The National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information
System (PROMIS) Roadmap initiative (www.nihpromis.org) is a 5-year cooperative group
program of research designed to develop, validate, and standardize item banks to measure
patient-reported outcomes (PROs) relevant across common medical conditions. In this
article, we will summarize the organization and scientific activity of the PROMIS
network during its first 2 years.
The network consists of 6 primary research sites (PRSs), a statistical coordinating
center (SCC), and NIH research scientists. Governed by a steering committee, the network
is organized into functional subcommittees and working groups. In the first year,
we created an item library and activated 3 interacting protocols: Domain Mapping,
Archival Data Analysis, and Qualitative Item Review (QIR). In the second year, we
developed and initiated testing of item banks covering 5 broad domains of self-reported
health.
The domain mapping process is built on the World Health Organization (WHO) framework
of physical, mental, and social health. From this framework, pain, fatigue, emotional
distress, physical functioning, social role participation, and global health perceptions
were selected for the first wave of testing. Item response theory (IRT)-based analysis
of 11 large datasets supplemented and informed item-level qualitative review of nearly
7000 items from available PRO measures in the item library. Items were selected for
rewriting or creation with further detailed review before the first round of testing
in the general population and target patient populations.
The NIH PROMIS network derived a consensus-based framework for self-reported health,
systematically reviewed available instruments and datasets that address the initial
PROMIS domains. Qualitative item research led to the first wave of network testing
which began in the second year.