QUALITY OF LIFE IN PATIENTS WITH PROSTATE CANCER: VALIDATION OF AN INSTRUMENT FOR CLINICAL PRACTICE

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1 Oncological Urology Arch. Esp. Urol. 15; 68 (5): QUALITY OF LIFE IN PATIENTS WITH PROSTATE CANCER: VALIDATION OF AN INSTRUMENT FOR CLINICAL PRACTICE Felipe Balbontín 1, Pablo Marchetti 1, Sergio Moreno 1, José Miguel Cabello 1, Christian Urzúa, Andrés Silva, Javier Avilés, Leonardo Badínez 3, Jazmín García 3, Apolo Salgado 3, Eugenio Vinez 1, Isabel Alliende 1, Andrea Canals 1 and Alfredo Velasco 1. 1 Clínica Santa María. Santiago. Chile. Urology Department. Hospital del Salvador. Santiago. Chile. 3 Radiotherapy Department. Fundación Arturo López Pérez. Santiago. Chile. Summary.- OBJECTIVES: Currently there are instruments to evaluate the different features of the impact on quality of life in those patients with prostate cancer undergoing any type of treatment, but most of them have 5 or more questions and they are difficult to apply in clinical practice. An English validation of a shortened version of the EPIC (Expanded Prostate Cancer Composite), the most used instrument to measure the quality of life in patients with prostate cancer, has been published recently. This version called EPIC-CP (Expanded Prostate Cancer Composite-Clinical Practice) consists of 16 questions arranged in a page, for easy and rapid clinical application. The objective of this work is to validate a Spanish version of the Felipe Balbontín Clínica Santa María Santiago (Chile) fbalbontin@gmail.com CORRESPONDENCE METHOD: An inversa-directa Spanish translation of the original version was performed. The EPIC-CP and EQ5D questionnaires were applied to 46 patients eligible to be subjected to different treatments - open prostatectomy (OP), Robotic Prostatectomy (RP), brachytherapy (Br) or conformational radiotherapy (CR) - and 8 patients already treated (9 OP, 13 RP, 7 Br, 4 CR). For reliability evaluation, the Cronbach s alpha was used to test the internal consistency for each domain of the EPIC-CP. Treated and untreated patients scores were compared with the Wilcoxon range sum test to assess the sensitivity to change. RESULTS: Cronbach s alpha was elevated in all the EPIC-CP domains (near or greater than.7), indicating a high internal consistency. There was no significant difference in age and educational level between treated and untreated patients. We found significant differences between treated and untreated patients in the total EPIC CP score, in the domains of urinary incontinence, bowel function, sexual function and hormonal function. CONCLUSION: The Spanish version of the EPIC-CP is reliable and valid, so it is a useful tool to measure the quality of life in patients with prostate cancer, as well as the impact of different treatments. Keywords: Prostate cancer. Quality of life. Radical prostatectomy. Radiotherapy. Brachytherapy. Accepted for publication: January 9 th, 15

