Wednesday, April 24, 2024

How artificial intelligence will make my work easier

A recent article in the Pittsburgh Post-Gazette outlined the various ways that artificial intelligence (AI) is improving health care in Pennsylvania. For example, AI software can serve as a "virtual scribe," listening to the doctor-patient conversation during an office visit and drafting a note, freeing the doctor to focus on the patient for 100% of the time. AI can "draft letters to health insurers on behalf of patients who need specialty medications, medical equipment or other care that's not standard in their insurance benefits," saving time for doctors and office staff. In the future, AI could respond to patient portal messages, triage phone calls, or even suggest diagnoses.

That all sounds great, but a lot of people thought that electronic health records would make clinicians' work easier when they were implemented, too, and we know how that worked out (or didn't). So what's the evidence that AI will actually deliver on its promise in health care?

A case study published in NEJM Catalyst described Kaiser Permanente (KP) Medical Group's implementation of AI scribes using smartphone microphones to document more than 300,000 patient encounters across all medical specialties:

The response from physicians who have used the ambient AI scribe service has been favorable; they cite the technology’s capability to facilitate more personal, meaningful, and effective patient interactions and to reduce the burden of after-hours clerical work. In addition, early assessments of patient feedback have been positive, with some describing improved interaction with their physicians. Early evaluation metrics, based on an existing tool that evaluates the quality of human-generated scribe notes, find that ambient AI use produces high-quality clinical documentation for physicians’ editing. Further statistical analyses after AI scribe implementation also find that usage is linked with reduced time spent in documentation and in the EHR.

How about the electronic inbox and the increasing burden of responding to patient portal messages? One approach to streamlining this workload is making sure that requests are routed to the right person in the practice, often front office staff or nurses rather than physicians. A research letter in JAMA Network Open illustrated the content of nearly 5 million electronic messages from patients received by KP Northern California between April and August 2023 and classified using real-time natural language processing. In a pilot quality improvement study in primary care and gastroenterology practices at Stanford Health Care, responses to messages were drafted by a large language model (LLM), and clinicians (physicians, advanced practice providers, nurses, and clinical pharmacists) were surveyed pre- and post-program implementation. Although the LLM drafted responses to 75% of messages, the average clinician used the draft only 20% of the time, with primary care clinical pharmacists using them the most (44%). There was no change in the amount of time clinicians spent managing their inboxes. However, task load and work exhaustion scores declined in the post-survey, and many clinicians appreciated that editing a draft required less effort than writing a response from scratch.

As a medical editor and author of hundreds of published papers, that last point makes sense - leading me finally to the use of AI outside of the clinic to draft scientific review articles. Currently, most journals either prohibit AI use or require authors to describe exactly how AI was used to develop a manuscript. A recent study compared papers on 3 topics related to bone health (Alzheimer's disease, fracture healing regulation, and effects if COVID-19) that were written by 1) a human only; 2) ChatGPT only; and 3) a human and ChatGPT working together ("AI-assisted"). Unsurprisingly, the most accurate papers that required the least amount of time to write were AI-assisted (human-supervised?) where the AI was given not only a prompt but an outline and references. I'm still waiting to see the first American Family Physician submission where the authors were assisted by AI. It's only a matter of time - unless, of course, it's already happened and I just didn't realize it.

Saturday, April 20, 2024

Reducing harms associated with PSA screening

In the U.K. Cluster Randomized Trial for PSA Testing for Prostate Cancer (CAP), more than 400,000 men in primary care practices between 2001 and 2009 were either invited to receive a single PSA screening test or usual care. After a median follow-up of 10 years, there were more prostate cancer diagnoses in the screening group, but no effect on prostate cancer mortality. (Men diagnosed with localized prostate cancer were invited to participate in a separate trial comparing active monitoring, surgery, and radiotherapy, which Dr. Middleton discussed previously on the AFP Community Blog.) In a secondary analysis of the CAP trial after 5 more years of follow-up, researchers found a small difference in prostate cancer mortality favoring the screening group (absolute reduction = 0.09%, number needed to screen = 1,111 to prevent one prostate cancer death). However, the screening group was at greater risk of detection of low-grade (Gleason score <=6) cancers that are likely to be clinically unimportant and represent overdiagnosis.

Magnetic resonance imaging (MRI) is increasingly being used as a triage strategy for men with suspected prostate cancer to avoid unnecessary biopsies while still detecting clinically significant cancers at curable stages. A 2024 systematic review and meta-analysis of 72 studies (n=36,366) examined associations between MRI Prostate Imaging Reporting & Data System (PI-RADS) findings, clinical data, and clinically significant prostate cancer. Compared to performing prostate biopsies on all patients, avoiding biopsies in patients with PI-RADS category 3 or lower lesions and PSA density of 0.10 or less reduced unnecessary biopsies by 30% and missed 1 in 17 significant tumors. Increasing the PSA density threshold to 0.15 reduced unnecessary biopsies by 48% and missed 1 in 15 significant tumors.

