Background:Heterogeneous outcome reporting is common in clinical trials of cardiac rehabilitation, so that some clinical trials cannot be included in systematic review. Developing a core outcome set (COS) may solve the problem. In this research, a COS of cardiac rehabilitation (CR) for clinical trials of acute myocardial infarction will be developed.
After searching the COMET database, we found that there is only one COS for myocardial infarction, the scope of the COS is for clinical trials of traditional Chinese medicine. No COS for CR in acute myocardial infarction.
Methods:First, we will develop a preliminary list of outcomes through systematic review. Second, patients’ semi-structured interviews will be carried out to add potential new outcomes. Third, two rounds of Delphi survey will be developed in different stakeholders, such as clinicians, researchers, and methodologist. Forth, patient survey with plain language will be conducted. Fifth, an in person consensus meeting will be held to develop the final COS.
Discussion:This COS will provide a standardized set of outcomes that should be measured and reported in clinical trials of CR for acute myocardial infarction. How to measure the core outcomes will be developed in the next stage.
Hongcai Shang and Jun Xia are the principal investigators.
Hongcai Shang: Dongzhimen Hospital, Beijing University of Chinese Medicine
Jun Xia, University of Nottingham
Other investigator: Ruijin Qiu, Dongzhimen Hospital, Beijing University of Chinese Medicine
Disease Category: Heart & circulation
Disease Name: Myocardial infarction
Age Range: 18 - 80
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers
- COS for clinical trials or clinical research
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Systematic review
We plan to approach this via a mixed methods approach using a focus group, systematic reviews, interviews, Delphi survey and consensus meeting. Initially, we will determine the scope of the core outcome set for the efficacy evaluation of traditional non-pharmacological therapies on cardiac rehabilitation through a focus group with cardiologists, researchers, patients and policy makers. Then an initial long list of outcomes will be developed through a systematic review and will be refined through further semi-structured interviews with patients and clinicians. The refinement process will be facilitated via a Delphi survey and consensus meeting. Once the core outcome set is finalised, a systematic review will be conducted to evaluate the performance of the available outcome measurement instruments for these outcomes. Informed by the evaluation and through a consensus process, the core outcome measurement instruments set will be developed for each individual core outcome. Using the core outcome set will improve consistency of outcome reporting and outcome measurement instruments used in all relevant clinical trials in future, hence improve data consistency and reduce research waste.