Wednesday, October 9, 2019

Should dietary guidelines suggest that people eat less meat?

There is a widespread consensus among nutrition and environmental scientists that reducing dietary meat intake, particularly red and processed meats, is not only beneficial for personal health, but also benefits the planet by reducing deforestation, freshwater consumption, and greenhouse gas emissions associated with cattle farming. As my colleague Caroline Wellbery, MD wrote in a 2016 editorial: "According to the 2015–2020 [U.S.] dietary guidelines, moderate to strong evidence demonstrates that healthy dietary patterns that are higher in fruits, whole grains, legumes, nuts, and seeds, and lower in animal-based foods are associated with more favorable environmental outcomes."

Although the effects of individual dietary counseling in patients without cardiovascular risk factors are limited, the Dietary Guidelines for Americans, which are updated every 5 years, have been influential in changing eating patterns. A recent analysis of cross-sectional data from the National Health and Nutrition Examination Survey found small but significant decreases in consumption of refined grains and added sugar and increased consumption of plant proteins, nuts, and polyunsaturated fats from 1999 to 2016. Bigger changes could be on the horizon, if the efforts of entrepreneurs profiled in a recent article in The New Yorker to bioengineer and distribute plant-based hamburger patties and other products that are indistinguishable from real meat prove to be successful.

The next iteration of the Dietary Guidelines will need to consider new evidence that beneficial health effects of eating less meat may not be as large or as certain as previously thought. In a clinical guideline published last week in the Annals of Internal Medicine, an international panel from the Nutritional Recommendations and Accessible Evidence Summaries Based on Systematic Reviews (NutriRECS) consortium made the somewhat shocking suggestion that adults can continue their current (over)consumption of red and processed meats without major health consequences. Four linked systematic reviews found low-quality evidence of small to no benefits on cardiometabolic and cancer outcomes from consuming less red and processed meat in cohort studies and in randomized trials, and a review of health-related values and preferences suggested that "omnivores are attached to [eating] meat and are unwilling to change this behavior when faced with potentially undesirable health effects." Importantly, none of the guideline authors or systematic reviewers received any financial support from the meat industry, though the lead author previously received funding from the International Life Sciences Institute, an industry trade group.

Critical responses from the medical and public health community have been swift and plentiful. Some experts challenged the guideline panel's assessment of the magnitude of beneficial health effects of eating less meat as "very small." For example, meta-analyses estimated that after about 11 years, dietary patterns with 3 fewer servings of red meat per week are associated with absolute risk differences of 6 fewer cardiovascular-related deaths (number needed to treat = 167) and 14 fewer persons developing diabetes (NNT = 71) out of every 1000 persons. To an individual, these differences seem small, but if true, they compare favorably with the NNTs of established clinical preventive services such as colorectal cancer screenings and therapy for osteoporosis. Others faulted the guideline for excluding benefits to animal welfare and the environment from lower population-wide meat consumption. Goals and guidelines for what constitutes a healthy diet will continue to evolve, but this one has provided much food for thought.

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This post first appeared on the AFP Community Blog.

Monday, September 30, 2019

Screening for autism spectrum disorder: the jury is still out

In 2007, the American Academy of Pediatrics (AAP) first recommended using a standardized autism-specific tool to screen all children for autism spectrum disorder at the 18- and 24-month well-child visits. In a recent national survey, most pediatricians reported following this guidance, but I suspect that screening rates are considerably lower among family physicians. In my practice, I don't use an autism-specific screening instrument unless either I or the child's parent or guardian have behavioral concerns, in which case it's no longer screening, but evaluation.

Why not? In 2016, the U.S. Preventive Services Task Force concluded that "current evidence is insufficient to assess the balance of benefits and harms of of screening for autism spectrum disorder (ASD) in young children for whom no concerns of ASD have been raised by their parents or a clinician." The Task Force observed that most ASD treatment studies included children who were considerably older than those identified through screening, and that no controlled studies have looked at the comparative clinical outcomes of screening-identified children with ASD, which is what a guideline writer would definitely want to know before recommending universal screening, even if the AAP didn't think so.

Dr. Doug Campos-Outcalt, a longtime colleague who has served as the American Academy of Family Physicians' liaison to the USPSTF, wrote in American Family Physician that four critical questions needed to be answered before screening for ASD would be "ready for prime time":

1. What are the sensitivity and false-positive rate of the best screening test for ASDs available in an average clinical setting?

2. How much earlier can screening tests detect ASDs compared with an astute clinician who asks a few key questions about, and acts on, parental concerns regarding a child's communication and interactions?

3. What are the potential harms of testing?

4. Does earlier detection by screening result in meaningful and long-lasting improvements compared with detection through routine care?

Although the answers to the second and fourth questions are arguably the most important, until last week there was little evidence to answer the first and third, either. If the recommended screening test, the Modified Checklist for Autism in Toddlers, Revised, with Follow-Up (M-CHAT-R/F), can't reliably detect most children who will eventually develop symptoms of ASD in later life, or there are so many false positives that the harms of parent anxiety and unnecessary diagnostic evaluations would outweigh the benefits, then universal screening is unlikely to work. Unfortunately, the first large study (n=26,000) of near-universal screening for ASD in 31 primary care clinics affiliated with Children's Hospital of Philadelphia just provided disappointing results on both of these fronts. Using an older version of the M-CHAT, the sensitivity of screening was only 38.8%, and only 14.6% of children who screened positive ultimately received an ASD diagnosis, with even lower positive predictive value in children residing in lower-income households.

The authors pointed out that nearly 60% of children with initial positive screens did not return for a follow-up interview that might have reduced false positives and improved predictive value, and that children with positive screens who were diagnosed with ASD were more likely to receive interventions at a younger age, potentially improving outcomes. But the former simply shows how a two-stage screening test performs in real life, rather than in a controlled research setting. As for the latter, outside of anecdotes from screening advocates, we still have no conclusive evidence that long-term outcomes turn out better in these children. The bottom line? For universal screening for ASD in toddlers, the jury is still out.

Monday, September 23, 2019

Using life expectancy and prognosis to support shared decision-making

Due to competing causes of death (e.g., heart disease, stroke, dementia), the benefits of most screening tests decline with increasing age; for example, screening for breast and colorectal cancers is not recommended in persons with a life expectancy of less than 10 years. However, estimating how much time an individual has left to live and incorporating that estimate into shared decision-making with patients is challenging. As a result, a 2014 U.S. population-based survey found that 31% to 55% of participants with a greater than 75% risk of death in the next 9 years were still receiving breast, colorectal, or prostate cancer screenings.

There are many reasons why physicians provide so many unnecessary and potentially harmful screening tests to older persons with limited life expectancies. In an editorial in the September 1 issue of American Family Physician, Dr. Emma Wallace and Norah Murphy observed that "barriers to discussing life expectancy include uncertainty in prognostic estimates, limited time to broach this sensitive topic, and concerns about upsetting the patient or getting negative reactions."

A systematic review of the prognostic value of the "Surprise Question" approach (which asks clinicians, "would you be surprised if this patient died in the next 12 months?") found that the answer has varying degrees of accuracy at identifying patients in their last year of life. The QMortality tool, in contrast, generates a more precise estimate of one-year mortality in persons age 65 to 99 years utilizing multiple clinical and demographic variables, and was found to have good predictive accuracy in 500,000 family practice patients in England.

Some patients may feel uncomfortable about stopping nonbeneficial screening tests even if they are objectively unlikely to benefit from them. In a mailed survey of patients age 50 years or older in the Veterans Affairs health system, nearly 30 percent reported being "not at all comfortable" with discontinuing screening colonoscopy in a hypothetical patient scenario where a colorectal cancer-specific risk calculator predicted a low likelihood of benefit. To help physicians sensitively incorporate prognostic information into discussions about continuing or discontinuing screening, the University of California San Francisco's ePrognosis website provides risk calculators and video examples demonstrating key communication skills.

