Abstract
BackgroundAn increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China. However, the heterogeneity of outcomes and outcome measurement instruments has produced little evidence for traditional Chinese medicine in treating NVAF because many trials cannot be included in a meta-analysis. The majority of the trials did not report endpoint outcomes, side effects or other important outcomes for patients, which makes it difficult to evaluate the efficacy and safety of traditional Chinese medicine. Therefore, it is important to develop a core outcome set (COS). Although there are two related COSs for clinical trials of atrial fibrillation, the methodology is limited, and the perspectives of Chinese experts and patients are unclear. Therefore, we will develop a COS and recommend outcome measurement instruments after finishing the COS, which can be used for clinical trials of traditional Chinese medicine in NVAF.Methods/designThe 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 NVAF, (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, (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, and (8) Recommendations of outcome measurement instruments (OMIs), which should be used in the COS, will be developed.DiscussionThe COS will improve the consistency of outcome reporting and reduce the reporting bias in NVAF clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials.Trial registrationThis study is not a clinical trial, so it is registered in Core Outcome Measures in Effectiveness Trials Initiative (COMET). Registration number: 941. Registered on 22 December 2016.
Highlights
An increasing number of clinical trials of traditional Chinese medicine are being conducted in the treatment of non-valvular atrial fibrillation (NVAF) in China
The core outcome set (COS) will improve the consistency of outcome reporting and reduce the reporting bias in NVAF clinical trials of traditional Chinese medicine to improve the value of traditional Chinese medicine clinical trials
(2) All of the clinicians should work in tertiary hospitals (3) There is no restriction in locations of the cities for clinicians and nurses (4) The clinicians and nurses should have a junior professional title or above that (5) Researchers as corresponding authors or co-authors should have published at least one article on clinical trials for NVAF in any field
Summary
There are many problems in outcomes’ reporting of clinical trials of traditional Chinese medicine. It is very important to develop a standardized and minimum outcome set, which can achieve consensus by different stakeholders so that it can be applied in clinical trials and systematic reviews to help translate the results into high-quality evidence. Many patients prefer to undergo traditional Chinese medicine treatment or integrative medicine treatment, and a large number of clinical trials are currently being conducted for the treatment of NVAF. ML, XZ, SC, and CL participated in the design of the study, and contributed to the final manuscript. Ethics approval and consent to participate Ethical approval for the entire project has been granted by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine (DZMEC-KY-201781). Informed consent will be obtained from patients who will attend the semi-structured interviews and the cross-sectional study. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
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