Cost Effectiveness of Rectal Culture-based Antibiotic Prophylaxis in Transrectal Prostate Biopsy: The Results from a Randomized, Nonblinded, Multicenter Trial.

Background: Culture-based antibiotic prophylaxis is a plausible strategy to reduce infections after transrectal prostate biopsy (PB) related to fluoroquinolone-resistant pathogens. Objective: To assess the cost effectiveness of rectal culture-based prophylaxis compared with empirical ciprofloxacin prophylaxis. Design setting and participants: The study was performed alongside a trial in 11 Dutch hospitals investigating the effectiveness of culture-based prophylaxis in transrectal PB between April 2018 and July 2021 (trial registration number: NCT03228108). Intervention: Patients were 1:1 randomized for empirical ciprofloxacin prophylaxis (oral) or culture-based prophylaxis. Costs for both prophylactic strategies were determined for two scenarios: (1) all infectious complications within 7 d after biopsy and (2) culture-proven Gram-negative infections within 30 d after biopsy. Outcome measurements and statistical analysis: Differences in costs and effects (quality-adjusted life-years [QALYs]) were analyzed from a healthcare and societal perspective (including productivity losses, and travel and parking costs) using a bootstrap procedure presenting uncertainty surrounding the incremental cost-effectiveness ratio in a cost-effectiveness plane and acceptability curve. Results and limitations: For the 7-d follow-up period, culture-based prophylaxis (n = 636) was €51.57 (95% confidence interval [CI] 6.52-96.63) more expensive from a healthcare perspective and €16.95 (95% CI -54.29 to 88.18) from a societal perspective than empirical ciprofloxacin prophylaxis (n = 652). Ciprofloxacin-resistant bacteria were detected in 15.4%. Extrapolating our data, from a healthcare perspective, 40% ciprofloxacin resistance would lead to equal cost for both strategies. Results were similar for the 30-d follow-up period. No significant differences in QALYs were observed. Conclusions: Our results should be interpreted in the context of local ciprofloxacin resistance rates. In our setting, from a healthcare perspective, culture-based prophylaxis was significantly more expensive than empirical ciprofloxacin prophylaxis. From a societal perspective, culture-based prophylaxis was somewhat more cost effective against the threshold value customary for the Netherlands (€80.000). Patient summary: Culture-based prophylaxis in transrectal prostate biopsy was not associated with reduced costs compared with empirical ciprofloxacin prophylaxis.

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial.

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 22-595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05480735.

Rectal Culture-Based Versus Empirical Antibiotic Prophylaxis to Prevent Infectious Complications in Men Undergoing Transrectal Prostate Biopsy: A Randomized, Nonblinded Multicenter Trial.

BACKGROUND: An increase in infections after transrectal prostate biopsy (PB), related to an increasing number of patients with ciprofloxacin-resistant rectal flora, necessitates the exploration of alternatives for the traditionally used empirical prophylaxis of ciprofloxacin. We compared infectious complication rates after transrectal PB using empirical ciprofloxacin prophylaxis versus culture-based prophylaxis. METHODS: In this nonblinded, randomized trial, between 4 April 2018 and 30 July 2021, we enrolled 1538 patients from 11 Dutch hospitals undergoing transrectal PB. After rectal swab collection, patients were randomized 1:1 to receive empirical prophylaxis with oral ciprofloxacin (control group [CG]) or culture-based prophylaxis (intervention group [IG]). Primary outcome was any infectious complication within 7 days after biopsy. Secondary outcomes were infectious complications within 30 days, and bacteremia and bacteriuria within 7 and 30 days postbiopsy. For primary outcome analysis, the χ2 test stratified for hospitals was used. Trial registration number: NCT03228108. RESULTS: Data from 1288 patients (83.7%) were available for analysis (CG, 652; IG, 636). Infection rates within 7 days postbiopsy were 4.3% (n = 28) (CG) and 2.5% (n = 16) (IG) (P value = .08; reduction: -1.8%; 95% confidence interval, -.004 to .040). Ciprofloxacin-resistant bacteria were detected in 15.2% (n = 1288). In the CG, the presence of ciprofloxacin-resistant rectal flora resulted in a 6.2-fold higher risk of early postbiopsy infection. CONCLUSIONS: Our study supports the use of culture-based prophylaxis to reduce infectious complications after transrectal PB. Despite adequate prophylaxis, postbiopsy infections can still occur. Therefore, culture-based prophylaxis must be weighed against other strategies that could reduce postbiopsy infections. Clinical Trials Registration. NCT03228108.

