在瘤学研究中,通过患者报告的结果指标评估的身体功能方面
Theresa Coles1, Rebecca Fillipo2, Kate Plyler2
1Center for Health Measurement, Department of Population Health Sciences, Duke University School of Medicine, 215 Morris St., Durham, NC, 27701, USA. Theresa.Coles@Duke.edu.
概括
这项研究确定和分类了癌症试验中使用的身体功能患者报告结果指标 (PROMs). 根据物理功能方面对PROM进行分类有助于研究人员选择临床试验的适当措施.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 身体功能 (PF) 是癌症临床试验中患者报告的核心结果 (PRO),由美国食品和药物管理局确定.
- 患者报告的结果措施 (PROMs) 对于在成人癌症群体中从患者的角度评估PF至关重要.
研究的目的:
- 确定适用于成人癌症患者的现有PF PROM.
- 根据他们评估的身体功能特定方面来分类这些PROM.
主要方法:
- 进行了有针对性的文献审查,以确定相关的PF PROM.
- 一个经过修改的Delphi研究和一个咨询小组被用来达成对每个PROM测量的PF方面的共识.
- 一个卡片排序活动将PROM项目按八个已识别的PF方面 (能力,完成,难度,限制,质量,频率,烦,满意度) 分类.
主要成果:
- 文献审查确定了13个符合纳入标准的PROM.
- 物理功能的八个方面被定义为分类.
- 在审查的PROM中,最常被评估的PF方面是能力,难度和限制.
结论:
- 根据其评估的方面对PF PROM进行分类,可以提高报告的清晰度和一致性.
- 这种分类系统将帮助研究人员优先考虑和选择适合癌症临床试验的PF PROM.
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