Friday, April 29, 2016

Medical officers' labor is essential, but often unheralded

I recently gave a talk on diabetes screening to Preventive Medicine residents at Uniformed Services University of the Health Sciences, where I re-connected with two former residents, now faculty, whom I supervised as a medical officer at the Agency for Healthcare Research and Quality (AHRQ) from 2006 to 2010. A lot has changed in the past six years. The Center for Primary Care, Prevention, and Clinical Partnerships, which housed the U.S. Preventive Services Task Force program, is now known as the Center for Evidence and Practice Improvement, and the role of USPSTF medical officers has been considerably circumscribed. Staff no longer perform in-house systematic reviews such as this one on prostate-specific antigen screening that won me AHRQ's Article of the Year Award in 2009. Individual medical officers are no longer even acknowledged by name in USPSTF documents, which now thank generic "AHRQ staff," I suppose to preemptively distance the agency from any politically controversial recommendations.

This isn't to say that I think the job is no longer worth doing. Indeed, when I found out earlier this year that AHRQ was looking to fill USPSTF medical officer positions, I shared the job description with contacts far and wide. Yes, the role may have changed, even somewhat diminished. Yes, it may never be more trendy to be anti-government (and less trendy to work for the government) than it is today, when an ignorant, unqualified billionaire reality TV star who can't let a day go by without offending another constituency is close to clinching a Presidential nomination. But the work of the Task Force must go on, as it has since 1984. And the engine that drives the Task Force's work is - and always has been - the labor of a group of unheralded, and now unnamed, medical officers at a small federal agency whose existence is perennially imperiled. To my former colleagues and others whom I haven't met, thank you for your selfless service, and for improving the health of all Americans.

Tuesday, April 26, 2016

Obstacles to stopping cancer screening in older adults

I recognized a glitch in my electronic medical record's decision support software when it prompted me to consider prostate and colorectal cancer screening in a 93 year-old man, who, though remarkably vigorous for his age, was unlikely to live for the additional 10 years needed to benefit from either test. Although deciding not to screen this patient was easy, determining when to stop cancer screening in older patients is often more challenging. In the April 15th issue of American Family Physician, Drs. Brooke Salzman, Kathryn Beldowski, and Amanda de la Paz present a helpful framework for decision making in these clinical situations, where population-level guidance derived from studies of screening younger patients "generally do not address individual variations in life expectancy, comorbid conditions, functional status, or personal preference."

The authors recommend that clinicians take into account not only average life expectancy at a given age, but also significant variations in life expectancy linked to functional impairment and comorbid conditions, using one or more validated prognostic tools. Although the U.S. Preventive Services Task Force (USPSTF) found insufficient evidence about screening mammography in women 75 years or older, modeling studies suggest that women with projected life expectancies of greater than 10 years may still benefit from this test - with these important caveats:

Although the sensitivity and specificity of mammography increase with age, overdiagnosis also increases because of reduced life expectancy and an increased proportion of slower-growing cancers. In other words, women with breast cancer diagnosed at an older age are more likely to die of something else, compared with younger women. In addition, treatment of breast cancer in advanced age is associated with greater morbidity, including an increased risk of postoperative complications and toxicity from chemotherapy.

Similar considerations apply to screening for colorectal cancer, which the USPSTF made a "C" grade recommendation (small population-level benefit, use individual decision making) for adults 76 to 85 years of age and recommended against screening adults older than 85 years, when the harms clearly exceed the potential benefits. Nonetheless, surveys have found that 31% of adults age 85 years and older, and 41% of adults with a life expectancy of less than 10 years, received screening colonoscopies. To discourage overuse of cancer screening without alienating patients, the authors advise: "It is important to convey that a decision to stop cancer screening does not translate into decreased health care. Rather, discussions can focus on health promotion strategies that are most likely to benefit patients in the more immediate future, such as exercise and immunizations."

A recent qualitative study in JAMA Internal Medicine explored the reluctance of primary care clinicians to explicitly incorporate long-term prognosis in the care of older adults. Most study participants relied on their own clinical experience, rather than validated tools, to estimate a patient's life expectancy, and were reluctant to stop screening in relatively younger patients even with limited life expectancies. Barriers mentioned by participants included inadequate training, time constraints, concern about negative patient reactions, competing practice incentives, and fear of lawsuits. Readers, do you share these concerns? What strategies do you use to communicate with an older adult whose age or life expectancy suggests stopping cancer screenings because harms outweigh benefits?


This post first appeared on the AFP Community Blog.

