Initial Validation of PROMIS Physical Function/Disability Scales in Rheumatoid Arthritis (RA)
Completed
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT00786227
- Run by
- Stanford University
- People needed
- 761
- Starts
- 2008-06-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2013-05-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Unable or unwilling to complete questionnaires
Where it is running
- Stanford University School of Medicine — Palo Alto, California, United States
Full record on ClinicalTrials.gov
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