which are necessary for isolated hypertension and embraced a “go-slow” treatment approach.

The newly released recommendations account for:

• Adjusting hypertension ranges and the initiation of therapy
• Setting ambulatory blood pressure monitoring as the gold standard for diagnosis and management decisions
• Prioritizing the treatment of comorbidities, such as diabetes, in a timely manner
• Using calcium channel blockers, diuretics, and ace-inhibitors as first-line agents after comorbidities are treated, or if none exist
• Treating patients with multiple medications as necessary if comorbidities do not exist 

Major changes in guidelines

Lowering hypertension-related blood pressure ranges was a significant adjustment in the ACC/AHA release, which will subsequently increase the number of patients classified with hypertension. Stage one hypertension systolic rates originally ranged from 140-159 and diastolic rates from 90-99, and are now set at 130 systolic and 80 diastolic. Stage two hypertension was altered from 160-179 systolic and 100-109 diastolic to 140 systolic and 90 diastolic.

While these new guidelines will lead to an increase in the number of stage one and two diagnoses, the change makes logical sense from a patient safety perspective. As hypertension exacerbates, it becomes more challenging to control. Thus, lowering the threshold for hypertension compels physicians to intervene earlier, ultimately slowing progression and resulting in fewer adverse events.

By lowering ranges, lifestyle interventions such as weight loss and adoption of a healthier nutrient intake can begin earlier in treatment plans. Not only does this help to eliminate the progression of hypertension, once diagnosed, it also facilitates increased patient engagement much sooner.

The decision to establish more lenient blood pressure thresholds was made in response to adverse patient events following aggressive treatment protocols — patients passing out from too much medication, for example. The commission failed to account for patients who benefit from higher blood pressures at rest, such as those who become hypotensive on dialysis or those with autonomic dysfunction that causes orthostatic hypotension upon standing. Further, JNC-8 assumed that hypertension exists on its own, thereby failing to recognize comorbid conditions that often more accurately direct anti-hypertensive treatment.

The recommendations also assumed that blood pressure monitoring could only be completed in the clinic, which left patients unmonitored and without critical support between clinic visits. Conversely, the ACC/AHA now strongly recommends ambulatory blood pressure monitoring, which can occur outside of the clinic if patients are supported with the appropriate tools, and tailoring the anti-hypertensive regimen to a patient’s comorbid conditions. While this is more complicated than the JNC-8 recommendations, the ACC/AHA guidelines are more appropriate, more accurate, and easily achievable with implementation of new technologies.

Leveraging technology to monitor blood pressure

The ACC/AHA recommends that patients with severe hypertension receive timely evaluation and drug treatment supported by patient monitoring and dose adjustments. Although it’s possible to remotely monitor hypertension and hypertension-related disorders, this process would require a tool that enables self-monitoring of blood pressure multiple times throughout the day. By allowing patients to self-monitor, they can effectively associate their symptoms or lack thereof with their blood pressure.

Telemedicine solutions offer promise in helping hypertensive patients record their blood pressure appropriately. Easily-understandable reminders can ensure that patients take the appropriate dose of medications at the prescribed time. As patients record data, providers must have the ability to aggregate and analyze the data and make titrations as needed. Small frequent titrations in blood pressure medications will allow for patients to rapidly reach treatment goals and prevent the occurrence of adverse events.

By centralizing communications, hypertension specialists can choose an optimal anti-hypertensive regimen for each patient based on their existing comorbid conditions. For example, a provider may prescribe beta blockers and ace-inhibitors for a patient with systolic heart failure, while avoiding beta-blockers as front-line agents and ace-inhibitors altogether for a patient with chronic kidney disease stage IV.

These solutions will also allow for individualization to occur in treatment. For instance, a telemedicine application can remind dialysis patients of the altered medication treatment plan on the days they receive treatment for their condition. If platforms adopt predefined hypertension regimens based on comorbid conditions, then provider organizations can achieve facility-wide standardization in hypertension treatments. Further, titration capabilities along with ambulatory blood pressure monitoring can provide patients with a sophisticated reorganization of blood pressure medications throughout the day, optimizing blood pressure rates and reducing adverse events, while allowing patients to manage their condition from the comfort of their own home.

As the ACC/AHA hypertensive guidelines align with the shift towards quality, health care organizations participating in quality programs may require more stringent blood pressure goals. To achieve these goals and ensure patient safety, it is essential that technology is leveraged to allow for tight control, real-time feedback and medication adjustments between clinic visits.

DUSTYN WILLIAMS, MD

Dr. Williams is the Co-founder and lead educator at OnlineMedEd, Co-founder at DoseDr, Clerkship Director Tulane Internal Medicine, LEAD

Thursday, May 09, 2019

by HEATHER HANSEN, JD

Twenty years of defending doctors and hospitals in medical malpractice cases has made me into a nervous patient. When you see the worst, you look for it. At least I do. That’s why when I was scheduled for a minor elective procedure, I was nervous. I set aside the day, canceling all of my depositions and planning to spend the day on emails and phone calls. My specialist’s office texted me to confirm the procedure date, which was a week away. Then I received an email from her office with the same date, but a different location. This made my med mal antenna go up, but I told myself to chill.

In the days leading up to the procedure I was traveling from NYC to San Francisco to teach, so when I hadn’t received any instructions I planned to call the specialist’s office the day before the procedure. When I did, the assistant informed me that my procedure was scheduled for that day, and to begin in an hour. Since I was in the green room at Dr. Oz at the time, this wouldn’t do. I told her that they had confirmed, by text and email, that the procedure was tomorrow. She didn’t apologize, but did reschedule me for one week later, on a Wednesday.

I asked her to send instructions for the prep. When I didn’t receive them by Friday morning, I emailed the office and asked for them. In response, I got an email with a messily scanned page of instructions. They said I couldn’t take Advil for a week before the procedure — I had taken Advil that morning. They said I needed an escort to and from the procedure — I hadn’t planned for that. I called the office, and the assistant said that I didn’t really need to avoid Advil and I didn’t really need the escort. I canceled the procedure. It was all too disorganized, impersonal and messy.

Minutes later, the doctor called me. She was very upset that I’d canceled my procedure because it messed with her schedule. I tried my best to remain professional in response to her unprofessional behavior. I wanted her to understand something. “Doctor, if I had any sort of complication as a result of this procedure, you’ve provided any good attorney with a way to pursue a case.”

I once heard a medical malpractice attorney who represents patients give a talk. He said “I look for damages. If there’s damages, I will take the case. I’m a good lawyer. I can create liability.”

Doctors make it easy for lawyers to create liability when they lack perspective, when they don’t have systems in place, and when they are just plain messy. Studies show that there is very little correlation between true negligence and lawsuits. I believe that the best way to avoid lawsuits is with better perspective and better systems. After 20 years of defending doctors, I know how to avoid lawsuits. If I were this doctor’s attorney, this is what I’d tell her.

1. Get a system

My specialist clearly did not have a system in place. Systems save lives, as anyone who has read Atul Gawande’s “The Checklist Manifesto” could tell you. But systems also save doctors from lawsuits. If, after all of the issues I described above, I’d had a complication during my procedure with my specialist, the jury wouldn’t like to see the lack of a system to ensure the patient didn’t take Advil and did get home safe. More importantly, the fact that I didn’t get the instructions until five days before the procedure could have caused a complication. If I bled as a result of the NSAID, or fell on my way home, the doctor would arguably be responsible. The assistant’s instruction that I didn’t need to follow those instructions also could have caused a complication. I kept notes on our phone calls — I bet she didn’t. When you don’t have a system, and you don’t have documentation, you do have a problem when it comes time for trial.

2. Get perspective

Had my doctor seen things from my perspective, she never would have called me to berate me for canceling. I was frustrated, nervous and confused. Now I was mad. And mad patients sue doctors. Wendy Levinson has been on the forefront of the work that shows us that patients sue doctors who don’t communicate well. Frustrated, nervous, confused patients are just looking for some empathy. If a doctor can’t put herself into a patient’s shoes, she is going to have trouble at trial when she has to put herself in a juror’s shoes. And she is far more likely to find herself having to do so.

