Articles: human.
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To the Editor: We are a group of physicians, bioethicists, and scholars in allied fields who agree with the Office for Human Research Protections (OHRP) that the informed-consent documents that were used in the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) were seriously inadequate.(1) The aims of the SUPPORT study were commendable, and the study addressed important clinical issues. Nevertheless, however complex and important a study may be, the consent process must be clear enough to enable informed decision making. ⋯ S. Code of Federal Regulations (45CFR46.116) includes the following requirements for informed consent: "A statement that the study . . .
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Best Pract Res Clin Haematol · Jun 2013
ReviewNew oral anticoagulants after acute coronary syndrome.
New oral anticoagulants (NOACs) have been developed that may further decrease the mortality and morbidity of ACS by complementing antiplatelet therapy. Optimal use of these agents can be achieved by maximum reduction in thrombotic events at the minimum bleeding risk when combining a long-term oral anticoagulant with anti-platelet therapy in patients with coronary heart disease. Although, based on the pharmacokinetics and -dynamics of NOACs, these agents could improve the current management of ACS patients, multiple trials consistently demonstrate a trend toward increased major and clinically relevant non major bleeding almost diminishing the benefits in reduction of ischemic events. Therefore, some critical issues need to be further evaluated in future trials.
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Circ Cardiovasc Genet · Jun 2013
Comparative StudyComparison of echocardiographic and cardiac magnetic resonance imaging in hypertrophic cardiomyopathy sarcomere mutation carriers without left ventricular hypertrophy.
Left ventricular hypertrophy (LVH) typically manifests during or after adolescence in sarcomere mutation carriers at risk for developing hypertrophic cardiomyopathy. Guidelines recommend serial imaging of mutation carriers without LVH (G+/LVH-) to monitor for phenotypic evolution, but the optimal strategy is undefined. Compared with echocardiography (echo), cardiac MRI (CMR) offers improved endocardial visualization and potential to assess scar. However, the incremental advantage offered by CMR for early diagnosis of hypertrophic cardiomyopathy is unclear. Therefore, we systematically compared echo and CMR in G+/LVH- subjects. ⋯ Echo is unlikely to miss substantial LVH; however, CMR identified mild hypertrophy in ≈10% of mutation carriers with normal echo wall thickness. CMR may be a useful adjunct in hypertrophic cardiomyopathy family screening, particularly in higher risk situations, or if echocardiographic images are suboptimal or suggest borderline LVH.
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Evid Based Child Health · May 2013
Review Meta AnalysisHome safety education and provision of safety equipment for injury prevention (Review).
In industrialised countries injuries (including burns, poisoning or drowning) are the leading cause of childhood death and steep social gradients exist in child injury mortality and morbidity. The majority of injuries in pre-school children occur at home but there is little meta-analytic evidence that child home safety interventions reduce injury rates or improve a range of safety practices, and little evidence on their effect by social group. ⋯ Home safety interventions most commonly provided as one-to-one, face-to-face education, especially with the provision of safety equipment, are effective in increasing a range of safety practices. There is some evidence that such interventions may reduce injury rates, particularly where interventions are provided at home. Conflicting findings regarding interventions providing safety equipment on safety practices and injury outcomes are likely to be explained by two large studies; one clinic-based study provided equipment but did not reduce injury rates and one school-based study did not provide equipment but did demonstrate a significant reduction in injury rates. There was no consistent evidence that home safety education, with or without the provision of safety equipment, was less effective in those participants at greater risk of injury. Further studies are still required to confirm these findings with respect to injury rates.