The PROMIS (Patient-Reported Outcomes Measurement Information System) initiative developed new ways to measure patient-reported outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and social role participation that have a major impact on quality-of-life across a variety of chronic diseases. Clinical measures of health outcomes, such as x-rays and lab tests, may have minimal relevance to the day-to-day functioning of patients with chronic diseases. Often, the best way patients can judge the effectiveness of treatments is by changes in symptoms. The goal of PROMIS was to improve the reporting and quantification of changes in PROs.
This initiative applied to a wide range of disorders including cancer, congestive heart failure, depression, arthritis, and multiple sclerosis, as well as chronic pain conditions. PROMIS created new paradigms for how clinical research information is collected, used, and reported. The PROMIS initiative addressed a need in the clinical research community for a rigorously tested PRO measurement tool that utilized recent advances in information technology, psychometrics, and qualitative, cognitive, and health survey research.
The PROMIS program developed, tested, and implemented a reporting system to collect and quantify clinically important outcomes such as pain, fatigue, physical functioning, emotional distress, and social role participation. During the first phase of the initiative, PROMIS formed a network of researchers that developed questions or "items" to analyze five outcomes or "domains." PROMIS created a psychometrically-robust computer adaptive testing (CAT) system, based on item response theory (IRT), to administer these items. In addition, it developed a web-based system to give clinical researchers access to the item banks and the CAT system. Whether administered through an iterative CAT system, that allows research flexibility, or by paper version short forms, PROMIS demonstrated improved efficiency and sensitivity in comparison with existing PROs. Long-term trials are planned to address issues of validity and sensitivity to change in clinical populations. The increased efficiency, flexibility, and sensitivity of PROMIS holds potential to become a widely-accepted, standardized PRO measurement tool that will allow greater comparability of studies, with reduced burden on patients.
The second phase of the PROMIS initiative continued to advance the field of patient self-reporting in clinical research and practice. This phase:
- developed new items and domains,
- translated items and domains into other languages such as Spanish and Chinese to facilitate international studies;
- conducted validation studies in large-scale clinical trials in a variety of clinical populations;
- made PROMIS tools accessible to a wider range of clinical researchers and patient-care communities, and optimized its usability for rapid adoption;
- provided education and outreach to familiarize users with new developments in PROMIS;
- improved PROMIS tools to allow for better outcomes in clinical trials, and, potentially, better individual and clinical decisions;
- engaged stakeholders at all levels, by interacting with other health-related federal agencies, forged new relationships with patients and patient organizations, and established public-private partnerships to sustain PROMIS once Common Fund support had ended.