Sunday, January 31, 2016

Managing hypertension with home blood pressure measurements

Several of my hypertensive patients always have significantly higher blood pressures at the office than at home. Even after verifying the appropriate size cuff, and re-measuring blood pressure several minutes into the visit, the numbers don't change. Since treating these patients based solely on office blood pressures risks overtreatment (prescribing too high a dose or too many drugs), I encourage them to keep logs of their home blood pressures for us to review at each followup visit. However, as outlined in this home blood pressure measurement protocol, interpreting the results can be complex and challenging to carry out in a time-constrained primary care visit.

In a recent study published in the Annals of Family Medicine, a team of Australian researchers monitored 286 patients with uncomplicated hypertension to determine a more efficient method for interpreting home blood pressure measurements. They found that participants with 3 or more of their last 10 home systolic blood pressures greater than or equal to 135 mm Hg were the most likely to have elevated 24-hour ambulatory blood pressures and signs of end organ disease on echocardiography. This correlation held even if patients did not follow the recommended home monitoring protocol. The researchers concluded that using this "3 in 10" threshold may be a more practical way to assess blood pressure control with home measurements.

Although this study only included patients with established hypertension diagnoses, the U.S. Preventive Services Task Force has emphasized the importance of obtaining blood pressure measurements outside of the clinical setting in its 2015 recommendation statement on screening for high blood pressure in adults. According to this Figure, 6 studies found that home blood pressure monitoring confirmed elevated office blood pressure readings only 45 to 84 percent of the time.

In light of the SPRINT trial findings that setting lower blood pressure goals may improve outcomes in patients at high risk for cardiovascular events, it will be even more critical to verify office blood pressure measurements with measurements outside of the office to maximize treatment benefits and minimize adverse effects.


This post first appeared on the AFP Community Blog.

Monday, January 25, 2016

College tuition and health care costs are unsustainable

Each of my four children has a 529 plan qualified education account into which my wife and I have invested a fixed monthly amount since the month each was born. Despite the impact of the Great Recession (two of my children were born before the fall of 2008) and other market downturns, these investments have grown substantially. Still, with eight and a half years to go until my eldest graduates from high school, we are likely to fall well short of fully financing a four-year college education for any of them due to the skyrocketing costs of college tuition. This will be true whether they aspire to attend my pricey alma mater, Harvard, or practically any other college in the nation. Students need no longer attend graduate or professional school to emerge with large amounts of educational debt; the average debt load of the Class of 2015 was more than $35,000, not counting loans that 17% of parents took out on their children's behalf.

Why have increases in college tuition constantly outpaced rates of inflation? On the New York Times's The Upshot blog, N. Gregory Mankiw recently offered these three reasons:

1) "Baumol's cost disease" - despite minimal advances in college productivity that would warrant our paying more for it, "because society overall is now richer, today's Socrates expects a reasonably high standard of living, and that implies hefty tuition."

2) Rising inequality - "it takes educated people to produce the next generation of educated people," and paying skilled workers is increasingly expensive.

3) Price discrimination - as colleges have raised published prices for the relatively well-off, they have also offered more financial aid based on a family's resources.

Even accounting for the impact of financial aid and subsidies to public universities, tuition costs are rapidly rising out of reach for most families. As Kevin Carey explained in a 2012 article in The New Republic:

Imagine you’re in the business of selling apples that cost $1 on the open market. Then the government decides that more people should have the opportunity to buy apples and society would benefit from a net increase in apple consumption. So it decides to drop the price of apples to 60 cents. Sometimes it does this by giving you 40 cents for every apple you sell, on the condition that you start selling apples for 60 cents. Sometimes it gives people vouchers worth 40 cents that can only be used to purchase apples from approved vendors.

At first, the policy works splendidly. Apples are effectively less expensive so more people buy them and the nation is suffused with apple goodness. But then you, the apple vendor, look at the situation and say “Hey, the market price of an apple is still $1. Wouldn’t it be great if I could charge $1 for apples, but still get 40 cents from the government for every apple I sell?” Raising the price all the way from 60 cents back to $1 in a single year would be too obvious and jeopardize political support for the apple subsidy program. So you start raising prices by three, four, or five percent above inflation annually. When annoyed public officials begin asking why, you explain that apple production is an expensive, labor-intensive business, and that all of the extra money is being used to produce the very best apples money can buy. Since apple quality is substantially a matter of taste, this is a hard claim to refute.

Meanwhile, you use some of your new profits to sponsor crowd-pleasing sports events on weekends, building public goodwill. Other profits are used to hire professional lobbyists to plead for both more subsidies and more freedom to set prices. You also convince the government to allow you and other incumbent apple sellers to form a private organization with the authority to decide whether new sellers can become “approved apple vendors” for the purposes of receiving public subsidies. Unsurprisingly, few new sellers are approved.

