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Displaying 521 - 530 of 6848 in Annals of Internal Medicine
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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.
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.
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.
Prevention, Diagnosis, Evaluation, and Treatment of Hepatitis C in Chronic Kidney Disease: Synopsis of the Kidney Disease: Improving Global Outcomes 2022 Clinical Practice Guideline
Description: The Kidney Disease: Improving Global Outcomes (KDIGO) 2022 clinical practice guideline on prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease (CKD) is an update of the 2018 guideline from KDIGO. Methods: The KDIGO Work Group (WG) updated the guideline, which included reviewing and grading new evidence that was identified and summarized. As in the previous guideline, the WG used the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach to appraise evidence and rate the strength of recommendations and used expert judgment to develop recommendations. New evidence led to updating of recommendations in the chapters on treatment of hepatitis C virus (HCV) infection in patients with CKD (Chapter 2), management of HCV infection before and after kidney transplant (Chapter 4), and diagnosis and management of kidney disease associated with HCV infection (Chapter 5). Recommendations in chapters on detection and evaluation of hepatitis C in CKD (Chapter 1) and prevention of HCV transmission in hemodialysis units (Chapter 3) were not updated because of an absence of significant new evidence. Recommendations: The 2022 updated guideline includes 43 graded recommendations and 20 ungraded recommendations, 7 of which are new or modified on the basis of the most recent evidence and consensus among the WG members. The updated guidelines recommend expanding treatment of hepatitis C with sofosbuvir-based regimens to patients with CKD glomerular filtration rate categories G4 and G5, including those receiving dialysis; expanding the donor pool for kidney transplant recipients by accepting HCV-positive kidneys regardless of the recipient’s HCV status; and initiating direct-acting antiviral treatment of HCV-infected patients with clinical evidence of glomerulonephritis without requiring kidney biopsy. The update also addresses the use of immunosuppressive regimens in such patients.