Kristina S. Boye, Amy Clark, Chisom Kanu, Lisa M. Neff, Anne M. Skalicky
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引用次数: 0
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.
期刊介绍:
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.