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Editorial: Do live case demonstrations have a future in surgical education?

The ever increasing desire for instant access to information is a reflection of our times facilitated by social networks and by video and information technology. Nowadays, sport events are dissected and quantified from every possible perspective. We know almost real-time any detail of a soccer match: how many miles each player runs, how many good or bad passages of play, how many faults and so on, including if needed the details of heart rate and weight loss. The same and even more is available for example in formula one racing. Theoretically the same could easily be applied to surgical performance and it is foreseeable it will be applied, as a self-performance improvement method and as a development of one of the most popular ‘scientific and educational’ activities during surgical meetings, live case demonstrations (LCDs). All this, together with simulation, could in the near future have a tremendous impact on surgical performance and training. Twitter and Instagram show the power of the immediate real-time diffusion of events, as condensed as possible, so that the tweet or the instantaneous image can be visible and digested without losing time. Video clips follow the same concept and certainly BJUI is pioneering the use of short surgical video clips that are easily accessible and usable at any spare time of a busy day.

The core issue about LCDs is that at present there is no solid scientific evidence of their educational value, and this is outlined in the paper by Elsamra et al. [1] published in this issue of BJUI, which commendably attempts to evaluate the educational benefit of LCDs in terms of perception, clearly not a very strong criterion.

Data about the outcomes of live surgery operations are scant. Clearly patient’s safety is the first goal of any surgical activity, and this applies to LCDs. As mentioned in the paper, the European Association of Urology (EAU) Executive felt the urgent need to establish procedures and regulations in order to endorse live surgery events. The reader can find all related information on the EAU website. These regulations are meant to be in the best interest of patients, surgeons and organisers. Among others, one important innovation is the requisite of a ‘patient advocate’ present during the LCD, being an experienced medical doctor, independent from the organising committee of the educational event, in charge of advising in case of unexpected events, which can endanger patient’s safety.

Moreover, the EAU has established a prospective database of all endorsed live surgery events. This will hopefully allow in a few years an answer, with solid data, to the question of whether an intervention performed during a live surgery event has the same outcome compared with the same intervention executed by the same surgeon in his usual environment. The more challenging goal is to quantify the educational value of a live surgical event and the jump from perception to scientific evidence is far from being an easy task.

Walter Artibani
Urologia – Azienda Ospedaliero Universitaria Integrata di Verona, Verona, Italy

Reference

  1. Elsamra SE, Fakhoury M, Motato H et al. The surgical spectacle: a survey of urologists viewing live case demonstrationsBJU Int 2014; 113: 674–678
 

Quality matters most where the BJUI and stone disease are concerned

Size (and shape) is important and sometimes strings should be attached, but quality matters most where the BJUI and stone disease are concerned …

The Editor-in-chief of the BJUI has consolidated the journal’s commitment to accepting only the highest quality papers, and this is certainly evident in the upper urinary tract section of this edition, where two studies demonstrate what it takes to be published in the journal nowadays.

In the first article, Kerri Barnes and colleagues from University of Iowa Department of Urology [1] have followed their own department’s earlier retrospective analysis of the benefit of “tethered stents” [2], by analysing the safety and effectiveness of this approach in a prospective, randomised controlled trial. It is often stated that randomised controlled trials are difficult in surgical disciplines, but this study affirms the proverb that “where there’s a will, there’s a way”. Although there was a substantial drop out in the number of patients that could have been included (three quarters of the patients approached for the study declined to be involved as they wished to determine the nature of the stent left in situ), statistical significance was not approached for any of the key concerns that leaving a stent on a string might cause for either the patient or their surgeon.

