Background/Purpose: The Patient Reported Outcomes Measurement Information System (PROMIS) is an NIH initiative to develop patient-reported outcome measures (PROs) for use across chronic conditions. PROMIS instruments assess outcomes relevant in Rheumatoid Arthritis (RA) including pain interference, physical function social function, fatigue, and depression. We sought to learn whether use of PROMIS instruments could inform the treat-to-target (T2T) approach to RA management, and whether patient reports of disease impact correlate with objective clinical measures. For this study, patients are treated for 1 year using a T2T approach. Using PROMIS item banks, we developed patient-centered targets in five domains: pain, fatigue, depression, physical function, and social function. We report on the preliminary physician assessment of the impact of the PROMIS instruments on their treatment decisions during the year.

Methods: Patients with RA diagnosed by 2010 ACR/EULAR criteria were recruited from our academic clinical practice. At baseline data collection, standard RA assessments included joint counts, RAPID3, and CDAI scores. The research assessment battery included clinical questionnaires, PROMIS CAT’s (computer adaptive tests), prioritization of PROMIS domains, and selection of five items that patients felt were most important within their most highly prioritized domain.

Results: The baseline sample consists of 119 RA patients; median age was 57 (range: 21-77) and 91% were female. Approximately 54% (n=57) exhibited moderate or high disease activity (CDAI m=13.4; SD=11.0). At the time of this analysis, 71 patients (60%) had completed 1 year of therapy. CDAI was recorded for 172 post-baseline visits, with 87 (51%) reporting CDAI >10 and 85 (49%) CDAI ≤10. At each visit, physicians were asked whether the PROs influenced their treatment decisions. For patients with CDAI >10 who had a treatment change (in accordance with T2T recommendations), PROs influenced this decision at 18/68 visits. When CDAI was >10 and treatment was not changed, PROMIS data influenced this decision at 15/40 visits. When CDAI ≤10, PROMIS data influenced decisions at 2/17 visits at which treatment was changed and 41/142 at which it was not. When asked whether the PRO data affected their disease management in some other way, physicians reported that it did for 20/262 post-baseline visits.

Conclusion: The PROMIS instrument collects information on patient impact of disease. In 20/85 (23.5%) visits to date, when treatment decisions were made contrary to T2T recommendations, rheumatologists reported that the PROMIS data influenced their care, suggesting that these data may provide relevant information that is not captured on standard, objective disease activity measures. Further analysis will explore other factors that may have affected care decisions, as well as any differential impact of the PRO data on treatment decisions in patients with either low or high disease activity.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/using-patient-reported-outcomes-to-inform-a-treat-to-target-treatment-approach-in-ra/