Should we SPRINT to lower blood pressure goals?

- Jennifer Middleton, MD, MPH

Just as we were all adjusting to JNC 8's blood pressure goal recommendations this past December (140/90 for most and 150/90 for adults over 60 without co-morbidities), in September the National Institutes of Health (NIH) issued a press release stating that they were halting SPRINT early due to preliminary findings that the benefits of a systolic blood pressure goal of 120 reduced the risk of cardiovascular events and mortality compared to a systolic blood pressure goal of 140.

SPRINT, the Systolic Blood Pressure Intervention Trial, aimed to prospectively enroll and then follow over 9000 patients during a four- to six-year time period to definitely answer that age-old blood pressure treatment question - how low should we go? Participants were at least 50 years of age, had a systolic blood pressure of at least 130, and had at least one additional risk factor for cardiovascular disease (chronic kidney disease, a Framingham score of at least 15%, and/or age of at least 75 years) but no prior history of cardiovascular disease. Patients with diabetes were excluded. The primary outcomes of interest were incidence of myocardial infarction (MI), acute coronary syndrome (ACS), stroke, heart failure, or cardiovascular death; they examined several other secondary outcome measures as well, including all-cause mortality and worsening chronic kidney disease.

Prior studies examining this question found no benefit for keeping systolic blood pressure under 120 but possible harm from doing so; Dr. Lin has reviewed this evidence base twice on the AFP Community Blog, in 2013 and again earlier this year. (There's also an AFP By Topic on Hypertension if you'd like to read more.) So, if the SPRINT findings are legitimate, significant changes may be quickly coming about blood pressure treatment recommendations, including the possible early retirement of JNC 8. The stakes are high.

Stopping a study early isn't necessarily a bad thing. If it's clear, for example, that one arm of the trial is causing harm, then researchers are ethically obligated to stop the study. Similarly, it can be questionable to continue a study when it's clear one treatment is far superior to the other. But stopping studies early also has risks; for example, a smaller number of participants, and/or a decreased amount of time following them, can skew results to look more impressive than they might otherwise have been.

The NIH has faced significant backlash on social media, but for more than just stopping the study early:

From Health News Review:

The big announcement about these “landmark” results doesn’t actually include any “results” from the SPRINT study. You can search the news release high and low but you’ll find nary a single statistic from the study or a number related to what the researchers found.

From The Incidental Economist:

[T]his is basically the release of conclusions without methods or even results. It hasn’t been peer reviewed. I don’t know the details....Those who conducted and funded the study can’t be the ones to judge its merit. 

From Scientific American:

Doctors and reporters only had the slick NIH press release, which glistened with words such as “landmark” and “life-changing” and provided hype but little substance. It did not emphasize that the findings may only apply to a limited segment of the population...and it did not mention potential risks associated with taking multiple blood pressure drugs...

From the PLOS blog:

If the primary outcome turns out to be rock solid and confirmed in the future, other aspects of the study...are vulnerable to the shorter intervention period. That includes knowledge about longer term and less common adverse events, and the impact on subgroups of sicker people.

From Forbes.com:

When it comes to data release of clinical trial results, the NIH should set the standards. It shouldn’t be moving the bar. In this case, one could imagine some overly pushy drug company using this data release to justify releasing more data on its own product. That leads us even further into a world where science is conducted by press release. That shouldn’t be an outcome anyone wants.

Your patients may already be reading and asking about SPRINT; how are you responding? What do you want to see from SPRINT before considering a change in how you manage patients with high blood pressure?

Update:
SPRINT was just published today, and no doubt there will be a lot of discussion in the coming weeks dissecting its findings. Watch for more on this topic from the AFP Community Blog, too!

If CBT came in a pill, how much would it cost?

- Kenny Lin, MD, MPH

Family physicians commonly treat patients with depression, anxiety disorders, attention-deficit/hyperactivity disorder (ADHD), sleep disorders, and other psychiatric conditions. Although some patients respond to medication, prescribing has significant downsides. Antidepressants can increase suicide risk, and a study that once declared medications to be superior to behavioral therapy for ADHD is now receiving a second look. In contrast, an article by Drs. Scott Coffey, Anne Banducci, and Christine Vinci in the November 1st issue of American Family Physician reported that cognitive behavior therapy (CBT) effectively relieves symptoms of all of these conditions, plus those from post-traumatic stress disorder, autism, obsessive-compulsive and tic disorders, personality disorders, and eating disorders. The article answered several common questions about CBT, including how it works:

The aim of CBT is to help patients adopt more adaptive patterns of thinking and behavior to improve function and quality of life. Treatment goals are selected collaboratively with patients to determine whether progress is being made. CBT involves three core strategies applied alone or in combination, depending on the patients' needs: (1) identifying and challenging problematic thoughts and beliefs, with the goal of helping patients develop more realistic and adaptive thoughts and beliefs, (2) scheduling pleasant activities to increase environmental reinforcement, and (3) extended exposure to unpleasant thoughts, situations, or physiologic sensations to decrease avoidance and arousal associated with anxiety-eliciting stimuli.

