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Abstract
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 % (p<0.001) for pain and 53.8% vs 29 % (p=0.003) for activity (Figure 1A). The changes from baseline to week 12 and 20 in patients reporting problems are shown in Figure 1B. The mean (SD) difference between patients and the Norwegian norms in the EQ-5D index score was small -0.033 (-0,16), p=0.147). The EQ5D VAS assessing “your own health today” was at baseline 61.7 (18) showing a mean difference (SD) of -16.7(19), (p<0.001) compared to the Norwegian norms. Overall the repeated measures analyses adjusted for age and gender showed no change over time for the EQ5D-index (SRM 0.02 (95% CI -0.4-0.4; p=0.105) or for the EQ-5D VAS (SRM -0.01 (95% CI -0.2-0.2; p=0.958.
Conclusion: 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.
- Clinical Trial
- Patient Reported Outcome Measures