PROMIS Pediatrics: Longitudinal Validation and Linking Pediatric and Adult Item B

描述(申请人提供)：这个项目的总体目标是验证PROM是4种儿科慢性疾病的儿科题库，并将儿科和成人题库联系起来。在第一个PROMIS资助周期中，我们开发了9个儿科题库，并对患有几种慢性病的儿童进行了横断面测试。这项拟议的工作是将PROMIS量表整合到临床研究中的自然下一步。我们建议对患有哮喘、癌症、肾病综合征和镰状细胞疾病的儿童进行纵向研究。每项研究都跟踪儿童经历已知影响健康相关生活质量的临床过渡，每项研究都将检查PROMIS仪器的响应性，并估计儿童的最小重要差异(MID)。作为这些研究的一部分，我们建议测试一种建立MID的新方法，并将该方法与传统的分布式方法和基于锚点的方法进行比较。第二个总体目标是将PROMIS儿科题库与PROMIS成人题库联系起来。我们设计了大多数儿科银行，以衡量与其对应的成人银行相同的潜在特征(例如，疲劳)，但使用了儿童的概念和语言。我们将通过横断面数据收集，对患有慢性病的青少年实施儿科和成人简表。为此，我们将使用因子分析和结构方程模型来建立儿科和成人题库和领域之间的经验关系，并在这些关系的支持下，使用项目反应理论将儿科和成人题库联系起来。这项研究将使研究人员能够在参与同一项研究的儿童和成人之间获得可比较的分数，并使跟踪儿童进入成年期的纵向研究成为可能。公共卫生相关性：在4种慢性疾病中进行纵向有效性研究将为未来的临床研究准备PROMIS。通过连接儿科和成人题库，加快儿童和成人疾病的研究，使研究人员能够研究从儿童到成年的健康相关生活质量轨迹。

DESCRIPTION (provided by applicant): The overall objectives of this project are to validate the PROM IS pediatric item banks in 4 pediatric chronic illnesses, and to link pediatric and adult item banks. We developed 9 pediatric item banks during the first PROMIS grant cycle and have performed cross-sectional testing in children with several chronic illnesses. The proposed work is the natural next step toward integration of PROMIS scales into clinical research. We propose longitudinal studies in children with asthma, cancer, nephrotic syndrome, and sickle cell disease. Each study follows children through a clinical transition known to affect health-related quality of life, and each study will examine the responsiveness of the PROMIS instruments and estimate the minimum important difference (MID) for children. As part of these studies, we have proposed to test a new method for establishing MID and to compare that method with traditional distributional and anchor-based methods. The second overall objective is to link PROMIS pediatric item banks with PROMIS adult item banks. We designed most of the pediatric banks to measure the same underlying trait as their counterpart adult banks (e.g., fatigue), but used the concepts and language of children. We will administer pediatric and adult short forms to adolescents with chronic illnesses with a cross-sectional data collection. For this objective, we will use factor analysis and structural equation modeling to establish the empirical relationships between the pediatric and adult item banks and domains, and, to the extent supported by those relationships, use item response theory to link the pediatric and adult item banks. This study will enable researchers to have comparable scores between children and adults participating in the same study and enable longitudinal studies that follow children into adulthood. PUBLIC HEALTH RELEVANCE: Performing longitudinal validity studies in 4 chronic illnesses will prepare PROMIS for use in future clinical research. By linking the pediatric and adult item banks, we will accelerate research on diseases that affect both children and adults and enable researchers to study trajectory of health-related quality of life from childhood to adulthood.