Aligning unhealthy drug use guidelines with evidence-based medicine

 - Kenny Lin, MD, MPH

According to a health advisory from the Centers for Disease Control and Prevention, drug overdose deaths increased substantially during the first few months of the COVID-19 pandemic, rising by a record 2,146 and 3,388 deaths from March to April and April to May 2020, respectively. Overall, "approximately 81,230 drug overdose deaths occurred in the United States in the 12 months ending in May 2020," with synthetic opioids, particularly illicit fentanyl, driving the increases. In response to this acceleration, last year the U.S. Preventive Task Force (USPSTF) for the first time recommended routine screening for unhealthy drug use in adults age 18 years and older, reasoning that identifying persons who are using illicit opioids, stimulants, cannabis, and other drugs would facilitate appropriate treatment. However, the American Academy of Family Physicians (AAFP), after reviewing the USPSTF's summary of the underlying evidence, determined that it did not support this sweeping recommendation. Instead, the AAFP issued an insufficient evidence statement on screening for all drugs except for opioid use disorder (OUD), and advised that clinicians screen adults selectively for OUD "after weighing the benefits and harms of screening and treatment."

In an editorial in the January 15th issue of AFP, Drs. Sarah Coles and Alexis Vosooney, members of the AAFP's Commission on the Health of the Public and Science (Dr. Coles is the current Chair of the Commission and an AFP contributing editor) explained their reasoning for disagreeing with the USPSTF. They noted that the originally commissioned USPSTF evidence report found that "for screen-identified populations, psychosocial interventions and pharmacotherapy do not improve drug use or the consequences." Although the USPSTF then requested a second report that found some effective interventions to reduce unhealthy drug use in treatment-seeking populations,

The AAFP believes that it was inappropriate to rely on this indirect evidence and to generalize the benefits of OUD treatment to screening and treatment of other substance use disorders [SUDs]. Readiness for treatment and availability of effective treatment modalities are key in the successful treatment of SUDs. These data prompted the AAFP to issue an insufficient evidence grade for screening for unhealthy drug use in adolescents and adults, except for OUD.

In an independent commentary that accompanied the publication of the USPSTF recommendation statement in JAMA, Dr. Richard Saltz made similar points in calling screening for unhealthy drug use "neither an unreasonable idea nor an evidence-based practice." Regarding the USPSTF's reliance on studies demonstrating benefits in treatment-seeking populations, he wrote:

Considering this latter set of studies that included patients seeking treatment for drug use is akin to considering studies of chemotherapy for patients seeking care for breast cancer or thrombolysis for symptomatic myocardial infarction as relevant to questions of cancer and cardiovascular disease screening efficacy; efficacious treatment is necessary but not sufficient for making a case for screening. ... Many patients identified with drug use by screening will not have any intention of changing their use of drugs and are not ready to begin treatment, whereas a patient seeking treatment is more ready for change and willing to begin treatment (the success of which relies on readiness and adherence).

Further, Dr. Saltz observed, "the applicability of both [USPSTF] reviews to primary care in the US ... may be limited because many studies were conducted in settings outside primary care; the good-quality studies in primary care settings were null." He also expressed concern that universal screening for unhealthy drug use in pregnant persons and documentation of such use, as the USPSTF advised, could cause considerable harm since nearly half of states consider drug use in pregnancy to be child abuse; in contrast, the only two studies of psychosocial counseling for unhealthy drug use in pregnancy found no benefits.

Lack of access to medication-assisted treatment with buprenorphine remains a significant problem for patients with OUD who desire it; a Graham Center One-Pager found that only 11% of psychiatrists and 2.4% of family physicians prescribed buprenorphine to Medicare beneficiaries between 2013 and 2016. In order to encourage more clinicians to treat OUD with evidence-based medications, the U.S. Department of Health and Human Services (HHS) recently announced that it would allow all outpatient physicians registered with the U.S. Drug Enforcement Administration, rather than only those with a Drug Addiction Treatment Act of 2000 or "X" waiver, to prescribe buprenorphine to up to 30 patients at one time. Unfortunately, the Biden administration is unlikely to implement the new guidelines due to concerns that HHS does not have the legal authority to override the act of Congress that established the "X" waiver process in the first place. For many communities devastated by the opioid overdose epidemic during the COVID-19 pandemic, the lack of accessible and affordable treatment for OUD may continue to be a barrier to care.

Do behavior therapy apps help people quit smoking?

