Key result
Protocol outlines methods to develop a core outcome set for traditional Chinese medicine in CHF.
Why the study?
Clinical trials evaluating traditional Chinese medicine for chronic heart failure have inconsistent and unclear outcome reporting, impeding data synthesis across studies.
This study protocol outlines the methodology for developing a core outcome set for traditional Chinese medicine in chronic heart failure to standardize reporting and reduce heterogeneity in future clinical trials.
May facilitate standardized TCM chronic HF trial reporting; leaves open heterogeneity reduction until core set is adopted.
INTRODUCTION: Chronic heart failure (CHF) is a serious and advanced stage of various cardiovascular diseases and portends poor prognosis. An increase in clinical studies has reported the effectiveness of traditional Chinese medicine (TCM). For example, intravenous Chinese medicine can significantly improve cardiac function and biomarkers in patients with CHF. However, there exists inconsistency, lack of practicality and unclear reporting of outcomes in these clinical trials causing difficulty in the comparison of results across similar studies during data synthesis. A core outcome set (COS) can help in the standardisation of outcomes reported across studies from the same healthcare area. The aim of this study is to develop a COS on TCM for CHF (COS-TCM-CHF) to reduce heterogeneity in reporting and improve quality assessment in clinical trials to support data synthesis in addressing the effectiveness of TCM treatment. METHODS AND ANALYSIS: This study will include constructing an outcome pool which will identify potential outcomes through systematic reviews of TCM randomised clinical trials, two clinical registry databases, semi-structured interviews of patients and the clinicians' questionnaire. According to the characteristics of TCM and a taxonomy recommended by the Core Outcome Measures in Effectiveness Trials (COMET) initiative, all outcomes in the outcome pool will be classified into different domains. A preliminary list of outcomes which will then be used in the Delphi survey is generated using a certain criteria based on the length of the pool. The Delphi survey will include two rounds with seven key stakeholder groups to select candidate items for a consensus meeting. A final COS-TCM-CHF will be developed at a face-to-face consensus meeting involving representatives from the different stakeholders. ETHICS AND DISSEMINATION: Ethical approval of this study has been granted by Evidence-based Medicine Centre of Tianjin University of Traditional Chinese Medicine Research Ethics Committee (TJUTCMEC201200002). We will disseminate our research findings of the final COS on the website of Chinese Clinical Trials for Core Outcome Set, with open access publications and present at international conferences to reach a wide range of knowledge users. TRIAL REGISTRATION NUMBER: http://www.comet-initiative.org/studies/details/1486.
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Zhang et al. (2021) studied Chronic heart failure. Core outcome set on traditional Chinese medicine (COS-TCM) was evaluated on Development of a core outcome set. This study protocol outlines the methodology for developing a core outcome set for traditional Chinese medicine in chronic heart failure using systematic reviews, interviews, and a Delphi survey.
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