JAMA network open
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Since the introduction of the Fast Track designation in 1988, the number of special regulatory programs available for the approval of new drugs and biologics by the US Food and Drug Administration (FDA) has increased, offering the agency flexibility with respect to evidentiary requirements. ⋯ In this study, more recent FDA approvals of new drugs and biologics were based on fewer pivotal trials, which, when aggregated by indication, had less rigorous designs but longer trial durations, suggesting an ongoing need for continued evaluation of therapeutic safety and efficacy after approval.
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Meta Analysis Comparative Study
Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults: A Systematic Review and Meta-analysis.
No consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift. ⋯ This meta-analysis suggests that operative treatment of distal radius fractures improves the medium-term DASH score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. The findings suggest that operative treatment might be more effective and have a greater effect on the health and well-being of younger, nonelderly patients.
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Randomized Controlled Trial
Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure: The ENABLE CHF-PC Randomized Clinical Trial.
Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. ⋯ This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes.
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Broad-spectrum antibiotics are recommended for all patients with suspected sepsis to minimize the risk of undertreatment. However, little is known regarding the net prevalence of antibiotic-resistant pathogens across all patients with community-onset sepsis or the outcomes associated with unnecessarily broad empiric treatment. ⋯ In this study, most patients with community-onset sepsis did not have resistant pathogens, yet broad-spectrum antibiotics were frequently administered. Both inadequate and unnecessarily broad empiric antibiotics were associated with higher mortality. These findings underscore the need for better tests to rapidly identify patients with resistant pathogens and for more judicious use of broad-spectrum antibiotics for empiric sepsis treatment.
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State vaccination benefits coverage and access for adult Medicaid beneficiaries vary substantially. Multiple studies have documented lower vaccination uptake in publicly insured adults compared with privately insured adults. ⋯ Even in programs with complete vaccination benefits coverage, reimbursement amounts to health care professionals for vaccine purchase and administration may not fully cover vaccination provision costs. Reimbursement amounts below costs may reduce incentives for health care professionals to vaccinate low-income adults and thereby limit Medicaid adult beneficiary access to vaccination.