Thursday, April 21, 2016

The best recent posts you may have missed

Every few months, I post a list of my top 5 favorite posts since the preceding "best of" list on this blog, for those of you who have only recently started reading Common Sense Family Doctor or don't read it regularly. Here are my favorites from November through March:

2) College tuition and health care costs are unsustainable (1/25/16)

3) Book Review: "Ending Medical Reversal" is revolutionary (11/11/15)

4) Pharma industry free speech is anything but free (12/16/15)

5) Is vitamin D supplementation good for anything? (1/14/16)

If you have a personal favorite that isn't on this list, please let me know. Thank you for reading!

Monday, April 18, 2016

A 1-page adult preventive health care schedule

For many years, the Centers for Disease Control and Prevention has published yearly single-page schedules of childhood and adult vaccinations recommended by its Advisory Committee on Immunization Practices. Even today, when this information can be easily referenced online or in a smartphone app, you will still see copies of these schedules taped to the walls of workstations in primary care physicians' offices. Until recently, an analogous schedule of adult preventive services recommended by the U.S. Preventive Services Task Force hasn't existed (though the Agency for Healthcare Research and Quality published a popular spiral-bound Guide to Clinical Preventive Services that included abridged versions of USPSTF recommendations for patients of all ages).

Family physician Paul Swenson, in collaboration with my American Family Physician editor colleague and former USPSTF member Mark Ebell, has filled this gap by creating a 1-page adult preventive health care schedule in AFP that contains all "A" and "B" grade recommendations relevant to adults as of April 5, 2016. This schedule will be updated periodically online and published in the journal annually, as are the CDC vaccination schedules. That's a good thing, since it is already slightly out of date - the USPSTF updated its recommendations on aspirin for primary prevention just last week. Clinicians or health professionals in training can read or listen to my latest Medscape commentary for the details on what's changed. For everyone else, here is the bottom line:

This time around, the Task Force narrowed the age range of patients for whom clinicians should consider preventive aspirin to 50-69 years and removed the previous distinction between men and women, recognizing newer evidence that both sexes benefit from reductions in heart attacks and strokes, as well as a decreased incidence of colorectal cancer. The USPSTF recommends that adults in their 50s start low-dose aspirin if they have a 10% or greater 10-year cardiovascular disease (CVD) risk, do not have bleeding risk factors, and are willing to take aspirin for at least 10 years. Adults in their 60s with similar CVD risk can also consider starting low-dose aspirin but are at higher risk of bleeding and so are less likely to benefit overall.

Tuesday, April 12, 2016

Patient-centered diabetes research needs family medicine perspectives

According to the American Diabetes Association's 2016 Standards of Medical Care in Diabetes, there is little comparative data to guide second-line drug choice after metformin in patients with type 2 diabetes. Few other medications have been shown to lower mortality, and even then only in specific populations, as Dr. Jennifer Middleton discussed in a recent AFP Community Blog post.

The National Institutes of Health is recruiting patients for a multicenter randomized trial, the Glycemia Reduction Approaches to Diabetes: A Comparative Effectiveness (GRADE) study, that will compare the benefits and harms of four medications commonly combined with metformin: 1) glimepride (a sulfonylurea); 2) sitagliptin (a dipeptidyl-peptidase-4 inhibitor); 3) liraglutide (a glucagon-like-peptide-1 receptor agonist); and 4) glargine insulin. Since the GRADE study was planned, the sodium glucose cotransporter 2 (SGLT-2) inhibitor class has come on the market, and a randomized trial found that empagliflozin reduces cardiovascular and all-cause mortality in patients with established cardiovascular disease and type 2 diabetes. This surprising result led some experts to suggest that SGLT-2 inhibitors be added to the GRADE trial or incorporated into some other comparative research study.

This kind of pragmatic diabetes research would seem to be a perfect fit for the Patient-Centered Outcomes Research Institute (PCORI). Created by the Affordable Care Act, PCORI's mission is to "improve the quality and relevance of evidence available to help patients, caregivers, clinicians, employers, insurers, and policy makers make informed health decisions" by funding comparative clinical effectiveness research and research methods. However, PCORI received criticism recently after an independent analysis of its first 6 funding cycles by the American Academy of Family Physicians' Robert Graham Center concluded that "less than one-third of PCORI studies involve or are relevant to primary care."

Last month, I represented the AAFP in the PCORI stakeholder workshop "Prioritizing Comparative Effectiveness Research for Second-Line Type 2 Diabetes Treatment." Other workshop participants included fellow primary care clinicians and representatives from relevant subspecialty societies, patient groups, benefits managers, clinical investigators, and the pharmaceutical industry. After listening to presentations on recent trials and the GRADE study, we were asked to formulate a research question in the PICO (Population, Intervention, Comparator, Outcome) format, keeping in mind the following criteria: patient-centeredness, health impact of the condition, assessment of current options, likelihood of implementation in practice, and durability of information.

