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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Measuring health care utilization and costs before death has the potential to initiate health care improvement. ⋯ In this study, health care use and spending in the last 2 years of life in Ontario were high. These findings highlight a trend in hospital-centered care before death in a single-payer health system.
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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.
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Obstructive sleep apnea has been associated with postoperative delirium, which predisposes patients to major adverse outcomes. Positive airway pressure may be an effective intervention to reduce delirium in this population. ⋯ After risk adjustment, this study found no association between obstructive sleep apnea and postoperative delirium in the context of usual care in the intensive care unit, with 99% CrIs excluding clinically meaningful associations. With limited precision, no association was found between positive airway pressure adherence and delirium. Selection bias and measurement error limit the validity and generalizability of these observational associations; however, they suggest that interventions targeting sleep apnea and positive airway pressure are unlikely to have a meaningful association with postoperative intensive care unit delirium.