Test yourself against our experts with our weekly quiz. You can type your answers here if you want to compare with our answers, or just click the ‘submit’ button below.
Image from Breen et al. BJU Int 2013; 112: 758–765
[wpsqt name=”Picture Quiz of the Week 6-12-13″ type=”quiz’ label=’
If you have a suggestion for a new Picture Quiz please email us.
It has been an important few weeks in for doctors in the United Kingdom, sensationalist headlines have been on the front pages of many of the national newspapers: “Doctors and nurses may face jail for neglect”
This has all stemmed for the publication of the Francis report and Berwick review into patient safety. They detail recommendations on how the National Health Service (NHS) can learn and improve the standard of patient safety. The Berwick report was led by Professor Don Berwick, an international expert and former adviser to US president Barack Obama, in patient safety. He was asked by the British Prime Minister David Cameron to carry out the review following the publication of the Francis Report into the breakdown of care at a Mid Staffordshire NHS Foundation Trust Hospital.
Stafford Hospital is an NHS hospital in the West Midlands area of England where hundreds of hospital patients died as a result of substandard care and staff failings between January 2005 and March 2009. The Mid Staffordshire Trust failed to provide safe care in the wards, people lay starving, thirsty and in soiled bedclothes. Decisions about which patients to treat were left to receptionists, inexperienced junior doctors were put in charge of critically-ill patients, and nurses switched off equipment because they did not know how to use it. The culture of the hospital Trust was one of secrecy and defensiveness. The inquiry highlights a whole system failure.
Both reports highlight the main problems affecting patient safety in some hospitals in the NHS and makes recommendations on how to address them. It says that the health system must, amongst many things, recognise the need for wide systemic change by abandoning blame as a tool and trust the goodwill and good intentions of the staff. The use of quantitative targets must be approached with caution and they should never displace the primary goal of better care.
The main headline grabbing item was the recommendation that the UK Government should create a new general offence of willful or reckless neglect or mistreatment applicable both to organisations and individuals.
Organisational sanctions might involve removal of the organisation’s leaders and their disqualification from future leadership roles, public reprimand of the organisation and, in extremis, financial sanctions but only where that will not compromise patient care.
Individual sanctions should be on a par with those in Section 44 of the Mental Health Capacity Act 2005 in UK law, which states that a person can be found guilty of an offence if he ill-treats or willfully neglects a person who lacks capacity and if convicted could be sentenced to imprisonment for a term not exceeding 5 years or a fine or both.
So does this affect us as urologists?
As doctors our first duty of care is towards our patients and patient safety should be our number one priority. However, in light of the report there is the possibility of a custodial sentence to individual(s) where the standard of care falls far short of expectations and blatant neglect is proven. In the age of clinical teams, proving that one individual was at fault is very difficult.
There has been a recent case in the UK press in which a surgeon has been jailed for two and a half years for manslaughter for gross negligence of a patient.
In another case in Australia a 63-year-old American surgeon working in a hospital in Queensland faced complaints from hospital staff that he had botched operations, misdiagnosed patients and used poor surgical techniques. He was arrested in the US in 2008 and extradited to Australia to stand trial. He was jailed for seven years in 2010 after being convicted of criminal negligence leading to the deaths of three patients.
These are two isolated cases but both demonstrate that the days when problematic surgeons were quietly retired are over. Our actions will be scrutinised by an ever demanding public with complications not just being discussed in mortality and morbidity meetings locally but in some cases publicly and in extreme situations in the courts.
My question to the readers is: what happens to clinical staff in your individual countries when clinical negligence and neglect is accused? Is jail time a possibility if proven?
Jonathan Makanjuola is a Urology Trainee, Innovator and techie based at King’s College Hospital, London, United Kingdom. @jonmakUrology
There is growing evidence that hexaminolevulinate (HAL) fluorescence cystoscopy increases detection of bladder cancer at the time of transurethral resection of bladder tumours (TURBT) and that this results in lower recurrence rates [1, 2]. One limitation in many prior studies was the lack of standardisation about the use of immediate postoperative chemotherapy, which has been shown to reduce recurrence in patients with non-muscle-invasive bladder cancer [3]. This raises the question of whether the benefit of HAL in reducing recurrences would be eliminated if patients did in fact receive postoperative intravesical chemotherapy, which would help eradicate any missed residual tumour.
