Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Collaborators:
QualityMetrics
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT00786227
First received: November 5, 2008
Last updated: May 1, 2013
Last verified: May 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
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Ability of Legacy or PROMIS instruments to detect change over 6 and 12 months in RA: (a) when an anti-TNF drug has been begun, (b) when the patient reports improvement over the prior period, (c) when the patient global has improved over the prior period [ Time Frame: Measured at 6 and 12 months ] [ Designated as safety issue: No ]

Enrollment: 761
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Legacy HAQ-DI first, PROMIS 20-item short form first
To eliminate effects due to order of administration, patients with RA will be randomized to complete either the Legacy measure HAQ-DI first in the assessment battery or the PROMIS 20-item short forms first.

Detailed Description:

This is a longitudinal clinical validation study of the PROMIS physical function, fatigue, and pain impact short forms in patients with rheumatoid arthritis (RA). Patients will complete assessments at two points: baseline and 6 months post-baseline. The responsiveness of six PROMIS static forms (physical function [HAQ, PF-10, 10 and 20 item short forms], fatigue, and pain impact) will be evaluated for change over the 6-month period. Physical function change scores will be contrasted with established Legacy physical function instruments. The test of "responsiveness" is defined as the ability of the instrument to detect change after major treatment intensification, self-reported improvement in functioning, or positive changes in patient global scores. The order of presentation of forms will be randomly assigned to eliminate questionnaire fatigue or other order effects as factors. We will also evaluate the test-retest reliability of four PROMIS static forms (HAQ and PF-10 physical function, fatigue, and pain impact) in a random subsample of patients at 1-week post-baseline. In addition, we will evaluate convergent validity of PROMIS measures of physical function by comparing self-report with observation of performance of physical function tasks in a subsample of patients randomly selected from the local geographic region.

  Eligibility

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

Patients from three sources will be included in the study: ARAMIS RA cohort, Stanford RA registry, and Stanford RA clinical trials patients.

Criteria

Inclusion Criteria:

  • Rheumatologist-diagnosed RA
  • Meets one of the conditions for treatment intensification as described in the protocol
  • Ability to read, write, and speak English
  • Ability to understand and provide informed consent

Exclusion Criteria:

  • Unable or unwilling to complete questionnaires
  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: NCT00786227

Locations
United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
QualityMetrics
Investigators
Principal Investigator: James F. Fries, MD Stanford School of Medicine
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT00786227     History of Changes
Other Study ID Numbers: 07-01, 5U01AR052158, 5U01AR052158-02
Study First Received: November 5, 2008
Last Updated: May 1, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014