基于中风病患者报告的结局评价量表的第二轮临床验证

Second run clinical verification of patient-reported outcome scale of stroke

目的:在前期工作的基础上,对研制的《基于中风病患者报告的临床结局评价量表》(初稿)进行第二轮临床验证,进一步对其性能进行考评,最终形成适合中国国情的《基于中风病患者报告的临床结局评价量表》,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:课题组在前期对《基于中风病患者报告的临床结局评价量表》(初稿)进行性能考评,在得到良好的信度和效度的基础上,经过进一步筛选条目,形成了包含4个维度36个条目的中风病PRO量表,2010年11月-2011年3月对中风病PRO量表进行第二轮多中心临床验证,进一步考评量表的性能。结果:前后2次量表的分半信度分别为0.839和0.848,Cronbach,s Alpha系数分别为0.906和0.924;前后2次测评量表总分与SS-QOL量表总分相关系数分别为-0.511和-0.522;因子分析结果4个因子所包含的内容与我们预想的结果一致;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,是进一步完善中风病中医临床疗效评价指标体系的有效工具。

Objective： On the basis of previous job, we have finished the second run clinical verification of Patient- Reported Outcome （PRO） draft scale of stroke to further evaluate its performance, at last we will develop a PRO scale of stroke which is consistent with China＇s national conditions to provide an effective method for TCM to further improve the clinical efficacy evaluation system of stroke. Methods： On the basis of evaluating the performance of PRO scale of stroke and getting good reliability and validity, after the further item screening, we formed the the PRO scale of stroke which has 4 dimension and 36 items. From 2010-11 to 2011-3 we had have finished the second run clinical verification of PRO scale of stroke to further evaluate its performance. Results： The half reliability of the scale one after anther were 0.839 and 0.848, Cronbach＇s Alpha coefficients were 0.906 and 0.924; Total score of PRO and SS-QOL one after anther were negatively correlated, the correlation coefficients were -0.511 and -0.522; 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.