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

NCT ID: NCT00786227

Last Updated: 2013-05-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 761 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-07-31

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 www.nihpromis.org.

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

NIH

Sponsor Role: collaborator

QualityMetrics

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James F. Fries, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford School of Medicine

Locations

Stanford University School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

5U01AR052158

Identifier Type: NIH

Identifier Source: secondary_id

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5U01AR052158-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

07-01

Identifier Type: -

Identifier Source: org_study_id