2 467 F. Balbontin, P. Marchetti, S. Moreno, et al. Resumen.- OBJETIVO: Actualmente existen instrumentos para evaluar los distintos aspectos en el impacto sobre la calidad de vida en aquellos pacientes portadores de cáncer de próstata que son sometidos a algún tipo de tratamiento, pero la mayoría son de 5 o más preguntas y de difícil aplicación en la práctica clínica. Recientemente se ha publicado la validación en inglés de una versión acortada del instrumento más utilizado para medir la calidad de vida en pacientes con cáncer de próstata: EPIC (Expanded Prostate Cancer Composite). Esta versión denominada EPIC-CP (Expanded Prostata Cancer Composite-Clinical Practice) consiste en 16 preguntas dispuestas en una página, de fácil y rápida aplicación clínica. El objetivo primario de este trabajo fue desarrollar y validar el cuestionario EPIC-CP en español como instrumento de evaluación de calidad de vida en pacientes con cáncer de próstata (CaP). Un objetivo secundario fue la observación de las diferencias de los aspectos que impactan en la calidad de vida entre los pacientes tratados y los candidatos a tratamiento. MÉTODOS: Se realizó una traducción inversa-directa al español de la versión original de la encuesta. Se aplicaron 18 cuestionarios de calidad de vida EPIC- CP y EQ5D (cuestionario de salud del EuroQuol Group Association) a 46 (4%) pacientes candidatos a ser sometidos a diferentes tratamientos Prostatectomía abierta (PA), Prostatectomía robótica (PR), Braquiterapia (Br) o Radioterapia Conformacional (RC)- y a 8 (64%) pacientes ya tratados (9 PA, 13 PR, 7 Br y 4 RC). Para evaluar la confiabilidad se evaluó la consistencia interna a través del Coeficiente Alfa de Cronbach para cada categoría de la EPIC-CP. Para valorar la sensibilidad al cambio se compararon las puntuaciones en pacientes tratados y no tratados con el test de Suma de Rangos de Wilcoxon. RESULTADOS: En todos los dominios de la EPIC-CP, se obtuvo un consistencia interna elevada (alfa de Cronbach,66-,9). No se encontraron diferencias significativas en la edad ni en el nivel educacional entre pacientes tratados y no tratados. Se encontraron diferencias significativas en la puntuación total de la EPIC CP entre pacientes tratados y no tratados en los dominios incontinencia urinaria (p=,), función intestinal (p=,4), sexual (p<,1) y función hormonal (p=,). CONCLUSIÓN: La versión en del EPIC-CP es confiable y válida, por lo que resulta una herramienta útil para medir la calidad de vida en pacientes con CaP, así como el impacto de distintos tratamientos en ella. Palabras clave: Cáncer de próstata. Calidad de vida. Prostatectomía radical. Radioterapia. Braquiterapia. INTRODUCTION Prostate cancer specific survival has progressively increased, this is due to both; to the early diagnosis of disease and the increase in the therapeutic arsenal, but the side effects of each treatment have been acquiring increasingly more relevant. Objectify, characterize and quantify the changes produced by them is a challenge, especially in saturated clinical practice. They have designed various instruments for measuring the impact of quality of life such as UCLA-PCI (1) or EPIC (), however these are difficult clinical application since they consist a minimum of 5 questions, so are mainly used in research or academia. As well as the IPSS (3) and the SHIM (4) used in the clinical evaluation of benign hyperplasia of the prostate and erectile dysfunction respectively, recently published a shortened version of the EPIC with 16 questions, making it easily applicable to clinical practice (5) called EPIC-CP (Expanded Prostate Cancer Composite - Clinical Practice). The questionnaire was designed to be available on a page and contains questions in 5 domains: incontinence and/or urinary obstruction, intestinal irritation, sexual and vitality / hormonal. Squealed of surgical, radioactive and hormonal treatments used in prostate cancer. 8 questions from UCLA-PCI, 6 of the EPIC-5/EPIC-6 and were included questions from EPIC 6 combinations. The objective of this work is to validate the EPIC-CP to a version in Spanish and to have this useful tool in clinical practice. METHOD EPIC-CP Both the EPIC and the this reduced version the EPIC-CP are self-administer to measure the impact on the quality of life of the radical prostatectomy, brachytherapy, external bean radiotherapy and hormone therapy on localized prostatic cancer. The EPIC-CP was build to fit on one page and has five domains that contains urinary incontinence, urinary irritation/obstruction, bowel function, sexual and vitality/hormonal function. Each domain has 3 questions with score to 4 each one where higher score means worst symptoms. Each domains scores from a minimum of and a maximum of 1. To final score is the sum of each domain from a minimum of and a maximum of 6.

