Wednesday, March 21, 2018

For hypertension and diabetes, lower treatment targets not necessarily better

- Kenny Lin, MD, MPH

In a previous AFP Community Blog post, Dr. Jennifer Middleton analyzed the 2017 American College of Cardiology / American Heart Association clinical practice guideline on high blood pressure in adults, which proposed lowering the threshold for hypertension from 140/90 to 130/80 mm Hg. Later, the American Academy of Family Physicians and the American College of Physicians independently declined to endorse this guideline, citing concerns about its methodology (e.g., no quality assessment for included studies), management of intellectual conflicts of interest, and lack of information on harms of intensive drug therapy.

The March 15th issue of American Family Physician included a Practice Guideline summary and an editorial perspective on the ACC/AHA guideline by Dr. Michael LeFevre, a member of the panel that developed the JNC 8 guideline for hypertension in adults. In his editorial, Dr. LeFevre pointed out that the guideline's strengths include its emphasis on proper blood pressure measurement technique to avoid overtreating adults with normal out-of-office blood pressures. On the other hand, he argued that "it is an overreach" to classify everyone with a blood pressure above 130/80 as having uncontrolled hypertension. He predicted that since intensive behavioral counseling has only modest benefits in lowering blood pressure, many patients at low risk of cardiovascular disease will end up being treated with medication:

Much harm will come if this change [to the definition of hypertension] is widely accepted and implemented, particularly if quality measures that echo this definition are put into place. Harms from the consequences of poor measurement, overmedication, and arbitrary quality measures can easily offset the small reduction in CVD events found in trials of high-risk persons.

Blood pressure is not the only area of family medicine where there is ongoing debate about appropriate treatment thresholds. In a recent clinical guidance statement, the American College of Physicians recommended that clinicians "aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes," and "consider deintensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%." This statement elicited a critical response from the American Diabetes Association and endocrinology groups, who argued that lower blood glucose targets are sometimes appropriate to reduce the risk of microvascular and perhaps cardiovacular complications.

This debate between lower and higher A1c targets has been ongoing for years, as illustrated by a pair of Pro and Con editorials on this topic that appeared in AFP in 2012. On the whole, however, more relaxed glucose control can have substantial benefits, especially for older persons with type 2 diabetes, as Dr. Allen Shaughnessy and colleagues argued in 2015:

A large part of the acceptance that “lower is better” hinges on a false belief that a pathophysiologic approach to decision making is always correct. It seems logical that reducing blood glucose levels to nondiabetic normal, no matter the risk or cost, should result in improved patient outcomes. But it doesn't. Today, an older patient with type 2 diabetes is more likely to be hospitalized for severe hypoglycemia than for hyperglycemia.

Underlining this point, a vignette-based study in the March/April issue of Journal of the American Board of Family Medicine found that primary care clinicians (particularly internists and nurse practitioners) would often chose to intensify glycemic control in an older adult with a HbA1c level of 7.5% and multiple life-limiting comorbidities. As family physicians look for opportunities to improve care for patients with hypertension and diabetes, we should not miss opportunities to avoid harm. 

Monday, March 12, 2018

Breastfeeding + pacifiers = no problem

- Jennifer Middleton, MD, MPH

In the designated "Baby-Friendly" hospital where I round, the use of pacifiers is discouraged in breastfeeding infants in the newborn nursery. Advising breastfeeding mothers about the risks of pacifier use contributing to early weaning is common practice, despite conflicting studies regarding the validity of this risk. A Cochrane meta-analysis, reviewed in the March 1 issue of AFP, may put the controversy to rest, as the reviewers found that pacifier use did not interfere with the establishment or duration of breastfeeding.