Furthermore, they have shown that that leaving the strings in place allowed patients to remove their stents significantly earlier (and in the convenience of their own home), than if they had to return to hospital for cystoscopic removal a week or so post-operatively. Despite the established knowledge that stents contribute to postoperative morbidity and can adversely affect quality of life, and the increasing evidence that stents are not required in “uncomplicated” ureteroscopy, it is clear that most urologists continue to leave a stent for a sense of security after performing ureteroscopic stone surgery. Shorter stent dwell times may help reduce the overall burden of stent related symptoms, and it is worth emphasising that none of the patients whose stent was removed at 7 days post operatively had any adverse consequences; neither did the 15% of this group whose stents fell out even earlier. As Fernando and Bultitude [3] comment in the associated editorial, the next question is: “If you are going to place a stent, how long does the stent need to stay for?” Perhaps, in order to emphasise that, where stent bother is concerned, shorter is better, this should be re-phrased as “how little time is enough time for a stent to stay in”…

In the second, Will Finch, from Norfolk and Norwich University Hospital, and his colleagues from Addenbrooke’s Hospital, Cambridge [4], have shown that stone size assessments from CT are most reliably calculated by a 3D-reconstructed stone volume. They have demonstrated that the maximum diameter of a stone tends to predict its overall shape such that a rugby ball-shaped stone (a “prolate ellipsoid”) has the polar diameter as the major axis, whereas a disc-shaped stone (an “oblate ellipsoid”) has the equatorial diameter as its major axis. Stones less than 9mm in diameter tended to be prolate, whilst those of 9–15 mm in diameter tended to be oblate; stones larger than 15 mm in diameter approach the more “random” shape of a scalene ellipsoid, for which the formula used to calculate stone volume (length (l) × width (w) × depth (d) × π × 0.167, which is often simplified to (l × w × d) / 2 in clinical practice) can be used.

However, if this is used for all stones regardless of their size and shape, rugby-ball and disc-like stones of less than 15mm in size are likely to have their volume over-estimated. Accordingly, the authors challenge the guidance of the EAU regarding stone volume calculations [5] to recommend that formulae based on the shape of the stone (π/6*a*a*c* for an oblate and π/6*a*b*b* for a prolate stone – see the paper itself to make sense of this) offer a more accurate assessment of stone volume.

Whilst these formulae are recommended for day-to-day calculations to guide treatment choices, they emphasise that 3D-reconstructed stone volumes should be used to report stone volume in research papers. In an age of stone surgery where CTKUB is so widely used in patients’ imaging assessment, and accepting that stone volume is the key determinant of achieving a stone free patient, this would allow the most accurate comparisons between the effectiveness of different surgical treatments.

Both articles are simple, straightforward, and well conducted studies that apply to the every-day practice of stone surgery. High quality papers are, of course, only really of benefit if they change practice for the better. So why not speak to your radiologist today about adding stone volume assessments to CTKUB reports (and point them to Finch et al. for the evidence) or even do it yourself! And the next time you put in a stent, reassure yourself, and the patient,

that there is no harm, and many benefits, in having some strings attached …

Daron Smith
University College Hospital, London, United Kingdom

Read the April issue

References

  1. Barnes KT, Bing MT, Tracy CR. Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trialBJU Int 2014; 113: 605–609
  2. Bockholt N, Wild T, Gupta A, Tracy CR. Ureteric stent placement with extraction strings: no strings attached? BJU Int 2012; 110 (11 Pt C): E1069–1073
  3. Fernando A, Bultitude M. Tether your stents! BJU Int 2014; 113: 517–518
  4. Finch W, Johnston R, Shaida N, Winderbottom A, Wiseman O. Measuring stone volume – three-dimensional software reconstruction or an ellipsoid algebra formula? BJU Int 2014; 113: 610–614
  5. Tiselius HG, Alken P, Buck C et al. European Association of Urology 2008 Guidelines on Urolithiasis. Available at: https://www.uroweb.org/fileadmin/user_upload/Guidelines/Urolithiasis.pdf. Accessed 17 June 2012
 

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Welcome to the world of digital audio recordings of your consultations

Has anybody ever tried to record one of your consultations? Yesterday, a patient of mine took his smartphone out of his pocket, placed it on my desk and said: “you don’t mind if I record this consultation do you doctor?” I tried not to look too surprised, gave my consent, and proceeded to go through the treatment options to him for his early prostate cancer.  As I did so, perhaps a little more thoroughly and carefully than usual, I vaguely wondered whether the recording would be admissible in court or in front of the GMC if things did not go according to plan later.

 By coincidence, last night I read in the BMJ a case where a patient had asked her family doctor whether she could use her smartphone to record the encounter (BMJ 2014;348g2078). Her doctor was apparently taken aback and paused to gather his thoughts. He asked the patient to put her phone away, saying that it was not the policy of the practice to allow patients to take recordings. The mood of the meeting shifted, initially jovial, the doctor had become defensive. She complied and turned off her smartphone.

