A new Pediatric Weight Questionnaire (PWQ) has been developed to assess obesity-related impacts in children and adolescents aged 6-17 years.
Eight relevant domains related to pediatric obesity were identified: physical symptoms, physical function, psychological health, emotional behavior/function, family and social relationships, school functioning, and health-related quality of life.
Twenty children and adolescents confirmed that physical symptoms and emotional and social impacts were highly relevant to their experiences with obesity.
The PWQ consists of three versions: a 23-item questionnaire for adolescents aged 12-17, a 17-item questionnaire for children aged 8-11, and a 13-item questionnaire for children aged 6-7.
Cognitive interviews with 34 participants indicated that the PWQ was easy to complete and relevant across the different age groups.
The findings support the of the PWQ for assessing treatment benefits in pediatric obesity research.
Simplified
INTRODUCTION: Development of obesity management medications (OMMs) for use in children and adolescents calls for (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 of this new measure for use in pediatric obesity clinical trials and observational research.
Key numbers
11.4 years
Mean Age of Participants
Participants in concept elicitation interviews.
75%
Percentage of Participants Endorsing Body Aches/Pain
From concept elicitation interviews with participants aged 6-17.
23
Number of Items in PWQ for Adolescents
The PWQ for adolescents aged 12-17 years.
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Declarations. Conflicts of Interest: Anne M. Skalicky and Amy Clark are employees of Evidera, which received funding from Eli Lilly to conduct the study. Kristina Secnik Boye, Chisom Kanu, and Lisa M. Neff are employees and shareholders of Eli Lilly and Company. Ethical Approval: The CE interview protocol was approved by a US ethical central institutional review board (IRB), in accordance with local law (IRB study number WCG IRB# 20225362), and the methodology was developed in line with the FDA and the ISPOR guidance on best practice for eliciting concepts for a new PRO instrument [9, 11]. This study was also performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practice and applicable regulatory requirements. Written informed consent was obtained from all participants to publish data and verbatim responses. Consent was obtained from parents and assent obtained from child and adolescent participants to publish verbatim responses.