There have been several studies that attempt to bring clarity to this issue. A study by Geavlete et al. [4] randomised 362 patients suspected of having bladder cancer to HAL vs white-light (WL) TURBT with a single postoperative mitomycin C instillation given in all cases. The authors found that the recurrence rate at 3 months was lower in the HAL group (7.2% vs 15.8%) due to fewer ‘other site’ recurrences when compared with the WL group. There continued to be an advantage for the HAL group with lower 1- and 2-year recurrence rates compared with the WL group (21.6% vs 32.5% and 31.2% vs 45.6%, respectively). The study did not stratify patients specifically to those with low-grade non-invasive tumours but patients with single tumors had a trend toward less recurrence (23.3% vs 35.3%, P = 0.064).
Grossman et al. [2] published the long-term follow-up for 551 patients enrolled in a prospective, randomised study of HAL vs WL for Ta or T1 urothelial bladder cancer with similar rates of intravesical therapy in the two groups (46% and 45%, respectively). They found that the median time to recurrence was 9.4 months in the WL group and 16.4 months in the HAL group (P = 0.04) but they did not report specifically on patients who received postoperative intravesical therapy. A meta-analysis of raw data from prospective studies on 1345 patients with suspected bladder cancer evaluating HAL-assisted cystoscopy vs WL found that both patients with low- and high-risk disease had statistically significant lower recurrence rates [1]. This meta-analysis was unable to stratify based on use of postoperative intravesical therapy.
O’Brien et al. [5] performed a randomised prospective study of HAL-assisted vs conventional WL TURBT, with all patients scheduled to get a single treatment of postoperative intravesical mitomycin C. There were 86 and 82 patients with cancer in the HAL and WL groups who completed the 12 months follow-up, respectively. In this study, 63% and 77% of the HAL and WL patients received mitomycin C, respectively. There was an increased detection of carcinoma in situ (CIS) in the HAL group (26% vs 14%) but no significant difference in recurrence at 3 and 12 months. When stratifying by low-grade tumours, the 3-month recurrence rates for HAL and WL were 19% vs 9% and at 12 months were 16% vs 22%, so that no significant differences were noted but the study was not powered to evaluate this subgrouping.
What can be concluded then about whether HAL assistance improves outcomes in patients who receive postoperative intravesical therapy? It appears the results are inconclusive and this is not surprising. The risk reduction of postoperative intravesical chemotherapy is primarily limited to patients with a single low-grade papillary tumour and one would need to treat 8.5 patients with peri-TUR chemotherapy to prevent one recurrence [3]. The benefits of peri-TUR chemotherapy in patients at intermediate- and high-risk are not well established [6]. Most of the studies of HAL-assisted TUR have not treated with postoperative intravesical therapy systematically. The studies that have tried to uniformly give postoperative therapy have not been sufficiently powered to evaluate those patients most likely to benefit, namely low-grade non-invasive cancer. As such, one cannot determine whether the benefit of potentially detecting additional low-grade tumours by HAL in patients with low-risk disease could be matched by postoperative intravesical therapy and such a study would require a very large number of low-grade solitary papillary tumours. However, it would minimise the benefits of HAL to focus on the benefit in the lowest risk patients. A meta-analysis of randomised trials found that HAL reduced the risk of recurrence independent of level of risk, such that there was reduced recurrence in patients with CIS, T1 and high-grade disease [1]. These are patients for which immediate postoperative intravesical therapy has shown minimal benefit and for which the benefit of HAL cannot be explained away. Furthermore a small but meaningful number of low-risk patients can be found to have intermediate- or high-risk disease, which would change their subsequent management [4]. As such if one had to choose between approaches rather than apply both, the use of HAL would appear to result in a greater benefit in managing patients with bladder cancer.
Yair Lotan
Department of Urology, UT Southwestern Medical Center at Dallas, Dallas, TX, USA
References
What is the ultimate endpoint of a residency or speciality training program? Is it to complete 5 or 6 years of training in core urological procedures? Is it to produce safe, competent independent urologists? Is it to achieve FRSC (Urol) certification? In an ideal world it would be a marriage of all three; a safe, competent, independent, certified, practising urologist ready and eager to tackle any urological referral. In reality, we know that not to be the case.
