• Int Urogynecol J · Sep 2011

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

    • Vítor Cavadas, Frederico Branco, Filipe L Carvalho, Luís Osório, Mário J Gomes, and Miguel Silva-Ramos.
    • Department of Urology, Centro Hospitalar do Porto, Porto, Portugal. vcavadas@gmail.com
    • Int Urogynecol J. 2011 Sep 1;22(9):1117-25.

    Introduction And HypothesisRandomized 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.MethodsRCTs 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.ResultsForty-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.ConclusionsRCTs in POP are scarce. The quality of reporting is suboptimal in many aspects and has not improved in recent years.

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