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Background: Systemic sclerosis (SSc) is a chronic multi-system autoimmune disease associated with disability and reduced quality of life. SSc specific patient reported outcome measures (PROMs) are in use for this disease-group to understand the complexity and impact of the disease on the patients' health status better. Other PROMs are generic, as the EuroQol Five-Dimensional descriptive system (EQ-5D), used to evaluate quality of life, and frequently included as secondary endpoints in randomized trials. Objectives: To describe health status in a Norwegian SSc cohort compared with population norms and to assess change over time measured with EQ-5D questionnaire. Methods: The EQ-5D-5L was included as secondary endpoint in the Norwegian 20 week randomized ReSScue trial. The first part of this PROM consists of five dimensions (mobility, self-care, usual activities pain/discomfort and anxiety/depression) with five answers (1=no problems, 2=moderate problems, 3=severe problems, 4=extreme problems, 5=unable to do). The EQ-5D-5L index was calculated by crosswalk index values using the United Kingdom (UK) Dolan value set in absence of a scoring algorithm for Norway. The index value reflects how good or bad the health state is according to the preferences of the general population of a country/region. Results vary from -0.59 (health worse than dead) and 1 (perfect health). The second part of the questionnaire consists of a single visual analogue scale (VAS) through which patients are asked to rate their health of the day from 0-100 were 0 means the worst health Patients age- and sex matched normative data were obtained from the first Norwegian population norms for the EQ-5D-5L consisted of 12790 randomly selected Norwegian citizens (1713 woman) who were aged 18 years and older 1. Standardized response mean (SRM) was computed and interpreted according to Cohen`s effect size index, in which 0.2 = small difference, 0.5 = moderate difference, and 0.8 = more as a large difference. Results: The study cohort included 67 SSc patients, with mean age 61 years and mean disease duration of 10 years (Table 1). In the EQ-5D dimensions, proportion of patients reporting problems compared to population norms was 96.9 % vs 69 % (pConclusion: Compared to the population norms the EQ-5D dimensions pain, activity and anxiety as well as the EQ-5D VAS were significantly impaired in SSc patients. Nor the EQ-5D index score or the EQ-5D VAS showed sensitivity to change. REFERENCES: 1 Garratt AM et.al. Norwegian population norms for the EQ-5d-5L; results from a general population survey. Acknowledgements: NIL. Disclosure of Interests: Torhild Garen: None declared, Cristina Nita: None declared, Håvard Fretheim: None declared, Imon Barua: None declared, Maylen N Carstens: None declared, Henriette Didriksen: None declared, Vikas K. Sarna: None declared, Øyvind Midtvedt: None declared, Øyvind Molberg: None declared, Anna-Maria Hoffmann-Vold Boehringer Ingelheim, Boehringer Ingelheim, Janssen, Medscape, Merck Sharp & Dohme, Novartis and Roche, ARXX, BMS, Boehringer Ingelheim, Genentech, Janssen, Medscape, Merck Sharp & Dohme and Roche, Boehringer Ingelheim, Janssen.
Garen et al. (Sat,) studied this question.