Tuesday, April 13, 2021

Premature adoption of 3D mammography threatens study that aims to prove its value

Although digital breast tomosynthesis (DBT; 3D mammography) was approved by the U.S. Food and Drug Administration a decade ago and has since been rapidly adopted by breast imaging centers, no studies have shown that it is more beneficial or less harmful for breast cancer screening than traditional digital mammography. In a Diagnostic Tests review in the April 1 issue of American Family Physician, Drs. Kathleen Barry and Chelsea Evans noted that DBT offers a "modestly increased cancer detection rate" and lower recall rate, but also costs about 40% more per test and exposes patients to a higher dose of radiation. It is unclear if additional cancers detected by DBT would have eventually become symptomatic, and "no studies have evaluated mortality as an outcome in women screened with DBT compared with digital mammography."

To address these important questions, in 2017 the U.S. National Cancer Institute (NCI) and the Canadian Cancer Trials Group launched a $100 million randomized trial, TMIST (Tomosynthesis Mammographic Imaging Screening Trial). With a planned enrollment of 165,000 women at 100 North American clinical sites, TMIST was designed to compare the incidence of advanced breast cancer after 4.5 years of follow up in women receiving either digital mammography or DBT. However, by early 2020, investigators had managed to enroll fewer than 23,000 women and were forced to expand to include overseas sites in Asia and Europe. The reason, according to an article in Medscape: already convinced that DBT was a superior technology, large numbers of U.S. and Canadian radiologists were declining to participate. Then the COVID-19 pandemic hit, further hindering recruitment efforts.

Meanwhile, a national study of Breast Cancer Surveillance Consortium sites found substantial racial and ethnic disparities in DBT access, with Black, Asian, and Hispanic women significantly less likely than White women to be screened at a facility with DBT or to receive DBT if the facility offered both DBT and digital mammography. If DBT is truly superior to digital mammography, this apparent disadvantage may worsen existing disparities in breast cancer outcomes. If it isn't, then widespread DBT use is unnecessary and wasteful.

After the NCI director suggested in the fall of 2020 that the "feasibility and relevance" of TMIST was in jeopardy, a working group was formed to reevaluate the trial. In its report released last month, the group recommended that the trial continue, but with protocol revisions that included reducing the sample size to 102,000 and developing specific targets for enrolling women from racial and ethnic minority groups. Unlike European trials that are also evaluating DBT, the group noted, TMIST is the only study that is representative of the U.S. population, includes women younger than age 50, and includes multiple rounds of screening.

In a 2019 commentary, Drs. Joy Melnikow and Joshua Fenton observed of DBT:

Diffusion of medical technology ahead of definitive evidence is common in the United States. ... Societal attitudes that place high value on innovation and technology create a fertile environment for the rapid adoption of novel but unproven interventions. ... When the evidence from randomized clinical trials catches up, interventions shown to add little value to previous approaches are often already embedded in practice, widely covered by health insurance (sometimes by mandate), and difficult to withdraw.

Initial findings from TMIST will be available in 2027 at the earliest if investigators can reach its lower enrollment goal. As radiology facilities across the country continue to "upgrade" from digital mammography to DBT and more states mandate insurance coverage of the newer but unproven technology, I'm not optimistic that this important study's findings will have beneficial effects on clinical practice.

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This post first appeared on the AFP Community Blog.

Thursday, April 8, 2021

Handoffs

I have started asking every patient I see, for whatever reason, if they have received or intend to receive one of the three available U.S. vaccines against COVID-19. In less than two weeks, every adult in every state will be eligible to get the shots, and in the next few months the Pfizer vaccine should become available to children as young as age 12. There is no question in my mind that getting vaccinated as soon as possible is the right choice to protect my patients and their loved ones and communities from the ravages of the virus. But like most primary care physicians, I don't have access to a supply of vaccines for use in my office - instead, I must direct patients to a website to sign up for an appointment to get it at another time, somewhere else. And for vaccine-hesitant patients or those who for whatever reason are unable to find the time to do this, this obstacle may leave many unvaccinated who (at least when they saw me) were perfectly willing to get the shot. In a recent Medscape commentary, I argued why "it's time to hand the [vaccine supply] baton to primary care for the final leg of the race to end this pandemic."

