ISSN / EISSN: 00987484 / 15383598
Published by: American Medical Association (AMA)
Total articles ≅ 286,652
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This Viewpoint examines the murky legal treatment of various health-related wearable or other general wellness products for patients, physicians, and manufacturers, and recommends solutions.
This Viewpoint discusses the importance of accurately categorizing and collecting race and ethnicity data, matching self-identity with race and ethnicity labels, in an effort to quantify the extent of health disparities.
This Medical News feature discusses the challenges of predicting how severe flu season might be.
JAMA, Volume 328, pp 1109-1110; https://doi.org/10.1001/jama.2022.12756
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.1 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.2
JAMA, Volume 328, pp 1073-1084; https://doi.org/10.1001/jama.2022.15632
Importance: Once-daily roflumilast cream, 0.3%, a potent phosphodiesterase 4 inhibitor, demonstrated efficacy and was well tolerated in a phase 2b trial of patients with psoriasis.Objective: To evaluate the efficacy of roflumilast cream, 0.3%, applied once daily for 8 weeks in 2 trials of patients with plaque psoriasis.Design, Setting, and Participants: Two phase 3, randomized, double-blind, controlled, multicenter trials (DERMIS-1 [trial 1; n = 439] and DERMIS-2 [trial 2; n = 442]) were conducted at 40 centers (trial 1) and 39 centers (trial 2) in the US and Canada between December 9, 2019, and November 16, 2020, and between December 9, 2019, and November 23, 2020, respectively. Patients aged 2 years or older with plaque psoriasis involving 2% to 20% of body surface area were enrolled. The dates of final follow-up were November 20, 2020, and November 23, 2020, for trial 1 and trial 2, respectively.Interventions: Patients were randomized 2:1 to receive roflumilast cream, 0.3% (trial 1: n = 286; trial 2: n = 290), or vehicle cream (trial 1: n = 153; trial 2: n = 152) once daily for 8 weeks.Main Outcomes and Measures: The primary efficacy end point was Investigator Global Assessment (IGA) success (clear or almost clear status plus ≥2-grade improvement from baseline [score range, 0-4]) at week 8, analyzed using a Cochran-Mantel-Haenszel test stratified by site, baseline IGA score, and intertriginous involvement. There were 9 secondary outcomes, including intertriginous IGA success, 75% reduction in Psoriasis Area and Severity Index (PASI) score, and Worst Itch Numeric Rating Scale score of 4 or higher at baseline achieving 4-point reduction (WI-NRS success) at week 8 (scale: 0 [no itch] to 10 [worst imaginable itch]; minimum clinically important difference, 4 points).Results: Among 881 participants (mean age, 47.5 years; 320 [36.3%] female), mean IGA scores in trial 1 were 2.9 [SD, 0.52] for roflumilast and 2.9 [SD, 0.45] for vehicle and in trial 2 were 2.9 [SD, 0.48] for roflumilast and 2.9 [SD, 0.47]) for vehicle. Statistically significantly greater percentages of roflumilast-treated patients than vehicle-treated patients had IGA success at week 8 (trial 1: 42.4% vs 6.1%; difference, 39.6% [95% CI, 32.3%-46.9%]; trial 2: 37.5% vs 6.9%; difference, 28.9% [95% CI, 20.8%-36.9%]; P < .001 for both). Of 9 secondary end points, statistically significant differences favoring roflumilast vs vehicle were observed for 8 in trial 1 and 9 in trial 2, including intertriginous IGA success (71.2% vs 13.8%; difference, 66.5% [95% CI, 47.1%-85.8%] and 68.1% vs 18.5%; difference, 51.6% [95% CI, 29.3%-73.8%]; P < .001 for both), 75% reduction in PASI score (41.6% vs 7.6%; difference, 36.1% [95% CI, 28.5%-43.8%] and 39.0% vs 5.3%; difference, 32.4% [95% CI, 24.9%-39.8%]; P < .001 for both), WI-NRS success (67.5% vs 26.8%; difference, 42.6% [95% CI, 31.3%-53.8%] and 69.4% vs 35.6%; difference, 30.2% [95% CI, 18.2%-42.2%]; P < .001 for both). The incidence of treatment-emergent adverse events was 25.2% with roflumilast vs 23.5% with vehicle in trial 1 and 25.9% with roflumilast vs 18.4% with vehicle in trial 2. The incidence of serious adverse events was 0.7% with roflumilast vs 0.7% with vehicle in trial 1 and 0% with roflumilast vs 0.7% with vehicle in trial 2.Conclusions and Relevance: Among patients with chronic plaque psoriasis, treatment with roflumilast cream, 0.3%, compared with vehicle cream resulted in better clinical status at 8 weeks. Further research is needed to assess efficacy compared with other active treatments and to assess longer-term efficacy and safety.Trial Registration: ClinicalTrials.gov Identifiers: NCT04211363, NCT04211389
JAMA, Volume 328, pp 1049-1050; https://doi.org/10.1001/jama.2022.14663
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.1 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.2
JAMA, Volume 328, pp 1029-1029; https://doi.org/10.1001/jama.2022.14713
JAMA, Volume 328, pp 1030-1030; https://doi.org/10.1001/jama.2022.14714
JAMA, Volume 328, pp 1123-1146; https://doi.org/10.1001/jama.2022.13081
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.
JAMA, Volume 328, pp 1045-1046; https://doi.org/10.1001/jama.2022.15544
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.