Saturday, June 30, 2018

Why do-it-yourself blood tests are a bad idea

It sounded too good to be true when I first heard about Theranos, a company that promised to revolutionize medical testing by making it possible to perform dozens of tests on a single drop of blood, rather than the several tubes that would typically be required. And that wasn't all. Former Theranos CEO Elizabeth Holmes, a Stanford dropout and media magnet whose wardrobe seemed to consist solely of all-black outfits, promised to empower patients by giving them the ability to order their own tests, rather than needing to ask a doctor to do so. As described in John Carreyrou's new book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, Holmes took Silicon Valley's "fake it till you make it" philosophy one step too far: she never stopped faking it.

Even if the technology Theranos claimed to have developed had actually existed, FiveThirtyEight reporter Katherine Hobson pointed out that routine blood testing in healthy people has numerous downsides that Holmes never mentioned, including poor predictive value, false positives, and overdiagnosis. And even if a test accurately diagnoses a risk factor such as high blood sugar levels, a United Kingdom study found that persons invited to diabetes screening were no more likely than controls to quit smoking, reduce alcohol consumption, or become more physically active.

Yet the fascination with do-it-yourself medical testing continues. A 2016 New York Times article led with the story of Kristi Wood, a 49 year-old woman who was experiencing fatigue and cognitive problems. Rather than seeing a doctor, she turned to a direct-to-consumer testing service which told her that her vitamin D levels were too high, apparently because she had been overdosing on vitamin D supplements. Once she reduced her supplement dose, "she almost immediately felt better." She credited the testing service for making this (obvious) diagnosis and now has a bunch of blood tests repeated every 4 months.

Although Ms. Wood would do well to read Ms. Hobson's FiveThirty Eight article and my American Family Physician editorial on the lack of evidence supporting vitamin D screening and supplementation, at least the results were clear-cut and actionable. That isn't true for most abnormal results, which require clinical context, careful interpretation, and sometimes additional testing, to distinguish a false from a true positive. A normal laboratory range means that the vast majority - but not all - of healthy people's results will be found between these values. Statistically, 1 in every 20 tests is likely to be abnormal simply by chance. Since blood tests are usually ordered in panels, I estimate that about half of my own patients' result reports have at least one item flagged, with nearly all of them being false positives. In the absence of an informed explanation and reassurance from a health professional who spent 4 years in medical school, 3 years in residency, and 14 years in practice, these results could be alarming and/or trigger unnecessary action like starting a potentially harmful testosterone supplement, as did another do-it-yourself testing patient in the New York Times article.

On a related note, a blog post by family physician colleague Jennifer Middleton raised some good questions about do-it-yourself screening for ovarian cancer. For $295, a woman concerned about her ovarian cancer risk can request on a commercial website that an instructional kit be shipped directly to her home. According to the website, the test is intended to be "routine." But there's absolutely nothing routine about it. The ongoing randomized trial evaluating the test's effectiveness hasn't yet determined if it causes more good than harm. For women at low risk, the American College of Obstetricians and Gynecologists and the Society of Gynecologic Oncology recommend against being tested. The moral of this story: if you aren't feeling well or worry about getting sick in the future, don't seek out do-it-yourself testing. Don't be duped by companies such as Life Line Screening. Make an appointment to see a family doctor instead.

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This post first appeared on Common Sense Family Doctor on June 8, 2016.

Friday, June 22, 2018

Safe summer travel tips for doctors and patients

As children finish school and the summer vacation season gets underway, regular or occasional readers of American Family Physician should know about all of the free resources available for prevention and management of medical conditions in travelers, the best of which are included in our Travel Medicine collection. Brush up on key components of the pretravel consultation for international travelers, including vaccination updates and malaria prophylaxis. Patients who plan to play in the water can be provided with recommendations for preventing recreational waterborne illnesses and tips for avoiding neurologic complications of scuba diving or surfing-related injuries. And anyone can learn to recognize and prevent heat-related illness.

Depending on the vacation destination, clinicians may need to counsel patients on risk factors and symptoms of altitude illness (which includes acute mountain sickness and less commonly, cerebral and pulmonary edema) or emerging vector-borne diseases such as West Nile virus, Dengue, Chikungunya, and, of course, Zika virus. A 2015 editorial reviewed advice for protection against mosquitoes and ticks that carry these and other diseases (such as Lyme disease, which doesn't always present with a classic "bull's eye" rash).

