HEALTH AND LITERACY IN CHILD AND ADULT ASSESSMENT: EXPANDED TESTING OF THE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项拟议的工作是对提案“儿童和成人评估中的健康和识字”(5 U01 AR052181)的补充，该提案是针对北卡罗来纳大学教堂山分校及其合作伙伴、北卡罗来纳大学教堂山分校及其合作伙伴、德克萨斯州A&M医学院和德克萨斯州坦普尔斯科特和怀特诊所的儿童医院提交的RFA-RM-04-011“患者报告的慢性病结果的动态评估”。PROMIS RFA的研究目标是确定一组核心问题，比较项目、工具和模式在不同人群中的表现，使用包括项目反应理论(IRT)在内的尖端测量方法来测试现有的和新的项目，为许多临床环境和慢性病人群开发一种新的计算机化适应性测试(CAT)工具，并以可扩展的、基于网络的方式完成所有这些工作，要求整合不同的方法并综合研究和临床经验。 该独立项目侧重于儿科人群，总体目标是(1)建立患者相关结果(PRO)项目库，衡量儿童重要的健康领域，(2)开发和试行CAT工具，以动态管理这些项目，并对8-17岁儿童的每个领域进行评分。长期目标是创建和测试CAT工具创建的模型，该模型可适用于在包括临床试验在内的广泛的健康领域和慢性儿童疾病的临床研究中评估一般儿童健康状况和治疗效果。 与PROMIS成人题库一样，在过渡到纵向验证研究之前，一些儿科题库可以从添加新项目和随后的测试中受益。儿科题库的资金水平明显低于PROMIS成人题库完成的可比工作。因此，儿科的总体样本量较小，并且没有收集整个银行的样本。目前的儿科样本中有各种慢性病，但其他疾病组的样本量较小，因此无法对哮喘以外的慢性病亚组进行数据分析。这一抽样方案允许做出合理的决定，将项目纳入最终的银行，然而，不可能提供成人项目所提供的关于单维度的相同水平的保证。此外，儿科项目是一个独立于PROMIS的项目，因此，项目开发数据、题库文件和项目校准数据目前不在PROMIS网络网站上维护。 本申请中提议的工作将缓解这些限制，并为儿科题库提供最佳机会，以便在PROIS 2开始时为严格的验证研究做好准备，并允许更广泛、一致地传播PROIS工具。此外，这一补充还与PROMIS工具的重要未来客户建立了合作伙伴关系，包括在风湿病、镰状细胞疾病、康复、癌症、肥胖和慢性肾脏疾病方面的数据收集工作。这些合作者有大型的国家研究项目，并对使用PROMIS工具感兴趣。这一合作将为PROMIS 2今后的工作奠定坚实的基础，并为整个PROMIS网络，特别是儿科项目提供一个强大的外联机制。CNMC将作为总共5个癌症设置的协调地点，总共将有300名儿童和青少年参加这项研究，以实现与PROMIS儿科数据库中的项目验证相关的补充的目标。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This proposed work is a supplement to the proposal, "Health and Literacy in Child and Adult Assessment," (5 U01 AR052181) which was submitted in response to RFA-RM-04-011, "Dynamic Assessment of Patient-Reported Chronic Disease Outcomes" by The University of North Carolina at Chapel Hill (hereafter UNC), and its partners, the UNC Health Care System, Texas A&M College of Medicine, and The Children's Hospital at Scott & White Clinic in Temple, Texas. The PROMIS RFA's research objectives  to identify a core set of questions, to compare item, instrument, and mode performance across diverse populations, to use cutting-edge measurement approaches including item response theory (IRT) to test existing and new items, to develop a new computerized adaptive testing (CAT) tool for many clinical settings and chronic disease populations, and to do all this in an expandable, web-based way call for an integration of different methods and for a synthesis of research and clinical experience. The independent project focuses on the pediatric population, with the overall objectives of (1) developing a bank of Patient Related Outcomes (PRO) items measuring important health domains for children, and (2) developing and pilot-testing a CAT tool to administer the items dynamically and to score each domain in children ages 8-17 years. The long-term objective is to create and test a model of CAT tool creation that can be adapted to assessing general childhood health status and treatment effects in clinical research, including clinical trials, across a wide range of health domains and chronic childhood diseases. As with the PROMIS adult item banks, some of the pediatrics banks could benefit from the addition of new items and subsequent testing before transitioning into longitudinal validation studies. The Pediatrics banks are being assembled with significantly lower funding levels than comparable work completed on the PROMIS adult item banks. Hence, the overall sample size was smaller for pediatrics and "whole bank" samples were not collected. A variety of chronic illnesses are represented in the current pediatrics sample, however small sample sizes in other disease groups preclude data analysis in chronic disease subgroups other than asthma. This sampling scheme allowed reasonable decisions to be made about inclusion of items in final banks, however, the same level of assurances about unidimensionality afforded the adult project are not possible. In addition the pediatrics project was a PROMIS Independent project and therefore, item development data, item bank documentation, and item calibration data are not currently maintained on the PROMIS Network website. The work proposed in this application will mitigate these limitations and provide the best opportunity for the pediatrics item banks to emerge ready for rigorous validation studies in the beginning of PROMIS 2 and allow for wider consistent dissemination of PROMIS tools. Moreover, this supplement establishes partnerships with important future customers of PROMIS tools including data collection efforts in rheumatology, sickle cell disease, rehabilitation, cancer, obesity, and chronic kidney disease. These collaborators have large national research programs and are interested in using PROMIS tools. This collaboration will provide a solid basis for future work in PROMIS 2 and represents a powerful mechanism to achieve outreach for the overall PROMIS Network and the pediatrics project in particular. CNMC will serve as the coordinating site for a total of 5 cancer settings that together will enroll 300 children and adolescents in this study to achieve the aims of the supplement related to validation of the items in the PROMIS pediatric banks.