为心肌梗塞患者的心脏康复制定一个核心结局:研究方案
Zhiyue Guan1, Xinyi Zhang1, Yinghui Jin2
1Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.
BMJ open
|June 10, 2024
概括
开发心肌梗塞 (MI) 后心脏康复的核心结果集 (COS) 将标准化报告并改进系统审查. 本研究旨在创建一个共识驱动的COS,涉及患者和利益相关者.
科学领域:
- 心脏病学 心脏病学
- 康复医学 康复医学 康复医学
- 临床试验方法论 临床试验方法论
背景情况:
- 对心肌梗塞 (MI) 的心脏康复试验中异质的结果报告阻碍了系统审查.
- 标准化结果报告对于综合证据和改善患者护理至关重要.
- 一个核心结果集 (COS) 可以解决试验数据收集和报告中的不一致性.
研究的目的:
- 为心肌梗塞 (MI) 后的心脏康复制定基于共识的核心结果集 (COS).
- 确保在COS开发过程中优先考虑以患者为中心的结果.
- 提高该领域临床试验的质量和可比性.
主要方法:
- 系统的文献审查以确定初步结果.
- 半结构化的患者访谈,以捕捉患者重要的结果.
- 两轮的Delphi调查与各种利益相关者 (临床医生,研究人员,方法学家) 进行.
- 使用普通语言问卷调查的患者调查.
- 面对面的共识会议以最终确定COS.
主要成果:
- 通过系统审查和患者采访,将确定初步的结果列表.
- 通过德尔菲调查和面对面会议,将通过利益相关者达成共识.
- 最终的COS将代表一个优先级和商定的MI心脏康复结果集.
结论:
- 开发的COS将标准化心肌梗塞心脏康复的结果报告.
- 这将促进更强大的系统审查和证据综合.
- 该研究促进了以患者为中心的研究,并提高了试验数据的临床实用性.
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