Urology is a broad and advancing speciality encompassing patients of all ages and both sexes involving a complexity of benign and malignant pathologies. It is unrealistic to be an expert in all the sub-specialties and be able to offer the best and least invasive treatments to our patients. Furthermore, with a necessary emphasis on patient safety, transparency and proficiency, surgical training programs face significant barriers in affording trainees the opportunity to operate, specifically in the working time directive era.
Fellowships are usually undertaken at the completion of higher surgical training scheme often in a centre of excellence overseas. Fellowships offer trainees intensive experience in their niche area. On completion of a coveted fellowship, trainees hope to have acquired and polished the required skills to practice independently in their chosen field.
A recent pan European survey of 219 urological residents demonstrated laparoscopy and robotics were available in 74% and 17% of centres respectively [1]. Only 23% of trainees report their exposure as ‘satisfactory’. 68% have not completed a laparoscopic radical nephrectomy as first operator. Despite this 81% are considering fellowships in laparoscopy.
Buffi et al., have called for a validated and structured training curriculum in robotic surgery [2]. Trainees acknowledge the challenges in the acquisition of such skills but the modularisation of training is the best way to learn a procedure. Step by step trainees can piece together the operations. Hours spent on simulators and in dry and wet laboratories enhances these techniques. Furthermore, the dual consoles offer invaluable experience in robotics, however, are scarcely available.
The governing bodies have a responsibility to maintain standards of training as well as a duty towards patients. Proficiency in modern techniques such as laparoscopy and robotics are deficient in most training programs. Training programs need to encompass these techniques in a modular fashion from an early stage to develop the skills of tomorrows’ urologists [3]. Fellowships will undoubtedly foster and enhance these skills but a core knowledge and technical proficiency even in a simulator setting should be encouraged.
In truth, our learning and development never should never stop.
‘Live as if you were to die tomorrow. Learn as if you were to live forever’ Mahatma Gandhi
Mr Gregory Nason is a Specialist Registrar in Urology at the University Hospital Limerick, Ireland
References
Test yourself against our experts with our weekly quiz. You can type your answers here if you want to compare with our answers, or just click the ‘submit’ button below.
[wpsqt name=”Picture Quiz of the Week 29-11-13″ type=”quiz’ label=’
If you have a suggestion for a new Picture Quiz please email us.
In this paper, Brookman-May et al. [1] used a large multi-institutional database of over 13 000 patients from 23 centres in both Europe and the USA to examine the prognostic indicators of cancer-specific survival (CSS) in patients who had recurrence after primary surgery for RCC. Their analysis was based on a subset of 1712 patients who had recurrence during a median follow-up period of 50 months. All patients had undergone either radical nephrectomy or nephron-sparing surgery, with no evidence of metastasis at the time of surgery.
The authors have previously shown, in a related study based on a subset of 5000 patients from the same database, that lymphovascular invasion, Fuhrman grade 3–4, and pT stage > pT1 at the time of diagnosis were significantly associated with the development of late recurrence (defined as after >5 years) [2]. In this paper, the primary objective was to look at the effect of time to tumour recurrence (TTR) on CSS. In addition, clinical and histopathological comparisons were made between patients with early (<5 years) and late recurrence (>5 years).
Patients often want to know whether if they are recurrence-free after a period of time, their subsequent risk of dying from recurrence is reduced; this paper goes some way towards answering this question and showing that those with later recurrence had improved survival times. Specifically, the authors found that TTR was an independent predictor of CSS; i.e. if patients recurred early they had a worse CSS than those recurring late. This is similar to results from another group who reported that recurrent disease, particularly before 12 months, was associated with a poorer prognosis [3]. In the first 4 years of follow-up, a shorter TTR independently predicted lower CSS after recurrence [1]. When divided into those with early recurrence, Group A (N = 1402), and those with late recurrence, Group B (N = 310), patients in Group A were more likely to be male, of advanced age, have a greater tumour diameter and stage, have Fuhrman grade 3–4, with lymphovascular invasion and positive lymph node disease, than those in Group B. Patients in Group A had a 3-year CSS of 30% compared with those in Group B whose CSS was better at 41%. Age and gender were also independent predictors of CSS.
