以患者报告结局为疗效评价指标时需注意的问题  

Problems to Pay Attention to in Taking Patient-reported Outcomes as Clinical Outcomes Assessment

作　　者：许卫华[1] 梁伟雄[1] 王奇[1] 温泽淮[1] 

机构地区：[1]广州中医药大学临床药理所DME中心,广州510405

出　　处：《中国中西医结合杂志》2011年第8期1135-1137,1145,共4页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：国家"十一五"科技支撑课题(No.2006BAI04A21-3);国家重大新药创制专项(No.2008ZX09312-021)

摘　　要：患者报告结局(patient-reported outcomes,PROs)为临床研究者提供了一个很好的从患者角度评价临床治疗效果的途径。笔者介绍了当以PROs为疗效评价指标时需着重注意的问题,包括PRO测量量表的选择、测量实施过程中质量控制、测量结果的解释以及PRO指标的适用范围。Patient-reported outcomes （PROs） provide clinical researchers with a good means to assess patient-based outcomes.Yet there are still some problems to pay attention to while using PROs as an effectiveness assessment index,including the selection of an appropriate scale of PRO,quality control in PRO data collection,and the interpretations and application ranges of the PRO results.

关 键 词：患者报告结局 量表 质量控制 疗效评价 

分 类 号：R45[医药卫生—治疗学]