Fosfomycin Vs Ciprofloxacin as Oral Step-Down Treatment for Escherichia coli Febrile Urinary Tract Infections in Women: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial.

BACKGROUND: We aimed to determine the noninferiority of fosfomycin compared to ciprofloxacin as an oral step-down treatment for Escherichia coli febrile urinary tract infections (fUTIs) in women. METHODS: This was a double-blind, randomized, controlled trial in 15 Dutch hospitals. Adult women who were receiving 2-5 days of empirical intravenous antimicrobials for E. coli fUTI were assigned to step-down treatment with once-daily 3g fosfomycin or twice-daily 0.5g ciprofloxacin for 10 days of total antibiotic treatment. For the primary end point, clinical cure at days 6-10 post-end of treatment (PET), a noninferiority margin of 10% was chosen. The trial was registered on Trialregister.nl (NTR6449). RESULTS: After enrollment of 97 patients between 2017 and 2020, the trial ended prematurely because of the coronavirus disease 2019 pandemic. The primary end point was met in 36 of 48 patients (75.0%) assigned to fosfomycin and 30 of 46 patients (65.2%) assigned to ciprofloxacin (risk difference [RD], 9.6%; 95% confidence interval [CI]: -8.8% to 28.0%). In patients assigned to fosfomycin and ciprofloxacin, microbiological cure at days 6-10 PET occurred in 29 of 37 (78.4%) and 33 of 35 (94.3%; RD, -16.2%; 95% CI: -32.7 to -0.0%). Any gastrointestinal adverse event was reported in 25 of 48 (52.1%) and 14 of 46 (30.4%) patients (RD, 20.8%; 95% CI: 1.6% to 40.0%), respectively. CONCLUSIONS: Fosfomycin is noninferior to ciprofloxacin as oral step-down treatment for fUTI caused by E. coli in women. Fosfomycin use is associated with more gastrointestinal events. CLINICAL TRIAL REGISTRATION: Trial NL6275 (NTR6449).

Type of treatment, symptoms and patient satisfaction play an important role in primary care contact during prostate cancer follow-up: results from the population-based PROFILES registry.

BACKGROUND: With the increasing attention for the role of General Practitioners (GPs) after cancer treatment, it is important to better understand the involvement of GPs following prostate cancer treatment. This study investigates factors associated with GP contact during follow-up of prostate cancer survivors, such as patient, treatment and symptom variables, and satisfaction with, trust in, and appraised knowledge of GPs. METHODS: Of 787 prostate cancer survivors diagnosed between 2007 and 2013, and selected from the Netherlands Cancer Registry, 557 (71%) responded to the invitation to complete a questionnaire. Multivariable logistic regression analyses were performed to investigate which variables were associated with GP contact during follow- up. RESULTS: In total, 200 (42%) prostate cancer survivors had contact with their GP during follow-up, and 76 (16%) survivors preferred more contact. Survivors who had an intermediate versus low educational level (OR = 2.0) were more likely to have had contact with their GP during follow-up. Survivors treated with surgery (OR = 2.8) or hormonal therapy (OR = 3.5) were also more likely to seek follow-up care from their GP compared to survivors who were treated with active surveillance. Patient reported bowel symptoms (OR = 1.4), hormonal symptoms (OR = 1.4), use of incontinence aids (OR = 1.6), and being satisfied with their GP (OR = 9.5) were also significantly associated with GP contact during follow-up. CONCLUSIONS: Education, treatment, symptoms and patient satisfaction were associated with GP contact during prostate cancer follow-up. These findings highlight the potential for adverse side-effects to be managed in primary care. In light of future changes in cancer care, evaluating prostate cancer follow-up in primary care remains important.

Identifying the relationship between postoperative urinary continence and residual urethra stump measurements in robot assisted radical prostatectomy patients.

OBJECTIVE: To investigate the feasibility of urethral stump length and width measurements in recorded videos of robot assisted radical prostatectomy procedures using the Kinovea software and to assess if these measurements could be used as predictors of postoperative urinary continence. METHODS: Fifty-three patients were selected from an institutional database of 1400 cases and included in the study. All videos were analysed using the computer software 'Kinovea'. All measurements were performed using the inserted bladder catheter as a reference point. RESULTS: The reference point (bladder catheter) was available in 33 out of 53 patients. The median surgical urethral length (SUL) was significantly higher in the continent group (1050 vs. 1294 mm, p = 0.018). The urethral width measurements did not show a difference between the groups. In order to validate the Kinovea software as an accurate tool for the measurement of the urethral stump length and width results were correlated with the magnetic resonance imaging measurements of the urethra. CONCLUSIONS: The results of this study showed a significantly longer median SUL incontinent patients.

