Introduction: Globally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine are gradually increasing in China. However, because the outcomes of clinical trials are subject to heterogeneity and selective reporting, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, and diminishing the value of clinical trials. Therefore, there is an urgent need to design a TCM or integrated medicine core outcome set (COS) for RHD.
Methods and analysis: The development of this study will take place in four stages under the direction of a multidisciplinary advisory board. (1) Establishing a comprehensive outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centres, patient's semistructured interviews, and clinician's questionnaire surveys; (2) Screen stakeholder groups from various fields to participate in the Delphi survey; (3) Two e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4) Hold a face-to-face consensus meeting to develop the COS-TCM-RHD.
Ethics and dissemination: The ethical approval for this study has been obtained from the Tianjin University of Traditional Chinese Medicine Ethics Committee (TJUTCM-EC20210008). The findings will be disseminated in peer-reviewed journals and meetings.
This study aims to determine which effectiveness and safety outcomes should be measured in TCM or integrated medicine clinical trials for RHD.
ContributorsXiaodi Sheng, Chao Chen, Zhaochen Ji, Haiyin Hu, Mingyan Zhang, Hui Wang, Bo Pang, Jingbo Zhai, Dong Zhang, Junhua Zhang, Liping Guo
Disease Category: Heart & circulation
Disease Name: Heart disease
Age Range: Unknown
Sex: Either
Nature of Intervention: Traditional Chinese Medicine
- COS for clinical trials or clinical research
- COS for practice