3. Get clean

I don’t mean wash your hands, though this goes without saying. I mean don’t be messy. When I have to defend a doctor with missing notes, inconsistent practices, and undocumented phone calls, I know I’m facing an uphill battle. Messiness gives the patient reason to be upset, and it gives the patient’s attorney so much to play with in establishing a case. When you’re messy, you are making the patient’s attorney’s job fun.

Defensive medicine adds $45 billion to the cost of health care. Doctors are ordering more tests, and doing more procedures in an effort to avoid lawsuits. I’ve defended doctors for over 20 years. I love and respect health care providers, but I know better than almost anyone how human they can be. And I know that small fixes can make a huge difference. Get a system, put it in place, and stick to it. Get perspective, be empathetic and communicate with your patients. Get clean, and don’t allow your practice to be messy and disorganized no matter how busy you may be. This is the best type of defensive medicine, and it is free.

HEATHER HANSEN, JD

Heather Hansen is a communications consultant and attorney.  She can be reached at Heather Hansen Presents.

Thursday, May 09, 2019

by SUBBARAO MYLA, MD

I view medicine as a team effort. Doctors, nurses, technicians, and patients work together to promote and improve health. Recently some new members have joined the team:  My patients’ Fitbits, phones, and watches.

For years, the pessimists out there have predicted that wearable technology would lead to mass hysteria. Patients would misdiagnose themselves as having heart attacks and strokes and fill the ER with blaring watch alarms but no actual symptoms.

I’m both an optimist and an early adopter. Wearable – even tattooable – technology, I have believed, is not only empowering for patients; it can be helpful to doctors.

I’ve had patients who we believed were experiencing atrial fibrillation (AFib) – an irregular heartbeat that can result in blood clots, strokes and heart attacks. It is common, dangerous and often difficult to detect.

There are many different monitoring options, but with the ECG app for the Apple Watch Series 4, my patients have been able to easily monitor elusive irregularities through this FDA-cleared electrocardiogram right on their wrist.

The significance of catching atrial fibrillation early can’t be overstated. A condition that leads to strokes, heart attacks and 130,000 deaths per year can now be monitored by a person’s watch. The implications for healthcare – and for giving patients more agency in their own wellness – is enormous.

The primary criticism of fitness tracking devices is that they are unreliable and offer incomplete data. But I believe patients understand the limitations of these tools, and I also believe these devices are getting better. I liken wearable trackers to home security cameras: cameras that detect motion are far more likely to capture actual cats than cat burglars, but they are still a good and useful tool.

Similarly, patients are smart enough to know that every flutter in their chest doesn’t warrant a trip to the ER. But if a wearable device offers a warning while a patient experiences the vague and sometimes difficult to assess symptoms of heart attack (sweating, dizziness, arm pain), the device just might point to legitimate trouble – and even save the patient’s life.

The “smarter” our smartwatches, phones, and fitness trackers get, the more informed doctors will be when making diagnoses and wellness plans. More importantly, the more educated patients become through these apps and devices, the more proactive they will be about their health.

The future always looks scary to pessimists, and yes, wearable technology might be misused or misunderstood. But it will more likely than not result in real and reliable data that physicians and patients can use to make informed health care decisions together.

Medicine is a group effort. And I welcome these new, wearable devices to the team.

SUBBARAO MYLA, MD

Subbarao Myla is a cardiologist and director of cardiac catheterization labs, Jeffrey M. Carlton Heart and Vascular Institute, Hoag Memorial Hospital Presbyterian, Newport Beach, CA.

Monday, April 01, 2019

by SEKISUI DIAGNOSTICS

For patients and physicians alike, it may feel like we’re bombarded with flu warnings from all sides, especially after the brutal 2017-2018 flu season. Walk into almost any drug store or grocery store and you’ll see signs advertising that flu shots are available. Clinicians likely have signs in the waiting room reminding you to get your vaccination, and once the season starts, cable news will certainly report on the severity of the virus this year.

Infectious mononucleosis (often referred to as simply mono) is the odd man out in this scenario. It certainly doesn’t have the bad boy reputation that the flu has and, unfortunately, there is no vaccine. Sometimes called the “kissing disease” because it is spread through saliva, mono is most often caused by the Epstein-Barr virus (EBV), a very common virus (though other viruses can also cause mono). In fact, before age 5, 50% of individuals are infected by EBV! So why does this disease sometimes fall, forgotten, through the cracks, undiagnosed and untested?

The Great Mimic

If that many are infected with EBV by such a young age, why don’t we see more cases of mono? Luckily, EBV infections in children typically do not cause symptoms, or the symptoms are quite mild. Thus, about 85% to 90% of adults in America and other developed countries have antibodies to EBV by the time they are 40 years old, though most of us don’t even know it. Adolescents, especially teenagers 15 to 17 years of age, and young adults are those most likely to develop the classic symptoms of mononucleosis. In less-developed nations, 90 percent of people become infected by age 2.

For those that do fall prey after sharing a coffee or kissing a loved one, diagnosing mono can be a challenge—many of the symptoms are similar to those of other illnesses. Mono can mimic strep throat, the common cold, or even a sinus infection. According to Cleveland Clinic, the most common symptoms are fever, sore throat, and swollen lymph glands, but additional symptoms include fatigue, muscle aches, white patches in the throat, skin rash, headache, and a loss of appetite.

Chicken Soup for the…Mono?

Rest, plenty of fluids, and acetaminophen or ibuprofen may be just what the doctor orders for mono, which cannot be treated with antibiotics. So what’s the point of getting tested if a little chicken soup and some extra sleep are all that are necessary?

That’s a rudimentary look at a disease that can still be dangerous in our modern age. If symptoms are severe, a doctor may recommend treating specific organ systems. Because the disease may cause an enlarged spleen, there’s a risk for a rupture. For kids, recent studies have found there’s an increased risk of systemic lupus erythematosus (SLE), multiple sclerosis (MS), rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), inflammatory bowel disease (IBD), celiac disease, and type 1 diabetes. Of course, you also want to help prevent the spread of the disease, which is more challenging if you’re misdiagnosed.

While most people infected with mono once will not get sick again, it can recur in rare cases. There is also a rare but serious condition called chronic active EBV infection, which is characterized by persistent symptoms and a viral infection that lasts longer than usual after the initial mononucleosis diagnosis.

Because there’s no vaccine, and antibiotics don't work against viral infections such as mono, treatment options are limited therefore knowing that one has mono is important to help patient care and reduce risk of further complications. 

Smooch Says Ask for the Mono Test!

Some physicians may not always use a lab test to diagnose mononucleosis, instead working off the patient’s symptoms alone. But because mono can mimic other diseases, a confirmed diagnosis will help physicians avoid the use of unnecessary antibiotics and allow for appropriate recommendations and follow-up visits.

Most clinicians would like to confirm their clinical impressions, and a variety of laboratory tests have been developed and are used to make a more definitive diagnosis. These include a blood count showing an increased number of lymphocytes, and/or a heterophile antibodies test which is specific heterophile antibodies produced by the immune system in EBV infection.  Smooch, Sekisui Diagnostics’ mascot if you will, for our OSOM® Mono Test, looks rather grumpy—which is how family and friends would certainly feel if you or a loved one passes mono on to them because you didn’t have a confirmed diagnosis!

The OSOM Mono Test has no age limitation and produces results in five minutes! It boasts         > 99% sensitivity and 96% specificity, and easy-to-read two-color results. Learn more here, and perhaps use Smooch to remind your customers or yourself to not let mono get lost in the plethora of strep throat and flu cases!