Prostate biopsy techniques and pre-biopsy prophylactic measures: variation in current practice patterns in the Netherlands.

BACKGROUND: The clinical landscape of prostate biopsy (PB) is evolving with changes in procedures and techniques. Moreover, antibiotic resistance is increasing and influences the efficacy of pre-biopsy prophylactic regimens. Therefore, increasing antibiotic resistance may impact on clinical care, which probably results in differences between hospitals. The objective of our study is to determine the (variability in) current practices of PB in the Netherlands and to gain insight into Dutch urologists' perceptions of fluoroquinolone resistance and biopsy related infections. METHODS: An online questionnaire was prepared using SurveyMonkey® platform and distributed to all 420 members of the Dutch Association of Urology, who work in 81 Dutch hospitals. Information about PB techniques and periprocedural antimicrobial prophylaxis was collected. Urologists' perceptions regarding pre-biopsy antibiotic prophylaxis in an era of antibiotic resistance was assessed. Descriptive statistical analysis was performed. RESULTS: One hundred sixty-one responses (38.3%) were analyzed representing 65 (80.3%) of all Dutch hospitals performing PB. Transrectal ultrasound guided prostate biopsy (TRUSPB) was performed in 64 (98.5%) hospitals. 43.1% of the hospitals (also) used other image-guided biopsy techniques. Twenty-three different empirical prophylactic regimens were reported among the hospitals. Ciprofloxacin was most commonly prescribed (84.4%). The duration ranged from one pre-biopsy dose (59.4%) to 5 days extended prophylaxis. 25.2% of the urologists experienced ciprofloxacin resistance as a current problem in the prevention of biopsy related infections and 73.6% as a future problem. CONCLUSIONS: There is a wide variation in practice patterns among Dutch urologists. TRUSPB is the most commonly used biopsy technique, but other image-guided biopsy techniques are increasingly used. Antimicrobial prophylaxis is not standardized and prolonged prophylaxis is common. The wide variation in practice patterns and lack of standardization underlines the need for evidence-based recommendations to guide urologists in choosing appropriate antimicrobial prophylaxis for PB in the context of increasing antibiotic resistance.

Analysis of the video motion tracking system "Kinovea" to assess surgical movements during robot-assisted radical prostatectomy.

BACKGROUNDS: Robot-assisted surgery facilitated the possibility to evaluate the surgeon's skills by recording and evaluating the robot surgical images. The aim of this study was to investigate the possibility of using a computer programme (Kinovea) for objective assessment of surgical movements in previously recorded in existing robot-assisted radical prostatectomy (RARP) videos. METHODS: Twelve entire RARP procedures were analysed by a trained researcher using the computer programme "Kinovea" to perform semi-automated assessment of surgical movements. RESULTS: Data analysis showed Kinovea was on average able to automatically assess only 22% of the total surgical duration per video of the robot-assisted surgery. On average, it lasted 4 hours of continued monitoring by the researcher to assess one RARP using Kinovea. CONCLUSION: Although we proved it is technically possible to use the Kinovea system in retrospective analysis of surgical movement in robot-assisted surgery, the acquired data do not give a comprehensive enough analysis of the video to be used in skills assessment.

A Prospective, Observational, Multicentre Study Concerning Nontechnical Skills in Robot-assisted Radical Cystectomy Versus Open Radical Cystectomy.

