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Background: The U.S. Food and Drug Administration has proposed administering annual SARS-CoV-2 vaccines. Objective: To evaluate the effectiveness of an annual SARS-CoV-2 vaccination campaign, quantify the health and economic benefits of a second dose provided to children younger than 2 years and adults aged 50 years or older, and optimize the timing of a second dose. Design: An age-structured dynamic transmission model. Setting: United States. Participants: A synthetic population reflecting demographics and contact patterns in the United States. Intervention: Vaccination against SARS-CoV-2 with age-specific uptake similar to that of influenza vaccination. Measurements: Incidence, hospitalizations, deaths, and direct health care cost. Results: The optimal timing between the first and second dose delivered to children younger than 2 years and adults aged 50 years or older in an annual vaccination campaign was estimated to be 5 months. In direct comparison with a single-dose campaign, a second booster dose results in 123 869 fewer hospitalizations (95% uncertainty interval [UI], 121 994 to 125 742 fewer hospitalizations) and 5524 fewer deaths (95% UI, 5434 to 5613 fewer deaths), averting $3.63 billion (95% UI, $3.57 billion to $3.69 billion) in costs over a single year. Limitations: Population immunity is subject to degrees of immune evasion for emerging SARS-CoV-2 variants. The model was implemented in the absence of nonpharmaceutical interventions and preexisting vaccine-acquired immunity. Conclusion: The direct health care costs of SARS-CoV-2, particularly among adults aged 50 years or older, would be substantially reduced by administering a second dose 5 months after the initial dose. Primary Funding Source: Natural Sciences and Engineering Research Council of Canada, Notsew Orm Sands Foundation, National Institutes of Health, Centers for Disease Control and Prevention, and National Science Foundation.

Enough Is Enough: On the Road to Eliminating “Sophie’s Choice” for U.S. Prescription Drugs

Trends in Discharge Rates for Acute Pulmonary Embolism in U.S. Emergency Departments

Background: Outpatient management of select patients with low-risk acute pulmonary embolism (PE) has been proven to be safe and effective, yet recent evidence suggests that patients are still managed with hospitalization. Few studies have assessed contemporary real-world trends in discharge rates from U.S. emergency departments (EDs) for acute PE. Objective: To evaluate whether the proportion of discharges from EDs for acute PE changed between 2012 and 2020 and which baseline characteristics are associated with ED discharge. Design: Serial cross-sectional analysis. Setting: U.S. EDs participating in the National Hospital Ambulatory Medical Care Survey. Patients: Patients with ED visits for acute PE between 2012 and 2020. Measurements: National trends in the proportion of discharges for acute PE and factors associated with ED discharge. Results: Between 2012 and 2020, there were approximately 1 635 300 visits for acute PE. Overall, ED discharge rates remained constant over time, with rates of 38.2% (95% CI, 17.9% to 64.0%) between 2012 and 2014 and 33.4% (CI, 21.0% to 49.0%) between 2018 and 2020 (adjusted risk ratio, 1.01 per year [CI, 0.89 to 1.14]). No baseline characteristics, including established risk stratification scores, were predictive of an increased likelihood of ED discharge; however, patients at teaching hospitals and those with private insurance were more likely to receive oral anticoagulation at discharge. Only 35.9% (CI, 23.9% to 50.0%) of patients who were considered low-risk according to their Pulmonary Embolism Severity Index (PESI) class, 33.1% (CI, 21.6% to 47.0%) according to simplified PESI score, and 34.8% (CI, 23.3% to 48.0%) according to hemodynamic stability were discharged from the ED setting. Limitations: Cross-sectional survey design and inability to adjudicate diagnoses. Conclusion: In a representative nationwide sample, rates of discharge from the ED for acute PE appear to have remained constant between 2012 and 2020. Only one third of low-risk patients were discharged for outpatient management, and rates seem to have stabilized. Outpatient management of low-risk acute PE may still be largely underutilized in the United States. Primary Funding Source: None.

