There has been increasing interest in en bloc resection of bladder tumour (ERBT) as an oncologically noninferior alternative to transurethral resection of bladder tumour (TURBT) with fewer ...complications and better histology specimens. However, there is a lack of robust randomised controlled trial (RCT) data for making recommendations.
We aimed to develop a consensus statement to standardise various aspects of ERBT for clinical practice and to guide future research.
We developed the consensus statement on ERBT using a modified Delphi method. First, two systematic reviews were performed to investigate the clinical effectiveness of ERBT versus TURBT (effectiveness review) and to identify areas of uncertainty in ERBT (uncertainties review). Next, 200 health care professionals (urologists, oncologists, and pathologists) with experience in ERBT were invited to complete a two-round Delphi survey. Finally, a 16-member consensus panel meeting was held to review, discuss, and re-vote on the statements as appropriate.
Meta-analyses were performed for RCT data in the effectiveness review. Consensus statements were developed from the uncertainties review. Consensus was defined as follows: (1) ≥70% scoring a statement 7–9 and ≤15% scoring the statement 1–3 (consensus agree), or (2) ≥70% scoring a statement 1–3 and ≤15% scoring the statement 7–9 (consensus disagree).
A total of 10 RCTs were identified upon systematic review. ERBT had a shorter irrigation time (mean difference –7.24 h, 95% confidence interval CI –9.29 to –5.20, I2 = 85%, p < 0.001) and a lower rate of bladder perforation (risk ratio 0.30, 95% CI 0.11–0.83, I2 = 1%, p = 0.02) than TURBT, both with moderate certainty of evidence. There were no significant differences in recurrences at 0–12, 13–24, or 25–36 mo (all very low certainty of evidence). A total of 103 statements were developed, of which 99 reached a consensus. A summary of statements is as follows: ERBT should always be considered for treating non–muscle-invasive bladder cancer; ERBT should be considered feasible even for bladder tumours larger than 3 cm; number and location of bladder tumours are not major limitations in performing ERBT; the planned circumferential margin should be at least 5 mm from any visible bladder tumour; after ERBT, additional biopsy of the tumour edge or tumour base should not be performed routinely; for the ERBT specimen, T1 substage, and circumferential and deep resection margins must be assessed; it is safe to give a single dose of immediate intravesical chemotherapy, perform second-look transurethral resection, and give intravesical bacillus Calmette-Guérin (BCG) therapy after ERBT; and in studies of ERBT, both per-patient and -tumour analysis should be performed for different outcomes as appropriate. Important outcomes for future ERBT studies were also identified. A limitation is that as consensus statements are brief, concise and binary in nature, areas of uncertainty that are complex in nature may not be addressed adequately.
We have provided the most comprehensive review of the evidence base to date using a meta-analysis where appropriate and applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and mobilised the international urology community to develop a consensus statement on ERBT using transparent and robust methods. The consensus statement will provide interim guidance for health care professionals who practice ERBT and inform researchers regarding ERBT-related studies in the future.
En bloc resection of bladder tumour (ERBT) is a surgical technique aiming to resect a bladder tumour in one piece. We included an international panel of experts to agree on the best practice of ERBT, and this will provide guidance to clinicians and researchers in the future.
An international collaborative consensus statement on en bloc resection of bladder tumour has been developed. The consensus statement serves as a standard reference for practising en bloc resection of bladder tumour and conducting future research work in this area.
The PIONEER Consortium has updated and integrated existing core outcome sets for prostate cancer for the different stages of the disease, assessed their applicability, and developed standardised ...definitions of prioritised outcomes for use in research settings and clinical practice.
Harmonisation of outcome reporting and definitions for clinical trials and routine patient records can enable health care systems to provide more efficient outcome-driven and patient-centred interventions. We report on the work of the PIONEER Consortium in this context for prostate cancer (PCa).
To update and integrate existing core outcome sets (COS) for PCa for the different stages of the disease, assess their applicability, and develop standardised definitions of prioritised outcomes.
We followed a four-stage process involving: (1) systematic reviews; (2) qualitative interviews; (3) expert group meetings to agree standardised terminologies; and (4) recommendations for the most appropriate definitions of clinician-reported outcomes.
Following four systematic reviews, a multinational interview study, and expert group consensus meetings, we defined the most clinically suitable definitions for (1) COS for localised and locally advanced PCa and (2) COS for metastatic and nonmetastatic castration-resistant PCa. No new outcomes were identified in our COS for localised and locally advanced PCa. For our COS for metastatic and nonmetastatic castration-resistant PCa, nine new core outcomes were identified.
These are the first COS for PCa for which the definitions of prioritised outcomes have been surveyed in a systematic, transparent, and replicable way. This is also the first time that outcome definitions across all prostate cancer COS have been agreed on by a multidisciplinary expert group and recommended for use in research and clinical practice. To limit heterogeneity across research, these COS should be recommended for future effectiveness trials, systematic reviews, guidelines and clinical practice of localised and metastatic PCa.