INTRODUCTION AND HYPOTHESES: valuation of surgical skills, both technical and nontechnical, is possible through observations and video analysis. Besides technical failures, adverse outcomes in surgery can also be related to hampered communication, moderate teamwork, lack of leadership, and loss of situational awareness. Even though some surgeons are convinced about nontechnical skills being an important part of their professionalisation, there is paucity of data about a possible relationship between nontechnical skills and surgical outcome. In robot-assisted surgery, the surgeon sits behind the console and is at a remote position from the surgical field and team, making communication more important than in open surgery and conventional laparoscopy. A lack of structured research makes it difficult to assess the value of the different analysis methods for nontechnical skills, particularly in robot-assisted surgery. Our hypothesis includes the following: (1) introduction of robot-assisted surgery leads to an initial decay in nontechnical skills behaviour during the learning curve of the team, (2) nontechnical skills behaviour is more explicitly expressed in experienced robot-assisted surgery teams than in experienced open surgery teams, and (3) introduction of robot-assisted surgery leads to the development of different forms of nontechnical skills behaviour compared with open surgery. DESIGN: This study is a prospective, observational, multicentre, nonrandomised, case-control study including bladder cancer patients undergoing either an open radical cystectomy or a robot-assisted radical cystectomy at the Catharina Hospital Eindhoven, the Netherlands, or at the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Amsterdam. All patients are eligible for inclusion; there are no exclusion criteria. The Catharina Hospital Eindhoven, the Netherlands, performs on average 35 radical cystectomies a year. The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital Amsterdam, performs on average 100 radical cystectomies a year. PROTOCOL OVERVIEW: The choice of treatment is at the discretion of the patient and the surgeon. Patient results will be obtained prospectively. Pathology results as well as complications occurring within 90 d following surgery will be registered. Surgical complications will be registered according to the Clavien-Dindo system. MEASUREMENTS: Nontechnical skills will be observed using five different methods: (1) NOTSS: Nontechnical Skills for Surgeons; (2) Oxford NOTECHS II: a modified theatre team nontechnical skills scoring system; (3) OTAS: Observational Teamwork Assessment for Surgery; (4) Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS): evaluation of nontechnical skills in robotic surgery; and (5) analysis of human factors. Technical skills in robot-assisted radical cystectomy will be analysed using two different methods: (1) GEARS: Global Evaluative Assessment of Robotic Skill and (2) GERT: Generic Error Rating Tool. SAFETY CRITERIA AND REPORTING: Formal ethical approval has been provided by Medical research Ethics Committees United (MEC-U), The Netherlands (reference number W19.048). We hope to present the results of this study to the scientific community at conferences and in peer-reviewed journals. STATISTICAL ANALYSIS: Frequency statistics will be calculated for patient demographical data, and a Shapiro-Wilk test with p > 0.05 will be used to define normal distribution. Univariate analysis will be conducted to test for statistically significant differences in observation scores between open radical cystectomy and robot-assisted radical cystectomy cohorts across all variables, using independent sample t tests and Mann-Whitney U testing, as appropriate. A variable-selection strategy will be used to create multivariate models. Binary logistic regression will be conducted to calculate odds ratios and 95% confidence intervals for significant predictors on univariate analysis and clinically relevant covariates. Statistical significance is set at p < 0.05 based on a two-tailed comparison. SUMMARY: This study uses a structured approach to the analysis of nontechnical skills using extracorporeal videos of both open radical cystectomy and robot-assisted radical cystectomy surgeries, in order to obtain detailed data on nontechnical skills during open and minimally invasive surgeries. The results of this study could possibly be used to develop team-training programmes, specifically for the introduction of the surgical robot in relation to changes in nontechnical skills. Additional analysis of technical skills using the intracorporeal footage of the surgical robot will be used to elucidate the role of surgical skills and surgical events in nontechnical skills.

Development and validation of the TOCO-TURBT tool: a summative assessment tool that measures surgical competency in transurethral resection of bladder tumour.

BACKGROUND: The current shift towards competency-based residency training has increased the need for objective assessment of skills. In this study, we developed and validated an assessment tool that measures technical and non-technical competency in transurethral resection of bladder tumour (TURBT). METHODS: The 'Test Objective Competency' (TOCO)-TURBT tool was designed by means of cognitive task analysis (CTA), which included expert consensus. The tool consists of 51 items, divided into 3 phases: preparatory (n = 15), procedural (n = 21), and completion (n = 15). For validation of the TOCO-TURBT tool, 2 TURBT procedures were performed and videotaped by 25 urologists and 51 residents in a simulated setting. The participants' degree of competence was assessed by a panel of eight independent expert urologists using the TOCO-TURBT tool. Each procedure was assessed by two raters. Feasibility, acceptability and content validity were evaluated by means of a quantitative cross-sectional survey. Regression analyses were performed to assess the strength of the relation between experience and test scores (construct validity). Reliability was analysed by generalizability theory. RESULTS: The majority of assessors and urologists indicated the TOCO-TURBT tool to be a valid assessment of competency and would support the implementation of the TOCO-TURBT assessment as a certification method for residents. Construct validity was clearly established for all outcome measures of the procedural phase (all r > 0.5, p < 0.01). Generalizability-theory analysis showed high reliability (coefficient Phi ≥ 0.8) when using the format of two assessors and two cases. CONCLUSIONS: This study provides first evidence that the TOCO-TURBT tool is a feasible, valid and reliable assessment tool for measuring competency in TURBT. The tool has the potential to be used for future certification of competencies for residents and urologists. The methodology of CTA might be valuable in the development of assessment tools in other areas of clinical practice.

