University North Carolina – Chapel Hill


Grant Number: 2U01AR052181-06
Project Title: PROMIS Pediatrics: Longitudinal Validation and Linking Pediatric and Adult Item Banks
PI Name, Title and Contact Information: Darren DeWalt, MD, MPH, Principal Investigator Assistant Professor of Medicine, Division of General Medicine, University of North Carolina at Chapel Hill
Other Key Personnel: Carlton Dampier, MD, CPI, Co-Investigator
Chan Huang, PhD, Co-Investigator
Pamela S. Hinds, PhD, RN, FAAN, Co-Investigator
Debbie Gipson, MD, MS, Co-Investigator
David Thissen, PhD, Co-Investigator
James W. Varni, PhD, Co-Investigator
Elizabeth Shenkman, PhD, Co-Investigator
Ulrike Ravens-Sieberer, PhD, Co-Investigator
Web Site:  

Abstract:

The overall objectives of this project are to validate the PROMIS pediatric item banks, developed during PROMIS 1, in four pediatric chronic illnesses, and to link pediatric and adult item banks. During PROMIS 1 we developed nine item banks using the qualitative item development and quantitative analysis strategies developed by the PROMIS Network. Currently, we are conducting a cross–sectional study of children with chronic illnesses to assess construct validity and confirm item calibrations. At the end of PROMIS 1, these nine item banks will be poised for longitudinal validity studies to assess the following:

  • (a) responsiveness to change during well defined clinical transitions,
  • (b) performance relative to established measures, and
  • (c) minimally important differences (MID)

The proposed set of validity studies will position the PROMIS pediatric item banks for use in clinical research, establish validity in four important clinical groups, bridge the PROMIS pediatric and adult scales for long–term longitudinal studies and studies that include children and adults, and lead to the next wave of item bank refinement and domain development for a PROMIS Pediatric Measurement System. This project proposes two specific aims:

Specific AIM 1. Perform longitudinal validity studies of the PROMIS pediatric item banks for four pediatric chronic illnesses. Each study includes comparison with legacy measures, evaluation of responsiveness to clinical change, and estimation of MID. Each study is longitudinal and focuses on an important clinical transition.

  • 1A. Asthma: Longitudinal study of children with asthma to measure the change in PROs with acute changes in clinical status.
  • 1B. Cancer: Longitudinal study of children with cancer to measure the change in PROs with chemotherapy and return to stability after chemotherapy.
  • 1C. Nephrotic Syndrome: Longitudinal study of children with nephrotic syndrome to measure change in PROs with change in nephrotic syndrome relapse or remission status.
  • 1D. Sickle Cell Disease (SCD): Longitudinal study of children with SCD to measure change in PROs during intermittent acute painful episodes and their subsequent recovery to baseline health status.

Specific AIM 2. Link the PROMIS pediatric item banks with the adult item banks to establish comparable scores and enable longitudinal studies that cross from childhood to adulthood.

  • 2A. Use factor analysis and structural equation modeling to establish the empirical relationships between the pediatric and adult item banks and domains.
  • 2B. To the extent supported by empirical analyses in 2A, link the pediatric item banks with the adult item banks to provide comparable scores and enable longitudinal studies that cross from childhood to adulthood.

For questions concerning UNC's role in the PROMIS network, please contact Darren DeWalt, MD, MPH, at dewaltd@med.unc.edu. For more information about the PROMIS network, go to http://www.nihpromis.org.