Background/Purpose: Quantitative disease activity measures are required to implement a treat-to-target algorithm for the treatment of rheumatoid arthritis (RA). Available measures based on patient-derived data have the advantage of ease of use and have been shown to correlate with physician-derived data. While data support the conclusion that the concept of treat-to-target is beneficial to patient outcomes, there is a paucity of data that show that the utilization of any specific disease activity measure improves outcomes. The purpose of this study was to test the hypothesis of whether the addition of the RAPID3 (Routine Assessment Of Patient Index Data 3) patient-reported outcome (PRO) data improves outcomes in RA. Disease activity as measured by DAS28 as well as patient-centric outcomes, including patient reported well-being, patient satisfaction and medication compliance, were measured.

Methods: The intervention design was a single blind, randomized controlled trial of US Veterans with RA. The intervention was to provide PRO data to rheumatologists treating patients in an outpatient setting. PRO data were not provided to physicians for control subjects. All participating physicians attended a lecture series providing education about treat-to-target strategies in RA. Baseline inclusion criteria were patients older than 18 who have had rheumatoid arthritis according to the 1987 ACR revised criteria for RA, and had been seen at least one time previously with diagnosis of RA. Subjects had at least moderate disease activity (DAS28-CRP> 3.2). Trial duration was 12 months. The primary outcome was a change in DAS28. Secondary outcomes included patient satisfaction, percent with minimal clinically important improvement (MCII) in patient global, medication compliance, DAS28, and frequency of achievement of remission criteria (DAS28-CRP<2.3).

Results: The study enrolled 141 subjects with PRO data provided to the treating physician for 71 subjects. Average subject age was 57, 88% were male, and average DAS28 score at entry was 4.01. The average duration of disease was 4.8 years. There were no significant differences in these measures between intervention and control subjects. Data for the primary outcome was available for 108 patients. The DAS28 score decreased to 3.63 ± 0.41 in the intervention group and 3.60 ± 0.43 in the control group. DAS28 remission criteria were met in 4 or 5.6% of intervention subjects and 6 or 8.6% of control subjects. There was a trend to improvement in the MCII for patient global scores in the intervention group.

Conclusion: In this population of US Veterans with relatively advanced RA, the provision of RAPID3 data to rheumatologists who were well-versed in the treat-to-target approach to RA did not significantly improve outcomes.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/incorporation-of-patient-reported-outcomes-data-in-the-care-of-us-veterans-with-rheumatoid-arthritis-a-randomized-controlled-trial/