Quality criteria for randomized controlled studies: Obstetric Journal Guidelines.

Abstract Background Most retractions of ob-gyn manuscripts are due to scientific misconduct. It would be preferable to prevent randomized controlled trials (RCTs) with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. Objective To evaluate the policies of ob-gyn and top medical journals in their author guidelines and electronic submission systems regarding prospective RCT registration, ethics committee approval, research protocols, CONSORT guidelines, and data sharing, and to detect the most common quality criteria requested for RCTs in these journals. Study design Author guidelines were identified via on-line Google searches from the websites of selected peer-reviewed medical journals. Journals in ob-gyn were selected from the list of journals with impact factors (IF) based on Journal Citation Report (JCR) released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular RCTs. In addition, four of the top IF peer-reviewed general medical journals publishing RCTs were included. The requirements for selected quality criteria for RCTs analyzed in the author guidelines for each journal were details of five general issues: prospective RCT registration (four subcategories); ethics committee approval (four subcategories); research protocol (three subcategories); CONSORT guidelines (three subcategories); and data sharing (three subcategories). To evaluate the requirements within the electronic submission system, a mock submission of an RCT was also done for each journal, and the same criteria were assessed on the online software for submission. The primary outcome was the overall percentage for each of the quality criteria that were listed as required within the author guidelines or required in the submission system amongst all journals. Planned subgroup analyses were top general medicine versus ob-gyn journals and top four ob-gyn versus other ob-gyn journals. Results The majority of the studied peer-reviewed journals listed in their author guidelines seven specific criteria for submission of RCTs: prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement. For the majority of journals, the submission software did not require these or any other criteria for submission. There were minimal differences in criteria listed for top medical journals versus other ob-gyn journals, and among top versus other ob-gyn journals. Conclusions Prospective registration and registration number; statement of ethical approval with name of approving committee and statement of informed consent; statement of adherence to CONSORT guidelines; and data sharing statement are the RCT quality criteria requested by leading medical and ob-gyn journals. These ob-gyn journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines, and also through improved submission software.