A core outcome set for clinical trials of Traditional Chinese Medicine in non-valvular atrial fibrillation

The morbidity of atrial fibrillation is about 0.65% in China. The patients with non-valvular atrial fibrillation account for 65.2%. An increasing number of trials had been conducted for Traditional Chinese Medicine (TCM) in treating non-valvular atrial fibrillation. However, the heterogeneous reporting of outcomes in these trials has hindered synthesizing the results in meta-analyses, which reduce the value of trials. Meanwhile, it may exist risk of selective outcome reporting bias in clinical trials. The development of a core outcome set (COS) that should be measured in all clinical trials for a specific health condition has been recommended. There is no standardized set of outcomes for non-valvular atrial fibrillation in China. So it is necessary to develop a COS for non-valvular atrial fibrillation in clinical trials of TCM.

Protocol: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2904-0


Hongcai Shang is the principal investigator, Ruijin Qiu,Xiaoyu Zhang, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China
Yaolong Chen, Lanzhou University, Lanzhou, China

Further Study Information

Current Stage: Ongoing
Date: January 2017 - August 2018
Funding source(s): National Natural Science Foundation of China (81430098)

Health Area

Disease Category: Heart & circulation

Disease Name: Atrial fibrillation

Target Population

Age Range: 18 - 75

Sex: Either

Nature of Intervention: Traditional Chinese Medicine, Complementary and alternative medicine (CAM) therapy

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Patient/ support group representatives
- Researchers

Study Type

- 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.

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