Cluster randomised trials : Methodological and ethical considerations
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چکیده
منابع مشابه
Surgical experimentation and clinical trials: differences and related ethical problems.
Surgical techniques are not introduced into clinical practice as the result of randomised clinical trials (RCT), but usually through the gradual evolution of existing techniques or, more rarely, through audacious departures from the norm that are decided by a surgical team on the basis of experience. Sham surgery is held by some to be not only an ethically acceptable procedure but also a perfec...
متن کاملMethodological quality and reporting of ethical requirements in phase III cancer trials.
BACKGROUND The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. METHOD Methodo...
متن کاملCLINICAL ETHICS Methodological quality and reporting of ethical requirements in phase III cancer trials
Background: The approval of a research ethics committee (REC) and obtaining informed consent from patients (ICP) could be considered the main issues in the ethics of research with human beings. The aim of this study was to assess both methodological quality and ethical quality, and also to assess the relationship between these two qualities in randomised phase III cancer trials. Method: Methodo...
متن کاملImpact of CONSORT extension for cluster randomised trials on quality of reporting and study methodology: review of random sample of 300 trials, 2000-8.
OBJECTIVE To assess the impact of the 2004 extension of the CONSORT guidelines on the reporting and methodological quality of cluster randomised trials. DESIGN Methodological review of 300 randomly sampled cluster randomised trials. Two reviewers independently abstracted 14 criteria related to quality of reporting and four methodological criteria specific to cluster randomised trials. We comp...
متن کاملMethodological bias in cluster randomised trials
BACKGROUND Cluster randomised trials can be susceptible to a range of methodological problems. These problems are not commonly recognised by many researchers. In this paper we discuss the issues that can lead to bias in cluster trials. METHODS We used a sample of cluster randomised trials from a recent review and from a systematic review of hip protectors. We compared the mean age of particip...
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