Abstract

The overall status in rheumatoid arthritis (OSRA) instrument is a simple summary of health status, including disease activity (OSRA-A) and damage (OSRA-D) scores. Despite evidence of the validity of the OSRA, uptake has been low. This study aimed to assess the responsiveness and re-examine the validity of the OSRA using the measures from the British Rheumatoid Outcome Study Group (BROSG) randomized controlled trial of aggressive vs symptomatic treatment of rheumatoid arthritis (RA) patients. 466 patients were recruited. Outcome measures included the OSRA, the OMERACT core set and the DAS28, and were collected at baseline and annually for the 3 yrs of the trial. X-rays of the hands and feet were taken at baseline and 3 yrs. Patients were assigned a Townsend score (a measure of social deprivation) according to area of residence. Construct validity was assessed by correlating the OSRA with a range of outcome measures, and testing for the known inequality in RA outcome between patients classified by social deprivation. Responsiveness to change was assessed against self-reported change over the first year of the trial. The OSRA-A and OSRA-D measures demonstrated construct validity, performing as hypothesized. The OSRA-A was the most responsive measure in the BROSG trial in detecting patient reported improvement and deterioration. The OSRA-D demonstrated similar responsiveness to alternative measures. Our results demonstrate the validity and responsiveness of the OSRA, and its potential for inclusion in clinical trials. More important, as the OSRA is quick and easily calculated, uses routinely collected information, and provides useful quantitative information about a patient's status and progress it is suitable for use in the routine clinic.

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