Reliability, Validity, and Responsiveness of the Pediatric Quality of Life Inventory™ (PedsQL™) Generic Core Scales and Asthma Symptoms Scale in Vulnerable Children With Asthma
Reliability, Validity, and Responsiveness of the Pediatric Quality of Life Inventory™ (PedsQL™) Generic Core Scales and Asthma Symptoms Scale in Vulnerable Children With Asthma
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DOI：
10.3109/02770900903533966
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发表时间：
2010-03-01
影响因子：
1.9
通讯作者：
Varni, James W.
中科院分区：
文献类型：
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作者：
Seid, Michael;Limbers, Christine A.;Varni, James W.
背景患者报告的结局，如健康相关生活质量（HRQOL）越来越多地用作临床试验的主要终点。儿科生活质量量表（PedsQL（TM））被广泛用作HRQOL的测量，并且可能是儿科哮喘临床试验中特别合适的主要结果。目标.在从联邦合格卫生中心招募的持续性哮喘易感儿童样本中，检查PedsQL（TM）4.0通用核心量表和PedsQL（TM）哮喘模块哮喘症状量表的信度、效度和对临床变化的反应性。方法.儿童（N = 252; 3至14岁），（27%轻度，40.9%中度，32.1%重度）（93.7%的母亲，83.3%的西班牙裔，76.9%说西班牙语，72.6%不到高中文凭）参加了一项临床试验完成了PedsQL（TM）4.0通用核心量表，PedsQL（TM）3.0哮喘模块哮喘症状量表，以及基线和3个月随访时哮喘症状频率的测量（用作临床变化的指标）。结果PedsQL（TM）表现出足够的内部一致性信度和收敛和区分效度。基于受试者内和受试者间的变化、效应量和测量标准误，PedsQL（TM）表现出对临床变化的响应性。结论.对于儿童自我报告和父母代理报告，PedsQL（TM）通用核心量表总量表评分和PedsQL（TM）哮喘症状量表适合用作主要哮喘临床试验结果。
Background. Patient-reported outcomes such as health-related quality of life (HRQOL) are increasingly used as primary endpoints in clinical trials. The Pediatric Quality of Life Inventory (TM) (PedsQL (TM)) is widely used as a measure of HRQOL and may be a particularly suitable primary outcome in pediatric asthma clinical trials. Objectives. To examine the reliability, validity, and responsiveness to clinical change of the PedsQL (TM) 4.0 Generic Core Scales and PedsQL (TM) Asthma Module Asthma Symptoms Scale in a sample of vulnerable children with persistent asthma recruited from Federally Qualified Health Centers. Methods. Children (N = 252; ages 3 to 14 years) with persistent asthma (27% mild, 40.9% moderate, 32.1% severe) and their parents (93.7% mother, 83.3% Hispanic, 76.9% Spanish-speaking, 72.6% less than a high school diploma) enrolled in a clinical trial completed the PedsQL (TM) 4.0 Generic Core Scales, the PedsQL (TM) 3.0 Asthma Module Asthma Symptoms Scale, and a measure of asthma symptom frequency (used as an indicator of clinical change) at baseline and 3-month follow-up. Results. The PedsQL (TM) demonstrated adequate internal consistency reliability and convergent and discriminative validity. Based on intra- and intersubject change, effect sizes, and standard errors of measurement, the PedsQL (TM) demonstrated responsiveness to clinical change. Conclusions. For both child self-report and parent proxy-report, the PedsQL (TM) Generic Core Scales Total Scale score and the PedsQL (TM) Asthma Symptoms Scale are suitable for use as primary asthma clinical trial outcomes.