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Editorial: ‘Discontent is the first necessity of progress’, Thomas A. Edison

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This study from Kaag et al. [1] investigates predictors of renal functional decline after radical nephroureterectomy (RNU) in patients with upper tract urothelial carcinoma (UTUC). They evaluate early (2 months) and late (6 months) predictors of renal functional decline, finding that on a multivariable model only age at surgery and preoperative renal function were independently associated with early postoperative function. This is an intuitive finding whereby we expect older patients and those with lower renal function to have a more dramatic decrease in renal function after RNU.

Age, preoperative renal function, and Charlson score were associated with late functional recovery. The latter is a counterintuitive finding, as higher Charlson score was associated with less decrease in renal function. Charlson comorbidity was not significant on univariate analyses. Why it would become significant on multivariate is unclear. Whether it is an artifact related to study methodology or is a real phenomenon will require further study.

Unquestionably, this study [1] adds to the growing discontent of our current management of UTUC. The authors cogently discuss the issues related to better risk stratification as a natural consequence of instituting a neoadjuvant chemotherapy paradigm in those with high-risk disease. Multiple retrospective studies have failed to show a benefit of adjuvant chemotherapy, whereas now we have a matched-cohort study showing significant rates of downstaging and complete remission [2], and as well significantly improved 5-year survival, with institution of a neoadjuvant paradigm [3]. One cannot view the dismal outcomes of this disease without being discontent and wishing for progress. We need to continue getting out the message to not only urologists who reflexively institute RNU in patients with a risk-unstratified upper tract filling defect, but as well many medical oncologists who can only function based on guidance from level I data, which for this disease, will be a long time coming.

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Surena F. Matin

Department of Urology, MD Anderson Cancer Center, Houston, TX, USA

References

1 Kaag M, Trost L, Thompson RH et al. Pre-operative predictors of renal function decline following radical nephroureterectomy for upper tract urothelial carcinoma. BJU Int 2014; 114: 674–9

2 Matin SF, Margulis V, Kamat A et al. Incidence of downstaging and complete remission after neoadjuvant chemotherapy for high-risk upper tract transitional cell carcinoma. Cancer 2010; 116: 3127–34

3 Porten S, Siefker-Radtke AO, Xiao L et al. Neoadjuvant chemotherapy improves survival of patients with upper tract urothelial carcinoma. Cancer 2014; 120: 1794–9

Article of the Month: One-stop clinic for ketamine-associated uropathy

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

One-stop clinic for ketamine-associated uropathy: report on service delivery model, patients’ characteristics and non-invasive investigations at baseline by a cross-sectional study in a prospective cohort of 318 teenagers and young adults

Yuk-Him Tam*, Chi-Fai Ng*, Kristine Kit-Yi Pang*, Chi-Hang Yee*, Winnie Chiu-Wing Chu†, Vivian Yee-Fong Leung†, Grace Lai-Hung Wong‡, Vincent Wai-Sun Wong‡, Henry Lik-Yuen Chan‡ and Paul Bo-San Lai*

Departments of *Surgery, Youth Urological Treatment Centre, †Imaging and Interventional Radiology, and ‡Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, China

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OBJECTIVE

To describe a service delivery model and report the baseline characteristics of patients investigated by a non-invasive approach for ketamine-associated uropathy.

PATIENTS AND METHODS

This was a cross-sectional study in a prospective cohort of patients who attended their first visit and underwent non-invasive investigations at a dedicated centre to treat ketamine-associated uropathy in Hong Kong from December 2011 to July 2013. Data on demographics, illicit ketamine use, symptoms scores and voiding function parameters at baseline were prospectively collected. Differences between active abusers and ex-abusers, and risk factors for the most symptomatic group were investigated by univariate and multivariate analysis.

