Friday, June 14, 2019

Behind the scenes of the AAFP guideline on depression after acute coronary syndrome

- Kenny Lin, MD, MPH

The June 15 issue of AFP features the original publication of an updated guideline from the American Academy of Family Physicians (AAFP) on screening and treatment of patients with depression following acute coronary syndrome. This is the first product of a new partnership between the best-read journal in primary care and the AAFP's Clinical Practice Guidelines development team. As a past Chair (2015-2017) of the AAFP's Subcommittee on Clinical Practice Guidelines (SCPG) of its Commission on Health of the Public and Science (CHPS), I know how much time and effort goes into creating evidence-based guidelines for family physicians. A series of four short videos on the AAFP website provides a general overview of the clinical practice guideline development and assessment process, which is documented in detail in its Clinical Practice Guideline Manual.

For this specific topic, a panel of 4 family physicians, an internist, a patient representative, and a PhD clinical policies strategist with no relevant conflicts of interest updated a 2009 AAFP guideline on detection and management of post-myocardial infarction depression. This topic was deemed still relevant to family medicine and nominated by the AAFP in 2016 to the Agency for Healthcare Research and Quality (AHRQ)'s Effective Health Care Program for an updated systematic evidence report. The independent systematic review team solicited input from subject experts and panel members to develop a structured research protocol that focused on answering two key questions:

1. What is the accuracy of depression screening instruments or screening strategies compared to a validated criterion standard for post-acute coronary syndrome (ACS) patients?

2. What are the comparative safety and effectiveness of pharmacologic and nonpharmacologic depression treatments in post-ACS patients?


The completed evidence report, posted on AHRQ's website and published in condensed form in the Annals of Internal Medicine in November 2017, served as the basis for the panel's recommendations. The panel rated the evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, which differs somewhat from AFP's Strength of Recommendation Taxonomy. GRADE provides a framework to assess the certainty of the evidence and develop structured statements based on that evidence and the values/considerations that influenced the recommendation.

The draft post-ACS depression guideline was internally peer reviewed by members of the SCPG and the AAFP's Science Advisory Panel, followed by external reviews by cardiology experts, mental health professionals, and representatives of other relevant organizations. After changes were made in response to peer review comments, the revised guideline was reviewed by the full SCPG and CHPS, then forwarded to the AAFP's Board of Directors for approval. The guideline makes two major recommendations:

1. The American Academy of Family Physicians recommends that clinicians screen for depression, using a standardized depression screening tool, in patients who have recently experienced an acute coronary syndrome event (weak recommendation, low-quality evidence). Individuals should undergo further assessment to confirm the diagnosis of depression (good practice point).

2. The American Academy of Family Physicians strongly recommends that clinicians prescribe antidepressant medication, preferably selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors, and/or cognitive behavior therapy to improve symptoms of depression in patients who have a history of acute coronary syndrome and have been diagnosed with depression (strong recommendation, moderate-quality evidence).

Notably, although treating depression after ACS improves depression symptoms, there remains insufficient evidence that depression treatments reduce cardiovascular or overall mortality. A Practice Guidelines synopsis in the June 15 issue also discusses barriers to implementing the guideline in practice such as lack of time, reimbursement, and institutional support for routine depression screening; and limited access to behavioral health services. Implementation resources available in the guideline itself include Tables comparing depression screening tools and medications and advice about use of practice champions.

Saturday, June 8, 2019

Has aspirin for primary prevention of CVD reached its expiration date?

- Kenny Lin, MD, MPH

A daily low-dose (81 mg) aspirin was once considered an essential component of cardiovascular disease (CVD) prevention for middle-aged and older adults. In 2006, the National Commission on Prevention Priorities ranked "discussing aspirin use in high-risk adults" the highest priority preventive service based on clinically preventable burden and cost effectiveness, and two years ago, in an updated set of rankings, it still rated aspirin use as the fifth highest priority for improving utilization. However, in 2018 the results of three large randomized trials suggested that the harms of aspirin taken to prevent a first CVD event outweigh its benefits for most persons. In an editorial in the June 1 issue of AFP, Dr. Jennifer Middleton and I reviewed the latest evidence and concluded:

The new data do not exclude the possibility that aspirin may still benefit adults at very high CVD risk (e.g., 20% or more over 10 years) or those at lower risk who are unable to tolerate statins, but the data otherwise suggest that the risks of low-dose aspirin therapy for primary prevention outweigh any potential benefits. For most patients, we should be deprescribing aspirin for primary prevention of CVD. To prevent heart attacks and strokes, family physicians should focus instead on smoking cessation and lifestyle changes, controlling high blood pressure, and prescribing statins when indicated.

In a 2019 clinical practice guideline, the American College of Cardiology / American Heart Association largely concurred, recommending against prescribing aspirin for primary prevention of CVD in adults older than age 70 and downgrading its role in other adults at high risk to "may be considered" on a case-by-case basis.

