4.2 Article

The quality of reporting of randomized controlled trials in pelvic organ prolapse

Journal

INTERNATIONAL UROGYNECOLOGY JOURNAL
Volume 22, Issue 9, Pages 1117-1125

Publisher

SPRINGER LONDON LTD
DOI: 10.1007/s00192-011-1426-z

Keywords

CONSORT; Pelvic organ prolapse; Randomized controlled trials; Reporting quality

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Introduction and hypothesis Randomized controlled trials (RCTs) must comply with the strict rules of design and conduct and their reporting should reflect it. Our aim was to evaluate how the quality of RCT reporting in pelvic organ prolapse (POP) has evolved. Methods RCTs in POP published between 1997 and 2010 were retrieved through a PubMed search. The quality of reporting was assessed by applying the 2010 revised Consolidated Standards of Reporting Trials (CONSORT) statement. Appropriate statistical analysis was performed. Results Forty-one RCTs were identified for review. The implementation of randomization, recruitment, blinding, outcomes with effect size and precision, trial registration, and full protocol availability were reported in less than half of the trials. Comparing two periods (1997-2006 and 2007-2010), there was no improvement in the quality of reporting for any of the CONSORT criteria. Conclusions RCTs in POP are scarce. The quality of reporting is suboptimal in many aspects and has not improved in recent years.

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