RESULTS

In all, 318 patients completed the non-invasive assessment at their first visit and were eligible for inclusion. In all, 174 were female and the mean (sd) age of the entire cohort was 24.4 (3.1) years. Patients had used ketamine for a mean (sd) period of 81 (36) months. The mean (sd) ketamine use per week was 18.5 (15.8) g. In all, 214 patients were active abusers while 104 were ex-abusers but had persistent lower urinary tract symptoms. The mean (sd) voided volume, bladder capacity, and bladder emptying efficiency were 111.5 (110) mL, 152.5 (126) mL and 73.3 (26.9)%, respectively. The ex-abusers had a lower symptom score (19.3 vs 24.1; P < 0.001), a larger voided volume (126 vs 85 mL; P < 0.001), and a larger bladder capacity (204.8 vs 126.7 mL; P < 0.001) compared with active abusers. Multivariate analysis found female gender was associated with a higher symptom score (odds ratio [OR] 2.39; 95% confidence interval [CI] 1.35–4.23; P = 0.003) and a smaller voided volume (OR 1.9; 95% CI 1.1–3.3; P = 0.02). Ketamine taken (g/week) was another risk factor for a higher symptom score (OR 1.03; 95% CI 1.01–1.05; P = 0.002). Status of ex-abuser was the only protective factor associated with fewer symptoms, larger voided volume and bladder capacity.

CONCLUSIONS

An effective service model for recruiting patients with ketamine-associated uropathy is possible. With such a service model as a platform, further prospective studies are warranted to investigate the appropriate choice of treatment for this new clinical entity.

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Editorial: Where next in ketamine uropathy? Dedicated management centres?

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Tam et al. [1] in this month’s BJUI publish the largest prospective cohort to date on ketamine uropathy (KU). KU is a growing international problem since initial reports in 2007 from Canada and Hong Kong, where ketamine is second only to heroin in popularity amongst drug takers [2, 3]. Prevalence of KU may be higher than previously thought with up to a quarter of people misusing ketamine reporting urinary symptoms [4].

Importantly, the Tam et al. [1] paper demonstrates the benefit of stopping ketamine amongst those presenting with KU. Dose, frequency and dependency upon ketamine have been reported as risk factors for developing KU [1, 4]. Achieving cessation is not always straightforward following identification, assessment and urology input. Consistent with the Winstock et al. [4] recommendations a multi-disciplinary approach is required to assess symptoms and risk profile. The recommendation of Tam et al. of a one-stop clinic is thus appealing.

The key to diagnosing KU, is a focused history including specific drug use, performing non-invasive uroflowmetry investigations and upper tract imaging. Urologists need to be aware of motivational interviewing strategies, and incorporate them in their assessment. Presenting symptoms include dysuria, frequency, urgency and pain that may be consequent on the small contracted bladder that develops in KU. The diagnosis should exclude other bladder diseases and cystoscopy and biopsy is advised [5]. If left late, pain and bladder contraction can be so severe that bladder augmentation, cystectomy and neobladder or ileal conduit may be required [6]. It is strongly advised that ketamine use is stopped before, as ketamine metabolites will be readily absorbed through bowel and potentially lead to a fatal overdose.

In the Tam et al. [1] paper, renal ultrasonography (US, performed on a second visit) showed hydronephrosis in 8%. However, their client uptake for renal US was only 50%. Having a one-stop KU clinic with integrated US is more patient-friendly and consistent with our unit’s one-stop clinic approach [7]. Management of hydronephrosis and reversal of renal impairment is crucial and more definitive surgical management may be warranted. Renal failure secondary to KU may rise as the numbers of ketamine users continues to climb.

What makes KU interesting and difficult to manage is the stigmatising nature of illicit drug use that makes patients uncomfortable in disclosing ketamine use. Patients may not recognise the causal link between ketamine use and their discomfort. Instead symptoms may be attributed to other pathologies such as UTIs, sexually transmitted infections (common in high-risk drug use behaviour), excessive alcohol or caffeine consumption or be mistaken for ‘K cramps’, which may be a direct result of ketamine itself [8]. Pain team input may be required. The Bristol unit report managing KU pain with buprenorphine patches, co-codamol (combination of codeine phosphate and paracetamol) and amitriptyline [5], whereas the Tam et al. [1] unit prefer a combination of diclofenac, anti-cholinergics and opioids.

Promoting early treatment seeking will help reduce the time between symptom onset and assessment. However, due to the nature of ketamine patients, their history may be unreliable, follow-up intermittent and compliance poor. These issues may lead to a delay in presentation and referral.

Ultimately, what is required is a raised awareness among users of the potential for ketamine to cause irreversible bladder and upper tract harm. While abstinence may be the most attractive option for clinicians this remains an unrealistic and unhelpful approach for many users including those most at risk. Consideration needs to be given to support users to reduce harm and to maintain abstinence once achieved. Stopping ketamine may require psychological, addiction and even psychiatric support.