I was impressed by the high quality of the discussion and the group's determination to come up with practical research questions that would provide meaningful answers to better inform family physicians and other clinicians who care for patients with type 2 diabetes. PCORI Executive Director Joe Selby, MD, MPH, who is also a family physician, told me how important it was to him that Family Medicine be actively engaged in shaping the organization's research agenda and priorities. PCORI offers many opportunities to get involved that range from suggesting new research questions, to providing input on current questions and methods, to serving on standing advisory panels on various cross-cutting topics.


This post first appeared on the AFP Community Blog.

Saturday, April 9, 2016

Walk, don't run to implement SPRINT findings in primary care

This the second part of a two-part commentary that I wrote in collaboration with Dr. Stephen Martin and Dr. John Mandrola. The first part is posted here.


In real-world practice, where measured blood pressure often skews high, the harm of overtreating patients whose clinic pressure is high due to artifact (but normal at home) is greater. And because adherence rates are typically lower in primary care practice, the incremental benefit of more intense blood pressure treatment will likely be smaller, or could even be outweighed by the harms.

We don’t know how effective treating to lower blood pressure targets will be when scaled into real-world practice. SPRINT’s limitations should give us pause before rushing to revise the Eighth Joint National Committee (JNC 8) evidence-based guidelines for hypertension treatment, as some have already called for. In practice, the high-risk inclusion criteria for SPRINT are likely to be broadened to those at lower risk. Quality metrics that rely on cut point outcomes, such as blood pressure (e.g., 140/90 mm Hg or 120/80 mm Hg), are especially vulnerable to “one-size-fits-all” efforts, which may cause harm when scaled to heterogeneous primary care populations.

We are also concerned that the momentum for more intense blood pressure control has not elicited calls for greater emphasis on lifestyle interventions or shared decision making. The word “lifestyle” appeared in the SPRINT publication exactly one time, which is remarkable for a study of hypertension treatment. Patients will be exposed to less harm with more intense blood pressure control if it is achieved with diet, exercise and sleep hygiene; with medication, over one-third of participants in both SPRINT trial arms experienced a serious adverse event. And in 2016, there is a broad consensus that high-quality care means aligning care with patients’ goals. Some patients may be willing to accept the risk of more intensive treatment. Others, when told of the absolute benefits and risks, may not want the extra burden of therapy. Rather than set absolute blood pressure targets, revised hypertension guidelines should recommend shared decision-making.

Although high blood pressure is the most commonly diagnosed medical condition in the U.S., it is not itself a disease, only a risk factor for poor cardiovascular outcomes. SPRINT suggests that selected people may be able to slightly reduce their risks for these outcomes with more intense treatment of blood pressure. The immense challenge will be translating SPRINT’s findings to primary care without breaking the number one rule of medicine—first, do no harm.

Thursday, April 7, 2016

Walk, don't run, to implement SPRINT findings in primary care

This the first part of a two-part commentary that I wrote in collaboration with Dr. Stephen Martin and Dr. John Mandrola. The second part is posted here.


When the Systolic Blood Pressure Intervention Trial (SPRINT) results were published last November, a New York Times headline announced “Data on Benefits of Lower Blood Pressure Brings Clarity for Doctors and Patients.” On the same day, in the same newspaper, writing in an editorial, Dr. Harlan Krumholz detailed “many nuances” of the study’s findings. Clarity or nuance, which is it?

Front-line clinicians are well aware of the dangers of overlooking nuance when applying clinical trial data to patient care. In this Commentary, we will make the case that implementing SPRINT in primary care warrants slow thinking, and that efficacy of setting lower blood pressure targets shown in this trial is not the same as effectiveness in the real world.

SPRINT enrolled a high-risk population of hypertensive adults age 50 years and older who also had actual blood vessel disease, chronic kidney disease (CKD) (estimated glomerular filtration rate 20 to less than 60), Framingham risk greater than 15%, or were older than 75. In fact, the average Framingham risk score was 20%. Patients with diabetes, prior stroke and those who had “any factors judged to be likely to limit adherence” were excluded by the trial design. Two specific features of SPRINT’s design would be difficult or even impossible to duplicate in real world practice. The first is that blood pressure was measured in an idealized way. After the study was suspended in September, principal investigator Dr. Suzanne Oparil noted that

We have to remember that in a randomized controlled trial, the clinic blood pressures are pretty accurate in the sense that these people are coming back visit after visit after visit, they're seen by the same coordinators who are very nice to them and don't upset them or anything, they have their blood pressure measured with an automated device according to AHA and international guidelines—sitting quietly with feet on the floor for 5 minutes, no smoking, no drinking coffee, no talking, no disturbance in the room. … So if you try to push … [artificially] high routine clinic pressures down to 120, you may get into trouble.