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This post first appeared on the AFP Community Blog.

Monday, September 16, 2019

Too much medicine: research spotlights tests and interventions to consider avoiding in practice

In the fourth installment of an annual series, Drs. Roland Grad and Mark Ebell presented the "Top POEMs of 2018 Consistent with the Principles of the Choosing Wisely Campaign" in the September 1 issue of American Family Physician. Unlike the official list of Choosing Wisely campaign recommendations produced by the American Academy of Family Physicians and many other medical organizations, these suggested clinical actions were generated from recent research studies whose findings were judged by members of the Canadian Medical Association to help reduce overdiagnosis and overtreatment in practice. Drs. Grad and Ebell reviewed 13 of these POEMs (patient-oriented evidence that matters) in a previous article on the top 20 research studies of 2018 for primary care physicians.

This year's Choosing Wisely review article covered musculoskeletal conditions, respiratory disease, infections, cardiovascular disease, and miscellaneous topics. Here is a handy "cheat sheet":

1. Subacromial decompression surgery does not work.

2. Amitriptyline has no long-term benefits for chronic lower back pain.

3. In adults with mild asthma, as-needed budesonide/formoterol is as effective as a daily inhaled steroid.

4. In children with acute respiratory infections, broad-spectrum antibiotics are not more effective, but cause more adverse events, than narrow-spectrum antibiotics.

5. For chronic sinusitis, saline irrigation helps, and irrigation plus an intranasal steroid may help a little more.

6. A lower threshold for defining high blood pressure may harm patients at low risk for cardiovascular disease.

7. Don't order a high-sensitivity troponin level for a patient with a low pretest likelihood of myocardial infarction.

8. For women with symptomatic postmenopausal atrophic vaginitis, a nonprescription nonhormonal lubricant may be as effective as a vaginal estrogen tablet.

9. In adults with type 2 diabetes, NPH insulin is a cost-effective alternative to insulin analogues.

10. Ibuprofen is as effective as oral morphine for pain relief in children after minor outpatient orthopedic surgery, and has fewer side effects.

11. Skip the bath oil in children with atopic dermatitis.

Many of these overused tests and interventions are based on faulty pathophysiologic reasoning (e.g., if lowering blood pressure somewhat is good, then lowering blood pressure more should be even better).

Another valuable review of other research studies published in 2018 that highlighted medical overuse and health care services of questionable benefit appeared in JAMA Internal Medicine last week.

In a recent commentary on overuse in BMJ Evidence-Based Medicine, Drs. David Slawson and Allen Shaughnessy argued that "reducing overuse begins with the recognition and acceptance of the potential for unintended harm of our best intentions." They provided five examples of unintended harms of making medical decisions based on "what ought to work" rather than "what does work": activism gone awry (believing that no one is harmed by screening); innocent bystanders (traumatized loved ones of newborns with false positive screening results); the worried well we create (prediabetes); the butterfly effect (higher motor vehicle accident rates in patients with diabetes due to medication-induced hypoglycemia); and out of Oz and back to Kansas (over-extrapolating from research studies performed in ideal circumstances to real-world practice).

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This post first appeared on the AFP Community Blog.

Tuesday, September 10, 2019

Draft USPSTF statement on screening for illicit drug use requires major revisions

It may surprise some observers that for its first quarter century, the U.S. Preventive Services Task Force did not post draft research plans, recommendation statements or systematic reviews online for public comments. Instead, these documents were developed and discussed on private conference calls and voted on at invitation-only Agency for Healthcare Research and Quality meetings, which I attended as a medical officer from 2006 through 2010. This policy changed after the media uproar over the USPSTF's 2009 mammography recommendations, which included criticism for the Task Force's lack of transparency in guideline development. Reluctant to open their meetings to the public out of fear that it would stifle candid debates about politically sensitive subjects, the USPSTF chose, instead, to institute a one-month public comment period on draft documents before finalizing their recommendations.

For the first few years, public comments resulted in few significant changes to draft statements. However, there are now examples of the public comment period leading to substantial changes in recommended testing options and letter grades in high-profile topics such as screening for colorectal cancer and cervical cancer. That's a good thing, since the USPSTF draft statement on screening for illicit drug use, which recently closed to public comments*, requires major revisions.

In 2008, the USPSTF concluded that "the current evidence is insufficient to assess the balance of benefits and harms of screening adolescents, adults, and pregnant women for illicit drug use." What specific evidence gap prevented them from making a recommendation?

The most significant research gap identified by the USPSTF is the lack of studies to determine if interventions found effective for treatment-seeking individuals with symptoms of drug misuse are equally effective when applied to asymptomatic individuals identified through screening.

Consequently, the research plan finalized by the USPSTF in October 2016 to update their 2008 statement focused on summarizing evidence of the benefits and harms of counseling interventions to reduce drug use in "screen-detected persons." Focusing the systematic review on this population recognized that their willingness and motivation to change their drug use behavior in response to an intervention likely differs from those who actively seek medical treatment.

The draft review produced by the team that carried out this research plan determined that a great deal more applicable evidence was published in the past decade: 27 randomized, controlled trials with a total of 8,705 participants. The studies' findings, however, were disappointing for advocates of screening:

Across all 27 trials, in general, there was no consistent effect of the interventions on rates of self-reported or biologically confirmed drug use at 3- to 12-month followup. Likewise, across 13 trials reporting the effects of the interventions on health, social, or legal outcomes, none of the trials found a statistically significant difference between intervention and control groups on any of these measures at 3- to 12-month followup.

In other words, interventions for persons who had illicit drug use detected by screening didn't reduce drug use, improve physical health, or lead to fewer brushes with the law. No benefit + no harm (though only 4 studies reported on potential screening harms) = no net benefit. So the appropriate response to the evidence would be to either recommend against primary care screening for illicit drug use (since it adds burden to practices without benefiting patients), or, if the studies were considered too heterogenous to make that definitive a conclusion, to declare the evidence insufficient to determine the balance of benefits and harms.

Here, though, is where the Task Force appears to have gone off the rails. Rather than draw one of these two evidence-based conclusions, they instead commissioned a second systematic review from a completely different team (without posting a new research plan for public comment) seeking evidence on interventions in treatment-seeking populations. This draft review concluded that psychosocial interventions increase the likelihood of abstinence from drug use for up to 12 months, and that there are effective medications for opioid use disorder in persons who desire treatment (nice to confirm, but hardly a novel finding). The USPSTF relied on this second review (and apparently ignored the first one) to support their draft "B" recommendation to screen for illicit drug use in adults age 18 years or older.

Don't primary care clinicians already ask their patients about illicit drug use? We certainly do, as part of taking the social history of a new patient, but not in the methodical, intensive way that the USPSTF is now recommending. Perhaps the Task Force felt compelled by the pressure of the opioid epidemic to offer something more in terms of clinical prevention than an "I" statement or a politically unpalatable "D" recommendation against screening. Regardless of their rationale, by bypassing their published methods and processes to produce a statement that the evidence clearly doesn't yet support, the USPSTF has ventured onto dangerous ground, raising questions about their scientific credibility at a time when evidence-based institutions need to be defended more than ever.

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* - A summary of my assertions in this post was submitted to the USPSTF during the public comment process.