3 QUALITY OF LIFE IN PATIENTS WITH PROSTATE CANCER: VALIDATION OF AN INSTRUMENT FOR CLINICAL PRACTICE 468 Spanish translation The EPIC-CP survey was carried out in the first place a translation to Spanish by three specialists and then a reverse translation was made to compare with the original survey in English (6). The survey represented in Figure 1 was obtained as a result. A pre-pilot study was performed in 15 patients with different educational levels to which the survey was apply. Is it counted the time destined to answer it and consulted with the patients if some of the words used in the survey are not understood or if they considered that it should modify any questions, etc. Population at study For the validation, first an estimation of sample size was made obtained a minimum of 1 patients. Between May and December 1, the survey was applied to 18 patients with diagnosis of CaP candidates for treatment (46) and treated 1 year or less (8) with the different techniques available (active follow-up, open radical prostatectomy, robotic radical prostatectomy and brachytherapy low rate, external radiation therapy, and hormone therapy or a combination of these. In addition to the EPIC-CP the EQ5D and EQVAS questionnaire of quality of life was applied, which are mainly focused on the ability of mobility and sensation of health status. The time destined to answer the survey, years of study of the patients, the treatment that have been submitted and the age of the patient. Also included the values of prostate specific antigen (PSA), Gleason score, number of compromised cores and the clinical or pathological stage. Statistic Analysis Shapiro Wilk Test was conducted to study the normality of continuous variables. The Test of Wilcoxo, in the case that there was not a normality of the continuous variable. The Chi-square or Fisher s exact Test was used to assess the association between categorical variables. The Spearman correlation was used to study the association between continuous variables not normal. To assess the internal consistency of each domain of the survey we calculated Cronbach s alpha coefficient (6).It was considered a high internal consistency when this value was.7. The respective confidence intervals were estimated by Bootstrap method. Statistical analyses were performed in IBM SPSS Statistics and Vista The Visual Statistics System software (7). RESULTS The study sample consisted of 18 patients: 46 candidates for treatment and 8 patients treated. Patients with the different types of treatments used for prostate cancer patients were included. The distribution of patients treated according to the method used is described in Table I. Of the total of patients treated, 17 (.7%) received supplemental hormone therapy, and 13 (15.9%) additional radiotherapy. The time to answer the questionnaire, most took less than 5 minutes (54.%), 33.6% took between 5 and 1 minutes, and 1.4% more than 1 minutes. An average of 64 years age, (range: y.) in treated patient an average age of 65 years, (range: 5-84.) There was no significant differences between treated and untreated patients (p=.). No significant differences were found between education level and the type of patients (candidate for treatment or treated) (p =, 8) (Table II). Also no difference was found between EPIC-CP score and education level (p=.4). Both patients; candidates for treatment such as treated: PSA, number of positives cores, score of Gleason and clinical stage were recorded (Table II). No significant differences were found when comparing the distribution of the responses to each question of the EQ5D among patients candidates for treatment and treated (Fisher s exact Test p >.5). Also no differences when comparing the distribution of the values of the EQVAS between treated and nontreated (p_.4). When comparing scores from different domains of the EPIC-CP among patients candidates for treatment and treated. They were significant differences in all domains with the exception of those for irritation and/or urinary obstruction, being the biggest difference between patients treated and untreated in the sexual domain with a p <.1 (Table III). We studied the relationship between the different domains of the EPIC-CP and the different

4 469 F. Balbontin, P. Marchetti, S. Moreno, et al. Figure 1.

