68: Characteristics of randomized controlled trials in gynecological surgery registered on clinicaltrials.gov

Abstract

In gynecological focused Practice Bulletins published by ACOG, only 34.7% of recommendations are based on Level A evidence (randomized controlled trials). The primary objective of this review was to identify factors associated with the successful completion and subsequent publication of randomized controlled trials in surgical gynecology. A secondary analysis compared completion and publication rates of surgical and nonsurgical randomized controlled trials in gynecology. For this retrospective cohort study, data was obtained from the National Institute of Health’s US National Library of Medicine database on ClinicalTrials.gov. Self-reported descriptive data was collected on studies registered over five years between 2009 and 2013. Gynecological studies were identified with the use of the search terms under the National Institutes of Health recommended: “Search by Topics.” Two authors examined all trials to ensure they met randomization and intervention criteria. All studies registered at Clinicaltrials.gov have their recruitment status defined. Based on this, trials with a “completed” status were identified. PubMed and Google Scholar were searched and all studies published in a peer-reviewed journal indexed to PubMed were considered “published.” Categorical variables were compared using chi-square and continuous variables were compared using the Wilcoxon rank-sum test. P values < 0.05 were considered significant. Between 2009 and 2013 there were 812 gynecological studies registered as randomized controlled trials. Of these, 123 (15.1%) were surgical and 689 (84.9%) were nonsurgical. Of the surgical cases, only 66 (53.7%) were “completed”. Of the completed surgical RCTs, only 41 (62.1%) were “published.” Between completed and published surgical RCTs, there were no differences noted in single site vs. multi-center trials or international vs. US studies (p=0.84). However, multiphasic surgical RCTs were more likely to be completed than single-phase RCTs (p=.004). Only 2 of the 66 surgical RCTs that achieved completion were federally funded. In comparing surgical and nonsurgical RCTs, there were no differences noted in enrollment patterns. Amongst published trials, the median enrollment in surgical and nonsurgical trials was 100 (Interquartile Range (IQR) 60-150) and 119 (IQR 55-287), respectively (p=0.23). There were also no differences noted in single site vs. multi-center trials (p=0.57), or international vs. US trials (p=0.35) when comparing publication rates of surgical versus nonsurgical published RCTs. Nonsurgical drug-related RCTs were the most likely to be published out of all of the intervention types (p<.001). This study highlights the lack of surgical randomized controlled trials that are completed and published in gynecology. It also brings attention to the lack of federal funding towards gynecological RCTs.