Transparency In Obgyn Trial Reporting: Are We Deficient?

Randomized controlled trials (RCTs) are considered the highest level of evidence but fewer than half are reproducible. Rigorous methodology improves RCT quality but reproducibility may be limited by lack of transparency in reporting. The Consolidated Standard of Reporting Trials (CONSORT) guideline defines reporting standards. We aimed to analyze published obstetrics and gynecology (OBGyn) RCTs in six journals to evaluate compliance with CONSORT guidelines. PubMed and manual searches were performed to identify all OBGyn RCTs published in three OBGyn (Obstetrics and Gynecology, AJOG, BJOG) and three non-OBGyn (NEJM, JAMA, The Lancet) journals between July 2017 and June 2019. We excluded non-human and non-parallel arm RCTs. CONSORT manuscript and abstract guidelines were made into scored checklists (38 and 16 components, respectively). Data were collected in duplicate on study characteristics (funding source, intervention type, location, etc.) and CONSORT checklist items. A CONSORT Score was calculated for each study and compliance was pre-specified as a score >/= 80%. Study characteristics of RCTs in the top quartile of CONSORT Score were compared to those in the lower three quartiles. Secondary analyses included assessment of score by journal type and primary outcome statistical significance (p<0.05). Of 170 RCTs included, 80% were compliant with CONSORT manuscript guidelines while only 65.9% were compliant with abstract guidelines (Figure). RCTs in the top quartile of CONSORT Score were more likely to be multicenter, international, and government funded (Table). There were more RCTs in the top quartile in non-OBGyn compared to OBGyn journals (64.9% v 25.7%, p<0.001). Studies with or without statistically significant primary outcomes were similarly distributed in the top quartile (31.4% v 41.0%, p=0.22). Twenty percent of OBGyn RCTs are not compliant with CONSORT guidelines. This represents a significant opportunity to improve transparency, reproducibility, and scientific rigor.View Large Image Figure ViewerDownload Hi-res image Download (PPT)