5 QUALITY OF LIFE IN PATIENTS WITH PROSTATE CANCER: VALIDATION OF AN INSTRUMENT FOR CLINICAL PRACTICE 47 Table I. Distribution treated patients according to treatment used. Treatment Open Prostatectomy Robotic Prostaetctomy Radiotherapy Brachytheraphy Hormone therapy alone Active surveillance % (n) 3,9% (7) 4,4% () 15,9% (13) 17,1% (14) 7,3% (6),4% () questions of the EQ5D by Spearman correlations. The relationship between the question about self-care of the EQ5D and the EPIC-CP domains couldn t be studied because all patients with the exception of one answered exactly the same in that question (Table IV). The urinary incontinence domain met significantly related with questions about usual activities, pain/discomfort and anxiety/depression. The EQ5D pain/discomfort question was found significantly related with both irritation and/or urinary obstruction and bowel function domains. The sexual function domain was found associated directly with questions about mobility, usual activities, pain/discomfort, and inversely with the values of EQVAS. The hormonal function domain was found associated directly with questions about mobility, usual activities, pain/discomfort, anxiety/ depression, and inversely with the values of EQVA. Table V shows a summary of the scores of the different domains of the EPIC-CP for all patients Table II. Descriptive Analysis of treated and untreated patients. Variable Patient candidate for Treated Comparison between treatment Patient groups (p value) Age (mean ± stnd. desv.) 63,5±7,7 65,5±7,7, Years of study (%) <8 8,9% 11,6% 8-1 4,% 44,%,8 >1 48,9% 44,% Prostatic Specific Antigen 9,3±5,58 1,49±19,5,3 (mean ± stnd.desv.) Cores (+) 3,5±,5 3,7±3,,6 (measn ± dstnd. desv.) ,3% 38,3%,3 Gleason (%) 7 6,% 48,% 8-1 6,67% 13,6% T1C 73,3% 5,7% T,% 1,4% Stage (%) TA 17,8% 4,7%, TB 4,4%,% TC 4,4% 5,5% T3,% 17,8%

6 471 F. Balbontin, P. Marchetti, S. Moreno, et al. Table III. Mean score in each domain of treated and untreated patients. Domain Patients candidates Patients Wilcoxon range sum test for treatment treated (p) Question urinary function 1 1,173* Urinary incontinence,* Irritation / urinary obstruction,796 Intestinal,46* Sexual,5 8 <,1* Hormonal 3,* Total EPIC-CP 7 16 <,1* *Significant diference with a 95% of confidence. and the internal consistency of each domain assessed by Cronbach s alpha coefficient with their respective 95% confidence intervals. In each domain in the EPIC-CP was found a high internal consistency (alpha of Cronbach, 7), with the exception of the domain Function hormone (alpha of Cronbach =, 66). DISCUSSION The validation of a questionnaire of quality of life is essential to be able to use those instruments, however, its applicability in clinical practice and what measures are much more important. Side effects of the different treatments have a severe impact on the quality of life of patients (8,9). There is a tendency to underestimate fronm the part of the physician the different side effects derived from available treatments (1-1). This discrepancy develop the questionnaires such as EPIC-5 or the UCLA-PCI (1,), however these questionnaires are useful in academic institutions but are difficult to apply in a busy clinical practice, because the extent of these and its complex score. The EPIC-CP questionnaire was designed to be available on a page and contains questions in 5 domains: incontinence, irritation and/or urinary obstruction, ileus, sexual and vitality / hormonal. We included 8 questions from UCLA-PCI, 6 of the EPIC-5/EPIC-6 and questions combined of both questionnaires. To compare the results obtained with the EPIC-CP in treated and untreated patients significant Table IV. Spearman correlations between domains of the EPIC-CP and the EQ5D questions. EQ5D EPIC-CP Urinary Irritation urinary Bowel Sexual Hormonal incontinence obstruction function function function Mobility,4 -,4,8,19*,* Usual activities,6*,16,15,8*,* Pain / discomfort,19*,4*,19*,3*,* Anxiety/depression,* 1,16 -,8,16,43* EQVAS -,8 -,13,4 -,38* -,4* * Significant correlation with a 95% confidence.

