Background Routine measurement of patient reported outcomes (PROs) is a priority for improving quality of care and outcomes in chronic rheumatic conditions including systemic lupus erythematosus (SLE). Measuring PROs at the point of care requires validated instruments with minimal responder burden. PROMIS10 is a 10 question universal (non-disease specific) PRO instrument measuring physical and mental health domains with T-scores normalized to the general population (mean score =50). The feasibility and validity of PROMIS10 have not been demonstrated in SLE.
Objectives To evaluate: 1) feasibility and 2) validity of PROMIS10 in outpatients with SLE.
Methods Adults meeting 1997 ACR SLE classification criteria were recruited from an SLE Center of Excellence. Subjects completed SF-36, LupusQoL-US, selected PROMIS Computerized Adaptive Tests (CATs), and PROMIS10. Construct validity was evaluated using Spearman's correlations comparing PROMIS10 physical and mental health scores with PROMIS CATs and legacy instruments. Test-retest reliability was evaluated in subjects reporting stable SLE activity at 2 assessments a week apart with intraclass correlation coefficients (ICCs). Focus groups of participants evaluated the relevance and utility of PROMIS10.
Results 204 (86%) of 238 patients approached, enrolled. There were no statistically significant differences in demographic characteristics between participants and non-participants. SLE patients scored worse than the general population in PROMIS10 physical health (mean T-score 41.6 +/- SD 8.8; range 19.9 - 67.7) and mental health (mean T-score 43.7 +/- SD 8.7; range 25.1 - 67.6). PROMIS10 physical health scores correlated strongly with physical function, pain, and social health domains in PROMIS CATs, SF-36, and LupusQoL, while PROMIS10 mental health scores correlated strongly with PROMIS depression CAT and SF-36 and LupusQoL mental health domains (Table 1). Test-retest reliability for both PROMIS10 physical and mental health scores was high with ICCs of 0.89 and 0.85 respectively. Median time to complete PROMIS10 was <2 minutes. Focus group participants found PROMIS10 relevant and useful.
Conclusions PROMIS10 is feasible to administer to outpatients with SLE and valid compared to legacy instruments. PROMIS10 can be used to quickly, accurately, and reliably screen for impaired physical function, pain, and depression and could be an important tool in the measurement of patient centered outcomes and improvement of quality of care in SLE.
Disclosure of Interest None declared