But eventually things start to break down. As time passes and price increases accumulate, the public starts to notice that while the taxes they pay to support apple subsidies are staying the same, the price of subsidized apples is creeping closer to the market price. This seems unreasonable. Meanwhile, when the economy turns sour, available tax receipts for apple subsidization decline. Instead of raising taxes to make up the difference, public officials drop the per-apple subsidy to 30 cents. This is bad for you, because it means you either have to spend less money on the exotic orchid greenhouse you’ve built next to the apple orchard—the reason, truth be told, you got into the apple business in the first place—or raise prices even further. Luckily, since you’ve kept new vendors out of the market and prices are still below the market rate, you can get away with raising prices, and so you do.

This is essentially the story of public higher education over the last thirty years. Diplomas are, of course, not apples. But they are more like apples than colleges like to pretend.

This blog is about health care, and college costs are not the same as health care costs. But they are a lot more similar than first meets the eye. Both colleges and health care organizations employ armies of highly skilled workers. Like a college education, access to health care is a good thing (although earning a college diploma improves health more than the best health care money can buy), but measures of quality are hard to find and hotly disputed. Higher prices are often conflated with higher quality (a strong incentive to raise prices), and there is little transparency in how colleges and health institutions come up with price tags beyond what the market will bear. The federal government's response to these rising costs has been to make it easier for students to borrow money for tuition and to subsidize the purchase of health insurance for lower-income persons, but in neither case has it done much to restrain cost growth. Finally, the trajectories of college tuition and health care costs are both unsustainable. These are observations, not solutions - but hopefully solutions to one problem will apply to the other as well.

Monday, January 18, 2016

This is 40: evidence-based vs politically mandated care

Ironically, my Viewpoint on public health and screening mammography appears in JAMA the day after I turned 40. Written with Georgetown law professor Lawrence Gostin, it articulates the reservations I expressed last week about Congress preemptively overruling the recently finalized U.S. Preventive Services Task Force breast cancer screening recommendations. Make no mistake: like the members of the USPSTF, I don't have a problem with ensuring that women who make informed decisions after considering the potential benefits and harms can undergo screening mammography at any time after age 40. What troubled me was the process that legislators chose to do this: rather than adding a coverage benefit on top of the Affordable Care Act's evidence-based preventive care mandate, Congress undermined the Task Force's scientific credibility by claiming that 14 year-old clinical guidance (the USPSTF's 2002 recommendations on breast cancer screening) is still relevant to women's health today.

Professor Gostin and I conclude: "The ACA improved the public's health by guaranteeing that insurers provide uniform, cost-free access to preventive services based on modern evidence of effectiveness. The public's health is best served when women's personal decisions about screening are informed by evidence rather than political considerations. Congress's paternalistic response to USPSTF mammography screening recommendations vividly illuminates the social costs of politically mandated care. Rather than benefiting women, political interference with science can discourage shared decision making, increase harms from screening, and foster public doubt about the value and integrity of science."

Thursday, January 14, 2016

Is vitamin D supplementation good for anything?

For as long as I can remember, throughout medical training and clinical practice, the message from my mentors and colleagues about vitamin D supplements was the same: the sooner patients started taking them, the better to prevent osteoporosis and fractures later in life. And that wasn't the only benefit: in 2012, the U.S. Preventive Services Task Force even recommended vitamin D supplementation in community-dwelling adults age 65 and older to prevent falls.

But the very same Task Force soon began to raise doubts about the value of vitamin D supplements. In 2014, it found insufficient evidence to recommend calcium and vitamin D to prevent fractures in premenopausal women or men, and recommended against postmenopausal women using daily vitamin D supplements containing 400 IU or less because these increased the risk of kidney stones without affecting fracture rates. What about a strategy of selective supplementation in vitamin D "deficient" persons? The USPSTF also found insufficient evidence that screening for vitamin D deficiency in adults improves health outcomes, and the American Society for Clinical Pathology recommended against screening for vitamin D deficiency in the Choosing Wisely campaign.

So what is vitamin D supplementation good for? Recognizing the vitamin D deficiency in older adults has been associated with functional decline, Dr. Heike Bischoff-Ferrari and colleagues recently performed a randomized controlled trial comparing high-dose (60,000 IU per month or 24,000 IU per month plus calcifediol, a liver metabolite of vitamin D) to low-dose (24,000 IU per month) vitamin D supplements in 200 community-dwelling men and women 70 years and older with a history of falls. After 12 months, participants receiving the high-dose supplement did not have better lower extremity function and were more likely to have experienced falls than participants in the low-dose group. The authors of an accompanying editorial noted that after many similar trials, vitamin D supplementation has only been shown to reduce fractures and falls in institutionalized older adults.

