Clinical trial registration and CONSORT adherence in obstetrics and gynecology journals: a cross-sectional analysis of Chinese- and English-language publications

妇产科期刊中临床试验注册和CONSORT遵循情况:中英文出版物的横断面分析

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Abstract

OBJECTIVE: Clinical trial registration and adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement are essential for improving transparency, reducing reporting bias, and enhancing the interpretability of randomized controlled trials (RCTs). However, the extent to which these practices are endorsed by journals and implemented in published trials varies across disciplines and publication contexts. This study aimed to evaluate journal policies regarding clinical trial registration and adherence to the CONSORT statement, and to assess registration and reporting practices among RCTs published in Chinese- and English-language medical journals in the field of obstetrics and gynecology. METHODS: We conducted a cross-sectional analysis of obstetrics and gynecology journals publishing RCTs between 2019 and 2024. Journal instructions for authors were reviewed to determine requirements for clinical trial registration and CONSORT adherence. Published RCTs were assessed for trial registration status and the inclusion of a CONSORT flowchart. Journal characteristics, including membership in the International Committee of Medical Journal Editors (ICMJE) and endorsement of CONSORT, as well as funding support, were extracted. Categorical variables were summarized as frequencies and percentages, and group comparisons were performed using Chi-square tests. RESULTS: A total of 59 journals (51 English-language and eight Chinese-language) and 1,234 RCTs were included. Among the English-language journals surveyed, 70.6% (36/51) required clinical trial registration and 49.0% (25/51) mandated adherence to the CONSORT statement, compared with 12.5% (1/8) of Chinese-language journals requiring either practice in their journal policies and instructions for authors. Overall, 84.1% (1,038/1,234) of RCTs were registered and 83.5% (1,030/1,234) reported a CONSORT flowchart. Registration and reporting practices were more frequently observed in journals with explicit registration requirements, CONSORT endorsement, ICMJE membership, and funding support. CONCLUSION: In this sample of obstetrics and gynecology journals, substantial differences were observed in journal policies and in the implementation of clinical trial registration and CONSORT-related reporting practices between Chinese- and English-language publications. These findings highlight the association between journal policies and reporting transparency, while underscoring the need for continued efforts to strengthen trial registration and reporting standards within the field.

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