Importantly, clinicians should accept that ketamine users are interested in their own health and wellbeing. They may appreciate learning strategies to minimise their harm risk. Harm reduction strategies as outlined in the Global Drug Survey Highway Code (stay well hydrated, have breaks between use periods, and avoid alcohol use) not only encourage safer use but can raise awareness of symptoms suggestive of KU [9].

Given the complexity of ketamine patients and the fact that users share information, provision of high-quality care from a dedicated understanding team has obvious advantages. An age-appropriate unit including a urologist, psychiatrist, pain management consultant and a sexual health expert provides a comprehensive approach. A one-stop clinic, as described by Tam et al., may expedite initial assessment but withdrawal from ketamine requires long-term investment to achieve overall improvements in KU outcomes.

The key message to get out to the ketamine-using community is that as a rule, marked improvement in function follows cessation of ketamine use. There is an increasing role for the urologist to be a source of credible information to ketamine users and healthcare professionals. Finally, dedicated management centres offering a holistic approach to the management of these patients seems ideal. This will concentrate exposure and understanding of KU, which we hope will help continue to improve management of this difficult condition.

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Claire F. Taylor, Adam R. Winstock* and Jonathon Olsburgh

Young Onset Urology Clinic, Urology/Renal Unit, Guy’s and St Thomas’ Hospital, and *South London and Maudsley NHS Trust, London, UK

References

1 Tam YH, Ng CF, Pang KK et al. One-stop clinic for ketamine-associated uropathy: report on service delivery model, patients’ characteristics and non-invasive investigations at baseline by cross-sectional study in a prospective cohort of 318 teenagers and young adults. BJU Int 2014; 114: 754–60

 

2 Chu PS, Kwok SC, Lam KM et al. ‘Street ketamine’-associated bladder dysfunction: a report of ten cases. Hong Kong Med J 2007; 13: 311–3

 

3 Shahani R, Streutker C, Dickson B, Stewart RJ. Ketamine-associated ulcerative cystitis: a new clinical entity. Urology 2007; 69: 810–2

 

4 Winstock AR, Mitcheson L, Gillatt DA, Cottrell AM. The prevalence and natural history of urinary symptoms among recreational ketamine users. BJU Int 2012; 110: 1762–6

 

5 Wood D, Cottrell A, Baker SC et al. Recreational ketamine: from pleasure to pain. BJU Int 2011; 107: 1881–4

 

6 NgCF,ChiuPK,LiMLetal.Clinical outcomes of augmentation cystoplasty in patients suffering from ketamine-related bladder contractures. Int Urol Nephrol 2013; 45: 1245–51

 

7 Coull N, Rottenberg G, Rankin S et al. Assessing the feasibility of a one-stop approach to diagnosis for urological patients. AnnRCollSurg Engl 2009; 91: 305–9

 

8 Winstock AR, Mitcheson L. New recreational drugs in the primary care approach to patients who use them. BMJ 2012; 344: e288

 

9 Global Drug Survey Ltd. Global Drug Survey Highway Code. Available at: https://www.globaldrugsurvey.com/wp-content/uploads/2014/04/The -High-Way-Code_Ketamine.pdf. Accessed September 2014

 

Article of the Week: Assessing extranodal extension and the size of the largest lymph node metastasis after RP

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Prognosis of patients with pelvic lymph node metastasis following radical prostatectomy: value of extranodal extension and size of the largest lymph node metastasis

Niccolo M. Passoni, Harun Fajkovic*, Evanguelos Xylinas†, Luis Kluth‡, Christian Seitz*, Brian D. Robinson§, Morgan Rouprêt¶, Felix K. Chun‡, Yair Lotan**, Claus G. Roehrborn**, Joseph J. Crivelli§, Pierre I. Karakiewicz††, Douglas S. Scherr§, Michael Rink‡, Markus Graefen‡, Paul Schramek*, Alberto Briganti, Francesco Montorsi, Ashutosh Tewari§ and Shahrokh F. Shariat*§**

Department of Urology, Urological Research Institute, University Vita-Salute San Raffaele, Milan, Italy, *Department of Urology, Medical University of Vienna, Vienna, Austria, †Department of Urology, Cochin Hospital, Assistance Publique-Hôpitaux de Paris, University Paris Descartes, ¶Academic Department of Urology of la Pitié-Salpêtrière, Assistance Publique-Hôpitaux de Paris, Faculté de medicine Pierre et Marie Curie, University Paris VI, Paris, France, ‡Medical Centre Hamburg-Eppendorf, Martini Clinic, Prostate Cancer Center at University Medical Center Hamburg-Eppendorf, Hamburg, Germany, §Department of Urology and Pathology, Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY, **Department of Urology, Southwestern Medical Center, University of Texas, Dallas, TX, USA, and ††Department of Urology, University of Montreal, Montreal, QC, Canada

