This perspective paper presents the case for adopting a new approach to the design and delivery of supportive care for those with bladder cancer. It is our assertion that the design and delivery of ...supportive care for those diagnosed with bladder cancer needs to (1) build on existing research and available tools and (2) address current limitations due to lack of use of said tools, lack of understanding of research and needs, lack of a shared language, and method of assessment and evaluation. This, we argue, can be achieved through a network-based approach (1) focussed on the structure, process, and outcome of supportive care.
Abstract Context Miniaturized instruments for percutaneous nephrolithotomy (PNL), utilizing tracts sized ≤22 Fr, have been developed in an effort to reduce the morbidity and increase the efficiency ...of stone removal compared with standard PNL (>22 Fr). Objective We systematically reviewed all available evidence on the efficacy and safety of miniaturized PNL for removing renal calculi. Evidence acquisition The review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses statement. Since it was not possible to perform a meta-analysis, the data were summarized in a narrative synthesis. Evidence synthesis After screening 2945 abstracts, 18 studies were included (two randomized controlled trials RCTs, six nonrandomized comparative studies, and 10 case series). Thirteen studies were full-text articles and five were only available as congress abstracts. The size of tracts used in miniaturized procedures ranged from 22 Fr to 4.8 Fr. The largest mean stone size treated using small instruments was 980 mm2 . Stone-free rates were comparable in miniaturized and standard PNL procedures. Procedures performed with small instruments tended to be associated with significantly lower blood loss, while the procedure duration tended to be significantly longer. Other complications were not notably different between PNL types. Study designs and populations were heterogeneous. Study limitations included selection and outcome reporting bias, as well as a lack of information on relevant confounding factors. Conclusions The studies suggest that miniaturized PNL is at least as efficacious and safe as standard PNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only two of which were RCTs. Furthermore, the tract sizes used and types of stones treated were heterogeneous. Hence, the risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. Patient summary Removing kidney stones via percutaneous nephrolithotomy (PNL) using smaller sized instruments (mini-PNL) appears to be as effective and safe as using larger (traditional) instruments, but more clinical research is needed.
Abstract Context Controversy remains over whether adrenalectomy and lymph node dissection (LND) should be performed concomitantly with radical nephrectomy (RN) for locally advanced renal cell ...carcinoma (RCC) cT3–T4N0M0. Objective To systematically review all relevant literature comparing oncologic, perioperative, and quality-of-life (QoL) outcomes for locally advanced RCC managed with RN with or without concomitant adrenalectomy or LND. Evidence acquisition Relevant databases were searched up to August 2012. Randomised controlled trials (RCTs) and comparative studies were included. Outcome measures were overall survival, QoL, and perioperative adverse effects. Risks of bias (RoB) were assessed using Cochrane RoB tools. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Evidence synthesis A total of 3658 abstracts and 252 full-text articles were screened. Eight studies met the inclusion criteria: six LNDs (one RCT and five nonrandomised studies NRSs) and two adrenalectomies (two NRSs). RoB was high across the evidence base, and the quality of evidence from outcomes ranged from moderate to very low. Meta-analyses were not undertaken because of diverse study designs and data heterogeneity. There was no significant difference in survival between the groups, even though 5-yr overall survival appears better for the RN plus LND group compared with the no-LND group in one randomised study. There was no evidence of a difference in adverse events between the RN plus LND and no-LND groups. No studies reported QoL outcomes. There was no evidence of an oncologic difference between the RN with adrenalectomy and RN without adrenalectomy groups. No studies reported adverse events or QoL outcomes. Conclusions There is insufficient evidence to draw any conclusions on oncologic outcomes for patients having concomitant LND or ipsilateral adrenalectomy compared with patients having RN alone for cT3–T4N0M0 RCC. The quality of evidence is generally low and the results potentially biased. Further research in adequately powered trials is needed to answer these questions.
Management of men with penile squamous cell carcinoma (PSCC) who have high-risk features following radical inguinal lymphadenectomy (ILND) remains controversial. European Association of Urology ...guidelines state that adjuvant inguinal radiotherapy (AIRT) is “not generally recommended”. Despite this, many centres continue to offer AIRT to a subset of men.
To undertake a systematic review of the evidence on AIRT in node-positive men with PSCC.
A systematic review was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, with no language or date restriction. Inclusion criteria were men with PSCC, pathologically staged inguinal node positive after ILND. The intervention included ILND with AIRT compared with ILND alone. Primary outcomes were relapse-free survival and toxicity. Risk of bias assessment was undertaken.