Several randomized trials are evaluating the effectiveness of a screening strategy combining MRI and a PSA-based biomarker risk score (e.g., 4-Kallikrein Panel) to determine which patients with abnormal PSA levels should be biopsied. The ProScreen trial, involving more than 60,000 Finnish men aged 50 through 63 years, recently reported preliminary results from its baseline screening round. Researchers found that compared to the usual care group, men invited for screening were more likely to have high-grade prostate cancer detected (1 per 196 men) at the cost of also being more likely to have low-grade prostate cancer detected (1 per 909 men). Whether these small differences will lead to meaningful improvements in prostate cancer mortality will not be known for at least several years.

A systematic review published on April 7 in JAMA reiterated the importance of continuing to use cancer-specific mortality as the primary outcome in randomized trials of cancer screening. The authors evaluated the strength of correlations between reductions in stages 3 and 4 cancer (a proposed surrogate outcome for trials of multicancer screening tests) and reductions in cancer-specific mortality in 41 published randomized trials of screening for breast, colorectal, lung, ovarian, prostate, and other cancers. They found high correlations for ovarian and lung cancers, but only a moderate correlation for breast cancer, and weak correlations for colorectal and prostate cancers.

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This post first appeared on the AFP Community Blog.

Saturday, April 6, 2024

Should race be incorporated into weight management decisions?

I have a personal stake in the answer to this question. For most of my adult life, my body mass index (BMI) has ranged between 22 and 25 kg/m2, which is considered to be in the normal range (the threshold for overweight is a BMI of 25, and obesity a BMI of 30). But it turns out that I've been overweight for most of that time if one applies a race-specific definition of overweight (BMI greater than 23) for individuals of Asian descent. Where did this race-based cutpoint come from, and is it still relevant in an era when we generally frown on using race as a surrogate for social determinants of health in making clinical decisions?

The story starts more than two decades years ago, when an expert committee convened by the World Health Organization (WHO) examined associations between BMI, body fat percentage, and risk factors for type 2 diabetes and cardiovascular disease in studies of Asian populations. They found that at similar BMI levels, Asian adults have higher body fat percentages and more metabolic risk factors than White adults. Although the WHO declined to formally establish different BMI thresholds for overweight and obesity in Asian populations, it suggested "additional trigger points for public health action": BMI greater than 23 represents "increased risk" and BMI greater than 27.5 represents "high risk."

In 2015, the American Diabetes Association (ADA) examined evidence from 4 cohort studies in Asian American populations and concluded that Asian American adults should be considered for diabetes screening if they have a BMI greater than 23, based on the prevalence of type 2 diabetes in this population being roughly equivalent to that in White Americans with a BMI greater than 25. (The U.S. Preventive Services Task Force recommends screening for prediabetes and diabetes in nonpregnant adults aged 35 to 70 with a BMI of 25 or greater, but it alludes to the ADA's lower threshold for Asian Americans in its practice considerations.) Notably, the studies cited by the ADA included virtually no persons of Chinese descent, despite Chinese being the largest Asian American subgroup. So this guideline does not necessarily apply to me.

However, a 2009 study of a large cohort (n=36,386) of Taiwanese civil servants and schoolteachers over age 40 found that all-cause mortality increased significantly at BMIs greater than 25, analogous to the increase in mortality seen in White populations with obesity (BMI > 30). Taiwanese adults with BMIs from 23 to 24.9 had no difference in all-cause mortality compared to persons with lower BMIs but showed a nonsignificant trend toward increased cardiovascular mortality that was not modified by smoking status. That this study suggested a nearly identical risk threshold as studies in other Asian American populations would argue that I am not exempt.

A more recent comparative study of minority populations living in England found that South Asians with lower BMIs had the highest risk of developing diabetes, followed by Arab, Chinese, Black, and finally White populations. Presumably, race and ethnicity were self-identified. Similarly, a 2023 scientific statement from the American Heart Association found that the risk of coronary artery disease appears to be highest among South Asian and Filipino Americans and lowest among Chinese, Japanese, and Korean Americans, but cautioned that limited disaggregated data precluded making clinical recommendations based on race or ethnicity. As a JAMA news article recently noted, the common practice of national surveys lumping diverse ethnic groups into a single "Asian" obscures disparities within those groups and frustrates efforts to achieve health equity.

My admittedly selective review of the data leads me to believe there is probably some value to considering more intensive lifestyle counseling and metabolic screening in Asian patients with BMIs between 23 and 25, like me. But what do we do about the rising numbers of American adults of mixed race? Perhaps "precision medicine" will eventually find a way to integrate genetic and environmental risks and let clinicians dispense entirely with numeric thresholds and race categories, but I would be surprised if this occurs before the end of my career in medicine.

