Background/Purpose: The aim of this study was to gain qualitative patient feedback on the appropriateness of two Patient Reported Outcome (PRO) measures as assessments of symptoms of Sjögren’s. The Sjögren’s Syndrome Symptom Diary (SSSD) is a novel daily diary assessing the severity of six core symptoms: eye dryness, mouth dryness, skin dryness, genital dryness (females only), fatigue, and muscle/joint pain. Recently, the SSSD fatigue item wording has been updated to ‘tiredness’ and two supplementary items have been drafted to capture the most bothersome and most important to improve symptoms from a patient perspective. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a well-established, 13-item measure of an individual’s fatigue and tiredness over the past week, however the content validity of the FACIT-F items has not been confirmed in Sjögren’s. In this study the 13-item FACIT-F and new and updated SSSD items were tested with patients with Sjögren’s. Patient perceptions of meaningful change on the SSSD were also explored.

Methods: Twelve semi-structured, cognitive telephone interviews were conducted with US adult patients with Sjögren’s to cognitively debrief the new SSSD items (‘most bothersome’ and ‘most important to improve’), and the updated SSSD ‘tiredness’ item. Cognitive debriefing involves actively testing a measure with patients to determine whether each instruction/item is understood as intended and relevant to patient experiences of the condition. In qualitative research a sample of 12 patients is typically considered sufficient to provide a comprehensive assessment of the PRO measure. Meaningful change was explored in relation to the six core SSSD items and for SSSD total average scores. Understanding and relevance of the 13 FACIT-F items were also explored.

Results: The new and updated SSSD items were well-understood by all patients (n=12/12) and all patients selected the same symptom as their most bothersome and the most important to improve from their perspective. The symptom most frequently reported as the most bothersome and important to improve was eye dryness (n=7/12). Meaningful improvement on individual SSSD items varied depending on patients’ current Sjögren’s severity, and meaningful improvement in relation to the SSSD total score varied from 1-point to 7-points (mean: 2.3 points; mode: 2 points). Such changes were described in relation to improvements in patients’ feeling and functioning. FACIT-F items were generally well-understood, although there were some instances of patients not understanding the term ‘listless’ (n=4/12) in the item ‘I feel listless (washed out)’. FACIT-F items were generally relevant; however, there was some variation in patient experiences of fatigue and tiredness related to Sjögren’s. The FACIT-F item ‘I am too tired to eat’ was not relevant to any patients.

Conclusion: These results suggest that the new and updated SSSD items, and FACIT-F items, have good content validity as PRO measures of Sjögren’s symptoms. Patient perceptions of meaningful change on the SSSD will be valuable for aiding interpretation of psychometrically-derived responder definitions and informing clinical trial endpoints.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/sjogrens-syndrome-symptom-diary-sssd-and-functional-assessment-of-chronic-illness-therapy-fatigue-facit-f-as-assessments-of-symptoms-in-sjogrens-syndrome-a-qualitative-explorati/