TY - JOUR
T1 - Reporting quality of randomized controlled trials of angina pectoris with integrated traditional Chinese and western medicine interventions: a cross-sectional study
AU - Deng, Jiashuai
AU - He, Juan
AU - Wang, Juan
AU - Cheng, Chung Wah
AU - Jiao, Yalin
AU - Wang, Nana
AU - Li, Ji
AU - Wang, Ping
AU - Han, Fei
AU - Lyu, Aiping
AU - Bian, Zhaoxiang
AU - Zhang, Xuan
N1 - Funding Information:
The authors thank all the financial supports from Chinese Medicine Development Fund, Hong Kong, China (20B2/027A); and China Center for Evidence Based Traditional Chinese Medicine, CCEBTM (2020YJSZX-5).
Funding Information:
This work is supported by Chinese Medicine Development Fund, Hong Kong, China (20B2/027A); and China Center for Evidence Based Traditional Chinese Medicine, CCEBTM (2020YJSZX-5). The funders had no role in the design of study, in the collection, analysis, and interpretation of data, nor in the writing of the manuscript.
Publisher Copyright:
© 2023, The Author(s).
PY - 2023/5/23
Y1 - 2023/5/23
N2 - 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 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. Methods: Through 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. Results: A 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. Conclusion: Although 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.
AB - 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 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. Methods: Through 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. Results: A 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. Conclusion: Although 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.
KW - Angina pectoris (AP)
KW - CONSORT guideline
KW - Integrated traditional Chinese and western medicine (ITCWM)
KW - Randomized controlled trials (RCTs)
KW - Reporting quality
UR - http://www.scopus.com/inward/record.url?scp=85159967015&partnerID=8YFLogxK
U2 - 10.1186/s12874-023-01953-1
DO - 10.1186/s12874-023-01953-1
M3 - Journal article
C2 - 37221472
SN - 1471-2288
VL - 23
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
IS - 1
M1 - 124
ER -