Finding a qualified therapist many be a challenge in some communities, and CBT usually doesn't come cheaply. However, CBT for most conditions is time-limited: one session per week for 8 to 12 weeks. At $150 to 200 per session, the typical cost for a treatment course would be between $1200 and $2400.

In comparison, a one-month supply of the newer antidepressants levomilnacipran, vortioxetine, and vilazodone (which are labeled only for treatment of major depressive disorder in adults, and are often prescribed indefinitely) cost $286, $254, and $149, respectively, at the time each drug was reviewed in AFP's STEPS (Safety, Tolerability, Effectiveness, Price, and Simplicity) department. So a newer antidepressant could cost as much or more than a course of CBT in as little as 4 to 8 months.

If CBT could somehow be packaged into a pill and patented, though, it would likely cost a lot more, given its versatility and enormous potential market share. It might become the next big blockbuster drug, like newer antiviral treatments for hepatitis C that cost between $84,000 and $156,000 for a 12-week course of treatment, or $1000 or more for a single pill. Or, since CBT has been around since the 1960s, perhaps a better benchmark would be the infamous recent example of the 62 year-old drug pyrimethamine (Daraprim), whose manufacturer raised the per-tablet price from $13.50 to $750, literally overnight.

Thickened feeds may help infant GERD but may also cause excess weight gain

- Jennifer Middleton, MD, MPH

Thickening infant feeds with rice cereal is not a new practice; my mother has told me more than once that doing so "cured" my belly woes as an infant, and she frequently recommends the same to new mothers whose babies are struggling with frequent spit-ups and fussiness. As discussed in an article in the current issue of AFP, thickening feeds is one of many remedies often tried for symptomatic gastroesophageal reflux disease (GERD) in infants prior to treating with medication, but this common remedy can be associated with excess weight gain.

This finding comes from a 2008 systematic review, cited by the AFP authors. The included studies also demonstrated mixed results regarding the efficacy of thickening feeds, and the systematic review authors, citing a 2002 guideline, assert that "thickening agents and infant diets containing thickening agents should be used only for selected infants with failure to thrive caused by excessive nutrient losses associated with regurgitation and used only in conjunction with appropriate medical treatment and supervision."

Although the connection between excess weight gain from thickening agents in formula and weight later in life has not been studied, another 2008 systematic review did find that overweight children tend to remain overweight into adulthood. This study, recently featured in the Journal of Family Practice, included 13 studies dating back to 2001 deemed to be of high quality and looking at children's weights as far back as 1 year of age; one study also included birth weights in its cohort. Although there was significant variability in study findings, in general, children with BMIs greater than the 85th percentile were at least twice as likely to be overweight as adults. It's perhaps not an impossible stretch that minimizing infants' excess calories may benefit them later in life, especially since even what our mothers ate while pregnant can affect our risk for obesity. 

There are several other conservative measures to recommend first for infants with GERD. If you'd like to read more, there's also an AFP article from 2009 on infant formula as well as an AFP by Topic on nutrition.

RightCare Action Week and Choosing un-Wisely

- Kenny Lin, MD, MPH

This week, American Family Physician is joining clinicians, patients and organizations all over the country in supporting the Lown Institute's RightCare Action Week (#RCAW), which aims to re-focus the U.S. health system on care that is "effective, affordable, needed and wanted by well-informed patients, and especially, free of clinical decisions that are made with financial or business considerations." This goal is more far-reaching than the three year-old Choosing Wisely campaign objective of encouraging conversations between physicians and patients about potentially unnecessary care. As Dr. Jennifer Middleton mentioned in last week's post, AFP has developed several resources to help family physicians implement Choosing Wisely in their practices. On the patient side, Consumer Reports has worked with more than 20 physician groups to create and distribute educational content about specific items in the campaign.

Are these efforts to reduce unnecessary care making a measurable difference? JAMA Internal Medicine recently published a study of national insurance claims data by Dr. Alan Rosenberg and colleagues that analyzed trends among seven of the earliest Choosing Wisely "don't do" recommendations from 2010 through 2013. Although there were statistically significant declines in CT and MRI for uncomplicated headaches and cardiac testing in patients without heart conditions, use of two other inappropriate services increased (NSAID prescriptions in patients with hypertension, heart failure, or chronic kidney disease; and primary HPV testing in women younger than age 30). Since the study didn't include data from 2014 or 2015, the results could either mean that the campaign isn't working or that it was just too early to tell.

Family physicians and patients should keep in mind that even care that is recommended by evidence-based guidelines and incentivized by pay-for-performance programs can be harmful if provided to patients without regard to their individual circumstances. In an Annals of Internal Medicine essay titled "The Tyranny of Guidelines," Dr. George Sarosi described the six-year saga of Mr. O, an independent octogenarian with mild hypertension and diabetes who suffered a hip fracture and subsequent stroke as the unfortunate end result of a "relentless downhill medical care spiral fueled by interventions ... to tightly control both the blood sugar and the blood pressure."

