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To me, "non-evidence-based" or "expert consensus" calls to mind an outdated process for developing guidelines (though some groups still use it): assemble a group of distinguished subject matter experts, ask them to formulate some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.