The Cochrane reviewers identified two randomized controlled trials (RCTs) for their meta-analysis, both of which divided breastfeeding mothers of newborn infants into two groups: one where pacifiers were prohibited, and one where pacifiers were permitted. Researchers in both RCTs found no difference in breastfeeding rates at 3-4 months of life between these two groups. Arguments against pacifier use have cited previous observational studies finding that pacifier use correlates with diminished establishment of maternal milk supply; the permissive pacifier groups in both of these RCTs, however, included pacifier use even in the immediate newborn period.

As these RCTs only included outcomes on breastfeeding rates in the first months of life, the AFP reviewers rightly encourage future research focusing on pacifiers' possible effect on additional outcomes including maternal confidence and total duration of breastfeeding. These more robust outcomes may dispel any lingering concerns about pacifier use. Adding pacifiers back to the tools available for comforting newborns certainly may benefit both babies and parents; since nonnutritive sucking is a natural self-soothing reflex in newborns, I suspect many parents would concur with my own experience regarding a pacifier's utility in calming a fussy baby.

If you'd like to read more, there are recent AFP articles on "Strategies for Breastfeeding Success" and "Risks and Benefits of Pacifiers," an editorial on "The Maternal Health Benefits of Breastfeeding," and a patient information page on "Helpful Tips for Breastfeeding." (Although these earlier articles do not reflect the findings of this new meta-analysis regarding pacifier use, they still contain a wealth of useful information for supporting breastfeeding in your practice.) The AAFP has a position paper on breastfeeding which encourages breastfeeding education in medical schools and residencies, breastfeeding-friendly office practices, and community advocacy to support breastfeeding mothers. This Society of Teachers of Family Medicine blog post from 2013 puts a compelling personal spin on the challenges of returning to work while breastfeeding, including suggestions on supporting breastfeeding within our own profession of working mothers.

Monday, March 5, 2018

Public health and advocacy resources in American Family Physician

- Kenny Lin, MD, MPH

Shaping local and national policies to improve patients' health outcomes is an appropriate and important role for family physicians. For the past several years, I have taught public health and advocacy skills to medical students, and last month, I attended Academy Health's National Health Policy conference in Washington, DC, for the first time. Although the majority of participants were researchers or policy analysts, family physicians were well-represented as medical directors, public health and insurance officials, and leaders of privately funded community health improvement projects.

In a previous blog post, I discussed the concept of assessing social determinants of health through "community vital signs," geocoded and individually linked data derived from public data sources. Although American Family Physician focuses on health interventions that clinicians provide in offices, emergency rooms, hospitals, and long-term care facilities, it also publishes resources to help family physicians improve social determinants outside of health care settings. For example, a 2014 editorial examined the role of the family physician in preventing and managing adverse childhood experiences, and a review article in the February 1 issue discussed implications for physicians of childhood bullying.

Previous editorials and articles have addressed environmental health hazards such as lead, radonair pollution and climate change, and a 2011 Letter to the Editor urged family physicians to take action to affect the built environment of American communities by "working to ensure that our patients have safe, convenient, and enjoyable places to walk, run, and bike." Other public health issues where physician advocacy can make a positive difference include food insecurity, homelessness, and firearm safety.

Family physicians are often first responders to natural and unnatural disasters in their communities. From influenza pandemics to bioterrorism, preparedness and early recognition is essential to protecting our patients. A 2015 editorial argued that the rapid spread of infectious diseases and migration and displacement of diverse populations have made global health knowledge essential for every family physician, regardless of location: "As the recent Ebola epidemic demonstrated, the world is not only smaller than ever, but it is also more intricately connected. Exotic diseases once confined to the third or developing world are now everyone's concern. Global has truly become local." For example, clinicians are likely to encounter victims of sex trafficking and labor trafficking in their practices.

AFP's sister publication, FPM, also provides resources for primary care clinicians with community and public health roles, from launching a community-wide flu vaccination plan, to following the Grand Junction, Colorado example of improving health system cost and quality outcomes, to working with community-based senior organizations. Finally, family medicine advocates can stay abreast of national initiatives that will shape the specialty's future, such as direct primary care, the patient-centered medical home, and the Medicare Access and CHIP Reauthorization Act (MACRA).