Saturday, March 23, 2024

HPV vaccination is highly effective but remains underused in the U.S.

Since human papillomavirus (HPV) vaccines were first added to the routine U.S. childhood immunization schedule nearly two decades ago, the evidence of their effectiveness has become stronger every year.

In 2019, a Medicine by the Numbers in American Family Physician summarized a Cochrane review of 26 randomized, controlled trials comparing HPV vaccines to placebo. The authors found that vaccination reduced the risk of precancerous cervical lesions (cervical intraepithelial neoplasia [CIN] grades 2 or 3 and adenocarcinoma in situ) with numbers needed to treat (NNT) ranging from 55 to 73, depending on participants’ baseline HPV status. A 2021 observational study of girls and young women in England found that vaccination at ages 16-18, 14-16, and 12-13 years was associated with reductions in cervical cancer of 34%, 62%, and 87%, respectively. Remarkably, a study published this year found that 30,000 Scottish women who received at least one dose of HPV vaccine at age 12 or 13 had developed zero cases of invasive cervical cancer 11 to 20 years later!

Nonetheless, HPV vaccination coverage among U.S. adolescents remains lower than that for other childhood vaccines. Although coverage has gradually increased over time, an analysis of 2022 National Immunization Survey (NIS) data found that only 69% of 13 year-olds and 77% of 17 year-olds had received at least one dose, and 50% and 68% of these respective age groups were up-to-date (had received 2 doses if starting the series before age 15, or 3 doses if starting later). In comparison, 90% of 17 year-olds had received a least one dose of tetanus, diphtheria, and acellular pertussis (Tdap) and at least 2 doses of measles, mumps, and rubella (MMR) vaccines.

Historically, children living in socioeconomically disadvantaged households have been less likely to be up-to-date on immunizations. The Centers for Disease Control and Prevention’s Vaccines for Children program, which celebrates its 30th anniversary this year, aims to eliminate disparities in access by providing vaccines at no cost to children who are uninsured, Medicaid-eligible, American Indian or Alaska Natives.

A recent study of the 2017-2021 NIS examined factors associated with the intent to vaccinate by socioeconomic status and education level among parents of adolescents who had not received HPV vaccine. Participating parents were considered “advantaged” if their income was greater than 200% of the federal poverty level and they had at least a high school education; parents with lower incomes who had not completed high school were considered “deprived.” Surprisingly, 65% of advantaged parents of unvaccinated adolescents reported no intent to vaccinate in the future, compared to 41% of parents in the deprived group. Reasons for not vaccinating also differed between the groups: the advantaged group most often cited “safety concerns,” while the deprived group reported “lack of knowledge,” “not recommended,” and “not needed.” These data suggest that HPV vaccine hesitant parents may respond to different approaches.

In a 2015 AFP editorial, Drs. Herbert Muncie and Alan Lebato advised presenting the vaccine’s benefit as cancer prevention rather than focusing on HPV as a sexually transmitted infection, and taking a non-judgmental approach when explaining the recommendation to vaccinate:

To improve acceptance of immunizations, physicians must be knowledgeable about vaccine safety and effectiveness, and non-judgmental about parents' beliefs. … Hesitant parents may respond to the CASE method: the physician corroborates the parents' concerns, talks about his or her own experience with the vaccine, summarizes the science about vaccine effectiveness and safety, and explains advice in terms of the child's health.

Regarding safety, the World Health Organization’s Global Advisory Committee on Vaccine Safety has repeatedly found no evidence of a causal association between HPV vaccination and a variety of serious adverse effects.

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This post first appeared on the AFP Community Blog.

Thursday, March 7, 2024

Deadly drivers and the limits of preventive counseling

I believe that I'm a pretty safe driver. I don't use my phone in the car except for calls on my Bluetooth hands-free system, I come to a complete stop at stop signs even when no one else is around, and I never get in the driver's seat after I've been drinking. During the fall of 2020 and spring of 2021, though, I paid more attention than usual to driving safely. Our auto insurance company offered a discount for installing a device in my car that monitored my driving behavior, and my then 15 year-old son (in Utah, the minimum age for a learner's permit is 15) began learning to drive.

There has been a lot of media attention in recent months to the increase in distracted driving and its deadly consequences since the start of the pandemic. After falling for decades thanks to legislation mandating safety features such as airbags to a low of 32,479 in 2011, annual traffic-related deaths (including pedestrians) gradually rose, then spiked during the pandemic from 38,824 in 2020 to 42,795 in 2022. This statistic is similar to the 48,000 firearm homicides and suicides that occur in the U.S. every year.

