高血压患者报告的临床结局测定量表的应用考评

Evaluation and Application of the Patients Reported Outcomes Measurement Scale for Hypertension

目的考评慢性病患者报告的临床结局测定量表体系中的高血压量表PROISCD-HY(V1.0)的信度、效度及反应度。方法在2020年5月至2020年10月期间对111例初患高血压的社区高血压患者进行PRO量表的2次调查(降压药物治疗前和治疗后)填写,基于量表得分评价其信度、效度和反应度。结果总量表的克朗巴赫系数α为0.894,分半信度系数为0.783。精神/信仰健康的克朗巴赫系数α为0.434,其他领域均在0.725及以上;身体健康、精神/信仰健康的分半信度系数分别为0.585、0.489,其他领域均在0.678及以上。量表根据FDA颁布的PRO量表研制和应用指南制定,具有较好的内容效度。因子分析显示共性模块和特异模块分别提取11个公因子和4个公因子,累计方差贡献率分别为79.275%和64.554%,量表有较好的结构效度。ES值在0.129至0.594之间,CR值在-8.911%至-1.796%之间,SRM值在0.103至0.516之间,量表在同一群体不同时间有较好的反应度。结论高血压患者报告的临床结局测定量表PROISCD-HY(V1.0)具有较好的信度、效度及反应度,可用于高血压患者报告的临床结局的测量。

Objective To evaluate the reliability,validity and responsiveness of Patient Reported Outcome Instruments System for Chronic Disease-Hypertension,PROISCD-HY(V1.0),a scale for measuring reported outcomes in patients with hypertension.Methods During May 2020 to October 2020,111 community hypertension patients with initial hypertension were enrolled in PRO scale two surveys(before and after antihypertensive drug treatment),and the reliability,validity and responsiveness were evaluated based on scale scores.Results The Cronbach’αof the total table was 0.894 and the split-half reliability coefficient was 0.783.The Cronbach’αof spiritual/belief health was 0.434,respectively,and 0.725 or above in other fields.The fractional reliability coefficients of physical health and spiritual/belief health were 0.585 and 0.489,respectively,and 0.678 and above in other fields.The scale was developed according to the PRO scale development and application guidelines issued by FDA,and has good content validity.Factor analysis of common modules extracted11 common factors,and the cumulative variance contribution rate was 79.275%.Factor analysis of specific modules extracted 4 common factors,and the cumulative variance contribution rate was 64.554%.The scale has good structural validity.The ES value ranged from 0.129 to 0.594,the CR value ranged from-8.911%to-1.796%,and the SRM value ranged from 0.103 to 0.516,indicating that the scale had a good response degree in the same population at different times.Conclusion PROISCD-HY(V1.0),a clinical outcome measurement scale reported by patients with hypertension,has good reliability,validity and reactivity,and can be used to measure the clinical outcome reported by patients with hypertension.