And whether your own summer plans include going on a medical humanitarian mission or just relaxing at your favorite fishing hole, AFP has you covered. Clinicians who plan to spend time near any body of water - including the backyard swimming pool - should consider familiarizing themselves with the essentials of prevention and treatment of drowning.

You can access patient education handouts on all of these activities and more from AFP and FamilyDoctor.org at home or on the go. Stay safe, and have fun!

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A slightly different version of this post originally appeared on the AFP Community Blog.

Thursday, June 14, 2018

Should divided guideline panels publish minority views?

When I give presentations on the guideline development process of the U.S. Preventive Services Task Force, a question I'm often asked is how many votes of the 16-member panel are needed to approve a recommendation statement. The answer is a two-thirds majority, with a minimum of 10 votes in favor in case of absences or conflict-of-interest recusals. In reality, though, during the four years I attended Task Force meetings, I can't recall a statement passing without overwhelming (15-1 or 14-2) or, more commonly, unanimous support. The feeling among members seemed to be that the lack of a strong consensus on a recommendation suggested that there was something missing about the way they were approaching the evidence.

The Supreme Court of the United States always provides justices in the minority the option to write a dissenting opinion for the record, whose legal reasoning sometimes informs future decisions. In contrast, minority opinions rarely accompany medical guidelines. In an unusual case, after the JNC 8 committee published its guideline for management of high blood pressure in adults, five former panel members who disagreed with the guideline's target systolic blood pressure of 150 mm Hg in persons aged 60 years or older formally published their minority view. Even then, this dissenting report appeared some time later, in a different journal than the original guideline.

In a 2016 article in Mayo Clinic Proceedings, Dr. Daniel Musher, a professor of medicine and infectious diseases at Baylor College of Medicine, made the case for regularly publishing dissenting opinions in medical guidelines. He cited his experience as a member of the Advisory Committee on Immunization Practices (ACIP) working group that recommended the use of 13-valent pneumococcal conjugate vaccine (PCV13) in adults 65 years and older, despite his strong disagreement. As is standard process for the ACIP and most guideline panels, he did not have the opportunity to voice his dissenting opinion and rationale in the text of the guideline. His view did not see publication until more than 18 months later, after the new recommendation had been largely implemented into clinical practice. Dr. Musher wrote:

The perceived problems with publishing dissenting opinions are that this practice would (1) cause confusion within the medical community and (2) diminish the force of the recommendations. Regarding the former, the current situation, in which dissent is not included but in which subsequent articles dispute the formal recommendations or different professional societies publish divergent guidelines, is amply confusing—witness the differing guidelines for screening for breast, lung, or prostate cancer. It defies reason to believe that every member of the American Cancer Society's committee thought that breast cancer screening should begin at age 40 years, whereas all who participated in the US Preventive Services Task Force agreed that screening should wait until age 50 years. Inclusion of dissenting opinions in the final version of published guidelines may well have reduced polarization and confusion by bringing dissent into the recommendation process.


I can't testify to the presence or absence of internal discord on the panels that produced the 2015 ACS or 2016 USPSTF guidelines on breast cancer screening, but my best recollection of the July 2008 meeting where the USPSTF first voted to recommend routine mammography starting at age 50 is that, contrary to Dr. Musher's suggestion, there was no minority view. When there is one, I agree with him and the Slow Medicine bloggers that making a forum available to describe conflicts that occurred within the guideline narrative (including all of the various options that were considered and later discarded) could reduce the intensity of second-guessing and better inform clinicians about the guideline's nuances and potential limitations. Now that I have had experience as a voting member of guideline panels on atrial fibrillation and cerumen impaction, though, I wonder if the explication of dissents belongs in the guideline itself, rather than as a separate stand-alone perspective.

Would the airing of minority views within medical guidelines provide useful perspectives for patients, clinicians, or policymakers, or are conflicting guidelines from different organizations already confusing enough as it is?

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A slightly different version of this post first appeared on Common Sense Family Doctor on June 24, 2016.

Friday, June 8, 2018

Health Systems Science - population health by another name?

In my book review of this textbook in the June 2018 issue of Family Medicine, I took the opportunity to comment not only on the strengths and weaknesses of the text, but the broader movement to incorporate population health concepts into medical education. Here are some excerpts:

Since Abraham Flexner published his report on the state of American and Canadian medical education in 1910, the pillars of medical education have been the basic and clinical sciences. Although in the past century both pillars have experienced dramatic changes, this educational structure has remained the same. Increasingly, however, medical educators have recognized that mastery of the basic and clinical sciences alone is insufficient preparation for clinical practice. In the early 20th century, there were no health maintenance organizations, continuous quality improvement processes, clinical informatics, or population health management—all concepts that are essential for today’s physicians to know.

