JAMA internal medicine
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JAMA internal medicine · Nov 2014
Assessing the safety and effectiveness of devices after US Food and Drug Administration approval: FDA-mandated postapproval studies.
Postmarketing surveillance is critical to evaluating the safety and effectiveness of medical devices. The US Food and Drug Administration (FDA) may order the manufacturer of a high-risk device to conduct postmarketing surveillance studies, known as postapproval studies (PASs), at the time of approval. ⋯ Postapproval studies have the potential to provide additional information to better understand medical device performance. However, small sample sizes, delays in reaching protocol agreement, and lack of availability of findings may hinder their ability to be clinically useful. Owing to the lack of information on the effect of studies, it is unclear whether the program achieves its aims. Improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices. To better understand the real-world performance of these products, they should be better integrated with other sources of information about device performance.
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JAMA internal medicine · Nov 2014
Comparative StudyEarly mortality after aortic valve replacement with mechanical prosthetic vs bioprosthetic valves among Medicare beneficiaries: a population-based cohort study.
Early mortality for patients who undergo aortic valve replacement (AVR) may differ between mechanical and biological prosthetic (hereinafter referred to as bioprosthetic) valves. Clinical trials may have difficulty addressing this issue owing to limited sample sizes and low mortality rates. ⋯ In this cohort analysis of Medicare beneficiaries, use of mechanical aortic valves was associated with a higher risk for death on the date of surgery and within the 30 days after surgery compared with bioprosthetic aortic valves among patients who underwent concurrent AVR and coronary artery bypass graft but not isolated AVR.
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JAMA internal medicine · Nov 2014
Quality of care for elderly patients hospitalized for pneumonia in the United States, 2006 to 2010.
Nearly every US acute care hospital reports publicly on adherence to recommended processes of care for patients hospitalized with pneumonia. However, it remains uncertain how much performance of these process measures has improved over time or whether performance is associated with superior patient outcomes. ⋯ Performance of processes of care for elderly patients hospitalized for pneumonia improved substantially from 2006 to 2010. Adjusted 30-day mortality declined slightly over time primarily owing to improved survival among non-ICU patients, and all individual processes of care were independently associated with reduced mortality.
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JAMA internal medicine · Nov 2014
Randomized Controlled Trial Comparative StudyBrief intervention for patients with problematic drug use presenting in emergency departments: a randomized clinical trial.
Medical treatment settings such as emergency departments (EDs) present important opportunities to address problematic substance use. Currently, EDs do not typically intervene beyond acute medical stabilization. ⋯ In this sample of drug users seeking emergency medical treatment, a relatively robust brief intervention did not improve substance use outcomes. More work is needed to determine how drug use disorders may be addressed effectively in the ED.