Rentz Anne M, Matza Louis S, Secnik Kristina, Swensen Andrine, Revicki Dennis A
Center for Health Outcomes Research, MEDTAP International, Bethesda, MD 20814, USA.
Qual Life Res. 2005 Apr;14(3):719-34. doi: 10.1007/s11136-004-0832-9.
Measuring health-related quality of life (HRQL) in children with attention-deficit/hyperactivity disorder (ADHD) in clinical trials can complement efficacy measures, offering a complete picture of the impact of disease and treatment on overall well-being. The purpose of the current study was to psychometrically validate a multidimensional, generic HRQL instrument completed by parents of children with ADHD. A total of 921 children and adolescents with ADHD participated in a clinical study of atomoxetine. Subjects' parents completed the 50-item Child Health Questionnaire-Parent Version (CHQ-PF50) at baseline and week 10. ADHD symptoms and behavioral problems were assessed using parent and clinician rating scales. Internal consistency reliability at baseline was 0.88 for the CHQ-PF50 Psychosocial Summary Score, ranging from 0.53 to 0.91 for subscale scores. Construct validity was supported by statistically significant correlations between CHQ-PF50 psychosocial scores and parent and clinician symptom ratings. Several methods were used to determine clinically meaningful differences in patient outcomes: inter- and intra-patient mean CHQ-PF50 change scores were tested and standard error of measurement (SEM) and effect sizes were calculated. Study results indicate the CHQ-PF50 is reliable, valid, and responsive to change in ADHD symptoms, suggesting it may provide a means of assessing HRQL outcomes associated with treatments for ADHD.
在临床试验中测量注意力缺陷多动障碍(ADHD)儿童的健康相关生活质量(HRQL)可以补充疗效测量,全面呈现疾病和治疗对整体幸福感的影响。本研究的目的是对一种由ADHD儿童家长完成的多维通用HRQL工具进行心理测量学验证。共有921名患有ADHD的儿童和青少年参与了一项关于托莫西汀的临床研究。受试者的家长在基线期和第10周完成了50项儿童健康问卷家长版(CHQ-PF50)。使用家长和临床医生评定量表评估ADHD症状和行为问题。CHQ-PF50心理社会总结分数在基线期的内部一致性信度为0.88,各子量表分数在0.53至0.91之间。CHQ-PF50心理社会分数与家长和临床医生症状评定之间具有统计学意义的相关性,支持了结构效度。使用了几种方法来确定患者结局中具有临床意义的差异:测试了患者间和患者内CHQ-PF50的平均变化分数,并计算了测量标准误差(SEM)和效应大小。研究结果表明,CHQ-PF50可靠、有效,且对ADHD症状的变化有反应,表明它可能提供一种评估与ADHD治疗相关的HRQL结局的方法。