Twitter:

#Mono or #kissingdisease as it can be referred to, may not be as widely discussed as the flu or strep throat, but it’s still important to accurately diagnosis. Read up on the causes, symptoms, and test and treatment options. https://blog.sekisuidiagnostics.com/2019/01/13/mononucleosis-forgotten-respiratory-condition/

Facebook:

Infectious mononucleosis is one of those diseases that’s easy to lose sight of in a sea of flu and strep throat diagnoses. Its symptoms can mimic other illnesses, making it difficult to diagnose, and its effects can last for weeks! This month, learn more about the causes, symptoms, and test and treatment options for mono. https://blog.sekisuidiagnostics.com/2019/01/13/mononucleosis-forgotten-respiratory-condition/

LinkedIn:

While the flu dominates the news, it’s easy to lose sight of some of the less widely-diagnosed diseases, such as infectious mononucleosis, despite the fact that mono has the potential to impact patients for weeks. Read up on the importance of understanding the causes, symptoms, and test and treatment options for this oft-forgotten respiratory condition. https://blog.sekisuidiagnostics.com/2019/01/13/mononucleosis-forgotten-respiratory-condition/

Saturday, March 09, 2019

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

As we enter the third decade of the twenty-first century, the practice of medicine continues to undergo rapid change, led by advances in molecular diagnostics and genetics, enabling the practice of personalized medicine; advances in mobile and point of care testing technology, enabling medical care in remote as well as non-traditional settings; an ever-more intensely information-driven society where ready access to one’s personal medical information  is now expected, enabling and encouraging patient involvement  in their own healthcare; and finally, change is led by the growing realization of financial constraints due to demographic changes leading to the adoption of a value-based approach to healthcare delivery.

While all aspects of healthcare delivery are changing, it is the clinical laboratory profession that is at the center of this dynamic due to the direct implementation of molecular diagnostic and genetic testing; the massive increase in patient data generated; the increased need for consultative physician communication; and the demand by patients for direct access to test ordering and test results. This has led to the increased visibility, importance, and responsibilities of the laboratory within healthcare delivery. 

Healthcare providers recognize the need for encouraging patients’ engagement in their own health care, for they know that an empowered patient:

• Understands their health condition and its effect on their body
• Feels able to participate in decision-making with their health care professionals
• Feels able to make informed choices about treatment
• Understands the need to make necessary changes to their lifestyle for managing their condition
• Is able to challenge and ask questions of the health care professionals providing their care
• Takes responsibility for their health and actively seeks care only when necessary
• Actively seeks out, evaluates and makes use of information

Patient Education Promotes Patient Empowerment

An estimated 7-10 billion laboratory tests are performed each year in the United States, and laboratory test results influence approximately 70% of medical decisions.  Yet the importance of lab tests reaches much further. They enable physicians and patients to:

• Identify disease and begin treatment earlier than ever before 
• Individualize care to meet the unique needs of the individual patients
• Monitor patient progress and adjust treatments accordingly
• Foster cost-savings and greater productivity in health delivery

When the patient understands the reasons specific tests are ordered, what the results mean, and how they are utilized in the diagnosis, treatment, and monitoring of their conditions, the more likely it is that the patient will do what is needed to attain and maintain a healthier state.  

Educating patients about the meaning of their laboratory tests is even more important now, because in the past, individuals had to visit a healthcare facility—a physician’s office, hospital, or clinical laboratory—to have blood or other specimens collected for clinical testing, and they had to wait a period of days to weeks for a call from their doctor with the results. 

What has changed?

Direct Access Testing (DAT)

Direct access testing (DAT), permits consumers to order laboratory tests directly from a laboratory without necessarily having to work with their healthcare provider. These test results may be used to monitor an existing health condition, identify a previously unknown medical disorder, or provide data regarding personal health characteristics. Direct access testing is a key element of ongoing efforts to increase individuals’ engagement in managing their healthcare, and it is critical that directly accessed test results are accurate and well understood. Laboratory professionals play a vital role in this process.

Currently almost 40 states and the District of Columbia permit consumers to order some or all of their laboratory tests directly— without the involvement of a physician. Similarly, the federal government joined this trend by issuing a regulation directing clinical laboratories to provide individuals with access to their test data upon request.  With these new policies in place, consumers are increasingly involved in guiding the health decisions that affect their lives.

Testing is no longer confined to the laboratory.  Technological innovations have led to testing that can be performed in other settings.

Point of Care Testing (POCT)

Consumers can also identify, order and buy laboratory services directly in a variety of convenient non-traditional settings, such as retail centers, pharmacies, mobile testing facilities, and wellness centers. These point of care testing (POCT) options provide individuals with immediate access to timely services and results.  Many of these tests are performed on waived devices, free from most Federal oversight requirements (as waived tests), by personnel with little or no professional experience. 

Direct to Consumer Testing (DTC)

Many more options exist for today’s consumers. Individuals now can buy over-the-counter test kits that allow them to collect a sample and mail it to a laboratory that performs the test, or, in some cases, conduct the test themselves in their own homes. This is known as Direct to Consumer Testing.  A major boost in utilization of DTC testing is the advent of home DNA testing. This provides information on an individual’s genetic disposition or risk for certain diseases or conditions.  This knowledge may help individuals make decisions about lifestyle choices. 

A concern about DTC laboratory testing:

While this can provide valuable information to individuals about their health status in a timely and convenient manner, questions have arisen about whether consumers have enough background knowledge and information to make sound decisions based on their test results. Consumers might not understand the limitations associated with some tests nor do they necessarily have the knowledge to interpret the tests without input from healthcare professionals. Over the past decade policymakers have been struggling to balance these concerns with a growing desire of individuals to take a more active role in making decisions affecting their health. Regardless of the method or setting, by which patients order their own tests, they must have the correct and complete information to understand what the results mean, when it is necessary to follow up with physicians visits, and when to seek immediate help.

Personalized Medicine: 

Personalized medicine, defined as the tailoring of medical treatment to the individual characteristics of each patient, is profoundly impacting all aspects of patient care, including prevention, diagnosis, treatment, and follow up. This approach relies on understanding how a person’s unique molecular and genetic profile makes them susceptible to certain diseases. 

If a person's genomic information indicates a higher-than-average risk of developing diabetes or a particular form of cancer, that person may choose a lifestyle, or sometimes be prescribed medications, to better regulate the aspects of health and wellness over which he or she has control. The person may benefit in the long run from making preventive lifestyle choices that will help counteract the biological risk. To have successful patient management of these potential health issues, there must be buy-in by the patient to the necessary regimens, including appropriate laboratory testing.  Educating the patient on how these tests work, what the results mean in terms of potential for developing these diseases, and the ramifications that can follow are vital.  

Test Reporting and Interpretation

Laboratory reports have been developed to provide specific information to highly trained and knowledgeable healthcare providers. As such, the reports typically provide a numeric value and a reference interval, and may also include a brief description of the result. This minimal information, when considered with all other factors such as any symptoms of disease that may be present, is sufficient for healthcare professionals to make clinical decisions. An individual consumer likely will need far greater context to fully understand the meaning of the test and to determine next steps. For example, an abnormal test result outside the reference interval may or may not indicate an underlying health problem. Alternatively, an individual may be falsely reassured by a test result in the normal range even when signs and symptoms warrant medical attention. Finally, consumers may not understand the limitations of the tests and therefore may interpret the results of their tests incorrectly.

Laboratory professionals can play a vital role in all aspects of this consumer-driven process, including educating individuals about the benefits and limitations associated with tests and assisting in the selection of the most appropriate test for that particular person. In addition, highly trained and experienced laboratorians can assist in the interpretation of test results and can provide consumers guidance on whether additional testing is required to confirm or clarify results, directing them to medical professionals for any necessary follow-up care. Patients can also access reliable information electronically. 

