基于中风病证相关患者报告结局测量量表的编制及初步考评

Development and Evaluation of the Syndrome Related Instrument for Patient Reported Outcome with the Stroke

目的:编制基于中风病证相关患者报告结局测量量表,对量表的可行性、信度、效度和反应度进行考评,探讨中医药治疗中风病疗效评估的方法学。方法:综合运用专家咨询、患者访谈、照料者访谈、既往病历查询、核心小组讨论、文献研究、借鉴国内外相关量表等方法,形成量表条目池,对条目进行初步的筛选和优化,开展小范围认知测试,经小样本预调查,形成量表初稿,在全国3个地区进行多中心量表测试,并对361份有效数据进行可行性、信度、效度、反应度分析。结果:初步形成具有3个维度、13个方面、71个条目的基于中风病证相关患者报告结局测量量表;量表接受率为95%,完成率为100%;量表总体和分半信度为别为0.828、0.905、0.912;量表总体克朗巴赫α系数(Cronbach’sα)为0.945,各维度Cronbach’sα系数均大于0.8;内容效度采用Pearson相关系数法计算,各维度与量表总分、各方面与维度得分的相关系数均大于0.6;结构效度采用主成分分析方法进行因子分析,用方差最大法正交旋转,提取特征根值大于1的18个公因子,累计方差贡献率为65.896%;急性期、恢复期、后遗症期3类人群量表总分以及所有维度得分组间均数差异均有统计学意义。结论:量表具有较好的可行性、信度、效度、反应度,可尝试作为中风病临床疗效评价研究的工具。

This study aimed to develop a syndrome related scale from reported outcomes of patients with stroke by assessing its practicability, reliability, validity and responsibility, and to explore the methodology of the curative effect evaluation of stroke in traditional Chinese medicine（TCM）. The scale was developed by establishing item pool through document research, expert consulting, patients interview, caregivers interview, clinical record inquiring, core group discussion, literalture study and learning the design of both domestic and foreign scales. Related items of the scale were selected and optimized, and small-scale cognitive tests and the small sample pilot survey were pushed ahead to form the primary scale. Then a multi-central clinical investigation was conducted among three regions across China, analyzing practicability, reliability, validity and responsibility from the dataof 361 effective respondents. As a result, a 3-dimention, 13-aspect, 71-item scale was formulated over the syndromes of stroke from patient reproted outcomes. The rate of acceptance was 95% with the completion rate of 100%. The split-half reliability coefficient of the scale was 0.828, while the two half part of the scale were 0.905 and 0.912, respectively. Cronbach α value of the scale was 0.945, while the coefficient of Cronbach α value of each dimension was over 0.8. For validity, the coefficient correlation of domain and total score, facet and total score were over 0.6. The accumulative offer rate of variance was 65.896% with factor analysis. The mean comparisons among patients of acute stage, decubation stage and chronic stage showed statistical significances in each domain and the total scores. In conclusion, the scale can be adopted to evaluate the effecacy of stroke in TCM with good practicability, reliability, validity and responsibility.