In Reply We thank Drs Sedghi and Siepmann for their comments. Indeed, all trials included in our individual participant meta-analysis enrolled only patients directly presenting at thrombectomy-capable stroke centers. Hence, the data presented in our study are applicable only to this exact clinical scenario. Because the likelihood of reperfusion after IVT is highly dependent on the time between administration of IVT and assessment of reperfusion, no extrapolations should be made to scenarios in which the time between administration of IVT and arterial puncture is expected to differ from the metrics reported in our study.
To the Editor A recent individual patient data meta-analysis of 6 randomized trials found that the beneficial effect of intravenous thrombolysis (IVT) before thrombectomy in patients with anterior-circulation large-vessel occlusion diminished with time from onset of stroke symptoms to administration of IVT and lost statistical significance after 2 hours and 20 minutes. However, as pointed out by the authors, all patients included in this analysis presented directly to a thrombectomy-capable center. For individuals who receive IVT at a thrombectomy-incapable hospital within a hub-and-spoke telestroke network, thrombectomy is inevitably delayed due to transfer. Prolongated exposure to IVT might increase the chance of early recanalization or thrombus migration to a more distal occlusion site. While early recanalization and distal thrombus migration have been shown to beneficially alter functional outcome after acute ischemic stroke, it remains unknown whether and to what extend this effect may counterbalance the decline of the beneficial effect of IVT with longer times from stroke onset to IVT. Future research on the effects of IVT before thrombectomy should include patients with stroke treated in telestroke networks to identify thrombectomy-eligible patients most likely to benefit from IVT, factoring in wider ranges of IVT-to-thrombectomy times.
This JAMA Patient Page discusses social isolation and loneliness as important public health concerns, especially among older adults.
In Reply We are grateful to Dr Thadani and colleagues for their interest in our work and applaud their efforts to improve outcomes from AKI around the world. We agree that AKI is important to assess and treat in children with sepsis in any environment and that children in some less-resourced environments are particularly vulnerable to AKI. However, we respectfully disagree with their statement that “shortcomings void the criteria used and perpetuate the neglect of children living in these settings.”
To the Editor We read Dr Sanchez-Pinto and colleagues’ study with interest, but we are concerned that the final Phoenix 4-organ model does not include acute kidney injury (AKI) assessment. Additionally, the Phoenix 8-organ model used only a single serum creatinine threshold. Despite inclusion of data from low- and middle-income countries, these shortcomings void the clinical utility of these criteria and perpetuate the neglect of children living in these settings.
This cross-sectional study uses data from retail pharmacies to examine shingles vaccine uptake among Medicare Part D beneficiaries following an IRA policy to eliminate cost sharing.
Without a dissenting vote, the House of Delegates of the American Medical Association adopted last week a resolution calling on the Board of Trustees to use its best endeavors to have repealed such sections of the national prohibition acts as may interfere with the proper relation between the physician and his patient in prescribing alcohol medicinally. The resolution has been greeted by the press of the country with general approval. Most of the Chicago newspapers have already expressed themselves editorially, and the following statements represent their general attitude:
US public health preparedness and response to highly pathogenic avian influenza A(H5N1) viruses are assessed in this survey study conducted by the CDC.
This Medical News article is an interview with Saurabh Jha, a cardiothoracic radiologist and an associate professor of radiology at the University of Pennsylvania, and JAMA Editor in Chief Kirsten Bibbins-Domingo.
Current strategies to protect children from malaria—administration of new RTS,S/AS01 or R21/Matrix-M vaccines as well as seasonal medications—require about 20 health care visits by the time a child reaches age 5 years. However, an approach involving the annual administration of a monoclonal antibody might provide similar malaria protection while reducing health care visits, a randomized clinical trial found.
Intradermal injections that were one-fifth of the standard mpox vaccine dose generated antibody responses equivalent to those of subcutaneous injections of the standard dose at 6 weeks, based on results from 225 US adults aged 18 to 50 years. No participants experienced serious adverse events related to the vaccine.
The proportion of people who die while pregnant or within 42 days after their pregnancy ends has been steadily increasing in the US. Now, updated numbers from the National Vital Statistics System indicate promising trends in maternal mortality rates. About 22 people per 100 000 live births died of pregnancy-related causes in 2022, down from about 33 per 100 000 in 2021. Although maternal mortality rates declined for Black, Hispanic, and White people, Black people died of pregnancy-related causes at a significantly higher rate than any other group.
Although heart failure mortality rates fell between 1999 and 2012, the proportion of people dying from the condition in the US has increased in recent years, according to a study published in JAMA Cardiology. By 2021, the heart failure mortality rate was higher than in 1999, signaling that earlier improvements have been “entirely undone” over the past 10 years, the researchers wrote. The findings were based on death certificate data collected by the US Centers for Disease Control and Prevention.
The US Food and Drug Administration recently approved pivmecillinam, sold as Pivya, for uncomplicated urinary tract infections (UTIs) in females aged 18 years or older with no structural abnormalities of their urinary tract. UTIs affect about 50% of females at some point during their life, the FDA noted.
Long-term Veterans Health Administration (VA) nursing home residents who started new medications to treat high blood pressure were more than twice as likely to experience a fracture than those who did not, according to a cohort study involving more than 29 600 VA participants, almost all male, aged 65 years or older.
Up to 45% of physicians are subject to noncompete clauses, contractual requirements that can prevent them from changing jobs, which can limit competition and access to care, according to the American Medical Association. However, employers will no longer be allowed to enforce noncompete clauses as of August, when a final rule issued by the Federal Trade Commission (FTC) banning noncompete clauses goes into effect. The move will reduce health care costs by up to $194 billion over the next 10 years, the FTC predicted.
This JAMA Insights provides recommendations for Chagas disease screening, diagnosis, and management in the US
This Viewpoint discusses dismantling language barriers via multipronged approaches grounded in innovation, human-centered design, and systems thinking in 3 key areas.
In this narrative medicine essay, a newly minted pediatric critical care physician learns firsthand what holistic medical care is from the love and attention she received during a hospitalization for mediastinal lymphoma.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
This study uses data from US retail pharmacies to assess national GLP-1RA dispensing to adolescents and young adults from 2020-2023.
A 36-year-old man with obesity and dyslipidemia presented with elevated liver enzymes following a liver transplant to treat acute-on-chronic liver failure due to alcohol-associated hepatitis. What would you do next?
This Special Communication examines the Federal Trade Commission’s policy and legal actions related to alleged misconduct, consolidation, and anticompetitive behavior in the pharmaceutical market between 2000 and 2022.
In Reply We appreciate the Letter by Drs Stern and Hafferty about our recent Viewpoint, which gave priority to highlighting the large and growing body of evidence that patients of physicians who demonstrate more medical knowledge have better prognoses on a host of important outcomes. In doing so, we were addressing the “patient outcomes issue” often raised in conversations about certification and maintenance of certification.
To The Editor The American Board of Internal Medicine (ABIM) has an outsized influence as the arbiter of internal medicine physician quality, given the alternatives of minimal state regulations, spotty insurance-based estimates, and random patient-based ratings. A recent Viewpoint responded to recent challenges to board certification by highlighting the evidence for improved clinical outcomes and asserting their renewed commitment to organizational transparency. However, they did not mention the more fundamental rationale for why an individual physician must seek external validation of competence.
The US Food and Drug Administration (FDA) granted emergency use authorization to pemivibart, marketed as Pemgarda, to protect people who are immunocompromised from COVID-19. Pemivibart is the only long-acting monoclonal antibody available in the US for preexposure prophylaxis after the FDA revoked authorization of tixagevimab copackaged with cilgavimab, also known as Evusheld, in January 2023.
