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Item does not contain fulltext, INTRODUCTION: Radical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50-65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient's preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC. METHODS AND ANALYSIS: This multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3-6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22

Radboud University, 10 februari 2023, Promotores : Witjes, J.A., Rovers, M.M. Co-promotor : Hannink, G.J., Contains fulltext : 288658.pdf (Publisher’s version ) (Closed access)

Item does not contain fulltext, BACKGROUND: Open radical cystectomy (ORC) is regarded as the standard treatment for muscle-invasive bladder cancer, but robot-assisted radical cystectomy (RARC) is increasingly used in practice. A recent study showed that RARC resulted in slightly fewer minor but slightly more major complications, although the difference was not statistically significant. Some differences were found in secondary outcomes favouring either RARC or ORC. RARC use is expected to increase in coming years, which fuels the debate about whether RARC provides value for money. OBJECTIVE: To assess the cost-effectiveness of RARC compared to ORC in bladder cancer. DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation was performed alongside a prospective multicentre comparative effectiveness study. We included 348 bladder cancer patients (ORC, n = 168; RARC, n = 180) from 19 Dutch hospitals. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Over 1 yr, we assessed the incremental cost per quality-adjusted life year (QALY) gained from both healthcare and societal perspectives. We used single imputation nested in the bootstrap percentile method to assess missing data and uncertainty, and inverse probability of treatment weighting to control for potential bias. Deterministic sensitivity analyses were performed to explore the impact of various parameters on the cost difference. RESULTS AND LIMITATIONS: The mean healthcare cost per patient was €17 141 (95% confidence interval [CI] €15 791-€18 720) for ORC and €21 266 (95% CI €19 163-€23 650) for RARC. The mean societal cost per patient was €18 926 (95% CI €17 431-€22 642) for ORC and €24 896 (95% CI €21 925-€31 888) for RARC. On average, RARC patients gained 0.79 QALYs (95% CI 0.74-0.85) compared to 0.81 QALYs (95% CI 0.77-0.85) for ORC patients, resulting in a mean QALY difference of -0.02 (95% CI -0.05 to 0.02). Using a cost-effectiveness threshold of €80 000, RARC was cost-effective in 0.6% and 0.2% of the replications for the healthcare and soc

Contains fulltext : 221515.pdf (publisher's version ) (Open Access), For the treatment choice of localized prostate cancer, effective patient decision aids have been developed. The implementation of decision aids in routine care, however, lags behind. Main known barriers are lack of confidence in the tool, lack of training on its use, lack of resources and lack of time. A new implementation strategy addresses these barriers. Using this implementation strategy, the implementation rate of a decision aid was measured in eight hospitals and questionnaires were filled out by 24 care providers and 255 patients. The average implementation rate was 60 per cent (range 31%-100%). Hardly any barriers remained for care providers. Patients who did not use the decision aid appeared to be more unwilling than unable to use the decision aid. By addressing known barriers, that is, informing care providers on the effectiveness of the decision aid, providing instructions on its use, embedding it in the existing workflow and making it available free of charge, a successful implementation of a prostate cancer decision aid was reached.

Contains fulltext : 210079.pdf (publisher's version ) (Closed access)

Contains fulltext : 215102.pdf (Publisher’s version ) (Open Access)

Contains fulltext : 208390.pdf (publisher's version ) (Open Access), BACKGROUND: The Bladder Cancer Index (BCI) and Functional Assessment of Cancer Therapy-Bladder-Cystectomy (FACT-Bl-Cys) were developed to measure disease-specific health-related quality of life (HRQOL) in bladder cancer patients and patients treated with radical cystectomy, respectively. Both patient-reported outcome measures (PROMs) are frequently used in clinical practice, but are not yet validated according to the COSMIN criteria and not yet available in Dutch. Therefore, the aim of this study was to translate the BCI and FACT-Bl-Cys into Dutch and to evaluate their measurement properties according to the COSMIN criteria. METHODS: The BCI and FACT-Bl-Cys were translated into Dutch using a forward-backward method, and subsequently administered at baseline (pre-operatively) and 3 months post-operatively in bladder cancer patients who received a radical cystectomy. Validity (content and construct), reliability (internal consistency, test-retest reliability, and measurement error), floor and ceiling effects, and responsiveness were assessed according to the COSMIN criteria. RESULTS: Forward-backward translation encountered no particular linguistic problems. In total 260 patients completed the baseline measurement, while 182 patients completed the three-month measurement. Only a ceiling effect was identified for the BCI. Hypotheses testing for construct validity was satisfying, as 67% and 92% of the hypothesized correlations were confirmed. Structural validity was moderate for both measures, as confirmatory factor analyses showed limited fit. Reliability of both PROMs was good. The intraclass correlation coefficient (ICC) of the BCI domains ranged from 0.47 to 0.93, minimal value of Cronbach's alpha was 0.70, smallest detectable change on group level (SDC group) ranged from 1.9 to 8.6. The ICC of the FACT-Bl-Cys domains ranged from 0.43 to 0.83, minimal value of Cronbach's alpha was 0.77, SDC group was around 1. Only the FACT-Bl-Cys total score was found to be respons

Contains fulltext : 195473.pdf (publisher's version ) (Open Access)

Contains fulltext : 169163.pdf (publisher's version ) (Open Access), OBJECTIVE: To develop and validate new regret scales and examine whether a decision aid affects different aspects of regret in the treatment choice for prostate cancer. METHODS: This was a multicentre trial (three sites) with imbalanced randomization (1 : 2). From 2008 to 2011, patients with localized prostate cancer were randomized 1 : 2 to usual care (N = 77) or usual care plus a decision aid presenting risks and benefits of different treatments (N = 163). The treatments were surgery and (external or interstitial) radiotherapy. Regret was assessed before, and 6 and 12 months after treatment, using the Decisional regret scale by Brehaut et al. (Medical Decision Making, 23, 2003, 281), and three new scales focusing on process, option and outcome regret. The relation between decision aid and regret was analysed by anova. RESULTS: The concurrent validity of the new regret scales was confirmed by correlations between regret and anxiety, depression, decision evaluation scales and health-related quality of life. With a decision aid, patient participation was increased (P = 0.002), but regret was not. If anything, in patients with serious morbidity the decision aid resulted in a trend to less option regret and less Brehaut regret (P = 0.075 and P = 0.061, with effect sizes of 0.35 and 0.38, respectively). Exploratory analyses suggest that high-risk patients benefitted most from the decision aid. CONCLUSION: The new regret scales may be of value in distinguishing separate aspects of regret. In general, regret was not affected by the decision aid. In patients with serious morbidity, a trend to lower option regret with a decision aid was observed.