Why have traffic-related deaths been going in the wrong direction? A New York Times Magazine story highlighted deferred road maintenance, larger and more powerful vehicles, aggressive driving and road rage, and the perennial culprit, intoxicated drivers. A recent analysis of data from the National Highway Traffic Safety Administration found that 1 in 5 deaths of child passengers in motor vehicle crashes involved an alcohol-impaired driver (blood alcohol concentration > 0.08 g/dL), and the more impaired the driver was, the less likely the child was to be wearing a seat belt.

 A Vox story pointed the finger at smartphones, noting that a company that sells a more sophisticated version of the device I installed in my car a few years ago - an app that measures phone motion and screen interaction while driving - found that in 2022, drivers interacted with their phones on nearly 58% of trips (an average of 2 minutes, 11 seconds per hour), more than one-third while driving over 50 miles per hour. This is when they knew the app was monitoring their behavior; one wonders if they would have been on their phones even more without it.

The difference between a medical and a public health problem is often merely a matter of perspective. For example, the solution to the medical problem of hypertension is to screen patients for high blood pressure and put the ones whom we diagnose on medications and/or encourage them to be more physically active and eat differently. But treating high blood pressure as a medical problem has been an abysmal failure. According to the National Health and Nutrition Examination Survey, of the one-third of Americans who had hypertension from 2017-2020, more than half had uncontrolled blood pressure (>140/90 mm Hg) and even among patients taking blood pressure medication, nearly one-third had uncontrolled blood pressure. Zoom out from the office setting to communities, counties, and states, and it's easy to see that hypertension is really a public health problem: too much sodium in food, too little access to safe places to exercise without a gym membership, difficulty getting a primary care appointment due to insufficient supply and uneven distribution, and so on.

Is impaired driving a medical or a public health problem? I got a lot of flak from readers when I wrote in a Medscape commentary that I would report to law enforcement a patient who declined to stop driving while high on cannabis. Clinical guidelines recommend counseling parents and guardians about keeping their children in rear-facing car seats until age two, using age and size-appropriate car and booster seats, and having children age 13 and younger ride exclusively in the back seat. With any adolescent approaching the minimum age for a learner's permit (16 years in Pennsylvania), I spend time during the well-child visit discussing the dangers of driving and texting, substance use before or while driving, and getting into a car with an impaired or distracted driver. Perhaps my counseling has saved a few lives over the past 20 years, but it's never been proven that this type of counseling improves health outcomes.

However, the evidence is clear that public health interventions and laws reduce motor vehicle crash injuries and deaths. The Community Preventive Services Task Force has evaluated a long list of interventions that save lives by reducing alcohol-impaired driving and increasing use of child safety seats, seat belts, and motorcycle helmets. The Vox story cited data that associated the passage of "hands free" phone laws with reductions in phone motion and driver distractions, but a lack of enforcement may cause these bad habits to reassert themselves over time.

Tuesday, February 27, 2024

Birthday blessings

The following is a guest post from my sister-in-law, Dr. Therese Duane, a trauma surgeon who is blogging about her medical mission in Uganda. You can read more about the essential work she and her colleagues have been doing at Mercy Trips Healthcare Outreach.

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As a little girl growing up in a big family, there were few things that I could actually call my own. Not only did I share a room, but for a long time my sisters and I even shared a twin bed. Going clothes shopping meant venturing into another sister’s closet for hand-me-downs, and toys belonged to whomever could run away fast enough without tripping and getting tackled by the rest of us. But there was one thing we could call our own, and that was our birthday—although I did share mine with an uncle and George Washington.

Still yet, in our home, my mother made an effort for each of her seven children to have a special birthday. I have fond recollections of sleepovers filled with giggles, scary movies, and not enough sleep that always culminated in Mickey Mouse pancakes my mother would prepare especially for me. I knew I was loved.

If someone had told me 40 years ago that I would have spent my birthdays in Uganda doing medical mission work, I am not sure I would have believed them. And yet, here I am turning 54 years old and instead of giggles with my girlfriends, I am getting chuckles from children who—despite being far from home undergoing painful procedures—still manage to share their smiles with strangers.

Caring for all these families, many of which are large, reminds me how the gift of family is universal. I see many women struggling with fertility with few options. One 42-year-old with only one child came to have her fibroids removed so she could carry another pregnancy to term, as she had previous miscarriages. Sadly, her evaluation demonstrated enormous tumors that were compressing her pelvic organs and causing significant pain. After explaining that her only option was removal of her uterus and more biological children weren’t possible regardless of surgery, I could see the devastation. She left clinic having been informed of the risks of delaying surgery and never returned, choosing instead to be in pain than accept the inevitable. Other women come in with many children, and want more, but need surgery for another complaint. Hence, fertility awareness education is incredibly important for this impoverished country so that couples can make healthy decisions for themselves as they cherish their gift of family.

