Tuesday, November 24, 2015

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 August, September and October:

2) Community health workers can complement primary care (9/11/15)

3) Liberty and health reform in America (10/2/15)

4) Right Care Action Week and Choosing un-Wisely (10/24/15)

5) Do sofosbuvir restrictions harm or protect the vulnerable? (8/19/15)

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

Friday, November 20, 2015

Two perspectives on the PSA screening pendulum

Two research studies published earlier this week in JAMA presented compelling evidence that the 2012 U.S. Preventive Services Task Force recommendation statement that discouraged prostate specific antigen (PSA)-based screening for prostate cancer has had a significant impact on clinical practice. In one study, researchers from the American Cancer Society used data from the Surveillance, Epidemiology, and End Results registries to document an 18% relative decrease (from 37.8% to 30.8%) from 2010 to 2013 in the percentage of men age 50 years and older who reported PSA screening in the previous 12 months. In another study, a separate team of investigators found a similar decline in the prevalence of PSA screening reported in the National Health Interview Survey in men age 50 to 74 years.

For me, and for other proponents of the view that PSA screening is not effective in reducing mortality from prostate cancer and instead leads to substantial psychological and physical harms, this reversal in practice is good news. In an editorial published in the October 15th issue of American Family Physician, Dr. Vinay Prasad argued that family physicians who reduce or discontinue their use of the PSA test for screening are on solid ground:

When it comes to PSA screening, the pendulum has swung. Not only has our understanding of the benefits and harms shifted, as reflected by a continual change in guidelines away from testing, but the burden to justify screening has also swung. For decades, critics of PSA testing have shown the many unintended repercussions of the test, cautioning that our initial widespread adoption was not justified. Moving forward, it must be the proponents of screening who shoulder the burden of proof. Their task will be to show in a future randomized study whether any PSA screening algorithm can improve survival or quality of life compared with what is now the standard of care—no routine screening. Before primary care physicians consider reintroducing the PSA test, they must have proof that it improves outcomes.

In another editorial that accompanied the JAMA studies, Dr. David Penson also described the shift in practice as a "pendulum," but took the position that until a better screening test is developed, "the PSA test can be deployed more effectively (or strategically), maximizing benefit while minimizing harm." If PSA screening does in fact save some lives, Dr. Penson argued, then extending screening intervals and focusing on men who are more likely to develop "high-risk" prostate cancer could be a better approach than not screening at all:

Certainly, physicians have been overly aggressive in their approach to prostate cancer screening and treatment during the past 2 decades, but the pendulum may be swinging back the other way. It is time to accept that prostate cancer screening is not an “all-or-none” proposition and to accelerate development of personalized screening strategies that are tailored to a man’s individual risk and preferences. By doing this, it should be possible to reach some consensus around this vexing problem and ultimately help men by stopping the swinging pendulum somewhere in the middle.

As it turns out, I've met both Dr. Prasad and Dr. Penson. Both men are outstanding researchers and compassionate physicians. Each believes strongly that his position on PSA screening is correct, and it's entirely possible that both could be right to some degree. If you are a clinician who cares for older men, where do you stand on the pendulum of PSA screening? If you are a man over 50 or a loved one, which approach to this test would you prefer?


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

Tuesday, November 17, 2015

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

My latest Medscape commentary concerns the primary care implications of the SPRINT trial of lower systolic blood pressure goals in patients at high risk for cardiovascular disease, whose initial findings appeared last week in the New England Journal of Medicine. My bottom line for clinicians is: don't throw out the JNC 8 guideline and blood pressure targets just yet. Here's a representative excerpt from the commentary:

It's worth noting that the SPRINT results do not completely upend JNC 8. SPRINT focused on an especially high-risk population of adults with hypertension who were aged 50 years or older and had an average Framingham risk score of 20%. Patients with diabetes or a history of a stroke were not included. According to a companion study published in the Journal of the American College of Cardiology, only 1 in 6 US adults currently receiving blood pressure treatment would have been eligible to participate in this trial. Until new treatment guidelines emerge, I think it is premature to extrapolate these findings to the majority of patients at lower cardiovascular risk—and therefore less likely to benefit—but equally vulnerable to the increased adverse effects observed in this study.