Injectable Bulking Agent to Treat Postprostatectomy Urinary Incontinence: A Safety and Effectiveness Pilot Study.

OBJECTIVES: To evaluate the safety and effectiveness of the injectable bulking agent Opsys® (Promedon, Cordoba, Argentina) for treating minimal postprostatectomy stress urinary incontinence (SUI). PATIENTS AND METHODS: Single-centre, pilot study on ten male patients with SUI, < 30 g urine loss/ 24 h, more than 1 year after radical prostatectomy. Patients were treated by endoscopic transurethral injections of bulking agent in the presphincteric zone of the urethral submucosa. The results were evaluated using a pad weight test to quantify the differences in urine loss at 1, 3, and 6 months after intervention. Subsequently, the results of treatment were also evaluated by International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF), Incontinence Impact Questionnaire (IIQ-7), Urogenital Distress Inventory Short Form (UDI-6-SF), and the Patient Global Impression of Improvement (PGI-I) at 1, 3, and 6 months after intervention. RESULTS: The primary outcome was the absolute result of the 24-hour pad weight test after treatment. Treatment success was defined as <3 g urine loss/24 h, improvement as ≥50% decrease in urine loss/ 24h, failure as <50% decrease in urine loss/24 h, or worsening of urine loss. Success was demonstrated in one, improvement in one, and failure in eight patients one month after treatment. One patient improved and 9 failed 3 and 6 months after treatment. The median 24-hour pad weight test was higher at all three moments of follow-up (1, 3, and 6 months after treatment). The median 24-hour pad weight test was before treatment 17.3g (6.4-20.9) and 1, 3, and 6 months after treatment, respectively, 40.3g (5.9-130.6) p= 0.038, 38.3g (18.3-202.1) p= 0.014, 55.0g (16.5-314.6) p= 0.028. The ICIQ-SF was significantly higher at 3 and 6 months, respectively 15.0 (12.0-18.5) p= 0.007 and 16.0 (12.5-17.5) p=0.012 versus 10.0 (9.0-12.0) before injection. No significant differences were found between IIQ-7, UDI-6-SF, and PGI-I before and after injection. Complications occurred in four patients: two patients reported spontaneously resolved haematuria and two patients reported urinary frequency. All complications were classified as Clavien-Dindo 1. CONCLUSION: Injection therapy with Opsys® bulking agent is not an effective treatment option for male SUI after radical prostatectomy. It is not a safe treatment option, due to worsening urine loss after treatment.

Cancer survivors' preference for follow-up care providers: a cross-sectional study from the population-based PROFILES-registry.

BACKGROUND: The best practice for the organization of follow-up care in oncology is under debate, due to growing numbers of cancer survivors. Understanding survivors' preferences for follow-up care is elementary for designing patient-centred care. Based on data from prostate cancer and melanoma survivors, this study aims to identify: 1) preferences for follow-up care providers, for instance the medical specialist, the oncology nurse or the general practitioner; 2) characteristics associated with these preferences and 3) the preferred care provider to discuss cancer-related problems. MATERIAL AND METHODS: Survivors diagnosed with prostate cancer (N = 535) and melanoma (N = 232) between 2007 and 2013 as registered in The Netherlands Cancer Registry returned a questionnaire (response rate was 71% and 69%, respectively). A latent class cluster model analysis was used to define preferences and a multinomial logistic regression analysis was used to identify survivor-related characteristics associated with these preferences. RESULTS: Of all survivors, 29% reported no preference, 40% reported a preference for the medical specialist, 20% reported a preference for both the medical specialist and the general practitioner and 11% reported a preference for both the medical specialist and the oncology nurse. Survivors who were older, lower/intermediate educated and women were more likely to have a preference for the medical specialist. Lower educated survivors were less likely to have a preference for both the medical specialist and the general practitioner. Overall, survivors prefer to discuss diet, physical fitness and fatigue with the general practitioner, and hereditary and recurrence with the medical specialist. Only a small minority favored to discuss cancer-related problems with the oncology nurse. CONCLUSION: Survivors reported different preferences for follow-up care providers based on age, education level, gender and satisfaction with the general practitioner, showing a need for tailored follow-up care in oncology. The results indicate an urgency to educate patients about transitions in follow-up care.