So, as this birthday comes to a close, I have already been privileged to bring a baby boy into this world through a c-section for one patient and remove a diseased ovary of a different woman, preserving her other, healthy ovary in the hopes that this will help her future fertility. In Uganda, general surgery is certainly general as we provide a wide array of service to the best of our ability. We strive to ensure that the gift of family is embraced, preserved, and expanded based on God’s will and that every person knows they are loved.


Before I rest for the evening in preparation for another long day in the OR tomorrow, I will call my mother to thank her for the gift of my life and family. And as we reminisce about Micky Mouse pancakes, I will remind her that it was her example and that of my father’s that began this call for me. I see the same generosity of spirit in all my siblings and pray to set the right example for my four children just as my parents did for me.

Wednesday, February 21, 2024

Appreciation (the changing of the guard)

Originally posted on Common Sense Family Doctor on February 7, 2018.

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The February 1, 2018 issue of American Family Physician marked the first time since 1988 that a family physician other than Dr. Jay Siwek was serving as the journal's editor-in-chief. Dr. Siwek, who bade farewell to readers in a poignant, memory-filled editorial in the January 15 issue, will stay on as editor emeritus. This month, Dr. Siwek introduced his successor, longtime associate editor Dr. Sumi Makkar Sexton. You can read about Dr. Sexton's extensive qualifications and experience in Dr. Siwek's latest piece and learn about her plans for the future of AFP, which include making journal content more usable at the point of care, in her introductory editorial.

It has been my good fortune to know Jay and Sumi for the past 20 years, since I arrived at Georgetown University School of Medicine as AFP's medical editing fellow in the summer of 2004. Both played critical roles in my development as a family physician and medical editor, during and after my one-year fellowship. It was Jay, in his previous capacity as Chair of Georgetown's Department of Family Medicine, who hired me as a junior faculty member and supported each of my subsequent promotions to assistant, associate, and full professor. After I left the department for several years to work as a medical officer at the Agency for Healthcare Research and Quality and earn a master's degree in public health, it was Jay who convinced me to return and deploy my new skills to direct the department's health policy fellowship and eventually take on other leadership and teaching positions in population health.

On the other hand, it was Sumi, as the editor of Tips from Other Journals (an AFP department that ended in 2013) who continued to hone my writing and evidence-based medicine skills for years after my fellowship ended. Under her supervision, from 2005 to 2010 I wrote more than 60 summaries of primary care-relevant research studies for AFP. And after my first post-fellowship clinical position unexpectedly fell through, it was Sumi who hired me to see patients at her thriving practice, Premier Primary Care Physicians, which was an early adopter of innovations such as electronic medical records and advanced-access scheduling.

As AFP's new deputy editor, I have worked closely with Sumi and Jay for the past several months to support their changing of the guard at editor-in-chief, and I look forward to many more years of collaborating with them both. Moving on from Dr. Siwek to Dr. Sexton is an important transition, but the best-read journal in primary care won't miss a beat.

Friday, February 16, 2024

Looking for a balanced approach to America's illicit drug use problem

In an earlier post about my frustrating experience serving on a District of Columbia grand jury that handled indictments for drug-related offenses, I wrote approvingly about Portugal's novel approach to decriminalizing illicit drug use. In short, rather than receiving criminal sentences and jail time, people caught using small amounts of drugs in Portugal receive citations and are offered counseling and medical treatment. Since then, the city of San Francisco and the state of Oregon have both implemented versions of Portugal's non-punitive approach, with mixed results.

A January 31 New York Times article compared Portugal to San Francisco, which saw its overdose death rate spike during the pandemic to more than twice the national average. Addiction treatment in San Francisco is fragmented and rarely accepted by people caught using drugs: "From May 30 [2023] to Jan. 4, just 25 people accepted treatment after an arrest, in a city where tens of thousands of people use drugs regularly." Harm reduction programs in San Francisco, unlike in Portugal, do not always push clients toward treatment. The culture of the California city is more libertarian than conservative Portugal, where drug use is discouraged and stigmatized. Finally, the drug response in San Francisco is not guided by a comprehensive strategy. The public health department and law enforcement agencies are divided on how much of the approach to recreational drug users should be carrots versus sticks, and other than reducing the overuse rate, the city has no clear goal.

A February 7 NPR story examined Portland, Oregon's experience with decriminalization of drug possession since a state ballot measure passed in November 2020: "So far, police have handed out more than 7,000 citations, but as of December, only a few hundred people had called the hotline to get assessed for a substance use disorder. And even fewer accessed treatment through the citation system." Opioid-related overdose deaths across the state rose from 280 in 2019 to 956 in 2022, though given the rise of fentanyl and homelessness and the impact of the pandemic on health care services, it's hard to know if the new approach contributed to the difference. The story quoted an addiction medicine physician arguing that the primary drivers of Oregon's rising overdose toll are "our decades-long, underbuilt system of behavioral health, substance abuse disorders, shelter and affordable housing" - not the decision to treat drug use as a medical problem rather than a crime.

