Validation and reliability of the Dutch version of the EORTC QLQ-BLM30 module for assessing the health-related quality of life of patients with muscle invasive bladder cancer

Background: Quality of Life (QoL) of bladder cancer patients has been largely neglected. This is partly due to the lack of well-validated QoL questionnaires. The aim of this study is to examine the structural validity, reliability (i.e., internal consistency and test-retest reliability), construct validity (i.e., divergent validity and known group validity) and responsiveness of the Dutch version of the European Organisation for Research and Treatment of Cancer QoL questionnaire for muscle invasive bladder cancer (EORTC-QLQ-BLM30). Methods: Patients with newly diagnosed muscle invasive bladder cancer (MIBC) participating in the population-based ‘Blaaskankerzorg In Beeld’ (BlaZIB) study who completed the EORTC-QLQ-BLM30 at baseline were included. BlaZIB is a Dutch nationwide population-based prospective cohort study collecting clinical data and QoL data of bladder cancer patients. QoL is assessed with a self-administered questionnaire at four points in time: 6 weeks (baseline), 6 months, 12 months and 24 months after diagnosis. Confirmatory factor analysis and multitrait scaling analysis were used to investigate and adapt the scale structure. Reliability, construct validity and responsiveness of the revised scales were evaluated. Results: Of the 1542 patients invited to participate, 650 patients (42.2%) completed the QLQ-BLM30 at baseline. The questionnaire’s scale structure was revised into seven scales and eight single items. Internal consistency and test-reliability were adequate for most scales (Cronbach’s α ≥0.70 and intraclass correlation coefficient ≥ 0.70, respectively), with the exception of the revised urostomy problem scale and abdominal bloating and flatulence scale. The questionnaire exhibited little overlap with the EORTC-QLQ-C30: all correlations were < 0.40, except for the correlation between emotional function (QLQ-C30) and future worries (QLQ-BLM30). The questionnaire was able to distinguish between patient subgroups formed on the basis of physical function, but not – as hypothesized– based on stage. Changes in health due to treatment were captured by the questionnaire, indicating that the questionnaire is responsive to change. Conclusions: This study shows that the adapted scale structure of the EORTC-QLQ-BLM30 generally exhibits good measurement properties in Dutch patients, but needs to be validated in other languages and settings. Trial registration: BlaZIB, NL8106, www.trialregister.nl

Intermediate-term survival of robot-assisted versus open radical cystectomy for muscle-invasive and high-risk non-muscle invasive bladder cancer in The Netherlands

Background: Radical cystectomy with pelvic lymph node dissection is the recommended treatment in non-metastatic muscle-invasive bladder cancer (MIBC). In randomised trials, robot-assisted radical cystectomy (RARC) showed non-inferior short-term oncological outcomes compared with open radical cystectomy (ORC). Data on intermediate and long-term oncological outcomes of RARC are limited. Objective: To assess the intermediate-term overall survival (OS) and recurrence-free survival (RFS) of patients with MIBC and high-risk non-MIBC (NMIBC) who underwent ORC versus RARC in clinical practice. Methods and materials: A nationwide retrospective study in 19 Dutch hospitals including patients with MIBC and high-risk NMIBC treated by ORC (n = 1086) or RARC (n = 386) between January 1, 2012 and December 31, 2015. Primary and secondary outcome measures were median OS and RFS, respectively. Survival outcomes were estimated using Kaplan-Meier curves. A multivariable Cox regression model was developed to adjust for possible confounders and to assess prognostic factors for survival including clinical variables, clinical and pathological disease stage, neoadjuvant therapy and surgical margin status. Results: The median follow-up was 5.1 years (95% confidence interval ([95%CI] 5.0–5.2). The median OS after ORC was 5.0 years (95%CI 4.3–5.6) versus 5.8 years after RARC (95%CI 5.1–6.5). The median RFS was 3.8 years (95%CI 3.1–4.5) after ORC versus 5.0 years after RARC (95%CI 3.9–6.0). After multivariable adjustment, the hazard ratio for OS was 1.00 (95%CI 0.84–1.20) and for RFS 1.08 (95%CI 0.91–1.27) of ORC versus RARC. Patients who underwent ORC were older, had higher preoperative serum creatinine levels and more advanced clinical and pathological disease stage. Conclusion: ORC and RARC resulted in similar intermediate-term OS and RFS in a cohort of almost 1500 MIBC and high-risk NMIBC

Intermediate-term survival of robot-assisted versus open radical cystectomy for muscle-invasive and high-risk non-muscle invasive bladder cancer in The Netherlands

Background: Radical cystectomy with pelvic lymph node dissection is the recommended treatment in non-metastatic muscle-invasive bladder cancer (MIBC). In randomised trials, robot-assisted radical cystectomy (RARC) showed non-inferior short-term oncological outcomes compared with open radical cystectomy (ORC). Data on intermediate and long-term oncological outcomes of RARC are limited. Objective: To assess the intermediate-term overall survival (OS) and recurrence-free survival (RFS) of patients with MIBC and high-risk non-MIBC (NMIBC) who underwent ORC versus RARC in clinical practice. Methods and materials: A nationwide retrospective study in 19 Dutch hospitals including patients with MIBC and high-risk NMIBC treated by ORC (n = 1086) or RARC (n = 386) between January 1, 2012 and December 31, 2015. Primary and secondary outcome measures were median OS and RFS, respectively. Survival outcomes were estimated using Kaplan-Meier curves. A multivariable Cox regression model was developed to adjust for possible confounders and to assess prognostic factors for survival including clinical variables, clinical and pathological disease stage, neoadjuvant therapy and surgical margin status. Results: The median follow-up was 5.1 years (95% confidence interval ([95%CI] 5.0–5.2). The median OS after ORC was 5.0 years (95%CI 4.3–5.6) versus 5.8 years after RARC (95%CI 5.1–6.5). The median RFS was 3.8 years (95%CI 3.1–4.5) after ORC versus 5.0 years after RARC (95%CI 3.9–6.0). After multivariable adjustment, the hazard ratio for OS was 1.00 (95%CI 0.84–1.20) and for RFS 1.08 (95%CI 0.91–1.27) of ORC versus RARC. Patients who underwent ORC were older, had higher preoperative serum creatinine levels and more advanced clinical and pathological disease stage. Conclusion: ORC and RARC resulted in similar intermediate-term OS and RFS in a cohort of almost 1500 MIBC and high-risk NMIBC

Intermediate term survival following open versus robot-assisted radical cystectomy in the Netherlands:results of the Cystectomie SNAPSHOT study

There is insufficient knowledge on intermediate-term survival of non-metastatic muscle-invasive bladder cancer (MIBC) after open (ORC) versus robot-assisted (RARC) cystectomy, with or without neo-adjuvant chemotherapy (NAC). This retrospective study was performed in 19 Dutch hospitals between 2012 and 2015 to assess the five-year survival after both interventions and the influence of NAC. Out of 1,534 cT1-4N0-1-patients, 1,086 patients were treated with ORC and 389 with RARC. The 5-year survival rate after ORC was 51% (95% CI 47–53) versus 58% after RARC (95% CI 52–63), hazard ratio 1.00 (95% CI 0.84–1.20) after multivariable analysis. 226 of 965 cT2-4aN0 patients were treated with NAC. More patients had ypT0 after NAC than after no NAC (31% vs 15%; p?&lt; 0.01). The best five-year survival was in patients with ypT0 after NAC (89%; 95% CI 81–97). This study shows similar five-year survival of MIBC patients treated with ORC or RARC and shows that the best survival was after NAC