The Data Management Core for this U19 PEPR proposed research network (center) will support the broad, long-range activities of the proposed projects, including all aspects of statistical support before, during and after data collection (University of North Carolina, UNC) and a scalable i2b2 data warehouse infrastructure to facilitate data sharing and use (Boston Children's Hospital, BCH). The Core will provide leadership and expertise in psychometrics, biostatistics, bioinformatics, and data management. Dr. Antonia Bennett (UNC) will serve as Director of the Data Management Core. As a member of the Executive Committee, Dr. Bennett will lead the activities of the Core in support of programmatic goals (Years 1-4). Dr. David Thissen (UNC, Lead Psychometrics) and Dr. Lloyd Edwards (UNC, Lead Biostatistician) will lead a highly qualified team of PhD and MS psychometricians and biostatisticians with substantial experience with PROMIS Pediatric measures in the data analyses for the proposed research project specific aims. Analyses will be conducted on both a disease- by-disease basis (beginning in Year 3) and combining data across disease conditions (Year 4). To facilitate the sharing and use of data collected by the Childhood Arthritis and Rheumatology Research Alliance (CARRA), the Cancer Pediatric PRO Research Network, and the Crohn's and Colitis Foundation of America (CCFA) Partners Kids and Teens Internet Cohort, the Data Management Core will host a virtual, federated i2b2 data warehouse led by Dr. Marc Natter (BCH, Lead Bioinformatician) (Year 4). To ensure high quality data and security of information, the Data Management Core will oversee and coordinate data management activities across research project disease groups, including establishing a common data dictionary, monitoring accrual, and compliance with data and resource sharing policies (Years 1-4). Through UNC's involvement in the PROMIS I and PROMIS II studies, the Data Management Core has substantial expertise and experience in the development, validation, implementation and analysis of PROMIS Pediatric measures. UNC has been a central coordinating center for the PROMIS Pediatric measures since the inception of PROMIS in 2004. For PROMIS I, UNC was the only site of the 6 PROMIS Network research sites to focus on pediatric PRO measures. UNC led the creation and initial validation of the original PROMIS Pediatric self-report measures, including PROMIS Pediatric item banks and short forms for: physical function- mobility [1], physical function-upper extremity [1], depressive symptoms [2], anxiety [2], fatigue [3], anger [4], pain interference [5], peer relationships [6], and asthma impact [7]. For PROMIS II, UNC was the main statistical and coordinating center (PI: Reeve) for the longitudinal validation of the original PROMIS pediatric measures in children with sickle cell disease (based at Emory University), asthma (at University of Florida) [8; 9], cancer at (Children's National Health System), and nephrotic syndrome (at the University of Michigan) [10]. The exceptional depth of expertise in PROMIS and modern test theory among members of this proposal, including Dr. Reeve (Overall PI), Dr. Thissen (lead psychometrician), Dr. Edwards (lead biostatistician), Dr. Wang (biostatistician/psychometrician), and Dr. Langer (psychometrician), will produce leading edge, high quality research on the clinical meaningfulness and usefulness of PROMIS Pediatric measures.
| Nigrovic, Peter A; Beukelman, Timothy; Tomlinson, George et al. (2018) Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST). Clin Trials 15:268-277 |
| Balevic, Stephen J; Becker, Mara L; Cohen-Wolkowiez, Michael et al. (2017) Clinical Trial Design in Juvenile Idiopathic Arthritis. Paediatr Drugs 19:379-389 |
| Hersh, Aimee O; Salimian, Parissa K; Weitzman, Elissa R (2016) Using Patient-Reported Outcome Measures to Capture the Patient's Voice in Research and Care of Juvenile Idiopathic Arthritis. Rheum Dis Clin North Am 42:333-46 |
