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Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol
  1. Ruijin Qiu1,
  2. Changming Zhong1,
  3. Songjie Han1,
  4. Tianmai He1,
  5. Ya Huang1,
  6. Manke Guan1,
  7. Jiayuan Hu1,
  8. Min Li1,
  9. Yiyi Lin1,
  10. Jing Chen2,
  11. Hongcai Shang1
  1. 1Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
  2. 2Tianjin University of Traditional Chinese Medicine, Tianjin, China
  1. Correspondence to Hongcai Shang; shanghongcai{at}foxmail.com

Abstract

Introduction Myocardial infarction (MI) is the most dangerous complication in patients with coronary heart disease. In China, there is an increasing number of randomised controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating MI. However, the inconsistency of outcome reporting means that a large number of clinical trials cannot be included in systematic reviews to provide the best evidence for clinical practice. The aim of this study is to develop a core outcome set (COS) for future TCM clinical trials of MI, which may improve the consistency of outcome reporting and facilitate the synthesis of data across studies in systematic reviews.

Methods and analysis We will conduct a systematic review of MI clinical trials with any intervention. Semistructured interviews will be conducted to obtain the perspectives of patients with MI. The outcomes from the systematic review and semistructured interviews will be grouped and used to develop a questionnaire. The questionnaire will be developed as a supplement for the TCM syndromes of MI and will be constructed from the results of a systematic review, existing medical records and a cross-sectional study. Then two rounds of the Delphi survey will be conducted with different stakeholders (TCM experts and Western medicine experts in cardiovascular disease, methodologists, magazine editors and patients) to determine the importance of the outcomes. Only the TCM experts will need to response to the questionnaire for core TCM syndromes. A face-to-face consensus meeting will be conducted to create a final COS and recommend measurement time for each outcome.

Ethics and dissemination This project has been approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine. The final COS will be published and freely available.

Trial registration number This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1243 (available at: http://www.comet-initiative.org/studies/details/1243).

  • myocardial infarction
  • protocols and guidelines
  • change management

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Footnotes

  • Contributors RQ, JC and HS conceived the project, and RQ and HS were the principal investigators of the study. CZ, JH and ML are responsible for conducting the systematic review, and RQ, SH, YH, MG, YL and TH are responsible for the management of the clinical research. JC and HS provided supervision for all aspects of the project. RQ wrote the protocol and manuscript and commented on the drafts of this manuscript. All authors have read and approved the manuscript.

  • Funding This work was supported by the National Key R&D Program of China (2017YFC1700400, 2017YFC1700402) and the Fundamental Research Funds for the Central Universities (2019-JYB-JS-033).

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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