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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786227
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : May 3, 2013
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Stanford University

Brief 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

Condition or disease
Rheumatoid Arthritis

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.

Study Type : Observational
Actual Enrollment : 761 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)
Study Start Date : June 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786227

United States, California
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: James F. Fries, MD Stanford School of Medicine

Responsible Party: Stanford University Identifier: NCT00786227     History of Changes
Other Study ID Numbers: 07-01
5U01AR052158 ( U.S. NIH Grant/Contract )
5U01AR052158-02 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: May 2013

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