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OBJECTIVE
  • To assess the prognostic role of extranodal extension (ENE) and the size of the largest lymph node (LN) metastasis in predicting early biochemical relapse (eBCR) in patients with LN metastasis after radical prostatectomy (RP).
PATIENTS AND METHODS
  • We evaluated BCR-free survival in men with LN metastases after RP and pelvic LN dissection performed in six high-volume centres.
  • Multivariable Cox regression tested the role of ENE and diameter of largest LN metastasis in predicting eBCR after adjusting for clinicopathological variables.
  • We compared the discrimination of multivariable models including ENE, the size of largest LN metastasis and the number of positive LNs.
RESULTS
  • Overall, 484 patients were included. The median (interquartile range, IQR) follow-up was 16.1 (6–27.5) months. The median (IQR) number of removed LNs was 10 (4–14), and the median (IQR) number of positive LNs was 1 (1–2).
  • ENE was present in 280 (58%) patients, and 211 (44%) had their largest metastasis >10 mm. Patients with ENE and/or largest metastasis of >10 mm had significantly worse eBCR-free survival (all P < 0.01).
  • On multivariable analysis, number of positive LNs (≤2 vs >2) and the diameter of LN metastasis (≤10 vs >10 mm), but not ENE, were significant predictors of eBCR (all P < 0.003).
  • ENE and diameter of LN metastasis increased the area under the curve of a baseline multivariable model (0.663) by 0.016 points.
CONCLUSIONS
  • The diameter of the largest LN metastasis and the number of positive LNs are independent predictors of eBCR.
  • Considered together, ENE and the diameter of the largest LN metastasis have less discrimination than the number of positive LNs.
Read more articles of the week

Editorial: Extent of lymph node metastases

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The role of prostatectomy in lymph node metastasized prostate cancer has been subject to changing opinions. Classically, a nodal dissection was performed as the initial step in the procedure and prostatectomy was avoided in men with cryosection-proven metastases. Biochemical recurrence during the first 3 years occurs in the majority of men with pN1 disease [1]. Early data from randomized trials shows only a 50% prostate cancer-specific survival 12 years after prostatectomy and nodal metastases without immediate adjuvant treatment [2]. Recently, Passoni et al. [3] showed a higher 10-year overall survival of 82.8% in men with nodal metastases, of whom the majority were treated with adjuvant androgen ablation and/or radiotherapy. This percentage is remarkably similar to the treatment arm of the earlier-mentioned study reported by Messing et al. [2], which showed a 10-year disease-specific survival of >80%. At 10 years about half the patients who died, did so from prostate cancer; therefore, although reasonable intermediate range survival can be obtained in men with nodal metastases of prostate cancer, the major cause of death remains prostate cancer when surgery is applied at the age of 65 years. Although adjuvant androgen ablation may improve survival, as suggested by the above-mentioned observations, some men may not experience recurrence after resection of nodal metastases and would experience the toxicity of androgen ablation unnecessarily. The identification of these men would reduce costs and toxicity.

Passoni et al. [3] presented a multicentre study on prognostic factors after prostatectomy for node-positive disease. The number of removed nodes (median 10) seems relatively low compared with the 17 reported in their earlier single-centre study, but may be a good reflection of urological practice in general. By comparison, the percentage of men who underwent adjuvant radiotherapy in the multicentre study was low (16%). Data from da Pozzo et al. [4] suggest that adjuvant radiotherapy may be of benefit in men with limited nodal metastases. It would be of interest to study whether men with a later biochemical recurrence would be those that did experience recurrence only locally and therefore would be those most likely to benefit from adjuvant (or salvage) radiotherapy.

In the current study by Passoni et al. [1] in the BJUI, the follow-up was relatively short (16 months). Earlier data from this author group showed that number of positive nodes and lymph node density were good predictors of cancer-specific survival after prostatectomy. This earlier observation is now confirmed in a multicentre analysis with a different endpoint: biochemical recurrence. What is notable is the fact that this confirmation was obtained in a series of patients with fewer nodes removed. The value of the marker ≤2 positive nodes becomes limited with the observation that this group contained 85% of men in their series. The second marker found, the size of the node, showed a more general distribution but as a single marker had no predictive value. The differences in Harrel’s c values from the base model containing other clinical characteristics are limited and reproducibility of measures needs attention. Still, the observation that extent of nodal metastases is of prognostic value after surgery is notable.

