OMERACT- determining a core domain set for Sjögren's disease: International focus group series

Sjögren's Disease (SjD) is a systemic autoimmune disease that is associated with a significant reduction in health-related quality of life (HRQoL). The goal of this study was to better understand HRQoL using a multi-national and rigorously defined SjD population according to 2016 ACR/EULAR classification criteria.

The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Sjögren's Disease Working Group conducted three regionally based focus groups (United States, Australia/China, the Netherlands) for adult patients with SjD who met classification criteria. The focus groups were semi-structured and designed to elicit feedback regarding important life impact domains, or aspects of disease, that should be included in future research. Additionally, a brief demographic survey was administered. Focus group transcripts were coded and analyzed for theme saturation and interpretation.

There were 29 participants with SjD who completed the focus groups (25 females, 4 males); 28 participants completed the surveys. Five codes and 19 subcodes were identified corresponding to the following relevant domains: pain interference, physical activity, dryness, fatigue, oral health, autonomic function, and sequelae of inflammation, brain fog, pregnancy/fertility, emotional health, social participation and engagement with others including medical providers, and worker productivity.

These findings from a multi-national sample reaffirm the relevance of established symptoms such as pain, fatigue, and dryness while elucidating a broader spectrum of disease impact reported by individuals with SjD. Domains related to cognitive impairment, autonomic dysfunction, oral health, emotional well-being, and social and occupational functioning emerged as salient features of the patient experience. These data support the need to expand current outcome frameworks to better capture the multidimensional burden of SjD and inform the development of more comprehensive, patient-centered assessment tools.