Another key point: The way that blood pressures were measured in this study is probably not the way they are measured in your offices. Although best practice guidelines suggest that patients should be seated and at rest for at least 5 minutes before blood pressure is measured, you and I know all too well how rarely this occurs when patients arrive late or we are running behind schedule.

Recognizing that blood pressures obtained in the office are often inaccurate, the US Preventive Services Task Force and the Community Preventive Services Task Force recommend confirming office measurements with self-measured blood pressure monitoring before starting or adjusting medications. In order to make this practice possible, and to implement lower blood pressure goals in selected patients without overtreating them, insurers absolutely must cover patients' purchase of validated blood pressure monitors and pay family physicians for the extra time it takes to make medication adjustments outside of office visits.

Saturday, November 14, 2015

How care teams can support shared decision making in primary care (2 of 2)

Yesterday, I delivered the keynote speech at the Team Care Challenge, sponsored by the Patient-Centered Primary Care Collaborative, Medstro, and the American Resident Project. This is the second of two posts containing the text of my talk. Part 1 is posted here.


Let’s take each of these clinical scenarios I brought up one by one. I prescribe medications for high blood pressure all the time, I’m familiar with the current treatment guidelines, and I have a pretty good grasp of the most common side effects. But I would wager that most clinical pharmacists know at least as much as I do about these drugs, if not more. Rather than relegating these team members to the role of dispensing prescriptions, why not co-locate them in large primary care practices, or use FaceTime or Skype for real-time consultations? Based on the eligibility criteria for the SPRINT study, my office could create screening protocols for medical assistants or licensed practical nurses to identify eligible patients at the time of check-in, just as they already pre-review immunization records to see who might need shots that day.

How about the question of when a woman should start screening mammograms? In this situation, competing guidelines make getting to the answer even more complex. But we should keep in mind that the starting and stopping ages in breast cancer screening guidelines were set by guideline developers who applied their own preferences and values to the balance of benefits and harms. We can do better than “what most women would want” – we should find out what the patient in front of us wants. The primary care team could create an agreed-on protocol in which a woman of a certain age could automatically be given a print or electronic decision aid at the time of a health maintenance visit. Medical assistants could ask initial questions about their preferences and concerns and document these in the chart so that when it was time to have the discussion and make a decision, the patient and clinician would already be on the same page.

Advance care planning is perhaps the most emotionally and logistically challenging scenario. Medicare says that we can have these discussions with the patient at a stand-alone visit, a wellness visit, or a visit for management of chronic medical issues. In this situation I envision the primary care team playing a vital behind-the-scenes role. My team members can remind me that I’ve never had this sort of discussion with Mr. Jones or Mrs. Smith, and give me an extra nudge if Mr. Jones or Mrs. Smith is over 65 or has one or more of several life-limiting health conditions. Or perhaps the patient’s advanced directive is several years old and it’s time to revisit it to make sure it still aligns with his or her wishes. To support shared decision making, my team can make sure that I have a blank copy of an advanced directive on hand, and that helpful videos and other educational resources are already open on the desktop computer in the examination room. This way I can focus completely on the patient rather than fumbling around for missing materials or forms.

Now what I’ve just told you is the way I wish things were rather than the way they really are in my practice, and in most primary care practices, even those that, like mine, have achieved certification as a “patient-centered medical home.” Don’t get me wrong, I am all for the PCMH, but I view it as a set of minimum requirements rather than aspirational goals.

And unfortunately, much of what I’ve described would be thwarted by our current, antiquated payment system that only assigns value (and dollars) to the things that doctors do. Who’s going to pay for the clinical pharmacist to spend all day in the outpatient setting providing medication counseling? Who’s going to pay for the extra medical assistant the practice must hire now that there’s have a lot more to do than checking patients in and taking their vital signs? Who’s going to pay for the home blood pressure monitor and the extra time the practice spends text messaging or on phone calls needed to intensify blood pressure treatment in patients who choose to do so?

