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的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项拟议的工作是对“儿童和成人评估中的健康和识字”提案的补充，（5 U 01 AR 052181），该报告是根据查佩尔山的北卡罗来纳州大学的RFA-RM-04-011“患者报告的慢性疾病结局的动态评估”提交的（以下简称“CME”）及其合作伙伴，德克萨斯州A&M医学院，德克萨斯州坦普尔斯科特和白色诊所的儿童医院。 PROMIS RFA的研究目标  确定一套核心问题，在不同人群中比较项目、工具和模式的表现，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和新项目，为许多临床环境和慢性病人群开发新的计算机化自适应测试（CAT）工具，并以可扩展的、基于网络的方式完成所有这些工作 需要不同方法的整合以及研究和临床经验的综合。 该独立项目侧重于儿科人群，总体目标是（1）开发一个衡量儿童重要健康领域的患者相关结局（PRO）项目库，以及（2）开发和试点测试CAT工具，以动态管理项目并对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工具创建模型，该模型可适用于在广泛的健康领域和慢性儿童疾病的临床研究（包括临床试验）中评估一般儿童健康状况和治疗效果。 与PROMIS成人项目库一样，在过渡到纵向验证研究之前，一些儿科项目库可以从添加新项目和后续测试中受益。 儿科数据库的资金水平大大低于PROMIS成人项目数据库的可比工作。 因此，儿科的总体样本量较小，未采集“整个样本库”样本。 目前的儿科样本中包含多种慢性疾病，但其他疾病组的样本量较小，无法对哮喘以外的慢性疾病亚组进行数据分析。 该抽样方案允许做出关于将项目纳入最终库的合理决定，然而，不可能提供与成人项目相同的关于一维性的保证水平。 此外，儿科项目是PROMIS独立项目，因此，项目开发数据、项目库文件和项目校准数据目前未保存在PROMIS网络网站上。 本申请中提出的工作将减轻这些限制，并为儿科项目库提供最佳机会，以便在PROMIS 2开始时进行严格的验证研究，并允许PROMIS工具更广泛地一致传播。 此外，该补充与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计划，并有兴趣使用PROMIS工具。这种合作将为PROMIS 2的未来工作提供坚实的基础，并代表了一个强大的机制，以实现整个PROMIS网络，特别是儿科项目的推广。CNMC将作为总共5个癌症机构的协调中心，这些机构将在本研究中共入组300名儿童和青少年，以实现与PROMIS儿科库中项目验证相关的补充目的。

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.