JAMA internal medicine
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Advanced dementia is characterized by severe cognitive impairment and complete functional dependence. Patients' goals of care should guide the prescribing of medication during such terminal illness. Medications that do not promote the primary goal of care should be minimized. ⋯ Most nursing home residents with advanced dementia receive medications with questionable benefit that incur substantial associated costs.
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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
Association between arterial catheter use and hospital mortality in intensive care units.
Arterial catheters are used frequently in intensive care units (ICUs). Clinical effectiveness and adverse events associated with the use of the catheters have not been formally evaluated in clinical studies. ⋯ In this propensity-matched cohort analysis, arterial catheters were not associated with improvements in hospital mortality in medical ICU patients requiring mechanical ventilation. Given the costs and potential harms associated with invasive catheters, randomized clinical trials are needed to further evaluate the usefulness of these frequently used devices.
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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.