Department of Urology, City Hospital Triemli of Zurich, Birmensdorferstrasse 497, 8063, Zurich, Switzerland.
Horten Centre of patient orientated research and knowledge transfer, University of Zurich, Zurich, Switzerland.
Health Qual Life Outcomes. 2018 Feb 20;16(1):36. doi: 10.1186/s12955-018-0859-1.
No official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID.
We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011. We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID.
For most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach's alpha 0.7-0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14-0.79, and 0.06-0.5 and 0.08-0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain.
The German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.
目前还没有官方的德语版 50 项扩展前列腺癌指数复合量表（EPIC），也尚未确定最小有意义差异（MID）。本研究旨在将 EPIC 翻译并文化调适为德语版本，以适应不同的德语国家，并确定 MID。
我们将 EPIC 翻译并文化调适为德语。为了验证，我们纳入了一个连续的局部前列腺癌接受根治性前列腺切除术的患者亚组，这些患者参加了前列腺癌结局队列。基线和随访评估分别在 2010 年和 2011 年前列腺切除术之前和之后的 6 周进行。我们评估了 EPIC、EORTC QLQ-PR25、感觉温度计、SF-36 和全球健康状况变化的总体评估。我们计算了内部一致性、重测信度、结构效度、反应性和 MID。
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了满足（结构可靠性：Cronbach's alpha 0.7-0.9；重测信度：组内相关系数≥0.7）。EPIC 和 EORTC QLQ-PR25 领域之间的横断面和纵向相关性范围为 0.14-0.79，0.06-0.5 和 0.08-0.72，分别为感觉温度计和 SF-36。我们确定了尿、肠、性和激素领域的 MID 值分别为 10、4、12 和 6。
德语版的 EPIC 是可靠、敏感和有效的，可用于测量前列腺癌患者的 HRQL，现已提供德语版本。通过建议的 MID，我们可以解释 HRQL 的变化在多大程度上对患者具有临床意义。因此，研究结果不仅在德语国家有意义。
