在癌症临床试验和常规临床实践中选择患者报告的结局指标:混合方法方法
Alexandra Gilbert1, Elaine O'Connell Francischetto2, Jane Blazeby2
1University of Leeds, Leeds, UK.
Lancet (London, England)
|August 28, 2015
概括
这项研究发现了患者报告的门癌症结果问卷中的差距. 由于门癌患者缺少的症状项目较少,因此建议使用EORTC-QLQ系统进行临床研究.
科学领域:
- 癌症学
- 临床研究方法
- 患者报告的结果
背景情况:
- 美国门癌的发病率不断上升,
- 同时进行门癌的化疗会增加不良反应.
- 患者报告的结果对于评估晚期不良事件至关重要.
研究的目的:
- 为门癌症研究和实践确定和选择最有效的PRO问卷.
- 解决缺少一个特定的门癌症PRO问卷.
主要方法:
- 混合方法方法结合系统审查和与卫生专业人员的半结构面试.
- 在癌试验中对PRO和临床报告工具的系统审查.
- 针对已识别的癌特异域,对选定的PROs (EORTC QLQ-C30,EORTC QLQ-CR38,NCI PRO-CTCAE) 的内容分析.
主要成果:
- EORTC QLQ-C30和EORTC QLQ-CR38是最常用的PRO; RTOG/EORTC和CTCAE是临床医生报告的常见标准.
- 采访显示卫生专业人员对问卷的内容或设计没有达成共识.
- EORTC问卷错过了4个领域/16个代码 (例如,辐射皮肤反应);NCI PRO- CTCAE错过了6个领域/45个代码 (例如,阴道狭窄,肠急性).
结论:
- 现有的PRO问卷在捕捉门癌特异性不良事件方面存在重大差距.
- 专家意见是有价值的,但在问卷设计上缺乏共识.
- 在接受 (化疗) 辐射的门癌症患者中,EORTC-QLQ系统显示缺失的症状项目最少.
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