Resources for Educating Patients About their Test Results

In summation, patient education about lab testing can be provided in many ways, including through:

• The physician directly
• Laboratory staff and other ancillary healthcare providers who have the education to provide this information, such as nurses, and pharmacists
• Reference laboratories, where patients can visit directly or receive information via mail or online 
• Government information sites such as the FDA, and the CDC
• Private laboratory information sites, such as Lab Tests Online; or Health Network Laboratories 
• Laboratory testing information provided online by major medical clinics and hospitals
• Health insurance companies
• Laboratory profession sites such as the American Association for Clinical Chemistry (AACC); the American Society for Microbiology(ASM), and the American Society for Clinical Pathology(ASCP)
• Laboratory Accreditation organizations, such as the American College of Physicians (CAP), COLA and The Joint Commission 

Patient’s Preferences for Receiving Laboratory Test Results

An important consideration when setting up a system for educating patients about their lab test results is an awareness of preferences for receipt of these results.  In a study conducted in 2015 to identify these preferences, all 200 patients in this study preferred online delivery. Also, 82.5% (n = 165) preferred to receive both normal and abnormal test results this way. The main reason for receiving results online was time savings, which was reported by 77% of participants, followed by lowering the chance of missing the results (31%). About 40% of participants thought e-mail notification was more secure than accessing the results through a facility website.  Findings showed that although patients wanted to benefit from online services for receiving their test results, they were concerned about confidentiality and security. Before using online technologies, security measures necessary to protect patient privacy and to gain the trust of patients should be assured.

Conclusion

Patient education about their laboratory test results is the most effective response for patient empowerment by the healthcare profession, whether for testing performed in the traditional setting of a physician office laboratory, a hospital, or a clinic; or in a non-traditional setting such as a pharmacy, a shopping mall, or at home.  Patient education is vital for achieving the best value-based healthcare, and to promote long-term partnerships between physicians and their patients. 

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

Friday, February 01, 2019

by BRANDON MCCUTCHEON, MD

If you are a physician or know a physician or have ever visited one, chances are you have probably heard them complain about technology in health care. More to the point, they are likely to be complaining about the one piece of technology that affects their lives minute-to-minute: the electronic health record (EHR). To get a sense of how central EHRs are to our daily routines, consider that physicians now spend more time in the EHR than they do seeing patients (6 hours of an average 11-hour work day). And while it is easy to write them off as luddites unable to adapt to new technology, an important study by the RAND organization noted that physicians approve of EHRs in principle and see the potential for the technology to improve the delivery of clinical care.

So where is the disconnect between the vision that physicians see for the EHR and its implementation in clinical practice? Instead of being a tool to facilitate communication and coordination, the EHR has become an additional burden. Common critiques include that fact that EHR technology interferes with face-to-face patient-physician communication (this has become the aptly named “screen between”), has significantly increased the amount of time physicians spend performing data entry and clerical duties (and in some cases, has created brand new administrative tasks), and is associated with poor user experience. It all feels as if the physician is working for the EHR rather than the other way around.

The changes physicians have had to make to clinical practice because of the EHR have had profound impacts. For example, EHRs have been identified as the #1 reason for physician burnout. This is particularly problematic given that one study demonstrated over half of all physicians are suffering from professional burnout. What’s more, physicians who were dissatisfied with their EHR and clerical burden were also more likely to have plans of leaving clinical practice. This adds to ongoing concerns of an impending physician workforce shortage.

How have physicians responded? Medical scribes have emerged as one solution. Medical scribes follow the physician into the exam room where they observe the interaction and subsequently draft up the physician’s documentation. While scribes are a great way to alleviate some of the EHR burden, they are not without limitations: scribes can be unaffordable for some providers (approximately $35,000 per year), require initial generalized training, need additional ramp-up time to learn the preferences of a specific physician, and are subject to turnover. Another approach has included retraining existing medical personnel such as clinic nurses or medical assistants to assist the physician with clerical duties. The challenge is both of these approaches involve mobilizing additional human resources to make up for the shortcoming of technology. Instead of creating more efficiencies and reducing human clerical burden, we continue to come up with creative workflow “hacks” for working around the EHR rather than improving it.

Technology is supposed to be an efficiency gainer. It is supposed to increase the productivity of the existing human workforce. Most sectors worry that technology will put humans out of work. With that said, skeptics may rightfully question the notion of improving technology with … more technology. However, the problem is not technology itself but rather the way it is envisioned, designed, and implemented into clinical practice.

Tools such as artificial intelligence (AI) and natural language processing (NLP) offer exciting opportunities to improve upon the existing healthcare IT environment. And If three easy steps are followed in implementing these tools, we can make an important leap from our current status quo to a future where technology integrates seamlessly into the clinical workflow.

First, the creators of technology must take a problem-oriented approach. Notice that above I mention “tools such as artificial intelligence (AI) and natural language processing (NLP).” That is because these should be seen as solutions to a specific problem rather than just another technology we should squeeze into the clinical workflow. Therefore, by viewing AI and NLP as one of perhaps many tools we can mobilize to solve the problem of excessive data entry and clerical duties for physicians, we are more likely to succeed in creating value for physicians and building a product that they actually love (rather than the ones they currently lament).

Second, we must include physicians in the solution creation process. Good entrepreneurs refer to this as customer discovery and would not dream of launching an initial product without getting extensive feedback from the end user. We must see the problem we are solving through the eyes of the physician. How do they understand it? How does it impact their workflow? Where are the greatest opportunities for improvement? By attempting to see the problem through their lens, we are able to build solutions with the right combination of features that physicians will actually want.

Third, we must see the problems as more than just equations to be solved. With AI and NLP, there is the tendency to think that all that is needed is more data and a better performing algorithm. While adequate performance is undoubtedly necessary, it is not sufficient. The challenge with making AI work for clinicians is as much one of packaging it into an intuitive design and an enjoyable user interface (UI)/user experience (UX) as it is about enhancing performance. The best performing model is not much good if the physician hates the way it looks and feels; or worse, if it adds additional time to their workflow.

The EHR we have today does not have to be the one we have tomorrow. Efficient and enjoyable clinical practice is possible. A future where doctors spend more time with their patients than they do with the EHR is achievable. It just requires a problem-oriented approach, end-user engagement, attention to the clinical workflow, and beautiful design.

BRANDON MCCUTCHEON, MD

Brandon A. McCutcheon, MD; Chief Executive Officer: Brandon is a neurosurgeon in residency at the Mayo Clinic with a passion for data science and novel analytic methods. He is enthusiastic about tackling large-scale, high-impact problems. Brandon has founded and led a prior healthcare IT startup in addition to publishing over 40 peer-reviewed scientific manuscripts in clinical data science and machine learning.

Wednesday, January 09, 2019

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

The 21st-century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centered. Laboratory medicine is integral to many of these objectives, involving disease prevention, diagnosis, treatment, and management. 

As a result, the laboratory profession continues to undergo rapid change.  Not only is there an impact through advances in technology, with new tests and test methodologies, new modes of communication, and new capacities for storage, retrieval and analysis and dissemination of  data, but through emerging socio-political trends resulting in changes to the very structure of organized medicine, and how medical care is delivered. These include major legislation such as the Affordable Care Act which encourages shifts from private practice to integrated healthcare networks; and the development of new models of healthcare delivery such as Accountable Care Organizations, which mandate value-based compensation models.   These changes, whether on a macro institutional level, or micro departmental level, impact our laboratories.  Millions more insured will lead to significantly increased demand for laboratory services at the same time that baby boomer staff (who have been the backbone of laboratory staffing since the 1960’s) are retiring in large numbers, but with fewer schools training replacements.  Exacerbating this is the continuing growth of tests available (currently at least 3500 tests), new specialties, new global health issues (i.e. Opiod epidemic), accelerating the increase in workload. 

Challenges and Changes Forecast for the Laboratory Profession

The two main forces directly affecting laboratory operations are rapid technological advances (e.g. total laboratory automation, molecular diagnostics techniques, digital technology; point-of-care and remote testing, etc.) and resultant  increased economic pressures, with the need to align to increasingly limited budgets

One major outcome of the introduction and growth of digital technology, in particular,is the huge increase in the generation and utilization of data, both for immediate patient care needs as well as population health management and trend analysis. This has resulted in the laboratory becoming “information central” within the greater healthcare environment, touching almost every point of healthcare delivery.  Under these circumstances it is easy to recognize that laboratory medicine has a pivotal role, increasingly integral to many clinical decisions on disease prevention, diagnosis, treatment and management. The overall challenge for the laboratory profession is to adapt to these rapid changes, while maintaining quality service. 

