Abstract
INTRODUCTION: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.