Volger Sheri, Landgraf Jeanne M, Mao Meng, Ge John, Northington Robert, Hays Nicholas P
Clinical Research, Research and Development, Nestlé Nutrition, 3000 Horizon Drive, King of Prussia, PA, 19406, USA.
HealthActCHQ, Inc. (HACHQ), 800 Boylston Street, 16th Floor, Boston, MA, 02199, USA.
Matern Child Health J. 2018 May;22(5):702-712. doi: 10.1007/s10995-018-2439-8.
Objective Evaluate the feasibility and psychometric properties of the Infant Toddler Quality of Life (ITQOL) questionnaire as a measure of health-related quality of life (HRQOL) in a sample of Chinese infants. Methods The linguistically validated Simplified Chinese version of the ITQOL was used in a multicenter, observational study of healthy, term infants (N = 427), age 6 weeks at enrollment, in China. At Days 1 and 48, parents/guardians completed the ITQOL, the Short Form Health Survey (SF-12v2) and the Infant Gastrointestinal Symptom Questionnaire (IGSQ). ITQOL feasibility, reliability, ceiling/floor effects, concurrent validity and discriminatory validity were evaluated. Results Feasibility of administering the ITQOL was supported by strong response rates (> 97%) with < 1% missing items for all scales except physical abilities. Reliability was acceptable (Cronbach's alpha > 0.70) for all scales except Day 1 General Health (0.67). Floor effects were minimal (< 2%), except Day 1 physical abilities (7%). Ceiling effects increased from Days 1 to 48 across all scales. Concurrent validity was demonstrated by correlations between ITQOL infant-focused scales and IGSQ score (r = -0.20 to - 0.34, p < 0.001) and between parent-focused scales and SF-12v2 mental health composite (MCS) scores (r = 0.29-0.46, p < 0.001). ITQOL scales discriminated between infant subgroups based on illness-related outcomes (sick visits, adverse events) and between parent subgroups based on SF-12v2 MCS scores. Conclusion The Simplified Chinese version of the ITQOL performed well in a community-based sample of Chinese infants, with evidence supporting the instrument's feasibility, reliability, and validity. These data support the ITQOL as a valuable tool to assess HRQOL in Chinese infants.
目的 评估婴幼儿生活质量（ITQOL）问卷作为衡量中国婴幼儿健康相关生活质量（HRQOL）指标的可行性和心理测量特性。方法 在中国进行的一项多中心观察性研究中，对427名健康足月儿（入组时年龄为6周）使用经语言验证的简体中文版ITQOL。在第1天和第48天，父母/监护人完成ITQOL、简短健康调查问卷（SF - 12v2）和婴幼儿胃肠道症状问卷（IGSQ）。评估ITQOL的可行性、信度、天花板/地板效应、同时效度和区分效度。结果 除身体能力量表外，所有量表的高应答率（> 97%）及< 1%的缺失项支持了ITQOL实施的可行性。除第1天的总体健康量表（0.67）外，所有量表的信度均可接受（Cronbach's α> 0.70）。除第1天的身体能力量表（7%）外，地板效应最小（< 2%）。所有量表从第1天到第48天天花板效应均增加。ITQOL以婴儿为中心的量表与IGSQ得分之间（r = -0.20至 -0.34，p < 0.001）以及以父母为中心的量表与SF - 12v2心理健康综合得分（MCS）之间（r = 0.29 - 0.46，p < 0.001）的相关性证明了同时效度。ITQOL量表能够根据疾病相关结局（就诊、不良事件）区分婴儿亚组，并根据SF - 12v2 MCS得分区分父母亚组。结论 简体中文版ITQOL在中国婴幼儿社区样本中表现良好，有证据支持该工具的可行性、信度和效度。这些数据支持ITQOL作为评估中国婴幼儿HRQOL的有价值工具。
