评估COVID-19症状的内容有效性 每日日记 每日日记
Jennifer Dine1, Yanfen Guan2, Mirline Milien1
1RTI Health Solutions, Research Triangle Park, Durham, NC, USA.
Patient related outcome measures
|January 22, 2025
概括
COVID-19症状日记 (CSDD) 是评估COVID-19治疗方法的临床试验的有效工具. 患者采访证实了其适用于测量症状严重程度和治疗疗效的适用性.
科学领域:
- 临床试验 临床试验
- 患者报告的结果
- 在COVID-19研究研究中.
背景情况:
- COVID-19 症状日记 (CSDD) 是患者报告的结果指标.
- 根据CDC的指导和临床试验的监管投入开发.
- 此外,还制定了一份COVID-19前症状问卷.
研究的目的:
- 评估CSDD对COVID-19临床试验的内容有效性.
- 确定CSDD是否适合用于支持疗效终点的目的.
- 评估COVID-19前症状问卷的适当性.
主要方法:
- 有针对性的文献审查,以确定相关的概念和缺失的症状.
- 混合定性面试 (概念诱导和认知总结).
- 美国有30名成年人最近接受了COVID-19诊断,经过3轮代面试.
主要成果:
- CSDD捕获了经常报告的和令人烦的COVID-19症状.
- 参与者发现CSDD概念突出,有明确的指令和响应选择.
- 对CSDD (吐/腹定义) 和COVID-19前问卷 (参考期/说明) 进行了轻微修改.
结论:
- 强有力的证据支持CSDD的内容有效性和项目适当性.
- 在临床试验中,CSDD适合用于COVID-19治疗的目的.
- 前COVID-19问卷适合其预期使用.
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