Arch Intern Med
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Chronic critical illness is a devastating syndrome of prolonged respiratory failure and other derangements. To our knowledge, no previous research has addressed brain dysfunction in the chronically critically ill, although this topic is important for medical decision making. ⋯ Severe, prolonged, and permanent brain dysfunction is a prominent feature of chronic critical illness. These data, together with previous reports of symptom distress and rates of mortality and institutionalization, describe burdens for chronically critically ill patients receiving continued life-prolonging treatment and for their families.
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Multicenter Study
Time course of depression and outcome of myocardial infarction.
Depression predicts worse outcomes after myocardial infarction (MI), but whether its time course in the month following MI has prognostic importance is unknown. Our objective was to evaluate the prognostic importance of transient, new, or persistent depression on outcomes at 6 months after MI. ⋯ Depressive symptoms after MI, irrespective of whether they persist, subside, or newly develop in the first month after hospitalization, are associated with worse outcomes after MI.
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Multicenter Study
Recent trends in the care of patients with non-ST-segment elevation acute coronary syndromes: insights from the CRUSADE initiative.
The extent to which national health quality improvement initiatives have altered reported treatment gaps among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unknown. We sought to determine recent trends in adherence to guideline-based therapies for NSTE ACS. ⋯ During the 4 years since the initial release of the ACC/AHA guidelines for NSTE ACS, adherence to class I recommendations has significantly improved among hospitals participating in CRUSADE. Still, further improvements are needed for optimal implementation of the these guidelines.
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The current Food and Drug Administration (FDA) system of regulating drug safety has serious limitations and is in need of changes. The major problems include the following: the design of initial preapproval studies lets uncommon, serious adverse events go undetected; massive underreporting of adverse events to the FDA postmarketing surveillance system reduces the ability to quantify risk accurately; manufacturers do not fulfill the majority of their postmarketing safety study commitments; the FDA lacks authority to pursue sponsors who violate regulations and ignore postmarketing safety study commitments; the public increasingly perceives the FDA as having become too close to the regulated pharmaceutical industry; the FDA's safety oversight structure is suboptimal; and the FDA's expertise and resources in drug safety and public health are limited. To address these problems, we urge Congress, which is ultimately responsible for the FDA's performance, to implement the following 5 recommendations: (1) give the FDA more direct legal authority to pursue violations, (2) authorize the adoption of a conditional drug approval policy, at least for selected drugs, (3) provide additional financial resources to support the safety operations, (4) mandate a reorganization of the agency with emphasis on strengthening the evaluation and proactive monitoring of drug safety, and (5) require broader representation of safety experts on the FDA's advisory committees.