Developing a Core outcome set of Traditional Chinese Medicine on Chronic Heart Failure

Chronic heart failure (CHF) is a serious and advanced stage of various cardiovascular diseases and portends poor prognosis. The prevalence of CHF is rising with the aging population and changes in lifestyle habits. China has an incidence rate of approximately 0.9% in HF, with 500,000 new HF patients being diagnosed every year and the mortality of CHF in five years is as high as 60% - 80%. Traditional Chinese Medicine (TCM) is commonly used for treating CHF in China, improving clinical symptoms and health status on the premise of long-term survival. 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. Developing a COS can help to overcome poor methodological quality present in clinical trials especially in the field of TCM.This research aims to establish COS for clinical trials of CHF in TCM.

Following the development of a COS, the next step is to select OMIs for outcomes included in a COS. Traditional Chinese Medicine (TCM) is commonly used for treating CHF in China and has achieved improvement of clinical symptoms and health status on the premise of long-term survival. Hence, the aim of this study is to develop OMIs for a COS of TCM on chronic heart failure (CHF).

Contributors

Principal investigator:
Junhua Zhang,Mingyan Zhang,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China
Other contributors:
Hui ZI CHUA,Kai Li,Bohan Niu,Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine,Tianjin,China

Further Study Information

Current Stage: Ongoing
Date: January 2020 - December 2021
Funding source(s): National Natural Science Foundation of China(No.81904056)


Health Area

Disease Category: Heart & circulation

Disease Name: Chronic heart failure

Target Population

Age Range: 0 - 120

Sex: Either

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

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (caregivers)
- Consumers (patients)
- Journal editors
- Methodologists
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)

Method(s)

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

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


(5)Systematic literature reviews to find existing OMIs
(6)Quality assessment of OMIs to rate each OMI
(7)Two rounds Delphi study to select OMIs for consensus meeting
(8)Consensus meeting to select final OMIs for COS of TCM on CHF

Linked Studies