 As soon as the phone was turned off, the doctor raised his voice and berated her for making the request, saying that the use of a recoding device would betray the fundamental trust that is the basis of a good patient-doctor relationship. The patient tried to reason, explaining that the recording would be useful to her and her family, but the doctor shouted at her asking her to leave immediately and find another doctor.

It later transpired that the patient could prove that this had happened because she had a digital recording of the encounter. Although she had turned off her smartphone, she had a second recording device in her pocket, turned on, that had recorded every word!

According to the MDU, patients do not need their doctors’ permission to tape a consultation, as the information they are recording is personal to them and therefore exempt from data protection principles. Section 36 of the UK Data Protection Act 1998 states: “Personal data processed by an individual only for the purposes of that individual’s personal, family or household affairs (including recreational purposes) are exempt from the data protection principles and the provisions of Parts II and III”. There have taken some time to look into some of the most popular Nintendo Switch headsets on the market in an effort to help you out. Yes, it is true that there are many options out there, and it can be a chore to have to go through all of them yourself. That’s where they step in…they have done the tough work for you, and now we can present the best products reviewed on Audio Direct.

If you suspect that a patient is covertly recording you, you may be upset by the intrusion but if you act in a professional manner at all times then it should not really pose a problem. Your duty of care also means you would not be justified in refusing to continue to treat the patient. If you did, it could easily rebound on you and further damage your relationship with the patient. And, as the case described above illustrates, your refusal to continue with the consultation could easily be recorded!

Roger Kirby, The Prostate Centre, London

Editorial: Radical cystectomy: how do blood transfusions affect oncological outcomes?

Kluth et al. [1] have conducted a large retrospective study from several institutions in North America and Europe to assess the impact of blood transfusion on oncological outcomes after radical cystectomy (RC) for bladder cancer. The hypothesis for a negative impact of transfusion on oncological outcomes stems from the observation that renal allograft survival is prolonged after pre-transplant blood transfusions because of its immuno-modulatory effects [2]. This finding prompted Gantt [3] to express concern about the possible adverse effects of transfusions in patients being treated for cancer. Since then, there have been numerous publications addressing this issue in various surgical journals including those of urology with conflicting messages.

Sadeghi et al. [4] queried the Columbia University Urologic Oncology Database. This included 638 patients undergoing RC between 1989 and 2010. Of these, 209 (32.8%) received perioperative blood transfusions. On univariate analysis, the number of units transfused was inversely related to overall and cancer-specific survival. However, on multivariate analysis, it did not prove to be an independent predictor of cancer-specific survival.

As the authors highlighted in this paper, Linder et al. [5] reported a large series of patients from the Mayo Clinic, which included 2060 patients undergoing RC over 25 years. Of this large cohort, 1279 (62%) received perioperative blood transfusion with adverse outcomes, not only in terms of overall and cancer-specific mortality, but also postoperative tumour recurrence.

RC is one of the most major surgical procedures performed in urological surgery. The vast majority of patients with bladder cancer requiring RC are in their mid-sixties, overweight and have several co-morbidities. Some of these patients present late and are anaemic at presentation.

Blood loss during open RC varies depending upon surgeons’ experience, patients’ body mass index, disease stage and availability of modern equipment, e.g. LigaSure™ or stapling devices. Blood transfusion may be required because of pre-existing anaemia or excessive blood loss during surgery. Variations exist in thresholds of anaesthesiologists and the surgeons for transfusions. All of these factors account for variation in reported frequency of transfusion rates for this operation and this is well reflected in many large series of RC.

As there are many confounding factors that may influence overall and cancer-specific survival in patients undergoing RC including stage of the disease, histological nature of the tumour, lymph node status and competing co-morbidities, it is very challenging to control for these factors in retrospective series. Hence, prospective well-controlled multicentre studies are the only way forward to answer this question.