Monday, February 26, 2018

Diagnosing concussion with a blood test?

- Jennifer Middleton, MD, MPH

The Food and Drug Administration (FDA) reported last week that it had approved a new blood test to help diagnose mild traumatic brain injury (mTBI or "concussion") called the Banyan Brain Trauma Indicator. The test measures two proteins, UCH-L1 and GFAP, that are released by the brain into the bloodstream within 12 hours of injury. The FDA press release includes discussion regarding this test's potential to reduce the number of CT scans patients with suspected mTBI receive. The study cited by the FDA to approve this test, however, has not yet been published for physicians to review.

A 2012 AFP article reviewing "Current Concepts in Concussion: Evaluation and Management" describes the difficulties in making a concussion diagnosis:
Concussion can be difficult to recognize, complicated by the lack of a universal definition. Additionally, there are no direct objective measures for diagnosis or recovery, no treatments with well-documented effectiveness, and limited empiric prospective data to guide return-to-play decisions.
The article reviews the high incidence of mTBI in the United States (estimated to be between 1.6-3.8 million injuries annually) and cites that over 1 million of these patients are evaluated in US emergency departments every year. Many of these patients get CT scans of their brain to rule out serious intracranial processes despite the existence of guidelines like the New Orleans criteria that discourage CT scans in patients without headache, vomiting, intoxication, amnesia, seizure, or visible trauma. Using serum biomakers to reduce the use of CT scans in suspect mTBI patients would save patients from unnecessary radiation exposure; this radiation exposure may increase risk for future cancers, especially in patients who receive multiple scans over their lifetimes. An AFP Journal Club article author from 2010 is quoted as saying, "After I have told a patient or parent that a head CT is the equivalent of 100 to 200 chest radiographs, you'd be surprised how many say they really don't need or want the test."

Prior studies regarding the utility of UCH-L1 and GFAP to diagnose concussion have had mixed findings. A previous study examining the use of these 2 proteins along with a 3rd not mentioned in the Banyan Brian Trauma Indicator found decent sensitivity for detecting mTBI but poor specificity; a positive test result was suggestive of mTBI, but a negative test result did not reliably rule it out. A systematic review of these biomarkers' utility from last year was less enthusiastic, finding "insufficient evidence" that these tests are "ready for clinical application."

While the FDA's desire to make this test available as quickly as possible is admirable, not sharing the data that led to its approval makes it challenging for physicians to use it. As with most medical diagnostic tests, the results of the Banyan Brain Trauma Indicator will not merely be "yes" or "no," and understanding the chances of a false positive (or negative) along with the positive (or negative) predictive value will be important for physicians to apply it thoughtfully. Hopefully more information will be forthcoming from the FDA soon, and hopefully, too, the study they cite will be available for our scrutiny as well. In the meantime, here are some mTBI resources from AFP for your review.

Monday, February 19, 2018

Enthusiasm should not outweigh evidence on vitamin D

- Kenny Lin, MD, MPJH

In 2005, Dr. Mark Ebell authored an AFP editorial on the rise and fall of vitamin E, subtitled "lessons in patient-oriented evidence." Observational studies associated lower vitamin E levels with coronary artery disease, leading many physicians to recommend that patients take vitamin E supplements for cardiovascular protection. 19 randomized, controlled trials later, the verdict was in: vitamin E supplementation actually increased all-cause deaths. Dr. Ebell viewed the "vitamin E saga" as an instructive cautionary tale:

It is important to remember that biochemical theory does not equal clinical benefit. Improvements in disease-oriented outcomes, such as free-radical activity, are no substitute for patient-oriented outcomes, such as all-cause mortality. Sometimes our enthusiasm for unproven treatments may harm our patients.

