Boye Kristina S, Clark Amy, Kanu Chisom, Neff Lisa M, Skalicky Anne M
Eli Lilly and Company, Indianapolis, IN, USA.
Evidera, Patient-Centered Research, Thermofisher, 929 North Front Street, Wilmington, NC, 28401, USA.
Adv Ther. 2025 Jul 11. doi: 10.1007/s12325-025-03277-6.
Development of obesity management medications (OMMs) for use in children and adolescents calls for patient-reported outcome (PRO) measures to evaluate treatment efficacy. Existing weight-specific symptom and impact PROs are limited to age ≥ 11 years and may not fully capture treatment benefit of new OMMs.
A targeted literature review was conducted to identify obesity symptom and impact outcomes and weight-specific PROs relevant to children and adolescents 6-17 years of age. Concept elicitation (CE) interviews were conducted by telephone with children and adolescents, including parents of children 6-11 years of age, to identify relevant weight-specific concepts. Key concepts relevant to three developmental age groups-6-7, 8-11, and 12-17 years-informed the creation of a pediatric weight-specific PRO to assess key symptoms and impacts of obesity: the Pediatric Weight Questionnaire (PWQ). Cognitive interviews (CI) were conducted by telephone to assess the comprehension, relevance, and comprehensiveness of the PWQ across the three age groups.
Eight domains were identified from the literature as relevant to pediatric obesity: physical symptoms, physical function, psychological health, emotional behavior/function, family and social relationships, school functioning, and health-related quality of life. No existing weight-specific PRO encompassing these domains was identified. Twenty CE interview participants (mean age 11.4 years, 60% female, 50% Hispanic/Latino) confirmed that physical symptoms and physical, emotional, and social impacts were most relevant to their weight experience. The 23-item PWQ for adolescents 12-17 years of age and the 17-item PWQ for children 8-11 years of age are self-administered, while the 13-item PWQ for children 6-7 years of age is interviewer-administered. The three versions of the PWQ were evaluated with 34 CI participants (mean age 12 years, 64.7% female, 17.6% Hispanic/Latino), who found the PWQ easy to complete, relevant, and comprehensive.
The PWQ provides a means of assessing the impact of obesity and benefits of treatment in children and adolescents 6-17 years of age with obesity. Study findings support the content validity of this new measure for use in pediatric obesity clinical trials and observational research.
开发用于儿童和青少年的肥胖管理药物(OMM)需要患者报告结局(PRO)指标来评估治疗效果。现有的针对体重的症状和影响PRO指标仅限于年龄≥11岁的人群,可能无法完全体现新型OMM的治疗益处。
进行了一项有针对性的文献综述,以确定与6-17岁儿童和青少年相关的肥胖症状、影响结局以及针对体重的PRO指标。通过电话对儿童和青少年(包括6-11岁儿童的父母)进行了概念激发(CE)访谈,以确定相关的针对体重的概念。与三个发育年龄组(6-7岁、8-11岁和12-17岁)相关的关键概念为创建一个评估肥胖关键症状和影响的儿科针对性体重PRO指标提供了依据:儿科体重问卷(PWQ)。通过电话进行认知访谈(CI),以评估PWQ在三个年龄组中的理解性、相关性和全面性。
从文献中确定了八个与儿科肥胖相关的领域:身体症状、身体功能、心理健康、情绪行为/功能、家庭和社会关系、学校功能以及与健康相关的生活质量。未发现现有涵盖这些领域的针对体重的PRO指标。20名CE访谈参与者(平均年龄11.4岁,60%为女性,50%为西班牙裔/拉丁裔)确认,身体症状以及身体、情绪和社会影响与他们的体重经历最为相关。12-17岁青少年的23项PWQ和8-11岁儿童的17项PWQ为自填式,而6-7岁儿童的13项PWQ由访谈者填写。34名CI参与者(平均年龄12岁,64.7%为女性,17.6%为西班牙裔/拉丁裔)对三个版本的PWQ进行了评估,他们认为PWQ易于完成、相关且全面。
PWQ为评估6-17岁肥胖儿童和青少年的肥胖影响及治疗益处提供了一种方法。研究结果支持这一新指标在儿科肥胖临床试验和观察性研究中的内容效度。