The Translation, Validation and Cultural Adaptation of Questionnaires Assessing the Quality of Life and Fatigue among Patients with Sjogren's Syndrome for the Romanian Context.

About 70% of patients with Sjogren's syndrome suffer from fatigue, and for a large proportion of patients, it is one of the most noticeable manifestations leading to disability. To date, no study has been conducted in Romania to determine the quality of life of patients and the impact of fatigue in patients with Sjogren's syndrome. The present work proposes the translation, cultural adaptation, and validation of two questionnaires for the Romanian context, namely the 'Profile of Fatigue and Discomfort-Sicca Symptoms Inventory' (PROFAD-SSI-SF) and 'Primary Sjogren's Syndrome-Quality of Life' (PSS-QoL), whose purpose is to assess quality of life and fatigue in patients with Sjogren's syndrome. These two questionnaires were administered to 52 patients with Sjogren's syndrome diagnosed according to the 2016 ACR-EULAR criteria. Subsequently, the conceptual, semantic, and operational analyses of the data were performed with the aim of cultural adaptation. The data obtained were statistically analyzed using indices of measurement accuracy such as internal consistency. Based on statistical analyses, this pilot study shows that the Romanian versions of the PROFAD-SSI and PSS-QoL questionnaires are as reliable as their English counterparts.