Abstract
BackgroundAlthough 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.MethodsA 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.ResultsThe 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.ConclusionsThe 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.
Highlights
The World Health Organization (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
Since the first clinical trial of TCM was registered in ClinicalTrials.gov on 2 November 1999 [7], the number of TCM trial registrations has increased rapidly, especially after the requirement of mandatory trial registration proposed by the International Committee of Medical Journal Editors on 1 July 2005 [8, 9]
Development of WHO TRDS-TCM 2020 As the scope of this WHO TRDS-TCM 2020 statement belongs to the reporting guideline, we referred a consensusdriven methodological framework recommended by “Guidance for developers of health research reporting guidelines” [21], but modified some steps in the development of this registration data set
Summary
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. Since the first clinical trial of TCM was registered in ClinicalTrials.gov on 2 November 1999 [7], the number of TCM trial registrations has increased rapidly, especially after the requirement of mandatory trial registration proposed by the International Committee of Medical Journal Editors on 1 July 2005 [8, 9]. To standard the reporting of CTR, the WHO Trial Registration Data Set (TRDS) was issued in May 2007, specifying a minimum of 20 registration items as the international standards [10]. In November 2018, the TRDS was further explained as “International Standards for Clinical Trial Registries” and published, with explanations of 24 items and 3 optional items [12]
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