This is where all of you come in – and by “all of you,” I mean the students and trainees in the audience just as much as the practicing clinicians. Attending this conference means that you already have a vision of the possibilities of team-based primary care that is far more expansive than mine was when I was in training. It will be up to your generation to advocate for changes in health care payment and practice organization that empower primary care teams to reach their full potential to support routine shared decision making. The direct primary care movement may be one answer. Insurers paying practices for health outcomes, rather than numbers of encounters or specific providers of services, is another.

There are countless creative ways we can put patients back at the center of care where they belong, and the ideas from today’s terrific presentations represent only the tip of the iceberg. All of these transformative ideas have this principle in common: they will work best when carried out by high-functioning care teams.

Thank you again for allowing me to speak to you today.

Friday, November 13, 2015

How care teams can support shared decision making in primary care (1 of 2)

Earlier this afternoon, I delivered the keynote speech at the Team Care Challenge, sponsored by the Patient-Centered Primary Care Collaborative, Medstro, and the American Resident Project. This is the first of two posts containing the text of my talk. Part 2 is posted here.


Good afternoon. Thank you for inviting me here today to speak to you about primary care teams. I was really inspired by all of today’s presentations, and I’m glad that I am not one of the judges, because it would have been a very tough choice!

You have all probably heard something about the White House’s Precision Medicine Initiative. I have expressed skepticism about this initiative because I think that focusing on differences in our genomes will divert attention and funding from social determinants of health that are far more powerful predictors of illness and wellness. The term “precision medicine” is often used interchangeably with “personalized medicine.” That’s too bad, since I would argue that family physicians and other primary care clinicians have been providing personalized medicine long before genomic medicine existed, approaching our patients as individuals with unique backgrounds, values, and preferences that can and should affect the care we provide. One powerful approach to providing this type of personalized care is shared decision-making.

What I’d like to talk about today is how care teams can support patients and health professionals in making shared decisions.

So what have been the big health news stories with implications for the practice of primary care over the past year? For me, three come immediately to mind.

#1. End-of-life counseling. Five years after the phony political uproar over “death panels” that were never included in any health reform legislation, Medicare will finally pay doctors to counsel patients about advance care planning and end-of-life options. This is welcome news.

#2. Breast cancer screening. After decades of insisting that all women at average risk undergo mammograms every year starting at age 40, the American Cancer Society relaxed its guidelines. They now agree with the U.S. Preventive Services Task Force that mammography should be optional for women in their early 40s and that every two years is a more beneficial interval for screening in women older than 55.

#3. Lower blood pressure goals. The NIH-sponsored SPRINT study showed that lower blood pressure goals may be better in some patients over 50 who are at high risk for cardiovascular events. Over a little more than 3 years of follow-up, about 60 people needed to be treated to a systolic BP of 120 to prevent one cardiovascular event or stroke compared to the traditional target of 140. On the flip side, more intensive treatment was associated with one more episode of severe hypotension, one case of syncope, and two more episodes of acute kidney injury for every 100 people.

The one thing that these stories all have in common is that they envision an increased role for shared decision making in primary care.

Some patients will want to receive few aggressive interventions at the end of life, some will want more.

Some women will be fine with waiting until age 45 or 50 to get their first mammogram, some will still want to start at 40.

For some patients, reducing their risk of heart attack or stroke will be worth the price of taking one extra medication and the associated adverse effects. For some patients, it won’t be.

It will be the primary care team’s job to guide patients in making these difficult health decisions.

I will admit to you right now that I’m no expert on shared decision making, and I consider myself to be mediocre at best in engaging patients in this process. Despite the many lectures I’ve given about why patients should think about foregoing PSA screening or mammograms due to the well-documented harms that can result from both tests, I still struggle to explain the relative pros and cons of competing choices and help my own patients pick one or the other. In part, this is because making shared decisions is naturally difficult. But I’ve started thinking that it may be harder than it needs to be because I’m usually trying to do it alone.

So how could a primary care team support shared decision making? A 2012 article in Family Practice Management identified six key characteristics of effective practice teams. These were: shared goals, clearly defined roles, shared knowledge and skills, effective and timely communication, mutual respect, and an optimistic can-do attitude. Effective primary care teams delegate responsibilities so that each staff member does only what he or she is uniquely trained to do, rather than wasting time and energy on tasks that can be performed more efficiently by other team members.

