Validating PROMIS Instruments in Back and Leg Pain

Back Pain Clinical Trial

Official title:

Validating PROMIS Instruments in Back and Leg Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784251
• Other study ID #: 33606-J
• Secondary ID: 5U01AR052171-02
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: December 10, 2013
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: December 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Leg Pain

Locations

Country	Name	City	State
United States	Harborview Medical Center	Seattle	Washington
United States	UWMC Sports and Spine Physicians	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS measures			Yes