High drug prices in the US are a serious problem for both patients and the health care system. Prices of branded drugs are driven higher by monopoly dynamics: patents and other exclusive marketing rights allow companies to increase prices and restrict supply. Firms earn extraordinary profits from exclusive rights and so have incentives to sustain or extend these rights, including in unfair and abusive ways. Firms build “thickets” of secondary patents (eg, for devices used to deliver a drug) around successful medicines to extend market control by many years, sometimes earning billions of dollars in return. In “pay-for-delay” deals, companies settle lawsuits brought by generic companies challenging patents by paying them or providing other benefits if they agree to stay out of the market. Market power comes not only from patents and regulatory barriers, but also market consolidation, which has affected the pharmaceutical industry like many others. Today, the 3 largest firms control 65% of the world market for generic drugs, and 75% of the national market for pharmacy benefit managers (PBMs), and evidence has emerged that firms in both settings are driving prices higher in ways that involve collusion or other anticompetitive practices.
This Viewpoint presents the components of the payment model and the implementation challenges among the Center for Medicare and Medicaid Innovation, state Medicaid agencies, patients, and manufacturers.
These are not the final few months of my life, not the last bowl of salad I add a few spoons of tuna and mayo to. I’m not going to die on a date printed in the calendar that hangs on my fridge with cheesy pictures of Yosemite and captions like Bike to Work Day. I can sit here at the kitchen window, watching my neighbor walk down the street with her daughter without the need to join them or to hurry someplace pretty to have a last look. According to statistics I’ve got at least five years left, or ten depending on the website. Which means I can sit here and eat chopped lettuce and carrots and celery as slowly as I like as if health required nothing but belief. I watch a car go by, and then another.
This randomized clinical trial assesses the effect of krill oil supplementation vs placebo on knee pain improvement in patients with knee osteoarthritis, significant knee pain, and effusion-synovitis.
This clinical trial evaluates whether computerized provider order entry prompts providing patient- and pathogen-specific multidrug-resistant organism risk estimates could reduce use of empiric extended-spectrum antibiotics for treatment of urinary tract infections.
This clinical trial examines the effect of an antibiotic stewardship bundle (education, feedback, and real-time multidrug-resistant organism risk-based CPOE prompts) vs routine stewardship on antibiotic selection during the first 3 hospital days in adults with pneumonia.
Approximately half of hospitalized adults in the US receive antibiotics, with pneumonia and urinary tract infection (UTI) being the 2 most frequent indications. Estimates suggest about 30% of all antibiotics prescribed in US hospitals are either unnecessary or suboptimal, and extended-spectrum antibiotic use is common. Unnecessary antibiotic use contributes to numerous harms, including drug-related adverse effects, increased risk of drug resistance, and higher costs.
This Viewpoint discusses how data gaps in published research impede clinicians’ ability to clearly discuss the risks and benefits of amyloid-lowering drugs for treating Alzheimer disease.
People who received a microneedle patch that delivered a measles and rubella vaccine mounted immune responses that were equivalent to those vaccinated via subcutaneous injection, according to data from a randomized clinical trial involving 285 participants from The Gambia, including 240 toddlers and infants. The results are the first to support microneedle patches as a safe and effective way to administer the vaccine to children, the researchers noted in The Lancet.
This Arts and Medicine feature discusses INSPIRE, a digital health game designed to foster adolescent health behavior change.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
Observational studies have suggested that rapid viral testing for respiratory viruses is tied to lower use of antibiotics. Now, a meta-analysis published in JAMA Internal Medicine suggests that may not be the case, based on results from 11 randomized clinical trials involving about 6100 participants.
This Viewpoint examines whether selective androgen receptor modulators have the potential to be transformative drugs or whether they herald the next drug epidemic.
This cohort study assesses differences in donor heart acceptance by transplant center teams for Black and White men and women on the transplant waiting list in the US.
In Reply Our Research Letter analyzed free-text entries for the optional ClinicalTrials.gov data element, Gender Eligibility Description, as provided by study sponsors and investigators during trial registration. Of 1573 trials initiated between 2017 and 2022, nearly two-thirds described eligibility criteria based on sex at birth while another 11% did not contain terms for either gender identity or sex at birth, indicating confusion about the concept of gender identity. Frequent conflation of terms for sex and gender in clinical research has been documented. For instance, one study found that the protocols and results publications for three-fourths of the sampled 128 randomized clinical trials in oncology included inconsistencies in sex and gender term usage.
To the Editor A recent Research Letter by Dr Burton and colleagues revealed that almost two-thirds of the trials included in ClinicalTrials.gov reported applying gender-based eligibility between 2017 and 2022 when, in fact, sex-based eligibility was used instead. According to the National Institutes of Health, sex is considered a biological component, including chromosomes and gonads, and gender comprises social, cultural, and behavioral factors that influence a person’s self-identity. Sex and gender can affect health in different ways and are not interchangeable.
This JAMA Insights Clinical Update discusses the symptoms, diagnosis, and management of eosinophilic gastrointestinal diseases.
Disparities in care and outcomes are common, complex problems and are well illustrated by heart failure, from the initial diagnosis to the treatment of advanced disease. In the US, Black individuals develop heart failure at a much younger age than individuals of other races, and the incidence for Black individuals is 50% higher than that for White individuals. Although the age-adjusted hospitalization rate for Black patients with heart failure in the US has decreased over the past 20 years, it was still approximately 2.2 times the rate for White patients in 2018. There is also a concern for disparities in unrecognized heart failure among Black patients and among female patients, as they are more likely to be diagnosed in the acute care setting despite having symptoms for months before diagnosis. The increased risk extends to those with end-stage heart failure, with Black patients accounting for 26.5% of hospitalizations coded as end-stage heart failure (2017-2020), which is double their 12.1% share of the overall US population in the 2020 US census.
This Viewpoint discusses the concept of CARE (compassion, assistance, respect, and empathy) as a way physicians can practice the art of medicine in the current era of care that increasingly incorporates predictive analytics and artificial intelligence.
This study discusses whether facilitated telemedicine for hepatitis C treatment increases cure rates compared with standard-of-care referral to hepatitis specialists.
This Medical News article discusses how aggregated data obscure large health disparities among the 24 million Asian American people in the US.
An estimated 8% of US adults, or about 20 million people, live with medical debt of at least $250, based on recent survey results from the nonprofits Peterson Health Center and KFF (formerly Kaiser Family Foundation). The majority of those with medical debt owe more than $1000. Now, a study that examined data from 93% of US counties found that the burden of unpaid medical bills might be affecting physical and mental health as well as shortening lives.
People will be able to buy an over-the-counter contraceptive pill, marketed by Perrigo Company as Opill, at major retailers and pharmacies in the US in late March, the manufacturer announced. A 1-month pack of the progestin-only pills costs $19.99, and a 3-month supply costs $49.99.
Past research has linked people’s exposure to microplastics and nanoplastics (MNPs) to health problems. MNPs have been found in a range of products, including food containers, cosmetics, and drinking water.
School shootings in the US surged over the past 25 years and mass shootings that occurred at kindergarten through 12th-grade school sites became more deadly, according to a study in Pediatrics.
This study uses data from the 2019 to 2022 cycles of the National Health Interview Survey to estimate the prevalence of type 1 diabetes among US youths and adults.
This study uses survey data to compare rates of political participation between US physicians and nonphysicians from 2017 to 2021.
This Review summarizes current best practices for risk stratification, clinical assessment, and selection of risk reduction interventions for falls in community-dwelling older adults.
Of the so-called received forms in poetry, the sonnet is most well-known and easily recognizable. Arriving into the English language in the 16th century from Italy, the most common variation is the so-called Shakespearian or English sonnet, comprising 14 lines in iambic pentameter (5 pairs of unstressed-stressed syllables), the first 3 quatrains with the familiar ABABCDCDEFEF rhyme scheme and concluding with a rhymed couplet. The first 12 lines typically frame a conceit or argument, which is then resolved, or revised, by the couplet. And of course, in keeping with Shakespeare’s (and Petrarch’s) famous use of the form, adored (or maybe endured!) by many of us during high school English class, sonnets are usually love poems.
