Abstract
PurposeTo evaluate the reliability and validity of 11 PROMIS measures to assess symptoms and impacts identified as important by people with rheumatoid arthritis (RA).MethodsConsecutive patients (N = 177) in an observational study completed PROMIS computer adapted tests (CATs) and a short form (SF) assessing pain, fatigue, physical function, mood, sleep, and participation. We assessed test-test reliability and internal consistency using correlation and Cronbach’s alpha. We assessed convergent validity by examining Pearson correlations between PROMIS measures and existing measures of similar domains and known groups validity by comparing scores across disease activity levels using ANOVA.ResultsParticipants were mostly female (82%) and white (83%) with mean (SD) age of 56 (13) years; 24% had ≤ high school, 29% had RA ≤ 5 years with 13% ≤ 2 years, and 22% were disabled. PROMIS Physical Function, Pain Interference and Fatigue instruments correlated moderately to strongly (rho’s ≥ 0.68) with corresponding PROs. Test-retest reliability ranged from .725–.883, and Cronbach’s alpha from .906–.991. A dose-response relationship with disease activity was evident in Physical Function with similar trends in other scales except Anger.ConclusionsThese data provide preliminary evidence of reliability and construct validity of PROMIS CATs to assess RA symptoms and impacts, and feasibility of use in clinical care. PROMIS instruments captured the experiences of RA patients across the broad continuum of RA symptoms and function, especially at low disease activity levels. Future research is needed to evaluate performance in relevant subgroups, assess responsiveness and identify clinically meaningful changes.
Highlights
There is growing recognition of the importance of placing patients at the center of healthcare by developing patient-centered care models and integrating patient-valued outcomes into shared decision-making [1, 2]
Participants were mostly female (82%) and white (83%) with mean (SD) age of 56 (13) years; 24% had high school, 29% had Rheumatoid arthritis (RA) 5 years with 13% 2 years, and 22% were disabled
A dose-response relationship with disease activity was evident in Physical Function with similar trends in other scales except Anger
Summary
There is growing recognition of the importance of placing patients at the center of healthcare by developing patient-centered care models and integrating patient-valued outcomes into shared decision-making [1, 2]. Patient-reported outcomes (PROs) contribute essential information from the perspective of people living with a chronic disease and its treatments about the status of or a change in their physical, emotional, and social health outcomes [3]. In RA, three PROs have been included within the American College of Rheumatology core set of outcome measures recommended for use in randomized clinical trials (RCTs) [10] and clinical care [11] including global ratings of disease activity or health, pain, and physical function; more recently, fatigue has been recommended for inclusion [10, 12, 13]. Other symptoms and impacts of importance to RA patients include stiffness, sleep disturbance, emotional distress, and participation in life activities [14,15,16,17,18]. With the goal of RA treatment remission or low disease activity (LDA), it is important to be able to monitor subtle improvements and worsening of symptoms and function [18,19,20]
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