Background: An 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/design: The 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.
Discussion: The 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.
Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2904-0
Qiu R., Sun Y., Han S., He T., Zhong C., Guan M., Hu J., Li M., Chen J.,Shang H.
Disease Category: Heart & circulation
Disease Name: Atrial fibrillation
Age Range: 18 - 75
Sex: Either
Nature of Intervention: Traditional Chinese Medicine, Complementary and alternative medicine (CAM) therapy
- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Delphi process
- Interview
- Systematic review
First, we conduct a systematic review to screen the range of potentially important outcomes. Steering Committee will confirm preliminary checklist of items for inclusion in the COS. Second, we will conduct two-round Delphi study to gain consensus opinion on items to be considered in the COS. Meanwhile, we will conduct semi-structured interviews with patients to acquire their value. Third, we will invite 25 experts to attend a face-to-face consensus meeting. The results of Delphi study and semi-structured interviews will be submitted to consensus meeting and discussed.
The experts will identify the main items which should be included in the COS.
After finishing the COS, we will find existing measurement instruments (OMIs) for the outcomes in COS and develope a list. Then the quality of OMIs will be assessed by COSMIN checklist. In the end, we will develop recommendations for OMIs which
should be used in the COS in consensus meeting.