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The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they can legally be placed on the market and extends requirements for rigorous clinical surveillance of benefits and harms to the entire life cycle of devices. New “expert panels” have been established by the European Commission to advise in the assessment of devices toward certification, and the role of previous “notified bodies” (private companies charged by the Commission with ensuring that manufacturers follow the requirements for device testing) is being expanded. The MDR does not contain a grandfathering clause; thus, all existing medical devices must be recertified under the stricter regulation. The recertification deadline has recently been extended to 2027 or 2028, depending on the device's risk class. Whether most device manufacturers can meet these new requirements is uncertain, and the MDR will likely have important consequences for manufacturers, researchers, clinicians, and patients. Enhanced collaborations between the medical device industry and physician partners will be needed to meet the new requirements in a timely manner to avoid shortages of existing devices and to mitigate barriers to development of new devices.

Reflections in a Mirror

Achieving Equity in Residency and Fellowship Applications With a Partial Blindfold: A Call for Measuring the Distance Traveled

Guideline Promoting Buprenorphine for Treatment of Chronic Pain: Transformative Yet Underdeveloped

Written by Humans or Artificial Intelligence? That Is the Question

Incidence of and Factors Associated With Recurrent Firearm Injury Among Patients Presenting to St. Louis Trauma Centers, 2010 to 2019: A Cohort Study: Annals of Internal Medicine: Vol 176, No 9

Background: Firearm injuries are a public health crisis in the United States. Objective: To examine the incidence and factors associated with recurrent firearm injuries and death among patients presenting with an acute (index), nonfatal firearm injury. Design: Multicenter, observational, cohort study. Setting: Four adult and pediatric level I trauma hospitals in St. Louis, Missouri, 2010 to 2019. Participants: Consecutive adult and pediatric patients (n = 9553) presenting to a participating hospital with a nonfatal acute firearm injury. Measurements: Data on firearm-injured patient demographics, hospital and diagnostic information, health insurance status, and death were collected from the St. Louis Region-Wide Hospital-Based Violence Intervention Program Data Repository. The Centers for Disease Control and Prevention (CDC) Social Vulnerability Index was used to characterize the social vulnerability of the census tracts of patients’ residences. Analysis included descriptive statistics and time-to-event analyses estimating the probability of experiencing a recurrent firearm injury. Results: We identified 10 293 acutely firearm-injured patients of whom 9553 survived the injury and comprised the analytic sample. Over a median follow-up of 3.5 years (IQR, 1.5 to 6.4 years), 1155 patients experienced a recurrent firearm injury including 5 firearm suicides and 149 fatal firearm injuries. Persons experiencing recurrent firearm injury were young (25.3 ± 9.5 years), predominantly male (93%), Black (96%), and uninsured (50%), and resided in high social vulnerability regions (65%). The estimated risk for firearm reinjury was 7% at 1 year and 17% at 8 years. Limitations: Limited data on comorbidities and patient-level social determinants of health. Inability to account for recurrent injuries presenting to nonstudy hospitals. Conclusion: Recurrent injury and death are frequent among survivors of firearm injury, particularly among patients from socially vulnerable areas. Our findings highlight the need for interventions to prevent recurrence. Primary Funding Source: Emergency Medicine Foundation–AFFIRM and Missouri Foundation for Health.

Effects of U.S. State Medical Cannabis Laws on Treatment of Chronic Noncancer Pain

