TY - JOUR
T1 - Quality criteria for randomized controlled studies
T2 - obstetrical journal guidelines
AU - Anderson, Kathryn
AU - Romero, Roberto
AU - Odibo, Anthony O.
AU - Rouse, Dwight
AU - Marsh, Michael
AU - Acharya, Ganesh
AU - Chitty, Lyn
AU - Ortmann, Olaf
AU - Geary, Michael
AU - Gratacos, Eduard
AU - Gallagher, Patrick G.
AU - Gupta, Janesh
AU - Renzo, Gian Carlo Di
AU - Maulik, Dev
AU - de Costa, Caroline
AU - Saade, George
AU - Dudenhausen, Joachim W.
AU - Berghella, Vincenzo
N1 - Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/5
Y1 - 2021/5
N2 - BACKGROUND: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. OBJECTIVE: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals. STUDY DESIGN: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial 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 among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals. RESULTS: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most 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 vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals. CONCLUSION: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.
AB - BACKGROUND: Most retractions of obstetrics and gynecology manuscripts are because of scientific misconduct. It would be preferable to prevent randomized controlled trials with scientific misconduct from ever appearing in the peer-reviewed scientific literature, rather than to have to retract them later. OBJECTIVE: This study aimed to evaluate the policies of obstetrics and gynecology and top medical journals in their author guidelines and electronic submission systems regarding prospective randomized controlled trial registration, ethics committee approval, research protocols, Consolidated Standards of Reporting Trial guidelines, and data sharing and to detect the most common quality criteria requested for randomized controlled trials in these journals. STUDY DESIGN: Author guidelines were identified via online Google searches from the websites of selected peer-reviewed medical journals. Journals in obstetrics and gynecology were selected from the list of journals with impact factors based on the Journal Citation Report released by Clarivate Analytics on June 29, 2020, focusing on those publishing original clinical research in obstetrics, in particular randomized controlled trials. In addition, 4 of the top impact factor peer-reviewed general medical journals publishing randomized controlled trials were included. The requirements for selected quality criteria for randomized controlled trials analyzed in the author guidelines for each journal were details of 5 general issues: prospective randomized controlled trial registration (4 subcategories), ethics committee approval (4 subcategories), research protocol (3 subcategories), Consolidated Standards of Reporting Trials guidelines (3 subcategories), and data sharing (3 subcategories). To evaluate the requirements within the electronic submission system, a mock submission of a randomized controlled trial 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 among all journals. Planned subgroup analyses were top general medicine vs obstetrics and gynecology journals and top 4 obstetrics and gynecology vs other obstetrics and gynecology journals. RESULTS: Most studied peer-reviewed journals listed in their author guidelines 7 specific criteria for submission of randomized controlled trials: prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement. For most 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 vs other obstetrics and gynecology journals and among top vs other obstetrics and gynecology journals. CONCLUSION: Prospective registration and registration number, statement of ethical approval with name of approving committee and statement of informed consent, statement of adherence to Consolidated Standards of Reporting Trials guidelines, and data sharing statement are the randomized controlled trial quality criteria requested by leading medical and obstetrics and gynecology journals. These obstetrics and gynecology journals agree to make, as much as possible, these criteria uniform and mandatory in author guidelines and also through improved submission software.
KW - CONSORT guidelines
KW - author guidelines
KW - data sharing
KW - ethical approval
KW - informed consent
KW - ob-gyn journals
KW - quality criteria
KW - randomized controlled trial
KW - registration
UR - http://www.scopus.com/inward/record.url?scp=85107088373&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85107088373&partnerID=8YFLogxK
U2 - 10.1016/j.ajogmf.2021.100334
DO - 10.1016/j.ajogmf.2021.100334
M3 - Article
C2 - 33607321
AN - SCOPUS:85107088373
SN - 2589-9333
VL - 3
JO - American Journal of Obstetrics and Gynecology MFM
JF - American Journal of Obstetrics and Gynecology MFM
IS - 3
M1 - 100334
ER -