The U.S. health care system is a culprit, too. Not only is a sizeable percentage of our population uninsured at any given time, people with drug use disorders are overrepresented in that group. And if you can afford to see a doctor, you can't necessarily find one willing to prescribe medications for opioid use disorder. My friend and fellow family physician, Dr. Corey Fogleman, recently co-authored a column in the Lancaster newspaper that observed how and why our county's outcomes have positively diverged from the rest of the state of Pennsylvania:

Lancaster County health care providers are unique in their willingness to provide buprenorphine treatment for opioid use disorder. Further, the Lancaster General Hospital Family Medicine Residency Program teaches this care to every medical student and medical resident educated in our system. Since 2016, Lancaster County has increased buprenorphine prescribing by 79% compared to a statewide average of 30%.

This has paved the way for crucial gains in fighting the opioid epidemic. Lancaster County has observed a notable and consistent downward trend in mortality due to this disease. Overdose deaths reached a peak in 2017, with more than 30 deaths per 100,000 residents that year. In 2022, per capita overdose deaths in Lancaster County dropped below 20 per 100,000 residents (106 total deaths). By comparison, Pennsylvania as a whole continues to observe a gradual upward trend in overdose fatalities, from 35 to more than 40 deaths per 100,000 residents during the same time frame (there were 5,155 total overdose deaths in the commonwealth in 2022).

It's true that local problems often require locally tailored solutions. Perhaps too much wishful thinking went into San Francisco's and Oregon's attempts to duplicate Portugal's successful approach to illicit drugs. On the other hand, Lancaster County has shown that it is possible to improve public health and save lives by engaging physicians and other health care professionals in overdose prevention efforts.

Sunday, February 11, 2024

Prenatal and congenital syphilis cases continue sharp rise in the U.S.

Last November, the Centers for Disease Control and Prevention (CDC) reported that cases of congenital syphilis in the U.S. had soared 755% over the past decade, peaking at more than 3,700 in 2022. The CDC’s review of that year’s cases revealed that nearly 90% were potentially preventable, resulting from a lack of timely testing and adequate treatment. An analysis of 2017-2019 Medicaid claims in 6 Southern states (Georgia, Kentucky, Louisiana, North Carolina, South Carolina, and Tennessee) found that despite state laws mandating prenatal syphilis screening, actual screening rates ranged from 56% to 91%.

In a previous blog post, I discussed how the diversion of public health personnel and resources during the COVID-19 pandemic had hampered contact tracing efforts to prevent the spread of syphilis and other sexually transmitted infections (STIs). Since June 2023, syphilis treatment has been affected by a global shortage of injectable benzathine penicillin, leading the CDC to advise prioritizing its use for infections in pregnant patients and babies with congenital syphilis (doxycycline can be used for infections in non-pregnant persons).

Although the U.S. Preventive Services Task Force recommends screening for syphilis in nonpregnant patients at increased risk so that persons testing positive can be treated to break the chain of infection, the number of syphilis cases in the U.S. continues to rise. The CDC’s latest Sexually Transmitted Infections Surveillance Report documented more than 207,000 cases in 2022 – a 17 percent increase over 2021 and the highest number reported since 1950. Few communities were spared; at least one case of congenital syphilis was reported in 47 states and the District of Columbia.

An editorial in the January 2024 issue of American Family Physician reviewed the management of STIs during pregnancy. At a minimum, all pregnant patients should receive screening for syphilis in the first trimester, with repeat screening recommended at 28 weeks and delivery for patients at high risk or living in high-prevalence communities. Clinicians should have a “low threshold of suspicion” for atypical presentations:

Although the classic syphilitic chancre is a single, sharply demarcated, painless ulcer, only 30% of patients have this presentation. Chancres may be hidden (e.g., in the cervix or rectum) or absent. Opt-out screening is essential because a large National Institutes of Health study found that 49% of pregnant women with syphilis from 2012 to 2016 had no identifiable risk factors.

A recent New England Journal of Medicine article reviewed the evaluation and management of neonates with congenital syphilis.

As my colleague Dr. Jennifer Middleton wrote, the CDC has proposed a novel prevention strategy called doxy-PEP (doxycycline preexposure prophylaxis for syphilis and other STIs) for cisgender men who have sex with men and transgender women who have sex with men with an STI diagnosis in the last year. Unfortunately, a recent trial of doxy-PEP in cisgender women in Kenya who were receiving HIV PrEP found no reduction in STI incidence, though participants’ overall adherence to doxycycline was low.

