Background/Purpose: Recent studies have demonstrated the reliability and validity of the NIH PROMIS (Patient-Reported Outcomes Measurement Information System) measures in SLE. Analyses of their responsiveness to changes in SLE disease and health status have not yet been reported.

Methods: Data were from the California Lupus Epidemiology Study (CLUES), a population-based, multi-ethnic cohort with physician-confirmed SLE. Subjects participated in structured interviews in English, Spanish, Mandarin, or Cantonese. Follow-up (FU) interviews were conducted an average of 12.8 months after baseline. Eight PROMIS short-forms (Tables) were administered and scored to derive T-scores scaled to population means of 50 and SD of 10. Race and ethnicity were self-reported. To determine the PROMIS measures’ responsiveness to change, we examined whether PROMIS score changes occurred in the appropriate direction and magnitude for individuals classified as improved or worse for two anchor items: self-rated health (SRH; 5 categories: excellent, very good, good, fair, poor) and self-reported lupus disease activity (Systemic Lupus Activity Questionnaire, SLAQ, score range 0–44). Improvement/worsening in SRH was defined as a 2-category change from baseline to FU (e.g., “good” to “poor”). Improvement/worsening in SLAQ scores was defined as a 4-point change in score (0.5 SD of baseline score). Changes in PROMIS scales from baseline to FU were calculated. Mean PROMIS change scores and standardized response means (SRM; mean change / SD of change) were calculated for the better and worse groups for each anchor item. SRMs were defined as small (0.20), medium (0.50), or large (0.80). Analyses were repeated within each of 4 racial/ethnic groups (white, Hispanic, black, Asian).

Results: 432 individuals completed baseline interviews; 337 have completed FUs to date (83% of eligible). 92% met 4/11 ACR criteria for SLE; the rest either had a diagnosis of lupus nephritis, or met 3 ACR criteria and were diagnosed by a rheumatologist. Mean age was 46 years, mean disease duration was 18 years. 89% were female, 97 (29%) white, 83 (25%) Hispanic, 37 (11%) black, and 120 (36%) Asian. Mean PROMIS changes and SRMs for better/worse groups (all race/ethnicities combined) are shown in the table. SRMs were medium to large for improvement and worsening for all scales except for Sleep Disturbance and Cognitive Ability (improvement). No substantive differences in responsiveness were noted by racial/ethnic group.

Conclusion: PROMIS scales appeared to be responsive to positive and negative changes in general health status and lupus disease activity, including within racial/ethnic groups, with the exception of the Sleep Disturbance and Cognitive Ability scales. Qualitative studies may be needed to determine reasons for lower responsiveness of these two scales. Overall, however, results add to the evidence supporting the use of PROMIS scales in lupus.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/responsiveness-of-promis-patient-reported-outcomes-measurement-information-system-measures-in-a-multi-racial-multi-ethnic-systemic-lupus-erythematosus-sle-cohort/