在临床试验中评估参与者与COVID-19症状日记的经验
T Michelle Brown1, Chisom Kanu1, Magdalena Harrington2
1RTI Health Solutions, Research Triangle Park, NC, USA.
Journal of patient-reported outcomes
|August 11, 2025
概括
这项研究验证了在nirmatrelvir/ritonavir的临床试验中使用的COVID-19症状日记. 该日记准确地记录了常见的症状,并且易于参与者使用,支持其内容有效性,用于评估患者报告的结果.
科学领域:
- 临床研究 临床研究
- 患者报告的结果
- 医疗信息学 医疗信息学
背景情况:
- 一项2/3期临床试验 (NCT05011513) 评估了尼尔马特里尔维尔/里托纳维尔用于COVID-19治疗.
- 患者报告的症状对于评估治疗疗效和疾病进展至关重要.
- 美国食品和药物管理局 (FDA) 建议评估患者报告的结果仪器的内容有效性.
研究的目的:
- 评估COVID-19症状电子日记和全球印象项目的内容有效性.
- 评估参与者对日记和相关的全球印象问题的理解和易用性.
主要方法:
- 进行了定性采访,对来自nirmatrelvir/ritonavir试验的参与者进行了次组采访.
- 来自10个临床场所的25名参与者在研究后接受了采访.
- 采访的重点是每天记录的14个COVID-19症状和3个全球印象项目的清晰度,可解释性和易用性.
主要成果:
- 至少有一名参与者报告了所有14个日记症状,其中低能量/疲劳是最常见的 (88.0%).
- 48.0%的参与者报告了日记中不包括的症状,最常见的是头 (12.0%).
- 大多数参与者发现日记项目清晰易用,尽管一些全球项目被认为是模糊或令人困惑的.
结论:
- COVID-19 症状日记证明了内容的有效性,有效地捕捉了临床试验参与者常见的症状.
- 电子日记和全球印象项目通常被很好地理解和易于使用,支持它们在临床研究中的实用性.
- 对总体印象项目的小修订可能会提高未来研究的清晰度和响应选择.
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