Adaptation and validation of the scleroderma skin patient-reported outcome questionnaire into Hungarian.

INTRODUCTION

Skin involvement in patients with systemic sclerosis (SSc) can significantly impair quality of life, affecting psychological, physical, and social well-being. The Scleroderma Skin Patient-Reported Outcome (SSPRO) questionnaire was developed to assess these dimensions.

OBJECTIVE

The aim of this study was to adapt and validate the SSPRO questionnaire in Hungarian.

PATIENTS AND

METHODS

The study enrolled 60 patients with SSc [53 women, 7 men; mean age 57.7 ± 13.5 years; diffuse cutaneous SSc n = 31 (51.7%)] and 31 age- and sex-matched healthy controls (mean age 57.9 ± 14.9 years). The 18-item SSPRO questionnaire was adapted into Hungarian using a standardized forward-backward cross-cultural translation procedure. Psychometric evaluation was performed in accordance with COSMIN recommendations and included assessment of content validity, structural validity, internal consistency, convergent validity, known-groups validity, reproducibility, and scaling properties.

RESULTS

No significant floor or ceiling effects were observed. Internal consistency was acceptable (Cronbach's α = 0.789). Structural validity analysis using principal component analysis identified a dominant first component explaining approximately 50% of the total variance, suggesting a primarily unidimensional structure with secondary underlying dimensions. Convergent validity analysis demonstrated significant correlations between SSPRO scores and established measures of quality of life and disease impact. Known-groups validity was confirmed by the ability of the questionnaire to distinguish between patients with SSc and healthy controls, while no significant differences were observed between limited and diffuse cutaneous SSc subgroups. Test-retest reliability demonstrated excellent agreement (ICC(2,1) = 0.894, 95% CI: 0.764-0.932).

CONCLUSION

The Hungarian version of the SSPRO questionnaire is a reliable and valid instrument for assessing skin-related quality of life in patients with SSc. It provides a quick, simple, and clinically useful tool that captures patient-reported aspects of disease burden not reflected by physician-based measures.