“I'm sorry, darling, that I missed your text; I've had 14 admissions overnight.” “Lucky and then some! Are the residents showing some pluck and helping in the fight?” “You know I find such metaphors distasteful; it's not a war; there are no enemies (except our charting software, which is hateful), just casualties of motiveless disease.” “No pensions, then, for widowers, I gather? The kids and I are going to be miffed if night rounds do you in.” “Sorry–I'd rather continue this but must complete my shift.” “Come home. I'll pin a medal on your scrubs.” “Hilarious. Just feed me breakfast, Hubs.”
This cross-sectional study discusses hospital performance after the incorporation of health equity adjustment into Medicare’s Hospital Value-Based Purchasing program.
In Reply We disagree with Drs Endo and Kami that the long duration of action of lepodisiran raises special safety concerns. Although we acknowledged in the article that a small phase 1 trial cannot definitively establish the safety of any new therapeutic agent, the observed incidence of minor concerns among participants shows no patterns suggestive of drug-induced adverse effects. Like many contemporary nucleic acid therapeutic agents, lepodisiran is conjugated with N-acetylgalactosamine, which facilitates rapid uptake of the drug by hepatocytes via asialoglycoprotein receptors expressed nearly exclusively in the liver. As a result of active hepatic uptake, the time during which lepodisiran is present in the systemic circulation is very short, with plasma levels undetectable by 48 hours after subcutaneous injection. The short presence in the circulation reduces the likelihood of systemic adverse effects. Other N-acetylgalactosamine–conjugated therapeutic agents in clinical use have prolonged effects without any major toxicity with administration as infrequently as twice per year.
To the Editor In a recent randomized clinical trial, Dr Nissen and colleagues found that lepodisiran, an extended-duration short interfering RNA targeting lipoprotein(a), demonstrated high tolerability while decreasing serum lipoprotein(a) concentrations in a dose-dependent way over an extended period. These results were unexpected, necessitating a cautious approach to their interpretation. A significant concern is the potential for long-term toxicities due to the persistent therapeutic effects after a single dose.
This article summarizes a 2022 clinical practice guideline on falls prevention and management in older adults from the World Falls Guidelines Initiative.
In this narrative essay, a physician reflects on the way in which his residency program director’s unique background as a Master of Divinity helped him to focus on his growth as a human being rather than concentrating solely on clinical evaluations.
This JAMA Patient Page describes hyperthyroidism causes, symptoms, diagnosis, and treatment options.
This Viewpoint suggests that medical and public health journals should publish articles focused singularly on health without political bias when reporting on the health consequences of war.
We write to respond to the Viewpoint by Greenland et al that proposes a form of content moderation for medical journals. Greenland et al suggest that articles dealing with health care and health consequences during war should assiduously avoid discussing the politics of war. While JAMA and other medical journals routinely practice content moderation as part of the editing process, the application of content moderation by medical editors is based on the quality and importance of the science and the insights for medicine and public health. Greenland et al are proposing something quite different. They insist that a specific area of content, the health consequences of war, should be regulated and subject to moderation by all medical journals.
In Reply We appreciate the Letters from Drs Imperiale and colleagues and Dr Baird. Regarding SSLs of at least 1 cm in size, we are following the most recent US Multi-Society Task Force guidelines, which were cited by Imperiale and colleagues. These guidelines state “Because evidence of the risk of metachronous neoplasia associated with serrated lesions is evolving, whenever possible we have chosen not to include SSPs [sessile serrated polyps] and HPs [hyperplastic polyps] in our definitions of low-risk adenoma, high risk adenoma, and advanced neoplasia, and will refer to these lesions separately.” This exclusion of SSPs was mainly due to “concern about pathologists’ consistency in distinguishing SSPs from HPs.” Furthermore, evidence for labeling SSLs of at least 1 cm as high-risk was deemed “weak,” due to “very low quality of evidence,” and was based on a single retrospective study. Most evidence supporting the risk of postcolonoscopy CRC comes from patients with traditional serrated adenomas, which we included in the advanced adenoma category. As such, we have chosen to follow the US Multi-Society Task Force guidelines and reported these lesions separately.
To the Editor Dr Barnell and colleagues reported an mt-sRNA colorectal cancer screening test with higher sensitivity for colorectal cancer compared with FIT (94.4% for mt-sRNA vs 77.8% for FIT). Although sensitivity is important in colorectal cancer screening, I believe the description of the lower specificity of mt-sRNA compared with FIT is misleading.
To the Editor The study by Dr Barnell and colleagues raises methodological and clinical concerns. First, sessile serrated lesions (SSLs) 1 cm or larger are widely considered to be advanced precancerous lesions comparable to advanced adenomas, and their categorization as a nonfinding and part of the specificity calculation is unconventional. From the study’s Table 2, moving these lesions to the sensitivity calculation reduces sensitivity for advanced precancerous lesions from 46% (278/606) to 39% (311/798) for multitarget stool RNA (mt-sRNA) testing and from 29% (175/606) to 23% (187/792) for fecal immunochemical testing (FIT). Can the authors provide an explanation for their classification and confirm our calculations using the more conventional definition of advanced precancerous lesions? Second, at equal colorectal cancer (CRC) specificity in Figure 2A, it appears that FIT is more sensitive than mt-sRNA testing. Full receiver operating characteristic curves for FIT and mt-sRNA would help clarify this issue. Third, eFigure 3 in Supplement 3 shows area under the curve (AUC) for the RNA component of the mt-sRNA test alone, with CRC and advanced adenoma both compared against all other findings having respective AUCs of 0.62 and 0.58. What were the respective AUCs for the combination of FIT and smoking status? Could smoking status or FIT account for the higher sensitivity of the mt-sRNA test for distal advanced adenomas vs proximal ones? And what was the incremental discrimination of the RNA component to FIT and smoking status? Lastly, the 100% CRC sensitivity for those aged 45 to 49 years is based on 5 cancer diagnoses and has a 95% CI of 48% to 100%, suggesting that caution should be taken when interpreting sensitivity of the mt-sRNA test for this age group. Clarification of these concerns is needed to provide comparison and interpretation of these new data for screening asymptomatic average-risk persons.
This Medical News article is an interview with JAMA Editor in Chief Kirsten Bibbins-Domingo and Virologist Davey Smith, head of the Division of Infectious Diseases and Global Public Health at the University of California, San Diego.
Deaths associated with excessive alcohol use have been rising over the past 20 years. But during 2020-2021 they went up dramatically—from an average of about 138 000 deaths during 2016-2017 to more than 178 000 deaths during the COVID-19 pandemic. The change represents a 29% increase in lives lost, according to results published in the MMWR.
People who slept 5 or fewer hours each night had a higher risk of being diagnosed with type 2 diabetes than those who slept 7 to 8 hours, even if they followed a healthy diet, a cohort study published in JAMA Network Open found. Sleeping 5 hours or 3 to 4 hours per day was linked with a 16% and 41% increased risk of type 2 diabetes, respectively.
Currently, the World Health Organization (WHO) recommends using dolutegravir, an integrase strand transfer inhibitor approved by the US Food and Drug Administration in 2013, as a first- and second-line drug for treating people with HIV. But resistance to the treatment is on the rise. About 4% to as many as about 20% of people in 4 countries reporting data—Malawi, Mozambique, Uganda, and Ukraine—who had not achieved viral suppression exhibited resistance while taking the drug as part of their antiretroviral therapy, a recent report by the WHO found.