Wednesday, November 11, 2015

Book Review: "Ending Medical Reversal" is revolutionary

The take-home message of the first lecture of my first clinical clerkship (Obstetrics and Gynecology) was that we should prescribe supplemental estrogen to all postmenopausal women to prevent cardiovascular disease. That lecture happened in 1999. Less than three years later, the Women's Health Initiative trial was stopped earlier than planned because it had already become clear to the data safety monitoring committee that estrogen therapy actually increased the risk of cardiovascular events, as well as strokes, breast cancer and pulmonary emboli.

If we couldn't protect older women's hearts, at least we could protect their bones by encouraging them to take vitamin D and calcium supplements starting in mid-life. "Don't wait until they develop osteoporosis, fall, and fracture their hips," I recall one of my mentors saying. By extension, no need to wait for the randomized trial, either. But in 2006, the Women's Health Initiative reported that calcium and vitamin D supplementation not only had zero effect on hip fracture rates, it increased the formation of kidney stones. Two years ago, the U.S. Preventive Services Task Force recommended against supplementation for the primary prevention of fractures. Finally, a pair of meta-analyses published in the BMJ earlier this year concluded that dietary calcium intake is not associated with fracture risk in community-dwelling adults and that increases in bone mineral density from calcium supplements are small and clinically insignificant.

In my relatively short career as a family physician, these two high-profile episodes represent a tiny fraction of what Drs. Vinay Prasad and Adam Cifu term "medical reversals" in their new book, Ending Medical Reversal: Improving Outcomes, Saving Lives. They provide other humbling examples, many of which I've blogged about over the years: mammography in women younger than 50, PSA screening, vertebroplasty for spinal fractures, coronary artery stenting for stable angina, and gown-and-glove precautions to prevent the spread of drug-resistant bacteria. In 2013, Prasad and Cifu collaborated with others on a review that found an astounding 40 percent of studies published during a 10-year period in the New England Journal of Medicine overturned an existing medical practice.

What can patients, physicians, and other health professionals do to make medical reversal less frequent and protect patients from useless or harmful tests and therapies? Prasad and Cifu don't advocate tinkering with the normal (and healthy) back-and-forth of the scientific process. However, they point out that in most clinical settings it makes sense to require a higher burden of proof before accepting the usefulness of a new treatment because "unlike pure science, medicine directly affects the lives of human beings." (For example, Prasad and a colleague determined that more than half of all cancer drugs approved by the FDA between 2008 and 2012, and 86% of those approved on the basis of a surrogate end point such as "tumor response rate," had either unknown effects or were later shown to have no effect on overall survival. Not good news for patients who were treated with those drugs.) And as I've argued before, the bar should be set even higher for screening tests and preventive medications offered to apparently healthy people who can only experience harm in the short term.

Prasad and Cifu make several excellent recommendations for reforms in how we apply the results of medical science. First, police sources of flawed data: industry-sponsored clinical trials, conflicted guideline developers, off-label marketing, hype about newer treatments always being better than established ones. Next, rethink the foundations of medical education: teach empiricism and evidence-based medicine (what works to help ill patients) before teaching basic science and mechanisms of disease (how therapies are understood to work). Third, value replication as much as discovery, and thoughtful narrative reviews as much as observational studies in decisions about academic promotion or tenure. Finally, make participation in randomized trials the default choice so that the majority of clinical questions, large or small, can be rapidly answered with experimental evidence.

In a recent research letter in JAMA Oncology, Prasad and a colleague reported that news articles about new cancer drugs employed superlatives such as "breakthrough," "miracle," "game changer," "groundbreaking," and "revolutionary" with ridiculous frequency, since more than half of the drugs discussed had not received FDA approval for any indication and several were supported by no human data whatsoever. I believe that this practice largely reflects lazy or uninformed health journalism. So when I describe Ending Medical Reversal as revolutionary, I don't use the term lightly. Go out and read it - right now.