Ideally, markers could predict the absence of further disease progression in men after prostatectomy for nodal metastasized prostate cancer. None of the studied characteristics fulfill this need because at 36 months after prostatectomy the majority of men, even those in the best prognostic group, do experience biochemical recurrence that will result in prostate cancer-related death. Gleason score is a strong predictor of the presence of nodal metastases [5], and some have suggested that nodal Gleason grade is of prognostic value in men with pN+ disease. Until these markers have been further evaluated, it remains important to address the fact that reported cancer-specific survival in most men with pN+ disease is >10 years [6]. Although tempting to speculate that prostatectomy and (extended) lymph node dissection plays a role in this, the almost inevitable development of biochemical recurrence reported in the current study by Passoni et al. [1], even in patients in the best prognostic group, stresses the systemic nature of this disease which will require a multimodality approach in most men at some point.

Read the full article

Henk G. van der Poel

Department of Urology, Netherlands Cancer Institute, Amsterdam, The Netherlands

References

1 Passoni N, Fajkovic H, Xylinas E. Prognosis of patients with pelvic lymph node metastasis following radical prostatectomy: value of extranodal extension and size of the largest lymph node metastasis. BJU Int 2014; 114: 503–10

2 Messing EM, Manola J, Yao J et al. Immediate versus deferred androgen deprivation treatment in patients with node-positive prostate cancer after radical prostatectomy and pelvic lymphadenectomy. Lancet Oncol 2006; 7: 472–9

3 Passoni NM, Abdollah F, Suardi N et al. Head-to-head comparison of lymph node density and number of positive lymph nodes in stratifying the outcome of patients with lymph node-positive prostate cancer submitted to radical prostatectomy and extended lymph node dissection. Urol Oncol 2013; 29: 29.e21–8

4 Da Pozzo LF, Cozzarini C, Briganti A et al. Long-term follow-up of patients with prostate cancer and nodal metastases treated by pelvic lymphadenectomy and radical prostatectomy: the positive impact of adjuvant radiotherapy. Eur Urol 2009; 55: 1003–11

5 Ross HM, Kryvenko ON, Cowan JE, Simko JP, Wheeler TM, Epstein JI. Do adenocarcinomas of the prostate with Gleason score (GS)</=6 have the potential to metastasize to lymph nodes? Am J Surg Pathol 2012; 36: 1346–52

6 Touijer KA, Mazzola CR, Sjoberg DD, Scardino PT, Eastham JA. Long-term outcomes of patients with lymph node metastasis treated with radical prostatectomy without adjuvant androgen-deprivation therapy. Eur Urol 2013; 65: 20–5

Article of the Week: Learning curves for urological procedures – a systematic review

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Learning curves for urological procedures: a systematic review

Hamid Abboudi, Mohammed Shamim Khan, Khurshid A. Guru*, Saied Froghi†, Gunter de Win‡, Hendrik Van Poppel§, Prokar Dasgupta and Kamran Ahmed

MRC Centre for Transplantation, King’s College London, King’s Health Partners, Department of Urology, Guy’s Hospital, London, UK, *Roswell Park Cancer Institute, Buffalo, NY, USA, †The Oxford Cancer Centre, Oxford University, Churchill Hospital, Oxford, UK, ‡Department of Urology, University Hospital Antwerp, Antwerp, Belgium, and §Department of Urology, University Hospital, KU Leuven, Leuven, Belgium

