Coronary heart disease (CHD) is the leading cause of cardiovascular disease-related deaths worldwide. The prevalence of coronary heart disease in China is on a continuous rise, and the readmission rate and long-term mortality rate of patients after discharge remain high. Home-based cardiac rehabilitation (HBCR), as a safe and convenient intervention method, can effectively improve patients' exercise capacity, reduce the risk of recurrence of cardiovascular events, and enhance patients' quality of life.
The existing ICHOM Core Outcome Set (COS; https://www.comet-initiative.org/Studies/Details/846) is applicable to all patients with coronary artery disease and is not restricted by the rehabilitation environment. In contrast, this study focuses on CHD patients receiving home-based exercise rehabilitation, with clear targeting. It should be clarified that there are significant differences in the implementation models of home-based exercise rehabilitation among different countries: in developed countries with sufficient medical resources, cardiac rehabilitation is mostly carried out in professional cardiac rehabilitation centers; however, the number of cardiac rehabilitation centers in China is relatively scarce, and home has become the main rehabilitation scene for patients. This situation is also common in other developing and underdeveloped countries, making this study more in line with the actual clinical needs of such regions.
At present, clinical trials related to home-based exercise rehabilitation for coronary heart disease generally have problems such as inconsistent outcome reporting, high heterogeneity, and insufficient attention to patients' core needs, which make it difficult to integrate and analyze research data and directly affect the quality of evidence and the scientificity of clinical decision-making. As a standardized set of outcome reports for clinical trials in specific medical fields, the Core Outcome Set (COS) can effectively address the above pain points. This study emphasizes the overall rehabilitation of patients, covering multiple dimensions including physical, psychological, social, and spiritual aspects. On the basis of drawing on existing studies, it focuses on the outcome indicators corresponding to intervention measures.
This study aims to develop a Core Outcome Set for Home-Based Cardiac Rehabilitation in Coronary Heart Disease Patients (COS-HBCR-CHD). By formulating a standardized core outcome set, it will standardize the outcome measurement and reporting processes of clinical trials on home-based exercise rehabilitation for coronary heart disease, reduce the arbitrariness in the selection of outcome indicators, thereby improving the quality assessment level of clinical trials, providing effective support for data integration in studies related to home-based exercise rehabilitation for coronary heart disease, and facilitating the optimization of clinical decision-making.
Hongwei Sun¹, Ruopei Liu¹, Shuo Liang¹,Yanmei Gu¹
1 Hebei University of Chinese Medicine
Disease Category: Heart & circulation
Disease Name: Coronary heart disease (CHD)
Age Range: 18 - 80
Sex: Either
Nature of Intervention: Exercise, Rehabilitation
- Clinical experts
- Journal editors
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus meeting
- Delphi process
- Interview
- Literature review
- Survey
- Systematic review
This study will be conducted in five phases in accordance with the Core Outcomes Set Standardized Protocol (COS-STAP) statement and the COMET initiative guidelines. Outcome Pool Construction: A comprehensive outcome pool will be established through systematic review of randomized controlled trials (RCTs) related to home-based exercise rehabilitation for coronary heart disease (CHD), retrieval from two clinical research registries, semi-structured interviews with patients, and clinical healthcare worker questionnaires. Outcome Consolidation and Classification: All outcomes in the pool will be categorized into different domains based on the COMET recommended classification system and the characteristics of home-based exercise rehabilitation. Preliminary Outcome List Generation: A specific standard will be formulated based on the size of the outcome pool to generate a preliminary outcome list for the Delphi survey. Two Rounds of Delphi Survey: Multiple stakeholders will be invited to participate in two rounds of Delphi surveys, where the importance of outcomes will be assessed using a 9-point scale, and the list will be refined with open-ended feedback. Consensus Meeting: Unresolved outcomes will be discussed in face-to-face meetings to ultimately determine the core outcome set and recommended measurement time points.