Background: State medical cannabis laws may lead patients with chronic noncancer pain to substitute cannabis in place of prescription opioid or clinical guideline–concordant nonopioid prescription pain medications or procedures. Objective: To assess effects of state medical cannabis laws on receipt of prescription opioids, nonopioid prescription pain medications, and procedures for chronic noncancer pain. Design: Using data from 12 states that implemented medical cannabis laws and 17 comparison states, augmented synthetic control analyses estimated laws’ effects on receipt of chronic noncancer pain treatment, relative to predicted treatment receipt in the absence of the law. Setting: United States, 2010 to 2022. Participants: 583 820 commercially insured adults with chronic noncancer pain. Measurements: Proportion of patients receiving any opioid prescription, nonopioid prescription pain medication, or procedure for chronic noncancer pain; volume of each treatment type; and mean days’ supply and mean morphine milligram equivalents per day of prescribed opioids, per patient in a given month. Results: In a given month during the first 3 years of law implementation, medical cannabis laws led to an average difference of 0.05 percentage points (95% CI, −0.12 to 0.21 percentage points), 0.05 percentage points (CI, −0.13 to 0.23 percentage points), and −0.17 percentage points (CI, −0.42 to 0.08 percentage points) in the proportion of patients receiving any opioid prescription, any nonopioid prescription pain medication, or any chronic pain procedure, respectively, relative to what we predict would have happened in that month had the law not been implemented. Limitations: This study used a strong nonexperimental design but relies on untestable assumptions involving parallel counterfactual trends. Statistical power is limited by the finite number of states. Results may not generalize to noncommercially insured populations. Conclusion: This study did not identify important effects of medical cannabis laws on receipt of opioid or nonopioid pain treatment among patients with chronic noncancer pain. Primary Funding Source: National Institute on Drug Abuse.

Comparison of Hospital Outcomes for Patients Treated by Allopathic Versus Osteopathic Hospitalists: An Observational Study: Annals of Internal Medicine: Vol 176, No 6

Background: The United States has 2 types of degree programs that educate physicians: allopathic and osteopathic medical schools. Objective: To determine whether quality and costs of care differ between hospitalized Medicare patients treated by allopathic or osteopathic physicians. Design: Retrospective observational study. Setting: Medicare claims data. Patients: 20% random sample of Medicare fee-for-service beneficiaries hospitalized with a medical condition during 2016 to 2019 and treated by hospitalists. Measurements: The primary outcome was 30-day patient mortality. The secondary outcomes were 30-day readmission, length of stay (LOS), and health care spending (Part B spending). Multivariable regression models adjusted for patient and physician characteristics and their hospital-level averages (to effectively estimate differences within hospitals) were estimated. Results: Of 329 510 Medicare admissions, 253 670 (77.0%) and 75 840 (23.0%) received care from allopathic and osteopathic physicians, respectively. The results can rule out important differences in quality and costs of care between allopathic versus osteopathic physicians for patient mortality (adjusted mortality, 9.4% for allopathic physicians vs. 9.5% [reference] for osteopathic hospitalists; average marginal effect [AME], −0.1 percentage point [95% CI, −0.4 to 0.1 percentage point]; P = 0.36), readmission (15.7% vs. 15.6%; AME, 0.1 percentage point [CI, −0.4 to 0.3 percentage point; P = 0.72), LOS (4.5 vs. 4.5 days; adjusted difference, −0.001 day [CI, −0.04 to 0.04 day]; P = 0.96), and health care spending ($1004 vs. $1003; adjusted difference, $1 [CI, −$8 to $10]; P = 0.85). Limitation: Data were limited to elderly Medicare patients hospitalized with medical conditions. Conclusion: The quality and costs of care were similar between allopathic and osteopathic hospitalists when they cared for elderly patients and worked as the principal physician in a team of health care professionals that often included other allopathic and osteopathic physicians. Primary Funding Source: National Institutes of Health/National Institute on Aging.

The War on Reproductive Health Care in the United States

Drug Repurposing and Observational Studies: The Case of Antivirals for the Treatment of COVID-19

Remdesivir and molnupiravir were the only 2 repurposed antivirals that were approved for emergency use during the COVID-19 pandemic. Both drugs received their emergency use authorization on the basis of a single industry-funded phase 3 trial, which was launched after evidence of in vitro activity against SARS-CoV-2. In contrast, for tenofovir disoproxil fumarate (TDF), little in vitro evidence was generated, no randomized trials for early treatment were done, and the drug was not considered for authorization. Yet, by the summer of 2020, observational evidence suggested a substantially lower risk for severe COVID-19 in TDF users compared with nonusers. The decision-making process for the launching of randomized trials for these 3 drugs is reviewed. Observational data in favor of TDF was systematically dismissed, even though no viable alternative explanations were proposed for the lower risk for severe COVID-19 among TDF users. Lessons learned from the TDF example during the first 2 years of the COVID-19 pandemic are described, and the use of observational clinical data to guide decisions about the launch of randomized trials during the next public health emergency is proposed. The goal is that gatekeepers of randomized trials make better use of the available observational evidence for the repurposing of drugs without commercial value.

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