The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials
نویسندگان
چکیده
1 Rotman Institute of Philosophy, Department of Philosophy, Western University, London, Ontario, Canada, 2 Department of Medicine, Western University, London, Ontario, Canada, 3 Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada, 4 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada, 5 Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada, 6 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, United Kingdom, 7 Division of Emergency Medicine, University of Calgary, Foothills Medical Centre, Calgary, Alberta, Canada, 8 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Ontario, Canada
منابع مشابه
The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees.
Cluster randomised trials have unique features that complicate the application of standard ethics guidelines for research. The Ottawa Statement on the ethical design and conduct of cluster randomised trials was developed to provide detailed guidance to researchers, research ethics committees, regulators, and sponsors as they seek to fulfil their respective roles.This article describes the devel...
متن کاملEthical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems
Cluster randomized trials 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 cluster randomized trials in routine health-care settings, which in turn poses practical and ethical chal...
متن کاملChallenges in the Design, Conduct, Analysis, and Reporting of Randomized Clinical Trial Studies in Iran: A Qualitative Study
Background and Objectives: Randomized clinical trials are the gold standard for evaluating the effectiveness and safety of medical interventions. Some unpredictable challenges may affect the results of these studies. Therefore, the aim of this study was to identify the challenges of clinical trial studies in different stages including design, conduct, analysis, and reporting. Methods: This ...
متن کاملاستانداردسازی گزارش در مطالعات کارآزمایی بالینی: کانسورت
Background and Objective: Interventional clinical trial is the study in which the participants are simultaneously placed in the intervention and control groups to investigate the cause-effect relationship between an intervention and an outcome. Because of the probability of some bias in human intervention, non-standard clinical trials design produce unreal interventional results. For standardiz...
متن کاملUsual and unusual care: existing practice control groups in randomized controlled trials of behavioral interventions.
OBJECTIVE To evaluate the use of existing practice control groups in randomized controlled trials of behavioral interventions and the role of extrinsic health care services in the design and conduct of behavioral trials. METHOD Selective qualitative review. RESULTS Extrinsic health care services, also known as nonstudy care, have important but under-recognized effects on the design and cond...
متن کامل