Thursday, September 5, 2019

What we choose to name a disease matters

A few years ago around this time, I was dealing with a series of minor health problems. I developed a sinus infection that took several weeks to resolve. I twisted one of my knees ice skating, and for a while I feared that I had torn a meniscus. Occasionally after eating a heavy meal, I had the sensation that food was getting stuck on the way to my stomach - so along with an x-ray and MRI for my knee, my doctor also sent me for an upper GI series. Finally, my blood tests for a new life insurance policy came back with a slightly high hemoglobin A1c level. The A1c test was once used only to monitor glucose control in patients with established diabetes, but in 2010 the American Diabetes Association changed their diagnostic criteria to classify an A1c level of 6.5% or greater as consistent with diabetes, 5.7% to 6.4% as prediabetes, and 5.6% or lower as normal. So on top of knee tendinitis and gastroesophageal reflux disease (GERD), I also found out that I had prediabetes.

Intellectually, I knew that there was no evidence that screening for prediabetes is beneficial (the life insurance company, not my doctor, had ordered the test), and that a screen-and-treat approach to diabetes prevention leads to lots of overdiagnosis. Emotionally, it was a different story. I had recently turned 40 and was feeling old. It had been years since I had gotten the recommended amount of physical activity for adults, and now I was doing even less because my knee hurt. It didn't help that the afternoon I found out about my A1c level, my wife called and asked me to pick up some Burger King sandwiches and fries to bring home for dinner. Not exactly what a pre-diabetic adult with GERD should be eating.

Would I have felt less sick if I had instead been told that I had "slightly high blood sugar"? In recent years, oncologists have recommended re-naming slow-growing lesions that we currently call cancer, such as "ductal carcinoma in situ" of the breast, indolent lesions of epithelial origin (IDLE), hoping that a less scary term will discourage patients from pursuing unnecessarily aggressive (and potentially harmful) treatment. Similarly, a study showed that telling patients that they have a "chest cold" rather than "acute bronchitis" will help them feel more satisfied when they don't receive an antibiotic prescription.

systematic review published in BMJ Open supported the notion that what clinicians choose to name a disease influences patients' management preferences. Some study examples: women who were told they had "polycystic ovary syndrome" were more likely to want a pelvic ultrasound than those who were told they had a "hormone imbalance." Women were more likely to want surgery if they had "pre-invasive breast cancer cells" versus "abnormal cells" or a "breast lesion." Patients were more likely to expect surgery or casting of a "broken bone" or "greenstick fracture" than a "hairline fracture" or "crack in the bone." In each of these cases, the use of a more medicalized or precise term led patients to prefer invasive management options that were no better than more conservative choices.

How will I apply this knowledge to my daily practice? Although I already use the term "prediabetes" sparingly (preferring "increased risk for diabetes"), I'm going to start telling more patients with A1c levels similar to mine that they have high blood sugar instead. That they have heartburn rather than GERD. That they have overuse knee strains instead of tendinitis. And certain medical terms, such as "advanced maternal age" (i.e., pregnancy after the age of 35, or my wife's age when she gave birth to 3 of our 4 children), I will strive to eliminate from my vocabulary entirely.

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A slightly different version of this post first appeared on Common Sense Family Doctor on October 5, 2017.

Thursday, August 22, 2019

Vaping and health: some answers, more questions

As the Centers for Disease Control and Prevention is actively investigating a cluster of severe lung illnesses in 14 states that may be linked to e-cigarette use among adolescents and young adults, an article in the August 15 issue of American Family Physician discusses common questions and answers about vaping and health. Since my colleague Dr. Jennifer Middleton's 2016 blog post on the promise and perils of e-cigarettes, more data has accumulated about the potential harms and benefits of this increasingly common activity. In 2017, one in five high school students reported e-cigarette use in the previous year, leading U.S. Surgeon General Jerome Adams to issue an advisory last year that labeled e-cigarette use in youth a "public health epidemic." More recent data from the Monitoring the Future survey suggested that this epidemic shows no signs of slowing:

Put in historical context, the absolute increases in the prevalence of nicotine vaping among 12th-graders and 10th-graders are the largest ever recorded by Monitoring the Future in the 44 years that it has continuously tracked dozens of substances. These results indicate that the policies in place as of the 2017–2018 school year were not sufficient to stop the spread of nicotine vaping among adolescents.

Although a nationally representative survey of parents of middle and high school students found that nearly all are aware of e-cigarettes, only 44% accurately identified an image of the "pod mod" device Juul; less than one-third reported concerns about their own child's use of e-cigarettes; and nearly three-quarters had received no communication from their child's school regarding the dangers of e-cigarettes. To help clinicians counsel parents and adolescents about vaping and Juuls, a patient education handout accompanying the AFP article highlights important discussion points.

It remains unclear whether e-cigarettes can help adults who are trying to quit smoking. E-cigarettes are not approved by the U.S. Food and Drug Administration as smoking cessation devices; however, a recent randomized trial in the U.K. National Health Service found that in smokers receiving weekly behavioral support, the 1-year abstinence rate in the e-cigarette group was superior to that of smokers using traditional nicotine replacement products. Notably, 80 percent of the e-cigarette group was still vaping after 1 year, compared with only 9 percent of the nicotine-replacement group - a troubling secondary finding given the unknown long-term health consequences of e-cigarette use.

In addition, the AFP article cautions that "unlike nicotine replacement therapy, the advertised nicotine dose on the labeling of e-cigarettes is not always consistent with laboratory analysis of the e-cigarette liquid, and the device and user behavior may affect the dose of nicotine received." Consequently, the authors recommend that clinicians first counsel patients to quit using evidence-based smoking cessation guidelines such as those from the U.S. Preventive Services Task Force, and only discuss using e-cigarettes if these methods are ineffective. In my own practice, I've yet to meet a patient who has successfully quit smoking by switching to e-cigarettes.

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This post first appeared on the AFP Community Blog.

Tuesday, August 6, 2019

What is the appropriate role of experts in primary care guidelines?

This week, a Health Affairs blog post titled "Fixing Clinical Practice Guidelines" echoed several concerns I've discussed previously: practice guidelines are being produced in abundance but often have variable methodological quality, financial conflicts of interest that threaten objectivity, and/or poor applicability to the clinicians and populations for whom they are intended. To address these problems, the authors reasonably suggested restoring funding for AHRQ's National Guideline Clearinghouse and giving this centralized guideline repository the authority to require that guidelines meet a universal, rigorous methodology standard (including policies to avoid conflicts of interest) for inclusion.

My only real quibble with the commentary is its title: clinical practice guidelines have problems, but they're not broken. I am currently a volunteer panel member for three guidelines in various stages of development, sponsored or co-sponsored by three different medical specialty societies. Each guideline is following the National Academy of Medicine's (formerly Institute of Medicine's) standards for trustworthy guideline development and on track to produce practical recommendations for clinicians that are consistent with the best evidence on each topic. If I didn't think that these guidelines were worthwhile endeavors, I wouldn't have agreed to spend so many hours reviewing and discussing studies, systematic reviews, and meta-analyses, and drafting the text of the recommendations.

Drs. Benjamin Djulbegovic and Gordan Guyatt recently argued in a JAMA Viewpoint that we should not make false distinctions between evidence-based and consensus-based guidelines, since the "evidence alone never speaks for itself" and interpretation of evidence by guideline panelists via a consensus process is always required. Therefore, consensus-based does not necessarily imply weak or insufficient evidence; rather, "the crucial difference between evidence-based medicine and non-evidence-based medicine methods is that the former necessitates that judgments are consistent with underlying evidence, whereas the latter do not."

To me, "non-evidence-based" or "expert consensus" calls to mind an outdated process for developing guidelines (though some groups still use it): assemble a group of distinguished subject matter experts, ask them to formulate some recommendations based on their own practices (which, since they're the experts, must be the most effective and efficient ways to manage patients with the condition), find some published references to support what the experts already know, then write up a report. Bonus points if the guideline panel has an authoritative-sounding name such as the Joint National Committee (whose hypertension guidelines, until JNC 8 at least, largely followed an expert consensus process).