High educational impact of a national simulation-based urological curriculum including technical and non-technical skills.

BACKGROUND: Although simulation training is increasingly used to meet modern technology and patient safety demands, its successful integration within surgical curricula is still rare. The Dutch Urological Practical Skills (D-UPS) curriculum provides modular simulation-based training of technical and non-technical basic urological skills in the local hospital setting. This study aims to assess the educational impact of implementing the D-UPS curriculum in the Netherlands and to provide focus points for improvement of the D-UPS curriculum according to the participants. METHODS: Educational impact was assessed by means of qualitative individual module-specific feedback and a quantitative cross-sectional survey among residents and supervisors. Twenty out of 26 Dutch teaching hospitals participated. The survey focussed on practical aspects, the D-UPS curriculum in general, and the impact of the D-UPS curriculum on the development of technical and non-technical skills. RESULTS: A considerable survey response of 95 % for residents and 76 % for supervisors was obtained. Modules were attended by junior and senior residents, supervised by a urologist, and peer teaching was used. Ninety percent of supervisors versus 67 % of residents judged the D-UPS curriculum as an important addition to current residency training (p = 0.007). Participants' aggregated general judgement of the modules showed a substantial percentage favorable score (M ± SE: 57 ± 4 %). The impact of training on, e.g., knowledge of materials/equipment and ability to anticipate on complications was high, especially for junior residents (77 ± 5 and 71 ± 7 %, respectively). Focus points for improvement of the D-UPS curriculum according to the participants include adaptation of the training level to residents' level of experience and focus on logistics. CONCLUSION: The simulation-based D-UPS curriculum has a high educational impact. Residents and supervisors consider the curriculum to be an important addition to current residency training. Focus points for improvement of the D-UPS curriculum according to the participants include increased attention to logistics and integration of a spiral learning approach.

The Simbla TURBT Simulator in Urological Residency Training: From Needs Analysis to Validation.

OBJECTIVE: To investigate the value of the physical Simbla Transurethral Resection of a Bladder Tumor (TURBT) simulator as an educational tool within urological residency training, by means of a training needs analysis (TNA) and assessment of its feasibility, acceptability, and face, content, and construct validity. METHODS: To analyze the training needs for TURBT, procedural steps and pitfalls were identified and the TNA was completed during an expert consensus meeting. Participants (n = 76) were divided into three groups based on their experience in TURBT: novices, intermediates, and experts. Participants performed two standardized TURBT procedures on the simulator. Face validity and content validity, as well as feasibility and acceptability, were assessed with a quantitative survey. Construct validity was assessed by comparing the performance of novices, intermediates, and experts on resection time, quality of tumor resection, and overall performance. RESULTS: Of the 21 procedural steps and 17 pitfalls defined in TNA, 13 steps and 8 pitfalls were covered by the Simbla. Participants rated the Simbla's overall realism (face validity) with a score of 8 of 10 (range 6-9). The simulator was judged to be most useful (content validity) for learning eye-hand coordination: score 8 (6-10). All aspects regarding realism and usefulness were rated above the acceptability threshold of 6/10. Intermediates (100%) and experts (96%) considered the Simbla to be a useful educational tool within the urological curriculum. Resection time was longer for novices than for experts (p < 0.05; construct validity). In addition, the overall performance of novices was rated lower compared with intermediates and experts, and novices showed more irradical resections and bladder perforations (all p < 0.05). CONCLUSIONS: The Simbla TURBT simulator is a valid, feasible, and acceptable educational tool for training procedural skills and may be implemented in the urological curriculum to complement learning in clinical practice. TNA is valuable in defining training objectives and evaluating the educational value of a simulator.

High acceptability of a newly developed urological practical skills training program.

BACKGROUND: Benefits of simulation training are widely recognized, but its structural implementation into urological curricula remains challenging. This study aims to gain insight into current and ideal urological practical skills training and presents the outline of a newly developed skills training program, including an assessment of the design characteristics that may increase its acceptability. METHODS: A questionnaire was sent to the urology residents (n = 87) and program directors (n = 45) of all Dutch teaching hospitals. Open- and close-ended questions were used to determine the views on current and ideal skills training and the newly developed skills training program. Eight semi-structured interviews were conducted with 39 residents and 15 program directors. All interviews were audiotaped, fully transcribed, and thereafter analyzed. RESULTS: Response was 87.4% for residents and 86.7% for program directors. Residents appeared to be still predominantly trained 'by doing'. Structured practical skills training in local hospitals takes place according to 12% of the residents versus 44% of the program directors (p < 0.001). Ideally, residents prefer to practice certain procedures on simulation models first, especially in endourology. The majority of residents (92%) and program directors (87%) approved of implementing the newly developed skills training program (p = 0.51). 'Structured scheduling', 'use of peer teaching' and 'high fidelity models' were indicated as design characteristics that increase its acceptability. CONCLUSIONS: Current urological residency training consists of patient-related 'learning by doing', although more practice on simulation models is desired. The acceptability of implementing the presented skills-training program is high. Design characteristics that increase its acceptability are structured scheduling, the use of peer teaching and high fidelity models.