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This post first appeared on the AFP Community Blog.

Wednesday, February 7, 2024

Research award recognition

I've written many papers for academic journals since my first article was published during my third year of my family medicine residency. My full-length CV that lists every one of them, which I update meticulously, now stretches to 18 pages in 11-point font. But the "Honors and Awards" section only takes up one-third of a page and includes three awards from residency. Until today, I would have said that the award I'm most proud of is the Article of the Year Award I received in 2009 from the Agency for Healthcare Research and Quality for my 2008 systematic review of the benefits and harms of PSA screening for prostate cancer. It launched my career in preventive medicine and guideline development and led to lots of invitations to speak and write other papers (like this one) on how to approach decision-making surrounding the PSA test in older men.

Today I learned that a recent systematic review that I co-authored on the harms of screening colonoscopy has won a major research award from the Society of Teachers of Family Medicine. I'm delighted, not only for the surprise recognition, but because earlier versions of this paper were rejected by several different gastroenterology and general internal medicine journals and panned by highly credentialed peer reviewers (who fervently believed that screening colonoscopy could only be a force for good) before it was finally accepted. It is testimony to the persistence of Dr. Alison Huffstetler and the rest of our team that the product of our many hours of slogging through the medical literature ever saw the light of day. Most importantly, I hope that this paper - like my prostate cancer paper in 2008 - makes a meaningful contribution to the conversations that family physicians and their patients have every day about the benefits and harms of cancer screening tests.

Sunday, January 28, 2024

Latent Autoimmune Diabetes in Adults (LADA): recognition and management

A recent KFF Health News article highlighted misdiagnoses of type 2 diabetes in several Black female patients who actually had latent autoimmune diabetes in adults (LADA), a slowly progressive form of type 1 diabetes. Although the article suggested that the patients’ race may have played a role in delaying their LADA diagnoses, this condition commonly goes unrecognized in primary care. According to Dr. Jeff Unger in a 2010 American Family Physician editorial, an estimated 10% of patients with a diagnosis of type 2 diabetes actually have LADA.

Unlike patients with classic type 1 diabetes, patients with LADA have initially preserved pancreatic beta cell function and thus may have a transient response to noninsulin therapy and lifestyle modifications. However, as the disease progresses, they will require insulin to maintain blood glucose control, generally within one year of diagnosis.

A feature that distinguishes LADA from type 2 diabetes is the presence of at least one autoantibody, most commonly islet call antibodies or antibodies to glutamic acid decarboxylase (GAD). While persons with type 2 diabetes have normal to high C-peptide levels, patients with LADA tend to have low levels. Dr. Unger provided other potential clues that should prompt clinicians to reconsider a type 2 diabetes diagnosis:

Suspicion of LADA should be heightened in patients with coexisting autoimmune disorders, such as hypothyroidism, who are not excessively overweight and who have deteriorating glycemic control despite intensification of oral therapies and the use of incretin mimetics. Physicians may consider GAD antibody testing to determine whether LADA is present.

A 2020 consensus statement from an international expert panel made treatment recommendations for patients with LADA. Although insulin is effective and safe, it is unclear if it should be given to patients in the early stages of LADA who may still respond to oral therapies such as metformin. The panel discouraged the use of sulfonylureas, which may accelerate loss of beta cell function. Dipeptidyl peptidase 4 inhibitors, glucagon-like peptide receptor 1 agonists, and sodium-glucose cotransporter 2 inhibitors have shown promise in small studies, but more research is required. The panel recommended that all patients with newly diagnosed type 2 diabetes be screened for LADA with a test for antibodies to GAD, followed by tests for other autoantibodies if clinical suspicion remains high.

In patients who have one or more autoantibodies and presumed LADA, the next step is C-peptide measurement. Those with C-peptide levels greater than 0.7 nmol/L can be managed similarly to patients with type 2 diabetes; those with levels lower than 0.3 nmol/L should start insulin. Patients in the “gray area” (with a C-peptide level between 0.3 and 0.7 nmol/L), should start metformin and other noninsulin agents based on blood glucose levels and cardiovascular and kidney disease risk; C-peptide levels should be rechecked every 6 months to monitor for the development of insulin deficiency.

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This post first appeared on the AFP Community Blog.