I ran track relays in high school: the 4 X 400 meters and 4 X 800 meters. The latter distance is long enough that baton-passing technique makes little difference in the final result, but in the shorter relay (just short of a mile in total) it matters. We runners on deck were taught two techniques: accepting the baton from a standing start or a running start. A standing start usually ensures a clean exchange, but the runner then loses time by being unable to accelerate until the baton is in hand. A running start ensures that momentum transfers smoothly from one runner to the next, but if not executed precisely, it can result in a botched handoff (either a dropped baton or disqualifying exchange outside of the legal zone), dooming the team's hopes. The running start also requires a lot more practice to get right.

What I and family physician colleagues are seeing across the U.S. right now, as primary care practices are gradually becoming involved in vaccination efforts in Maryland and other states, is handoffs from a standing start. Even though many practices went to great lengths to identify and reach out to their patients at the highest risk of complications in anticipation of being able to administer vaccines (running start), the belated recognition by the federal government and state health departments of their critical role in reaching more reluctant patients has forced them to halt these efforts while they wait for adequate supplies to trickle in. This is a huge lost opportunity, and I fear that this lack of coordination between public health and primary care will result in unnecessarily prolonging the pandemic.

Monday, March 29, 2021

Increasing clarity about benefits and harms of screening for diabetes

Affecting about 6 percent of pregnancies in the United States, gestational diabetes increases risks of preeclampsia, shoulder dystocia, and macrosomia, and is associated with a 10-fold greater risk of developing type 2 diabetes mellitus in later life. In a recent draft statement, the U.S. Preventive Services Task Force (USPSTF) affirmed its previous recommendation to screen pregnant persons for gestational diabetes at or after 24 weeks of gestation. Historically, there have been two screening options: a non-fasting 50 gram oral glucose challenge test followed by a fasting 100 gram glucose tolerance test if the first test result exceeds a threshold value (typically 130-140 mg/dL), or a single fasting 75 gram glucose tolerance test. Although two-step screening is more commonly used in the U.S., until recently the comparative outcomes of these approaches were uncertain. This evidence gap is important because the diagnosis is associated with increased psychological and emotional burden; labeling more persons as having gestational diabetes with the one-step screening approach would only be justified if doing so resulted in better pregnancy outcomes than the two-step approach.

A pragmatic, randomized trial recently compared the one-step and two-step approaches in more than 23,000 women who received prenatal care at Kaiser Permanente Northwest and Kaiser Permanente Hawaii. Researchers evaluated five primary outcomes: "diagnosis of gestational diabetes, large-for-gestational-age infants, a perinatal composite outcome (stillbirth, neonatal death, shoulder dystocia, bone fracture, or any arm or hand nerve palsy related to birth injury), gestational hypertension or preeclampsia, and primary cesarean section." As expected, a diagnosis of gestational diabetes was more common in participants who underwent one-step screening (16.5%) compared to the two-step approach (8.5%). However, intention-to-treat analyses found no statistically significant differences in any perinatal or maternal complications. Although the trial was not designed to measure potential long-term benefits of post-pregnancy risk-reduction strategies to prevent type 2 diabetes, the results suggest that the two-step approach produces equivalent benefits, and fewer harms, than the one-step approach.