A total of 913 abstracts were identified and screened independently by two reviewers. Seven studies were eligible for inclusion: six full-text manuscripts and one conference abstract. All were retrospective series and at a high risk of bias. The selected studies included 1605 men. Indications for AIRT varied but were typically involvement of two or more inguinal nodes or extranodal extension. Regional recurrence rate following AIRT was reported at 10–91.7%. Only one study reported on toxicity. Two studies compared recurrence and survival between men who received and who did not receive AIRT, with no significant difference (p>0.05).
The evidence indicates that men treated with AIRT do not gain benefit with respect to relapse or survival. Uncertainty remains due to the retrospective nature and high risks of bias across the evidence. Given the lack of evidence supporting AIRT, it cannot be recommended for routine practice.
Men with penile cancer who have involvement of the inguinal lymph nodes are at a high risk of cancer recurrence and death. We reviewed the literature to see if radiation treatment after removal of the nodes provided benefit. We did not find any good-quality evidence supporting this treatment, and hence it cannot be recommended.
The published evidence on adjuvant inguinal radiotherapy following radical inguinal lymphadenectomy in men with penile cancer is limited and at a high risk of bias. The evidence identified failed to demonstrate any evidence of a recurrence or survival benefit.
Renal stones are common, with a lifetime prevalence of 10% in adults. Global incidence is increasing due to increases in obesity and diabetes, with these patient populations being more likely to ...suffer renal stone disease. Flank pain from stones (renal colic) is the most common cause of emergency admission to UK urology departments. Stones most commonly develop in the lower pole of the kidney (in ~35% of cases) and here are least likely to pass without intervention. Currently there are three technologies available within the UK National Health Service to remove lower pole kidney stones: extracorporeal shockwave lithotripsy (ESWL), percutaneous nephrolithotomy (PCNL) and flexible ureterorenoscopy (FURS) with laser lithotripsy. Current evidence indicates there is uncertainty regarding the management of lower pole stones, and each treatment has advantages and disadvantages. The aim of this trial is to determine the clinical and cost effectiveness of FURS compared with ESWL or PCNL in the treatment of lower pole kidney stones.
The PUrE (PCNL, FURS and ESWL for lower pole kidney stones) trial is a multi-centre, randomised controlled trial (RCT) evaluating FURS versus ESWL or PCNL for lower pole kidney stones. Patients aged ≥16 years with a stone(s) in the lower pole of either kidney confirmed by non-contrast computed tomography of the kidney, ureter and bladder (CTKUB) and requiring treatment for a stone ≤10 mm will be randomised to receive FURS or ESWL (RCT1), and those requiring treatment for a stone >10 mm to ≤25 mm will be randomised to receive FURS or PCNL (RCT2). Participants will undergo follow-up by questionnaires every week up to 12 weeks post-intervention and at 12 months post-randomisation. The primary clinical outcome is health status measured by the area under the curve calculated from multiple measurements of the EuroQol five dimensions five-level version (EQ-5D-5L) questionnaire up to 12 weeks post-intervention. The primary economic outcome is the incremental cost per quality-adjusted life year gained at 12 months post-randomisation.
The PUrE trial aims to provide robust evidence on health status, quality of life, clinical outcomes and resource use to directly inform choice and National Health Service provision of the three treatment options.
ISRCTN: ISRCTN98970319. Registered on 11 November 2015.
Considerable efforts have been made to improve guideline adherence in healthcare through de-implementation, such as decreasing the prescription of inappropriate medicines. However, we have limited ...knowledge about the effectiveness, barriers, facilitators and consequences of de-implementation strategies targeting inappropriate medication prescribing in secondary care settings. This review was conducted to understand these factors to contribute to better replication and optimisation of future de-implementation efforts to reduce low-value care.
A systematic review of randomised control trials was conducted. Papers were identified through CINAHL, EMBASE, MEDLINE and Cochrane register of controlled trials to February 2021. Eligible studies were randomised control trials evaluating behavioural strategies to de-implement inappropriate prescribing in secondary healthcare. Risk of bias was assessed using the Cochrane Risk of Bias tool. Intervention characteristics, effectiveness, barriers, facilitators and consequences were identified in the study text and tabulated.
