Background: An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of myocardial infarction (MI) in China. However, the heterogeneity of outcomes and outcome measurement instruments has produced little evidence for traditional Chinese medicine in treating MI because many trials cannot be included in a meta-analysis. So it is important to develop a core outcome set (COS).
Methods/design: The method of the study will include eight stages led by a national multidisciplinary Steering Committee: (1) A systematic review will be developed to identify currently reported outcomes and traditional Chinese medicine syndromes in clinical trials of MI
(2) Semi-structured interviews of patients will be conducted to fill gaps in potential outcomes
(3) Traditional Chinese medicine syndrome names will be identified from medical records and systematic review,
(4) A dataset of traditional Chinese medicine syndrome names will be developed
(5) The investigation of traditional Chinese medicine syndromes will be conducted from cross-sectional study
(6) Two rounds of Delphi surveys will be carried out
(7) A consensus meeting will be conducted to develop a COS
(8) Recommendations of outcome measurement instruments (OMIs), which should be used in the COS, will be developed.
Discussion: The COS will improve the consistency of outcome reporting and reduce the reporting bias in MI for clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials.
Ruijin Qiu and Hongcai Shang are the principal investigators.
Songjie Han, Tianmai He, Changming Zhong
Dongzhimen Hospital, Beijing University of Chinese Medicine
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Systematic review
We will conduct a systematic review to develop an outcome list. We will interview patients to fill the gaps of outcome. A cross-sectional study will be conducted to investigate the traditional Chinese medicine syndrome of the patients. Then two rounds of Delphi process and a consensus meeting will be conducted to develop a COS.
A systematic review will be conducted to identify the potential outcome measurement instruments (OMIs) for every outcomes that included in the COS. The COSMIN checklist will be used to assess the quality of the OMIs. Then two rounds of Delphi process and a consensus meeting will be conducted to develop a core OMIs set that can be used to measure the core outcome.