Putting this all together, the next time a healthy adult of any age asks me if he or she should be taking a vitamin D supplement, I plan to answer: we don't know for sure, but probably not - and we don't need to know what your vitamin D level is, either.


This post first appeared on the AFP Community Blog.

Monday, January 11, 2016

What scientific progress? For breast cancer screening, Congress acts like it's still 2002

When I resigned from the staff of the U.S. Preventive Services Task Force to return to academia, I said that one of my reasons was to give the USPSTF one more "private sector ally" by being freed to "speak my mind" about the adverse effects of political interference with the scientific process. Well, I'm speaking my mind now. Below is the text of a press release that my institution issued last week regarding the Task Force's soon-to-be-finalized updated recommendations on screening for breast cancer.


As the U.S. Preventive Services Task Force (USPSTF) prepares its final breast cancer screening recommendations, Georgetown family medicine physician Kenneth Lin, MD, MPH, points out that, regardless of what the USPSTF decides, the U.S. Congress has already preemptively overruled them.

In the 2016 spending bill (H.R. 2029), passed in mid-December 2015, Congress included language (Sec. 229) that selectively negated a provision of the Affordable Care Act that requires private health insurance plans to provide preventive services recommended by the USPSTF free of charge (without copayments or deductibles). In essence, the act requires insurers to disregard the USPSTF’s most recent determinations about the benefits and harms of breast cancer screening, dictating that the task force’s 2002 recommendations continue to determine insurance reimbursement.

“The U.S. Congress thinks it's perfectly acceptable, even preferred, for a scientific document from 14 years ago to guide coverage policy on screening for breast cancer in women,” says Dr. Lin, a former USPSTF staff member and a nationally recognized expert on cancer screening in primary care.

“As the American Cancer Society concluded in its 2015 guidelines, scientific evidence shows that a strategy of starting screening mammography later than age 40 may significantly reduce harms for many women. Thus, the decision about when to start screening should not be reflexive, but rather a shared decision between a woman and her doctor. The action taken by Congress does not serve women well and ignores medical and scientific advances in understanding the benefits and harms of screening,” Lin says.

He adds, “In 2002, the Palm Pilot was state-of-the-art, handheld technology, virtually no doctors used electronic medical records and Medicare did not cover prescription drugs for seniors. What patients would want to go back to those primitive days? But Congress wants to turn back the clock to 2002 on breast cancer screening.

“As a country, we have spent hundreds of millions of dollars researching ways to reduce the burden of breast cancer that cause the least harm to women. Allowing politicians to cherry-pick scientific guidelines that suit their agendas best will do lasting damage to women’s health,” Lin concludes.

Wednesday, January 6, 2016

Persistent unanswered questions in screening for hepatitis C

About a year ago, I co-authored an analysis in BMJ with Ronald Koretz, John Ioannidis, and Jeanne Lenzer that challenged the growing consensus about the value of routine, rather than risk-based, screening for hepatitis C virus in the "baby boomer" generation (the cohort of persons born from 1945 to 1965). We called for a point-of-entry randomized trial to test the hypothesis that screening the 60 million Americans in this age group and treating those who test positive for HCV will reduce deaths from liver disease and hepatocellular carcinoma. To my knowledge, no health agency or other organization has stepped forward to support such a trial, which leaves unanswered the critical question of whether the hundreds of billions of dollars that will ultimately be spent on $1000 antiviral pills as a result of widespread screening for hepatitis C (Medicare spent $9.2 billion on hepatitis C drugs in 2015) will lead to more population health benefits than harms.

In a recent editorial in American Family Physician, I explained why I continue to feel that family physicians should not be required to institute routine birth cohort screening for hepatitis C. Please read the whole piece if you can, but if you don't have a personal or institutional subscription to the journal, here is the bottom line:

In summary, recent innovations in identification and management of patients with HCV infection have left family physicians facing important unanswered questions. Is it worthwhile to modify practice workflows to prioritize screening for HCV in middle-aged and older adults without any known risk factors, who are more likely to be at risk of cardiovascular disease and cancer than HCV infection? In persons who test positive for HCV, who should be treated or referred for treatment, knowing that many will not benefit?

Given current scientific uncertainties, limited resources, and evolving guidelines, a reasonable middle ground would be for family physicians to collaborate with subspecialty colleagues and focus HCV testing and therapy on patients who are most likely to have long-term complications from the infection, such as those with human immunodeficiency virus infection or type 2 diabetes mellitus, rather than instituting more broad screening and treating everyone who tests positive.