Validation of the LupusPRO version 1.8: an update to a disease-specific patient-reported outcome tool for systemic lupus erythematosus

Abstract

Objectives LupusPRO has shown good measurement properties as a disease-specific patient-reported outcome tool in systemic lupus erythematosus (SLE). For the purpose of clinical trials, the version 1.7 (v1.7) domain of Pain-Vitality was separated into distinct Pain, Vitality and Sleep domains in v1.8, and the psychometric properties examined. Methods A total of 131 consecutive SLE patients were self-administered surveys assessing fatigue (FACIT, SF-36), pain (Pain Inventory, SF-36), insomnia (Insomnia Severity Index), emotional health (PHQ-9, SF-36) and quality of life (SF-36, LupusPRO) at routine care visits. Internal consistency reliability (ICR) for each domain was obtained using Cronbach's alpha. The convergent construct validity of LupusPRO domains with corresponding SF-36 domains or tools were tested using Spearman correlation. Varimax rotations were conducted to assess factor structures of the LupusPRO v1.8. Results Mean (SD) age was 40.04 (14.10) years. Scores from the LupusPRO-Sleep domain strongly correlated with insomnia scores, while LupusPRO-Vitality correlated strongly with fatigue (FACIT) and SF-36 vitality. The LupusPRO-Pain domain correlated strongly with pain (SF36 Bodily-Pain, Pain Inventory) scores. Similarly, the LupusPRO domains of Physical and Emotional Health had significant correlations with corresponding SF-36 domains. The ICR for HRQoL and non-HRQoL were 0.96 and 0.81. LupusPRO (domains HRQoL and QoL) scores correlated with disease activity. Principal component analysis included seven factor loadings presenting for the HRQOL subscales (combined Sleep, Vitality, and Pain), and three factors for the NHRQoL (Combined Coping and Social Support). Conclusions 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 assessment.

Fatigue in systemic lupus: the role of disease activity and its correlates

“…The sample in which the LupusPRO v1.8 was validated included 50% AA participants, confirming its use in this population. 40 Reliability among this sample for the physical health subscale was high with a Cronbach's alpha of 0.96.…”

“…Only the physical health subscale, five items totaled, was included as a predictor of fatigue in this analysis and examples include identifying the frequency of one’s ability in “taking care of your personal needs (dress, comb hair, toilet, eat, bathe),” “getting in and out of a bed or chair,” and “being a burden to family or friends due to your physical abilities.” The sample in which the LupusPRO v1.8 was validated included 50% AA participants, confirming its use in this population. 40 Reliability among this sample for the physical health subscale was high with a Cronbach’s alpha of 0.96.…”

“…39 The LupusPRO v1.8 includes 48 items that measure both health-and non-health-related quality of life aspects pertinent to SLE disease. 40 The response scale includes a five-point Likert scale where 0 indicates ''none of the time'', 1 indicates ''a little of the time,'' 2 indicates ''some of the time,'' 3 indicates ''most of the time,'' 4 indicates ''all of the time,'' and when appropriate the response option of ''not applicable'' is available. Higher scores indicate higher quality of life.…”

Health‐Related Quality of Life Measures in Adult Systemic Lupus Erythematosus

“…In cross‐sectional analyses, significant associations were reported with categories of patient‐reported health status across all domains except social support, coping, satisfaction with medical care, and procreation. Lupus symptom scores and pain/vitality scores differentiated between patients with flare/active disease and those without; however, estimates of effect size were not reported .…”

The Arabic LupusPRO: A Cross-Cultural Validation of a Disease-Specific Patient-Reported Outcome Tool for Quality of Life in Lupus Patients

“…LupusPRO version 1.8 has two constructs: Health-Related QOL (HRQOL) and non-health-related quality of life (N-HRQOL). 18 The HRQOL domains are (1) Lupus Symptoms, (2) Cognition, (3) Lupus Medications, (4) Procreation, (5) Physical Health, (6) Sleep, (7) Fatigue/Vitality, (8) Pain, (9) Emotional Health, and (10) Body Image. The N-HRQOL domains are (1) Desires/Goals, (2) Social Support, (3) Coping, and (4) Satisfaction with Care.…”