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BAUS 2018 Highlights Day Three

June 28, 2018/1 Comment/by John Davis

BAUS Day 3—Going home images and snippets…

On the final night of BAUS, I had the honor of giving a dinner talk to the IBUS group—International British Urology Society. With BAUS contracting from 4 to 3 days, some of the previous joint sessions fell by the wayside, but IBUS president Subu Subramonian put together a nice evening program for the group.

The Day 3 morning session started with what is likely an original debate topic: “Consenting to Death.” The pro/con centered around whether or not every circumcision operation should be consented for the possibility of death. The idea was nominated by Jonathan Glass who also did a Twitter poll on the subject, which was similar to this audience poll—around 90% saying no.

The general flow of the debate was whether or not the rare incidence of a complication should be left off, so as not to alarm/concern the patient with minutia. On the other had, severe complications and death should potentially be consented even if rare.

Note the risk of everyday life compared to surgery: soccer was 1: 50,000. Mr. Glass had a nice display on how choices of driving routes to the hospital could affect the risk of dying. Turns out the bus is safest.

At the end of the debate, the voting shifted slightly to around 30% saying they would consent for death for a circumcision.

As Mr. O’Brien asked—do you also have to show the patient some horrific picture of gangrene so they are truly informed as to the risk of serious infection?

My favorite phrase on the serious but rare event is “its low risk, but never zero…perhaps a lightning strike.” Never say “routine surgery,” as that is always what the newspaper says: “ He died after routine surgery.” Routine sounds like zero risk. I must say also that the risk of “bleeding, infection, cardiac event, stroke, and death” is on almost every U.S. hospital template consent. So I think patients are used to it and will not freak out. Also vis-a-vie the Day 2 Blog on Dr. Wachter’s talk, an unintended consequence of the EPIC EMR is that we rarely print consents for patient review—rather we shows them on a screen and they digitally sign. But I bet they read the details less often than before. Oddly, they are not able to view their consents with their personal accounts, yet they can read clinic notes, diagnostics, imaging, path ,etc. Need a solution here.

Always good to have some humor in the slides.

Next, we heard a lecture from a truly unique individual. Mr. David Sellu gave us his personal account of how he was brought before a criminal court for manslaughter when a patient had a bowel perforation after a knee operation—he was in call coverage. He served time but won his appeals to drop charges and clear his name. I’m sure there were errors in the case, but in the U.S. this would likely have been a malpractice/civil court case and the hospital would have been co-defendant (system errors). Roger Kirby has tweeted the progress of this case for years, so it was interesting to hear from him personally.

Look at the multiple layers of jeopardy his case took him through over a 6 year period.

Here is a link to a previous blog on the case:

https://blogs.bmj.com/bmj/2018/03/20/the-case-of-david-sellu-a-criminal-court-is-not-the-right-place-to-determine-blame-in-complex-clinical-cases/

The Urology Foundation sponsored a session. They recognized a recent research scholarship awarded to Mr. David Eldred-Evans “The PROSTAGRAM trial: a prospective cross-sectional study assessing the feasibility of novel imaging techniques to screen for prostate cancer.

Roger Kirby then gave a guest lecture on his personal journal with prostate cancer as a surgeon and patient. He highlighted his actual biopsy specimens and RP path. He is 5 years disease free. He also showed some great nostalgia as he was being interviewed >20 years ago at the launch of Proscar to the market. He had 2 interviewers trying to gang up on him on conflict of interest and trying to make the drug sound toxic. I wonder how he would have handled those two in this era.

Some highlights of his slides on advice to surgeons. Thanks for all you do Roger.

Finally, there was an interesting session on the Global practice of urology with emphasis on training pathways and what has changed over the decade. Alan Partin presented his department’s approach to urology training at Johns Hopkins and the US perspective. James N’Dow outlined how diverse urologic training and credentialing is organize across Europe. Sanjay Kulkarni gave in Indian perspective—noteworthy that the urologist does not have such constraining credentialing pathways, and often will have private practice across multiple hospitals. He has attended over 60 and now owns one for his urethroplasty cases. Times are changing globally for urologic training, and Dr. Partin summed it up well by pointing out that the process of training is highly scrutinized now and seemingly higher priority than the final trained product. Does anyone think that a urology graduate in 2018 is better trained than 1998?

Ok—time to get back to work in Houston.

John W. Davis, MD, FACS

Associate Editor, BJUI.