The USPSTF is also updating its recommendation on screening for prediabetes and type 2 diabetes in nonpregnant adults. Compared to its 2015 statement, which recommends screening overweight or obese adults between the ages of 40 and 70, the updated draft statement lowers the age range to include persons aged 35 to 39 years. Although the focus of the Task Force's old and new diabetes screening guidelines is identifying persons with prediabetes in order to prevent them from developing diabetes and its complications, the utility of the term "prediabetes" is controversial, as Dr. Jennifer Middleton discussed in a previous AFP Community Blog post. In older adults, prediabetes is extremely common. In a prospective cohort study of community-dwelling adults aged 71 to 90 years, 73 percent met one or both of the diagnostic criteria for prediabetes (hemoglobin A1c level of 5.7% to 6.4%, impaired fasting glucose of 100-125 mg/dL). After 6.5 years of follow-up, persons with prediabetes at baseline were substantially more likely to revert to normoglycemia or to die than to progress to diabetes. Based on these findings, stopping diabetes screening after age 70 will avoid overdiagnosis and unnecessary treatment.

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This post first appeared on the AFP Community Blog.

Sunday, March 14, 2021

Can Choosing (more) Wisely prevent chronic low back pain?

More than a dozen Choosing Wisely campaign recommendations concern what not to do for patients with acute low back pain. Based on a clinical practice guideline from the American College of Physicians, the American Society of Anesthesiologists and several other groups recommend avoiding imaging studies within the first six weeks in patients without red flags or specific clinical indications. The American Academy of Orthopedic Surgeons and the American Academy of Physical Medicine and Rehabilitation (AAPMR) advise avoiding opioids for these patients unless other alternatives have not provided pain relief. The AAPMR and the North American Spine Society discourage bed rest as treatment for acute low back pain. These recommendations are intended to reduce downstream harms and costs: for example, a spurious finding on MRI could lead to unnecessary surgery; use of opioids could lead to physical dependence and opioid use disorder; bed rest and avoidance of physical activity could increase the risk of long-term disability.

Can guideline-discordant care for patients with acute low back pain increase the risk of progression to chronic low back pain? In an inception cohort study published in JAMA Network Open, researchers enrolled 5233 adults with acute low back pain from 77 U.S. primary care practices, assessed their baseline risk of transition to chronic pain using the Subgroups for Targeted Treatment (STarT) Back prognostic tool, and followed them for 6 months. 32% of participants met clinical criteria for chronic low back pain at the study's end. Characteristics associated with transition to chronic pain included obesity (adjusted odds ratio, 1.52), tobacco use (aOR, 1.56), severe baseline disability (aOR, 1.82), and a depression and/or anxiety diagnosis (aOR, 1.66). Researchers also examined associations between chronic low back pain and inappropriate care processes within 21 days of the initial visit: 1) any opioid prescriptions, or benzodiazepines or systemic steroids prescribed without an NSAID or skeletal muscle relaxant; 2) diagnostic imaging; 3) medical subspecialty referral for back pain. Compared to the 52% of participants who received none of these, patients with 1, 2, or 3 inappropriate care processes were 1.39, 1.88, and 2.16 times more likely to develop chronic low back pain after controlling for clinical characteristics.

Although adherence to Choosing Wisely recommendations was associated with a lower risk of patients developing chronic low back pain in this study, it is disappointing that almost half of them received at least some inappropriate care. Is care for back pain an outlier, or does it reflect national trends? A recent cross-sectional study examined the use of 32 low-value health services in Medicare fee-for-service beneficiaries. The study found modest progress from 2014 to 2018 in the percentage of persons receiving any low-value service (declined from 36.3% to 33.6%), number of low-value services per 1000 persons (declined from 678 to 633), and spending per 1000 persons on low-value care (declined from $52,766 to $46,922). Three services comprised about two-thirds of low-value care: preoperative laboratory testing, opioids for back pain, and antibiotics for upper respiratory infections. While preoperative testing decreased during the study period, opioid and antibiotic prescribing both increased.

Since the campaign's inception in 2012, Choosing Wisely recommendations have been widely disseminated in American Family Physician (AFP), FPM (formerly Family Practice Management), and other family medicine journals. The American Academy of Family Physicians periodically updates and adds new "don't do" recommendations, most recently in 2018. Other studies have recognized that clinicians in underserved or "safety net" practices are as likely to provide low-value care as clinicians in better resourced settings. A 2018 AFP editorial by Dr. Jennifer Middleton recognized that increasing awareness of best practices is necessary but not sufficient to drive implementation: "For meaningful change to occur, the workflows and systems we operate within must change so that new habits become routine." The Medicare study suggests that workflows and systems have not changed enough in the past decade to undo entrenched low-value practices.