Applying the evidence-based paradigm to primary care guidelines, then, what is the appropriate role of experts? Since a well-conducted systematic review ought to retrieve all relevant research evidence, and guideline panelists should already have expertise in evidence interpretation and grading of recommendations, what more can experts bring to the table? In a BMJ analysis, Dr. Holger Schunemann and colleagues make a useful distinction between "expert evidence" and "expert opinion": evidence is factual, while opinion is a judgment that may (or may not) be based on facts:

For example, a patient might say: “I had prostate cancer detected by prostate specific antigen (PSA) screening and I am alive 10 years later.” That is evidence. It is not the same as saying: “PSA screening saved my life.” That is an opinion. Similarly, a clinical expert might say: “I operated on 100 patients with prostate cancer and none of them died from prostate cancer.” That is evidence. It is not the same as saying: “Prostatectomy is effective.” That is an opinion. In both cases, the opinions might be based on that evidence, but the evidence is clearly not the same as the conclusion.

Schunemann and colleagues review several pitfalls of expert evidence and opinion: not distinguishing between the two; untimely introduction of expert evidence; inadequate disclosure or management of financial and intellectual conflicts of interest; and inadequate appraisal of expert evidence. To make the influence of expert evidence on guidelines more transparent, they advise (and I agree) that it be collected systematically and appraised using the same methodology as for research evidence, which gives more weight to experimental studies or systematically collected observations that are less likely to be biased than a subspecialist physician's personal experiences.

Sunday, July 28, 2019

Deliberate clinical inertia protects patients from low value care

Clinical inertia is usually considered to be a negative term, used to refer to situations in which clinicians do not appropriately initiate or intensify therapy for uncontrolled chronic conditions. For example, a recent study in JAMA Internal Medicine found that less than one-quarter of patients with chronic hypercalcemia in the Veterans Affairs health system received recommended parathyroid hormone level testing, and only about 13 percent of patients who met diagnostic criteria for primary hyperparathyroidism underwent parathyroidectomy.

However, clinical inertia has also been described as a "clinical safeguard" against aggressive consensus guideline prescriptions that do not account for patient preferences and/or potential harms of intensifying treatment. For example, an analysis of the incremental benefits of and harms of the 2017 American College of Cardiology / American Heart Association guideline that redefined hypertension as a sustained blood pressure of >= 130/80 mm Hg concluded:

For most adults newly classified as having high blood pressure under the ACC/AHA guideline (the 80% of those newly diagnosed who have <10% 10-year risk), there is no incremental benefit in CVD risk reduction, but potential incremental harms from disease labeling, and, for those who meet the threshold for drug treatment, from adverse drug effects.

In this instance, a large number of patients with systolic blood pressures between 130 and 140 mm Hg could potentially benefit from clinical inertia by avoiding a hypertension diagnosis, additional testing, or prescription medications.

In a 2011 JAMA commentary, Drs. Dario Giugliano and Katherine Esposito observed that clinical inertia "also may apply to the failure of physicians to stop or reduce therapy no longer needed," but that "this neglected side of clinical inertia does not seem to generate as much concern among physicians or scientific associations." A review of polypharmacy in the July 1 issue of American Family Physician noted that regular use of at least five medications is associated with decreased quality of life, increased mobility problems and falls, greater health system use, and increased long-term care placement. Judicious deprescribing can help reduce polypharmacy and improve patient outcomes.

Another (sometimes better) strategy is not starting nonbeneficial medications for unclear reasons in the first place. In a 2018 article in Emergency Medicine Australasia, Dr. Gerben Keijzers and colleagues defined "deliberate clinical inertia" as "the art of doing nothing as a positive response." Arguing that doctors generally have a bias to intervene with diagnostic tests, drugs, or procedures, they suggested reframing the typical decision-making approach:

In clinical practice, 'risk versus benefit' is usually considered in terms of missing a diagnosis rather than potential risks of treatment, so a better approach to care may be to ask, 'Is this intervention more likely to cause harm than the underlying condition with its possible harm or risk?' There are many reasons why 'doing nothing' is difficult, but doing what we can to provide excellent care while preventing medical harm from unnecessary interventions must become one of the pillars of modern holistic healthcare.

Health professionals may readily grasp the rationales behind campaigns to avoid harms and costs of low value care such as Choosing Wisely and Right Care, but patients may be skeptical. Dr. Keijzers and colleagues suggested several ways to support deliberate clinical inertia in practice: empathy and acknowledgment; symptom management; clinical observation; explanation of the natural course of the condition; managing expectations; and shared decision-making ("communicating rather than doing").

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This post first appeared on the AFP Community Blog.

Tuesday, July 23, 2019

Admissions straight talk from ... me!

Many thanks to Linda Abraham for interviewing me on Admissions Straight Talk about my path in medicine and recent blog post critiquing the U.S. News & World Report's medical school rankings. You can either listen to the full podcast episode embedded below or read a summary of the high points on her Accepted website.


Wednesday, July 17, 2019

The places in America where doctors won't go

Two years ago, I attended the annual Teaching Prevention conference in Savannah, Georgia. Since I hadn't spent much time in Georgia outside of Savannah and Atlanta, the welcoming plenary on improving health outcomes for the state's rural and underserved populations was eye-opening. According to Dr. Keisha Callins, Chair of the Department of Community Medicine at Mercer University, Georgia ranked 39th out of 50 states in primary care physician supply in 2013 and was projected to be last by 2020. 90% of Georgia's counties are medically underserved. Mercer supports several pipeline programs that actively recruit students from rural areas, expose all students early to rural practice and community health, and provide financial incentives for graduates who choose to work in underserved areas of the state. But it's an uphill battle. Even replicated in many medical schools across the country, these kinds of programs likely won't attract enough doctors to rural areas where they are most needed.

When people talk about places where doctors won't go, they tend to focus on international destinations, such as war zones in Syria or sparsely populated areas of sub-Saharan Africa. It's hard to believe that many places in America are essentially devoid of doctors, and access to medical care is as limited as in countries where average income is a tiny fraction of that in the U.S. Providing health care coverage for everyone, while important, won't automatically ensure the availability of health professionals and resources in rural communities. In a JAMA Forum piece, Dr. Diana Mason discussed the financial struggles of rural hospitals that support community health alongside primary care clinicians, which become more acute when budget cuts to rural health programs and grants occur.

Georgia is hardly the only state struggling to attract doctors to rural communities. In the Harper's Magazine story "Where Health Care Won't Go," Dr. Helen Ouyang chronicled the tuberculosis crisis in the Black Belt, a swath of 17 historically impoverished, predominantly African American counties in rural Alabama and Mississippi. In Marion, Alabama, a single family doctor in his mid-fifties and an overwhelmed county health department grappled daily with the lack of resources to contain the spread of the disease:

There is no hospital in town. The nearest one, twenty minutes away in Greensboro, has minimal resources. The road to get there is narrow, unlit at night, and littered with roadkill. Perry County has only two ambulances, one of which is on standby for the local nursing home. Life expectancy here is seven years lower than the U.S. average, and the percentage of obese adults is almost a third higher; by the latest count, more than a quarter of births take place without adequate prenatal care. [Dr. Shane] Lee’s clinic is Marion’s only place for X-rays.

Ouyang went on to describe the University of Alabama's Rural Health Leaders Pipeline, a program that recruits and trains medical students from rural communities to eventually become primary care physicians for those communities. Although the program has been modestly successful (since 2004, "more than half have gone on to work in rural areas, compared with only 7 percent of their classmates"), many Black Belt counties have yet to benefit from it. Many medical schools use a minimum score cutoff on the Medical College Admission Test (MCAT) that tends to penalize applicants from rural and minority communities, even though those students are more likely to become primary care physicians for underserved populations:

The purpose of doctors, after all, is to tend to patients’ ultimate needs. Increasing the supply of primary care physicians is linked to lower mortality rates; after compiling data from studies across different parts of the country, a group of public health researchers found that by adding one more doctor for every 10,000 people, as many as 160,000 deaths per year could be averted. When the same researchers considered race as a factor, this benefit was found to be four times greater in the African-American population than among white people. Studies have also observed that the availability of primary care significantly reduces health disparities that result from income inequality.


