Validating PROMIS Instruments in Back and Leg Pain
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Validating PROMIS Instruments in Back and Leg Pain|
- PROMIS measures [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
The University of Washington Center on Outcomes Research in Rehabilitation (UWCORR) is a member of the Patient Reported Outcomes Information System (PROMIS) Network. PROMIS is funded by the NIH Roadmap initiative, working to improve the efficiency and accuracy of measuring patient-reported outcomes. UWCORR works collaboratively with five research sites (Stanford University, Duke University, State University of New York, University of Pittsburgh, and University of North Carolina) and a Statistical Coordinating Center (NorthShore University HealthSystem).
Collectively, the goal of the PROMIS Network is to create a publicly available system that can be periodically added to and modified and that allows clinical researchers to access a common repository of items and computerized adaptive tests. The first step in achieving this goal was to build item pools and develop core questionnaires that measure key health outcome domains that are manifested in a variety of disabilities and chronic conditions. The resulting six item banks cover the domains of pain, fatigue, social health, physical functioning, emotional functioning, and sleep-wake functioning.
The next step in this process is to validate the PROMIS item banks and to examine their utility as computerized adaptive tests (CATs) with individuals diagnosed with a variety of chronic conditions and disabilities. At UWCORR, we will recruit patients with back and leg pain who were treated with epidural steroid injections. This protocol is aimed at comparing the psychometric properties of the PROMIS item banks with non-PROMIS 'gold standard' instruments, diagnostic data, and medical records. We will compare de-identified data from this study with de-identified data from other PROMIS research centers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784251
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|UWMC Sports and Spine Physicians|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Dagmar Amtmann, PhD||University of Washington|