慢性阻塞性肺病患者多种长期疾病的临床研究变量推导和定义:为修改的德尔菲方法和国际心血管和呼吸系统联盟代表的共识研究的议定书
Tobin Joseph1,2,3, Mohit Bhutani4, Amy Couper5,6
1Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
Pragmatic and observational research
|December 22, 2025
概括
本研究概述了一种方法来定义慢性阻塞性肺病 (COPD) 患者的关键临床变量,这些患者有多种健康状况. 其目标是改善临床研究报告和质量改善举措.
科学领域:
- 临床研究方法论 临床研究方法论
- 肺部病理学 肺部病理学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 标准化变量和定义对于可靠的临床研究和慢性阻塞性肺病 (COPD) 的质量改善至关重要.
- 本协议解决了在经历多病症或高风险的COPD患者中定义临床研究变量的需要.
- 建立一致的数据点对于推进COPD护理和研究至关重要.
研究的目的:
- 描述 COPD 多病症患者的临床研究变量推导和定义的理由和方法.
- 建立一个标准化的变量集,以便在COPD研究中进行一致的数据收集和报告.
- 促进更好的质量改进计划和COPD临床试验结果的改善.
主要方法:
- 一个由四个步骤组成的过程,涉及执行委员会,指导委员会和国际共识小组.
- 系统的文献审查,以确定和提出潜在的临床研究变量定义.
- 修改了Delphi流程,具有代投票和委员会之间的反,以在变量和定义上达成共识.
主要成果:
- 为COPD开发最终一套国际商定的,分层分类的临床研究变量.
- 通过达成共识,完善选择的候选临床研究变量的定义.
- 建立一个标准化的框架,用于临床研究中选择COPD的变量.
结论:
- 由此产生的变量和定义将提高COPD临床研究和质量改进工作的可靠性.
- 预计这种标准化的方法将改善COPD研究中的数据一致性和可比性.
- 这些发现将通过同行评审的出版物和演讲传播,以告知科学界.
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