 - Jennifer Middleton, MD, MPH

A common New Year's resolution is tobacco cessation, but for many patients, 2021 will be far from the first time they've tried to quit. Enter a new smartphone app, iCanQuit, which showed promising results in a recent study. Although there are some methodological concerns with the study's outcomes, this app may still be worth discussing with patients eager to improve their chances of finally quitting tobacco.

The researchers conducted a randomized, double-blind clinical trial comparing iCanQuit to the National Cancer Institute (NCI) QuitGuide app. The researchers recruited participants with online (primarily Facebook) advertisements; the mean age of participants was 38.2 years, and most (83%) had smoked for over 10 years. 70.4% of identified as female, and 35.9% identified as a member of a racial/ethnic minority group. Since all participants were enrolled and followed online only, the researchers took extra measures to ensure that responses were legitimate by requiring CAPTCHA authentication, monitoring IP addresses, and monitoring the time participants spent completing their online surveys. They enrolled 2415 participants who reported active tobacco smoking, provided the apps, and followed them for 12 months. 

Acceptance and commitment therapy (ACT), the theoretical underpinning for iCanQuit, emphasizes "acceptance of smoking triggers," while the NCI QuitGuide app emphasizes "avoidance of smoking triggers." 87% of participants stuck with the study for the entire 12 months; after that time, participants in the iCanQuit group were more likely to report having been smoke-free for 30 days prior (odds ratio 1.49; 95% confidence interval 1.22-1.83). There has been significant debate regarding the need for more objective measures (such as saliva or urine cotinine measurements) to validate self-reported cessation, but one of this study's shortcomings may be the impossibility of verifying these online participants' reports of smoking cessation. One argument supporting these participants' veracity, though, is their reported success rates; among all participants, 24.6% achieved 30-day cessation by the 12 month mark, while only 10.6% achieved "prolonged abstinence" (>30 day cessation). These rates are consistent with the success rates reported for several other tobacco cessation interventions. 

The use of apps to facilitate tobacco cessation is not new, but the evidence for their efficacy has room for improvement. A 2019 Cochrane review on mobile tobacco cessation programs found only low quality evidence for smartphone apps, though it found text-based smoking cessation programs to have modest efficacy. A 2020 systematic review that focused on smartphone apps found that:

The majority of studies that use tobacco cessation apps as an intervention delivery modality are mostly at the pilot/feasibility stage. The growing field has resulted in studies that varied in methodologies, study design, and inclusion criteria. More consistency in intervention components and larger randomized controlled trials are needed for tobacco cessation smartphone apps.

Tobacco smoking remains the "leading cause of preventable disease and death in the United States," and working with our patients to empower them to quit can have a tremendous impact on their health. Apps such as iCanQuit and the NCI QuitGuide may be another tool to share with patients. Check out the AFP By Topic on Tobacco Abuse and Dependence, which includes evidence-based overviews of several other cessation supports, if you'd like to read more. 

Gender equity gaps persist in family medicine

 - Kenny Lin, MD, MPH

In a Graham Center Policy One-Pager in the January 1 issue of AFP, Dr. Yalda Jabbarpour and Elizabeth Wilkinson examined the growing role of women in family medicine. Compared to 2010, when 34% of practicing family physicians in the American Medical Association Physician Masterfile were identified as women, the share of women rose to 42% in 2020, mirroring increases in the share of female physicians in primary care and all medical specialties during the past decade. Another recent analysis by Dr. Jabbarpour and others found a statistically significant increase in female first and last authorship of research articles published in 3 family medicine journals (Family Medicine, Journal of the American Board of Family Medicine, and Annals of Family Medicine) between 2008 and 2017. However, they noted that women represented less than 40% of the combined editorial boards of these journals, which did not change significantly during this time.

A Graham Center study utilizing 2017 and 2018 certification survey data from the American Board of Family Medicine found that women self-reported working an average of 49 total hours and 34 direct patient care hours per week compared to 54 and 39 hours, respectively, self-reported by men. In an accompanying commentary on this "gender penalty," Dr. Kathryn Hart (an academic family physician colleague of mine) observed:

Traditional gender roles are still very much at play. The “invisible work” of raising children often falls on mothers, regardless of employment status. This begins with breastfeeding (and the natural carry-over to the intensive caregiving responsibilities of infancy) and evolves into scheduling doctor's appointments, completing school forms, coordinating activities, and arranging childcare, among thousands of other small tasks that cumulatively take up hours over the course of the week.

The work disparities that affect female-male dual professional couples have widened over the past year. The widespread transition to virtual learning from home during the COVID-19 pandemic has substantially increased the burdens of unpaid work (domestic chores and family care) that employed women perform relative to employed men worldwide.

