Selecting appropriate outcomes is crucial for enhancing the comparability and relevance to clinical trials, yet uptake of core outcome sets (COS) remains low. This study aims to develop a framework to improve the quality and value of outcome selection in cardiovascular disease research. The FAVOUR framework is intended to assist clinical trialists in selecting meaningful and feasible outcomes and to support COS developers in creating more implementable and patient-centered outcome sets
ContributorsRuijin Qiu,Shuangqiu Wang, Changhe Yu ,Chen Zhao, Zhiyue Guan, Siyi Li,
Yinghui Jin Min Li,Shuling Liu, Shiguang Chai, Hong Chen,Zhuo Chen, Hongcai Shang
Disease Category: Heart & circulation
Disease Name: Acute heart failure, Angina (stable angina pectoris), Atrial fibrillation, Hypertension, Myocardial infarction
Age Range: 18 - 90
Sex: Either
Nature of Intervention: N/A
- Clinical experts
- Methodologists
- Patient/ support group representatives
- Researchers
- COS methods research
- Consensus meeting
- Delphi process
- Interview
- Systematic review
The method of systematic reviews, semi-structured interviews, two-round Delphi survey, and consensus meeting will be used.
In the first phase, we will conduct a systematic review.
In the second phase, interviews will be carried out to identify the rationale and values of outcome selection for patients and healthcare professionals.
In the third phase, the results from the first and second phases will be presented in a Delphi survey, and the importance of each item through ranked.
In the fourth phase, an consensus meeting will be conducted to develop the final framework to improve the quAlity and Value of choosing OUtcomes in cardiovascular disease Research (FAVOUR).