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This post first appeared on the AFP Community Blog.

Thursday, March 4, 2021

Misinformation can be as contagious and harmful as COVID-19

At the end of August 2020, when around 1,000 Americans were dying from COVID-19 each day, I posted on my personal Facebook account a straightforward translation of the deaths statistic: averaged over 24 hours (86,400 seconds), one U.S. resident was dying every 86 seconds. In another post, I expressed my concern for the mental health and safety of hundreds of public health officials all over the country who were being threatened and harassed for recommending or enforcing measures aimed at stemming these horrifying losses, such as restricting restaurant capacity, banning large gatherings, and mandating mask-wearing when social distancing wasn't possible.

It didn't occur to me that either of these posts would be the least bit controversial among my friends and family. But later that night, a friend from college whom I've known for more than a quarter of a century commented that I was greatly exaggerating the death toll and "fear mongering." Do the math, I responded. He countered by claiming that doctors were inflating COVID-19 death counts for financial benefit and that just because thousands were dying with COVID, they weren't necessarily dying of COVID. The flu kills 100,000 people every year, he wrote, and we don't shut down the country for that. I gently pointed out that according to official CDC statistics, no more than 60,000 people have died in a single influenza season for the past decade, and those numbers are estimates, not actual case counts. We went back and forth like this for a while. Finally, exasperated, I observed that my friend is a lawyer, while I have medical and public health degrees and was probably a little bit more informed than he was. "Elitist," he taunted, your fancy education doesn't mean anything. The great thing about social media is that it's the ultimate equalizer - no one needs to "bow down" to your supposed expertise. By the way, he wrote, right before I wished him well and blocked him from posting more misinformation on my page, those public health officials you support all march in lockstep with the Democratic Party, so as for the harassment, well, they had it coming.

Six months later, more than half a million Americans have died from the pandemic, and though new infections have fallen from their post-holiday peak, we're still losing about 2,000 people every day (or one every 43 seconds). Despite the greatly increased pace of vaccination since President Biden took office, as of today less than 10 percent of the U.S. population is fully vaccinated, and less than 20 percent has received at least one dose of the Pfizer or Moderna two-dose vaccines (the Johnson & Johnson vaccine is a single dose). Nonetheless, the misinformed governors of Texas and Mississippi have declared victory, discarding their mask mandates and restrictions on businesses and sending the message that if COVID-19 was ever a serious public health problem, it isn't any longer.

Of course, online misinformation abounded well before COVID, infamously leading many parents to refuse the measles, mumps, and rubella vaccine for their children because they feared, based on a single fraudulent, discredited and retracted scientific article, that it might cause autism. And I'm deeply concerned that the crazy myths now proliferating online about COVID vaccines - that they make changes to your DNA, they cause infertility, they contain tiny microchips to allow Bill Gates can track your movements, that their side effects are worse than the disease - pose a huge obstacle to achieving herd immunity through vaccinating 70 percent or more of the population. (And don't get me started on the barbaric "let's achieve herd immunity through natural infection." One might as well go back to the days of bloodletting and Hippocrates' four humors, for the immense harms that strategy would cause.) Let me be clear: I don't think that vaccination should be mandatory for every adult (or child, when it is shown to be safe and effective in children), but those who decline it for themselves or on someone else's behalf should do so because they have concerns that medicine can't yet answer (e.g., are there any side effects that don't show up for a year or more?), not because they fall for misinformation or conspiracy theories.

Monday, February 22, 2021

Are physicians overdiagnosing melanoma?