The problem of too few primary care clinicians is not limited to rural America, but those communities are where the need is greatest, since a town without a family doctor is unlikely to have any other types of physicians. Medical schools can't easily change social determinants of health on their own, but they can rewrite their mission statements to emphasize providing health care to everyone regardless of geography, and implement recruitment and admissions policies that actually support that goal.

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This post first appeared on Common Sense Family Doctor on June 5, 2017.

Tuesday, July 9, 2019

Population health, colorectal cancer screening, and guideline development

Although a recent vacation and catching up after returning to work have delayed posting to the blog, I wanted to share three of my recent publications in other venues that you might find to be of interest. In my latest Medscape commentary, I added my voice to an ongoing debate about the future role of family physicians in addressing population health and social determinants. Should we expect all family physicians to be "experts in population health," or limit population health training to basic competencies that are generally tied to clinical settings?

My view is that medical schools and residency programs should offer a scope of population health training that falls somewhere in between Dr. DeVoe's aspirational goals and Dr. Campos-Outcalt's minimum objectives, consistent with their institutional mission statements, faculty resources, and existing connections with community organizations. 

For example, over the past several years, my students and family medicine residents have benefited from classroom and experiential learning from faculty in Georgetown's Department of Health Systems Administration, its law school, and its school of public policy. Each year we raise the bar for population health in undergraduate medical education so that our graduates will be able to utilize population health skills in residency and, if desired, incorporate them into their future practices.

Meanwhile, over at American Family Physician, fellow Deputy Editor Mark Ebell, MD, MS and I launched a feature that evaluates new diagnostic tests:

[Diagnostic Tests: What Physicians Need to Know] uses a structured approach to review key test characteristics, including discussions of accuracy, benefits, harms, cost, and cost-effectiveness. It concludes with a clinical bottom line: Is there a role for this test in primary care practice and, if so, for which patients? We aim for this new feature to cut through the “hype” and provide independent, objective assessments of new diagnostic tests that readers are considering incorporating into their practices.

Family physicians and other primary care clinicians who read AFP can find my first piece in the series, mSEPT9 Blood Test (Epi proColon) for Colorectal Cancer Screening, in the July 1 issue of the journal.

Finally, on the AFP Community Blog, I took readers "behind the scenes" of the updated American Academy of Family Physicians (AAFP) clinical practice guideline on depression following acute coronary syndrome events. Those of you who are interested in learning more about how the AAFP develops guidelines can check out some of their background resources, such as a short video series and the detailed Clinical Practice Guideline manual. I am currently working with the AAFP to develop clinical practice guidelines on two common conditions encountered by family physicians.

As Common Sense Family Doctor approaches its 10-year anniversary (July 24, 2019), topics on deck for future posts include artificial intelligence (AI) in primary care, the upside of clinical inertia, and more developments in overdiagnosis. Stay tuned.

Saturday, June 22, 2019

Fear-mongering in thyroid and breast cancer screening

A large part of practicing primary care consists of providing reassurance to healthy persons. The patient who asks me to look at the mole on her back to make sure it isn't melanoma. The patient who recently recovered from a cold but is still coughing and wants to know that it isn't a sign of something more serious. The patient whose friend's doctor found a lump on his thyroid gland and wants to have his neck checked too.

The last time the U.S. Preventive Services Task Force recommended against screening for thyroid cancer was in 1996. That it took more than 20 years to release an updated recommendation statement (still a "D," or don't do) speaks to how non-controversial the Task Force judged this topic to be. Unfortunately, in the interim many clinicians and patients ignored this advice. In South Korea, a national cancer screening program that began in 1999 encouraged general practitioners to routinely perform thyroid ultrasound scans, resulting in an "epidemic" of new thyroid cancers but no change in thyroid cancer deaths. In the United States, papillary thyroid cancer diagnoses have quadrupled since 1995, again with no change in mortality. In both countries and around the world, physicians are finding and treating thousands of pseudo-cancers that would not have otherwise been found and don't need to be treated. Overdiagnosis begets more overdiagnosis: patients who are "successfully" diagnosed and treated tell friends and relatives to have their necks palpated or scanned for thyroid tumors. And if that feedback cycle wasn't enough, advocacy groups such as the Light of Life Foundation initiated fear-mongering awareness campaigns, as Dr. Gilbert Welch described in an editorial accompanying the USPSTF recommendation:

About a decade ago, public service announcements began to appear encouraging people to have their physicians “check your neck.” The Light of Life Foundation campaign featured actual testimonials of patients describing their positive health behaviors on the day before they were diagnosed with thyroid cancer. The ads used compelling language: “Thyroid cancer doesn’t care how healthy you are. It can happen to anyone. Including you. That’s why it is the fastest growing cancer in the US. Ask your doctor to check your neck. It could save your life.” The campaign’s title—and its main slogan—was “Confidence Kills.” That’s a great public health message: if you feel good, you are about to die.


Fear-mongering isn't limited to thyroid cancer, of course. From the 1980s-era American Cancer Society print advertisement that lectured women, "If you haven't had a mammogram, you need more than your breasts examined," promoters of breast cancer screening long used fear to motivate women to undergo screening mammography. In 2015, several advocacy organizations successfully persuaded the U.S. Congress to override the U.S. Preventive Services Task Force's "C" grade (small net benefit) on screening mammography for women aged 40-49 with a "Stop the Guidelines" campaign that included full-page advertisements in major newspapers asking the rhetorical question "Which of our wives, mothers, daughters, and sisters would be be OK to lose?"

The major difference between screening for thyroid and breast cancer is that the latter actually reduces cancer deaths. But women under 50 are less likely to benefit because there is less lethal breast cancer to be found in younger women, and consequently much higher false positive rates that affect more than half of all women receiving annual mammograms from age 40 to 50. And the USPSTF didn't tell clinicians don't screen - more accurately, they said don't screen reflexively, and the message to younger women is not to avoid mammograms, but to talk about the pros and cons with your doctor.

That hasn't stopped a new alliance of radiologists and breast cancer surgeons from targeting the Task Force with a 40not50 campaign which encourages women in their 40s to turn off their brains, eschew shared decision-making, and demand that their doctors start screening them at age 40 because mammograms save lives, and a government-appointed panel (whose 16 current members include 6 women) wants to prevent women from seeing their 50th birthdays. Notwithstanding the ulterior motives behind this absurd campaign, it is insulting to women. It says that they can't be trusted to consider the medical evidence, have conversations with their primary care physicians, and make decisions about their healthcare that are right for them.

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This post first appeared on Common Sense Family Doctor on May 16, 2017.

Monday, June 17, 2019

For most, an aspirin a day won't keep the doctor away

A daily low-dose (81 mg) aspirin was once considered an essential component of cardiovascular disease (CVD) prevention for middle-aged and older adults. In 2006, the National Commission on Prevention Priorities ranked "discussing aspirin use in high-risk adults" the highest priority preventive service based on clinically preventable burden and cost effectiveness, and two years ago, in an updated set of rankings, it still rated aspirin use as the fifth highest priority for improving utilization. However, in 2018 the results of three large randomized trials suggested that the harms of aspirin taken to prevent a first CVD event outweigh its benefits for most persons. In an editorial in the June 1 issue of American Family Physician, Dr. Jennifer Middleton and I reviewed the latest evidence and concluded:

The new data do not exclude the possibility that aspirin may still benefit adults at very high CVD risk (e.g., 20% or more over 10 years) or those at lower risk who are unable to tolerate statins, but the data otherwise suggest that the risks of low-dose aspirin therapy for primary prevention outweigh any potential benefits. For most patients, we should be deprescribing aspirin for primary prevention of CVD. To prevent heart attacks and strokes, family physicians should focus instead on smoking cessation and lifestyle changes, controlling high blood pressure, and prescribing statins when indicated.

