Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS).

OBJECTIVE: The Patient-Oriented Prostate Utility Scale (PORPUS) is a combined profile and utility-based quality of life measure for prostate cancer patients. Our objectives were to adapt the PORPUS into Spanish and to assess its acceptability, reliability, and validity. METHODS: The PORPUS was adapted into Spanish using forward and back translations and cognitive debriefing. PORPUS was administered jointly with the SF-36 and the Expanded Prostate Index Composite (EPIC) to 480 Spanish prostate cancer patients treated with radical prostatectomy or radiotherapy. The Spanish PORPUS scores' distribution and reliability were examined and compared with the original instrument. To evaluate construct validity, relationships were assessed between PORPUS and other instruments (testing hypotheses of the original PORPUS study), and among known groups defined by side effect severity. RESULTS: Reliability coefficient was 0.76 (similar to the original PORPUS' 0.81). Spanish PORPUS items presented correlations ranging 0.57-0.88 with the corresponding EPIC domains, as in the original PORPUS study (0.60-0.83). Both PORPUS-P and PORPUS-U showed significant differences and large effect sizes (0.94-1.90) when comparing severe versus no problem groups on urinary, bowel, sexual and hormonal side effects defined by EPIC. CONCLUSIONS: A conceptually equivalent Spanish version was obtained, with high reliability and good construct validity, similar to the original Canadian PORPUS version. It can therefore be used to measure health-related quality of life and utilities in Spanish prostate cancer patients.

[Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC]. / Evaluación de la calidad de vida de los pacientes con cáncer de próstata localizado: validación de la versión española del cuestionario EPIC.

BACKGROUND AND OBJECTIVE: The EPIC (Expanded Prostate Cancer Index Composite) is a specific questionnaire for patients with prostate cancer designed to evaluate the impact of treatments on their quality of life. It contains 50 items divided in 4 summaries: urinary, intestinal, sexual and hormonal. The objective was to adapt the EPIC to Spanish and to evaluate its metric characteristics. METHOD: The method followed for the adaptation included translation and back-translation. The metric characteristics were evaluated in 50 patients from each treatment -prostatectomy, brachytherapy and external radiotherapy-, all of whom were administered the EPIC, SF-36 and FACT (Functional Assessment of Cancer Therapy) pre and post intervention. Reliability was evaluated with the Cronbach alpha coefficient. Construct validity was assessed by means of correlations between subscales of the EPIC and questionnaires, and comparing the patients with and without hormonal therapy (T-test). In order to value sensitivity to change, the standardized effect size was calculated after the intervention. RESULTS: The Cronbach's alpha of the EPIC summaries was high (0.66-0.89). The correlations between the EPIC and the FACT were near or higher than 0.4. Differences were found in the hormonal and sexual summaries between the patients with and without hormonal therapy (p<0.01). The standardized effect size was large (>0.8) in the urinary (3 groups) and sexual (group of prostatectomy) summary, and moderate in the intestinal summary (0.6 and 0.7) for the 2 groups of radiotherapy. CONCLUSIONS: The Spanish version of the EPIC is reliable, valid and presents an excellent sensitivity to change, being a useful tool to compare the impact in the quality of life of the 3 treatments.

Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up.

PURPOSE: To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. MATERIAL AND METHODS: Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003-2005. QoL was measured by the EPIC questionnaire, with urinary irritative-obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0-100). RESULTS: Brachytherapy's QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of -12.0 (95% CI=-15.0, -9.0) in incontinence and -5.3 (95% CI=-7.5, -3.1) in irritative-obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative-obstructive but -17.1 (95% CI=-22.7, -11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (-19.1; 95% CI=-25.1, -13.1) and external radiotherapy groups (-7.5; 95% CI=-12.5, -2.5). CONCLUSIONS: Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.

Evaluación de la calidad de vida de los pacientes con cáncer de próstata localizado: validación de la versión española del cuestionario EPIC / Evaluation of the quality of life of patients with localizad prostate cancer: validation of the Spanish version of the EPIC

Fundamento y objetivo: el EPIC (Expanded Prostate Cancer Index Composite) es un cuestionario específico para la evaluación del impacto de los tratamientos en la calidad de vida de los pacientes con cáncer de próstata. Contiene 50 ítems divididos en 4 sumarios: urinario, intestinal, sexual y hormonal. El objetivo de este trabajo ha sido adaptar el cuestionario EPIC al español y evaluar sus características métricas. Método: para la adaptación se siguió el método de traducción directa-inversa. Las características métricas se evaluaron en 50 pacientes de cada tratamiento ¿prostatectomía, braquiterapia y radioterapia externa¿, a quienes se administraron el EPIC, SF-36 y FACT (Functional Assessment of Cancer Therapy) antes y después de la intervención. Con el coeficiente alfa de Cronbach se evaluó la fiabilidad. La validez de constructo se estudió mediante correlaciones entre subescalas del EPIC y entre cuestionarios, y comparando a los pacientes con y sin hormonoterapia (prueba de la t de Student). Para valorar la sensibilidad al cambio se calculó el tamaño del efecto estandarizado tras la intervención. Resultados: el alfa de Chronbach de los sumarios del EPIC fue elevado (0,66¿0,89). Las correlaciones entre el EPIC y el FACT fueron cercanas o superiores a 0,4. Se encontraron diferencias en los sumarios hormonal y sexual entre los pacientes con y sin hormonoterapia (p<0,01). El tamaño del efecto estandarizado fue grande (>0,8) en los sumarios urinario (3 grupos) y sexual (grupo de prostatectomía), y moderado en el sumario intestinal (0,6 y 0,7) para los 2 grupos de radioterapia. Conclusiones: la versión en castellano del EPIC es fiable y válida, y presenta una sensibilidad al cambio excelente, por lo que resulta una herramienta útil para comparar el impacto en la calidad de vida de los 3 tratamientos (AU)

Background and objective: The EPIC (Expanded Prostate Cancer Index Composite) is a specific questionnaire for patients with prostate cancer designed to evaluate the impact of treatments on their quality of life. It contains 50 items divided in 4 summaries: urinary, intestinal, sexual and hormonal. The objective was to adapt the EPIC to Spanish and to evaluate its metric characteristics. Method: The method followed for the adaptation included translation and back-translation. The metric characteristics were evaluated in 50 patients from each treatment ¿prostatectomy, brachytherapy and external radiotherapy¿, all of whom were administered the EPIC, SF-36 and FACT (Functional Assessment of Cancer Therapy) pre and post intervention. Reliability was evaluated with the Cronbach alpha coefficient. Construct validity was assessed by means of correlations between subscales of the EPIC and questionnaires, and comparing the patients with and without hormonal therapy (T-test). In order to value sensitivity to change, the standardized effect size was calculated after the intervention. Results: The Cronbach's alpha of the EPIC summaries was high (0.66¿0.89). The correlations between the EPIC and the FACT were near or higher than 0.4. Differences were found in the hormonal and sexual summaries between the patients with and without hormonal therapy (p<0.01). The standardized effect size was large (>0.8) in the urinary (3 groups) and sexual (group of prostatectomy) summary, and moderate in the intestinal summary (0.6 and 0.7) for the 2 groups of radiotherapy. Conclusions: The Spanish version of the EPIC is reliable, valid and presents an excellent sensitivity to change, being a useful tool to compare the impact in the quality of life of the 3 treatments (AU)