Target Trial Emulation for Evaluating Health Policy

Target trial emulation is an approach to designing rigorous nonexperimental studies by “emulating” key features of a clinical trial. Most commonly used outside of policy contexts, this approach is also valuable for policy evaluation as policies typically are not randomly assigned. In this article, we discuss the application of the target trial emulation framework in a policy evaluation context. The policy trial emulation framework includes 7 components: the units and eligibility criteria, definitions of the exposure and comparison conditions, assignment mechanism, baseline (“time zero”) and follow-up, outcomes, causal estimand, and statistical analysis and assumptions. Policy evaluations that emulate a randomized trial across these dimensions can yield estimates of the causal effects of the policy on outcomes. Using the policy trial emulation framework to conduct and report on research design and methods supports transparent assessment of threats to causal inference in nonexperimental studies intended to assess the effect of a health policy on clinical or population health outcomes.

What Internal Medicine Physicians Need to Know About Contraception

The Mifepristone Litigation: Untangling the Implications of the Fifth Circuit’s Decision for Abortion Access and the U.S. Food and Drug Administration

In August 2023, a federal appeals court issued an opinion in Alliance for Hippocratic Medicine v FDA, a case wherein a group of antiabortion medical organizations and physicians have challenged U.S. Food and Drug Administration (FDA) approval and regulation of mifepristone. This opinion contained some good news for the FDA, drug makers, and patients: the appeals court declined to halt the marketing of mifepristone altogether (as the trial court judge would have). But the court also decided that the FDA’s 2016 and 2021 actions expanding the indication for mifepristone, lowering the drug’s dose, and loosening restrictions on its distribution and use were likely unlawful, and it thus affirmed the trial court’s order staying these actions. In this article, we explain key aspects of the opinion to health care professionals and consider the ways in which the appeals court’s reasoning and conclusions, if followed by the Supreme Court, could undermine abortion access and public health going forward.

Responding to Reviewers and Editors About Statistical Significance Testing

An Ethical and Financial Obligation for Sickle Cell Disease Gene Therapy in the United States

Long-Term Effects of Individualized Acupuncture for Chronic Neck Pain: A Randomized Controlled Trial: Annals of Internal Medicine: Vol 177, No 10

Background: Long-term effects of individualized acupuncture in persons with chronic neck pain (CNP) remain unknown. Objective: To evaluate the efficacy and safety of pressure pain, sensory-based individualized acupuncture for relieving CNP. Design: A 24-week multicenter randomized controlled clinical trial. (ChiCTR1800016371) Setting: Outpatient settings at 4 clinical centers in China from May 2018 to March 2020. Participants: 716 participants with CNP. Intervention: Participants were randomly assigned to a waiting list (WL) group or to 1 of 3 interventions, which consisted of 10 sessions over 4 weeks: higher sensitive acupoints (HSA), lower sensitive acupoints (LSA), and sham acupoints (SA) acupuncture groups. Measurements: The primary outcome was the change in the visual analogue scale (VAS) score for neck pain (range, 0 to 100) from baseline to 4 weeks, with a difference of 10 points considered the minimum clinically important threshold. The VAS was also assessed every 4 weeks through 24 weeks. Results: The modified intention-to-treat population included 683 participants. The mean baseline VAS was 50.36, 50.10, 49.24, and 49.16 for HSA, LSA, SA, and WL, respectively. Compared with a mean baseline to week 4 change of −12.16 in the HSA group, the mean changes were −10.19 in the LSA group (net difference [ND], −1.97 [95% CI, −5.03 to 1.09]), −6.11 in the SA group (ND, −6.05 [CI, −9.10 to −3.00]), and −2.24 in the WL group (ND, −9.93 [CI, −12.95 to −6.90]). The intervention effects persisted at 24-week follow-up. Limitation: Lack of complete blinding and limited generalizability. Conclusion: Individualized acupuncture interventions using high- or low-sensitivity acupuncture points were more effective in reducing CNP than SA and WL control groups sustained through 24 weeks, but the magnitude of relative improvement did not reach a minimal clinically important difference. Primary Funding Source: National Natural Science Foundation of China.

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