Eleven studies were included, of which seven were reported as effectively de-implementing low-value prescribing. Included studies were judged to be mainly at low to moderate risk for selection biases and generally high risk for performance and reporting biases. The majority of these strategies were clinical decision support at the 'point of care'. Clinical decision support tools were the most common and effective. They were found to be a low-cost and simple strategy. However, barriers such as clinician's reluctance to accept recommendations, or the clinical setting were potential barriers to their success. Educational strategies were the second most reported intervention type however the utility of educational strategies for de-implementation remains varied. Multiple barriers and facilitators relating to the environmental context, resources and knowledge were identified across studies as potentially influencing de-implementation. Various consequences were identified; however, few measured the impact of de-implementation on usual appropriate practice.
This review offers insight into the intervention strategies, potential barriers, facilitators and consequences that may affect the de-implementation of low-value prescribing in secondary care. Identification of these key features helps understand how and why these strategies are effective and the wider (desirable or undesirable) impact of de-implementation. These findings can contribute to the successful replication or optimisation of strategies used to de-implement low-value prescribing practices in future.
The review protocol was registered at PROSPERO (ID: CRD42021243944).
Most series have suggested better perioperative outcomes of laparoscopic radical nephroureterectomy (RNU) over open RNU. However, the oncological safety of laparoscopic RNU remains controversial.
To ...systematically review all relevant literature comparing oncological outcomes of open versus laparoscopic RNU.
A systematic literature search using the Medline, Embase, and Cochrane databases and clinicaltrial.gov was performed in December 2014 and updated in August 2016. Randomised controlled trials (RCTs) and prospective or retrospective nonrandomised comparative studies comparing the oncological outcomes of any laparoscopic RNU with those of open RNU were included. The primary outcome was cancer-specific survival. The risk of bias (RoB) was assessed using Cochrane RoB tools. A narrative synthesis of the evidence is presented.
Overall, 42 studies were included, which accounted for 7554 patients: 4925 in the open groups and 2629 in the laparoscopic groups. Most included studies were retrospective comparative series. Only one RCT was found. RoB and confounding were high in most studies. No study compared the oncological outcomes of robotic RNU with those of open RNU. Bladder cuff excision in laparoscopic groups was performed via an open approach in most studies, with only three studies reporting laparoscopic removal of the bladder cuff. Port-site metastasis rates ranged from 0% to 2.8%. No significant difference in oncological outcomes was reported in most series. However, three studies, including the only RCT, reported significantly poorer oncological outcomes in patients who underwent laparoscopic RNU, especially in the subgroups of patients with locally advanced (pT3/pT4) or high-grade upper tract urothelial carcinoma (UTUC), as well as in instances when the bladder cuff was excised laparoscopically.
The current available evidence suggests that the oncological outcomes of laparoscopic RNU may be poorer than those of open RNU when bladder cuff is excised laparoscopically and in patients with locally advanced high-risk (pT3/pT4 and/or high-grade) UTUC.
We reviewed the literature comparing the outcomes of two different surgical procedures for the treatment of upper tract urothelial carcinoma. Open radical nephroureterectomy is a surgical procedure in which the kidney is removed through a large incision in the abdomen, while in laparoscopic radical nephroureterectomy, the kidney is removed through a number of small incisions. Our findings suggest that the outcomes of laparoscopic radical nephroureterectomy may be poorer than those of open radical nephroureterectomy, particularly when the bladder cuff is also required to be removed. Laparoscopic radical nephroureterectomy may also be less effective in patients with locally advanced (pT3/pT4) or high-grade upper tract urothelial carcinomas.
The oncological outcomes of laparoscopic radical nephroureterectomy may be poorer than those of open radical nephroureterectomy when bladder cuff is excised laparoscopically, and in patients with locally advanced high-risk (pT3/pT4 and/or high-grade) upper tract urothelial carcinoma.