In a 2019 clinical practice guideline, the American College of Cardiology / American Heart Association largely concurred, recommending against prescribing aspirin for primary prevention of CVD in adults older than age 70 and downgrading its role in other adults at high risk to "may be considered" on a case-by-case basis.

Although aspirin is still strongly recommended to prevent recurrent CVD events, its rise and fall in primary prevention seems to have become another case of medicine reversing itself. Unlike other notable examples of medical reversal such as menopausal hormone therapy and tight glucose control in type 2 diabetes, the effectiveness of aspirin was supported by many well-conducted randomized, controlled trials. Aspirin worked ... until it didn't. In a recent commentary in the Journal of General Internal Medicine, Palmer Greene and colleagues suggested that it may be a good idea to consider established evidence-based practices as having an "expiration date":

An “evidentiary statute of limitations” would require the occasional reassessment of accepted therapies to consider which might no longer be of use—possibly because of changes in the population as a whole, a changing understanding of whom the treatment is appropriate for, or evolving therapies for the prevention or treatment of the disease in question. Not only should we consider if older data still applies, we should also strive to anticipate the factors to which the results of a newly published positive study might be sensitive. For instance, is there an event rate in the control group below which the harms of the therapy might outweigh the benefit? Is there a treatment success rate that, when achieved, would make screening inefficient?

Not starting aspirin is relatively straightforward, but patients who have taken aspirin for many years without adverse effects or CVD events may resist discontinuing it. After making sure that we are appropriately treating all of their risk factors (e.g., high blood pressure, high cholesterol, diabetes, tobacco use), I have taken a shared decision-making approach to these deprescribing discussions, emphasizing the small additional benefit of aspirin compared to the increased risk of serious bleeding events.

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This post first appeared on the AFP Community Blog.

Monday, June 10, 2019

The problems with using population-level data to estimate prostate screening benefits

Almost any debate about the effectiveness (or lack thereof) of PSA-based screening for prostate cancer in the U.S. will usually involve whether the results of the two largest randomized screening trials or national mortality statistics more accurately represent the effects of intensive screening from the early 1990s to the late 2000s. Putting aside the conflicting results of the U.S. Prostate, Lung, Colorectal, and Ovarian Cancer Screening (PLCO) trial and the European Randomized Study of Screening for Prostate Cancer (ERSPC) - for which there are many plausible explanations - even the most optimistic statistical interpretation of these trials suggests that PSA screening reduces prostate cancer mortality by 25-30% at best, which does not fully account for the observed 40% decline in prostate cancer mortality from 1991 to 2008. Since the effectiveness of standard prostate cancer therapy did not change significantly during this time frame, PSA screening advocates have suggested that the discrepancy is probably due to flaws in the trials, rather than issues with "real-world evidence" derived from population-level mortality data.

However, in a thoughtful commentary recently published in Mayo Clinic Proceedings, Drs. Joaquin Chapa, Alyson Haslam  and Vinay Prasad provide lots of good reasons to question the validity of prostate cancer mortality trends. First, as any clinician who has filled out a death certificate knows, determining the underlying cause of death can be difficult in a patient with several serious health conditions. Patients with metastatic prostate cancer may die with incurable cancer, but not of it. Then, the algorithm used by the Mortality Medical Data System may introduce error, noise, and bias because prostate cancer is accepted as an underlying cause of death for many conditions (e.g., cirrhosis, bacterial endocarditis) that could be related to the cancer but could also simply co-exist.

In addition, studies show that patterns in attribution of causes of death often change over time due to factors other than actual changes in underlying causes. Changes in population composition (e.g., increases in the Hispanic and Asian proportion of the population relative to whites and African Americans) can also result in different overall prostate cancer mortality rates by increasing the percentages of populations who have lower cancer mortality.

In contrast, the methods used to determine causes of death in PLCO and ERSPC were much more rigorous; the cause listed on the death certificate was double-checked by 1 to 3 independent, blinded reviewers. These processes demonstrated that assigning a cause of death is potentially fraught with error and subject to human bias. As Chapa and colleagues observe:

Even with more rigorous processes for determining COD in the PLCO and ERSPC trials, COD determination remains difficult and is subject to uncertainty. Of all deaths in the PLCO study, 28% required additional human review because of discordance between the death certificate and the initial human reviewer. Of reviewed cases, 3% required a conference call to resolve discordance among 3 reviewers.

I've always thought that crediting PSA screening for the historical decline in U.S. prostate cancer mortality made little sense; for one thing, one wouldn't expect a mortality difference to be visible for at least 7-8 years after screening became common in clinical practice, the earliest point in the ERSPC trial when the survival curves separate. That would have been 1997 or 1998 at the earliest, not 1991. Other studies have observed that prostate cancer mortality also began falling in the U.K. in the 1990s, even though PSA screening was uncommon. This new analysis provides even more reason to doubt that there is a straightforward cause-and-effect relationship - if, indeed, there is any relationship at all.

By the way, I'd like to give a shout-out to the terrific medical podcast Plenary Session, hosted by Dr. Prasad. An interview with Dr. Chapa in a recent episode was the reason I knew about his paper in the first place. Plenary Session is too new to have made my most recent list of favorite podcasts, but you can bet that it will be on the next one.

Wednesday, May 29, 2019

Reforming medical school rankings and admissions criteria to meet urgent national needs

If you read my curriculum vitae, you might assume that I must have a high opinion of the U.S. News & World Report higher education rankings. I earned my bachelor's degree from Harvard University, #2 behind Princeton in the "Best National Universities" category. My Master of Public Health degree is from Johns Hopkins, the #1 public health school. And my medical degree is from NYU, tied with Cornell and the Mayo Clinic as the 9th ranked research medical school, and likely to move up due to its decision to go tuition-free last fall (though whether NYU will improve its middling primary care ranking is uncertain at best). To top it all off, I even wrote a blog for U.S. News for a year called "Healthcare Headaches."

I admit that when I applied to college and medical school, I placed a great deal of stock - far too much - in these rankings. (I ended up at Johns Hopkins for public health because it was local, offered a part-time/online option, and I already had connections there.) But as my formal education recedes into the rearview mirror of my career, I find, instead, that I agree with Northwestern University professor William C. McGaghie's renewed critique of the U.S. News rankings published recently in Academic Medicine.

Dr. McGaghie observed that "the methods used by U.S. News & World Report to rank medical schools are based on factors that can be measured easily but do not reflect the quality of a medical school from either a student or patient perspective." For example, 20% of the research and primary care ranking reflects "student selectivity," a combination of incoming students' mean undergraduate grade point averages (GPAs), Medical College Admission Test (MCAT) scores, and acceptance rates. These criteria may modestly predict academic performance in preclinical courses, but have virtually no impact the quality of doctors schools produce. They also have real downsides. As Dr. Arthur Kellermann, dean of the Herbert School of Medicine at Uniformed Services University, wrote in explaining his school's 2016 decision to stop participating in the U.S. News medical school rankings:

Schools have a perverse incentive to boost their rank at the expense of applicants and the public. Based on the methodology used by U.S. News, a medical school that wants to boost its rank should heavily favor applicants with super-high MCAT scores and grade point averages and ignore important attributes such as character, grit, and life experiences that predict that a student will become a wonderful doctor. A school might also encourage applications from large numbers of people with little or no chance of acceptance simply to boost its “selectivity” score.

