Standard quality criteria in retracted vs nonretracted obstetrical randomized controlled trials

Abstract

The number of retracted articles in peer-reviewed journals is increasing within the field of obstetrics. The most common reason for article retraction is scientific misconduct. Unfortunately, article retraction often occurs years after publication, allowing inaccurate data to be widely distributed to readers. There exists a great need for validated screening criteria for obstetric journals to use when reviewing randomized controlled trials for scientific misconduct. This study aimed to compare retracted obstetric randomized controlled trials with nonretracted randomized controlled trials with regard to their inclusion of 7 quality metrics: prospective trial registration, trial registration number, ethics approval statement, name of the approving committee, statement of informed consent, adherence to the Consolidated Standards of Reporting Trials guidelines, and a data sharing statement. Obstetric randomized controlled trials retracted between 1995 and 2021 identified through Retraction Watch were compared with nonretracted randomized controlled trials published between 2018 and 2020 with regard to inclusion of the 7 quality metrics. The main outcome was the difference in prospective trial registration. Secondary outcomes were the percentage of individual criteria met and the screening performance of quality criteria in predicting article retraction. A total of 150 randomized controlled trials were identified, of which 14 (9.3%) were retracted and 136 (90.7%) nonretracted. Retracted randomized controlled trials were less likely than nonretracted randomized controlled trials to be prospectively registered (14.3% vs 80.1%; P<.001). The median number of quality criteria met was lower for retracted randomized controlled trials (3 vs 6; P<.01). Using a cutoff of ≤4 criteria was associated with 85.7% (95% confidence interval, 57.2-98.2) sensitivity and 92.0% (95% confidence interval, 86.2-96.0) specificity in distinguishing the retracted randomized controlled trials from nonretracted studies. Retracted obstetric randomized controlled trials were less likely to include the 7 quality metrics required on submission by most top obstetrics and gynecology journals.