PROMIS Measures Linked to Improvements in Disease Activity in RA

Incorporating Patient Reported Outcomes Measurement Information System (PROMIS) measures into the treat-to-target (T2T) approach for managing patients with rheumatoid arthritis (RA) was associated with disease activity improvements in this patient population, according to a study published in The Journal of Rheumatology.¹ Additionally, improvement in disease activity was linked to improvements in PROMIS measures.

Karen Kaiser, PhD

Credit: Northwestern University

“Although patient involvement is central to the T2T recommendations for RA therapy, clinical trials evaluating the efficacy of the T2T strategy have focused mainly on composite disease activity measures and states (eg, low disease activity, remission); limited research has examined outcomes that are driven by patient perspectives and priorities,” wrote Karen Kaiser, PhD, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, and colleagues. “It is important to address patient-centered outcomes, such as ability to work, and acknowledge patient concerns, such as cost of therapy, to effectively implement and assess T2T strategies in RA clinical care.”

Involving patients in the decision-making process has been associated with increased satisfaction with treatment as well as treatment adherence in patients with RA. However, investigators noted that patients and clinicians may differ in their consideration of certain aspects of disease when making treatment decisions as improvements in conventional measures of disease activity may not reflect improvement in patient-reported outcomes.²

The longitudinal, observational pilot study assessed the effect of a patient-centered disease management approach on patient satisfaction with care as well as patient outcomes. Investigators integrated PROMIS measures for physical function, social function, pain interference, depression, and fatigue. Eligible patients were recruited from an academic rheumatology clinic between May 2014 and September 2015.

Patients selected 1 PROMIS domain to target their treatment around and participated in quarterly follow-up assessments over a 12-month period. Improvements were defined as a Clinical Disease Activity Index (CDAI) change of >5 points. Changes in scores were evaluated among the group with improved CDAI and compared with those who experienced unchanged or worsened CDAI.

Satisfaction with care was determined using the Functional Assessment of Chronic Illness Therapy – Treatment Satisfaction – Patient Satisfaction Scale (FACIT-TS-PS), which includes subscales for technical competence, treatment staff communication, nurse communication, physical communication, and confidence and trust. Other information collected included a sociodemographic survey and PROMIS computer adaptive tests (CATs).

A total of 119 patients with PROMIS data were included in the study, with a mean age of 57 years. Most (90.8%) participants were female and 76.5% (n = 91) completed all follow-up visits. The analytical sample was split between patients with CDAI >10 (n = 63) and CDAI ≤10 (n = 53).

At the 1-year mark, improvement in CDAI by >5 was reported in 66% (n = 27/41) of patients with baseline CDAI >10 and 13% (n = 6/47) of those with CDAI ≤10. Improvements in CDAI by >5 points were associated with improvements in the 5 PROMIS domains and increased satisfaction with RA treatment. Those with baseline CDAI ≤10 reported more improvement in depression; however, improvements in all other domains were independent of baseline disease activity. Changes in CDAI were greatest among patients who selected pain as a priority domain.

Investigators noted limitations including the observational study design and a lack of control group. Additionally, logistical challenges regarding collecting and scoring PROMIS data in a timely manner were observed.

“Our previous research demonstrated that PROMIS measures can be integrated into the routine clinical care of a sample of patients with RA, and rheumatologists indicated that integration occurred without significant disruption of clinic flow,” investigators noted. “The present study, which incorporated these measures, showed that changes in disease activity at 1 year were related to baseline disease activity.”

References

1. ^{Greene GJ, Beaumont JL, Bacalao EJ, et al. Integrating PROMIS Measures in a Treat-to-Target Approach to Standardize Patient-Centered Treatment of Rheumatoid Arthritis [published online ahead of print, 2023 May 1]. J Rheumatol. 2023;jrheum.2022-1176. doi:10.3899/jrheum.2022-1176}
2. ^{Curtis JR, Shan Y, Harrold L, Zhang J, Greenberg JD, Reed GW. Patient perspectives on achieving treat-to-target goals: a critical examination of patient-reported outcomes. Arthritis Care Res 2013;65:1707-12.}