Read the full article
OBJECTIVE
  • To determine the number of cases a urological surgeon must complete to achieve proficiency for various urological procedures.
PATIENT AND METHODS
  • The MEDLINE, EMBASE and PsycINFO databases were systematically searched for studies published up to December 2011.
  • Studies pertaining to learning curves of urological procedures were included.
  • Two reviewers independently identified potentially relevant articles.
  • Procedure name, statistical analysis, procedure setting, number of participants, outcomes and learning curves were analysed.
RESULTS
  • Forty-four studies described the learning curve for different urological procedures.
  • The learning curve for open radical prostatectomy ranged from 250 to 1000 cases and for laparoscopic radical prostatectomy from 200 to 750 cases.
  • The learning curve for robot-assisted laparoscopic prostatectomy (RALP) has been reported to be 40 procedures as a minimum number.
  • Robot-assisted radical cystectomy has a documented learning curve of 16–30 cases, depending on which outcome variable is measured.
  • Irrespective of previous laparoscopic experience, there is a significant reduction in operating time (P = 0.008), estimated blood loss (P = 0.008) and complication rates (P = 0.042) after 100 RALPs.
CONCLUSIONS
  • The available literature can act as a guide to the learning curves of trainee urologists. Although the learning curve may vary among individual surgeons, a consensus should exist for the minimum number of cases to achieve proficiency.
  • The complexities associated with defining procedural competence are vast.
  • The majority of learning curve trials have focused on the latest surgical techniques and there is a paucity of data pertaining to basic urological procedures.
Read more articles of the week

Editorial: Is surgery a never ending learning process?

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The concept of the learning curve is one of the most important issues in surgery and also one of the most overlooked. In the present issue of BJUI, Abboudi et al. [1] present an interesting review paper evaluating the concept of the learning curve in urological procedures. Specifically, the authors have conducted a methodologically consistent systematic review on the literature focused on the learning curve of some urological procedures, including mainly radical prostatectomy (RP), robot-assisted partial nephrectomy (RAPN) and percutaneous nephrolitotomy [1]. Surprisingly, nothing was available for BPH treatments, which are among the most prevalent urological procedures. 

Most of the studies are focused on robot-assisted RP (RARP), but the available literature is of poor methodological quality, including mainly surgical series evaluating a limited number of surgeons, with a heterogeneous selection of outcomes from which to study the learning curve and a focus on short-term outcomes. Conversely, the literature on retropubic RP or laparoscopic RP is of higher quality, including a few very large multi-institutional studies encompassing the performances of several surgeons (reference nos. 24, 26, 29 and 30 in the review) and adopting sophisticated statistical methodology; however, the current interest for these procedures is quite limited, RARP being more commonly preferred. With the above-mentioned limitations in mind, what we have learnt is that RARP operating time plateaus after 50–200 cases, positive surgical margin (PSM) rates after 50–1600 cases, and continence and potency after 200 cases [1]. Such data are only partially in line with the findings of a recent prospective Australian study [2], not included in the present systematic review, which evaluated the learning curve with RARP of a high-volume open surgeon (>3000 retropubic RPs performed before the study beginning). In that study, Thompson et al. [2] demonstrated that performances with RARP surpassed those with retropubic RP after ∼100 cases for sexual function scores and PSM rates in pT2 cancers, whereas ∼150 cases were needed to reach the same target with urinary function scores. Moreover, RARP performances kept on improving, with sexual and urinary scores plateauing after 600–700 and 700–800 cases, respectively. Similarly, with regard to PSMs, it was demonstrated that PSM rates in pT2 and pT3–4 cancers plateaued after 400–500 and 200–300 cases, respectively [2]. Although improvement is likely, it is not clear how much these performances might improve with further extension of the caseload. 

Taken together, those data suggest that even with robotic assistance, a high volume of cases is strongly associated withimproving oncological and functional outcomes after RARP. This is not an extraordinarily original concept, but implies that the daVinci platform, by itself, cannot guarantee excellent surgical quality and that the relevance of the surgeon is as high as ever. 

Limited data are available on other major robotic procedures, such as RAPN and robot-assisted radical cystectomy (RARC). Specifically, 20–75 cases are thought to be needed to observe a plateau in warm ischemia time (WIT) during RAPN, which is in line with our previous findings demonstrating a continuous decrease in WIT during the first 50 cases [3]. Similarly, 20–30 cases are supposed to be needed to achieve acceptable operating times, lymph node yields and PSM rates after RARC; however, those findings do not take in account the burden of robotic experience achieved with RARP before embarking in RARC, which is clearly a major issue [4]. 

Considering that the improvements in performances along the learning curve exceeded any effect sizes we might reasonably expect from a novel drug [5], it is clear that any attempt to centralise treatments for complex procedures in high-volume centres with high-volume surgeons should be attempted. Obviously, that is a very critical target, which is hard to achieve in many realities. In parallel, interventions to improve the performance of surgeons in order to,reduce the learning curve are mandatory. For example, fellowship-trained RARP surgeons have been shown to outperform experienced open or laparoscopic surgeons moving to RARP without specific training [6,7]. For those surgeons for whom fellowship is unfeasible or unpractical, structured courses with integration of simulation, dry laboratory, wet laboratory and da Vinci modular training, for example, using the model of the recently concluded European Robotic Urology Society Pilot Study, can significantly ease the first steps of the learning curve, reducing patients risk. In parallel, intensive courses focused on specific procedures could help those surgeons who had completed the initial steps of their learning curve to master the specific technical details necessary to improve outcomes.

