Juravle Ioan-Bogdan, Hiriscau Elisabeta Ioana, Coroi Tudor, Feciche Bogdan-Ovidiu, Crisan Nicolae, Coman Ioan, Pop Cristian-Doru
Urology Department, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Urology Department, Emergency County Hospital, Zalau, Romania.
Med Pharm Rep. 2024 Jul;97(3):330-337. doi: 10.15386/mpr-2757. Epub 2024 Jul 30.
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.
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.
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.
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.
为了详细评估接受前列腺癌治疗患者的生活质量，需要一份可获取、内容广泛且易于管理的问卷。自我管理的50项“扩展前列腺癌指数综合问卷”（EPIC）就是用于此目的的工具，但它尚未正式翻译成罗马尼亚语。本研究的目的是翻译并验证EPIC的罗马尼亚语版本。
我们将EPIC翻译成罗马尼亚语并进行文化调适。为进行验证，我们纳入了对112例行机器人辅助根治性前列腺切除术患者的回顾性分析以及一项前瞻性研究，该前瞻性研究包括120例手术治疗前住院的连续患者。在2014年1月至2015年12月期间，在基线以及术后6个月、2年和5年进行基线和随访评估。我们在基线时对EPIC、AUASI和SF - 12进行横断面相关性分析、因子分析并计算内部一致性。
对于大多数EPIC领域和子量表，我们预先定义的可靠性标准得到满足（克朗巴哈系数α为0.7 - 0.9）。EPIC量表与AUASI领域之间的横断面相关性范围为0.23 - 0.69，与SF - 12领域的相关性范围分别为0.21 - 0.53和0.22 - 0.61。回顾性分析显示对EPIC问卷的接受度和理解程度中等。在前瞻性研究中，修订后的EPIC草案显示总体接受度更高，在5年随访时的回复率为66%。除6个月随访时的激素部分（克朗巴哈α = 0.67）外，所有领域均表现出良好的内部一致性。
EPIC的罗马尼亚语版本在测量前列腺癌患者的健康相关生活质量方面是可靠、敏感且有效的。EPIC问卷被证明是评估罗马尼亚前列腺癌患者生活质量的一份详尽且可重复的工具。
