基于中风病患者报告的结局评价量表的第一轮临床验证

First clinical verification of patient-reported outcome scale of stroke

目的:研制符合中国国情的《基于中风病患者报告的临床结局评价量表》并对其性能进行考评,为进一步完善中风病中医临床疗效评价体系提供有效方法。方法:从中风患者的自我感觉症状出发,借鉴心理测量学的方法,参照美国FDA发布的患者报告的结局(PRO)研究方法指南,采用专家问卷和患者访谈相结合筛选量表条目,形成量表初稿。通过多中心临床验证收集数据,考评量表的性能。结果:前后2次量表的分半信度分别为0.849和0.873,Cronbach,s Alpha系数分别为0.892和0.918;前后2次测评量表总分与SS-QOL量表总分相关系数分别为-0.741和-0.756;因子分析结果4个因子所包含的内容与预想的结果一致;前后2次PRO量表总分经非参数秩和检验,P<0.01。结论:《基于中风病患者报告的临床结局评价量表》的研制方法科学,具有良好的信度、效度和反应度,有助于进一步完善中风病中医临床疗效评价指标体系。

Objective： To develop a PRO scale of stroke which is consistent with China,s national conditions and evaluate its performance,provide an effective method for TCM to further improve the clinical efficacy evaluation system of stroke.Methods： Starting from stroke patients,self-feeling symptoms,refering to the method of psychometric and the guidelines of PRO research issued by the U.S.FDA,combinated questionnaires and interviews with patients to select items of the scale,form the draft scale,collect data by multi-center clinical validation and evaluate the scale,s performance.Results： The half reliability of the scale one after anther were 0.849 and 0.873,Cronbach,s Alpha coefficients were 0.892 and 0.918;Total score of PRO and SS-QOL one after anther were negatively correlated,the correlation coefficients were-0.741 and-0.756;Factor analysis,s results showed the content which were contained in the four factors were consistent with our expected results;The total scores of the PRO scale before and after analysised by non-parametric rank sum test,P〈0.01.Conclusion： Our method to develop the PRO scale of strok is scientific,the reliability,validity and responsiveness of scale were good.It,s helpful to further improve the clinical efficacy evaluation system of stroke.