Whether the physician gender pay gap can be attributed solely to female physicians working fewer hours than men was the subject of a recent analysis of data from more than 24 million primary care office visits in 2017. Despite spending 2.6% more observed time in visits overall than male primary care physicians, female primary care physicians conducted 10.8% fewer total visits and consequently generated 10.9% less revenue. Female physicians spent 15.7% more time (2.4 minutes) with each patient than male physicians did, but generated no more revenue per visit. In addition to the many other good reasons to retire the antiquated fee-for-service payment system in primary care, this study suggested that it remains an inherent obstacle to pay equity between male and female physicians.

Introducing Dr. Renee Crichlow, AFP's Medical Editor for Diversity, Equity, and Inclusion

 - Jennifer Middleton, MD, MPH

In AFP's first editorial of 2021, "Systemic Racism and Health Disparities: A Statement from Editors of Family Medicine Journals," the editors of several Family Medicine journals "commit to actively examine the effects of racism on society and health and to take action to eliminate structural racism in our editorial processes." AFP committed last year to "recruit editors and editorial board members from groups underrepresented in medicine," and please join us in welcoming AFP's new medical editor for Diversity, Equity, and Inclusion, Renee Crichlow, MD, FAAFP. Dr. Crichlow is the Director of Advocacy and Policy at the University of Minnesota School of Medicine where she holds the Mac Baird Endowed Chair in Family Medicine Advocacy and Policy. Here are some highlights from a recent interview!

1. Tell us a little about yourself and your background.

I grew up in the South, and I have lived on both coasts, the Mountain West, and the Midwest. I have seen communities and medical practice in many regions and I have come to realize that, first and foremost, I am a Family Medicine zealot. This country needs us. I have always practiced and taught full-spectrum care with Obstetrics having lived and worked in both rural and urban communities. I have known these communities as both a physician and a patient. When I gave birth to my son, I lived in a town of fewer than three thousand people and the hospital two blocks from our house had stopped doing deliveries a few years prior. I know personally what it means for a patient to drive sixty miles from home to have a safe delivery. I have done two fellowships, one at UCSF/UCDavis as a clinical research, faculty development fellow and the second through a Department of Health and Human Services Primary Care Health Policy Fellowship. As such, I believe that Family Medicine physicians working with their patients in the exam room is necessary for the health of our patients, and Family Medicine physicians working with health systems, stakeholders, and policymakers to develop evidence-based decisions is necessary for the health of our communities and the survival of our specialty.

2. What are your goals for this new position at AFP?

We aim to provide systemic support, including advising for authors and editors as we all engage with becoming an anti-racist, inclusive, and equitable specialty in our efforts to both care for and represent all of the communities we serve.

3. What advice might you share regarding specific actions each of us can take toward a more inclusive and equitable world?

First, do no harm, primum non nocere.

Second, ask yourself if you really care about anti-racism and inclusion and their impact on health equity. You may be comfortable with the current health inequities and prefer to attribute their causes to poor personal and individual choices. If not, you may care that the structures of current systems facilitate and perpetuate the status quo, a status quo that is inequitable to many of the patients and communities we serve. Third, consider this work more with a mindset of transformation than a change. The idea of change can seem very polarizing, e.g. light switch turns on the light, the light switch shuts off the light. That is categorical change and that type of change is not possible when dealing with anti-racism, inclusion, and equity, because the work that needs to be done has no predictable path; at its best, this process is co-creative where, working together, we all engage in transforming our systems to facilitate more inclusive and equitable outcomes.

4. Is there anything else you'd like AFP readers to know about you?

We are Family Medicine physicians. We deal with growth and change every day. I believe we are our best when we are helping each other grow through the challenges and choices of life, and these are indeed challenging times. Right now, our whole society is undergoing growth and change at an unprecedented pace. As with all growth, there will be some discomfort. We are Family Medicine physicians, trained to care for the full life cycle of our patients. We are not afraid of growth. I understand that, often, what people really fear is not change but loss. We understand that people may be concerned with changes where they will lose systems and structures that were familiar and dependable. But we know that the current systems and structures are inequitable for many and expensive and inefficient for all. I believe that addressing healthcare information and education using the lens of health equity and inclusion can contribute to systemic transformation. It provides a path for functional excellence, evidence-based structural revision, and systemic transformation.

Caring for all of our patients in an equitable and effective health system is a reasonable goal. We are Family Medicine. We can do this. 

