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Validation of the Arabic version of the Functional Assessment of Cancer Therapy-Bladder questionnaire in Egyptian patients with bladder cancer

Objectives To validate the Arabic version of the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) questionnaire in Egyptian patients who underwent radical cystectomy (RC) and orthotopic neobladder (ONB) construction. Patients, subjects and methods The English version of the FACT-Bl was translated into the Arabic language using multi-step process by two urologist and two independent translators. The Arabic version was validated by inviting 90 patients who underwent RC and ONB and 72 normal individuals to complete the questionnaire. The reliability of the questionnaire was tested for internal consistency using the Cronbach’s α test. Inter-domain association was tested by Spearman’s correlation coefficient. The discrimination validity was measured by comparing the scores in RC patients and in normal individuals using the Mann–Whitney U-test and independent sample t-test. Results Internal consistency was high for all domains. There was high correlation between all domains. This high internal consistency and good correlation was maintained when assessment included patients with <7.5 and those with ≥7.5 years follow-up. Discrimination validation was confirmed by the statistically significant lower scores of all domains in the studied patients in comparison to the controls. Conclusion The Arabic version of the FACT-Bl is a reliable and validated instrument that can be used to evaluate health-related quality of life in patients after RC and ONB.


Introduction
Radical cystectomy (RC) and urinary diversion remains the 'gold standard' treatment for organ-confined muscleinvasive bladder cancer [1]. However, it is a traumatic procedure that adversely affects various aspect of patients' health-related quality of life (HRQoL). Over the past three decades, there have been many advances in RC techniques and the types of urinary diversion, seeking to improve patients' satisfaction and HRQoL. Assessment of HRQoL after RC and urinary diversion has been the focus of much research over the last decade. Many tools have been used to objectively assess different aspects of patients' HRQoL; some being generic instruments that can be used for assessing HRQoL in different conditions and others specific for patients with cancer [2].
One of the commonly used instruments is the Functional Assessment of Cancer Therapy-Bladder (FACT-Bl) questionnaire. It is a bladder cancer-specific module of the Functional Assessment of Cancer Therapy-General (FACT-G) [3]. It objectively assesses the four subscales of the FACT-G, physical, social, emotional and functional well-being, plus a bladder cancer subscale that assess urinary tract, intestinal and sexual symptoms [3]. Validated versions of the FACT-Bl have been published in the Japanese, Chinese, Hungarian, and Italian languages [4][5][6][7].
In Egypt, bladder cancer is the most common cancer of the urinary tract in males and the fourth most common in females. Also, Arabic is the native language in Egypt and one of the most common languages in the world, being one of the six official languages in the United Nations [8]. This explains the ultimate need for the availability of a validated Arabic version of the FACT-Bl questionnaire to allow for its use in future research in Arab-speaking countries. In the present study, we provide a reliable validation of the Arabictranslated version of the FACT-Bl questionnaire for use in patients with bladder cancer.

Patients, subjects and methods
According to the guidelines for cross-cultural adaptation of HRQoL measures, a multi-step process was used to produce the Arabic version of the FACT-Bl questionnaire. The process included forward translation to Arabic by both urologists and independent, native Arabicspeaking professional translators who had English as the first foreign language. Then back translation to English by a native English-speaking urologist who had Arabic as the first foreign language. The two forms of the questionnaire (original and translated) were compared and differences were resolved in a consensus meeting. The revised version was used in the study (Appendix A) [9].

Cognitive and pilot testing
Cognitive and pilot testing of the FACT-Bl questionnaire was performed initially on patients who underwent RC and urinary diversion. Data were collected by faceto-face interview by a third party not involved in the study. The pilot test results indicated that all items were not confusing, upsetting and difficult to understand nor associated with difficulty in response [9]. So, no further modifications were made.

Participant and data collection
Data for evaluation and validation of the Arabic version of the FACT-Bl were collected between August 2011 and June 2015. The study included 90 patients who underwent RC and orthotopic neobladder (ONB) construction for muscle-invasive bladder cancer and attended for routine follow-up at our outpatient clinic. The included patients had all had their surgery at 12 months beforehand and had no evidence of oncological failure. All patients were adult and able to provide informed consent to participate in the study. Patients at <12 months after the operation or with evidence of local recurrence or distant metastasis were excluded from the study. All patients were asked to respond to the FACT-Bl questionnaire by face-to-face interview by a third party not included in the study. The available data were tested for reliability and validity. To perform a discrimination validity of the questionnaire, a control group of age-matched healthy individuals were included after accepting to participate in the study.

Statistical analysis
The reliability of the Arabic version of the FACT-Bl questionnaire (Appendix A) was evaluated for internal consistency using Cronbach's a coefficient for each scale. The structure of the domains was examined by inter-domain association using Spearman's correlation coefficient (q). The discrimination validity was evaluated by comparing the scores of the questionnaire between the study and control groups using the Mann-Whitney U-test. All statistical tests were done using the Statistical Package for the Social Sciences (SPSSÒ version 16.0 for Microsoft; SPSS, Inc., Chicago, IL, USA), with a P < 0.05 considered to indicate statistical significance.