In an editorial in the February 1 issue of American Family Physician, Dr. Jenny Doust and colleagues wrote about the problem of widening disease definitions, a common phenomenon in which the definition of a disease is "broadened over time to include milder and earlier cases," leading to harm "by exposing more patients to the adverse effects of treatments, triggering investigation and prescribing cascades, increasing anxiety, and placing a financial burden on patients and the wider society." Expanding the number of patients diagnosed with disease increases the burden on primary care physicians called on to manage these additional cases, even when it is uncertain if earlier interventions prevent morbidity or mortality. Illustrative examples of wider disease definitions include hypertension, polycystic ovary syndrome, breast cancer, and autism. What can family physicians do about it? The authors responded:

Recognizing the problem is the first step in tackling it. In particular, family physicians should not blindly accept new definitions and testing guidelines without an adequate understanding of the harms and benefits of the changes and the implications for our patients and wider practice.

Along similar lines, a recent analysis in the New England Journal of Medicine by Dr. H. Gilbert Welch and colleagues examined the drivers of the dramatically increased incidence of cutaneous melanoma in the U.S., which today is 6 times as high as in 1975 despite essentially no change in melanoma mortality. They pointed out that exposure to ultraviolent (UV) radiation (including tanning bed use) cannot account for more than a small portion of this increase. Instead, they argued that increased diagnostic scrutiny - "the combined effect of more screening skin examinations, falling clinical thresholds to biopsy pigmented lesions, and falling pathological thresholds to label the morphologic changes as cancer" - is most likely to be responsible for the epidemic of new diagnoses. Not only has the annual percentage of fee-for-service Medicare beneficiaries undergoing skin biopsies nearly doubled since 2004, but pathologists frequently upgraded skin biopsy specimens obtained in the late 1980s from benign to malignant when evaluating the same specimen two decades later. Primary care physicians contribute to widening the definition of cutaneous melanoma by performing or referring for biopsy small (<6 mm), incidentally detected skin lesions and screening patients with dermoscopy, which identifies more melanomas than visual inspection alone but is not well studied in primary care settings.

The U.S. Preventive Services Task Force (USPSTF) has concluded that current evidence is insufficient to assess the balance of benefits and harms of skin cancer screening in asymptomatic adults. Nonetheless, more than half of family physicians and general internists in a 2011 survey reported performing full-body skin examinations for skin cancer screening. In a 2020 AFP editorial, Drs. Michael Pignone and Adewole Adamson (Dr. Adamson also co-authored the NEJM analysis) observed that "compared with usual care, potential effects of screening on morbidity and mortality from keratinocyte carcinoma are at most small, and screening cannot be justified based on the impact on keratinocyte carcinoma alone." Dr. Welch and colleagues went one step further, arguing that the established harms of skin cancer screening already outweigh any potential benefits:

The increase in melanoma diagnoses by a factor of 6, with at least an order of magnitude more persons undergoing a biopsy and no apparent effect on mortality, is more than enough to recommend against population-wide screening. ... It [screening] has been effectively promoted under the guise of public health, with the combination of frightening messages about skin cancer and the premise that screening can only help. However, medical care should be driven by patient needs, not system needs. Now is not the time to add more anxiety and expense to an already anxious and expensive world.

Not surprisingly, dermatologists have a more positive view of skin cancer screening, as reported in a news story about the analysis by Dr. Welch and colleagues that quoted the president of the American Academy of Dermatology as stating that "an aggressive approach to prevention and treatment is entirely appropriate for a disease that kills 20 Americans each day." Of course, no one is urging clinicians to stop counseling patients on minimizing their exposure to UV radiation; indeed, the USPSTF recommends behavioral counseling to prevent skin cancer, particularly for children, their parents, and young adults. But screening for skin cancer, which has effectively widened the definition of cutaneous melanoma and driven widespread overdiagnosis - is a different story. To give Dr. Doust and colleagues the last word: "We [primary care physicians] are not here to passively enact specialist recommendations. Instead, we need to more assertively act as advocates for our patients and our communities."

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This post first appeared on the AFP Community Blog.

