Randomized controlled trials (RCTs) are the top evidence for effectiveness research of a new intervention or treatment. Multicenter design is commonly used in RCTs to increase the sample size and improve the external validity, particularly in Phase II or III studies. 1 With the globalization of drug development, increasing emphasis is being placed on multicenter randomized controlled trials (MRCTs). 2 However, MRCTs reach their full potential only if they are designed, conducted, and reported appropriately. In our previous survey in 2021, we have analyzed 2844 final reports of MRCTs during 1975-2019 and found that several multicenter-related information was absent or incompletely provided in their publications. To investigate the reason for unsatisfactory reporting level of MRCTs, we also identified that only 19% studies provided their trial protocol that can be accessed, and 11% descripted the consistency or disparity of protocols across centers. 3 Given the This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

Review question / Objective: The aim of this systematic review and meta-analysis of randomized controlled trials is to evaluate the efficacy and safety of Chinese medicine for PCSD. Condition being studied: Previous cesarean scar defect (PCSD) is a gynecological disease that can causes bleeding after intercourse, prolonging menstrual period, intermenstrual bleeding, dysmenorrhea and other symptoms, and even lead to infertility. The treatment of this disease INPLASY 1

Background and objective: Integrated traditional Chinese and western medicine (ITCWM), as a representative type of complex intervention, is commonly used for the treatment of angina pectoris (AP) in clinical practice. However, it is unclear whether the details of ITCWM interventions, such as selection rationale, implementation, study design and potential interactions, were adequately reported. Therefore, this study aimed to assess the quality of reporting in the ITCWM interventional randomized controlled trials (RCTs). Methods: Through a search of 7 international electronic databases, we identified RCTs of AP with ITCWM interventions published in both English and Chinese from 1st Jan 2017 to 6th Aug 2022. The general characteristics of included studies were summarized, further, the quality of reporting was assessed based on three Checklists, including the CONSORT (Consolidated Standards of Reporting Trials) with 36 items (except for one item 1b about abstract), the CONSORT for abstracts (17 items), and a self-designed ITCWM-related checklist (21 items covering design rationale, intervention details, outcome assessment and analysis). The quality of RCTs published in English journals, Chinese journals and dissertations were also compared. Results: A total of 451 eligible RCTs were included. For the reporting compliance, the mean score (standard deviation) of the CONSORT (72 score in total), CONSORT for abstract (34 score in total), and ITCWM-related (42 score in total) checklists was 35.67 (4.02), 13.17 (2.14), and 20.93 (3.95), respectively. More than 50% items were evaluated as poor quality (reporting rate＜50%) among each Checklist. Moreover, the reporting quality of publications in English journals was significantly higher than that in Chinese journals regarding the CONSORT compliance (p<0.05), but there were no differences among journals regarding the CONSORT for Abstract and ITCWM-related reporting (p>0.05). The reporting of dissertations was better than journal publications in comparison of the CONSORT and ITCWM-related items (p<0.05). Conclusion: Although CONSORT appears to have enhanced the reporting of RCTs in AP, the quality of ITCWM specifics is variable and in need of improvement. Reporting guideline of the ITCWM recommendations should be developed thus to improve their quality.

Objectives Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely “The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM).” Methods A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. Results A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. Conclusions The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

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