PO:23:044 | Understanding fatigue through patients' eyes: development of a novel questionnaire capturing the complexity of real-life fatigue in Sjögren's disease

Flavia Riccio¹, Mariachiara Visconti¹, Corrado Parlati¹, Nicola Della Rossa¹, Sabrina Marrone¹, Enrico Tirri², Francesco Ciccia¹, Saviana Gandolfo². | ¹UOC di Reumatologia, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy; ²UO di Reumatologia, Ospedale del Mare, Napoli, Italy.

Background. Fatigue is one of the most frequent and impactful symptoms for patients with Sjögren's Disease (SjD), and one of the most challenging to measure. There are no PROs fully capturing fatigue as experienced by patients in their daily lives. The purpose of this study was to define a new PRO for assessing fatigue and its impact on the quality of life of patients with SjD, based on lived experiences and their own definitions of fatigue.

Materials and Methods. A 15-item questionnaire was developed to capture different types of fatigue in SjD, based on a patient-authored essay published online. Items were formulated using patient-derived language and refined through expert review. Content validity was confirmed via CVI. A pilot phase with cognitive debriefing and patient feedback assessed clarity and relevance. Preliminary psychometric testing evaluated internal consistency. Items cover 15 distinct types of fatigue: basic fatigue, rebound fatigue, sudden fatigue, weather-related fatigue, molten lead phenomenon, tired-wired, flare-related fatigue, fatigue related to other physical causes, fatigue-related concentration impairment, stress/distress/anxiety/depression-related fatigue (SDAD), not sleeping well fatigue, normal aging fatigue, chronic illness fatigue, fatigue from trying to keep up with family and friends without a chronic illness, doctor fatigue.

Results. 90 consecutive patients (female 93.4%) fulfilling SjD ACR/EULAR 2016 criteria, mean age 57.1 years (range 21–82), completed the questionnaire. The most frequently reported types of fatigue were SDAD (88.9%), basic (86.7%), and rebound (86.7%), while the least reported was weather-related (60%). The SDAD had the highest impact on quality of life (mean impact score 82.8%). Males more frequently reported SDAD (100%), doctor fatigue (100%), and not sleeping well (83.4%), while females reported rebound (89.3%), basic (88.1%), and SDAD (88.1%). Younger and older patients reported basic fatigue more frequently (85.7% and 100%, respectively), compared to middle-aged groups, reporting SDAD (36–59 years: 92.1%; 60–70 years: 87.5%). Rebound was the only type correlating with disease duration (r=0.22, p0.03). SDAD did not significantly correlate with ESSPRI, whereas strong correlations were observed between ESSPRI and other types of fatigue, particularly basic (r=0.54, p< 0.0001) and rebound (r=0.50, p< 0.0001). Certain types of fatigue strongly correlated with each other, such as basic and rebound (r=0.90, p< 0.0001), or specifically with other symptoms, such as flare-related and VAS global pain (r=0.41, p< 0.0001). No correlations were observed with ESSDAI or laboratory parameters, except for the molten lead phenomenon with CRP (r=0.55, p = 0.007).

Conclusions. This novel SjD fatigue questionnaire captures aspects of real-life fatigue previously underrepresented in existing PROs and reveals heterogeneity in patient experiences. These differences underscore the importance of a fatigue-based patient profiling. Ongoing efforts focus on validating the questionnaire, stratifying patients based on fatigue, and establishing its role as an outcome measure.