确定患者评估结果,用于眼表面疾病干预的早期阶段试验
Anita L Slade1, Alberto Recchioni2, Olalekan L Aiyegbusi3
1Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, United Kingdom; National Institute for Health and Care Research (NIHR) Applied Research Collaboration West Midlands, Birmingham, United Kingdom; NIHR Birmingham Biomedical Research Centre, University of Birmingham, United Kingdom; NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, United Kingdom.
The ocular surface
|July 19, 2023
概括
对于干眼症状 (DES) 的患者报告结果 (PRO) 需要改进. 这项研究对患者的体验进行了映射,揭示了环境影响和疼痛等关键问题,这些问题在临床试验当前的PRO措施中没有被捕捉到.
科学领域:
- 眼科医生 眼科 眼科
- 临床研究 临床研究
- 患者报告的结果
背景情况:
- 患者报告的结果 (PROs) 对于评估干眼症状 (DES) 对日常生活的影响至关重要.
- 早期临床试验为改进PRO策略提供了机会.
- 目前对DES的PRO措施遗漏了对患者体验至关重要的概念.
研究的目的:
- 开发干眼症状 (DES) 的概念地图.
- 评估经历DES的患者识别的概念的相对重要性.
- 找出目前对DES的PRO措施中的差距.
主要方法:
- 采用了基于网络的群组概念映射方法.
- 该研究涉及三个阶段:陈述生成,主题排序和陈述的重要性和相关性等级.
- 从英国患者支持小组招募了39名参与者.
主要成果:
- 125个声明组成了六个主题集群,其中环境影响在重要性方面得分最高.
- 疼痛和不适,以及眼部治疗也获得了很高的评分.
- 患者报告的关键问题,如"紫外线水平"",炎热干燥的天气"",疼痛的时间方面"和"夜间驾驶"被确定在当前的PRO中缺失.
结论:
- 集团概念映射确定了DES个体的关键问题,目前现有PRO没有解决这些问题.
- 显然需要将额外的PRO项目纳入DES临床试验.
- 这项研究强调以患者为中心的数据收集,以全面了解DES的影响.
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