The Romanian translation and validation of the Extended Prostate Cancer Index Composite in patients undergoing radical prostatectomy.

ABSTRACT

Background and aims: To evaluate the quality of life in patients treated for prostate cancer in detail, an accessible, extensive, and easy-to-administer questionnaire is needed. The self-administered 50-item "Expanded Prostate Cancer Index Composite" (EPIC) is an instrument used for this purpose, but it is not officially translated into Romanian. The aim of the study was to translate and validate the Romanian version of the EPIC. Methods: We translated and culturally adapted the EPIC into Romanian. For validation, we included a retrospective analysis of 112 patients who underwent robotic radical prostatectomy and a prospective study including 120 consecutive patients hospitalized before surgical treatment. Baseline and follow-up assessments took place before and at six months, two, and five years post-surgery, between January 2014 and December 2015. We performed cross-sectional correlations between the EPIC, AUASI, and SF-12 at baseline, factor analysis, and calculated the internal consistency. Results: For most EPIC domains and subscales, our a priori-defined criteria for reliability were fulfilled (Cronbach's alpha 0.7-0.9). Cross-sectional correlations between EPIC scales and AUASI domain ranged from 0.23-0.69, and SF-12 domains ranged from 0.21-0.53 and 0.22-0.61, respectively. The retrospective analysis showed a medium acceptability and understanding of the EPIC questionnaire. In the prospective study, the revised EPIC draft showed an overall higher acceptability with a responding rate of 66% at a 5-year follow-up. All domains exhibited good internal consistency except for the hormonal section (Cronbach's α = 0.67) at the 6-month follow-up. Conclusion: The Romanian version of the EPIC is reliable, responsive and valid for measuring HRQL in prostate cancer patients. The EPIC questionnaire proved to be an exhaustive and reproducible instrument for evaluating the quality of life in Romanian prostate cancer patients.