Validating PROMIS Instruments in Back and Leg Pain

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dagmar Amtmann, University of Washington
ClinicalTrials.gov Identifier:
NCT00784251
First received: October 30, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition
Leg Pain
Back Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validating PROMIS Instruments in Back and Leg Pain

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • PROMIS measures [ Designated as safety issue: Yes ]

Enrollment: 226
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with back and leg pain who are scheduled for epidural steroid injections and who have had pain for at least 6 weeks.

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784251

Locations
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
UWMC Sports and Spine Physicians
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Dagmar Amtmann, PhD University of Washington
  More Information

No publications provided

Responsible Party: Dagmar Amtmann, Study Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00784251     History of Changes
Other Study ID Numbers: 33606-J, 5U01AR052171-02
Study First Received: October 30, 2008
Last Updated: December 10, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Pain
Leg pain
Back pain
PROMIS

Additional relevant MeSH terms:
Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014