Validating PROMIS Instruments in Back and Leg Pain

Completed

Conditions studied: Leg Pain, Back Pain

In brief

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.

Key facts

Study ID

NCT00784251

Run by

University of Washington

People needed

226

Starts

2008-07-01

Expected to finish

2010-06-01

Last updated by the study team

2013-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Back pain for at least 6 weeks
• Scheduled for any kind of spinal injection (i.e. epidural steroid injection, facet joint injection or sacroiliac joint injection) recommended by clinic physician

You may not qualify if…

• Not scheduled for ESI
• Has dementia or other cognitive impairments that would interfere with questionnaire completion
• Lumbar surgery within the last year; unstable neurological symptoms (e.g., experiencing bowel or bladder incontinence, numbness in groin area, new or worsening weakness in legs, or new numbness or tingling in legs); cauda equine syndrome; cancer; spinal cord injury (SCI); vertebral fractures; or multiple sclerosis (MS)

Where it is running

• Harborview Medical Center — Seattle, Washington, United States
• UWMC Sports and Spine Physicians — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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