Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
Center for Evidence-Based and Translational Medicine, wuhan daxue zhongnan yiyuan, Wuhan, Hubei, China.
BMJ Open. 2024 Jun 10;14(6):e083633. doi: 10.1136/bmjopen-2023-083633.
Heterogeneous outcome reporting is common in clinical trials focused on cardiac rehabilitation for myocardial infarction (MI); this practice often results in the exclusion of data from clinical trials in systematic reviews. Developing a core outcome set (COS) may solve this problem.
We will first identify a preliminary list of outcomes through a systematic review. Next, we will conduct semistructured interviews with patients to explore additional potential outcomes deemed important by patients. Then, we will engage various stakeholders such as clinicians, researchers and methodologists in two Delphi survey tends to refine and prioritise the identified outcomes. Subsequently, we will gather insights directly from patients with MI by administering plain language patient surveys; patients will be involved in questionnaire development. Finally, we will hold two face-to-face consensus meetings for patients and other stakeholders to develop the final COS for cardiac rehabilitation in MI.
The Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine approved this study (2022DZMEC-349). The final COS will be published in a peer-reviewed journal and disseminated in conferences.
We registered this study in the Core Outcome Measures in Effectiveness Trials Initiative (COMET) platform.
1725 (http://www.comet-initiative.org/studies/details/1725).
针对心肌梗死（MI）心脏康复的临床试验中，结果报告存在异质性的情况较为常见；这种做法往往会导致系统评价中排除临床试验数据。制定核心结局集（COS）可能会解决这个问题。
我们将首先通过系统评价确定一个初步的结局清单。接下来，我们将对患者进行半结构式访谈，以探讨患者认为重要的其他潜在结局。然后，我们将让临床医生、研究人员和方法学家等各种利益相关者参与两轮 Delphi 调查，以完善和优先考虑已确定的结局。随后，我们将通过向 MI 患者发放通俗易懂的患者调查问卷，直接从患者那里收集见解；患者将参与问卷的制定。最后，我们将举行两次 MI 心脏康复患者和其他利益相关者的面对面共识会议，以制定最终的 COS。
北京中医药大学东直门医院伦理委员会批准了这项研究（2022DZMEC-349）。最终的 COS 将发表在同行评议的期刊上，并在会议上传播。
我们在核心结局测量有效性试验倡议（COMET）平台上注册了这项研究。