While we await robust evidence on the influence of perioperative transfusion on oncological outcomes, several potential options could be explored to avoid homologous blood transfusion. These include preoperative optimisation of haemoglobin levels through iron infusions, administration of erythropoietin where appropriate, and preoperative autologous-banking. Intraoperatively meticulous surgical technique, use of modern devices, e.g. LigaSure/stapler and Cell Savers, could be used to avoid homologous blood transfusion.

Fortunately, these studies aimed at raising awareness of potential risks of transfusions are appearing in the urological literature at a time when urologists are moving away from open to minimally invasive oncological surgery with a steady decline in the need for perioperative blood transfusion. This is one of the important steps in the right direction and will have a major impact on the need for blood transfusion in foreseeable future.

Muhammed S. Khan
Department of Urology, Guy’s Hospital and King’s College London School of Medicine, London, UK

Read the full article

References

  1. Kluth LA, Xylinas E, Rieken M et al. Impact of perioperative blood transfusion on the outcome of patients undergoing radical cystectomy for urothelial carcinoma of the bladderBJU Int 2014; 113: 393–398
  2. Opelz G, Sengar DP, Mickey MR, Terasaki PI. Effect of blood transfusions on subsequent kidney transplantsTransplant Proc 1973; 5: 253–259
  3. Gantt CL. Red blood cells for cancer patientsLancet 1981; 2: 363
  4. Sadeghi N, Badalato GM, Hruby G, Kates M, McKiernan JM. The impact of perioperative blood transfusion on survival following radical cystectomy for urothelial carcinomaCan J Urol 2012; 19: 6443–6449
  5. Linder BJ, Frank I, Cheville JC et al. The impact of perioperative blood transfusion on cancer recurrence and survival following radical cystectomyEur Urol 2013; 63: 839–845
Read more articles of the week

Future Proofing Urology – Conference Highlights from the USANZ ASM 2014

Dr Marnique Basto (@DrMarniqueB) 

 

 

Delegates of #USANZ14 received a sunny welcome at this year’s 67th annual scientific meeting in Brisbane, affectionately coined by Aussies as ‘Bris-vegas’ attributed to a love of Elvis and the city’s growing live music scene. The reins were passed from Professor Damien Bolton and A/Professor Nathan Lawrentschuk (@lawrentschuk) who convened last year’s ASM in Melbourne to Greg Malone (@DrGregJMal) and Eric Chung. @BJUIjournal Editor-in-chief Prokar Dasgupta (@prokarurol) praised the USANZ organising committee for their tremendous hospitality.

A star studded international faculty made the long-haul down under including Shahrokh Shariat, Alan Partin, Gerry Andriole, James Eastham, Rainy Umbas, Per-Anders Abrahamsson, Monique Roobol, Hein Van Poppel, Jean de la Rosette, Gerald Brock, Brad Leibovich, Gary Lemack, Tom Lue, Jonathan Coleman, Michael Jewett, Oliver Traxer, Eric Small, Adrian Joyce, Roger Kirby, Gopal Badlani, Sunil Shroff, Eila Skinner, Jaspreet Sandhu, Matthew Rettig, Pilar Laguna, Jaime Landman, Irwin Goldstein, Todd Morgan and Gregor Goldner.

The hype around #USANZ14, however, had kicked off well before conference doors opened with @USANZUrology mounting the largest pre-conference social media (SoMe) campaign of any Urology conference internationally to date. Over 200 tweets were generated in the five-day lead-up from the @Urologymeeting account, doubling last year’s efforts of the social media team at the Prostate Cancer World Congress in Melbourne. It’s fair to say Australia is setting a blazing pace in the use of SoMe to amplify the Urology conference experience and generate international engagement and global reach.

“Future proofing urology” was the conference theme this year to promote and foster multidisciplinary collegiality and evidenced urological practice. The theme was entwined throughout the four-day conference with the final day showcasing a multidisciplinary forum with international experts discussing complex cases. Additionally the Australian and New Zealand Urological Trials (@ANZUPtrials) session highlighted the interplay between urology, radiation and medical oncology and the current trials underway. 

USANZ president David Winkle officially opened conference proceedings and we had the honour of Scottish-born Australian Scientist Professor Ian Frazer AC, the mastermind behind the Human Papilloma Virus vaccine and the fight against cervical cancer, deliver the Harry Harris oration. Professor Frazer’s ongoing dedication to implementing vaccination programs in low GDP countries such as Vanuatu and Butan was truly inspirational. Harry Harris was the first full time Urology specialist in Australia, and suitably the award of the seven newest fellows of the USANZ collegiate followed. Congratulations to all.

