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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.

Investigation of the shortcomings of the consort 2010 statement for the reporting of group sequential randomised controlled trials