The top ten AFP Community Blog posts of 2020

 - Kenny Lin, MD, MPH

Unsurprisingly, 7 of our 10 most-viewed blog posts from this pandemic year were related to COVID-19. Beginning in February, when I wrote with concern about initial reports of a novel coronavirus that was rapidly spreading from its original epicenter in Wuhan, China, the pandemic accelerated, transmitting exponentially across the United States by mid-March and causing state governments to close schools and non-essential businesses. In addition to the worldwide death toll (which, per the Johns Hopkins University Coronavirus Resource Center, stood at nearly 1.8 million as of today), we forecasted the staggering mental health impacts of the virus and prolonged economic disruption and social isolation.

Contributing editor Allen Shaughnessy, PharmD and his colleague Dr. Andrea Gordon provided ten points to consider when applying evidence-based medicine in a pandemic. Dr. Middleton described one of the more unusual manifestations of COVID-19 infection, "COVID toes," and our 2019-20 Resident Representative, Dr. Enkhee Tuvshintogs, discussed how medical students were adapting to disruptions in their educational programs and personal lives. Finally, we reviewed fraudulent COVID-19 research publications and the summer of #BlackLivesMatter protests against police violence and the persistence of structural racism that produced, among other things, vast disparities in coronavirus infections and mortality among African Americans.

Of course, 2020 included other important medical stories. Personally, we mourned the passing of AFP executive editor Joyce Merriman, who capably led our professional editor team for 15 years. Two past AFP Podcast co-hosts reviewed 9 other highly ranked podcasts for family physicians for medical education or moving health narratives. And Dr. Middleton argued that the results of a recent randomized controlled trial could mean that intermittent fasting's time in the popular diet limelight may be up.

All of us at American Family Physician hope that you and your loved ones are having an enjoyable holiday season, and we look forward to 2021 being a less unprecedented and more optimistic year.

Here come the COVID vaccines

 - Jennifer Middleton, MD, MPH

Last month, I wrote about the process for vaccine approval by the United States (US) Food and Drug Administration (FDA). Since then, the Pfizer/BioNTech SARS-CoV-2 vaccine has received Emergency Use Authorization (EUA), joined by the National Institutes of Health (NIH)/Moderna vaccine at the end of last week. These two vaccines use a novel mRNA process to induce immunity; a third vaccine by Oxford/AstraZeneca, which instead uses a chimpanzee adenovirus vector ("viral vector"), has just published its interim analysis data.

The Oxford/AstraZeneca ChAdOx1 vaccine was tested in nearly 35,000 individuals across Brazil, the United Kingdom (UK), and South Africa in phase 2/3 trials. Importantly, only adults aged 18-55 were enrolled. When researchers received the manufactured vaccine in the UK, though, their measurement of the viral particle concentration was higher than expected. To maximize safety while their teams resolved this discrepancy, they chose to inoculate the first group of participants with a lower dose for their first injection. Once the researchers settled the issue with their quantification methods, all participants then received the originally planned full dose of the vaccine for their second injection. Later UK enrollees and participants at the other trial sites received the full dose for both injections. 

Interestingly, the low dose cohort had better protection against COVID-19 than the participants who received two full dose injections:

In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010).

The researchers did not have an explanation for this surprising finding, though they rightly point out that the confidence intervals are quite wide for both values.

This vaccine is unlikely to achieve EUA status in the US soon. Oxford/AstraZeneca failed to promptly notify the FDA of the dosing snafu as well as the decision to pause trials in September after a participant was diagnosed with transverse myelitis. The FDA reportedly learned about these issues via the lay press and not the study investigators, which reportedly did not sit well with FDA leadership. The FDA didn't clear Oxford/AstraZeneca to resume vaccine trials in US until October, which put them behind Pfizer/BioNTech and NIH/Moderna in the race to generate phase 3 trial data. And, they have yet to produce any data regarding their vaccine's efficacy in adults over the age of 55, the population arguably at greatest risk of COVID-19 mortality.

Assuming it eventually catches up, the Oxford/AstraZeneca vaccine has several appealing properties. Unlike the two mRNA vaccines by Pfizer/BioNTech and NIH/Moderna, the Oxford vaccine does not require ultra-cold storage and is much less expensive to produce. For parts of the world where storing and/or procuring an mRNA vaccine is not affordable or practical, the Oxford/AstraZeneca vaccine offers an alternative. 

The AAFP held a virtual town hall last week about the COVID-19 vaccines, and the Centers for Disease Control and Prevention (CDC) has also outlined its allocation recommendations for the initially limited supply of vaccine. We'll also continue to update the AFP By Topic on Coronavirus Disease 2019 (COVID-19).