Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials
نویسندگان
چکیده
Methods We undertook a systematic review by searching Ovid MEDLINE (01/01/2001 to 23/09/2014), supplemented with RCTs from an audit study. We included parallel group, confirmatory, group sequential RCTs that were prospectively designed using a Frequentist approach. Eligible RCTs were examined for reporting compliance against the CONSORT 2010 checklist. Proposed modifications were added to capture group sequential aspects such as use statistical bias correction due to early stopping.
منابع مشابه
Adherence to the CONSORT Statement in the Reporting of Randomized Controlled Trials on Pharmacological Interventions Published in Iranian Medical Journals
Background: Among manuscripts submitted to biomedical journals, randomized controlled trials (RCTs) form the backbone of evidence-based medicine. Hence, their protocol should be designed rigorously and their results should be reported clearly. To improve the quality of RCT reporting, researchers developed the CONSORT Statement in 1996 and updated it in 2010. This study was designed to assess th...
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The Consolidated Standards of Reporting Trials (CONSORT) statement was developed to improve the reporting of randomised controlled trials. It was initially published in 1996 and focused on the reporting of parallel group randomised controlled trials. The statement was revised in 2001, with a further update in 2010. A separate CONSORT statement for the reporting of abstracts was published in 200...
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