Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study

BMC Medical Research Methodology

Research

Aiping Lyu¹  Chung Wah Cheng¹  Juan Wang¹  Nana Wang¹  Zhaoxiang Bian²  Xuan Zhang²  Fei Han³  Ji Li³  Juan He⁴  Jiashuai Deng⁴  Yalin Jiao⁴  Ping Wang⁵ 

[1] Chinese EQUATOR Centre, Chinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China;Chinese EQUATOR Centre, Chinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China;Centre for Chinese Herbal Medicine Drug Development Limited, Hong Kong Baptist University, Hong Kong SAR, China;Department of Pediatrics, Guang’anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China;School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China;Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China;

关键词: Angina pectoris (AP);    CONSORT guideline;    Randomized controlled trials (RCTs);    Reporting quality;    Integrated traditional Chinese and western medicine (ITCWM);   

DOI  :  10.1186/s12874-023-01953-1

 received in 2023-01-16, accepted in 2023-05-16,  发布年份 2023

来源: Springer

【 摘 要 】

Background and objectiveIntegrated 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 rationale for selection and design, implementation and potential interactions for different therapies, were adequately reported. Therefore, this study aimed to describe the reporting characteristics and quality in randomized controlled trials (RCTs) of AP with ITCWM interventions.MethodsThrough a search of 7 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 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 rationale and details of interventions, outcome assessment and analysis). The quality of RCTs published in English and Chinese, as well as journals and dissertations were also compared.ResultsA total of 451 eligible RCTs were included. For the reporting compliance, the mean score (95% Confidence Interval) of the CONSORT (72 scores in total), CONSORT for abstract (34 scores in total), and ITCWM-related (42 scores in total) checklists was 27.82 (27.44–28.19), 14.17 (13.98–14.37) and 21.06 (20.69–21.43), respectively. More than half items were evaluated as poor quality (reporting rate < 50%) among each Checklist. Moreover, the reporting quality of publications in English journals was higher than that in Chinese journals in terms of the CONSORT items. The reporting of published dissertations was better than that in journal publications regarding both the CONSORT and ITCWM-specific items.ConclusionAlthough the 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.

【 授权许可】

CC BY   
© The Author(s) 2023

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