The pitfall in this case wasn't the guidelines themselves as much as the one-size-fits-all way they were applied by "the system" to the patient. Dr. Sarosi concluded, "We need a system that rewards the physician who understands the limitations of guidelines." Indeed, a Right Care system would reward physicians who prevent patients from receiving too much medicine.

RightCare Action Week is next week!

- Jennifer Middleton, MD, MPH

Overuse of medical services - unnecessary prescribing, testing, and hospital care - may represent as much as 30% of the medical services we provide in the United States. Besides wasting resources, these unnecessary medical services can also cause patient harm and even death. Led by the Lown Institute's RightCare Alliance, several leading patient care advocacy organizations have declared October 18-22 RightCare Action Week:

RightCare Action Week is a grassroots initiative for clinicians and others who want to take action that demonstrates how much better our healthcare system can be.Our healthcare system has strayed from its mission: Healthcare that is effective, affordable, needed and wanted by well-informed patients, and especially, free of clinical decisions that are made with financial or business considerations. (http://rightcareactionweek.org/about/)

RightCare Action Week is an opportunity for all of us to show our patients that they deserve better than to be harmed by unnecessary medical services. You may feel, as a busy family doctor, that participating in such initiatives is unrealistically time consuming, but this week provides plenty of opportunities to get involved on even a very small scale - and when those small actions are added up across the country, they can make a very powerful voice.

The RightCare Action Week Guide to Taking Action describes easy ways to get involved. First, consider participating in an overuse count; simply observe how many unnecessary medical services you see during all or part of the week and share your tally at rightcareactionweek.org. Second, look for or organize a story slam, a time when healthcare workers can come together and share stories of overuse - and possibly associated harms - they've seen. Third, and perhaps the quickest of all, consider participating in their photo campaign - a pic of you holding a sign describing what "right care" means to you, tweeted or e-mailed to the Lown Institute. You can find more details about each of these initiatives here.

You can also count on AFP to provide you with the point-of-care resources you need to avoid overuse. If you haven't checked out our Choosing Wisely search tool, it's a great way to quickly access those evidence-based guidelines. Under the Department Collections tab on the AFP home page (hyperlink), you can find AFP Journal Club, where AFP editors critically assess recent studies, Medicine by the Numbers, which provides clear-cut summaries of the harms and benefits of various interventions, and a POEMs (Patient Oriented Evidence that Matters) archive which includes the top 20 POEMs by calendar year. Each of these resources has interactive search tools and provide quick answers intended to enhance the care you provide to your patients every day.

If you'd like to read more about overuse, AFP ran a series of editorials on overscreening, overdiagnosis, and overtreatment by Dr. Mark Ebell, AFP Deputy Editor for Evidence-Based Medicine, earlier this year along with an accompanying editorial by AFP Editor Dr. Jay Siwek. 

RightCare Action Week starts in just 7 days; please consider taking part in at least some small way! Maybe you'll commit to trying one of the AFP resources above that is new to you, or maybe you'll try an overuse count, story slam, or photo campaign. Share your involvement on social media with #rightcare and watch for RightCare Action Week updates from @AFPjournal and myself, @SingingPenDrJen, too.

How can tech help Family Medicine for America's Health?

- Kenny Lin, MD, MPH

A randomized trial published last month in JAMA found that sending lifestyle change text messages to patients with coronary artery disease improved smoking cessation rates, increased physical activity, and reduced other cardiovascular risk factors. After only 6 months, the texted group had lower low-density lipoprotein, systolic blood pressure, and body mass index measurements than the usual care group. This was an impressive finding, but an unsettling one, since I had just finished reading an American College of Physicians position paper on the use of telemedicine in primary care settings. Taken together, these publications suggest that virtual care technologies, broadly defined, could make many in-person clinical encounters unnecessary. That's good for patient convenience, but potentially threatens one of the best parts about practicing family medicine: seeing patients in person.

Health information technology (IT), as embodied in electronic medical record systems that have replaced paper charts in most family practices, has thus far been a mixed blessing for our specialty. But what about tech beyond traditional health IT? The technology "tactic team" of Family Medicine for America's Health published a special article in Family Medicine that described strategies for family physicians to utilize an array of evolving technologies to strengthen therapeutic relationships and improve outcomes:

1) Smartphone apps and wearable devices that capture data about patients' health habits and give feedback to influence their behavior

2) Point-of-care musculoskeletal ultrasound

3) Web-based communication for "virtual" hospital rounding and specialist consultations

4) Web-based videos to provide patient and professional education

Although all of these initiatives have great potential to benefit patients, many are being developed in silos without leadership or input from family physicians. Therefore, the paper's authors proposed that Family Medicine for America's Health work to integrate these overlapping efforts into "a united front improving health IT and other technologies for the specialty."

Key opportunities for family physicians "to capitalize on our collective strengths" in the near future include partnering with developers to create health IT tools that improve clinical outcomes (rather than merely serving administrative or billing functions); supporting primary care-centric data models; participating in the development of primary care quality measures; and collaborating with patient and consumer organizations locally and nationally to identify and promote patient- and family-centered technology solutions that complement the vital functions of family medicine.