Study design
In order to evaluate the differences in terms of HRQOL among women treated with CUS, or BK-IC or ONB-VIP after RC for clinically localized bladder cancer, all consecutively female patients treated in two urological institutions from January 2000 to December 2008 without any evidence of tumor recurrence after at least 36 months from surgery were considered for this study. We enrolled disease-free patients in order to exclude bother related to adjuvant and salvage therapies and avert the social/emotional implication of disease progression. Another reason to enroll patients after at least 36 months after surgery was to avoid the biases of peri-operative care (more complex urinary diversions require more intensive nursing care in the postoperative recovery period).
All patients were retrospectively assessed with the following self-administered questionnaires (they had help to filling the questionnaire in if it was needed): the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific surveys (QLQ-BLM30) and the Functional Assessment of Cancer Therapy for Bladder Cancer (FACT-BL). For analysis, patients were stratified according to urinary diversion type.
Subsequently the responses were entered into a database. Data from the questionnaires were analyzed in order to test differences among the groups. Informed consent was obtained from all patients. The study was conducted in accordance with the principles of research involving human subjects as expressed in the Declaration of Helsinki and with Good Clinical Practice.
Inclusion and exclusion criteria
Included patients were at least 18 years of age, who underwent RC and urinary diversion for clinically localized bladder cancer in accordance with EAU criteria [14]. Only disease free females at least 36 months after RC were included in this study. All enrolled patients were able to ply the study design, including to self compile the selected questionnaires. We excluded patients with major concomitant medical or psychological diseases, including those with remarkable bowel disease and those with previous lower tract surgery, with the exception of staging TURBT. Likewise, patients previously treated with neoadjuvant chemotherapy or radiation therapy were excluded.
Surgical techniques and surveillance
Patients were followed according to the surveillance schedules suggested in EAU guidelines [14]. RC with pelvic lymphadenectomy was performed as described by Skinner, et al [15]. ONB-VIP was performed in patients without locally advanced disease (including absence of hydroureteronephrosis) or bladder neck involvement, normal renal and bowel function, and functional capability to manage urinary diversion. For those women who did not meet criteria for ONB, we performed a non-orthotopic urinary diversion. All procedures were performed by two dedicated surgeons.
We classified perioperative complications according to the Clavien–Dindo classification [16]. For risk adjustment, we calculated each patient’s Charlson Comorbidity Index [17]. Follow-up after urinary diversion was scheduled every 3 months during the first 2 years and subsequently every 6 months for 5 years or more. Follow up included general physical examination, routine serum chemistries, urinary cytology, total abdominal US, chest x-ray, CT urography, and cystoscopy (only in very selected cases).
HRQOL measurement and questionnaire descriptions
We used the general and bladder cancer-specific HRQOL questionnaires EORTC QLQ-C30 [18], EORTC QLQ-BLM30 [19] and FACT-BL [20]. All questionnaires were self-administered during a scheduled follow-up visit.
EORTC QLQ-C30
We used the Italian version of the EORTC QLQ-C30. In brief, the EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the quality-of-life construct [18]. It incorporates five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and a global health and quality-of-life scale. The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnea, loss of appetite, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of cancer and its treatment [18]. The majority of questions were assigned a score from one to four (1=not at all, 4= very much) [18]. Questions 29 and 30 were assigned a score from 1 to 7. All scores were linearly transformed to a 0-100 scale. Lower score matches to higher HRQOL
EORTC QLQ -BLM30
We used the validated Italian version of QLQ-BLM30 from EORTC to assess bladder cancer-specific HRQOL [19]. All questions are specific to patients treated for muscle-invasive bladder cancer. The EORTC QLQ-BLM30 was developed to evaluate the HRQOL detriments associated with having a urostomy and measures the effects of the urostomy appliance on patients’ HRQOL following urinary diversion [19]. Patients with continent cutaneous pouches can answer questions concerning their ability to perform catheterization. Due to the fact that cystectomy and urinary diversion involves major physical changes, the instrument is also designed to assess any changes in the patient’s body image. Moreover, it evaluates the physical changes that affect the patient’s sexual life and the patient’s mood [18]. Finally, the bowel aspect was evaluated in relation to presence of intestinal reconfiguration. Each question was assigned a score from one to four (1=not at all, 4= very much) [19]. All scores were linearly transformed to a 0-100 scale. Lower score matches to higher HRQOL
FACT (BL-VCI)
The FACT-BL similarly evaluated patients’ bladder cancer-specific HRQOL. We used the validated Italian version of FACT-BL [20]. FACT-BL is useful for comparisons of the HRQOL of patients with various diversions including an ileal conduit, a continent cutaneous reservoir, or an orthotopic neobladder. The scores were calculated from the FACT-BL questionnaire and subsetted into the domains of: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), total FACT-G score (which is incorporated into the FACT-BL), overall bladder cancer-specific subscale, and total FACT-BL score (FACT-G + bladder cancer subscale) [20]. The survey is composed of 39 questions. Each question was assigned a score from one to four (1=not at all, 4= very much) [20]. A total of 17 additional questions were added to the FACT-G to create the Vanderbilt Cystectomy Index (FACT-VCI) [20]. Lower score matches to higher HRQOL.
Statistical analysis
As null hypothesis we assumed that there was no difference among the urinary diversion groups in terms of HRQOL. Continuous, normally distributed variables were reported as the mean value with standard deviation (SD). Summary scores and responses to individual items are presented using descriptive statistics.
All data were stratified according to urinary diversion with univariate ANOVA analyses (all diversions) and with unpaired sample T tests. Statistical significance was achieved if p was <0.05. All reported p-values were two-sides. All data were recorded, collected and analyzed by using Statistical Package for the Social Sciences 16.0 for Microsoft (SPSS, Inc., Chicago, Illinois, USA).