These results can help to guide the aftercare management of patients after primary surgery. Currently, primary surgery is the only recommended option for patients with localized RCC, although results from several phase III clinical trials looking at the role of adjuvant therapy, such as the SORCE, PROTECT and S-TRAC trials, are still awaited [4]. Furthermore, it is not known which group of patients are suitable for adjuvant chemotherapy, which is reflected in the subtly differing eligibility criteria for recruitment to the various trials [4]. The authors of the present study pointed out that a method of risk stratification may be useful to allow equal representation of early and late recurrence patients in treatment arms for clinical trials. Potentially, understanding the predictors of early recurrence may help to identify patients for whom adjuvant therapy may be beneficial.
Only 12% of patients with localized RCC in the present cohort developed recurrence after surgery [1]. This rate is lower than that found in the literature, where 20–30% recurrence rates of localized RCC have been reported [2, 5, 6]. Brookman-May et al. speculate that this lower rate is attributable to both an increase in early detection as well as improved surgical management in recent years. Furthermore, they acknowledge that the database is heterogeneous and that the study therefore has all the inherent limitations of a retrospective study.
The present paper clearly shows that the earlier the recurrence after surgery the lower the survival rate, but a clear strategy for the surveillance of localized RCC after primary surgery is currently lacking. Most follow-up protocols exercise a blanket ‘one for all’ policy with follow-up spaced at regular intervals to ensure patients who recur are detected early. Such a policy may not be intensive enough to detect early recurrence in some patients and may be excessive for the majority of patients where the risk of recurrence is low. Risk stratification of patients, by understanding the predictors of CSS after surgery, may help to tailor surveillance protocols to the individual and identify those for whom adjuvant therapy may be beneficial.
Kathie Wong and Ben Challacombe
The Urology Centre, Guy’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK
References
Test yourself against our experts with our weekly quiz. You can type your answers here if you want to compare with our answers, or just click the ‘submit’ button below.
[wpsqt name=”Picture Quiz of the Week 22-11-13″ type=”quiz’ label=’
If you have a suggestion for a new Picture Quiz please email us.
Commemorating the #urojc one year mark, Brian Stork reflected on the year that was, with a fun visual diagram on the most common words used during this period.
A fitting paper for moving into Season 2 of the #urojc, with the November International Journal Club discussion on Twitter was based on the paper “Detrusor Underactivity and the Underactive Bladder: A New Clinical Entity? A Review of Current Terminology, Definitions, Epidemiology, Aetiology, and Diagnosis” by Osman et al from European Urology, 26 October 2013.
Osman et al, attempted to provide clarity around the nonobstructive impairment of voiding function, referred to as detrusor underactivity and the underactive bladder, as a clinical entity, and provide consensus on the standardising of current concepts. In their attempt to achieve this aim, a wide ranging literature review was conducted on varying terms commonly pertaining to detrusor underactivity.
So, does definition matter when discussing bashful bladders?
Early discussion centred on how frustrating detrusor underactivity was as an entity in part due to lengthy and complex mathematical equations,
difficult in defining, with Amrith Rao, adding another term into the mix,
and often concomitant disease processes.
Surgical intervention for a bashful bladder is not a new concept, with Amrith Rao noting a partial cystectomy for hypotonic bladder was offered in the 1970’s.
This lead to a clinical discussion with participants asked who would perform a TURP on a man with an underactive bladder as suggested by urodynamics? Nadir Osman brought to our attention a study published in The Journal of Urology by Djavan et al in 1997, which concluded patient age was the key factor in treatment failure. However, with no solid evidence, participants agreed it often came down to patient choice.
Although a smaller group of participants for this month’s discussion, conclusions included:
The main messages I took from this discussion were:
This month had a strong showing from Sheffield urologists and alumni including Nadir Osman, Kate Linton, Jake Patterson, Jim Catto, Henry Woo and Chris Chapple who was listening in from his newly created Twitter account. The winner of the best tweet prize for the November #urojc is Jake Patterson. BMC Urology have kindly donated a complimentary manuscript submission to this open access journal (of course pending peer review process).