In several JAMA articles published in 2022 and 2023, an incorrect institution was published in Dr Califf’s conflict of interest disclosure statements: the Center for Policy Analysis on Trade and Health should have been listed as the Critical Path Institute. The articles have been corrected online.
This Viewpoint discusses the US Supreme Court’s decision in Dobbs v Jackson Women’s Health Organization, describes how that decision threatens birth equity for some racial and social groups, and suggests a reproductive justice approach to address racial and social inequalities and ensure reproductive freedom and autonomy for all people.
Spring 2022 saw the emergence of a global outbreak of monkeypox virus infections, affecting more than 70 000 people in more than 107 countries by early October of this year. A recent Review article in JAMA Neurology details neurologic symptoms of both monkeypox and smallpox. Although smallpox has been eradicated, its complications “may be relevant to monkeypox,” the authors noted.
For older adults, the use of gabapentin to manage pain after major surgery can lead to adverse events in the hospital. Perioperative gabapentin has increasingly been added to analgesia regimens to reduce opioid use among surgical patients. But a study in JAMA Internal Medicine casts doubt on the drug’s benefit for people aged 65 years or older.
A practical but effective approach to getting children to sleep longer is to put them to bed earlier, according to a systematic review and meta-analysis of nonpharmacological sleep interventions for healthy children. Most children today are sleep deprived. Only a third or fewer children get the recommended amount of sleep per night—11 to 14 hours per night for toddlers, 10 to 13 hours for preschool-aged children, 9 to 11 hours for school-aged children, and 8 to 10 hours for teenagers.
Soaps, lotions, and fragrances that are advertised as “clean” and “natural” may still cause skin issues, a research letter in JAMA Dermatology suggests. Researchers who analyzed 1651 so-called natural personal care products (NPCPs) found that most contained ingredients that can lead to allergic contact dermatitis. The incidence of the skin disease related to personal care products has increased 2.7-fold between 1996 and 2016.
Over the past 2 decades, the US Preventive Services Task Force (USPSTF) has issued 5 updates to its recommendation on menopausal hormone therapy (MHT), each time recommending against use of estrogen with or without a progestin for prevention of chronic conditions such as coronary heart disease (CHD). The first of these appeared in 2002, shortly after the first Women’s Health Initiative (WHI) trial enrolling more than 16 000 US women aged 50 to 79 years from 40 clinical centers reported an unfavorable overall benefit-to-risk ratio of postmenopausal estrogen with progestin for primary prevention of chronic diseases, followed by another update in 2005 after the WHI estrogen-only trial enrolling more than 10 000 additional women drew similar conclusions for unopposed estrogen. The next was in 2012, after findings from longer-term follow-up and subgroup analyses from the WHI and other smaller trials supported the same conclusions. In 2017, the task force reissued its recommendation, again based on substantially the same evidence.
Evidence-based care for early pregnancy is well established and includes strong evidence for safe abortion as part of the reproductive health care spectrum. Legal interference to provision of safe, accessible abortion diverts the time, attention, and skills of clinicians from other pressing health concerns, especially improving maternal health and birth equity. The rate of maternal mortality in the US, already unacceptably high, surged from 20.1 deaths per 100 000 live births in 2019 to 23.8 deaths per 100 000 live births in 2020; the increases were significantly higher for Black and Hispanic people. Maternal deaths (during pregnancy or within 42 days of the end of pregnancy from any cause related to or aggravated by the pregnancy or its management) are anticipated to increase as evolving abortion restriction laws undermine physicians’ ethical and professional mandate to prioritize patients’ well-being.
A potential wireless communication risk could allow Medtronic MiniMed 630G and MiniMed 670G insulin pumps to be taken over by an unauthorized user, which may cause the pumps to deliver too much or too little insulin, the FDA warned.
Selpercatinib was granted regular approval from the FDA to treat adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. A companion diagnostic test also was approved.
The FDA issued new guidance designed to make naloxone more readily available for reversing opioid overdoses in underserved areas.
An autologous hematopoietic stem cell (HSC)–based gene therapy for treating early, active cerebral adrenoleukodystrophy (CALD) in boys aged 4 to 17 years gained accelerated FDA approval. Until now, allogeneic HSC transplant was the only treatment for CALD, requiring compatible donors, who cannot always be found, and which can cause toxicities.
FDA and the National Institutes of Health (NIH) launched a public-private partnership to advance understanding of and treatments for amyotrophic lateral sclerosis (ALS) and other rare neurodegenerative diseases.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
Sydenham defined disease as “an effort of Nature, striving with all her might to restore the patient by the elimination of morbific matter,” an implication of the modern idea of disease as a struggle for existence between invading micro-organisms and those factors residing in the body which make for immunity. The development of bacteriology emphasized the desirability of keeping the harmful germs away from the individual—of preventing disease by eliminating or restraining its causative agents. The accomplishments of public hygiene in this direction have undoubtedly been most significant; yet the hopes of many health officials have been somewhat disappointed because infectious ailments have not been eliminated in civilized communities. They have failed, however, to reckon with the innumerable unknown modes of invasion. Thus, the menace of the healthy carrier of infectious micro-organisms was scarcely recognized a generation ago; and, year by year, new sources of bacterial danger are being brought to notice. The great epidemics of meningitis or cerebrospinal fever, poliomyelitis, influenza and epidemic encephalitis, ravaging even the countries in which the medical sciences and protective arts have been most assiduously cultivated, have brought discouragement to many.
This study uses a US claims database to compare morbidity and delivery outcomes among pregnant 10- to 13-year-olds vs 14- to 17-year-olds and 18- to 19-year-olds.
This study assesses changes in online telemedicine requests to self-manage abortions with medications before vs after the Dobbs v Jackson Women’s Health Organization Supreme Court decision overturning Roe v Wade.
To the Editor A recent article explored the association of patient characteristics with postoperative mortality in children undergoing tonsillectomy in 5 US states. As otolaryngologists, we are concerned that the authors did not determine the cause of death, especially tonsillectomy-specific death.
To the Editor As academic hand surgeons, we were delighted that JAMA published a comprehensive Review article on 4 common hand conditions. Understanding that the article had a broad scope and was not focused on the epidemiology of carpal tunnel syndrome (CTS), we were nevertheless surprised that genetics was conspicuously missing as a risk factor for CTS, and an entire section was dedicated to “occupational risks.”
In Reply Our study of postoperative mortality associated with pediatric tonsillectomy was based entirely on a longitudinal analysis of inpatient and outpatient discharge data from 5 US states. These data provided no information about some of the factors (surgical technique, type of tonsillectomy, postoperative narcotic use) suggested by Dr Huang and colleagues as having possible relationships with mortality. Our analysis did include a case-by-case evaluation of diagnosis and procedure codes associated with preoperative, surgical, and postoperative encounters in all fatal cases. As stated in our study, we found that 28 of 36 fatal cases (77.8%) were associated with discharge codes indicating a life-threatening respiratory problem (respiratory failure, pulmonary edema, pneumonia, aspiration) or otherwise unexplained cardiac arrest and that the number of fatal cases associated with code(s) indicating hemorrhage was very small (exact number suppressed according to data use agreement). We cannot speculate about whether some cases of ostensibly isolated respiratory failure were in fact precipitated by unrecognized or unrecorded bleeding. However, our findings about cause of death were consistent with published information from provider surveys and malpractice claims that collectively described a total of 191 tonsillectomy cases with severe adverse outcomes (including 144 deaths). A total of 48 of 191 cases (25.1%) were attributed to bleeding, and the majority, 115 of 191 (60.2%), were attributed to isolated apnea, respiratory failure, or unexplained causes. Serious comorbid conditions, particularly neuromuscular disorders, were considered important co-factors in a number of cases. Taken together, this evidence confirms that bleeding remains an important but less common cause of tonsillectomy-related deaths than isolated respiratory complications. Whether rates of bleeding-related mortality could be further reduced by certain surgical techniques or type of tonsillectomy (partial vs total) is, to our knowledge, unknown and would require very large studies to evaluate. Huang and colleagues also express interest in whether obesity was associated with postoperative death in our study, but we found very few deaths (exact number suppressed) coded for this comorbidity and, accordingly, decided not to pursue a quantitative analysis of this potential factor.