Wednesday, January 24, 2024

A venerable family medicine journal exits the stage

Six years ago, I was promoted to the rank of deputy editor at American Family Physician. On the whole, I continue to find translating the latest scientific evidence into continuing medical education for family physicians and trainees to be satisfying and intellectually rewarding. As I pass the likely midpoint of my career, I have achieved all of my editorial goals, save one. In pursuit of that goal, in March 2023 I applied for the position of editor-in-chief at The Journal of Family Practice, a widely respected primary care journal for nearly 50 years (AFP will celebrate its 75th anniversary in 2025) whose editor's chair had been vacated by the sudden passing of the legendary family physician educator John Hickner, MD. I began reading JFP during my residency 20 years ago, and its editorial board still included the same faculty mentor (now retired) who launched my editing career by urging me to write a clinical review article for AFP. The timing seemed favorable for me to climb the last rung of the editorial ladder.

Alas, not only was another very well-qualified candidate selected instead, but in November, JFP permanently ceased publication for financial reasons. It happened so abruptly that the journal had a backlog of accepted but unpublished articles that would need to find new homes elsewhere; I'm happy to share that a few of them will appear in future issues of AFP. In the January issue of Family Medicine, Dr. John Frey penned an eloquent "curtain call" for JFP:

A superior group of editorial board members guided publication of research on topics that still are the source of much of the literature in the discipline and philosophical and intellectual articles by some of the most important writers and researchers in the first 20 years of family medicine’s existence. That the journal continued to publish after shifting from a primary research journal to a quality review journal, and managed to survive as long as it did is a tribute to the integrity and hard work of the many distinguished academic editors over its history. ... JFP was one of the principal reasons that family physicians, who were unused to reading primary sources of clinical research, began to change both by reading and contributing to the scholarship of a new field.

Although the past half-century has seen an outpouring of scholarship on clinical questions relevant to family physicians, academic family medicine remains woefully undervalued by research funders such as the National Institutes of Health, which from 2017 to 2021 devoted a paltry 0.2 percent of its budget to grants to family medicine departments. Nonetheless, a 2019 study found that faculty in family medicine departments publish 84% of the time in non-family medicine journals, paralleling my own publication record. This statistic suggests that the exit of JFP hardly closes the door on the possibility of new family medicine journals being launched to publish a share of the discipline's future scholarly output.

Saturday, January 13, 2024

Despite weak evidence, spinal cord stimulators are big business

A Cochrane for Clinicians article in the December 2023 issue of American Family Physician reviewed randomized trials assessing the effectiveness of surgically implanted spinal cord stimulation devices for the treatment of chronic low back pain. These devices come with a high price tag ($30,000) and potential complications that include electrode migration, hematoma formation, infection, spinal cord injury, and cerebrospinal fluid leak. Dr. Brian Nelson and colleagues summarized a Cochrane review of 13 placebo-controlled trials with 699 adult participants (mean age 47 to 59 years) who had low back pain for at least 12 weeks. Primary outcomes included pain intensity, physical function, and quality of life. Most studies reported outcomes at follow-up dates of one month or less; only one study reported outcomes at six months.

Overall, the body of evidence was assessed as having significant bias, including selection bias (five studies), performance and detection bias (10 studies), attrition bias, and selective reporting bias. The largest study, with 50 participants, found no statistical benefits. Three smaller trials suggested that “adding spinal cord stimulation to medical management may slightly improve function and slightly reduce opioid use in the medium term (i.e., one to less than 12 months).” Based on these findings, Dr. Nelson concluded:

The data do not support the use of spinal cord stimulation to manage low back pain outside of a clinical trial, and it is unclear if spinal cord stimulation has long-term clinical benefits to reasonably outweigh the costs and risks of surgical intervention.

In a recent commentary in JAMA Internal Medicine, two of the Cochrane review authors discussed tactics used by the spinal cord stimulator industry to dismiss the findings of their review and other independent reviews and studies that came to similar conclusions. These tactics included publishing lengthy critiques in paywalled industry-affiliated journals rather than the journal where the original study was published. They stated that “the credibility of our review team was attacked because one of the authors … had authored books on harms in health care,” equating this intellectual interest with financial conflicts held by supporters of spinal cord stimulators. Finally, critics conflated approval of spinal cord stimulators by the U.S. Food and Drug Administration (FDA) through the “substantial equivalence” 510(k) pathway with evidence of effectiveness and safety, even though this pathway does not require evidence of that kind.

In a 2022 Lown Right Care article on interventional procedures for low back pain, Drs. Alan Roth and Andy Lazris noted that “Surgery for low back pain is one of the most overused procedures in the United States, with more than 1.2 million back surgeries performed every year.” At an estimated 50,000 procedures annually, spinal cord stimulators make up a relatively small portion of these back surgeries. However, in a 2020 letter to health care providers, the FDA reported that over the preceding four-year period, it received “a total of 107,728 medical device reports related to spinal cord stimulators intended for pain, including 497 associated with a patient death [representing 428 deaths], 77,937 with patient injury, and 29,294 with device malfunction.” That seems like an unacceptably high rate of unintended effects for a device with modest benefits.

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This post first appeared on the AFP Community Blog.