Validating PROMIS Instruments in Back and Leg Pain

Status:	Completed
Conditions:	Back Pain, Chronic Pain
Therapuetic Areas:	Musculoskeletal
Healthy:	No
Age Range:	18 - Any
Updated:	3/30/2013
Start Date:	July 2008
End Date:	July 2009
Contact:	Alyssa Bamer, MA
Email:	adigiaco@u.washington.edu
Phone:	206-221-5302

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.

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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

We found this trial at

sites

Harborview Medical Center

325 9th Ave
Seattle, Washington 98104

(206) 744-3300