In Reply In their Letter about our article on common hand conditions, Dr Wiberg and colleagues describe the genetic component of CTS etiology, citing twin and genome-wide association studies that provide convincing data supporting heritability of CTS. Because our article was not a comprehensive review, we prioritized occupational risks that are frequently encountered by primary care physicians who evaluate and counsel these patients.
This Medical News article discusses how the overturning of Roe v Wade will change training for future obstetrician-gynecologists in states where abortion is banned or severely restricted.
This systematic review and meta-analysis uses online databases and manual review of reference lists to evaluate associations of unintended pregnancy with maternal and infant health outcomes during pregnancy and post partum in the US.
This JAMA Patient Page summarizes the US Preventive Services Task Force’s recommendations on use of hormone therapy for prevention of chronic conditions in postmenopausal individuals.
In this narrative medicine essay, a retired family physician considers whether it is appropriate to offer medical advice to friends and family and ultimately decides that these consults are fine as long as the individual talks with their physician.
This systematic review to support the 2022 US Preventive Services Task Force Recommendation Statement on hormone therapy for primary prevention of chronic conditions summarizes published evidence on the benefits and harms of estrogen only or estrogen plus progestin for the primary prevention of chronic conditions in generally healthy perimenopausal and postmenopausal persons eligible for hormone therapy.
This 2022 Recommendation Statement from the US Preventive Services Task Force recommends against the use of combined estrogen and progestin for the primary prevention of chronic conditions in postmenopausal persons (D recommendation) and against the use of estrogen alone for the primary prevention of chronic conditions in postmenopausal persons who have had a hysterectomy. (D recommendation).
This Viewpoint discusses how limited or blocked access to legal abortion will affect the provision of emergency and critical care, including negative effects on patient health, legal intrusion into the patient-physician decision-making process, and concerns about legal jeopardy.
This Viewpoint proposes a solution to better safeguard reproductive health information in patient records that are now more complete owing to the interoperability of health information exchange networks.
This Viewpoint discusses the exclusion of abortion care from many established medical sources (such as hospitals) and from coverage by many major payers and how the health care system should legitimize and ensure clinician training in safe abortion care.
This Viewpoint discusses the ways in which the Supreme Court’s ruling in Dobbs v Jackson Women’s Health Organization, which triggered abortion bans or restrictions in half of states, presents serious legal risks to clinicians and major ethical dilemmas.
This Viewpoint discusses passage and implementation of Law 27.610, which legalized abortion in Argentina under certain circumstances, and examines the ongoing clinical issues and legal challenges to the law.
This Viewpoint details how clinicians can treat patients who have self-managed an abortion without putting the patient at risk for criminalization.
This Viewpoint discusses how states’ restrictions on abortion will affect medical students’ training in providing reproductive health care and also create moral distress by being forced to provide care that may harm patients.
Genital herpes simplex virus (HSV) infections are among the most common sexually transmitted infections encountered by humans and, in 2018, were estimated to occur in approximately 27% of US adults. There is no cure for HSV infection; consequently, infection can be transmitted from individual to individual, most often because of asymptomatic viral shedding. Thus, the reservoir of individuals infected with HSV continues to increase.
This study examines genital HSV-1 transmission and oral and genital viral shedding patterns among persons with first-episode genital HSV-1 infection.
This Medical News article discusses how abortion bans could affect patients for whom teratogenic drugs are the standard of care.
This medical news feature discusses the challenges of treating pregnant patients diagnosed with cancer following the reversal of Roe v Wade.
This retrospective study examines trends in urinary catheter use in US emergency departments between 2002 and 2019.
This Medical News feature discusses the challenges of predicting how severe flu season might be.
This study assesses the association between COVID-19 mRNA booster immunization compared with vaccination with the primary mRNA vaccination series alone and odds of hospitalization for COVID-19.
This Viewpoint discusses ways in which free time during patient visits, resulting from removal of tradition- and reimbursement-driven care in favor of more evidence-based care, could be used to achieve better health outcomes based on recommendations from the US Preventive Services Task Force evidence-based preventive care.
This 2022 Recommendation Statement from the US Preventive Services Task Force recommends screening for major depressive disorder (MDD) in adolescents aged 12 to 18 years (B recommendation) and concludes that current evidence is insufficient to assess the balance of benefits and harms of screening for MDD in children 11 years or younger (I statement) and of screening for suicide risk in children and adolescents (I statement).
This systematic review to support the 2022 US Preventive Services Task Force Recommendation Statement on screening for depression and suicide risk in children and adolescents summarizes published evidence on the benefits and harms of screening for and treatment of depression and suicide risk in children and adolescents 18 years or younger.
This JAMA Patient Page summarizes the US Preventive Services Task Force’s recommendations on screening for depression and suicide risk in children and adolescents.
Suicidal behavior is among the most critical of medical emergencies for adolescents. Among US youth aged 15 to 24 years, intentional self-harm (suicide) is the second leading cause of death and accounted for 6807 deaths in 2018. Recent statistics are ominous regarding significant increases in suicidal behavior among adolescents; from 2009 and 2019, there were significant increases in the prevalence of those who reported having seriously considered attempting suicide (13.8% to 18.8%) and having attempted suicide (6.3% to 8.9%). These increases occurred prior to the COVID-19 pandemic. A study that evaluated emergency department visits for suspected suicidal behavior among persons aged 12 to 25 years before and during the COVID-19 pandemic found that the mean number of weekly visits for suspected suicide attempts increased from February through March 2021, compared with the same period in 2019, with a 50.6% increase among girls and a 3.7% increase among boys.
This Viewpoint explains how a recent Supreme Court decision clarifies rules for prescribing controlled substances so that patients are not denied appropriate care and physicians are not unjustly prosecuted.
This Viewpoint discusses the potential benefits and harms of prior authorization in Medicare Advantage and the health policy implications and opportunities for improvement.
Little more than half of health care facilities worldwide meet the criteria for basic hand hygiene services, according to a recent report.
Underdeveloped regions such as sub-Saharan Africa are disproportionately affected by both climate change and HIV. Now, researchers have used survey data collected over 12 years in 21 countries in sub-Saharan Africa to explore the associations between HIV infections and heavy rainfall.
About 10.5 million children worldwide experienced COVID-19–associated loss of parents and caregivers through May 1, 2022, according to estimates based on World Health Organization (WHO) data. COVID-19 orphaned an estimated 7.5 million of those children.
Rotavirus was the leading cause of diarrhea requiring hospitalization among young children in 28 low- and middle-income countries despite the introduction of rotavirus vaccine, according to a study published in BMJ Global Health.
This study uses a prospective cohort of essential and frontline workers in 6 US states with SARS-CoV-2 infection to examine associations between 2 or 3 doses of mRNA COVID-19 vaccine and attenuation of symptoms and viral RNA load across SARS-CoV-2 viral lineages.
This placebo-controlled, crossover randomized clinical trial compares the effects of spinal cord burst stimulation vs placebo stimulation in patients with chronic radiculopathy after surgery for degenerative lumbar spine disorders.
This cross-sectional analysis estimates the proportion of health care spending contributed by prescription drugs as well as examines spending for retail and clinician-administered prescriptions.