Read the full article

Alexander Mottrie*† and Giacomo Novara†‡

*OLV Vattikuti Robotic Surgery Institute and † Department of Urology, OLV Hospital Aalst, Aalst, Belgium and ‡ Department of Surgery, Oncology and Gastroenterology, Urology Clinic University of Padua, Padua, Italy

References

1 Abboudi H, Khan MS, Guru KA et al. Learning curves for urological procedures: a systematic review. BJU Int 2014; 114: 617–29

2 Thompson JE, Egger S, Böhm M et al. Superior quality of life and improved surgical margins are achievable with robotic radical prostatectomy after a long learning curve: a prospective single-surgeon study of 1552 consecutive cases. Eur Urol 2014; 65: 521–31

3 Mottrie A, De Naeyer G, Schatteman P et al. Impact of the learning curve on perioperative outcomes in patients who underwent robotic partial nephrectomy for parenchymal renal tumours. Eur Urol 2010; 58: 127–32

4 Hayn MH, Hellenthal NJ, Hussain A et al. Does previous robot-assisted radical prostatectomy experience affect outcomes at robot-assisted radical cystectomy? Results from the International Robotic Cystectomy Consortium. Urology 2010; 76: 1111–6

5 Vickers AJ. What are the implications of the surgical learning curve? Eur Urol 2014; 65: 532–3

6 Kwon EO, Bautista TC, Jung H et al. Impact of robotic training onsurgical and pathologic outcomes during robot-assisted laparoscopicradical prostatectomy. Urology 2010; 76: 363–8

7 Leroy TJ, Thiel DD, Duchene DA et al. Safety and peri-operative outcomes during learning curve of robot-assisted laparoscopicprostatectomy: a multi-institutional study of fellowship-trainedrobotic surgeons versus experienced open radical prostatectomysurgeons incorporating robot-assisted laparoscopic prostatectomy. J Endourol 2010; 24: 1665–9

 

Article of the Week: Assessing prostate cancer brachytherapy using patient-reported outcomes

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Every week the Editor-in-Chief selects the Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video from Dr. James Talcott discussing his paper. 

If you only have time to read one article this week, it should be this one.

Using Patient-Reported Outcomes to Assess and Improve Prostate Cancer Brachytherapy

James A. Talcott 1, 2, 10, 11, Judith Manola 3, Ronald C. Chen 4, Jack A. Clark 5, 6, Irving Kaplan 7, 8, Anthony V. D’Amico 8, 11 and Anthony L. Zietman 9, 11

1 Massachusetts General Hospital Cancer Center, Boston, MA, 2 Continuum Cancer Centers of New York, New York, NY, 3 Dana-Farber Cancer Institute, Boston, MA, 4 Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 5 Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, 6 Boston University School of Public Health, 7 Beth Israel-Deaconess Medical Center, 8 Brigham and Women’s Hospital, 9 Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, 10 Albert Einstein School of Medicine, New York, NY, and 11 Harvard Medical School, Boston, MA, USA

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OBJECTIVE
  • To describe a successful quality improvement process that arose from unexpected differences in control groups’ short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity.
PATIENTS AND METHODS
  • Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study.
  • Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals.
  • Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change.
RESULTS
  • The patient groups were demographically and clinically similar.
  • In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BT1 patients.
  • The studies treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter.
  • After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged.
CONCLUSION
  • Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care.
  • We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.
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Editorial: Patient-reported outcomes – a force for clinical improvement or another way for ‘big brother’ to survey clinicians?

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In the 19th century Lord Kelvin wrote, ‘If you cannot measure it, you cannot improve it’. Since then clinical improvement has often been about measuring outcomes to determine what elements of healthcare are working well and what can be improved. The early studies of antisepsis and surgical technique had endpoints, which were measured by doctors deciding whether a wound infection, cancer recurrence or even death had occurred. These outcomes were usually discrete with little room for describing states between success and failure.

