Developing a Core Outcome Set for Traditional Chinese Medicine for Stable Angina Pectoris

Angina pectoris was a condition due to the imbalance between the demand and consumption of myocardial oxygen. Its prevalence increases with age in both sexes, from 2% to 5% in men aged 45 to 54 years, to 11% to 20% in those aged 65 to 74 years. Angina causes an important limitation of everyday activities and impairs quality of life. Currently, nitrates, beta-blockers, ACEI and ARB have been the mainstay of medical therapy of SAP. Platelet antagonists are also commonly used drugs. Traditional Chinese Medicines are commonly used for treating SAP in China. However, there is still lack of hard evidence due to the methodological problems, especially lack of objective and acknowledged outcome measures. Developing core outcome set for clinical trials of Traditional Chinese Medicine is necessary and urgent task. This research aims to establish a core outcome set for clinical trials of SAP in traditional Chinese medicine.

Contributors

Junhua Zhang is the principal investigator, Dongmei Xing, Evidence-Based Medicine Center,Tianjin University of Traditional Chinese Medicine.

Hongcai Shang, Evidence Base Medicine Center, Tianjin university of Traditional Chinese Medicine, Tianjin, China.

Further Study Information

Current Stage: Completed – pending publication
Date: January 2014 - January 2016
Funding source(s): None


Health Area

Disease Category: Heart & circulation

Disease Name: Angina (stable angina pectoris)

Target Population

Age Range: 18 - 75

Sex: Either

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

Stakeholders Involved

- Academic research representatives
- Epidemiologists
- Patient/ support group representatives
- Researchers
- Statisticians

Study Type

- COS for clinical trials or clinical research

Method(s)

- Delphi process
- Systematic review

Outcome measures used in clinical trial of SAP will be retrieved by systematic reviews. All included outcomes will be ascribed into four domains: patient, clinicians, academics and regulator. Participants will be asked to rate how important they think each SAP domain is from 1-9. Responses will be analyzed and the SAP domains with the top average ratings will then be sent to all the participants again in Questionnaire 2. A summary of the average group ratings for each SAP domain will also be sent to participants, and they will be given the opportunity to keep their answers the same, or change them, based on the group feedback. In the third questionnaire, participants will be asked to decide for each SAP domain whether it should be included in the final core outcome set.

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