Qualitative interview study in patients with SLE to assess patient perception of fatigue and skin-related symptoms.

Abstract

Objective: SLE is a chronic autoimmune disorder with a range of symptoms. While these are broadly reported in the literature, the symptom impact of SLE on patient health-related quality of life is less well documented. This qualitative interview study aimed to understand the nature and importance of skin symptoms, evaluate the content validity of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale in SLE and assess what constitutes meaningful change in SLE-associated fatigue and skin symptoms.

Methods: In August 2023, 60 min individual interviews were conducted virtually with 18 adults in the USA who self-reported a diagnosis of SLE and reported experiencing SLE-related fatigue within the prior 30 days. 17 participants also reported experiencing SLE-related skin symptoms. Participants described their experiences with these symptoms and their perceptions of the smallest meaningful improvement using their own words and using the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) scales. Cognitive debriefing was conducted to evaluate content validity of the 13-item FACIT-Fatigue scale (V.4) for SLE-related fatigue.

Results: Of the 18 participants interviewed (mean age 51.7 years (range 33-67 years)), 17 were female and nine were white. All participants acknowledged that all items of the FACIT-Fatigue scale were relevant to SLE-related fatigue and most could comprehend and answer all items without difficulty. 13 participants indicated that a one-point improvement in fatigue on the PGIS would be meaningful. All participants with skin symptoms understood the skin-specific PGIS and PGIC items without difficulty. A one-point improvement on the PGIS and 'a little better/moderately better' on the PGIC represented meaningful improvements in skin symptoms by most participants.

Conclusion: These results support the use of the FACIT-Fatigue scale in SLE trials and suggest that even minimal improvements in fatigue and skin symptoms are meaningful to patients.