The Patient-Reported Outcomes Measurement Information System (PROMIS)

TLDR

The NIH Patient‑Reported Outcomes Measurement Information System (PROMIS) Roadmap is a five‑year cooperative program that develops, validates, and standardizes item banks to measure patient‑reported outcomes across common medical conditions. This article summarizes the organization and scientific activities of the PROMIS network during its first two years. The network, comprising six primary research sites, a statistical coordinating center, and NIH scientists, is governed by a steering committee and organized into functional subcommittees and working groups that use a WHO‑based framework, item‑response‑theory analysis of 11 large datasets, and qualitative item review to select and refine items for testing. During the first year the network created an item library and activated three protocols (Domain Mapping, Archival Data Analysis, and Qualitative Item Review), and in the second year it developed item banks for five broad health domains and initiated testing of these banks in general and target patient populations.

Abstract

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.