Development of a core outcome set on traditional Chinese medicine (COS-TCM) for rheumatic heart disease (RHD): study protocol

Abstract

ABSTRACTIntroductionRheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents globally. Clinical trials on RHD treatment with traditional Chinese medicine (TCM) are gradually increasing in China. However, because clinical trials are heterogeneous and report outcomes selectively, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, diminishes the value of clinical trials, and results in a waste of research resources. Therefore, there is an urgent need to develop a core outcome set of traditional Chinese medicine for rheumatic heart disease (COS-TCM-RHD). This study will report the protocol development process for COS-TCM-RHD.Methods and analysisA multidisciplinary Steering Committee will lead the development of this protocol through four stages (1). Establishing a comprehensive and systematic outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centers, patient’s semi-structured interviews, and clinician’s questionnaire surveys; (2). Screen stakeholder groups from various fields to participate in the Delphi survey; (3). Two rounds of 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 disseminationEthical approval has been granted by the Tianjin university of Traditional Chinese Medicine Ethics Committee. The findings will be published in peer-reviewed journals and the website of Chinese Clinical Trials for Core Outcome Set.Trial registrationThis study protocol has been prospectively registered with the Core Outcome Measures in Effectiveness Trials (COMET):http://www.comet-initiative.org/Studies/Details/1743.Strengths and limitations of this study▪This protocol is the first core outcomes set registered on the Core Outcome Measures in Effectiveness Trials (COMET) website for the treatment of rheumatic heart disease by Traditional Chinese medicine.▪This study is guided by the Core Outcome Set-STAndards for Development and Core Outcome Set-Standardized Protocol Items, with recommendations of the COMET.▪A multidisciplinary Steering Committee will supervise this research, and stakeholders from different fields including clinicians, patients, methodologists, and COS developers will be engaged.▪Systematic reviews, qualitative research (patient’s semi-structured interviews and clinician’s questionnaire surveys), Delphi surveys, and consensus meetings will be used for core outcome set development.▪Traditional Chinese medicine is mainly used in China. Thus, the geographical distribution of stakeholders will be a limitation.