7 QUALITY OF LIFE IN PATIENTS WITH PROSTATE CANCER: VALIDATION OF AN INSTRUMENT FOR CLINICAL PRACTICE 47 Table V. Summary scores for mastery of EPIC-CP and Cronbach s alpha. Domain Average Standard Medium Minimum Maximum Cronbach s alpha deviation (95% CI) Urinary incontinence ,75 (,66,8) Irritation / urinary obstruction ,81 (,74,86) Intestinal ,9 (,86,9) Sexual ,86 (,81,9) Hormonal ,66 (,54-,75) differences were observed in all domains in the survey, with the exception of the domain irritation and/or urinary obstruction. This may be due to that both treatments of Conformal radiotherapy and brachytherapy, (which normally produce irritative symptoms), were applies with urethral sparing which is reflected in less irritative symptoms. The results obtained through the EPIC-CP were compared with those obtained in the survey EQ5D. While the EQ5D is designed to measure quality of life, it is not specific for patients with prostate cancer, while relationships were found between the different domains of the EPIC-CP and the EQ5D were expected, with the exception of the inverse relationship between sexual and hormonal domains, and the EQVAS, which indicates the health status at the time of the survey. A high internal consistency (Cronbach.7 alpha) was observed in all domains with the exception of the hormone (alpha of Cronbach =.66) domain (table 5), as well as what was observed in the validation of the original North American version where this domain also presented an internal consistency that is lower than the rest of the domains (alpha of Cronbach =.64). However, the confidence interval for Cronbach of this domain s, does not exclude the.7 value by what could not be concluded that the internal consistency of this domain is low. The high values of Cronbach s alpha coefficient for all domains, indicate that different items in each domain are highly interrelated, which would allow to have is a global score and is adequate when represents the level of quality of life in patients with prostate cancer. Within the limitations, this is an instrument that was validated in several centers of health in different hospitals in the city of Santiago de Chile by what variations of the Spanish language in different parts of the country or in other Spanish-speaking countries may need the corresponding adaptations. Another limitation is that the comparison between treated and untreated patients are different, it is the measurement of the same patient before and after. The high internal consistency and the similarity of our results with the original version support the reliability of the Spanish version of the EPIC-CP questionnaire, constituting a new clinical tool that allows to evaluate the impact on the quality of life of the different treatments for prostate cancer and compare changes in quality of life before and after treatment. The version of the Spanish language of the EPIC-CP survey shows results of reliability and construct validity, as well as a high sensitivity to the change. REFERENCES AND RECOMMENDED READINGS (*of special interest, **of outstanding interest) *1. ** Litwin MS, Hays RD, Fink A et al: The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure. Med Care 1998; 36: 1-1. Wei JT, Dunn RL, Litwin MS et al: Development and validation of the Expanded Prostate Cancer Index Composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology ; 56: Barry MJ, Fowler FJ Jr, O Leary MP et al: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol 199; 148: Rosen RC, Cappelleri JC, Smith MD et al: Development and evaluation of an abridged, 5-item version of the International Index of Erectile

8 473 ** *8. *9. 1. Function (IIEF-5) as a diagnostic tool for erectile dysfunction. Int J Impot Res 1999; 11: Chang P, Szymanski KM, Sanda MG et al: Expanded Prostate Cancer Index Composite for Clinical Practice: Development and Validation of a Practical Health Related Quality of Life Instrument for Use in the Routine Clinical Care of Patients With Prostate Cancer. J Urol 11; 186: M. C. Martín Arribas. Diseño y validación de cuestionarios. Matronas Profesión 4; 5(17): 3-9. Rubén Ledesma. AlphaCI: un programa de cálculo de intervalos de confianza para el coeficiente alfa de Cronbach. Psico-USF, 4; 9( 1): Chen RC, Clark JA and Talcott JA: Individualizing quality-of-life outcomes reporting: how localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function. J Clin Oncol 9; 7: Stanford JL, Feng Z, Hamilton AS et al: Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA ; 83: Lepor H, Williford WO, Barry MJ et al: The efficacy of terazosin, finasteride, or both in benign *13. *14. *15. prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med 1996; 335: McConnell JD, Bruskewitz R, Walsh P et al: The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group. N Engl J Med 1998; 338: McConnell JD, Roehrborn CG, Bautista OM et al: The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med 3; 349: Sanda M, Dunn RL,Micjalski J. Quality of life and satisfaction with outcome among prostate cancer survivors. N.England J. Med 8;358: Sacco E, Prayer Galetti, Pinto F. Urinaria incontinence after radical prostatectomy : Incidencia by definition risk factors and temporal trend in a large series. BJU 6;97: Alemozaffar M, Regan M, Cooperberg M et al: Prediction of Erectile Function Following Treatment for Prostate Cancer. Jama 11; 36:

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