Although aspirin is still strongly recommended to prevent recurrent CVD events, its rise and fall in primary prevention seems to have become another case of medicine reversing itself. Unlike other notable examples of medical reversal such as menopausal hormone therapy and tight glucose control in type 2 diabetes, the effectiveness of aspirin was supported by many well-conducted randomized, controlled trials. Aspirin worked ... until it didn't. In a recent commentary in the Journal of General Internal Medicine, Palmer Greene and colleagues suggested that it may be a good idea to consider established evidence-based practices as having an "expiration date":

An “evidentiary statute of limitations” would require the occasional reassessment of accepted therapies to consider which might no longer be of use—possibly because of changes in the population as a whole, a changing understanding of whom the treatment is appropriate for, or evolving therapies for the prevention or treatment of the disease in question. Not only should we consider if older data still applies, we should also strive to anticipate the factors to which the results of a newly published positive study might be sensitive. For instance, is there an event rate in the control group below which the harms of the therapy might outweigh the benefit? Is there a treatment success rate that, when achieved, would make screening inefficient?

Not starting aspirin is relatively straightforward, but patients who have taken aspirin for many years without adverse effects or CVD events may resist discontinuing it. What approaches have you taken to this complex discussion?

Sunday, June 2, 2019

Making the most of screen time: recommendations for families

- Jennifer Middleton, MD, MPH

With the academic year wrapping up, planning for the summer months is a reality for many American families. While planning for vacations and other away activities is often paramount, considering in advance how to spend days at home can be equally valuable. Setting expectations and limits on screen time at the beginning of the summer break can set families up for success in encouraging physical activity and good sleep habits.

The American Academy of Pediatrics (AAP) recommends no screen time for children younger than ages 18-24 months and limiting screen time to one hour of “high-quality programming” for children aged 2-5 years. For older children, the AAP advises setting limits that are consistent with “your family’s values and parenting style.” Engaging in media use with children and teens is preferred to unsupervised use, and families are discouraged from placing televisions, computers, and video game consoles in children’s bedrooms. Parents and guardians can use a Family Media Plan tool to develop personalized screen time expectations.

Last summer, the American Heart Association (AHA) also weighed in on screen time recommendations, publishing a scientific statement in Circulation describing concerns with increased sedentary behavior, obesity, and future health risks linked to excessive screen time. The authors cited data showing that adolescents who exceed two hours of screen time daily are 1.8 times more likely to be obese (odds ratio 1.82 [95% confidence interval 1.06-3.15]); this study also found that “screen time is a stronger factor than physical activity in predicting weight status in both children and adolescents.” The AHA has similar recommendations as the AAP regarding screen time use: set time limits, keep screens out of bedrooms, and engage in media together as a family.

You can find more recommendations from the AAP, including specifics about social media safety for teens, at this website. A wealth of parent and patient education materials is available at healthychildren.org’s Media page, including advice about when to give children their first smartphone, identifying age-appropriate media, and combating cyberbullying. The American Academy of Family Physicians' Familydoctor.org website also offers a helpful patient education handout on healthy habits for TV, video games, and the Internet.

Thursday, May 23, 2019

Counseling families about water safety

- Jennifer Middleton, MD, MPH

Memorial Day weekend traditionally marks the opening of outdoor pools across the United States, and balmier temperatures mean that recreational boating, swimming, and other water activities will begin to increase. With nearly 4,000 drowning deaths in the U.S. annually, now is the time of year to counsel families regarding safety in and around natural or man-made bodies of water.

A 2016 AFP article on “Prevention and Treatment of Drowning” reminded readers that “[d]rowning is rarely caused by a single factor” and “prevention strategies should not be pursued in isolation.” The American Academy of Pediatrics (AAP) recently updated its policy statement on prevention of drowning, noting that the highest death rates occur in children 12 to 36 months of age, followed by adolescents age 15 to 19 years, with alcohol consumption being a leading risk factor. The AAP has created an online Drowning Prevention Toolkit that features resources for physicians and child safety advocates, including public service announcements, infographics, information for parents, and sample social media posts with the hashtag #DrowningPrevention.

The American Red Cross encourages swimming lessons and avoidance of alcohol around pools and bodies of water for persons of all ages. They further recommend fences around home pools and to “actively supervise kids whenever around the water.” There’s even a “Swim” IPhone app by the American Red Cross (also available on Google Play) that can track progress through swim lessons and includes educational games for children that reinforce water safety tips.

The Centers for Disease Control and Prevention (CDC) reminds swimmers to check for pool safety and cleanliness before getting in by ensuring that drain covers are intact and clear of debris, along with ensuring that no cleaning chemicals or supplies are accessible. If no lifeguard is present, swimmers should familiarize themselves with the location of first aid and rescue equipment.  The CDC also discourages urinating or defecating in a pool; all swimmers should take a break once an hour, which is perfect for checking younger children’s diapers and encouraging older children to take a restroom break. You can find patient education handouts on water safety on the AFP website and the American Red Cross website.

