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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR020359-05S2
Application #
8167303
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2010-01-20
Project End
2010-06-30
Budget Start
2010-01-20
Budget End
2010-06-30
Support Year
5
Fiscal Year
2010
Total Cost
$12,232
Indirect Cost
Name
Children's Research Institute
Department
Type
DUNS #
143983562
City
Washington
State
DC
Country
United States
Zip Code
20010
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