Rigor, reproducibility, and transparency of randomized controlled trials in obstetrics and gynecology

Abstract

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Probiotics, a promising therapy to reduce the recurrence of bacterial vaginosis in women? a systematic review and meta-analysis of randomized controlled trials

“…Future trials should be strategized to reduce drop-outs while adopting a longer period of follow-up, preferably up to 1 year after the completion of probiotic treatment. Furthermore, future systematic review should also focus on inclusion of RCTs with larger sample sizes, preferably RCTs whose sample sizes were calculated a priori using statistical power analysis ( 56 ).…”

Challenges in Interpreting Obstetrics and Gynecology Literature

“…Our group performed an assessment of CONSORT guideline compliance, and agreement between protocols in pretrial registries and in final publications, in a cross-sectional analysis of 170 OBGYN RCTs published in 6 journals between 2017 and 2019. We found that 80% of trials were compliant (defined as 80% or more checklist items completed) with CONSORT 30. Further, while 98% of trials completed pretrial registration, there were discrepancies between pretrial registry protocols and the final publications in the prespecified primary outcomes (23% discordance), secondary outcomes (68% discordance), and planned sample sizes (40% discordance) 30…”

“…We found that 80% of trials were compliant (defined as 80% or more checklist items completed) with CONSORT. 30 Further, while 98% of trials completed pretrial registration, there were discrepancies between pretrial registry protocols and the final publications in the prespecified primary outcomes (23% discordance), secondary outcomes (68% discordance), and planned sample sizes (40% discordance). 30 Pretrial registry and reporting guidelines are only beneficial if used.…”

“…30 Further, while 98% of trials completed pretrial registration, there were discrepancies between pretrial registry protocols and the final publications in the prespecified primary outcomes (23% discordance), secondary outcomes (68% discordance), and planned sample sizes (40% discordance). 30 Pretrial registry and reporting guidelines are only beneficial if used. These studies highlight that while reporting guidelines and pretrial registry are generally requested by journals, they are not optimally followed.…”