Translation and Spanish validation of the Quality of Life Questionnaire for patients with perianal fistula in Crohn's disease (Sp CAF-QoL Scale).

INTRODUCTION

Perianal fistulizing disease in Crohn's disease (CD) is associated with a marked impairment in quality of life. Currently, there are no Spanish-validated disease-specific instruments available to assess this impact. The aim of this study was to cross-culturally adapt and perform an initial psychometric validation of the Crohn's Anal Fistula Quality of Life (CAF-QoL) scale in a Spanish-speaking population with CD and perianal fistulas.

MATERIALS AND

METHODS

The original questionnaire was translated and back-translated following international guidelines for cross-cultural adaptation. The Spanish version (Sp CAF-QoL) was then administered in a prospective cohort of patients with CD and perianal fistulas, together with four validated questionnaires assessing quality of life and disease activity. Internal consistency (Cronbach's alpha and McDonald's omega), test-retest reproducibility (Lin's concordance correlation coefficient and Bland-Altman analysis), and convergent validity (Pearson correlations) were evaluated.

RESULTS

Of 178 patients contacted, 94 completed the questionnaire and 60 completed the test-retest assessment four weeks later. The scale showed excellent internal consistency (α = 0.971; ω = 0.947). Lin's concordance correlation coefficient for the global score was 0.812, indicating moderate-to-good reproducibility. Moderate correlations were observed with the IBDQ-9, HADS, and PROMIS instruments, confirming adequate convergent validity.

CONCLUSIONS

The Sp CAF-QoL appears to be a valid and reproducible Spanish version of the CAF-QoL for initial use in clinical and research settings. However, multicenter validation studies are still required, as well as assessment of responsiveness to clinical change and determination of the minimal clinically important difference.