In 2013, the American Medical Association formed the Accelerating Change in Medical Education Consortium, a group of 11 medical schools tasked with developing innovative curricula to encompass the additional knowledge, attitudes, and skills necessary to prepare students and residents for 21st-century practice. Although my home institution was not part of the consortium, as director of a required first-year course in health disparities and health policy, and as advisor for our population health scholarly track, I have followed its work with great interest. In a series of papers in
Academic Medicine, consortium leaders proposed adding a third pillar of medical education called “health systems science. ...

A concluding chapter suggests structural reforms to make it easier to integrate this content into medical education, such as preferentially admitting students with well-developed teamwork skills, teaching with simulation and in community-based settings, and involving students in real-life practice improvement and health care delivery transformation.

Whether or not this collection of topics truly constitutes a new “science” rather than a blending of existing fields is debatable, but it is certain that in the future, more physicians will be caring for populations within health systems rather than individual patients one at a time.

Monday, June 4, 2018

Curiosity and family medicine

I have never been invited to give a commencement address. The closest I came was my own high school graduation, when I was the unofficial valedictorian. Since my school did not have a tradition of the highest-ranked student addressing the class on graduation day, though, I didn't get the chance. Our commencement speaker, a television news anchor and former graduate, delivered a great speech that I still remember more vividly than the addresses by bigger names at my college, medical school, and public health graduation ceremonies.

Obviously, I have not had the good fortune of hearing Dr. Atul Gawande speak at a commencement. (Atul, if you're reading this, Georgetown University School of Medicine would be delighted to have you address a future graduating class.) Instead, three days ago he delivered a profoundly insightful address at UCLA that has been going viral on social media. It's worth reading in its entirety, but the point he drove home is that in a time when discrimination and unequal treatment have become as socially acceptable in some circles as in the pre-American Civil Rights era, it remains the sacred calling of medicine to recognize that all lives have equal worth, and that doctors and patients share a "common core of humanity":

Without being open to their humanity, it is impossible to provide good care to people—to insure, for instance, that you’ve given them enough anesthetic before doing a procedure. To see their humanity, you must put yourself in their shoes. That requires a willingness to ask people what it’s like in those shoes. It requires curiosity about others and the world beyond your boarding zone.

Curiosity. If medicine were only about the science of the human body in health and disease, I would never have become a family doctor. Fortunately, that isn't so; in fact, after years of practice I often feel that the science has become incidental to doctoring. Yes, the knowledge base for medicine is always expanding, but as I tell students, regardless of what field of medicine you choose, the technical aspects eventually become routine. Even emergency and family physicians, who encounter the largest variety of symptoms and diagnoses, get acclimated to bread-and-butter encounters: back pain, chest pain, respiratory infections, the management of common chronic conditions under or out of control.

What keeps my work meaningful is learning about the details of my patients' lives that aren't strictly medical. As Dr. Faith Fitzgerald wrote in a classic article nearly two decades ago:

What does curiosity have to do with the humanistic practice of medicine? ... I believe that it is curiosity that converts strangers (the objects of analysis) into people we can empathize with. To participate in the feelings and ideas of one’s patients—to empathize—one must be curious enough to know the patients: their characters, cultures, spiritual and physical responses, hopes, past, and social surrounds. Truly curious people go beyond science into art, history, literature, and language as part of the practice of medicine.

Then, as now, pressures to be efficient in evaluating patients threatened to suppress natural curiosity. Dr. Fitzgerald bemoaned an educational system that produces medical students who were too un-curious to ask a patient how he had been bitten in the groin by a snake ("How could one not ask?"), or to question the "BKA (below-knee amputation) times two" description in the chart of a patient who obviously had legs. Finally, she mentioned one patient who had been deemed by the housestaff to be the "dullest" (least interesting) on the service: an old woman who (upon further inquiry) turned out to have survived the sinking of the Titanic.

2018 graduates, I wish that more of you were entering family medicine, but regardless of the medical specialty you've chosen, don't ever stop being curious - especially about the most "difficult" patients and the ones you least understand. It is that skill, more than any other, that will sustain you in your work and that separates the merely competent doctors from the truly great ones.