OBJECTIVES

This study aimed to explore the disease experiences of patients with systemic lupus erythematosus (SLE) and evaluate the content validity of seven SLE patient-reported outcome (PRO) measures for use in systemic lupus erythematosus (SLE) clinical trials: Worst Pain numerical rating scale (NRS), Worst Fatigue NRS, Worst Joint Pain NRS, Severity of Morning Joint Stiffness NRS, Duration of Morning Joint Stiffness Likert-scale, Patient Global Assessment of Disease Activity (PGA-DA) Likert-scale and Patient Global Impression of Disease Severity (PGI-S) Likert-scale.

METHODS

Patients diagnosed with SLE participated in 90-minute, face-to-face qualitative interviews to discuss their disease experience and cognitively debrief two versions of each PRO, one requiring 24-hour recall and another requiring 7-day recall. Thematic methods were used to analyze patients’ disease experience. Cognitive debriefing data were analyzed through framework analysis and iterative coding for evidence of conceptual relevance and patients’ comprehension.

RESULTS

Thirty patients (87% female, aged 28–69) participated. Pain/aches were the most frequently reported symptoms (n=30); the most bothersome symptoms were pain, particularly joint pain, and fatigue. Current treatments did not alleviate pain and fatigue. All PROs were well understood and patients endorsed the relevance of assessing their pain, joint stiffness and fatigue. Some confusion was observed as to what ‘disease activity’ conceptualized on the PGA-DA; patients better understood the PGI-S. Some patients experienced joint stiffness throughout the day and not only in the morning. Recall preference was split amongst the sample; however, some patients were unable to accurately recall their symptoms over 7 days, while all patients could recall over 24 hours.

CONCLUSIONS

All the PRO measures are suitable for SLE patients to self-report symptom severity except the PGA-DA; the PGI-S is a preferable global assessment. A 24-hour recall period would provide a more accurate representation of symptom experience than a 7-day recall period. Patients highlighted a need for new SLE therapies.