Thursday, February 18, 2021

Don't put me in a (political) box

On any given day, several hundred people read one or more of my blog posts. I don't have a good sense of who they are or where they stand on the various health and health policy issues that I've been writing about for the past decade. Since I turned off the blog Comments function a few years ago because it was being deluged in spam advertisements for cut-price Viagra and such, the only way I receive feedback about what I've written is when a reader reaches out directly, through an e-mail or private social media message, to let me know what they thought. The exception is my wife, who isn't a regular reader but does me the favor of promoting my blog within her social and professional circles from time to time. That isn't to say that we see eye to eye on all or even most of these topics. In fact, recently she shared, after not reading the blog for quite a while, that she was surprised by how "political" my posts had become. It wasn't only the recent Donald Trump post, which I'll freely admit is out of character for Common Sense Family Doctor and not likely to recur in the post-Trump Presidency era, but also posts about COVID-19 where I've seemed to come down on one partisan side or the other regarding elements of the public health response.

I don't feel that I've become more "political," but rather that public health and scientific evidence have been increasingly politicized. For example, wearing a mask indoors to slow the spread of SARS-CoV-2 wasn't a Republican or Democratic issue until the President declined to wear one and starting mocking rival politicians who did. Closing and re-opening public schools with safety protocols wasn't a liberal or conservative issue until the President, months prior to the results of definitive studies that confirmed that schools can re-open safely, insisted that they all re-open immediately and threatened to withhold federal funding if they didn't. And it became more politicized when teachers' unions, bastions of Democratic support, disregarded the science and insisted on conditions such as having children vaccinated prior to teachers returning, which effectively would keep school online for the remainder of this academic year and likely most of the next one.

I resist being categorized as partisan based on my position on any single issue. I am not currently registered with any political party, and though I voted for Joe Biden for President in 2020, eight years ago I voted for Mitt Romney and would probably vote for Romney again if he chose to run in 2024, based not only on his principled opposition to Trump's unchecked lawbreaking but his role as one of the original architects of Obamacare when he was the governor of Massachusetts. I am as vocal about my support of mask mandates as I am about opening schools. I criticized President Obama's health policy team for suppressing the U.S. Preventive Services Task Force's politically inconvenient statement on prostate cancer screening, and I criticized President Trump's first Secretary of Health and Human Services, Tom Price, for trying to do the same thing when he was a member of Congress. I praised Obama's health officials for aiming to de-stigmatize substance use disorders and later bemoaned the Biden administration's recent decision to block implementation of a proposal to expand access to medication-assisted treatment for opioid use disorder by no longer requiring clinicians to hold a special waiver to prescribe buprenorphine.

In short, I've been on both sides of the partisan divide. My health policy views hew not to any political identity or ideology, but have always been guided by my interpretation of what the evidence says or doesn't say. So when you read something I write, here or anywhere else, please don't automatically put me into a political box and assume that because I'm for this, I must be for or against that. I'm a family doctor, and my goal is to take a commonsense, less-is-more approach to health care.

Tuesday, February 16, 2021

How state policies influence how long you live

Last summer, I temporarily moved from one of the most politically liberal places in America to one of the most conservative. In the 2020 Presidential election, Joe Biden carried DC's 3 electoral votes with more than 92% of ballots cast, while Donald Trump carried Utah's 6 electoral votes over Biden by a comfortable 58% to 38% margin. As the COVID-19 pandemic became increasingly politicized, the orientations of DC and Utah predicted their public health responses. Although nearly all public and private schools in both places initially switched to online learning, most Utah schools re-opened for in-person learning last fall, while DC public schools stayed closed and are only beginning to re-open this month. DC's mayor instituted a mask-wearing mandate on July 22, while Utah's governor did not do so until November 9, when its hospitals were nearly full and the per capita incidence of COVID-19 was among the top 5 states in the nation. DC has also kept in place more restrictive rules on operating restaurants (including closing indoor dining entirely from Dec. 18 to Jan. 22) and other "non-essential" businesses than most parts of Utah.