This isn't to say that prospective medical students can't have stellar test scores and GPAs and great character and life experiences - I interview several every year. But I wonder how many outstanding future physicians we also prematurely weed out by our slavish devotion to the former metrics. I write from personal experience: my overall undergraduate GPA was 3.4, and my GPA in science prerequisite courses closer to 3.2, which caused my applications to be automatically rejected at several medical schools I applied to - including the one where I'm now a full Professor.

From the perspective of a patient or a community, the outcome that matters most for a medical school is how well it fulfills its social mission: to produce physicians who improve the health of the communities it serves, including an optimal mix of generalists and subspecialists; urban, suburban, and rural physicians; practicing physicians, teachers, and researchers. In 2010, Dr. Fitzhugh Mullan and colleagues published the first ranking of medical schools based on social mission, which eventually evolved into the Robert Wood Johnson Foundation-supported Social Mission Metrics Initiative, a national survey that enables dental, medical, and nursing school deans to receive confidential feedback on their performance in 18 social mission areas.

As Dr. Eric Topol wrote in Deep Medicine, the forthcoming integration of artificial intelligence (AI) into medical care over the next few decades is another good reason to change the way we evaluate medical school applicants:

Are we selecting future doctors on a basis that can be simulated or exceeded by an AI bot? ... Knowledge, about medicine and individual patients, can and will be outsourced to machine algorithms. What will define and differentiate doctors from their machine apprentices is being human, developing the relationship, witnessing and alleviating suffering. Yes, there will be a need for oversight of the algorithmic output, and that will require science and math reasoning skills. But emotional intelligence needs to take precedence in the selection of future doctors over qualities that are going to be of progressively diminished utility.

In another Academic Medicine commentary, Dr. Melanie Raffoul (a former Georgetown Health Policy Fellow) and colleagues offered a starting point for medical and other health professions schools to "meet the needs of tomorrow's health care system." Among other things, they proposed 1) incorporating emotional intelligence testing into admissions criteria; 2) specifically recruiting from rural and underserved settings; 3) "consciously reaching out to disadvantaged and underrepresented students at the primary and secondary education levels"; 4) establishing community partnerships to develop pools of eligible trainees; 5) bridging gaps between health care and public health; and 6) supporting health professions education research. Ironically, the most effective way to motivate schools to make these wide-ranging changes might be for U.S. News to weigh these factors heavily in next year's rankings. If that happened, my current dim view of the rankings would change dramatically.

Saturday, May 25, 2019

Reducing medication cost burden in primary care: challenges and opportunities

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) finalized a new rule requiring that pharmaceutical companies disclose drug list prices in direct-to-consumer television advertisements for drugs that cost more than $35 for a month's supply or usual course. A fact sheet further explaining the rule noted that "the 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy." Although pricing transparency could push patients to select more affordable or non-pharmacologic alternatives, and help clinicians improve high-value prescribing, it unfortunately does not make these drugs any less expensive.

In an editorial in the April 1 issue of American Family Physician, Dr. Randi Sokol discussed four strategies for helping patients with type 2 diabetes mellitus afford insulin while providing evidence-based care: 1) Relax A1c goals to 8% or less; 2) Switch to human insulins instead of insulin analogues; 3) use Health Resources and Services Administration-certified 340B pharmacies and patient assistance programs; and 4) join advocacy efforts to reduce the high cost of insulin and other drugs, such as the Lown Institute's Right Care Alliance and the American Medical Association's Truth in Rx.

Family physicians can take a systematic approach to reducing prescription costs for all of their patients. In an article published in FPM, Dr. Kevin Fiscella and colleagues described the approach taken by 7 primary care practices in New York, Georgia, and California. Office staff screen patients for prescription cost concerns by privately asking them, "Is the cost of any of your medications a burden for you?" For patients who answer yes, clinicians briefly explore the circumstances (e.g., unmet deductible, use of brand name drugs) and employ several cost-reducing strategies, including deprescribing unnecessary medications, using extended (90-day) prescriptions, and substituting lower-cost medications or referring patients to large chain pharmacy discount programs (e.g. "$4 lists").

In a preliminary study published in a supplement to the Annals of Internal Medicine, Dr. Fiscella's team found that a single 60-minute training for clinicians and staff on cost-of-medication importance, team-based screening, and cost-saving strategies increased the frequency of cost-of-medication conversations from 17% to 32%. Other helpful articles in the same supplement supported by the Robert Wood Johnson Foundation included "The 7 Habits of Highly Effective Cost-of-Care Conversations" and "Tools to Help Overcome Barriers to Cost-of-Care Conversations." The American College of Physicians offers several additional cost-of-care conversation resources on its website.

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This post first appeared on the AFP Community Blog.

Tuesday, May 21, 2019

Is Common Sense Family Doctor a professional liability?

In the many talks I've given about blogging and social media over the years, one question that almost always came up was some variation of, "can being opinionated on social media hurt my career?" My usual response is no, provided that you don't do unprofessional things like post photos of identifiable patients or insult current or former supervisors. And even if some readers have been turned off by my less-is-more medical philosophy (which my friend and cardiologist John Mandrola recently termed "being a medical conservative"), for me any negative consequences of blogging are greatly outweighed by the positives. These include many speaking and writing invitations, positive recognition in family and conservative medicine communities, and appointments to practice guideline and advisory panels such as the Advisory Committee on Breast Cancer in Young Women. At the Society of Teachers of Family Medicine conference in Toronto, I was humbled by how many people introduced themselves to me the way I imagine one would approach a celebrity or high-ranking dignitary, simply because they counted themselves among my ten thousand or so Twitter followers.

That was my view, anyway, until this year. Now I wonder if my nearly 10-year commitment to blogging for Common Sense Family Doctor and other outlets (e.g., Medscape) is more of a professional liability than I believed.

Before getting into that, I want to make clear that I recognize how fortunate I've been in my career path to this point. I divide my time between teaching, editing, writing, and patient care so that these activities often complement each other, and I greatly appreciate the flexibility and support that the family medicine department at Georgetown/Medstar has provided for the past several years since I returned to academic practice. Being deputy editor of the most-read medical journal in primary care is a great privilege. I have a terrific relationship with the editor-in-chief, who goes out of her way to acknowledge the value of my contributions and has been extremely understanding when I have pursued other opportunities that could significantly reduce the time I have to devote to American Family Physician.

That said, last month I experienced a crushing professional disappointment. I had the opportunity to interview for a senior science position at an organization I greatly respect, and for which I have volunteered hundreds of hours of time over the past 5 years. The position would have involved moving my family across the country, and frankly, I could not imagine a more qualified candidate being willing to do so. In short, I thought that I had the inside track on the job. So I was shocked to receive a form e-mail from their Human Resources department just two days after my on-site interview, informing me that they had decided to move forward with another candidate. A more personal follow-up e-mail the next day explained that they wanted to fill the position more quickly than I was willing to leave my current institution and clinical practice.

Fair enough. Except this: the position is now being widely advertised again on social media and multiple listserves to which I subscribe. It clearly has not been filled by a competing candidate, and if negotiations with that candidate unexpectedly fell though, they haven't reached out to me to extend a backup offer. Did I really bomb the interview that badly? Were my shirt buttons misaligned, or was there something hanging out of my nose? It got me thinking about something that vaguely bothered me about the interview and the telephone interview that preceded it: their repeatedly asking me if I would be willing to publicly support organizational positions that I personally disagreed with. I repeatedly answered yes, explaining that I understood the nature of the position required it, and as long as I had input in coming up with any scientific stance (as they assured me I would), that would be fine by me. Maybe they didn't buy my assurances. Maybe they didn't believe that an opinionated social media star could suppress his ego in order to toe the party line. (They would have been wrong. Had I accepted this position, I fully intended to stop writing this blog and substantially tone down my Twitter feed.)

