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, Chun Pong
AU - ZHONG, Lidan
AU - Cheng, Chung Wah
AU - Lam, Wai Ching
AU - Tian, Ran
AU - Zhao, Chen
AU - Wu, Tai Xiang
AU - Shang, Hong Cai
AU - LYU, Aiping
AU - BIAN, Zhaoxiang
N1 - Funding Information:
sources of funding for the trial, as this is essential information for readers assessing a trial. An increasing number of TCM clinical trials, especially CHM interventional trials, are funded by the pharmaceutical industry. Studies have shown that research sponsored by the pharmaceutical industry are more likely to produce results favoring the product made by the company sponsoring the research than studies funded by other sources [25]. The level of involvement by a funder and their influence on the design, conduct, analysis, and reporting of a trial varies. It is therefore important that the authors describe in detail the role of the funders [26]. For the records of trial registration, we suggest researchers to report whether any conflicts of interest will possibly exist between the funder and research. And we also want to point out that it is necessary to apply this requirement to all trial registration, not just for TCM.
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 - Article
C2 - 32680474
AN - SCOPUS:85088212942
VL - 20
JO - BMC Medical Research Methodology
JF - BMC Medical Research Methodology
SN - 1471-2288
IS - 1
M1 - 192
ER -