Patient Safety Risks of Basic Urological Procedures Performed by Junior and Senior Residents.

OBJECTIVE: To investigate the current performance of urological residents regarding basic urological procedures in relation to patient safety issues and the identification of specific training needs. DESIGN: Observational data of 146 urethrocystoscopies (UCSs), 27 transrectal ultrasounds of the prostate (TRUSs), 38 transrectal ultrasound-guided prostatic biopsies (TRUSPs), and 30 transurethral resections of bladder tumor (TURBTs) were collected. Performance was evaluated using scoring lists including details on completeness of procedural steps, level of independence, time, and the incidence of unintended events. The causal factors contributing to the unintended events were identified by 2 expert urologists and classified according to the recognized PRISMA method. SETTING: This study was performed in 5 teaching hospitals in the Netherlands. PARTICIPANTS: We included 11 junior residents and 5 senior residents in urology in the final study cohort. RESULTS: Senior residents showed a lower degree of completeness in material usage than junior residents did during UCS (p < 0.01) and in preparation, material usage, and procedure during TRUSP (all p < 0.05). In UCS and TURBT, senior residents received significantly less feedback than junior residents did (both p < 0.01). Incidence of unintended events for junior vs senior residents was 11% and 4% in UCS, 0% and 7% in transrectal ultrasound of the prostate, 36% and 62% in TRUSP, and 41% and 23% in TURBT, respectively. Overall, unintended events were mainly caused by human factors, in particular, verification and skills-based issues. CONCLUSION: Present performance of basic urological procedures involves a high percentage of unintended events, especially in TRUSP and TURBT, which are mainly caused by human factors and are a potential threat for patient safety. Junior residents are less independent but more thorough in the performance of UCS and TRUSP than senior residents are. Targeted skills training including assessment should be implemented before privileges for independent practice are granted to reduce the incidence of unintended events and optimize patient safety.

Evaluation of the educational value of a virtual reality TURP simulator according to a curriculum-based approach.

PURPOSE: This study aimed to evaluate the place of the TURPsim (Simbionix/VirtaMed, Beit Goal, Israel) within a urologic residency training curriculum, including training needs analysis (TNA) and investigating its validity. MATERIALS AND METHODS: Training needs analysis was conducted by an expert panel to identify procedural steps and pitfalls. Performance metrics of the simulator were compared with the TNA results. Participants were distributed according to their level of experience (completed transurethral resection of the prostate [TURP] procedures) as follows: novices (0), intermediates (1-50), and experts (>50). They followed standardized instructions and then performed 2 complete TURP procedures on the TURPsim. RESULTS: Ten of 22 procedural steps (TNA) and 4 of 11 pitfalls were covered by the TURPsim. A total of 66 participants, 22 in each group, were included. Median general judgment (face and content) about the TURPsim was rated 7.3 (median, 7; range, 3-9). Ninety-three percent of all participants qualified the TURPsim as a useful training model. Intermediates and experts had a significant faster resection time and less blood loss compared with novices (construct) (P = 0.001). Novices needed to re-resect previous lobes, and they also resected the prostate in the incorrect order more frequently compared with intermediates and experts. CONCLUSIONS: Training needs analysis is of paramount importance in the evaluation process of a training program. This curriculum-based approach including validity of a simulator seems valuable and may narrow the gap between skills laboratory and clinical practice. This study showed face, content, and construct validity of the TURPsim, and this simulator finds its place in the current urologic curriculum to train basic and procedural TURP skills.

Ergonomics in endourology and laparoscopy: an overview of musculoskeletal problems in urology.

