Percutaneous cryoablation vs. open partial nephrectomy in small kidney cancers: the Italian experience.

INTRODUCTION: The aim of the present work was to analyze the economic impact of PCA (percutaneous cryoablation) vs. OPN (open partial nephrectomy), as it represents the most common standard of care for SRMs (small renal masses), namely T1a renal cancers (<4 cm), in Italy. EVIDENCE ACQUISITION: A cost analysis was performed to compare the difference of the total perioperative costs between PCA and OPN, both from the perspective of the National Healthcare System and the hospital. Clinical and resources consumption inputs were retrieved by a non-systematic literature search on scientific databases, complemented by a grey literature research, and validated by expert opinion. Costs calculation for the NHS perspective were based on reference tariffs published by the National Ministry of Health, while for the hospital perspective, unit costs published in the grey literature were used to compare the two alternatives. EVIDENCE SYNTHESIS: Assuming the NHS perspective, the cost analysis shows there is an economic advantage in using PCA vs. OPN (€4080 vs. €7541) for the treatment of SRMs. Hospitalization time is the driver of the total costs, while the costs of complications are quite negligible in both groups. From the hospital perspective the costs of PCA is slightly higher (+€737) than OPN, with cryoprobes contributing as the greatest cost component. However, this increase is quite restrained and is offset by an inferior use of healthcare resources (surgery room, healthcare personnel, length of stay in the hospital). CONCLUSIONS: According to our analysis, PCA results an advantageous technique compared to OPN respectively in terms of costs and resource consumption from both the NHS and the hospital perspective.

Health-related quality of life after BCG or MMC induction for non-muscle invasive bladder cancer.

INTRODUCTION: To evaluate health-related quality of life (HRQoL) in patients with non-muscle invasive bladder cancer (NMIBC) during the induction phase of intravesical instillations with BCG or MMC. MATERIALS AND METHODS: HRQoL was measured by two questionnaires from EORTC (QLQ-C30 and QLQ-BLS24), stratifying results by gender, age and therapy at the start of the therapy (T0), at last instillation (T1) and at 3 months after T1 (T2). The persistence of QoL-related side effects after 3 months from the end of the induction cycle was evaluated. RESULTS: We enrolled 108 naïve patients and 103 patients self-completed the questionnaires. Treatment was well tolerated in both groups. Side effects were reported by 46.6% of patients at T1 and 47.5% of patients at T2. QoL dropped at T1, returning to the baseline at T2. Drop of QoL was greater in the physical, role, emotional and social functioning domains and in some clinical domains as pain, fatigue and insomnia. Our stratified analysis showed that patients > 70 years have a worsening of QoL, a higher incidence of patient-reported side effects or symptoms in the BCG arm as compared to MMC arm. CONCLUSIONS: Our study shows that intravesical instillations of BCG or MMC during the induction phase might have a relevant effect on HRQoL.

Quality of Life Assessment With Orthotopic Ileal Neobladder Reconstruction After Radical Cystectomy: Results From a Prospective Italian Multicenter Observational Study.

OBJECTIVE: To assess health-related quality of life (HRQoL) parameters in patients who received radical cystectomy (RC) with ileal orthotopic neobladder (IONB) reconstruction and to identify clinic-pathologic predictors of HRQoL. PATIENTS AND METHODS: From January 2010 to December 2013, a multicenter, retrospective on 174 RC-IONB patients was carried out. All patients completed the following questionnaires: the European Organization for Research and Treatment of Cancer (EORTC) generic (QLQ-C30) and bladder cancer-specific instruments (QLQ-BLM30) and the IONB-Patient Reported Outcome (IONB-PRO). Univariate and multivariate analyses were computed to identify clinic-pathologic predictors of HRQoL. RESULTS: Median age was 66 years (range, 31-83), and 91.4% of patients were men. Median follow-up period was 37 months (range, 3-247). The EORTC QLQ-C30 revealed that age >65 years, absence of urinary incontinence, and absence of peripheral vascular disease were independent predictors of deteriorated body image. A follow-up > 36 months and the presence of urinary incontinence were independent predictors of worsened urinary symptoms, whereas the absence of urinary incontinence was an independent predictor of a worsened body image according to EORTC QLQ-BLM30 results. A follow-up >36 months and the absence of urinary incontinence were independent predictors of better functioning in terms of relational life, emotional life, and fatigue as revealed by the IONB-PRO. CONCLUSION: Age, presence of urinary incontinence, length of follow-up, and comorbidity status may influence postoperative HRQoL and should all be taken into account when counseling RC-IONB patients.

Development of a questionnaire specifically for patients with Ileal Orthotopic Neobladder (IONB).

BACKGROUND: The ileal orthotopic neobladder (IONB) is often used in patients undergoing radical cystectomy. The IONB allows to void avoiding the disadvantages of the external urinary diversion.In IONB patients the quality of life (QoL) appears compromised by the need to urinate voluntarily. The patients need to wake up at night interrupting the sleep-wake rhythm with consequences on social and emotional life.At present the QoL in IONB patients is evaluated by generic questionnaires. These are useful when IONB patients are compared with patients with different urinary diversions but they are less effective when only IONB patients are evaluated. To address this problem a specific questionnaire-the IONB-PRO-was developed. METHODS: A) Based on a conceptual framework, narrative-based interviews were conducted on 35 IONB patients. A basic pool of 43 items was produced and organized throughout two clinical and four QoL dimensions. An additional 15 IONB patients were interviewed for face validity testing.B) Psychometric testing was conducted on 145 IONB patients. Both classic test strategy and Rasch analysis were applied. Psychometric properties of the resulting scales were comparatively tested against other QoL-validated scales. RESULTS: The IONB-PRO questionnaire includes two sections: one on the QoL and a second section on the capability of the patient to manage the IONB. For evaluation of the QoL, three versions were delivered: 1) a basic 23-item QoL version (3 domains 23-items; alpha 0.86÷ 9.69), 2) a short-form 12-item QoL scale (alpha = 0.947), and 3) a short-form 15-item Rasch QoL scale (alpha = 0.967). Correlations of the long version scales with the corresponding dimensions of the EORTC-QLQ C30 and the EORTC-BLM30 were significant. The short forms exhibited significant correlations with the global health dimension of the EORTC-QLQ and with the urinary subscales of the EORTC-BLM30. The effect size was approximately 1.00 between patients at the 1-year follow-up period and those with 3, 5, and > 5-year follow-up periods for all scales. No relevant differences were observed between the 12-item short-form and the Rasch scale. CONCLUSIONS: The IONB-PRO long and short-forms demonstrated a high level of internal consistency and reliability with an excellent discriminanting validity.