Physicians and patients, it turns out, were already turning to testing and treatment with another vitamin that was a marker of chronic health conditions in observational studies: vitamin D. Between 2000 and 2010, the volume of serum 25-hydroxyvitamin D levels in Medicare patients increased 83-fold, and by 2014, 4 out of 10 adults 70 years or older reported taking a daily vitamin D supplement of at least 1,000 IU, and nearly 7 percent of adults over 60 were taking more than 4,000 IUs daily, a level that the National Academy of Medicine considers to be potentially toxic.

Unfortunately, the vitamin D saga has much in common with the vitamin E saga. According to a review article in the February 15th issue of AFP by Drs. Michael LeFevre and Nicholas LeFevre, vitamin D supplementation in community-dwelling adults has not demonstrated any benefits for ischemic heart disease, cerebrovascular disease, or cancer in clinical trials. The U.S. Preventive Services Task Force and the American Academy of Family Physicians concluded that there is inadequate evidence that supplements improve psychosocial or physical functioning in persons with lower vitamin D levels.

In an accompanying editorial, I argued that the harms of routine screening and supplementation with vitamin D outweigh the benefits, especially when the costs of testing (more than $300 million annually in Medicare alone) are considered:

It is time for clinicians and patients to curb our enthusiasm for vitamin D screening and supplementation. Strategies to decrease unnecessary testing could include distributing the patient handout on vitamin D tests created by Consumer Reports for the Choosing Wisely campaign and implementing clinical decision support for ordering laboratory tests. ... Family physicians should also counsel patients on the recommended dietary allowance for vitamin D (600 IU per day in adults 70 years and younger, and 800 IU per day in adults older than 70 years), and discourage most patients from using supplements, especially in dosages near or above the tolerable upper limit of 4,000 IU per day.

Monday, February 12, 2018

Treating and preventing disease with dietary fiber

- Jennifer Middleton, MD, MPH

The current issue of AFP includes a review article on Hemorrhoids: Diagnosis and Treatment Options that discusses the roles fiber intake has both in contributing to hemorrhoids (when too low) and treating them (when appropriately increased). The authors recommend that patients with hemorrhoids increase their fiber intake to 25-35 grams per day and provide a link to a handout listing high fiber foods. As a high fiber diet can also help prevent and treat hyperlipidemia, constipation, and diverticulosis, family physicians should be proficient in discussing this important digestive component with patients.

Adequate daily fiber intake may protect against the development of hyperlipidemia. Children with chronic constipation consume less fiber than their peers with normal bowel patterns. Inadequate fiber intake is associated with the development of diverticulosis, which can put patients at risk for diverticulitis.

Increasing dietary fiber can modestly reduce LDL levels, improve constipation, and, along with exercise and weight loss if indicated, reduce the risk of recurrent diverticulitis. (Of note, a Cochrane meta-analysis found no role for using fiber supplementation to improve symptoms of irritable bowel syndrome.) Increasing fiber by increasing consumption of high-fiber whole foods, and not with fiber product supplementation, provides the most benefit.

Most Americans consume less than half of those recommended 25-35 grams of fiber daily, though many are trying to increase their consumption by choosing more fruits, vegetables, and whole grain products. Unfortunately, many products marketed as "whole grain" in the United States contain very little fiber. We should counsel patients to look beyond claims about whole grain content and examine food labels to choose products with a minimum of 3 grams of fiber per serving. Advising patients, also, to gradually increase their fiber intake may help them minimize the unpleasantness of bloating and excess flatulence that can accompany a rapid change in fiber consumption. Patients may find nutrition tracking apps such as My Diet Coach, reviewed in the current issue of Family Practice Management, to be useful in monitoring their daily fiber intake. Other apps such as (Fooducate and Shopwellcan help patients make more informed choices at the grocery store.

Providing specific advice in the context of motivational interviewing increases our patients' likelihood of success at making any behavioral modification stick; there's an AFP By Topic on Health Maintenance and Counseling as well as an AFP By Topic on Nutrition if you'd like to read more. What resources have you found useful to help patients increase their daily fiber intake?