Kathryn Anderson1, Roberto Romero2, Anthony O Odibo3, Dwight Rouse4, Michael Marsh5, Ganesh Acharya6, Lyn Chitty7, Olaf Ortmann8, Michael Geary9, Eduard Gratacos10, Patrick G Gallagher11, Janesh Gupta12, Gian Carlo Di Renzo13, Dev Maulik14, Caroline de Costa15, George Saade16, Joachim W Dudenhausen17, Vincenzo Berghella18. 1. Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA (Mrs Anderson). 2. Perinatology Research Branch, Division of Obstetrics and Maternal-Fetal Medicine, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health and United States Department of Health and Human Services, Detroit, MI (Prof Romero). 3. Division of Maternal-Fetal Medicine, University of South Florida Morsani College of Medicine, Tampa, FL (Prof Odibo). 4. Department of Obstetrics and Gynecology, Brown University, Providence, RI (Prof Rouse). 5. Department of Obstetrics and Gynaecology, King's College Hospital NHS Foundation Trust, London, United Kingdom (Prof Marsh). 6. Division of Obstetrics and Gynecology, Department of Clinical Science, Intervention and Technology, Center for Fetal Medicine, Department of Obstetrics and Gynecology, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden (Prof Acharya). 7. Genetic and Genomic Medicine, University College London Great Ormond Street Institute of Child Health, London, United Kingdom (Prof Chitty). 8. Department of Gynecology and Obstetrics, University Medical Center, Regensburg, Germany (Prof Ortmann). 9. Department of Obstetrics and Gynaecology, Rotunda Hospital, Dublin, Ireland (Prof Geary). 10. Department of Maternal-Fetal Medicine, BCNatal, Barcelona Center for Maternal-Fetal and Neonatal Medicine, Hospital Sant Joan de Déu and Hospital Clínic, Universitat de Barcelona, Barcelona, Spain; Institut de Recerca August Pi Sunyer, Barcelona, Spain; Center for Biomedical Network Research on Rare Diseases, Instituto de Salud Carlos III, Barcelona, Spain (Prof Gratacos). 11. Division of Perinatal Medicine, Department of Pediatrics, Yale School of Medicine, New Haven, CT (Prof Gallagher). 12. Centre for Women's and Newborn Health, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham Women's and Children's NHS Foundation Trust, England, United Kingdom (Prof Gupta). 13. Department of Obstetrics and Gynecology, Centre of Perinatal and Reproductive Medicine, University of Perugia, Italy (Prof Renzo). 14. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Missouri-Kansas City, Kansas City, MO (Prof Maulik). 15. Department of Obstetrics and Gynaecology, James Cook University College of Medicine and Dentistry, Cairns, Australia (Prof Costa). 16. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Texas Medical Branch at Galveston, Galveston, TX (Prof Saade). 17. Department of Obstetrics, Charité University School of Medicine, Berlin, Germany (Prof Dudenhausen). 18. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, PA (Dr Berghella). Electronic address: vincenzo.berghella@jefferson.edu.
Abstract
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.
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.
Authors: Suneet P Chauhan; Vincenzo Berghella; Maureen Sanderson; Everett F Magann; John C Morrison Journal: Am J Obstet Gynecol Date: 2006-06 Impact factor: 8.661
Authors: Esmée M Bordewijk; Rui Wang; Lisa M Askie; Lyle C Gurrin; Jim G Thornton; Madelon van Wely; Wentao Li; Ben W Mol Journal: Eur J Obstet Gynecol Reprod Biol Date: 2020-04-11 Impact factor: 2.435
Authors: Carrie Bennett; Laura M Chambers; Leen Al-Hafez; Chad M Michener; Tommaso Falcone; Meng Yao; Vincenzo Berghella Journal: Am J Obstet Gynecol MFM Date: 2020-08-19