Development of a core outcome set (COS) and selecting outcome measurement instruments (OMIs) for non-valvular atrial fibrillation in traditional Chinese medicine clinical trials: study protocol

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2904-0) contains supplementary material, which is available to authorized users.

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

“…In our previous review, we found that TCM syndrome names are nonstandard, so that it is difficult to assess the efficacy of TCM syndromes 18. Therefore, we proposed a method to solve the problem in the development of COS,19 and it has been used in our previous research 9…”

“…To collect data on the symptoms and signs of patients, an information sheet for the four methods of diagnosis will be developed. We will develop the sheet of information with the method that has been used in our previous research 9…”

“…In round 1 of the Delphi survey, we will collect participants’ demographic information. We will use a 9-point scoring system, which has been used in the development of COSs 9 20. Participants will have the opportunity to score the importance for all of the outcomes in the questionnaires.…”

“…The consensus definition is given in table 6. We define the consensus according to previous COS research 9 21…”

“…In this study, we will use mixed-methods research to develop a COS that includes TCM core syndrome for MI to determine what outcomes to measure and when to measure them. The abovementioned methods have been used in the development of a COS for non-valvular atrial fibrillation in clinical trials of TCM 9…”