A research study in Science Advances examined the relationship between social mobility, community COVID-19 incidence, and partisan differences. Logically, people should be more likely to stay at home when viral spread is higher, and more likely to go out when viral spread is lower. Instead, the researchers found that there was only a weak association of mobility with COVID-19 activity over time; a far stronger predictor of people's willingness to leave home to socialize with others outside of their immediate family was party affiliation:

Using daily data on the reported activities of 1,135,638 U.S. adults collected starting on 4 April 2020, we show that partisanship is 27 times more important than the local incidence of COVID-19 in explaining mobility. Moreover, all else equal, Democrats are 13.1% less likely to be socially mobile over time compared to independents, while Republicans are 27.8% more likely to be mobile.

This study's findings correlate with my own experience. I can't remember seeing anyone indoors in DC who wasn't wearing a mask after mid-March, but outside of Salt Lake City (which leans liberal and has a Democratic mayor) it was common to see unapologetically maskless people shopping in stores where mask-wearing was required by law. In a recent article in The New Yorker, Dr. Atul Gawande reported on the debate surrounding mask mandates in Minot, North Dakota, which in mid-October 2020 held the unenviable distinction of being the county seat of "the worst-hit county in the worst-hit state in the worst-hit country" in the world in new COVID-19 cases and deaths per capita. From a public health perspective, a mask mandate ought to have been a no-brainer. Instead, as the city council debated a mask mandate motion for an hour, a YouTube chat of residents watching the proceedings online erupted with angry comments such as "unconstitutional," "tyrannical," and threats of "mass protests." (The council ultimately adopted a mask mandate with no penalties or other means of enforcement.) A few weeks later, Donald Trump easily carried Ward County over Joe Biden, 65% to 32%.

The influence of partisanship on states' public health approaches to the coronavirus is just the tip of the health policy iceberg, though. A study in Pediatrics showed that higher state and local expenditures on non-health care services such as social services, environment and housing were associated with lower infant mortality from 2000 to 2016. Another, more ambitious study graded state policies on a conservative to liberal continuum from 1970 to 2014 ("liberal was defined as expanding state power for economic regulation and redistribution or for protecting marginalized groups, or restricting state power for punishing deviant social behavior, conservative was defined as the opposite") and found that people consistently live longer in states with more liberal policies than in those with conservative ones. The authors estimated that overall U.S. life expectancy (which since the 1990s has been at or near the bottom of the world compared to other high-income countries) would be nearly 3 years longer among women and 2 years longer among men "if all states enjoyed the health advantages of states with more liberal policies," and would mostly erase the current U.S. life expectancy disadvantage. A few years may not seem like that much, but consider this: the 350,000 excess deaths that the U.S. experienced in 2020 due to COVID-19 reduced life expectancy at birth by just over a year, enough to lower U.S. life expectancy to its lowest level since 2003.

In a recent perspective in The Milbank Quarterly, Dr. Jennifer Karas Montez observed that as states became increasingly polarized to the right or the left in their politics, the range of state life expectancies widened from 5.4 to 7 years between 1980 and 2017. She hypothesized that two major factors have driven the widening disparities between liberal and conservative states: devolution (transferring federal oversight and fiscal responsibilities to the state level) and state preemption laws, which "prohibit or severely restrict local governments from legislating on certain issues," such as social distancing and mask regulations in Florida, Mississippi, and Georgia in 2020. Of course, millions of people immigrate from outside of the U.S. and move from one state to another every year, which complicates the picture: it's possible that healthier people move to certain states in order to enjoy the benefits of more livable environments or liberal policies, rather than those environments or policies creating better health. But all things considered, it's important to recognize that what my Georgetown family physician colleague Ranit Mishori calls "the political determinants of health" act powerfully at the state level, not only through national legislation and executive actions.

Saturday, January 30, 2021

Aligning unhealthy drug use policies with evidence

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, 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 American Family Physician, 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) 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 decided against implementing 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 will continue to be a substantial barrier to care.