A summary of these challenges include:

• Increased scope of services offered, requiring changes in laboratory organization and communication, including workflow, scheduling, reporting policies, data transmission and storage; expanded relationships with other healthcare providers; integrated roles for information technologists; and increased direct interaction with the public.
• New roles and responsibilities of the laboratory due to changes in healthcare delivery through integrated network organizations —Accountable Care Organizations (ACOs) and Patient Centered Medical Homes (PCMHs), integrating the laboratory as a part of team-based care 
• The need for updating policies and procedures to reflect this new paradigm of increased scopes of practice and involvement
• New personnel requirements, recruitment and training to ensure a competent workforce to meet these challenges.
• Adjusting to the new age of patient empowerment:  patient initiated testing; and test results reported and interpreted directly to patients. 
• Keeping up with the changing political and regulatory climate
• Changing population demographics and the need for interventions for specific subsets of the population; use of big data influencing government resource allocation.

Dealing with all these changes can be stressful for laboratory professionals. The clinical laboratory industry is already embracing networking, consolidation, integration, outsourcing, and creating additional value by providing knowledge services related to in vitro diagnostics. Clinical laboratory services are also increasingly defined by their value provided for patient outcomes.  Already, there is evidence that ongoing technological developments have considerably improved the productivity of clinical laboratories. 

The next thirty years comprise a perfect storm scenario for laboratory medicine in terms of meeting professional staffing needs to meet these challenges:

• Millions more people will be insured and able to access the healthcare  system far more comprehensively than ever before, including laboratory services
• Millions of baby boomers adding to the post-65 year old demographic, requiring more frequent and intensive healthcare, including laboratory services
• Significant numbers of boomer clinical laboratory professionals are part of this retirement tidal wave, contributing to the shortage of available staff
• The continued rapid development of advanced technology such as molecular genetics. requiring ever more sophisticated instruments and advanced training by staff
• Increased competition from other healthcare professions that are able to promise and deliver on better working conditions, higher compensation, and greater recognition.  
• Lack of adequate funding for enough schools and graduation capacity to provide the needed numbers of laboratory professionals.

Resilient Leadership

As a result, these times call for leadership that is more adaptive and agile than ever before, i.e. resilient leadership. This is leadership that understands change, and can adapt through creating an organizational culture of resilience; going beyond continuous quality improvement to embrace change on an institutional as well as departmental level, enabling their laboratory operation to not only survive but prosper and grow. 

Resilient Laboratories

These are laboratories that are able to respond effectively, and adapt to all kinds of changes in operation, internal and external demands, and expectations, through effective planning and resource allocation, thus allowing the continuation of normal services without compromising quality. Gaps in the continuity of healthcare threaten a patient’s well-being and introduce the potential for adverse events. Whether, or how, a system responds to fill such gaps in care continuity indicates its resilience. Adaptations include new clinician initiatives, adaptive instrumentation, flexible staffing patterns, continuous quality improvement practices, and institutional networking leading to improvements in performance and service.  These approaches make up the resilience that is built into the system to help accommodate demands for care.  Resilience provides the means for organizations to target resource investments by integrating safety and productivity concerns. Quality work processes are not static properties of an organization, embracing resilience reflects a dynamic effort to maintain quality.

A culture of resilience

A culture of resilience recognizes the value of the laboratory staff, the stresses that they may be experiencing, the training that is needed, and the need to be supportive and understanding.  It goes beyond a culture of continuous quality improvement to include trust, teamwork, tolerance, and a global perspective that more change is inevitable.  The properties necessary for resilient organizations include: 

Top Management commitment: to recognize performance concerns and addresses them with continuous and extensive follow-through based on applying competency improvement processes utilizing coaching and management observation. 

Key management strategies include: providing staff with key information about future plans for the development of the laboratory, and involving the staff when possible; and determining how to implement these changes through adjustments to job assignments; staffing levels; policies and procedures; management of timelines and budgets. 

The characteristics of a resilient laboratory include support for: 

An open and fair culture: the reporting of issues, problems, events, and errors throughout the organization is supported and encouraged, but culpable behaviors are not tolerated. 

A Learning culture: Wherein issues, problems, events, and errors are handled with an eye toward correction, and solution, not denial;  but not a “blame game” attitude either

Realism: Management is aware of any potential for serious problems and events due to weaknesses inherent in their operation, and continuously monitor these. 

Awareness: Management collects ongoing data to gather insight into quality of performance, problems, and the state of safety defenses.  Utilizes the staff for feedback and innovative ideas.

Flexibility: New or complex problems are handled in a way that maximizes the ability to solve the problem without disrupting overall work.  

Transparency: Management keeps staff informed of all happenings, both good and bad.  This can open up new avenues of discussion, problem-solving, and team-building.

Resilience relies on constant feedback from the staff regarding the effectiveness of the changes made by management.   Additional steps that enhance the ability of the laboratory to successfully adapt to these challenges include: 

1. Encouraging two-way communication 

2. Recognize and reward achievement.   

3. Help employees succeed. Provide employees with the resources and support to do their work, and as they show signs of readiness, be willing to entrust them with new tasks and greater responsibility.

4. Provide continuing education. This should include a formal orientation program, cross-functional training, maintenance of professional skills, coaching, career development, and personal development. 

Out of this develops a resilient innovative workforce, one that is capable of adaptively learning to correct errors and to take advantage of new opportunities (e.g., digital technology; remote testing; ACOs), to improve quality of service. 

The end result is the leveling of silos, enhancing communication, creating a workforce that is not hesitant to innovate and adapt to change; feels appreciated and experiences less stress when change is needed.

IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

Irwin Z. Rothenberg is a Technical Writer/Quality Advisor for COLA’s Educational subsidiary, COLA Resources, Inc. (CRI), a leader in online continuing education for physicians, laboratory personnel, and allied health professionals.  CRI offers continuing education through online courses, informational products in both electronic and hard copy form, webinars on cutting-edge technology and regulatory issues, and CRI on-site Symposia for Clinical Laboratories, providing live educational sessions and interactive workshops with leading industry organizations. For more information, visit their website at www.criedu.org or call 1-800-981-9883.

Tuesday, January 01, 2019

by DYLAN J. CHADWICK

We all laughed at Casey, bright-eyed and eager, when we started our hike. He'd seemingly bought out an entire military surplus store in preparation, while we'd opted (through a heady combination of laziness and daring) to pack as little as possible. Most curiously was Casey's hand-pump micron water filter. Roughly the size of a cinder-block and forged from heavy metal, we snorted incredulously as he clipped the device to his pack, hiked up his shorts and started his journey, clattering like an old Buick.

However, hiking a 70 mile swatch of the Appalachian trail proved more treacherous than we'd imagined, and as the sweltering humidity of the Tennessee backwoods enveloped us, the need for water grew to maddening levels. The iodine tablets we'd packed tasted too strongly of paint, rendering anything we put them in practically undrinkable and our \"fool-proof\" method of boiling water to purify it took way too long. In a moment of parched desperation, we turned to Casey, sitting cross-legged on an old stump, patiently pumping ice-cold potable water into his canteen. Sheepishly, we approached him for help. \"Sure,\" he replied with a grin. \"I ought to charge you though.\" It occurred to me, there in the Appalachian wilderness, that Casey had taken the time to specialize, and despite the additional weight and effort his equipment entailed, he now had what we all wanted...and was poised to make a killing. 

Similarly, in a changing medical landscape, physicians willing to specialize their practices are the ones who'll succeed. Though evolving technology and its subsequent improvements in patient patient care have brought substantial changes to the medical sector, an era of economic uncertainty and fiscal instability may wring just as prescient an effect. According to an article by Ben Brown, MD, reductions in Medicare contract payments (some as much as 21.3%) and physician reimbursements from insurers might result in critical decreases in physician salaries, medical profits and general revenue for a practice. What proves even more concerning for physicians and patients alike, is a present medical landscape of high healthcare costs, an ever-increasing need for healthcare options and diminishing resources. Furthermore, caring physicians want to be effective providers for their patients, but they also want the appreciation and financial compensation for their profession demands.