A lively point-counterpoint debate on the viability of prostate cancer prevention then ensued between Shahrokh Shariat (@DrShariat) on the negative and Gerald Andriole (@uropro) on the affirmative. Interestingly both parties used the same sets of data to reach opposite conclusions. The ability to use the opposition’s prior publications against them became the clincher in several of the debates throughout the conference; however, it was the ‘no show’ of hands from the audience when asked “who currently uses chemoprevention?” that reinforced the inevitable conclusion.

The BJUI session was then underway and A/Prof Nathan Lawrentschuk, Associate Editor of the BJUI USANZ supplement, outlined his vision for the journal going forward. The winner of the BJUI Global Prize awarded to a trainee who significantly contributed to the best international article went to Dr. Ghalip Lidawi for his paper titled High detection rate of significant prostate tumours in anterior zones using transperineal template saturation biopsy. In an Oscar-style award ceremony Dr Lidawi was broadcast from Tel Aviv. Professor Alan Partin (@alan_partin) went on to deliver a brilliant and balanced rationale behind why Gleason 6 IS prostate cancer and potentially coined the alternative name PENIS (‘Prostatic epithelial neoplasm of indeterminate significance’).  News of ‘PENIS of the prostate’ hit social media channels instantly with Urologists chiming in from the US to give their opinion within minutes and before Dr Partin had even stepped down from the podium.

Dr. Ghalip Lidawi accepting his BJUI Global Prize via video message (photo courtesy of Imogen Patterson).

After the opening plenary each morning, the 950 delegates were treated to a range of concurrent sessions from the faculty, which included localised prostate cancer, endourology, andrology/prostheses, high risk prostate cancer, LUTS/BPH, prostate cancer multidisciplinary forum, urology general, bladder cancer, kidney cancer and abstract poster presentations. There was a concurrent nursing program also running during the USANZ schedule that proves year after year to be a huge success.

A stand out session of the meeting was on high-risk prostate cancer section on Monday afternoon. Professor James Eastham (who is rumoured to have just joined twitter!) discussed the role of pelvic lymph node dissection (PLND) for diagnostic and therapeutic purposes with reference to the Memorial Sloan Kettering (MSK) experience and the role of salvage PLND after radical prostatectomy for choline PET detected retroperitoneal or pelvic node recurrence. Professor Hein van Poppel went on to support the role of surgery in high-risk disease in this session, while Drs Shariat and Per Anders Abrahamsson discussed the latest in hormonal adjuvant therapy. 

What makes USANZ special?

The abstract submissions this meeting far superseded last year in volume and quality requiring two concurrent poster presentation sessions running most of the conference. The use of transperineal template biopsy was a prominent theme again in the abstract series, as was active surveillance for low risk prostate cancer. Pleasingly we saw the development of large international collaborations involving Australia such as the Vattikuti Global Quality Initiative on Robotic Urologic Surgery where Mr Daniel Moon has collaborated with nine hospitals throughout Europe, North America and India on their growing robotic partial nephrectomy series. 

Each year a select group of our young talented trainees compete for the prestigious Keith Kirkland (KK) clinical and Villis Marshall (VM) basic science prizes. This year Dr Kenny Rao (@DrKennyRao) was awarded the VM prize from a field of five candidates for his work titled ‘Zinc preconditioning protects the rat kidney against ischaemic injury’. Dr Helen Nicholson (@DrHLN) took out the KK prize over 10 other candidates for her work; ‘Does the timing of intraoperative non-steroidal anti-inflammatory analgesia affect pain outcomes in ureteroscopy? A prospective, single-blinded, randomised controlled trial’. These were awarded at the gala ball located at the Brisbane townhall, a venue soon to be filled by some of the most prominent in the world for the G20 summit. Other awards on the night included the Alban Gee for best poster to Shomik Sengupta (@shomik_s), the BAUS trophy (@BAUSUrology) to Michael Holmes and the Abbvie Platinum award to Niall Corcoran.

