TY - JOUR
T1 - WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020
T2 - recommendations, explanation, and elaboration
AU - Zhang, Xuan
AU - Lan, Liang
AU - Chan, Jacky C. P.
AU - Zhong, Linda L. D.
AU - Cheng, Chung Wah
AU - Lam, Wai Ching
AU - Tian, Ran
AU - Zhao, Chen
AU - Wu, Tai Xiang
AU - Shang, Hong Cai
AU - Lyu, Ai Ping
AU - Bian, Zhao Xiang
N1 - Funding Information:
This work was supported by the FSFT Foundation, Hong Kong, SAR, China; and National Natural Science Foundation of China (No. 81704198). The funding bodies had no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.
Publisher copyright:
Copyright © 2020, The Author(s)
PY - 2020/7/17
Y1 - 2020/7/17
N2 - Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy.Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization.Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated.Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.
AB - Background: Although the WHO Trial Registration Data Set (TRDS) has been published for many years, the quality of clinical trial registrations with traditional Chinese medicine (TCM) is still not satisfactory, especially about the inadequate reporting on TCM interventions. The development of the WHO TRDS for TCM Extension 2020 (WHO TRDS-TCM 2020) aims to address this inadequacy.Methods: A group of clinical experts, methodologists, epidemiologists, and editors has developed this WHO TRDS-TCM 2020 through a comprehensive process, including the baseline survey, draft of the initial items, three-round of Delphi survey, solicitation of comments, revision, and finalization.Results: The WHO TRDS-TCM 2020 statement extends the latest version (V.1.3.1) of TRDS published in November 2017. The checklist includes 11 extended items (including subitems), namely Source(s) of Monetary or Material Support (Item 4), Scientific Title (Item 10a and 10b), Countries of Recruitment (Item 11), Health Condition(s) or Problem(s) Studied (Item 12), Intervention(s) (Item 13a, 13b and 13c), Key Inclusion and Exclusion Criteria (Item 14), Primary and Key Secondary Outcomes (Item 19 to 20), and Lay Summary (Item B1). For Item 13 (Interventions), three common TCM interventions--i.e., Chinese herbal medicine formulas, acupuncture and moxibustion—are elaborated.Conclusions: The group hopes that the WHO TRDS-TCM 2020 can improve the reporting quality and transparency of TCM trial registrations, assist registries in assessing the registration quality of TCM trials, and help readers understand TCM trial design.
KW - Chinese medicine
KW - Clinical trial registration
KW - Recommendation
KW - Trial registration data set (TRDS)
KW - World Health Organization (WHO)
UR - http://www.scopus.com/inward/record.url?scp=85088212942&partnerID=8YFLogxK
U2 - 10.1186/s12874-020-01077-w
DO - 10.1186/s12874-020-01077-w
M3 - Journal article
C2 - 32680474
AN - SCOPUS:85088212942
SN - 1471-2288
VL - 20
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
IS - 1
M1 - 192
ER -