In this regard, many physicians, Urologists, Oncologists, Gastroenterologists and Dermatologists for example, have made conscious efforts to optimize their practices in an effort to generate other streams of ancillary income. One specializing measure has been opening in-office testing labs (POL's) directly at their office location. These labs, carefully stocked and equipped to run routine (but important) procedural tests, provide real life \"one stop shop\" scenarios for patients with busy schedules and limited funds, and can quickly develop into thriving profit centers for small practices...but before opening up a lab, let's talk some basics.

Physicians have a number of options when it comes to medical testing. The first, and least efficient, is for them to refer patients to a hospital or an off-site lab for their tests. This method, though convenient for practices with a high volume of appointments, generally proves inconvenient for the patient, who has to make a additional trips for a singular medical problem. Additionally, it yields a low (virtually non-existent) financial return for the physician.

Another \"off-site testing\" option for physicians is to take the samples in the office, and then send them to an off-site lab for analysis. Commercial Reference Labs (CRL), like Quest Diagnostics, Laboratory Corporation of America Holdings and Bio-Reference Medical Labs, have carved a space in physician circles as adept facilities that aid practices by doing the testing work for them. Still, the method is not without its downsides as it creates another process \"step\" for physicians who must take the test samples in-house, and then send them off-site before a further diagnosis can be made. Turn-around times increase as patients and physicians wait for their samples, shipping expenses must be considered and again, since Commercial Reference Labs are compensated for their lab work, financial returns for the  actual physician are low. 

In the immediate sphere, these off-site methods may take stones from practices' proverbial backpack as they're \"freed up\" to see more patients, but in more pressing ways they're potentially yanking dollars from a practice's proverbial wallet. 

A viable route for physicians is to run the testing themselves using products that have been specifically waived by the Clinical Laboratory Improvement Amendments (CLIA). Established in 1988, the CLIA sets standards and issues certifications for clinical laboratory testing, with an emphasis on ensuring accuracy, reliability and timeliness. Using CLIA waived products keeps the testing in-house, and can generate much-needed revenue for a physician by steering testing and procedural fees directly to the practice. However, testing done on CLIA waived products isn't always the most extensive and can be limited in scope.

In an efforts to generate additional income for their practice, and to creating an efficient and all-encompassing experience for their patients, physicians may be better advised not to stop simply at CLIA products, but to establish an entire CLIA certified lab in their office. 

In his article Oncologists Advised to Build Their Own In-Office Clinical Labs Michael McBride cites an anecdote by Tim Dumas, a lab scientist and POL consultant, when he says \"someone's going to run and get paid for these tests. It might as well be you.\" In the article, Dumas references a three doctor Oncology practice in Raleigh North Carolina that generates an additional $400,000 annually with their own Physician office lab. He even predicts that a ten to twelve doctor practice can look at $7-800,000 a year in additional revenue if they implement such a facility.

Besides the extra cash flow, in-house Physician Office Labs usher in various benefits for small and mid-level practices. For one, waiting games and turn around time between specimen collection, analysis and patient follow up are diminished. Since tests don't need to be sent out, appointment is maximized and the practice becomes more beneficial both to the patient and to the physician.

Besides adopting the role of a pratice's lucrative profit center, Physician's office labs will help practices save money. Tim Dumas goes as far as to accuse practices of \"wasting revenue\" when they \"decide not to install their own Physician's office lab.\" He contends that a practice can save anywhere from $100,000 to $1 million (depending on the size) simply by the cut expenses that an in-house lab espouses.

That's not to say that establishing an in-house Physician's Office Lab doesn't have its own set of costs that a practice must take into account. For one, it will require a CLIA certification (approximately $1,200). Depending on the type of practice, it will also require specialized equipment and a space in which to house it. Physicians must make their own decision whether to purchase equipment or to lease it, but Dumas insists that leasing it is cheap and cost effective. Finally, a well-oiled Physician's office lab requires a competent staff of specially trained individuals (the number depends on the size of the lab) and a competent medical lab manager (approximate salary of $75,000 a year) to oversee the testing.

Though hefty, they're necessary expenses and serve multiple worthwhile purposes. For one, specialized staff ensures accuracy and efficiency in testing, and a CLIA certification will protect practices from any legal red tape. Additionally, by putting concentrated amounts of time, effort and resources into their Physician's Office Lab, practices make their lab more attractive to managed care organizations (MCOs) and insurance companies. Subsequently, these organizations are far more likely to give generous reimbursements when they're assured that a POL promotes customer satisfaction, emphasizes quality and generally has effectiveness and efficiency in their top priority.

While many physicians might seek to avoid what Michael Sanders MD calls the \"headache\" of dealing with CLIA, MCOs and the insurance companies, a top notch Physician's office lab has far more advantages than it does hindrances, and the financial benefits far outweigh the expenses. For example, a standard CBC test for an oncology practice usually costs around $1 to run, but the insruance reimbursement is around $10. After deducting the fixed costs of the lab, profits become substantial, even more so for tests like CEA, CA 125 and CA 27-29 which cost between $3-4 to run and receive insurance reimbursements of $20-30 each.

From simplifying the overall patient experience to whipping together an ancillary stream of income for a practice, it's win-win on all counts. \"A practice is at its most efficient, when it's generating revenue,\" says Tim Dumas. Though it will take effort to get started, the returns will come quickly and practices will come upon their destination, be it financial success, an increase in disposable revenue or a better patient experience, much quicker and more seamlessly with one than without.

References:

Brown, MD, Benjamin. \"The Deceptive Income of Physicians.\" The Deceptive Income of 

Physicians. 20 June 2010. Web. 14 May 2012. 

<http://benbrownmd.wordpress.com/>.

Chesanow, Neil. \"Business of Oncology: An Office Lab Can Turn a Tidy Profit.\"Medscape. 22 

Feb. 2011. Web. 14 May 2012. 

<http://www.medscape.com/viewarticle/737426>.

McBride, Michael. \"Oncologists Advised to Build Their Own In-Clinic Medical Laboratories.\"  DARK Daily Laboratory and Pathology News. 30 Mar. 2011. Web. 14 May 2012. 

<http://www.darkdaily.com/oncologists-advised-to-build-their-own-in-clinic-medical- laboratories-33011>.

Powell, Ken. \"Physician Office Market Re-Discover Diagnostic Testing Revenue Opportunities.\" 

Physician Office Market Re-Discover Diagnostic Testing Revenue Opportunities. High Table Clinical Diagnostics. Web. 14 May 2012. <https://www.hightable.com/clinical-diagnostics/insight/physician-office-market-rediscover-diagnostic-testing-revenue-opportunities-53269>.

Wolfe, Marleen, and Gary Wolfe. \"Physician's Office Laboratories: How Viable Are They?.

March 2004. Clinical Lab Products.\" Physician's Office Laboratories: How Viable Are They?  Clinical Lab Products, Mar. 2004. Web. 14 May 2012. <http://www.clpmag.com/issues/articles/2004-03_01.asp>.

DYLAN J. CHADWICK

Staff writer for Physicians Office Resource

Thursday, November 01, 2018

by DYLAN J. CHADWICK

There’s an increasingly circulated anecdote (usually among graphic designers) about a big-time representative from a big-time tech company meeting before a middle school class. He asks the students, presumably born in the early 2000s, if they know what a floppy disk is. He's met with silence. Then, he produces a floppy disk from his sport coat pocket and shows it to them. “This is a floppy disk,” he says, turning it over in his hands to show them. “Now, have any of you seen one of these before?” After a few more beats of silence, a child raises her hand to say that she recognizes the object as the icon she clicks on to save her progress on Microsoft office. A few seconds later, another child raises his hand because he’s seen it on his Angry Birds game. A wave of recognition floods the classroom as the children place a function and a purpose to a tangible object they’re encountering for the very first time. 