Unlike any other Urology meetings worldwide, the USANZ ASM is compulsory for all trainees from their third year on and is encouraged in the first two years. Trainees were treated to a breakfast meeting with Dr Shahrokh Shariat who imparted 14 career tips and then assisted @lawrentschuk in grilling trainees on difficult case studies in preparation for their fellowship exams. A brilliant learning opportunity! Trainees also got to meet one-on-one with international faculty members of their choice to facilitate potential future fellowships in somewhat of a staged ‘speed-dating’ affair – 10 minutes chat, then move on. To top off the trainee program, the @BJUIjournal delivered an extremely practical and useful workshop focussed on getting published in the digital and social media era where blogs are encouraged, tweets are citable and your CV now contains a social media section.

A SoMe session attracted a lot of attention from international delegates and twitter activity on the #USANZ14 hashtag skyrocketed as we were joined by Stacy Loeb (@LoebStacy) in Moscow, Alexander Kutikov (@uretericbud) in the US and Rajiv Singal (@DrRKSingal) in Canada. Declan Murphy (@declangmurphy), Henry Woo (@DrHWoo) and Todd Morgan (@wandering_gu) put on a masterful (and non-nauseating) prezi display with the audience taken on an e-health journey of novel gadgets and devices including one that measured tumescence and sends the file automatically to the physician records. The possibilities are endless! Twitter boards were back in force; a sign of a quality and successful conference according to @declangmurphy. The wifi at the conference venue could not be faulted!

Controversial areas of SoMe were also broached including the APRAH Advertising Guidelines that came into effect this week, Monday March 17. Australian Plastic surgeon Jill Tomlinson (@jilltomlinson) has actively opposed the guidelines that will see physicians responsible for all testimonials associated with them on the internet. The policy mandates this information be removed otherwise a fine of up to $5000 is possible, many feel this places an unreasonable burden on health practitioners to be responsible for content that they may potentially be unaware of. Read Jill Tomlinson’s letter to APRAH here.

The @BJUIJournal and its editors @prokarurol, @lawrentschuk, @declangmurphy and @alan_partin (left to right below) and off screen @drHwoo were prominent SoMe influencers of the meeting two years running. We were also delighted to have Mike Leveridge (@_theurologist) from Canada attending, one of the pioneering uro-twitterati. A mention goes out to fellow countryman @drrksingal who was again mistaken for being at the conference due to his strong SoMe presence from afar. The twitter activity for the conference period March 16 (00:00) to March 19 (23:59) generated nearly 1.4 million impressions and 2,326 tweets or approximately 344K impressions and 581 tweets per day. Based on the study conducted by our team examining metrics of all eight major urological conferences of 2013, #USANZ14 would comparatively rate second only to the AUA in the international engagement and global reach attained. Congratulations to @USANZUrology and @Urologymeeting for enhancing our conference experience and sending our message out to almost 1.4 million potential viewers in just a 4-day period. 

The BJUI Workshop featured Editor-in-Chief Prokar Dasgupta and Associate Editors Nathan Lawrentschuk, Declan Murphy and Alan Partin.

In 2015 we take a trip to Adelaide for the 68th Annual Scientific Meeting of USANZ with experts already confirmed including Steven Kaplan, Martin Koyle, Morgan Rupert, Matthew Cooperberg and Glenn Preminger. See you all there!

 

Dr Marnique Basto (@DrMarniqueB) is a USANZ trainee from Victoria who has recently completed a Masters of Surgery in the health economics of robotic surgery and has an interest in SoMe in Urology.

Check out the new BJUI Instagram feed for more photos from #usanz14 www.instagram.com/bjui_journal

 

 

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Image from Sabnis et al. BJU Int 2013; 112: 355–361. doi: 10.1111/bju.12164

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Editorial: mTOR-related non-infectious pneumonitis: a potential biomarker of clinical benefit?

The study by Atkinson et al. [1] published in the present issue of the BJUI is the largest study to date to address the role of non-infectious pneumonitis (NIP) as a predictive biomarker in patients with RCC who are treated with mammalian target of rapamycin (mTOR) inhibitors. It is also the first article to correlate mTOR-related NIP with improved overall survival (OS). Until now, only radiological response as measured by RECIST and progression-free survival (PFS) had been correlated to the onset of NIP in two small retrospective studies [2, 3], but the results obtained in those studies were contradictory and, therefore, this correlation remains controversial.

