Protocol for the development of a reporting guideline for clinical trials with integrated Chinese and western medicine interventions: the CONSORT extension for ICWM

Juan Wang; Xuan Zhang; Ping Wang; Fei Han; Ji Li; Yanfang Ma; Aiping Lyu; Zhaoxiang Bian

doi:10.3389/fmed.2023.1190560

Protocol for the development of a reporting guideline for clinical trials with integrated Chinese and western medicine interventions: the CONSORT extension for ICWM

Front Med (Lausanne). 2023 Jun 29:10:1190560. doi: 10.3389/fmed.2023.1190560. eCollection 2023.

Authors

Juan Wang¹, Xuan Zhang^{1

2}, Ping Wang³, Fei Han⁴, Ji Li⁴, Yanfang Ma¹, Aiping Lyu¹, Zhaoxiang Bian^{1

2}

Affiliations

¹ Chinese EQUATOR Centre, Chinese Clinical Trial Registry (Hong Kong), Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong SAR, China.
² Centre for Chinese Herbal Medicine Drug Development, Hong Kong Baptist University, Kowloon, Hong Kong SAR, China.
³ Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
⁴ Department of Pediatrics, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, China.

Abstract

Background: While Integrated Chinese and Western Medicine (ICWM) has become widely accepted as a necessary intervention for treating various diseases, key information about ICWM interventions is often missing in published clinical trials. To facilitate complete, transparent, and consistent reporting of clinical trials with ICWM interventions, an extension of the CONSORT guideline is necessary to be developed: the CONSORT-ICWM guideline.

Methods: The CONSORT-ICWM guideline will be developed in five stages in accordance with recommendations for the development of reporting guidelines from the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, including (1) project launch and registration; (2) literature review and checklist draft; (3) Delphi survey; (4) consensus meeting; and (5) finalization of the guideline. Additionally, the working group will be composed of professors with expertise in integrated medicines, traditional Chinese medicines, biomedical informatics, statistics, methodology, development of reporting guidelines, epidemiology, health economics, and paper publications.

Discussion: The CONSORT-ICWM guideline is to improve the reporting quality of clinical trials with ICWM interventions by ensuring the reports are complete, informative, clear, and transparent.

Keywords: CONSORT; Chinese medicine; Delphi survey; ICWM; reporting guideline.