对慢性阻塞性肺病患者进行维护性肺康复试验的过程评估
Derrick Lopez1, Susan Jenkins1,2,3,4, Nola Cecins2
1School of Population and Global Health, The University of Western Australia, Crawley, Western Australia, Australia.
概括
对慢性阻塞性肺病 (COPD) ComEx3试验的过程评估显示,承诺和患者的愿望促进了实施. 这项研究为未来的肺部康复 (PR) 随机对照试验 (RCT) 提供了指导.
科学领域:
- 肺部康复治疗 肺部康复治疗
- 慢性阻塞性肺病 (COPD) 是一种慢性阻塞性肺病.
- 临床试验过程评估临床试验过程评估.
背景情况:
- 在ComEx3随机对照试验 (RCT) 中,研究了在COPD患者中维持运动效益的最佳策略.
- 进行了过程评估,以评估试验实施的真实性,障碍,促进者和影响机制.
研究的目的:
- 评估ComEx3社区扩展维护肺部康复 (PR) RCT的实施情况.
- 确定影响试验流程和参与者坚持的障碍和促进者.
- 探索PR影响COPD患者的机制.
主要方法:
- 混合方法方法利用PR课堂记录,学习日记和采访 (n=21).
- 基于现有文献的报告框架的开发.
- 收集数据的内容分析,以评估实施和确定主题.
主要成果:
- 由于COVID-19大流行,试验结束前干预组的高出席率 (≥70%).
- 与对照组相比,干预组对家庭炼计划的坚持更强.
- 识别了跨站点标准化流程的挑战,但观察到物理治疗师的积极行为变化.
结论:
- 试验实施在很大程度上是成功的,这是由于研究团队的承诺和患者的动机.
- 有效的PR RCT需要强大的组织技能,清晰的文档,以及对患者需求和挑战的理解.
- 过程评估对于指导未来干预至关重要,即使RCT尚未完成.
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