While the predictive relationship between NIP and OS needs to be further investigated in well-designed prospective clinical trials, the implications of such a relationship may be significant because no predictive biomarkers for mTOR inhibitors have been validated to date. In the era of targeted therapies, the detection of biomarkers of treatment efficacy is crucial to differentiate the subpopulations of patients who are most likely to benefit from treatment. Several biomarkers, such as the development of arterial hypertension and hypothyroidism, have been correlated with improved outcomes in patients with advanced RCC treated with vascular endothelial growth factor pathway inhibitors [1]; however, there are currently very limited data regarding the potential predictors of the clinical efficacy of mTOR inhibitors. A recent study by Lee et al. [4] showed that greater increases in serum cholesterol levels from baseline in patients with advanced RCC treated with temsirolimus were significantly associated with longer PFS and OS. Interestingly, temsirolimus-related hypertriglyceridemia and hyperglycaemia were not associated with improved clinical outcomes. Although NIP or hypercholesterolaemia must still be validated prospectively to ascertain whether they are true surrogate biomarkers of pharmacodynamic effect or just confounding epiphenomena, these promising findings may be the first steps in the identification of predictive biomarkers in mTOR inhibitor therapy.

Other important aspects addressed by Atkinson et al. [1] are the uncertainty of the pathogenesis of mTOR-related NIP and the lack of clinical predictive factors. Older age and treatment with everolimus were the only significant predictive factors of onset of NIP in their multivariate analysis. Similarly, a retrospective study by Dabydeen et al. [2] showed a statistically nonsignificant higher incidence of NIP in patients with RCC treated with everolimus compared to those treated with temsirolimus. Interestingly, in a randomized phase II study testing three different dose levels of temsirolimus (25,75 and 250 mg/week) in patients with advanced RCC, none of the six patients diagnosed with NIP were in the highest dose group of 250 mg/week [5], suggesting that mTOR-related NIP might have a non-dose-dependent pathogenesis. Similarly, a meta-analysis of 2233 patients affected by different tumours including RCC treated with an mTOR inhibitor failed to show any relationship between median treatment duration and incidence of NIP [6]. Finally, underlying respiratory conditions before treatment, such as the presence of lung metastases [6], chronic obstructive pulmonary disease or smoking habit [2], were not shown to be predictive factors of development of mTOR-related NIP. Another study by White et al. [3] showed that the development of pneumonitis in patients with RCC treated with everolimus was not associated with more impaired baseline pulmonary function tests, indicating that pulmonary function tests may not help identify patients with an increased risk of pneumonitis nor predict its severity. At present, there are therefore very few pretreatment clinical predictive factors to help clinicians identify patients at higher risk of developing mTOR-related NIP.

In conclusion, given the potential value of NIP as a predictive biomarker of survival in patients with RCC treated with mTOR inhibitors, Atkinson et al. [1] suggest that efforts should be made to avoid dose reductions and treatment discontinuation whenever possible. However, predictive factors of the severity of lung toxicity are needed to identify those patients at risk of developing life-threatening NIP as the maintenance of dose intensity may be crucial for maximizing clinical benefit.

Read the full article

Alejo Rodriguez-Vida, Noan-Minh Chau and Simon Chowdhury
Department of Medical Oncology, Guy’s Hospital, London, UK

