WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020: recommendations, explanation, and elaboration

Abstract

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.

Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

“…First, our last search was in early 2020, which might not cover all the TCM CTs for COVID-19. Second, WHO Trial Registration Data Set (TRDS) extension for traditional Chinese medicine 2020 has been published recently and it includes more items specific to TCM (Supplementary material 2 ) [ 32 ]. Future studies should update the search and use the TRDS-TCM for the registration quality assessment.…”

The effect of Baduanjin Qigong combined with five-elements music on anxiety and quality of sleep in asymptomatic patients with COVID-19 infection: A randomised controlled trial

“…TCM was used in the prevention and treatment process at the beginning of the spread of the COVID-19, and has achieved good results [ 28 ]. The World Health Organization (WHO) affirmed the effectiveness and safety of TCM in the treatment of COVID-19 infection but more rigorous clinical evidence was needed [ 29 ]. Baduanjin Qigong is a traditional Chinese mind-body exercise routine, characterized by slow, coordinative, and sequential movements [ 30 ].…”

Journal Club

“…All major methodological recommendations for enhancing the reporting quality of controlled rando-mised trials, such as the CONSORT checklist [6,7], have been adapted to the different TCM methods such as acupuncture (STRICTA), moxibustion and the Chinese medicines (Chinese Herbal Medicine Formulas) [8][9][10][11][12][13][14][15][16]. There are also current recommendations for the registration of TCM studies with the WHO-ICTRP on how TCM studies can be better described in terms of their TCMspecific information, in order to achieve more quality and transparency [17]. For example, the current 2020 checklist for registration with the WHO TRDS platform contains a total of 11 items for TCM studies, which also take into account "TCM patterns" (e.g.…”

“…qi deficiency pattern, qi stagnation pattern) and detailed descriptions of TCM interventions for the various forms of acupuncture, moxibustion and traditional Chinese medicines (decoctions, pills, powders, granules, capsules, etc.) [17,18].…”