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This post first appeared on the AFP Community Blog.

Wednesday, January 20, 2021

Gender equity gaps persist among family physicians

In a Policy One-Pager in the January 1 issue of American Family Physician, Dr. Yalda Jabbarpour and Elizabeth Wilkinson from the American Academy of Family Physicians' Robert Graham Center 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.

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This post first appeared on the AFP Community Blog.

Monday, January 11, 2021

Personally responsible: President Donald Trump and America's Plague Year

A notable historical site in Lancaster, Pennsylvania, where I completed my residency in Family Medicine, is Wheatland, the estate of the 15th American President, James Buchanan. Buchanan, who preceded Abraham Lincoln in office and is often considered by historians to be the worst President ever, did absolutely nothing as the first 7 states of the 11 that would go on to form the southern Confederacy seceded from the Union. Although Buchanan believed that secession was unconstitutional, he did not interpret his oath to "preserve, protect, and defend the Constitution of the United States" as giving him the authority to use force to prevent states from leaving. In the four months between Lincoln's election and inauguration (until 1937, Inauguration Day was March 4th), Lincoln watched helplessly as Buchanan's inaction and the scheming of his Southern-dominated Cabinet (including Secretary of War John B. Floyd, who later became a Confederate general) allowed the country to break in two.

Although there were some tense moments in early 1861 and in the summer of 1864, when Confederate General Jubal Early's Army of the Valley briefly skirmished with Union forces in the ring of forts surrounding Washington, DC, no insurrectionists would succeed in breaching the U.S. Capitol with a Confederate battle flag until January 6, 2021. On that date, a violent mob incited by the current President overpowered police and broke into the Capitol building, intending to stop the Congressional certification of November's election result, in which former Vice President Joe Biden defeated President Donald Trump by 7 million popular and 74 electoral votes. They threatened to hang Vice President Pence from a noose for not going along with Trump's illegal plan to disqualify enough electors to swing the election his way, and, before authorities reoccupied the building, mortally wounded one Capitol police officer and likely contributed to the suicide of a second officer three days later.

When historians assess the Trump Presidency, will they judge his anti-democratic actions to be worse for the nation than James Buchanan's inaction? Will they judge Trump to have been personally responsible for creating the movement that, if not for the quick thinking of courageous Capitol Police officer Eugene Goodman, could very well have resulted in live-streamed assassinations of Senators and staffers?

I hold President Trump personally responsible for a large portion of the 375,000 U.S. deaths from the pandemic to date. Admittedly, it's impossible to assign an exact number. As convincingly argued in the tour-de-force New Yorker article "The Plague Year," there were 3 critical missed opportunities to decisively alter the trajectory of COVID-19 deaths in the U.S.: 1) China's initial suppression of evidence of SARS-CoV-2's human-to-human transmission capability, including refusing to allow the CDC to conduct its own outbreak investigation; 2) the CDC's failure to develop and distribute an error-free test for the virus in February when doing so could have facilitated effective isolation of small numbers of infected patients by state health departments; and 3) Trump's refusal to wear a face mask in public and repeatedly suggesting that doing so was a sign of weakness, particularly when the mask-wearer was his election opponent. It's hard to blame the President for the first two, but the third was all on him.

Trump's responsibility - personal and historical - is even clearer for what happened at the Capitol last week. When you spend months telling supporters that if you don't win the election it will have been due to "massive voter fraud"; when you refuse to concede that you've lost a free and fair contest and file a blizzard of lawsuits that are so legally feeble that conservative judges that you appointed dismiss them out of hand; when you encourage supporters to show up in force on January 6th, appear before them in person to fire them up even more, then send them marching toward America's seat of democracy - you knew exactly what would happen, Mr. President. It's why you deserve to be removed from office before your term expires in 9 days, or failing that, be impeached by the House and convicted by the Senate so that you can never hold public office and wound or sicken this country again.