References

  1. Atkinson BJ, Pharm D, Cauley DH et al. mTOR inhibitor-associated non-infectious pneumonitis in patients with renal cell cancer: management, predictors, and outcomesBJU Int 2014; 113: 376–382
  2. Dabydeen DA, Jagannathan JP, Ramaiya N et al. Pneumonitis associated with mTOR inhibitors therapy in patients with metastatic renal cell carcinoma: incidence, radiographic findings and correlation with clinical outcomeEur J Cancer 2012; 48:1519–1524
  3. White DA, Camus P, Endo M et al. Noninfectious pneumonitis after everolimus therapy for advanced renal cell carcinomaAm J Respir Crit Care Med 2010; 182: 396–403
  4. Lee CK, Marschner IC, Simes RJ et al. Increase in cholesterol predicts survival advantage in renal cell carcinoma patients treated with temsirolimusClin Cancer Res 2012; 18: 3188–3196
  5. Atkins MB, Hidalgo M, Stadler WM et al. Randomized phase II study of multiple dose levels of CCI-779, a novel mammalian target of rapamycin kinase inhibitor, in patients with advanced refractory renal cell carcinomaJ Clin Oncol 2004; 22: 909–918
  6. Iacovelli R, Palazzo A, Mezi S, Morano F, Naso G, Cortesi E. Incidence and risk of pulmonary toxicity in patients treated with mTOR inhibitors for malignancy. A meta-analysis of published trialsActa Oncol 2012; 51: 873–879

 

Wearable Technology in Urology

Wearable Technology

Everywhere I look these days, it seems like I am reading more and more about wearable technology. Earlier this year, I started using Fitbit to “quantify myself” in an effort to improve my overall health. As a urologist, I started wondering about the technology our patients might be wearing in the near future.

I did some research, and found some interesting examples of wearable technology in urology.

Diapers that Warn of Infection


We all have incontinent patients in our practice who are prone to developing recurrent urinary tract infections. When these patients begin to develop an infection, their symptoms are not always readily recognized.

Pixie Briefs are diapers with an embedded patch that tests urine for evidence of urinary tract infection. When the patient voids into the diaper, the patch on the front of the Pixie Brief is scanned with a mobile device. The data collected is automatically entered into an algorithm. When the algorithm detects evidence of a urinary tract infection, or dehydration, an alert is made. This technology is already available for infants and toddlers in the form of the Smart Diaper.

Leg Bags that Empower Patients

Foley catheters and suprapubic tubes are used in a wide variety of patients for the management of urinary retention. Many of these patients have mobility issues, I suggest the use of a high quality Folding Power Wheelchair, as due to their condition we can’t allow them to make any kind of physical effort using a traditional wheelchair, specially with their arms or their abdominal zone, otherwise the patient would be unable to sit out of bed. For these patients, day-to-day living with a leg bag can present a significant challenge.

The Melio leg bag system is designed to help these patients better manage themselves. The system consists of a leg bag with an embedded sensor, a patient controller, and a pump with extension tubing. The sensor within the Melio leg bag begins alerting the patient when the leg bag is two-thirds full of urine.  Once alerted, the patient uses the controller to activate the pump.  The pump pushes the urine out of the leg bag and into extension tubing that the patient can easily reach and readily control. The device allows patients who may have previously required assistance to empty their leg bag to have complete control over the emptying process.

Ostomy Bags with Benefits

As urologists, we are all very familiar with the surgical steps involved in creating an ostomy.

I think it’s fair to say, however, that most of us are far less familiar with the day-to-day challenges that accompany living with an ostomy.

The Ostom-i-Alert system is the brainchild of ostomate Michael Seres. This product is a sensor that clips onto any standard ostomy bag. The sensor collects data as the ostomy bag fills with urine, or bowel contents, and transmits the data to an application on the patient’s mobile phone.

The app then alerts the ostomate when the ostomy bag needs to be drained. Output data acquired by the sensor is securely stored and, if necessary, can be e-mailed to the surgeon, ostomy nurse, or any other member of the health care team.

Wearable Technology – A Growing Trend

Recently, there has been a tremendous  amount of investment, research and development, and direct patient marketing in the field of wearable medical technology. In the next couple of years, we are likely to see many more products being introduced into the marketplace.

Some of these products will undoubtedly be of help to our patients. Other products will probably just be fancy gadgets with very limited, if any, real clinical value.

As urologists, I believe we need be aware of these devices. We also need to start seriously thinking about how we are going to partner with our patients and their families to appropriately interpret, and responsibly act upon, quantified-self data.

 

Dr. Brian Stork is a community urologist who practices in Muskegon and Grand Haven, Michigan, USA.  He is a member of the American Urological Association Social Media Committee and is the Social Media Director at StomaCloak. You can follow Dr. Stork on Twitter @StorkBrian.

 

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Atkinson et alBJU Int 2014; 113: 376–382. doi: 10.1111/bju.12420

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