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10.1177/1740774515571140 http://scihub22266oqcxt.onion/10.1177/1740774515571140 C4498459!4498459!25733677     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=25733677&cmd=llinks): Failed to open stream: HTTP request failed! 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Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems |pdf=|usr=}}{{25733677}} gab.com Text Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems JO: Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=25733677 #FOAvip Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. Twit Text FOAVip Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems ????Clin Trials http://www.kidney.de/pget.php?&tw=1&pmid=25733677 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25733677 #FOAvip English Wikipedia <ref>{{Cite pmid|25733677}}</ref> Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems #MMPMID25733677 Anderson ML; Califf RM; Sugarman J Clin Trials 2015[Jun]; 12 (3): 276-86 PMID25733677show ga Cluster randomized trials (CRTs) randomly assign groups of individuals to examine research questions or test interventions and measure their effects on individuals. Recent emphasis on quality improvement, comparative effectiveness, and learning health systems has prompted expanded use of pragmatic CRTs in routine healthcare settings, which in turn poses practical and ethical challenges that current oversight frameworks may not adequately address. The 2012 Ottawa Statement provides a basis for considering many issues related to pragmatic CRTs but challenges remain, including some arising from the current U.S. research and healthcare regulations. In order to examine the ethical, regulatory, and practical questions facing pragmatic CRTs in healthcare settings, the National Institutes of Health (NIH) Health Care Systems Research Collaboratory convened a workshop in Bethesda, Maryland in July of 2013. Attendees included experts in clinical trials, patient advocacy, research ethics, and research regulations from academia, industry, the NIH, and other federal agencies. Workshop participants identified substantial barriers to implementing these types of CRTs, including issues related to research design, gatekeepers and governance in health systems, consent, institutional review boards, data monitoring, privacy, and special populations. We describe these barriers and suggest means for understanding and overcoming them to facilitate pragmatic CRTs in healthcare settings. äEthical and regulatory issues of pragmatic cluster randomized trials i(epmc).pdf DeepDyve Pubget Overpricing