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The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

ABSTRACT: 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.

SUBMITTER: Umbehr MH

PROVIDER: S-EPMC5819270 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

Umbehr Martin H MH Bachmann Lucas M LM Poyet Cedric C Hammerer Peter P Steurer Johann J Puhan Milo A MA Frei Anja A

Health and quality of life outcomes 20180220 1

<h4>Background</h4>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.<h4>Methods</h4>We translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 pati ...[more]

PMID: 29458434

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Project description:BackgroundThe discriminatory ability of multi-attribute utility (MAU) measures compared to condition-specific measures (CSM) in assessing health-related quality of life (HRQoL) among patients with chronic obstructive pulmonary disease (COPD) is an unsettled issue. This study investigated the quality of life of patients with COPD with three different HRQoL instruments and examined whether they could differentiate between adjacent severity groups in a statistically and clinically meaningful manner. In the process, the minimal clinically important differences (MCID) of the EQ-5D utility index were estimated.MethodsCross-sectional survey data were collected from patients with mild to very severe COPD in South Korea. In addition to demographic and clinical information, the following HRQoL questionnaires were used: The three-level five-dimensional Euro-Quality of Life tool (EQ-5D-3L), the EQ-Visual Analog Scale (EQ-VAS), and the Chronic Obstructive Pulmonary Disease Assessment Test (CAT). Patients' health-related quality of life was analyzed with reference to severity groups based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification. To investigate the discriminatory ability of the HRQoL instruments between COPD severity groups, tests examining variance, covariance, and standardized mean difference were performed. After estimating the MCID of the EQ-5D utility index using the anchor-based method, we investigated whether the differences in the EQ-5D utility scores between groups exceeded the clinically meaningful minimum level.ResultsA total of 298 patients completed this study. All the quality of life scores showed statistically significant differences between the GOLD severity groups. The pooled MCID estimate for the EQ-5D utility index was 0.028 (range: 0.017-0.033). Even after adjusting for other factors affecting quality of life, the EQ-5D utility index differentiated the GOLD groups well.ConclusionsWe conclude that the EQ-5D utility index is a valid instrument for measuring the quality of life of patients with COPD, and the pooled MCID estimate for the EQ-5D utility index was 0.028.

Project description:BACKGROUND:The Expanded Prostate Index Composite for Clinical Practice (EPIC-CP) is a short version of the original EPIC, developed to facilitate the instrument's use in routine care. This study aimed to validate the EPIC-CP Portuguese version, and evaluate its role in presenting early functional outcomes of surgically treated prostate cancer patients at a Latin American referral center. METHODS:The EPIC-CP was self-administered prospectively and individually by all localized prostate cancer patients, before and after robotic-assisted radical prostatectomy, from March 2017 to June 2018 at a single institution. For validation, we used the Cronbach's alpha coefficient to evaluate internal consistency. The EPIC-CP domains were compared before surgery, and 6 months and 12 months after surgery. Statistical analyses were performed using the student's t test, and Wilcoxon and Friedman tests, with p values?<?0.05 considered significant. RESULTS:One hundred and fifty two patients answered the EPIC-CP. The patients had a median age of 62.7 (±?8.5) years and prostate specific antigen level of 6.3 (±?4.6) ng/ml. The Cronbach's alpha varied from 0.75 to 0.77 for all domains with good internal consistency, except for the "vitality/hormonal" domain, which had a score of 0.35. The domain evolution for the preoperative and 6-month postoperative groups revealed that the domains related to urinary continence and bowel worsened, and were increased during the first 6 months; however, this variation had no obvious clinical implications, and the irritative symptoms improved. Regarding the sexual domain, the scores worsened, and also increased over the first 6 months. The results of the confirmatory factor analysis were robust, with an explained variance of 0.951 and covariance of 0.929. CONCLUSIONS:The Portuguese version of the EPIC-CP is a reliable and valid questionnaire for postoperative patients, and very useful to improve the knowledge of the early functional outcomes of men treated for prostate cancer.

Project description:BackgroundDifferent standardized questionnaires are used to assess tinnitus severity, making comparisons across studies difficult. These questionnaires are also used to measure treatment-related changes in tinnitus although they were not designed for this purpose. To solve these problems, a new questionnaire - the Tinnitus Functional Index (TFI) - has been established. The TFI is highly responsive to treatment-related change and promises to be the new gold standard in tinnitus evaluation. The aim of the current study was to validate a German version of the TFI for a German-speaking population in Switzerland.MethodsAt the ENT department of the University Hospital Zurich, 264 subjects completed an online survey including the German version for Switzerland of TFI, Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) and sociodemographic variables. Internal consistency of the TFI was calculated with Cronbach's alpha coefficient. Pearson correlation coefficients were used for the test-retest reliability of the TFI and to investigate convergent and discriminant validity between the THI and the BDI and BAI, respectively. Factor analysis was assessed using a principal component analysis with oblique rotation. The different factors extracted were then compared with the original questionnaire.ResultsThe German version of the TFI for Switzerland showed an excellent internal consistency (Cronbach's alpha of 0.97) and an excellent test-retest reliability of 0.91. The convergent validity with THI was high (r = 0.86). The discriminant validity with BAI and BDI showed moderate results (BAI: r = 0.60 and BDI: r = 0.65). In the factor analysis only five factors with one main factor could be extracted instead of eight factors as described in the original version. Nevertheless, relations to the original eight subscales could be demonstrated.ConclusionThe German version of the TFI for Switzerland is a suitable instrument for measuring the impact of tinnitus. The reliability and validity of this version are comparable with the original version of the TFI. Although this study showed only five factors in the factor analysis, relations to the original eight subscales were identified. Therefore, the German version of the TFI for Switzerland can deliver relevant information regarding the different tinnitus domains.Trial registrationClinical trial registration number on clinicaltrial.gov: NCT01837368 .

Dataset Information

The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

Publications

The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation.

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