Patient outcomes after treatment for prostate cancer (PCa) are difficult to compare because of variability. To allow better use of data from patients with PCa, the PIONEER Consortium has standardised and recommended outcomes (and their definitions) that should be collected as a minimum in all future studies.
Objective
To understand the barriers and facilitators to single instillation of intravesical chemotherapy (SI‐IVC) use after resection of non‐muscle‐invasive bladder cancer (NMIBC) in Scotland and ...England using a behavioural theory‐informed approach.
Subjects and Methods
In a cross‐sectional descriptive study of practices at seven hospitals, we investigated care pathways, policies, and interviewed 30 urology staff responsible for SI‐IVC. We used the Theoretical Domains Framework (TDF) to organise our investigation and conducted deductive thematic analyses, while inductively coding emergent beliefs.
Results
Barriers to SI‐IVC were present at different organisational levels and professional roles. In four hospitals, there was a policy to not instil SI‐IVC in theatre. Six hospitals’ staff reported delays in mitomycin C (MMC) ordering and/or local storage. Lack of training, skills and perceived workload affected motivation. Facilitators included access to modern instilling devices (four hospitals) and incorporating reminders in operation proforma (four hospitals). Performance targets (with audit and feedback) within a national governance framework were present in Scotland but not England. Differences in coordinated leadership, sharing best practices, and disliking being perceived as underperforming, were evident in Scotland.
Conclusions
High‐certainty evidence shows that SI‐IVC, such as MMC, after NMIBC resection reduces recurrences. This evidence underpins international guidance. The number of eligible patients receiving SI‐IVC is variable indicating suboptimal practice. Improving SI‐IVC adherence requires modifications to theatre instilling policies, delivery and storage of MMC, staff training, and documentation. Centralising care, with bladder cancer expert leadership and best practices sharing with performance targets, likely led to improvements in Scotland. National quality improvement, incorporating audit and feedback, with additional implementation strategies targeted to professional role could improve adherence and patient outcomes elsewhere. This process should be controlled to clarify implementation intervention effectiveness.
Bladder stones (BS) constitute 5% of urinary stones. Currently, there is no systematic review of their treatment.
To assess the efficacy (primary outcome: stone-free rate SFR) and morbidity of BS ...treatments.
This systematic review was conducted in accordance with the European Association of Urology Guidelines Office. Database searches (1970–2019) were screened, abstracted, and assessed for risk of bias for comparative randomised controlled trials (RCTs) and nonrandomised studies (NRSs) with ≥10 patients per group. Quality of evidence (QoE) was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool.
A total of 2742 abstracts and 59 full-text articles were assessed, and 25 studies (2340 patients) were included. In adults, one RCT found a lower SFR following shock wave lithotripsy (SWL) than transurethral cystolithotripsy (TUCL; risk ratio 0.88, p=0.03; low QoE). Four RCTs compared TUCL versus percutaneous cystolithotripsy (PCCL): meta-analyses demonstrated no difference in SFR, but hospital stay (mean difference MD 0.82d, p<0.00001) and procedure duration (MD 9.83min, p<0.00001) favoured TUCL (moderate QoE). Four NRSs comparing open cystolithotomy (CL) versus TUCL or PCCL found no difference in SFR; hospital stay and procedure duration favoured endoscopic surgery (very low QoE). Four RCTs compared TUCL using a nephroscope versus a cystoscope: meta-analyses demonstrated no difference in SFR; procedure duration favoured the use of a nephroscope (MD 22.74min, p<0.00001; moderate QoE). In children, one NRS showed a lower SFR following SWL than TUCL or CL. Two NRSs comparing CL versus TUCL/PCCL found similar SFRs; catheterisation time and hospital stay favoured endoscopic treatments. One RCT comparing laser versus pneumatic TUCL found no difference in SFR. One large NRS comparing CL techniques found a shorter hospital stay after tubeless CL in selected cases; QoE was very low.
Current available evidence indicates that TUCL is the intervention of choice for BSs in adults and children, where feasible. Further high-quality research on the topic is required.
We examined the literature to determine the most effective and least harmful procedures for bladder stones in adults and children. The results suggest that endoscopic surgery is equally effective as open surgery. It is unclear whether stone size affects outcomes. Shock wave lithotripsy appears to be less effective. Endoscopic treatments appear to have shorter catheterisation time and convalescence compared with open surgery in adults and children. Transurethral surgery, where feasible, appears to have a shorter hospital stay than percutaneous surgery. Further research is required to clarify the efficacy of minimally invasive treatments for larger stones and in young children.
Endoscopic treatments offer a shorter hospital stay and recovery than open surgery, with an equivalent stone-free rate (SFR). Transurethral cystolithotripsy is quicker with a continuous flow instrument and offers a shorter hospital stay compared with percutaneous cystolithotripsy. Shock wave lithotripsy appears to offer an inferior SFR.