Results
The study included 90 patients (52 females and 38 males) who underwent RC and ONB and 72 age-matched healthy individuals. The demographic criteria of the study population are shown in Table 1.
The internal consistency was high for all scales except for the bladder cancer subscale (BICS), which was intermediate as shown in the Cronbach's a coefficient test ( Table 2). There were good correlations between physical well-being (PWB) and social well-being (SWB) (q = 0.68), emotional well-being (EWB) (q = 0.63) and functional well-being (FWB) (q = 0.67). Also, there was a good correlation between SWB and EWB (q = 0.51) and FWB (q = 0.74). Another good correlation was detected between EWB and FWB (q = 0.53) ( Table 2).
We divided the patients into two groups according to follow-up duration. Group 1 included 44 patients with a follow-up period of <7.5 years and Group 2 included 46 patients with a follow-up period of 7.5 years. The internal consistency of the scales and inter-scales corre-lation was measured in each group. In Group 1, the internal consistency was high for PWB, SWB and FWB, intermediate for EWB and low for BICS (Table 3). There were persistent good correlations between PWB and SWB, EWB and FWB and between SWB and FWB (Table 3). In Group 2, the internal consistency between scales was high for all scales except BICS, where it was intermediate (Table 4). Also, there was good correlation between PWB and SWB, EWB and FWB and between SWB and FWB (Table 4).
In comparison to the control group, the study group showed statistically significant lower scores for all the sub-scales and the total FACT-Bl score ( Table 5).

Discussion
After RC and ONB, patients wish to gain and maintain good health status, improve their functional abilities as much as possible, and achieve a satisfactory HRQoL [2]. HRQoL is a dynamic multidimensional construct that changes over time and can be modified by age and experience. It means different things to different people. Simply put, it can be defined as a patient's evaluation of the impact of a health condition and its treatment on relevant aspects of their life [10]. Assessment of HRQoL is important to judge overall treatment efficacy, determine whether the goals of treatment have been met, educate patients and clinicians about the full spectrum of treatment outcomes, and to facilitate medical decision-making [11].
There are numerous HRQoL instruments that have been validated and used in urological diseases. Some are generic and others are cancer specific.
The FACT is usually applied as a two part instrument that includes a general item set pertaining to all patients with cancer (FACT-G) and one of several item sets containing special questions for patients with specific tumours [3]. The FACT-Bl was designed as a validated HRQoL tool consisting of the 27-item FACT-G (four subscales: PWB, SWB, EWB and FWB) plus an additional 12-item bladder cancer subscale that assesses urinary tract, intestinal and sexual symptoms. The score of all items ranges from 1 to 4. The score is reversed for certain items. To calculate the subscales score, the sum of the item scores is multiplied by the number of items in the subscale and then divided by the number of items answered. The five scales were scored separately and the scores ranged 0-28, 0-28, 0-24, 0-28 and 0-48 for PWB, SWB, EWB, FWB and BICS scales, respectively. Then the sum of the scales is calculated giving a score of 0-156 with a higher score indicating a better outcome [3]. Since the introduction of FACT-Bl questionnaire, it has been widely used in the evaluation of HRQoL after RC and urinary diversion. Many linguistic translations have been done and validated versions in the Japanese, Chinese, Hungarian, Italian and Swedish languages are now available [4][5][6][7]12]. In the present study, the reliability of the Arabic version is confirmed by the high internal consistency for PWB, SWB, EWB and FWB scales and intermediate consistency for BICS, and the good inter-domain correlation. The lower internal consistency for the BICS scale may be due to the absence of response to the last two items, which assess presence of appliance and its effect on HRQoL and this is not applicable to patients with ONB. Also, the inclusion of patients with ileal conduits in this cohort would affect the results of the Cronbach's a coefficient test, as complete response data would not be available. This required re-validation of the questionnaire in ileal con-duit patients in a separate study. The discrimination validity of the questionnaire is confirmed by the statistically significant lower scores in the RC patients with ONB compared to the controls. Test-retest validation was not performed, as it requires repeated assessment of the same study group at different intervals, which was not available currently. Yet, we assessed the reliability in patients with <7.5 years follow-up and repeated this for patients with 7.5 years follow-up. The reliability of the Arabic version was maintained. This may be a confirmation of the validity of the instrument's use in patients after the procedure at different intervals with reliable results and confirms its responsiveness and how sensitive the scales are to changes over time. Comparison with different bladder cancer-specific HRQoL questionnaires was not done, which may be a limitation of the present study.

Conclusion
The results of the present study show that the Arabic version of the FACT-Bl is a valid and reliable method for assessing HRQoL in Arabic-speaking patients after RC and ONB.