Perhaps the anecdote is exaggerated (aren't they all?), but the intended principle rings relevant: words need context to be fully understood. Consider the mind-blowing fact that this anecdote actually reveals: for the last 18 years, floppy disks have only really existed as skeuomorphic (a fancy term for \"making digital items resemble their real-world counterparts\") “save” graphics on our computers and mobile apps, and children born after 2000 are extremely unlikely to have ever seen one \"in the wild.\" 

On Creating Buzzwords

These divides in comprehension crisscross every facet of culture and industry as our old processes continually blur into neutralizing digital futures, and medicine is no exception. Consider a medical buzzword construction like “Orphan Annie Eyes,” a phrase which describes the cells that help diagnose papillary thyroid cancer. As John Biemer outlines in his article Is it time to Update Antiquated Medical Buzzwords? it’s a term with resonance, first officially appearing in a 1971 book entitled Basic Endocrine Pathology and referring to the cell nucleus as “relatively empty (like Orphan Annie Eyes.).” Practicing American physicians of the era would have likely understood the reference because the Little Orphan Annie comic strip was a daily comic strip that ran in syndication from 1894 to 1968. In fact, many physicians currently practicing would understand the reference as Little Orphan Annie is a bona fide cultural icon, but this kind of ubiquity won’t last forever and decreases with each passing year. The term is still taught to young medical students mostly unfamiliar with the character, many of whom were born and raised outside of the united states and have absolutely no context of Annie, her eyes or the adventure she shares with her rich benefactor, Daddy Warbucks. 

I’m no stooge. I know that of buzzwords lend a gleeful air of contemporaneity to the language we use, and can even clarify its meaning, with “laymen” cultural definitions. Still, for our language to remain truly effective in a globalizing industry, we must assure that all who engage it are acutely familiar with the backstory and in an age with such rapid informational turnover, we simply can’t count on our buzzwords to stay in vogue infinitely.

Do They Really Matter Though?

We likely use buzzwords, phrases and sayings every day that betray their original intention. I won’t claim to know the etymological backstory of “OK” for example, and I can admit that I just barely learned that when we say “pull out all the stops” we’re actually referring to an organ player increasing the volume of the instrument. Does my understanding of this organ player backstory enhance my knowledge and understanding of the phrase? I'd like to think so.

Buzzwords are often a product of timing and through generations and evolution, they lose their original prescribed meaning. Those buzzwords and phrases with user-friendly applications (like “the whole 9 yards”) adapt and continue in our language while too niche or obscure fall out of our spoken canon where they stay hidden away, only resurrected for stodgy discussion in dusty college literature programs. Linguists often describe our language in the same terms they would a casserole or stew of social developments, one shaped and flavored the various ingredients and cultural impressions throughout history. Biemer describes antiquated medical phrases like \"currant jelly sputum\" to describe the appearance of bloody mucous coughed up by someone with pneumonia or the \"Maltese cross\" shape of the fatty casts contained within the urine of those with necrotic syndrome…and while these buzzwords work in their time, we cannot assume that blackberry currants or the Knights of Malta will hold the same relevance today as they did in the past. It's for this reason that our language, often without our own input, updates itself to stay relevant.

More Work/Little Pay Off

Some medical students use Buzzwords to keep the staggering overflow of medical info and jargon straight in their brains, or simply as mental crib sheets a big exam. Maybe these buzzwords offer a quick workaround explanation for an improvising professor. That's all fine and good. Where buzzwords become problematic is when they require clarification and explanation in order to be truly useful to those who hear them. If you think about it in a The Tibetan Book of Living and Dying kind of way, all the time you’d save inventing new term, even those which sidestep medical jargon, you’ll lose explaining to the next few generations what that buzzword even means. 

Don’t get me wrong, buzzwords are great fun, in any capacity. Who doesn’t love bemoaning a once-lauded TV-program's fall from greatness by saying they “jumped the shark?” Buzzwords simply don't contain much substance terms of long term value. During their relatively small window of contemporary relevance, buzzwords provide some enhancement to our language (think \"Brangelina\" from a few years back), but it’s a gimmick that will quickly devolve into more aqueous terms which float, unconnected to their original intended function, begging to be explained and contextualized by those old or cultured enough to know. (Here's where I explain to those who don't know: \"Jumping the shark\" is an idiom used to describe the moment in arc of television show when it begins a decline in quality; based on a scene from a fifth-season episode of the sitcom Happy Days when the character Fonzie jumps over a shark while on water-skis). 

So, to the gatekeepers and dispensers of medical information, be responsible with buzzwords and use them sparingly, especially when it comes to medicine. In the meantime, think about how you'll be explaining flip phones to your grandkids.  

References

Bavle, Radhika M. \"ORPHAN ANNIE-EYE NUCLEI.\" 

Journal of Oral and Maxillofacial Pathology, Summer 2013. Web. 14 Nov. 2015.

Biemer, John, MD. \"Is It Time to Update Antiquated Medical Buzzwords?\" 

KevinMD.com. KevinMD, 10 Nov. 2015. Web. 14 Nov. 2015.

Khan A, Haque S, Shah SQ, Irfan J. “Orphan annie eyes: From Comics to Clinics.” 

International Journal of Pathology, 2011;9:47–8.

McFedries, Paul. The Complete Idiot's Guide to Weird Word Origins.

 Indianapolis, IN: Alpha, 2008. Print. 

DYLAN J. CHADWICK

Staff writer for Physicians Office Resource

Thursday, November 01, 2018

Prostate cancer represents about 27% of all cancers in men, and is the second deadliest form of cancer. Last year, an estimated 26,000 men died of prostate cancer. 

The American Cancer Society’s estimates for prostate cancer in the United States for 2017 include:

• about 161,360 new cases of prostate cancer.
• about 26,730 deaths from prostate cancer.
• about 1 man in 7 will be diagnosed with prostate cancer during his lifetime.
• Prostate cancer develops mainly in older men. About 6 cases in 10 are diagnosed in men aged 65 or older, and it is rare before age 40. The average age at the time of diagnosis is 66.

(Read more at the American Cancer Society). 

African-Americans at Higher Risk

According to the Prostate Cancer Foundation: “African-American men are the group – out of all men in the world – hardest hit by prostate cancer…[and] are 1.6 times more likely to get prostate cancer, and more than twice as likely to die from it.”

An article at Wiley’s Newsroom pointed out:

“a new study indicating that higher prostate cancer death rates among black men in the U.S. may be due to a higher risk of developing preclinical prostate cancer, and a higher risk of that cancer progressing more quickly to advanced stages. The investigators estimated that 30 percent to 43 percent of black men develop preclinical prostate cancer—prostate cancer that is not symptomatic—by age 85, a risk that is 28 percent to 56 percent higher than that among men of any race.”

This further highlights the need for prostate cancer screening among at-risk populations. 

The PSA Test

The Prostate-Specific Antigen (PSA) test measures the level of PSA in a man’s blood. Because the PSA biomarker is only expressed in prostate tissue, it can aid in the early diagnosis of prostate cancer.

PSA Testing: Controversy…or Just Confusion?

The confusion surrounding the use of PSA testing — when to screen and when not to screen — continues because prostate tumors may be very slow-growing (in general, about two-thirds of prostate tumors are categorized as slow-growing), and require only monitoring.

It is important to understand that the controversy around PSA screening is not about the PSA test, but rather about when or whether to treat based on the test result. 

Since the FDA approval of the PSA test in 1994, the age-adjusted mortality rates for prostate cancer in the U.S. have declined 50%. LINK TO WEBINAR EXEC SUMMARY(In that time period, mortality due to prostate cancer has declined more than mortality for any other type of cancer.

The value of PSA screening in terms of early detection of prostate cancer and reducing related morbidity, mortality, and cost is well established, when implemented in combination with passive surveillance.