In this era whether the patient perceived that the treatment had been successful or not was irrelevant to the ‘success’ of treatment providing that the medical world agreed that the treatment had been a success. As treatments have become more established and the medical and pharmaceutical world has become more patient focussed, interest has increased in how patients report the outcome of treatment, often using questionnaires.

The pioneers of this work were mainly psychiatrists concerned about patient anxiety and depression [1] and clinical oncologists, aware that multimodal chemoradiotherapy treatments, which might in many cases be offered with palliative rather than curative intent, had the potential to cause a net loss in quality of life even if patients lived a short time longer on treatment.

As these patient-reported outcome measures (PROMs) became more commonly used in clinical trials, their focus has extended to quite specific outcomes, such that in the current era it is unusual to see papers on LUTS or erectile function presented that do not use validated PROMs, such as the IPSS [2] or International Index of Erectile Function (IIEF) [3].

The current era of research is starting to make new use of the data sources that are useful both as absolute values relating to the severity of symptoms but also particularly in measuring change in level of symptoms. Hard outcomes, such as death from cancer, have been found to be related to patient reported quality of life at presentation [4].

Clinicians are now starting to develop the necessary skills to analyse PROMs. In this setting Talcott et al. [5] have used PROM data to identify unexpected variances in symptomatic outcome after prostate brachytherapy. This was an unexpected post hoc analysis of a difference in outcomes between the two control groups in a study. It found that there was a significant difference in outcome between patients who had received an implant in two centres, which might have been expected to have similar outcomes. Analysis of differences in the implant technique in the two institutions suggested that the use of a urethral catheter to clearly visualise the urethra might be the difference and modification of this part of the technique resulted in similar PROMS outcomes in both institutions.

This is a novel quality improvement approach, which may become more widespread as institutions more frequently collect, analyse and present their PROMS. The bio-informatics skills needed to analyse this type of data meaningfully may become a greater part of everyday practice in the modern era, especially for the ‘index’ most common operations in surgical specialities. It would be interesting to see what a similar approach would produce if variance in PROMs after transurethral prostate surgery were analysed between centres in the UK and USA. Organisations with a track record for effective data analysis and reporting such as Dr Foster will be watching this evolve.

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Alastair Henderson

Maidstone and Tunbridge Wells NHS Trust, Department of Urology, Maidstone Hospital, Maidstone, Kent, UK

References

1 Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiat Scand 1983; 67: 361–70

2 Barry MJ, O’Leary MP. Advances in benign prostatic hyperplasia. The developmental and clinical utility of symptom scores. Urol Clin North Am 1995; 22: 299–307

3 Cappelleri JC, Rosen RC, Smith MD, Mishra A, Osterloh IH. Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999; 54: 346–51

4 Montazeri A. Quality of life data as prognostic indicators of survival in cancer patients: an overview of the literature from 1982 to 2008. Health Qual Life Outcomes 2009; 7: 102

5 Talcott JA, Manola J, Chen RC et al. Using patient-reported outcomes to assess and improve prostate cancer brachytherapy. BJU Int 2014; 114: 511–6

Video: PROs in Prostate Brachytherapy

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Using Patient-Reported Outcomes to Assess and Improve Prostate Cancer Brachytherapy

James A. Talcott 1, 2, 10, 11, Judith Manola 3, Ronald C. Chen 4, Jack A. Clark 5, 6, Irving Kaplan 7, 8, Anthony V. D’Amico 8, 11 and Anthony L. Zietman 9, 11

1 Massachusetts General Hospital Cancer Center, Boston, MA, 2 Continuum Cancer Centers of New York, New York, NY, 3 Dana-Farber Cancer Institute, Boston, MA, 4 Department of Radiation Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, 5 Center for Health Quality, Outcomes, and Economic Research, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA, 6 Boston University School of Public Health, 7 Beth Israel-Deaconess Medical Center, 8 Brigham and Women’s Hospital, 9 Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA, 10 Albert Einstein School of Medicine, New York, NY, and 11 Harvard Medical School, Boston, MA, USA

Read the full article
OBJECTIVE
  • To describe a successful quality improvement process that arose from unexpected differences in control groups’ short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity.
PATIENTS AND METHODS
  • Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study.
  • Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals.
  • Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change.
RESULTS
  • The patient groups were demographically and clinically similar.
  • In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BT1 patients.
  • The studies treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter.
  • After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged.
CONCLUSION
  • Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care.
  • We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.
Read more articles of the week
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