So is Common Sense Family Doctor sometimes a professional liability? It probably is; I can't say for certain either way. But as a dear friend consoled me after learning that I was not offered this position that I coveted, "they are truly missing out and we get to retain a fabulous family doc and educator at Georgetown." I hope she's right. I am grateful to my colleagues, students, and patients for making this latest disappointment sting a little bit less than it could have.

Monday, May 6, 2019

Making the case for primary care-led, federally funded clinical practice guidelines

Talk about throwing down the gauntlet. In a provocative editorial published last year in Circulation: Cardiovascular Quality and Outcomes, Dr. John Ioannidis, who in 2005 shocked the scientific research community with his article "Why Most Published Research Findings Are False," took aim at medical professional societies authoring clinical practice guidelines and disease definition statements. He observed that despite notable progress in improving the trustworthiness of guidelines since the 2011 Institute of Medicine report Clinical Practice Guidelines We Can Trust, guideline panels continue to be plagued by financial conflicts of interest, lack of methodologist involvement, and domination by specialists "who have overt preferences (even without overt conflicts)."

Recent studies support Dr. Ioannidis's points. One study found that more than half of authors of gastroenterology guidelines received industry payments between 2014 and 2016. Another study of the top 10 highest-revenue medications of 2016 determined that more than half of authors of related guidelines had financial conflicts of interest, many of which were not disclosed in the journal publications. Finally, a study evaluating levels of evidence supporting U.S. and European cardiology guidelines from 2008-2018 found that only 8 to 14% of recommendations were supported by evidence from multiple randomized, controlled trials (RCTs) or a single, large RCT, while 42% and 55% of U.S. and European recommendations, respectively, were based on expert opinion only. In sum, even when guideline authors weren't on the take, eminence-based medicine trumped evidence-based medicine.

Poorly conducted professional society guidelines don't benefit front-line clinicians, but Ioannidis noted that they do have other benefits:

Guidelines writing activities are particularly helpful in promoting the careers of specialists, in building recognizable and sustainable hierarchies of clan power, in boosting the impact factors of specialty journals and in elevating the visibility of the sponsoring organizations and their conferences that massively promote society products to attendees. However, do they improve medicine or do they homogenize biased, collective, and organized ignorance?

A way to move beyond the production of clinical practice guidelines that are essentially "industry-friendly opinion pieces" is to centralize development efforts within government health agencies, or publicly-supported independent panels such as the U.S. Preventive Services Task Force (USPSTF). A recent review of 421 clinical practice guidelines for noncommunicable diseases in primary care concluded that guidelines developed or financed by governments were substantially more likely to be rated high-quality according to the AGREE-II tool than those developed by others. Dr. Michael LeFevre, a family physician colleague and former USPSTF chairman, suggested in a 2017 editorial that public investment is "essential" to producing trustworthy guidelines:

A substantial and consistent funding stream should be available for the development of clinical practice guidelines and should be awarded competitively through a process similar to research grant funding. The logical place for this funding to occur is through the Agency for Healthcare Research and Quality (AHRQ). ... The topic, guideline development panel, and methodology would be part of a competitive grant proposal. ... Proposals receiving funding would be assigned an evidence-based practice center (EPC) to work with the guideline development panel to provide an independent systematic review of the literature. The [EPC] program would need additional funding, but the focus of the efforts would shift to be channeled to producing reviews that would be assured of being used in the development of a clinical practice guideline we can trust.

Unfortunately, funding for AHRQ has always been politically precarious, and the closure of the National Guideline Clearinghouse last year does not bode well for starting a major new program to support guideline development and assessment, even as AHRQ-supported researchers continue to break new ground with the National Guideline Clearinghouse Extent of Adherence to Trustworthy Standards (NEATS) instrument.

And what about the problem of intellectual bias - being unable to see beyond the scope of one's own limited clinical experience to evaluate evidence impartially? Dr. Ioannidis first proposed having methodologists and patients write guidelines, with content experts serving as non-voting reviewers. Alternatively,

another possibility is to recruit also to the writing team medical specialists who are unrelated to the subject matter. Involvement of such outsiders (eg, family physicians involved in cardiology guidelines) could be refreshing. These people may still have strong clinical expertise, but no reason to be biased in favor of the specialized practices under discussion. They may scrutinize comparatively what is proposed, with what supporting evidence, and at what cost. Devoid of personal stake, they can compare notes to determine if this makes sense versus what are typical trade-offs for evidence and decisions in their own, remote specialty.

As a family physician who has served on guideline panels for cardiology (Pharmacologic management of newly detected atrial fibrillation) and otolaryngology (Cerumen impaction) topics, I find a great deal of merit in the latter approach, and a similar effort led by Dr. Ray Moynihan and primary care colleagues to reform disease definitions so that potential harms of expanding diagnostic criteria are considered along with the benefits for chronic conditions such as hypertension. It's no accident that the USPSTF has long been considered an exemplar of guideline development: the panel's members are all primary care clinicians or methodologists, and have one of the strictest conflict-of-interest policies in the field. Their recommendations don't make everyone happy or anyone wealthy, and that's most likely a good thing for patients.

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This post first appeared on The Daily Physician.

Wednesday, May 1, 2019

High blood pressure: is lifestyle change counseling underutilized?

Since July 2018, the U.S. Food and Drug Administration (FDA) has issued more than 20 recalls of the angiotensin-receptor blockers (ARBs) valsartan, irbesartan, and losartan because they contained potentially carcinogenic contaminants. As a result, there are now widespread shortages of these blood pressure lowering drugs that have affected many of my patients. Although the FDA's internal analyses and published studies suggest that the excess cancer risk is small even with long-term use, and the FDA has posted a list of currently available ARBs that have been tested and found safe, identifying substitutes has been difficult. Many patients prescribed ARBs already take other first-line anti-hypertensive drugs at maximum doses and/or are unable to tolerate angiotensin-converting enzyme (ACE) inhibitors due to cough.

One underutilized alternative is motivating patients with high blood pressure to make therapeutic lifestyle changes. In a Lown Right Care article in the March 15 issue of AFP, Drs. Ann Lindsay, Ajay Sharma, and Alan Glaseroff observed that "physicians ... often go straight to telling patients what to do without listening to what the patient thinks or is willing to do." Evidence suggests that patients are more likely adhere to treatment plans if physicians first get to know the patient's story and health goals, and that five key clinician behaviors are associated with better health outcomes: "(1) emphasizing patient ownership—work on patient goals; (2) partnering with patients on what they are willing and able to do; (3) identifying small steps to ensure success; (4) scheduling frequent follow-up visits to cheer successes or problem solve; and (5) showing care and concern for the patient."

A recent commentary in the Annals of Internal Medicine noted that the 2017 ACC/AHA hypertension guideline barely mentioned the value of lifestyle interventions for persons with hypertension or the barriers to providing them in primary care settings:

Practices that are not structured and staffed to systematically assess patient lifestyle factors, support behavior modification counseling, and provide follow-up will face obstacles to implementation. Clinicians in these practices also must be supported by relevant competencies; professional guidelines; routine feedback; and on-site training in practice change, such as academic detailing and practice facilitation. ... Ensuring that clinicians knowledgeable in behavior change theory and evidence-based lifestyle interventions are part of the primary care team is even more important.


Clinicians and patients may question if exercise programs have the same blood pressure-lowering benefits as medications. The answer appears to be yes. Although no randomized, controlled trials have directly compared exercise against medication, a systematic review and network meta-analysis of 391 trials found that in persons with hypertension, endurance or dynamic resistance exercise was equally effective for lowering systolic blood pressure as ACE inhibitors, ARBs, beta-blockers, and diuretics.

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This post first appeared on the AFP Community Blog.