Monday, May 20, 2019

Reducing medication cost burden in primary care: challenges and opportunities

- Kenny Lin, MD, MPH

Earlier this month, the Centers for Medicare & Medicaid Services (CMS) finalized a new rule requiring that pharmaceutical companies disclose drug list prices in direct-to-consumer television advertisements for drugs that cost more than $35 for a month's supply or usual course. A fact sheet further explaining the rule noted that "the 10 most commonly advertised drugs have list prices ranging from $488 to $16,938 per month or usual course of therapy." Although pricing transparency could push patients to select more affordable or non-pharmacologic alternatives, and help clinicians improve high-value prescribing, it unfortunately does not make these drugs any less expensive.

In an editorial in the April 1 issue of AFP, Dr. Randi Sokol discussed four strategies for helping patients with type 2 diabetes mellitus afford insulin while providing evidence-based care: 1) Relax A1c goals to 8% or less; 2) Switch to human insulins instead of insulin analogues; 3) use Health Resources and Services Administration-certified 340B pharmacies and patient assistance programs; and 4) join advocacy efforts to reduce the high cost of insulin and other drugs, such as the Lown Institute's Right Care Alliance and the American Medical Association's Truth in Rx.

Family physicians can take a systematic approach to reducing prescription costs for all of their patients. In an article published in FPM, Dr. Kevin Fiscella and colleagues described the approach taken by 7 primary care practices in New York, Georgia, and California. Office staff screen patients for prescription cost concerns by privately asking them, "Is the cost of any of your medications a burden for you?" For patients who answer yes, clinicians briefly explore the circumstances (e.g., unmet deductible, use of brand name drugs) and employ several cost-reducing strategies, including deprescribing unnecessary medications, using extended (90-day) prescriptions, and substituting lower-cost medications or referring patients to large chain pharmacy discount programs (e.g. "$4 lists").

In a preliminary study published in a supplement to the Annals of Internal Medicine, Dr. Fiscella's team found that a single 60-minute training for clinicians and staff on cost-of-medication importance, team-based screening, and cost-saving strategies increased the frequency of cost-of-medication conversations from 17% to 32%. Other helpful articles in the same supplement supported by the Robert Wood Johnson Foundation included "The 7 Habits of Highly Effective Cost-of-Care Conversations" and "Tools to Help Overcome Barriers to Cost-of-Care Conversations." The American College of Physicians offers several additional cost-of-care conversation resources on its website.

Monday, May 13, 2019

Should physicians de-prescribe statins in older adults?

- Michael J. Arnold, MD

I work hard to de-prescribe unnecessary medications in my older patients, but I have never known what to do with statins. Are they preventing cardiovascular events or just causing trouble? Published studies included limited numbers of participants aged 75 years and older, so it has been difficult to know what to recommend.

A recent meta-analysis in The Lancet divided the subjects of 28 statin randomized trials by age groups, and identified over 14,000 who were over 75 years old. The analysis found that older adults benefit from statins for prevention of recurrent cardiovascular events (secondary prevention), but did not see a benefit for primary prevention. In the 6,000 older patients without a prior cardiovascular event, those taking statins weren't any less likely to have an event within 5 years than those taking placebos.

Unfortunately, the results aren’t definitive for primary prevention in older adults. Patients had less than a 3% risk of a cardiovascular event in the 5 years, leading to fewer than 100 events in each group - numbers too small to make firm conclusions. However, the low event rate should reassure primary prevention patients who wish to stop statins that any potential benefit is small. In addition, a large retrospective cohort study found that adults 75 years or older without vascular disease or diabetes did not benefit from statins. An ongoing primary prevention trial involving 18,000 adults over 70 years old will hopefully settle this question.

Even statins for secondary prevention in adults over 75 years old are not as valuable as in younger patients. The number needed to treat (NNT) is 125 to prevent a recurrent vascular event in 5 years, higher than the NNT for any other age group.

Another issue relevant to the decision to deprescribe a statin is the legacy effect. There is evidence of a significant benefit from having taken statins in the past, even in patients who have stopped taking them. Numerous studies have shown long-term benefit from taking statins during trials lasting only a few years. Another meta-analysis suggested that the legacy effect could be stronger for primary prevention.

Outside of the cardiovascular benefit, there isn’t much other evidence of statin benefits for older adults. The Lancet meta-analysis saw no difference in cancer incidence with statins. A Cochrane review showed that statins have no benefit for decreasing incidence of dementia.

Yet the argument for stopping statins is not strong either. Trials show that statins don’t have many adverse effects. They aren’t more likely to be associated with myalgia, rhabdomyolysis, hemorrhagic stroke or liver enzyme elevations than placebo. They do seem to increase the risk of developing diabetes at higher doses.

Deprescribing decisions will still require individualized shared decision making. An older adult without vascular events can likely stop a statin with minimal effect on risk, while a patient with a prior event will still benefit from continuing the statin, provided that he or she isn't experiencing adverse effects. You can find more in-depth information about statin use in this 2017 article on hyperlipidemia and the Practice Guidelines in the May 1 issue of AFP.

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Dr. Arnold is AFP's 2019-20 Jay Siwek Medical Editing Fellow. The views expressed in this article are those of the author and do not necessarily reflect the official policy or position of the Department of the Navy, Uniformed Services University of the Health Sciences, Department of Defense, nor the U.S. Government.