PURPOSE: This study aims to provide an overview of type and frequency of musculoskeletal complaints among urologists. In addition, the urologists' knowledge about ergonomic conditions during minimally invasive urology was assessed, and they were asked how they would prefer to gain knowledge about this topic. MATERIALS AND METHODS: An online and hard copy version questionnaire was administered to urologists from different countries, mainly from Europe, performing endourology and laparoscopy. RESULTS: Of the 285 respondents, 245 (86.0%) urologists experienced musculoskeletal complaints in the past 12 months and 62.1% were considered to be work related. Most common areas for chronic complaints were neck, back, and shoulders. Almost 50% of the urologists experienced chronic musculoskeletal complaints, for which endourology (odds ratio [OR] 3.06; 95% confidence interval [CI] 1.37-6.80) and laparoscopy (OR 1.70; 95% CI 1.27-2.28) were significant risk factors. One third of the urologists considered their knowledge about ergonomics minimal, and 8% stated that they had no knowledge about these topics. Fifty percent of the respondents preferred to integrate information about ergonomic rules into hands-on training of urologic skills. CONCLUSION: High prevalence of experienced musculoskeletal complaints was found among urologists predominantly related to endourology and laparoscopy. Urologists indicate that they have a lack of knowledge about ergonomics in the operating room. Hence, we recommend integration of ergonomics in hands-on training programs early in the residency curriculum to gain knowledge and awareness and hopefully to offer possibilities to prevent these complaints in the future.

Results of the European Basic Laparoscopic Urological Skills examination.

BACKGROUND: In 2011, the European Basic Laparoscopic Urological Skills (E-BLUS) examination was introduced as a pilot for the examination of final-year urologic residents. OBJECTIVE: In this study, we aimed to answer the following research questions: What level of laparoscopic skills do final-year residents in urology have in Europe, and do the participants of the E-BLUS pass the examination according to the validated criteria? DESIGN, SETTING, AND PARTICIPANTS: Participants of the examination were final-year urology residents from different European countries taking part in the European Urology Residents Education Program in 2011 and 2012. SURGICAL PROCEDURE: The E-BLUS exam consists of five tasks validated for the training of basic urologic laparoscopic skills. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Performances of the tasks were recorded on DVD and analysed by an objective rater. Time and number of errors made in tasks 1-4 were noted. Furthermore, all expert laparoscopic urologists were asked to score participants on a global rating scale (1-5) based on three items: depth perception, bimanual dexterity, and efficiency. Participants were asked to complete a questionnaire on prior training and laparoscopic experience. RESULTS AND LIMITATIONS: Seventy DVD recordings were analysed. Most participants did not pass the time criteria on task 4 (90%), task 2 (85.7%), task 1 (74.3%), and task 5 (71.4%). Task 3 was passed by 84.3%. The overall quality score was passed by 64%. When combining time and quality, only three participants (4.2%) passed the examination according to the validated criteria. According to the questionnaire, 61% did not have the opportunity to train in laparoscopic skills. CONCLUSIONS: The results of the E-BLUS examination show that the level of basic laparoscopic skills among European residents is low. Although quality of performance is good, most residents do not pass the validated time criteria. Regular laparoscopic training or a dedicated fellowship should improve the laparoscopic level of residents in urology.

Patients with prostate cancer continue to have excess mortality up to 15 years after diagnosis.

OBJECTIVE: To estimate the population-based conditional 5-year relative survival rates for patients with prostate cancer (PCa). PATIENTS AND METHODS: All 98 672 patients, aged 45-89 years, diagnosed in the Netherlands with PCa (clinical T stage 1-4) in the period 1989-2008 were selected from the Netherlands Cancer Registry and followed up until 2010. The conditional 5-year relative survival rate was estimated for every subsequent year of survival up to 15 years after diagnosis. RESULTS: The conditional 5-year relative survival rate decreased with survival time from diagnosis. Excess mortality (conditional 5-year relative survival rate <95%) for patients with clinical T1 stage only became manifest 5 years after diagnosis and increased to almost 10% after 10 years. Patients with more advanced disease (cT2-cT4) were found to have an excess mortality rate of 6-12% at diagnosis, which increased to 15-22% after 10 years. Excess mortality occurred earlier for the older age groups. The 5-year relative survival rate at diagnosis was <90% for all age groups of patients with cT3/cT4 disease and excess mortality for this group increased to >20% for those who had already survived for 5 years since diagnosis. CONCLUSIONS: Patients with PCa were found to have excess mortality within 10 years of diagnosis. Excess mortality was found at an earlier timepoint for patients with a more advanced stage and for older age groups. Quantitative insight into conditional survival is useful for caregivers to help plan optimum cancer treatment and surveillance and to inform patients about their actual prognosis during follow-up, taking the current condition of the patient into account.