The rate of postoperative complications might vary according to the method used to collect perioperative data. We aimed at assessing the impact of the prospective implementation of the European ...Association of Urology (EAU) guidelines on reporting and grading of complications in prostate cancer patients undergoing robot-assisted radical prostatectomy (RARP). From September 2016, an integrated method for reporting surgical morbidity based on the EAU guidelines was implemented at a single, tertiary center. Perioperative data were prospectively and systematically collected during a patient interview at 30 d after surgery as recommended by the EAU Guidelines Panel Recommendations on Reporting and Grading Complications. The rate and grading of complications of 167 patients who underwent RARP±pelvic lymph node dissection (PLND) after the implementation of the prospective collection system (Group 1) were compared with 316 patients treated between January 2015 and August 2016 (Group 2) when a system based on patient chart review was used. No differences were observed in disease characteristics and PLND between the two groups (all p≥0.1). Postoperative complications were graded according to the Clavien-Dindo classification system. Overall, the complication rate was higher when the prospective collection system based on the EAU guidelines was used (29%) than when retrospective chart review (10%; p<0.001) was used. In particular, a substantially higher rate of grade 1 (8.4% vs 4.7%) and 2 (14% vs 2.8%) complications was detected in Group 1 versus Group 2 (p<0.001). Although the rate of complications occurred during hospitalization did not differ (13% vs 10%; p=0.3), 31 (19%) complications after discharge were detected in Group 1. This resulted into a readmission rate of 16%. Conversely, no complications after discharge and readmissions were recorded for Group 2. The implementation of the EAU guidelines on reporting perioperative outcomes roughly doubled the complication rate after RARP and allowed for the detection of complications after discharge in more than 15% of patients that would have been otherwise missed, where patients assessed with the EAU implemented protocol had a threefold higher likelihood of reporting complications.
The implementation of the European Association of Urology guidelines on reporting and grading of complications after urologic procedures in prostate cancer patients roughly doubled the complication rate after robot-assisted radical prostatectomy compared to retrospective patient chart review. Moreover, it allowed for the detection of complications after discharge in more than 15% of patients that would have been otherwise missed.
The implementation of the European Association of Urology guidelines on reporting and grading of complications after urologic procedures roughly doubled the complication rate after robot-assisted radical prostatectomy in prostate cancer patients and allowed for the detection of complications after discharge in more than 15% of patients that would have been otherwise missed.
The objective of the study was to explore the impact of different feedback strategies on (1) subsequent agreement and (2) variability in Delphi studies.
A two-round Delphi survey, with a list of ...outcomes generated from the results of a systematic review and interviews, was undertaken while developing a core outcomes set for prostate cancer including two stakeholder groups (health professionals and patients). Seventy-nine outcomes were scored on a scale of one (not important) to nine (critically important). Participants were randomized in round 2 to receive round 1 feedback from peers only, multiple stakeholders separately, or multiple stakeholders combined.
Agreement on outcomes retained for all feedback groups was high (peer: 92%, multiple separate: 90%, multiple combined: 84%). There were no statistically significant reduction in variability for peer vs. multiple separate (0.016 −0.035, 0.067; P = 0.529), or multiple separate vs. multiple combined feedback (0.063 −0.003, 0.129; P = 0.062). Peer feedback statistically significantly reduced variability compared with multiple combined feedback (0.079 0.001, 0.157; P = 0.046).
We found no evidence of a difference between different feedback strategies in terms of the number of outcomes retained or reduction in variability of opinion. However, this may be explained by the high level of existing agreement in round 1. Further methodological studies nested within Delphi surveys will help clarify the best strategy.
To compare monopolar and bipolar transurethral resection of the prostate (TURP) for clinical effectiveness and adverse events.
We conducted an electronic search of MEDLINE, Embase, CENTRAL, Science ...Citation Index, and also searched reference lists of articles and s from conference proceedings for randomised controlled trials (RCTs) comparing monopolar and bipolar TURP.
Two reviewers independently undertook data extraction and assessed the risk of bias in the included trials using the tool recommended by the Cochrane Collaboration.
The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
From the 949 s that were identified, 94 full texts were assessed for eligibility and a total of 24 trials were included in the review.
No statistically significant differences were found in terms of International Prostate Symptom Score (IPSS) or health‐related quality of life (HRQL) score.
Results for maximum urinary flow rate were significant at 3, 6 and 12 months (all P < 0.001), but no clinically significant differences were found and the meta‐analysis showed evidence of heterogeneity
Bipolar TURP was associated with fewer adverse events including transurethral resection syndrome (risk ratio RR 0.12, 95% confidence interval CI 0.05–0.31, P < 0.001), clot retention (RR 0.48, 95% CI 0.30–0.77, P = 0.002) and blood transfusion (RR 0.53, 95% CI 0.35–0.82, P = 0.004)
Several major methodological limitations were identified in the included trials; 22/24 trials had a short follow‐up of ≤1 year, there was no evidence of a sample size calculation in 20/24 trials and the application of GRADE showed the evidence for most of the assessed outcomes to be of moderate quality, including all those in which statistical differences were found.
Whilst there is no overall difference between monopolar and bipolar TURP for clinical effectiveness, bipolar TURP is associated with fewer adverse events and therefore has a superior safety profile.
Various methodological limitations were highlighted in the included trials and as such the results of this review should be interpreted with caution.
There is a need for further well‐conducted, multicentre RCTs with long‐term follow‐up data.
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