Pediatric PROMIS: Advancing the Measurement and Conceptualizaiton of Child Health

描述（由申请人提供）：健康包括抵抗疾病、适应需求和疾病以及繁荣所必需的资源。对儿童来说，健康是参与刺激身体、认知和社会发展的日益具有挑战性的活动的基础。目前，在儿科临床研究和实践中，我们缺乏一套跨越疾病类别和年龄范围的常见的患者报告的结果测量方法。为成人开发的工具不太可能捕捉到由于发育变化而导致的童年现实，而且它们在阅读理解和应答负担方面通常不合适。拟议项目的目标是制定儿童感知健康的新措施（儿童和家长回答版本），这些措施基于全面的、达成共识的、了解发展情况的、对儿童敏感的健康模式。具体而言，我们的目标是：(1)在现有的PROMIS框架中概念化和整合新的儿童感知健康结构，包括身体活动、身体舒适/症状、压力体验、主观幸福感、家庭归属感和学校归属感；(2)为这些健康构建建立儿科项目库；(3)在5000对父母/子女中校准、验证和发展相等的项目池；(4)在400例炎症性肠病（IBD）患儿中开展PROMIS信息库的临床验证研究。我们将使用

DESCRIPTION (provided by applicant): Health comprises resources necessary for resisting illness, adapting to demands and disease, and flourishing. For children, health is the foundation for engaging in increasingly challenging activities that stimulate physical, cognitive, and social development. Currently, we lack a common set of patient-reported outcome measures that span disease categories and age ranges for pediatric clinical research and practice. Instruments developed for adults are unlikely to capture the realities of childhood that result from developmental change, and they typically are not suitable in terms of reading comprehension and respondent burden. The goal of the proposed project is to develop novel measures of children's perceived health-child and parent respondent editions-that are based in a comprehensive, consensus-derived, developmentally informed, child-sensitive model of health. Specifically, our aims are to: (1) conceptualize and integrate within the existing PROMIS framework the novel pediatric perceived health constructs of physical activity, physical comfort/symptoms, experience of stress, subjective well-being, family belonging, and school belonging; (2) develop pediatric item pools for these health constructs; (3) calibrate, validate, and developmentally equate the item pools among 5,000 parent/child dyads; and, (4) perform a clinical validation study of PROMIS item banks among 400 children with inflammatory bowel disease (IBD). We will use literature reviews, secondary data analyses, focus groups, and an international/cross-cultural consensus development process to expand the PROMIS conceptual framework to ensure it is sensitive to the unique characteristics of children. Data will be collected at two of the nation's largest pediatric integrated delivery systems and several school systems. A key innovation is our focus on children's development, a sensitivity that will imbue the conceptualization of child health, qualitative approaches to item pool development, and statistical methods for analyzing developmental change. Our team of child health experts and pediatric perceived health instrument developers has arguably contributed more to the conceptualization and measurement of health and disease in childhood and adolescence than any other group in the world. PUBLIC HEALTH RELEVANCE: This research will greatly expand the availability of developmentally appropriate pediatric patient-reported outcome tools. Once these exist, it will be possible to evaluate health across developmental periods and ultimately the lifespan, work that will dramatically advance the science of pediatric clinical trials, inform our understanding of childhood disease, and elucidate previously unknown effects of pediatric healthcare.