Introduction: Patient-reported outcome measures (PROMs) represent important endpoints in metastatic prostate cancer (mPCa). However, the clinically valid and accurate measurement of health-related ...quality of life depends on the psychometric properties of the PROMs considered. Objective: To appraise, compare, and summarize the properties of PROMs in mPCa. Evidence acquisition: We performed a review of PROMs used in RCTs, including patients with mPCa, using Medline in September 2021, according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) criteria. This systematic review is part of PIONEER (an IMI2 European network of excellence for big data in PCa). Results: The most frequently used PROMs in RCTs of patients with mPCa were the Functional Assessment for Cancer Therapy—Prostate (FACT-P) (n = 18), the Brief Pain Inventory—Short Form (BPI-SF) (n = 8), and the European Organization for Research and Treatment of Cancer quality of life core 30 (EORTC QLQ-C30) (n = 6). A total of 283 abstracts were screened and 12 full-text studies were evaluated. A total of two, one, and two studies reported the psychometric proprieties of FACT-P, Brief Pain Inventory (BPI), and BPI-SF, respectively. FACT-P and BPI showed a high content validity, while BPI-SF showed a moderate content validity. FACT-P and BPI showed a high internal consistency (summarized by Cronbach’s α 0.70–0.95). Conclusions: The use of BPI and FACT-P in mPCa patients is supported by their high content validity and internal consistency. Since BPI is focused on pain assessment, we recommend FACT-P, which provides a broader assessment of QoL and wellbeing, for the clinical evaluation of mPCa patients. However, these considerations have been elaborated on in a very limited number of studies. Patient summary: In this paper, we review the psychometric properties of PROMs used with patients with mPCa to find the questionnaires that best assess patients’ QoL, in order to help professionals in their intervention and improve patients’ QoL. We recommend the use of BPI and FACT-P for their high content validity and internal consistency despite the limited number of studies considered.
ObjectivesAs part of the PIONEER Consortium objectives, we have explored which diagnostic and prognostic factors (DPFs) are available in relation to our previously defined clinician and ...patient-reported outcomes for prostate cancer (PCa).DesignWe performed a systematic review to identify validated and non-validated studies.Data sourcesMEDLINE, Embase and the Cochrane Library were searched on 21 January 2020.Eligibility criteriaOnly quantitative studies were included. Single studies with fewer than 50 participants, published before 2014 and looking at outcomes which are not prioritised in the PIONEER core outcome set were excluded.Data extraction and synthesisAfter initial screening, we extracted data following the Checklist for Critical Appraisal and Data Extraction for Systematic Reviews of prognostic factor studies (CHARMS-PF) criteria and discussed the identified factors with a multidisciplinary expert group. The quality of the included papers was scored for applicability and risk of bias using validated tools such as PROBAST, Quality in Prognostic Studies and Quality Assessment of Diagnostic Accuracy Studies 2.ResultsThe search identified 6604 studies, from which 489 DPFs were included. Sixty-four of those were internally or externally validated. However, only three studies on diagnostic and seven studies on prognostic factors had a low risk of bias and a low risk concerning applicability.ConclusionMost of the DPFs identified require additional evaluation and validation in properly designed studies before they can be recommended for use in clinical practice. The PIONEER online search tool for DPFs for PCa will enable researchers to understand the quality of the current research and help them design future studies.Ethics and disseminationThere are no ethical implications.
As part of the PIONEER initiative, we conducted a study of patient-clinician communication in the prostate cancer setting in six European countries. Survey responses from 372 patients highlighted ...areas for improvement, such as clarifying misunderstanding, tailoring information presentation, handling challenging questions, and supporting emotional needs. Efforts to address these issues could help in enhancing patient-clinician communication and shared decision-making for men diagnosed with prostate cancer.
The ability of health care professionals to communicate with patients compassionately and effectively is crucial for shared decision-making, but little research has investigated patient-clinician communication. As part of PIONEER—an international Big Data Consortium led by the European Association of Urology to answer key questions for men with prostate cancer (PCa), funded through the IMI2 Joint Undertaking under grant agreement 777492— we investigated communication between men diagnosed with PCa and the health care professional(s) treating them across Europe.
We used the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Communication 26, which was shared via the PIONEER and patient organisations on March 11, 2022. We sought men who spoke French, Italian, Spanish, German, Dutch, or English who were diagnosed with PCa and were undergoing or had already received treatment for their PCa.
A total of 372 men reported that they communicated with their clinician during either the diagnostic or the treatment period. Overall, the majority of participants reported positive experiences. However, important opportunities to enhance communication were identified, particularly with regard to correcting misunderstandings, understanding the patient’s preferred approach to information presentation, addressing challenging questions, supporting the patient’s comprehension of information, attending to the patient’s emotional needs, and assessing what information had already been given to patients about their disease and treatment, and how much of it was understood.
These results help us to identify gaps and barriers to shared treatment decision making. This knowledge will help devise measures to improve patient-health care professional communication in the PCa setting.
As part of the PIONEER initiative, we investigated the communication between men diagnosed with prostate cancer and their health care professionals across Europe. A total of 372 men from six different countries participated in the study. Most participants reported positive experiences, but areas where communication could be improved were identified. These included addressing misunderstandings, tailoring the presentation of information to the patient’s preferences, handling difficult questions, supporting emotional needs, and assessing the patient’s understanding of their diagnosis and treatment.
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