Revised USPSTF Prostate Cancer Screening Standards

 In April, the U.S. Preventative Services Task Force (USPSTF) released new draft guidelines for PSA prostate cancer screening – bringing it more in-line with American Urological Association and American Cancer Society recommendations.  (Read more on the draft recommendations at https://screeningforprostatecancer.org.)  

The 2017 draft recommendations are based on new findings tracking PSA testing in clinical trials. From an April 11, 2017 NBCNews.com article (Men Should Ask About Prostate Cancer Test, Panel Advises - 4/11/17) comes this:

“After following patients for a longer period of time, it was shown that for every 1,000 men screened, one to two lives were saved. “We are more confident about the benefits of screening,” said Bibbins-Domingo. \"We now think, on balance, there is a small benefit.\"

PSA – 15 Minute Results

Testing confusion aside, two of the benefits of the PSA test are the ease of testing and rapidity of results. Patients - tested in a doctor’s office during a visit - can receive the results in 15 minutes.

This can potentially eliminate the need for a follow-up visit to review results - and allow the doctor and patient to develop a follow-on plan of action - if any is needed - during the initial visit.  

Sekisui Diagnostics recently sponsored a webcast at Clinical Lab Products on this topic: Critical Thinking for Early Diagnosis of Prostate Cancer. It is available, on-demand free (Duration: 1 hour, 5 minutes). The webcast - moderated by Steve Halasey, chief editor of Clinical Lab Products. - explores:

• The current controversy surrounding screening and diagnosis of prostate cancer.
• The importance of digital rectal examination.
• Optimizing the clinical application of PSA testing. 

Tuesday, October 09, 2018

by IRWIN Z. ROTHENBERG, MBA, MS, CLS(ASCP) 

The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection.

As a result, laboratory professionals have long expressed concern about the quality of testing performed in these laboratories.  This concern has only grown with the rapid proliferation of waived tests, along with point of care /remote testing sites.

Quality Concerns

As a response to these concerns, both CMS and the CDC conducted random surveys of waived laboratories several years after CLIA 88 was enacted.  These labs had significant quality issues, including the lack of available written procedures; adequate personnel training, quality control performed as required; also, the lack of a proper attention to reagent expiration dates and storage requirements; and the failure to enter test results into electronic medical records.   Although not usually specified in the product insert (and therefore not a CLIA requirement), proper documentation and recordkeeping of patient and testing information are also important elements of good laboratory practices. 

Among the waived laboratories surveyed, the study also found:

• High staff turnover

• Lack of formal laboratory education

• Limited training in test performance and quality assessment

Strategies to Address These Concerns

1. Competent Management and Organization

To be effective, efforts to achieve quality waived testing through good lab practice must start even before the testing process, all the way back to assessing the laboratory structure, organization, and purpose. These include:

1. Commitment to Constant Oversight of the Testing Process

In POLs, this might be a physician or someone in a senior management position who has the appropriate background and knowledge to make decisions about laboratory testing. 

1. Anticipating and Addressing Personnel Needs 

Personnel competency and turnover are important factors affecting the quality and reliability of waived testing results. While there are no CLIA requirements for personnel performing waived testing, all applicable state or local personnel regulations must be met. 

Personnel issues to consider include assessment of present staffing levels and training, to ascertain whether employees have sufficient time and skills to reliably perform all activities needed for testing. 

1. Personnel Training

Personnel should be trained and competent in each test they will perform before reporting patient results.   It is the responsibility of the laboratory director or other supervisory staff to ensure that this training has occurred, along with proper documentation of these efforts. 

1. Competency Assessment 

To ensure testing procedures are performed consistently and accurately, periodic evaluation of competency is recommended, with retraining, as needed, on the basis of results of the competency assessment. 

1. Development and Maintenance of Procedure Manuals

It is good laboratory practice to develop written policies and procedures so that responsibilities and testing instructions are clearly described for the testing personnel.  Written test procedures also form the basis of training and evaluation of testing personnel. These procedures should be derived from the manufacturer's instructions, and include directions for specimen collection and handling, quality control, test and reagent preparation, and instructions for test performance, interpretation, and reporting.

New testing procedures should be reviewed, signed, and dated by the laboratory director before incorporating them into the procedure manual. The manual should be updated as tests or other aspects of the testing service change and should be reviewed by the director whenever changes are made. When procedures are no longer used, the date of discontinuance should be noted, and they should be removed from the manual.  The manual should always be readily available to all testing personnel.

1. Maintenance of Complete and Accurate Documents and Records 

Proper documentation is necessary for monitoring and assessing test performance, identifying and resolving problems that could affect patient testing, retrieving and verifying information, and maintaining adequate patient and personnel records. Log books or electronic systems can be used for maintaining and tracking information. In some cases, records might be part of the patient's medical chart. 

1. Performance of Quality Assessment 

Good laboratory practices can be expanded to include activities to evaluate and improve the quality of waived site testing, utilizing both internal and external quality assessment activities. Results from these assessment activities should be documented and evaluated, noting any irregularities and the actions taken to resolve problems or improve processes or procedures.

1. Follow Best Practices During Testing

1. The Pre-analytic phase

1. Test orders

Confirm that the written test order is correct. If there is a question, check with the ordering clinician before proceeding. 

1. Patient identification

Use two unique identifiers to ensure accurate identification of the patient before the specimen is collected. Names can be similar and lead to confusion, therefore use birth dates, middle initials, patient identification numbers or other means to ensure correctness.

1. Pretest instructions and information

Some tests require special preparation on the patient’s part (e.g. fasting), or that the patient collect the specimen (e.g. urine or stool). Provide the patient with pretest instructions when appropriate, and verify that patients have received and understood the instructions before collecting or accepting the specimen 

1. Specimen collection and handling 

The product insert provides details on proper collection, handling and storage of patient specimens. Specimens need to be adequately labeled to prevent mix-up. Always label specimens as soon as they are collected with pertinent patient information. Labeling should also include the date and time of collection and identification of the collector.

1. The Analytic Phase 

1. Quality Control (QC) 

Quality control provides assurance that the test system has performed as expected, and alerts the user when problems occur which may affect patient results; these can be problems due to operator error, reagent or test kit deterioration, instrument malfunction or improper environmental conditions. 

If quality control testing fails to perform as expected, patient testing should not be performed or results should not be reported until the problem is identified and corrected. QC test results should be recorded and monitored. Records of control results should be periodically reviewed by the person responsible for testing oversight to detect shifts or changes in performance over time which may affect patient results.

1. Test Performance 

Follow the steps in the test procedure exactly as described in the manufacturer’s product 

insert and /or the written procedures.

1. Results Interpretation. 

Results can be recorded directly in a patient's chart, in log books, or on a separate report form. Interpretation of the results should be in accordance with instructions in the product insert.

1. Resolving problems

If a test result is not acceptable or requires repeat testing (e.g., out of range or invalid), record the initial result, noting it was unacceptable, take steps necessary to resolve the problem, then repeat the test and record the correct result. Good laboratory practice includes recording what happens, whether acceptable or not, and what is done to correct problems encountered during testing. Results should not be reported until the problem is resolved. Follow the steps in the product insert to resolve problems with the test results. If repeat testing does not resolve the problem, contact the manufacturer or technical representative. 

1. The Post-analytic phase:

1. Reporting Test Results 

Patient reports should be legible and reported in a timely manner to the appropriate person. All verbal reports of test results should be documented and followed by a written report. Critical values require immediate notification of the clinician, and procedures should be in place to ensure documentation of these values along with the time of notification of the proper medical personnel. 

1. Confirmatory testing

The product insert should explain when additional testing is needed to confirm a waived test result or when the test is to be used as part of a multi-test algorithm (e.g. throat culture needed to confirm a negative result for rapid group A strep antigen). There should be written policies and procedures to ensure that all confirmatory and supplemental testing is performed when needed. When collecting specimens for referral to another laboratory, the instructions provided by the reference laboratory must be followed, and the appropriate request form completed. 

1. Maintaining records of referred testing