Background/Purpose: Disease Specific Patient reported outcome measures capture unique domains relevant to patients with a specific disease. LupusPRO is targeted towards measuring health (HRQOL) and non-health related quality of life (Non HRQOL) among patients with systemic lupus erythematosus (SLE). LupusPRO V 1.7 and its translated versions in various languages have measurement equivalence and are responsive to changes in changes in patient reported changes in health and physician-based disease activity assessments. LupusPRO v1.8 has separate domains of sleep, pain and vitality, and has shown good reliability and validity among 50 SLE patients¹. Herein, we present the confirmation of the psychometric properties of LupusPRO v1.8 in a larger sample size.

Methods: 122 consecutive SLE patients fulfilling ACR classification criteria were given self-administered surveys (MOS SF36 FACIT-Fatigue, Pain, Insomnia Severity Index for sleep, Perceived Stress Scale (PSS)-4, Patient Health Questionnaire-9 (PHQ-9) for depression, LupusPRO V 1.8) to complete at routine care visit.  Disease activity and damage were assessed at visit using SELENA-SLEDAI (SS), numeric BILAG and SLICC-SDI/ACR (SDI). Internal consistency reliability (ICR) for each domain was obtained using Cronbach alpha. Convergent construct validity (CV) with corresponding domains of SF36 was tested using Spearman correlation coefficient.

Results: Mean (SD) age was 40.7±14 yrs., 90% of participants were women, and mean disease duration was 8.7 years. Ethnic background was as follows:  56% Blacks, 24% Whites, 10% Asians and 10% others. Median (IQR) values of PGA, total SS, and SDI were 0.5 (0.6), 4.0(6.0) and 0.0(1.0), respectively.  Results for LupusPRO V1.8 domains descriptives, ICR and CV are shown in Table 1. Several domains, HRQOL and QOL scores were associated with disease activity. LupusPRO Sleep domain scores strongly correlated with the Insomnia severity index scores, while LupusPRO Vitality correlated strongly with FACIT-Fatigue and SF36 Vitality scores. LupusPRO Pain domain correlated strongly with the Pain score and SF36 Bodily pain domain.  Lupus symptom domain (3 items) showed significant correlation with PGA and SS, but not with SDI.  Similarly, LupusPRO domains of Physical and Emotional Health had good ICR and significant correlation with corresponding SF36 domains (Table 1). ICR for HRQOL and non HRQOL were 0.96 and 0.81.

Conclusion: LupusPRO V1.8 (including its sleep, vitality and pain domains) has acceptable reliability and validity. Use of lupusPRO as an outcome measure in clinical trials would facilitate responsiveness evaluation and provide important insight into patients’ assessment concerning the test therapies.