In Reply In their letter, Drs Spence and Hankey discuss what they describe as an exception to the USPSTF’s recent recommendations that the evidence is insufficient to assess the balance of benefits and harms of the use of single or paired nutrient supplements (other than beta carotene and vitamin E) or multivitamins for the prevention of cardiovascular disease or cancer. In response, the USPSTF would like to highlight the important differences between the evidence Spence and Hankey cite in their letter and the USPSTF Recommendation Statement, as well as to clarify the meaning of an I statement.
In Reply We appreciate the comments by Dr Jiang and colleagues regarding our recent Research Letter. In our cohort, 5 of 79 patients (6.3%) during the Delta wave and 5 of 33 patients (15.1%) during the Omicron wave received a second dose of the SARS-CoV-2 vaccine at least 2 weeks prior to hospital admission; none of the vaccinated patients were admitted to intensive care units or required treatment with vasopressors. The incidence rate of MIS-C during the Omicron wave was lower than during both the Delta and Alpha waves.
To the Editor A recent recommendation of the US Preventive Services Task Force (USPSTF) concluded that there is no convincing evidence that vitamin supplements are beneficial for primary prevention of cardiovascular disease or cancer. However, we would like to highlight an important exception: B vitamins used to lower homocysteine levels do prevent stroke.
To the Editor A recent study from Israel showed that multisystem inflammatory syndrome in children (MIS-C) during the Omicron wave was less severe than during the Alpha and Delta waves. None of the vaccinated children with SARS-CoV-2 infection were admitted to the intensive care unit or required vasopressors. Receipt of 2 doses of SARS-CoV-2 vaccine, which increased from 6.3% during the Delta wave to 15.1% during the Omicron wave, was associated with a lower incidence and more favorable outcomes of MIS-C. However, it is important to note that SARS-CoV-2 vaccination can also lead to MIS-C. Because of the absence of data on blood antibody testing, we wonder if some patients in this study developed MIS-C from SARS-CoV-2 vaccination.
The study of epidemiology is awakening a greater interest, and enlisting larger efforts in its behalf, than ever before. In his History of Medicine, Garrison speaks of it even today as “the infantile science of epidemiology, just emerging from the descriptive stage.” The predisposing factors of many epidemics of the medieval period, such as the crowded condition and bad sanitation of the walled towns, “the squalor, misrule and gross immorality occasioned by the many wars, by the fact that Europe was overrun by wandering soldiers, students and [others], and by the general superstition, ignorance and uncleanliness of the masses”—many of these have gone, let us hope, forever. If some epidemic diseases have almost vanished, or at least become greatly modified in severity or distribution, there are, nevertheless, others still with us to take their victims, and consequently to demand renewed investigation.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
The FDA and the National Institutes of Health (NIH) have launched a public-private partnership to advance the understanding of and accelerate the development of treatments for rare neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS).
Philips Respironics has recalled more than 17 million masks used with bilevel positive airway pressure and continuous positive airway pressure machines because they contain magnets that could affect a wide range of implanted metallic medical devices, resulting in injury or death, the FDA recently announced.
Reports of squamous cell carcinomas and various lymphomas in scar tissue around breast implants spurred the FDA to issue a recent safety alert.
The prescription drug pricing provisions in the Inflation Reduction Act of 2022 constitute the most transformative reform to the Medicare prescription drug benefit since its inception almost 20 years ago. These provisions, including manufacturer rebates for price increases above inflation, negotiation of prices for high-spending drugs, and a cap on Part D out-of-pocket expenses, are the result of decades-long efforts to control increases in pharmaceutical spending and improve drug affordability in Medicare.
In the JAMA Patient Page titled “Statins for the Prevention of Cardiovascular Disease,” published in the August 23/30, 2022, issue of JAMA, an error in wording occurred. In the fifth paragraph of text, the parenthetical listing of CVD risk factors should have read “(dyslipidemia, high blood pressure, diabetes, and smoking).” This article was corrected online.
In this narrative medicine essay, a third-year pediatric resident’s descriptions of the yellow colors in medicine demonstrate her sense of comfort in her profession in contrast with the uncertainty she feels as she enters her new life of motherhood.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
More evidence about the safety of fertility preservation procedures in women with breast cancer is reported in a study in JAMA Oncology.
This JAMA Patient Page describes types of long-acting reversible contraception, how they are placed and removed, and their potential side effects.
This case series describes the clinical resolution of systemic symptoms and lesions, along with any adverse events, in patients with monkeypox infection who were treated with tecovirimat on a compassionate use basis.
This study uses electronic health record data to evaluate medical record closure outcomes before and after the use of medical scribes at a large academic medical center.
This Medical News article discusses a trend of gabapentin misuse and harms, including fatal overdoses.
Anthony Fauci, MD, who announced he will step down as chief medical advisor to US President Joe Biden and as director of the National Institute of Allergy and Infectious Diseases, discusses best practices for conveying scientific information to the public in a polarized era.
This JAMA Clinical Guidelines Synopsis summarizes the 2022 ACC/AHA/HFSA guidelines for management of heart failure in adults with a diagnosis of or at risk for heart failure.
This Viewpoint discusses the rapid advances in molecular cell biological approaches over the past 50 years and the many avenues for future advances that have been opened, including direct applications for therapeutic and regenerative medicine.
In this Viewpoint, Lauren Gardner, winner of the 2022 Lasker-Bloomberg Public Service Award for creating the COVID-19 Dashboard, discusses the development of the Dashboard and the factors that contributed to its success.
In this Viewpoint, 2022 Lasker-DeBakey Clinical Medical Research Award winner Y. M. Dennis Lo discusses his discovery and application of cell-free fetal DNA for noninvasive prenatal testing.
This Review discusses the incidence, diagnosis, symptomatic characteristics, treatment, and prognosis for patients with pulmonary embolism.
In this narrative medicine essay, a family physician maintains her patient’s trust despite missing what could have been a catastrophic diagnosis because she apologized for her oversight.
After she’s sanitized, pricked (on demand), suctioned your blood, the phlebotomist bares her arm voluntarily,
This randomized clinical trial compares the efficacy of cefepime/enmetazobactam vs piperacillin/tazobactam in achieving overall treatment success in patients with complicated urinary tract infections (UTIs) or acute pyelonephritis.
This clinical trial compares the amount of opioids used by patients who underwent arthroscopic knee or shoulder surgery randomized to a pain management protocol involving patient education, nonsteroidal anti-inflammatories, and acetaminophen or to the current pain management care.
This randomized clinical trial compares the effect of telmisartan on 6-minute walk distance compared with placebo in patients with lower extremity peripheral artery disease at 6-month follow-up.
In Reply In response to our recently published trial about the effect of awake prone positioning in patients with COVID-19 and acute respiratory failure, Dr Gershengorn states that to minimize bias we should have either mandated criteria for endotracheal intubation or used another primary outcome. Although we agree, in principle, that standardizing co-interventions and trial outcomes is important in situations when blinding is not possible, there were barriers to implementing this concept in our trial.
In Reply In our Research Letter, we reported that average manufacturer list prices for newly marketed drugs increased by 20% per year from 2008 to 2021. We believe our results provide important insight into some of the broader trends in the prescription drug market.
To the Editor We are writing about the recent COVI-PRONE (Awake Prone Position in Hypoxemic Patients with Coronavirus Disease 19) trial, which investigated the effect of awake prone positioning on endotracheal intubation in patients with COVID-19 and acute respiratory failure. Culture varies across countries and may affect the causal pathway being tested. The findings in this trial, which included aggregated data from 4 countries, may differ if data from Middle Eastern and Western countries are analyzed separately.
To the Editor In their recently published randomized clinical trial evaluating the efficacy of awake prone positioning in patients with COVID-19 and acute respiratory failure, the authors chose the primary outcome of endotracheal intubation within 30 days of randomization. I wonder about the implications of this choice because there was no provision of a standardized approach to intubation decisions and this trial was unblinded; the participants, research team, and treating clinicians all knew the group to which patients were assigned. Because blinding is used to avoid introducing bias, it is really important that the primary outcome is as resistant to bias as possible in trials that cannot be blinded.