Whilst these non-oncology topics see smaller participation, these topics will continue to be supported to provide variety and to maintain interest to the general #urojc audience.
Helen Freeborn is an Australian Urology Trainee, currently completing a General Surgical year at Cairns Base Hospital, QLD. She is interested in surgical leadership and the power of social media in connecting health professionals. Twitter @DrHelenF
In the accompanying paper, Yan et al. [1] present the outcomes of their study on percutaneous nephrolithotomy (PCNL) guided only by ultrasonography (US).
This is the largest series (705 patients) to date on PCNL purely under US control and reports stone-free and complication rates that are consistent with those commonly reported for PCNL guided by X-ray or by a combination of X-ray and US.
Since its introduction more than three decades ago, PCNL has traditionally been performed under fluoroscopic control by the majority of urologists, even though US guidance has now gained wide acceptance as a means of achieving renal access. Now, the most important international guidelines suggest that US be used in addition to fluoroscopy [2]. US guidance has the following advantages: it minimizes radiation exposure, allows the detection of viscera that can sometimes lie in the trajectory of the puncturing needle and avoids contrast-related complications. Furthermore, US provides imaging of the collecting system in three-dimensional orientations and helps to distinguish between anterior and posterior calyces with great accuracy. Nevertheless, the innovative concept proposed by Yan et al. [1], with their impressive series, concerns the whole procedure (puncture, creation of renal access and final look to rule out eventual residual fragments), and not only the safe accomplishment of the puncture solely under US guidance.
Caution should be taken in interpreting their results. This is a purely retrospective study which guarantees only a low level of evidence (3B). In addition, even though major complications arising during the creation of access were not reported in the paper, doubts remain about the safety of using only US guidance in monitoring the dilatation process by either balloon or coaxial dilators. The following questions still need to be addressed. How can the progression of dilators be monitored to avoid excessive inadvertent medial advances with the accompanying high risk of collecting system perforation? How can false passage of a working guidewire be detected early by US? What about obese patients in whom the effectiveness of US is generally impaired?
To balance the risks and benefits of guidance solely by US, a middle ground could be represented by US guidance aided by ureteroscopic monitoring of the dilatation process using the so-called ‘Endovision technique’ [3], as is possible during endoscopic combined intrarenal surgery (ECIRS) (Fig. 1). In view of the risks, it should be stressed that, even though PCNL guided solely by US is an attractive option, biplanar C-arm fluoroscopy should always be present in the operating room.
It is well known that radiation hazard is directly proportional to cumulative radiation exposure time, so US guidance provides an obvious advantage in terms of absence of radiation for patient and operating room staff, but is the extent of this advantage really known? It is important to underline that the amount of radiation exposure during PCNL is not particularly great, measuring on average 0.56 mSv for the patient and 0.28 mSv for the urologist [4]. By contrast, unenhanced CT involves a significant radiation exposure of 8.6 mSv [5], which is of course particularly relevant for patients with stones, who are often quite young and likely to experience recurrence. According to the ‘as low as reasonably achievable’ (or ALARA) principle, replacing CT scans with US in the follow-up would have a much greater impact on reducing radiation exposure in adult patients (in the present series patients undergo two CT scans after surgery, at 48 h and 4 weeks, and one preoperative CT scan!) than would renouncing the safety guaranteed by X-ray monitoring during endourology.
Finally, it is of paramount importance to stress that, in the current climate in which malpractice litigation related to endourology continues to rise [6], it is still advisable that PCNL guided solely by US should be performed only in trials for which approval of the local institutional review board has been obtained.
To conclude, Yan et al. [1] propose an alternative approach to PCNL that involves solely US guidance, but some doubts remain. Only further well designed, prospective, comparative and possibly randomized studies will allow us to draw definitive conclusions.
Guido Giusti
Head of Stone Center & European Training, Center in Endourology, Humanitas Clinical and Research Center, Milan, Italy
References
Test yourself against our experts with our weekly quiz. You can type your answers here if you want to compare with our answers, or just click the ‘submit’ button below.
Image from Gao X, Pang J, Si-tu J et al. BJU Int 2013; 112: 944–952.
[wpsqt name=”Picture Quiz of the Week 15-11-13″ type=”quiz’ label=’
If you have a suggestion for a new Picture Quiz please email us.