Anesthesiology
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Large randomized trials provide the highest level of clinical evidence. However, enrolling large numbers of randomized patients across numerous study sites is expensive and often takes years. There will never be enough conventional clinical trials to address the important questions in medicine. ⋯ This article presents trial designs including cluster designs, real-time automated enrollment, and practitioner-preference approaches. Then various adaptive designs that improve trial efficiency are presented. And finally, the article discusses the advantages of embedding randomized trials within registries.
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There is intense debate around the use of altered and waived consent for pragmatic trials. Those in favor argue that traditional consent compromises the internal and external validity of these trials. Those against, warn that the resultant loss of autonomy compromises respect for persons and could undermine trust in the research enterprise. ⋯ S. regulations, but many countries do not have equivalent frameworks. Investigators should not assume that all consent models permitted in the United States are legal in their jurisdictions, even if they are deemed ethically defensible. The authors summarize ethical and regulatory considerations and present a framework for investigators contemplating trials with altered or waived consent.
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Extracellular vesicles and their microRNA cargo are crucial facilitators of malignant cell communication and could mediate effects of anesthetics on tumor biology during cancer resection. The authors performed a proof-of-concept study to demonstrate that propofol and sevoflurane have differential effects on vesicle-associated microRNAs that influence signaling pathways involved in tumor progression and metastasis. ⋯ This proof-of-concept study provides preliminary evidence that anesthetic agents have specific effects on microRNA profiles in circulating vesicles. These findings could form the basis for larger and mechanistically oriented outcome studies in cancer patients.
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Frailty is associated with adverse postoperative outcomes, but it remains unclear which measure of frailty is best. This study compared two approaches: the Modified Frailty Index, which is a deficit accumulation model (number of accumulated deficits), and the Hopkins Frailty Score, which is a phenotype model (consisting of shrinking, weakness, exhaustion, slowness, and low physical activity). The primary aim was to compare the ability of each frailty score to predict prolonged hospitalization. Secondarily, the ability of each score to predict 30-day readmission and/or postoperative complications was compared. ⋯ The Modified Frailty Index and Hopkins Frailty Score were similarly poor predictors of perioperative risk. Further studies, with different frailty screening tools, are needed to identify the best method to measure perioperative frailty.