基于高血压患者报告的临床结局评价量表的计量心理学特征测评

Psychometric assessment of patient-reported outcome scale for hypertension

目的为考察用于新药临床试验或临床疗效评价的基于高血压患者报告的临床结局评价量表(Hyper-PRO)的科学性,对其计量心理学特征进行评价。方法用Hyper-PRO量表对620例样本(536例高血压患者和84名健康人)进行自评量表式调查,对其信度、效度、反应度和临床可行性等计量心理学特征进行考评。结果分半信度系数:生理领域0.882,心理领域0.924,社会领域0.834,治疗领域0.950,整个量表0.950。克朗巴赫系数:生理领域0.839,心理领域0.905,社会领域0.770,治疗领域0.859,整个量表0.948。内容效度满意。因子分析显示量表的结构效度良好。高血压患者与健康人在每个方面的测评结果比较,除外焦虑和抑郁,其余各方面分量表及总量表得分差异均有统计学意义。结论 Hyper-PRO量表具有较好的信度(分半信度、克朗巴赫系数)、效度(内容效度、结构效度)、反应度和临床可行性,可以作为高血压临床疗效评价研究的工具。

Objective To justify the role of patient-reported outcome scale for hypertension（Hyper-PRO） in clinical trials of new drug development,and to evaluate its psychometric characteristics.Methods A total of 620 subjects（536 with hypertension and 84 healthy individuals） received outcome scale interview using Hyper-PRO.Psychometric characteristics,for instance,reliability,validity,responsiveness and clinical feasibility,were evaluated.Results Split-half reliability was 0.882,0.924,0.834,0.950 and 0.950 in physiological,psychological,social,treatment dimension and the whole scale,respectively.While the Cronbach′s coefficient was 0.839,0.905,0.770,0.859 and 0.948 in physiological,psychological,social,treatment dimension and the whole scale,respectively.Content validity was satisfied,and factor analysis showed preferable construct validity.Statistically significant difference was revealed in each dimension between patients with hypertension and normal individuals（P0.05）,with the exception of anxiety and depression scores.Conclusion With preferable reliability（split-half reliability and Cronbach′s coefficient）,validity（content and structure）,responsiveness as well as clinical feasibility,Hyper-PRO scale can be the tool for clinical assessment of hypertension.