Development of a core outcome set for myocardial infarction in clinical trials of traditional Chinese medicine: a study protocol

Abstract

IntroductionMyocardial 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 analysisWe 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 disseminationThis 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 numberThis 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).

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“…Referring to the experience of semi-structured interviews in previous COS research, 34, 35 The sample size of patients in this study will be at least 40 cases. We will fully consider the patient’s gender, age, the stage of RHD, and the diversity of treatment history.…”

Development of a Core Outcome Set for the Benefits and Adverse Events of Acute Heart Failure in Clinical Trials of Traditional Chinese Medicine and Western Medicine: A Study Protocol

“…The questionnaire for round 1 of the Delphi survey will include all candidate outcomes in different outcome domains and scoring. A nine-point scoring system will be used in the questionnaire, wherein "1-3" indicates that the outcome is not important in the COS, "4-6" indicates that the outcome is important but not critical in the COS, and "7-9" indicates that the outcome is critical in the COS (23,26). Participants will also have the option to choose "unclear" for each outcome, if they find it difficult to score in terms of importance.…”