To the Editor We believe that a recent Research Letter advanced a misleading narrative—namely, that US prescription drug spending is growing at alarming rates—because it does not consider the broader pharmaceutical life cycle that uses competition to create savings while simultaneously incentivizing the development of new medicines to address unmet needs.
When huge armies were throwing every ounce of their energies against the opposing line, it was constantly realized that the spread of epidemic disease might mean defeat for the affected side. Preventive medicine, in thus being called on to keep every possible man at the front, came into unusual prominence. Foci of contagion existed in various parts of the globe, and the intermingling of peoples, and the crossing and recrossing of seas, invited contagion to spread; but with one exception, the major demons were kept confined to regions in which they commonly prevail in endemic form. With the World War ended, the sanitary organization was largely dismantled; but the urge for conservation of life and energy did not stop and is still going on. From an examination of developments in the world-wide warfare on disease now being waged by various institutions and agencies, Showalter, in an illustrated article in the National Geographic Magazine (September), predicts three announcements of almost unprecedented importance to mankind at no distant date: that (1) yellow fever has been banished from the face of the earth; (2) hookworm disease can be driven from any community which has the will to get rid of it, and (3) malaria can be eradicated from almost any community having enough vital force left to push a thorough yet inexpensive campaign for its extirpation. The widespread incidence of hookworm disease is revealed when it is known that three out of five persons examined in China, three out of four in Siam, and five out of eight in various parts of India are so afflicted. Similar conditions prevail in Brazil, Colombia, Central America, the West Indies and elsewhere. How successful a campaign against this disease may be was shown in Richmond County, Va., where the world-wide fight against hookworm had its inception. About thirteen years ago, when the eradication work began, 82 per cent. of the people of Richmond County had this disease. A survey a few years later showed that only 35 per cent. had the disease; a more recent survey reduced it to 2 per cent., and in 1922 there is apparently not a single person in the county with symptoms of hookworm disease.
Using psilocybin (a psychedelic commonly known as “magic mushrooms”) in combination with psychotherapy reduced the percentage of heavy drinking days of patients with alcohol use disorder, according to a randomized clinical trial published in JAMA Psychiatry. The trial expands on a proof-of-concept study in 2015 that found psilocybin was well tolerated by patients dependent on alcohol and that it had reduced drinking.
Philips Respironics recalled certain bilevel positive airway pressure (BiPAP) machines that may contain contaminated plastic, the FDA warned. That plastic may release certain chemicals called volatile organic compounds (VOCs) or cause machine failure.
The FDA has updated a checklist designed to help evaluate potential drug interactions and other patient factors before prescribing Paxlovid (copackaged nirmatrelvir and ritonavir tablets) for COVID-19. It incorporates additional guidance on drugs that should not be taken with Paxlovid or may require dose or other treatment adjustments.
Treatment of complicated urinary tract infections (UTIs) has become increasingly complex, with rising antimicrobial resistance, high-risk patient populations, and limited numbers of novel antimicrobial therapies for resistant organisms. There is a particular need for effective therapies to treat complicated UTIs caused by organisms that produce extended-spectrum β-lactamases (ESBL).
Lower extremity peripheral artery disease (PAD) is a morbid manifestation of atherosclerosis that affects an estimated 230 million people worldwide. In the context of an aging population and the increasing rates of diabetes, the prevalence of PAD is expected to increase. Patients with PAD, by virtue of having atherosclerosis, have a heightened risk of myocardial infarction and stroke; thus reducing these risks has been the primary focus of most medical interventions. Although these efforts are warranted, recent evidence has broadened awareness that the dominant morbidity involves the limbs, including functional impairment and adverse limb events such as acute limb ischemia and amputation. Recent advances in medical therapeutics have brought hope by demonstrating benefits in reducing amputation and acute limb ischemia. However, effective therapies to address functional impairment remain an area of unmet need. It has been more than 2 decades since the last medical therapy for intermittent claudication was approved by the US Food and Drug Administration. The TELEX (Telmisartan Plus Exercise to Improve Functioning in Peripheral Artery Disease) randomized clinical trial reported by McDermott et al in this issue of JAMA is an important reminder of both the challenges and the great need for development of effective therapies to improve functional impairment in patients with PAD.
In the Viewpoint titled “Remote Patient Monitoring During COVID-19: An Unexpected Patient Safety Benefit,” published in the March 22, 2022, issue of JAMA, and in a related Letter in Reply titled “Remote Patient Monitoring During COVID-19—Reply,” published in the July 19, 2022, issue of JAMA, the authors’ conflict of interest disclosures were incomplete. For the Viewpoint, the disclosures should have read as follows: “Dr Pronovost reported grants from Masimo (collection of data on remote monitoring) during the conduct of the study. Ms Cole reported receipt of grants from Masimo (analysis of home-monitoring data). Dr Hughes reported receipt of a grant from Masimo (analysis of home-monitoring data).” For the Letter in Reply, the disclosures should have read as follows: “Dr Pronovost reported grants from Masimo (collection of data on remote monitoring) during the conduct of the study. Ms Cole reported receipt of grants from Masimo (analysis of home-monitoring data) and from the Federal Communications Commission (FCC) Coronavirus Aid, Relief, and Economic Security (CARES) Act (for purchase of home-monitoring devices). Dr Hughes reported receipt of a grant from Masimo (analysis of home-monitoring data).” These articles have been corrected online.
Postacute sequelae of SARS-CoV-2 infection (PASC) appears to be uncommon in children and presents with features different from long COVID in adults, according to a cohort study published in JAMA Pediatrics that included 659 286 children.
The likelihood of financial problems increases with a greater number of chronic medical conditions, according to the results of a study published in JAMA Internal Medicine.
This Medical News article discusses recent European reports of asymptomatic monkeypox virus infections.
This Medical News article discusses the first reported instance of polio in the US since 2013.
This Medical News feature examines whether the newly authorized Novavax COVID-19 vaccine will spur unvaccinated holdouts to finally get immunized.
This cohort study examines the validity of the Kidney Donor Profile Index’s hepatitis C virus (HCV) penalty during the direct-acting antiviral era by comparing 5-year allograft survival between recipients of kidneys from HCV-RNA–positive donors vs HCV-RNA–negative donors.
This Viewpoint from FDA Commissioner Robert Califf, MD, emphasizes the agency’s overarching priorities focused on helping to create a system that benefits from abundant high-quality evidence in a transparent environment.
This Viewpoint describes the provisions and limitations of prescription drug pricing reforms enacted by US Congress as part of the Inflation Reduction Act in August 2022.
The Letter to the Editor titled “Review of Antiseizure Medications for Adults With Epilepsy,” published in the August 16, 2022, issue of JAMA, included an error in the spelling of the first author’s first name. The author byline has been corrected online and now lists Chaudry Nasir Majeed as the first author.
In Reply Pharmaceutical manufacturers have unilaterally adopted a range of policies concerning the delivery of 340B discounted drugs to contract pharmacies, from requiring that certain covered entities submit insurance claims data for 340B drugs dispensed at these locations to limiting the number of contract pharmacies a covered entity can engage. We believe that it is accurate to label the former policy, which imposes a limiting condition, as a restriction. We also believe, contrary to Dr Daifotis’ assertion, that the US District Court for the District of Columbia’s discussion of using insurance claims data “to implement the antifraud audit and dispute resolution provisions” of the 340B statute did not constitute an endorsement of the practice. The court explicitly noted that “[b]ecause the parties had not adequately argued their respective positions” on whether conditions were permitted under the 340B statute, it declined to rule on the issue. Of note, the US District Court for the District of New Jersey referred to a similar policy requiring the submission of insurance claims data as a restriction and held that the policy violated the 340B statute.
