Primary author: Kara Egan

PROMIS: Patient-Reported Outcomes Measurement Information System

PROMIS is “a network of network of NIH-funded primary research sites and coordinating centers working collaboratively to develop a series of dynamic tools to reliably measure patient-reported outcomes (PROs)"(1). PROMIS is a part if the NIH sponsored Roadmap network project (2). Patient reported outcomes, or the patients’ belief of the outcome of their medical treatment, have become a new outcome variable for medical procedures. PROMIS is working to develop new ways to produce valid and reliable data from patients about their health related outcomes. The Patient Reported Outcomes, or PROs, are collected via Item Response Theory (IRT) and Computerized Adaptive Testing (CAT). These tools collect data that is more precise and requires fewer subjects to achieve statistical significance in clinical trials (2). Data collected from PROMIS will ultimately be used to determine efficacy of biomedical treatments and to increase research efficiency by reducing patient numbers and therefore research costs.

History:
PROMIS was started by the National Institute of Health in 2004 as a multicenter initiative to support the “Re-engineering of the Clinical Research Enterprise Initiative” (1). This followed the 2002 meetings held by the NIH to develop a ‘roadmap’ for new routes in biomedical research in the 21st century that no single NIH Institute could handle by itself (2). The Roadmap developed ways to improve medical research by increasing productivity and efficiency in three areas: “New Pathways to Discovery, Research Teams of the Future, and Re-engineering the Clinical Research Enterprise” (1).

Development:
To develop questionnaires, PROMIS investigators searched four databases to identify instruments that had been previously used to collect medical outcome data and had been validated. Inclusive searches were done to collect information on physical, emotional, social, pain, and fatigue outcomes after medical treatment(1).

Primary Research Sites:
The PROMIS Network consists of thirteen primary research sites (PRS) and three coordinating centers which all work together with the NIH and contribute to the Roadmap reengineering initiative.
Duke University; Stanford University; Stony Brook University; University of North Carolina at Chapel Hill; University of Pittsburg; University of Washington; Children’s Hospital of Philadelphia; Cincinnati Children’s Hospital Medical Center; Georgetown University; University of California at Los Angeles; University of Maryland; Boston University / Kessler Foundation
Each of these institutes participates in the planning and implementation of PROMIS activities designed to address the Strategic Plan and Research Agenda (SPRA). However, NIH has principle responsibility for the project, including research design and protocol development (1).

Centers:
PROMIS Statistical Center; PROMIS Network Center; and the PROMIS Technical Center.

PROMIS Statistical Center (PSC):
The PSC provides researchers at the primary research sites with advisement on the use of proper qualitative and quantitative research methods. They develop and implement processes to ensure data quality; assist in the development and implementation of protocols. Consultation is provided to each site on research design, sample size, sampling plans and power estimates for item database testing and other statistical support for the network (1).

PROMIS Network Center (PNC):
The PNC helps to further development the PROMIS SPRA and ensures site fidelity. The PNC focuses on “supporting the long-term viability and sustainability of the PROMIS Network” (1).

PROMIS Technical Center (PTC):
The PTC provides a resourceful and secure data collection, storage, and dissemination system for the Roadmap project and PROMIS primary research sites. The PTC raises awareness for PROMIS by publishing results and updates, giving presentations, and printing educational materials (1).

Success of PROMIS:
Early Successes of the first round of PROMIS funding (2004 to 2009) included the design and implementation of a web based interface along with the specific items of inquiry for both adult and pediatric item databases. The PROMIS questionnaire was created and given to individuals suffering from chronic diseases and the resulting data used to build the PROMIS database. From this database, an online tool was created where individuals can input their data and get instant health assessments. Finally, a plan to “establish a public-private partnership to sustain the repository, ensure scientific excellence, improve future data collection activities, add new domains and items to the system, test and adapt the system for new populations, maintain the system in the public domain, and extend the application of the system for clinical research and practice” was developed (1).

The Future of PROMIS:
From 2009 through 2013 the PROMIS Network will continue to work to expand the framework. The items will be translated into other languages so that international research will be possible. PROMIS will be made available to more communities and clinics, and tutorials seminars will be available to demonstrate the utility of PROMIS.

National Cancer Institute:
The National Cancer Institute utilizes PROMIS by using it as a web-base resource to survey and measure patient’s symptoms and HRQOL (pain, fatigue, depression and physical function). By using this resource researches are able to better monitor their patient’s conditions as well as increase their understanding of the disease and how to provide better solutions for their patient’s needs (3).

Aside from monitoring patient’s symptoms, health officials may utilize PROMIS for intervention strategies such as those relating to smoking and alcohol abuse. A patient may be more likely to report accuracy through using this system instead of reporting face to face.

Public Health Application:
PROMIS was created to improve efficiency in clinical trials, and, potentially, better individual and clinical decisions. By creating an effective, reliable, and valid way to determine effective treatment of chronic disease, clinical trials can demonstrate significance with fewer subjects. This results in a reduction of costs to conduct research studies, faster identification of effect treatments, and the opportunity for more patients to benefit from the treatment.

References

1. PROMIS: Patient-reported outcomes measurement information system; dynamic tools to measure health outcomes from the patient perspective. Retrieved fromhttp://www.nihpromis.org/default.aspx.

2. Fries, J. F. Bruce, B., Cella, D. (2005). The promise of PROMISE: Using item response theory to respond to assessment of patient-reported outcomes. Clinical and Experimental Rheumatology. 23,(S39), 853-857.

3. How is NCI Supporting PROMIS (2010). National Cancer Institute. Retrieved from
http://outcomes.cancer.gov/tools/promis/.