The primary PROMIS network projects at the University of North Carolina (UNC) at Chapel Hill include the Qualitative Item Review (QIR) Work Group and the Social Outcomes Domain Work Group. UNC co-chairs the QIR Work Group, which develops standards for items to meet for inclusion in the PROMIS network item bank. This work involves establishing procedures for review of items from existing questionnaires. This includes procedures for elimination ("winnowing") of items not meeting PROMIS standards and procedures for expert review and rewriting of items. The QIR Work Group works closely with the Domain Hierarchy Group of the PROMIS network. Another part of the work of the QIR Work Group involves establishing standards for the network to use in conducting cognitive interviews of persons with low literacy to ensure that they can adequately understand and appropriately respond to all items that are to be included in the item bank. The procedures and standards developed by the QIR Work Group are documented in the QIR Protocol.
For example, the QIR Work Group establishes standards for the network to use in conducting focus groups and cognitive interviews of persons with low literacy. This is an effort to ensure that PROMIS participants can adequately understand and appropriately respond to items that are included in the item bank.
As part of the network projects, UNC chairs the Social Outcomes Domain Work Group. The aims of this work group include (1) to define the scope of the social outcomes domain, (2) to delineate subdomains within social outcomes, (3) to identify existing self-report items pertaining to social outcomes and its subdomains, (4) to perform the QIR process for those items, (5) to administer items so that they may be formally assessed by the Statistical Coordinating Center using IRT, and (6) to provide expertise in methods for the network to evaluate the performance of those items in anticipation of their inclusion in a CAT.
The UNC primary research site is the only PROMIS independent project primarily focused on children (younger than 18 years). The long-term objective of this independent project is to develop an item bank and CAT module for children (age 8 to 17) similar to that being developed by the network for adults. However, because of funding limitations, the work of the independent project will focus on pediatric asthma—by far the most common chronic childhood disease in children—and healthy children. We anticipate extending coverage of the pediatric item bank to other childhood chronic diseases through extensions of the UNC parent grant and through supporting pediatric supplements submitted by other primary research sites, and coordinated by the PROMIS Pediatric Network Work Group. UNC chairs the PROMIS Pediatric Network Work Group.
The UNC independent project will (1) use IRT to evaluate item parameters for the PedsQLT4.0 in 8,000 children in four core domains (physical, emotional, social, and school/cognitive) and an asthma-specific domain, taking this widely used instrument as a starting point for a pediatric item bank, (2) develop new items and collect data in 1,060 children in North Carolina and Texas, using IRT to estimate item parameters, (3) develop and pilot-test a CAT tool and use it to survey 375 children in North Carolina and Texas. Our long-term objective is to develop a CAT to assess patient-reported outcomes in clinical research across a wide range of chronic childhood diseases. However, this initial data collection will be in children with asthma and in healthy children.
For questions concerning UNC's role in the PROMIS network, please contact either Darren DeWalt, PhD, at dewaltd@med.unc.edu or Debra Irwin, PhD, MSPH, by e-mail at dirwin@email.unc.edu.