This randomized clinical trial evaluates whether helmet noninvasive ventilation compared with usual respiratory support reduces mortality in patients with acute hypoxemic respiratory failure due to COVID-19 pneumonia.
These randomized clinical trials assess the effect of roflumilast cream, 0.3%, compared with vehicle cream on clinical status at 8 weeks among patients with chronic plaque psoriasis.
This randomized clinical trial compares the effect of intravenous infusions of tocilizumab vs placebo on patients with polymyalgia rheumatica who were receiving glucocorticoid therapy.
The woman with fewer than six months got engaged today in the exam room. Both of them seemed pleased, saying Yes and Yes over and over, smiling. Who knows why—perhaps the breathless part of him that already mourns and calls my office over and over saying What can I do for her, what can I do?
In this narrative medicine essay, a pediatrician describes his lingering questions about the care his daughter received during her very brief life while he was barred from operating room and compares it to being present when another daughter experienced a stressful birth.
This Special Communication describes Medicaid eligibility, enrollment, and spending as well as examines areas of Medicaid policy, Medicaid expansion, racial and ethnic health disparities, and the potential to achieve health equity.
This Viewpoint concludes the series on diagnostic excellence and explores the future of diagnostics that emphasize prediction of future health state rather than identification of current disease.
Worldwide childhood vaccinations continued to decline in 2021, fueled by a multitude of factors from COVID-19 to challenging immunization settings, according to a statement by the World Health Organization (WHO) and the United Nations Children’s Fund (UNICEF).
A combination of transport-related and unintentional injuries accounted for one-quarter of deaths among adolescents and young adults worldwide in 2019, showing little improvement from 3 decades earlier, according to a study in The Lancet Public Health.
Looser COVID-19 health policies in Sweden during the pandemic did not translate into better short-term economic performance, according to a study in the Journal of Global Health.
This Arts and Medicine feature describes use of improvisational theater techniques to train health care workers to have persuasive and respectful conversations with vaccine-hesitant patients about accepting COVID-19 vaccination.
An 18-year-old woman had a 14-year history of recurrent skin, nail, and oral mucosal abnormalities, treated with 3- to 6-month courses of itraconazole; the abnormalities typically recurred within 6 to 12 months of discontinuing itraconazole. Skin scrapings from the lower extremities demonstrated fungal elements; fungal culture of the skin scrapings grew Candida albicans. What is the diagnosis and what would you do next?
This study investigates whether resistance-associated mutations develop after treatment with sotrovimab in high-risk patients infected with the SARS-CoV-2 Omicron variant.
This JAMA Patient Page describes the combination medication tixagevimab-cilgavimab, which is used to help prevent COVID-19 infection in people with immunosuppression or who have had a COVID-19 vaccine reaction.
The FDA recently approved the first cell-based gene therapy for patients with β-thalassemia who require red blood cell transfusions.
Over-the-counter hearing aids could be available in US retail stores by mid-October as a result of a new FDA final rule.
The FDA recently recommended against blood banks asking donors specific questions about possible exposure to the monkeypox virus or using laboratory diagnostic tests to screen them for it.
Listen to the JAMA Editor’s Audio Summary for an overview and discussion of the important articles appearing in this week’s issue of JAMA.
To the Editor We have some comments about the recent TESTING trial that found that oral methylprednisolone significantly reduced the risk of the composite outcome of kidney function decline in patients with IgA nephropathy.
In Reply In their Letter about the recent TESTING trial, Drs Ye and Liu point out that previous studies have suggested that individuals of Asian descent may have a worse kidney prognosis than individuals of European descent. However, this does not necessarily mean that the effects of treatment vary by ethnicity. Indeed, previous meta-analyses have found consistent benefits of corticosteroids across trials conducted in people of both Asian and European backgrounds.
To the Editor In our study of the costs of drug development published in JAMA, we used clinical trial success rates to account for the costs of failed trials. We sourced these rates from a previous study. We recently became aware that the authors of that study issued a correction to the aggregate phase 2 success rate reported in their article. Initially, they reported that 35.1% of drugs that enter phase 2 clinical testing are ultimately approved by the US Food and Drug Administration, whereas the corrected percentage is 21.0%. Because we based our analysis on the initial figure (35.1%), we have now updated our analysis using the corrected data of 21.0%.
From its humble beginnings in 1965 as a supplement to Medicare designed to provide health insurance for individuals living in poverty, Medicaid has evolved to become a primary strategy to expand coverage and a critical part of the national social safety net. In recent years, with the expansion enabled by the Affordable Care Act (ACA) and the maintenance of coverage required by the Families First Coronavirus Response Act, Medicaid has significantly eclipsed Medicare in the number of individuals covered and arguably rivals it in importance.
Plaque psoriasis is a multisystem inflammatory disease that affects children and adults. Skin lesions are the most prominent manifestation, appearing as localized or widespread red plaques with silvery scale. Psoriasis may be associated with arthritis, obesity, metabolic syndrome, psychiatric disease, impaired quality of life, and increased risk of cardiovascular disease. The etiology and precise pathogenesis of psoriasis remain unclear. Treatment selection depends on body surface area affected, lesion characteristics (thickness, location), symptoms such as itch and pain, and comorbidities. Topical medications are prescribed in almost all cases, alone or in combination with other therapies.
In a 1953 report, Bagratuni described 7 older patients with symptoms of “generalized aching, especially in the shoulders and cervical region,” combined with fever, weight loss, elevated erythrocyte sedimentation rate, and anemia, a syndrome that was likely first reported 2 years earlier by Kersley. Bagratuni noted that this entity was similar to rheumatoid arthritis (RA), but without the typical articular manifestations of stiffness, pain, and swelling in the peripheral joints associated with RA. He suggested that the phrase rheumatoid disease be applied to such patients. Four years later, Barber first coined the term polymyalgia rheumatica in a description of 12 patients who had symptoms of pain and systemic inflammation, but lacked tender, swollen, or deformed peripheral joints, which are classic features of RA. In this report, Barber recognized the importance of differentiating this novel disease from other inflammatory conditions, such as RA and polymyositis.
The Original Investigation titled “Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018,” published in the March 3, 2020, issue of JAMA, was corrected to update data throughout the article. The data changes originated because of corrections to one of the studies used as a source for clinical trial success rates. In addition to updated data throughout the Original Investigation, accompanying Editorials and Letters necessitated corrections to data. These articles have been corrected online, and a letter of explanation appears in this issue.
The Viewpoint titled “Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability,” published in the May 3, 2022, issue of JAMA, misreported that the Health Resources and Services Administration (HRSA) sued 6 pharmaceutical manufacturers when the agency had instead issued enforcement letters. The Viewpoint also should have used the words interpretive guidance instead of the word rules when talking about the history of court rulings on compliance with the HRSA interpretive guidance. This article has been corrected online.
This Appendix presents data derived from the 2021-2022 Liaison Committee on Medical Education Annual Medical School Questionnaire-Part II.
This Appendix presents 2021 National GME Census data detailing the numbers and types of ACGME-accredited training programs and the residents and fellows in them.
To the Editor As a supporter of the 340B Drug Pricing Program and its originally intended mission, I read the recent Viewpoint entitled “Risks to the 340B Drug Pricing Program Related to Manufacturer Restrictions on Drug Availability” with great interest.
Terminology → Nomenclature → Coding → Classification! The relationships of one facet of medical documentation and data handling to another are portrayed sequentially, as above. Similar interrelationships prevail in the fields of fundamental science and business. Accordingly, certain functions include data evaluations as in research, planning, and fiscal compensation. In medicine, the interests encompass determinations of quality of medical care, notably the effectiveness of diagnostic and therapeutic procedures.