The second is that anti-hypertensive medications were provided directly to SPRINT participants for free. This extraordinary convenience, combined with a trial run-in period which allowed the investigators to exclude patients who may not take medications properly, assured the enrollment of participants most likely to adhere to the many drug adjustments made in the trial. In the real world, patients travel to pharmacies to pay for and pick up their prescriptions, and clinicians can’t ignore patients who forget to take pills or have trouble following directions.

We view SPRINT as a proof-of-concept and efficacy trial. It asked the question: in high-risk patients, does further lowering of blood pressure with drugs help, harm, or have no effect? The answer is all three. Although the intervention group in SPRINT had better outcomes than the control group, the absolute benefits of treating to a systolic blood pressure goal of 120 mm Hg versus 140 mg Hg were modest (Table). 62 people needed to be treated more intensively to prevent one cardiovascular event or stroke, and 85 needed to be treated to prevent one death from all causes. These benefits came with costs: more intensive treatment—three blood pressure drugs on average compared with two in the control group—was associated with one additional episode of severe hypotension, one case of syncope, and two more episodes of acute kidney injury for every 100 participants. We note that for 98 to 99 percent of participants, there was no difference in outcomes.


ARR (%)
PSR (%)
Primary Outcome*
CV Mortality
Serious adverse event
Serious adverse event^
* First occurrence of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from cardiovascular causes
^ Possibly or definitely related to the intervention, including hypotension, syncope, electrolyte abnormalities, and acute kidney injury in the invasive group

Table courtesy of (

Monday, April 4, 2016

Addressing the social determinants of pain

Over the past few months, the federal government has mobilized against what is being called "the opioid crisis": a national epidemic of fatal overdoses that in 2014 claimed more than 14,000 lives, the most ever recorded. Since most of these opioids were originally prescribed by physicians to treat pain, the Centers for Disease Control and Prevention recently finalized a guideline containing recommendations for appropriate opioid prescribing. The Food and Drug Administration will require that all opioid-containing medications be labeled with a new boxed warning about "the serious risks of misuse, abuse, addiction, overdose and death" associated with these drugs. And the Office of the Assistant Secretary for Health has released a National Pain Strategy that is designed to complement restrictions on opioids by promoting and reducing access barriers to non-pharmacologic management options for patients with chronic pain.

What is notably missing from these efforts is an attempt to understand why more people are experiencing chronic pain in the first place. In a recent article published in the Harvard Business Review, public policy and business professors Eileen Chou, Bidhan Parmar, and Adam Galinsky reviewed studies that linked widening U.S. income inequality and unemployment to greater levels of physical pain and purchases of over-the-counter painkillers. They also demonstrated in a series of experiments on college students that the prospect of economic insecurity increased the perception of pain and reduced pain tolerance. Chou and colleagues wrote:

Why does economic insecurity hurt? The cause is likely rooted in human psychology. When people encounter economic insecurity, they typically feel a loss of control. A sense of control is one of the foundational elements of well-being. When people lose this sense of control, their body goes a bit haywire and responds to stimuli differently — displaying weakened resilience and a lower pain threshold.

They went on to suggest that public and private organizations could do much to address the opioid crisis by restoring people's sense of personal control through policy changes designed to promote economic security. Increasing wages and reducing layoffs are obvious (if not always possible) solutions, but so are rent controls, education and childcare subsidies, and free-market policies aimed at reducing the cost of living.

One of the questions on my practice's intake questionnaire asks whether the patient is experiencing financial insecurity. It has always struck me as a bit odd: compared to, say, the question that asks if they feel safe at home, there seemed to be little I could do in the clinic to lift the burden of someone's student loans or persistent joblessness. A similar argument has been made against proposals to present "Community Vital Signs" data in electronic health records - how are individual physicians supposed to act on information about social determinants of health? On the other hand, I can tell you all about the connections I've seen between economic stress and physical symptoms such as headaches or backaches, and how knowing more about my patients' day-to-day struggles to stay financially afloat has frequently averted our going down an unproductive path of invasive and/or expensive testing. So it isn't a stretch to suggest that well-intentioned government efforts to stem the tide of opioid overdoses may founder without explicitly addressing the social determinants of pain.