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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Multicenter Study
Association Between Early Recovery of Kidney Function After Acute Kidney Injury and Long-term Clinical Outcomes.
The severity of acute kidney injury (AKI) is usually determined based on the maximum serum creatinine concentration. However, the trajectory of kidney function recovery could be an additional important dimension of AKI severity. ⋯ This study suggests that the 72-hour period immediately after AKI distinguishes the risk of clinically important kidney-specific long-term outcomes. The identification of different AKI recovery patterns may improve patient risk stratification, facilitate prognostic enrichment in clinical trials, and enable recognition of patients who may benefit from nephrology consultation.
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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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On October 1, 2015, the US transitioned to the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) for recording diagnoses, symptoms, and procedures. It is unknown whether this transition was associated with changes in diagnostic category prevalence based on diagnosis classification systems commonly used for payment and quality reporting. ⋯ These findings suggest that the ICD-10-CM transition was associated with large prevalence changes for many diagnostic categories. Diagnostic classification systems developed using ICD-9-CM may need to be refined using ICD-10-CM data to avoid unintended consequences for disease surveillance, performance assessment, and risk-adjusted payments.
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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.