Developing a core outcome set of using Traditional Chinese Medicine (TCM) in clinical trials on rheumatic heart disease

Rheumatic heart disease (RHD) is a chronic valvular disease caused by heart valve damage from severe or repetitive episodes of acute rheumatic fever (ARF). In low- and middle-income countries, RHD remains a major public health concern owing to issues of overcrowding, poor hygiene, and low adherence to secondary prophylaxis. It is also the cause of most of the cardiovascular mortality in young people, leading to about 250,000 deaths per year worldwide. Traditional Chinese Medicine (TCM) can improve clinical symptoms and health status on the premise of long-term survival. TCM related clinical trials have been on the rise annually. However, the heterogeneous reporting of outcomes in these clinical trials lack consistency and transparency, making it difficult to compare the effectiveness of various trials during meta-analysis synthesis. Furthermore, there exist a risk of selective outcome reporting bias in these clinical trials. Therefore, it is necessary and urgent to establish a core outcome set (COS) on TCM for chronic pulmonary heart disease.

Contributors

Principal investigator:
Junhua Zhang, Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China

Other contributors:
Mingyan Zhang, Bohan Niu, Xiaodi Sheng, Hui ZI CHUA, Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, China

Further Study Information

Current Stage: Ongoing
Date: January 2021 - December 2022
Funding source(s):


Health Area

Disease Category: Heart & circulation

Disease Name: Heart disease

Target Population

Age Range: 1 - 90

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Literature review
- Nominal group technique (NGT)

(1) Systematic literature review
(2) Qualitative semi-structured interview
(3) Two rounds Delphi Survey
(4) Consensus conference