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Research article
Zhaoxiang Bian
Hong Kong Baptist University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6206-1958
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Medical Research Methodology.
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.
Trial registration: Not applicable.
Keywords
Clinical trial registration, Chinese medicine, Recommendation, Trial Registration Data Set (TRDS), World Health Organization (WHO)
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CURRENT STATUS: Published
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Posted 02 Jul, 2020
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On 17 Jul, 2020
No community comments so far
Editorial decision: Accept
On 08 Jul, 2020
Editor assigned
On 30 Jun, 2020
Submission checks complete
On 29 Jun, 2020
Editor invited
On 29 Jun, 2020
No comments provided
Submission checks complete
On 29 Jun, 2020
Editorial decision: Minor revision
On 29 Jun, 2020
No comments provided
Reviewer #1 agreed
On 24 Jun, 2020
Review #1 received
Received 24 Jun, 2020
Editorial decision: Minor revision
On 24 Jun, 2020
Reviewers invited
Invitations sent on 24 Jun, 2020
Editor assigned
On 22 Jun, 2020
Submission checks complete
On 21 Jun, 2020
Editor invited
On 21 Jun, 2020
No comments provided
Editorial decision: Major revision
On 12 Jun, 2020
Review #2 received
Received 02 Jun, 2020
Reviewer #2 agreed
On 25 Mar, 2020
Review #1 received
Received 16 Mar, 2020
Reviewer #1 agreed
On 02 Mar, 2020
Reviewers invited
Invitations sent on 17 Feb, 2020
Editor assigned
On 23 Jan, 2020
Submission checks complete
On 22 Jan, 2020
Editor invited
On 22 Jan, 2020
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Subject Areas
Health Economics & Outcomes Research
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This preprint is under consideration at BMC Medical Research Methodology. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Zhaoxiang Bian
Hong Kong Baptist University
Corresponding Author
ORCiD: https://orcid.org/0000-0001-6206-1958
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Version 4
Posted 02 Jul, 2020
Published
On 17 Jul, 2020
No community comments so far
Editorial decision: Accept
On 08 Jul, 2020
Editor assigned
On 30 Jun, 2020
Submission checks complete
On 29 Jun, 2020
Editor invited
On 29 Jun, 2020
No comments provided
Submission checks complete
On 29 Jun, 2020
Editorial decision: Minor revision
On 29 Jun, 2020
No comments provided
Reviewer #1 agreed
On 24 Jun, 2020
Review #1 received
Received 24 Jun, 2020
Editorial decision: Minor revision
On 24 Jun, 2020
Reviewers invited
Invitations sent on 24 Jun, 2020
Editor assigned
On 22 Jun, 2020
Submission checks complete
On 21 Jun, 2020
Editor invited
On 21 Jun, 2020
No comments provided
Editorial decision: Major revision
On 12 Jun, 2020
Review #2 received
Received 02 Jun, 2020
Reviewer #2 agreed
On 25 Mar, 2020
Review #1 received
Received 16 Mar, 2020
Reviewer #1 agreed
On 02 Mar, 2020
Reviewers invited
Invitations sent on 17 Feb, 2020
Editor assigned
On 23 Jan, 2020
Submission checks complete
On 22 Jan, 2020
Editor invited
On 22 Jan, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Health Economics & Outcomes Research
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Medical Research Methodology.
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.
Trial registration: Not applicable.
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