| 1. |
- Akdemir, E, et al.
(author)
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EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial
- 2023
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In: BMJ open. - : BMJ. - 2044-6055. ; 13:3, s. e071304-
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Journal article (peer-reviewed)abstract
- 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 analysisThis 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 disseminationEthical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22–595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals.Trial registration numberNCT05480735.
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| 2. |
- Akdemir, E, et al.
(author)
-
EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial
- 2023
-
In: BMJ open. - : BMJ. - 2044-6055. ; 13:3, s. e071304-
-
Journal article (peer-reviewed)abstract
- 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 analysisThis 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 disseminationEthical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22–595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals.Trial registration numberNCT05480735.
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| 3. |
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| 4. |
- Flach, RN, et al.
(author)
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Use of the ISUP e-learning module improves interrater reliability in prostate cancer grading
- 2024
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In: Journal of clinical pathology. - : BMJ. - 1472-4146 .- 0021-9746. ; 77:1, s. 22-26
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Journal article (peer-reviewed)abstract
- Prostate cancer (PCa) grading is an important prognostic parameter, but is subject to considerable observer variation. Previous studies have shown that interobserver variability decreases after participants were trained using an e-learning module. However, since the publication of these studies, grading of PCa has been enhanced by adopting the International Society of Urological Pathology (ISUP) 2014 grading classification. This study investigates the effect of training on interobserver variability of PCa grading, using the ISUP Education web e-learning on Gleason grading.MethodsThe ISUP Education Prostate Test B Module was distributed among Dutch pathologists. The module uses images graded by the ISUP consensus panel consisting of 24 expert uropathologists. Participants graded the same 10 images before and after e-learning. We included those who completed the tests before and after training. We evaluated variation in PCa grading in a fully crossed study design, using linearly weighted kappa values for each pathologist, comparing them to other pathologists and to the ISUP consensus panel. We analysed the improvement in median weighted kappas before and after training, using Wilcoxon’s signed rank-test.ResultsWe included 42 pathologists. Inter-rater reliability between pathologists improved from 0.70 before training to 0.74 after training (p=0.01). When compared with the ISUP consensus panel, five pathologists improved significantly, whereas the kappa of one pathologist was significantly lower after training. All pathologists who improved significantly, graded with less than substantial agreement before training.ConclusionsISUP Prostate Test B e-learning reduces variability in PCa grading. E-learning is a cost-effective method for standardisation of pathology.
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