Current opinion in critical care
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Curr Opin Crit Care · Dec 2004
ReviewPatient care versus research: does clinical research provide individual benefit to patients enrolled in trials?
Historically, clinical research and patient care have long been intertwined. Until the mid-1970s, physicians in both North America and Europe considered that research on their patients was an integral part of the care that they delivered to them. In the United States, it was after the recommendations of the Belmont report, in 1979, that both medical activities were clearly separated. But, in Europe, the concept of "individual direct benefit from research" is still prevailing in some national legislation. ⋯ The European directive on clinical research, voted on in 2001 and still in the process of being implemented in national laws of the European Union Member States, mandates clarification of these issues. All European investigators are concerned because the framework of regulations governing clinical research will be markedly altered. The replacement of the distinction between research with and without direct benefit by the evaluation of the risk/benefit ratio by ethics committees is one of the most important changes that is due to happen soon.
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Curr Opin Crit Care · Dec 2004
ReviewLipids in the nutritional support of the critically ill patients.
This review reports recent findings on lipid use in artificial nutrition in patients with acute respiratory failure or severe sepsis or undergoing major surgery. It examines current knowledge of fatty acid safety, biologic effects, and the impact on patients' morbidity and mortality. The newly emerging area of genotypic influence and timing of immunonutrition is also discussed. ⋯ Overall, lipids, in particular n-3 fatty acids, emerge as powerful nutrients with pharmacologic properties potentially improving prognosis in critically ill patients. However, heterogeneity in study design makes the interpretation of available studies difficult. Consequently, larger prospective, randomized, double-blind trials with comparable methodologies are necessary for detailed evaluation of the pharmacologic impact of lipids. In addition, a better knowledge of the influence of genotypic variation and postinjury inflammatory/immune temporal patterns may improve our current therapeutic use of various fatty acids.
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The trauma population is at increased risk of venous thromboembolic disease, a potentially preventable cause of mortality and morbidity. Although the association between trauma and venous thromboembolism has been recognized for more than a century, there is still great variability in the clinical practices with respect to prophylaxis. This thorough review of recent literature aims to clarify the incidence and risk factors for deep venous thrombosis and pulmonary embolism after trauma, review options and recommendations for detection of deep venous thrombosis and pulmonary embolism, and give evidence-based recommendations for prophylaxis. Special attention is paid to patients with spinal cord injury, patients with head injury, and pediatric trauma patients. ⋯ Venous thromboembolism remains an area of active clinical research focusing on evolving diagnostic techniques, newer methods of chemical and mechanical prophylaxis, and improved understanding of the etiologic factors of posttraumatic venous thromboembolism. These efforts will undoubtedly decrease the posttraumatic morbidity and mortality associated with venous thromboembolism.
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Most critical care physicians believe that randomized, controlled trials provide the best available evidence. This review contends that the importance of randomized, controlled trials was overemphasized and that they do not add more to knowledge and practice than physiologic and observational studies. In addition, protection of both patients and proxies may be less adequately ensured during randomized, controlled trials than during observational studies. ⋯ We may see in the future the twilight of randomized, controlled trials in critically ill patients because scientific, ethical, and sociologic substrata will be progressively lacking as will be funding.