BAUS 2018 Highlights Day Two: The 2018 BJUI Guest Lecture

June 28, 2018/by John Davis

Achieving the Promise of Digital Health: Are we There Yet? If Not, When…and How? Dr. Robert Wachter

Day 2: The 2018 BJUI Guest Lecture: Dr. Robert Wachter. Achieving the Promise of Digital Health: Are we There Yet? If Not, When…and How?

Image 1: Q&A with Dr. Robert Wachter, moderated by BJUI Trustee Chair, Prof. Krishna Sethia.

For Day 2 of BAUS18, the BJUI team invited a very unique expert to the podium. Dr. Robert Wachter is chief of medicine at the University of California San Francisco. He is more than an international guest flown across the pond for a keynote speech. Rather he is an expert in the digitization of health care and has consulted with the NHS in the past and extensively toured UK facilities. In a prior era of his career, he is credited with inventing the term “hospitalist” as internal medicine trained doctors who only service hospital-based points of care rather than the traditional outpatient clinic.

As a preface, he showed U.S. statistics that in ten years, we transformed from a < 10% to > 90% rate of electronic medical record (EMR) adoption—much of it spurred by financial incentives from the federal government. We all assume EMRs are more accurate and cut down on medical errors—queue the picture of the poor penmanship resulting in wrong drug/wrong patient/wrong dose. Yet he showed a post digitization era mistake where a drug was given 39 times rather than once due to mg vs mg/kg confusion—somehow the error made it through the whole system of EMR check points, robotic pharmacy dispensing, bar coders, and administration. The patient somehow survived. The take home point is the unintended consequences of the EMR.

What drives the EMR? Familiar themes of safety, accuracy, and low cost. At my hospital, we went through the famous EPIC EMR transformation in 2016. We lost so much money in the transition, it was fodder for articles in our national press and it certainly had an impact of several administrators’ careers. But even > 2 years later, I can say that I can make EPIC work at the level I worked before. But am I any faster? Definitely not. And the InBasket feature is a never-ending taskmaster of clinic results and messages and notifications.

Dr. Watcher showed a nice children’s drawing of a visit to her pediatrician. Everyone in the family is drawn, and she is on the exam table. The doctor? Back turned to the patient and clicking away at the EMR. So true and I’m as guilty as anyone. The only mistake made by the 7-year-old artist was that the doctor is smiling while clicking away on the computer! You can see the image yourself (copyrighted) in the article by Toll E, JAMA 2012 PMID 22797449. He pointed out that in most industries, digitization and automation would normally contract the work force and reduce or transfer out job positions. But not in health care—the popular solution to the physician’s back to the patient is to hire a “medical scribe” to do all of the EMR work while the doctor returns to the face to face role. In another talk on Global trends in health care and education, Dr. Allan Partin pointed out that it is increasingly popular in the USA for undergraduate students to take a “gap” year after graduation and before medical school, where they often do research, travel, work in the field, etc. Both trends are now part of my household—my older daughter graduated Baylor University with Health Sciences Studies degree and is both taking a gap year and taking a job as a medical scribe while applying to medical school.

Next is really the key point to where we are now in health care—yes we have converted to the EMR, and yes we have a few tricks like voice recognition software, medical scribes, and *** template phrases to speed up or at least maintain the pace of the pre-EMR era. However, what lies ahead is how to unlock the mystery of how to increase productivity. As far as we know, no one is more productive with an EMR across the board. In some cases, it can still be the opposite—the EMR became such a temptation for hospitals to “tack on” more tasks while they have us in there: not just an H&P but lets add TMN cancer staging, and a problem list, and reconcile meds, and an enormous review of systems, and review outside problems, and do all of the coding and billing. And at least in the EPIC version of the EMR, if any members of your extended team (nursing, trainees, advanced practice providers, etc.) make a mistake in their documentation, you usually can neither correct the error yourself nor close the encounter. So you have to chase them down by email to finish the work. At our center they now want encounters done by 7 days and promise to fine us starting day 14.
So that might be the future—improvements to EMRs or use of artificial intelligence to make our work better and more efficient. A quick example was an endocrine service where the chief could use the EMR to screen hospitalized patients at risk for hyperglycemic complications. He could send alerts to the nursing team on how to further assess and avoid problems. He can scan the whole hospital to flag 20 cases, and send 10 messages—all in the course of an hour. If any one of those 20 cases became a consult, it would probably be an hour each—so that’s the efficiency multiplier.
Overall it was an excellent and thought-provoking lecture. It fits thematically with the prior 2 blogs in the sense of looking at the effects of “mandating” quality improvement projects or “mandating” MDT discussion of all cancer cases—what are the unintended consequences and where is the next paradigm shift.

As I sign off, I think everyone of a certain age’s favorite example of unintended consequences was the story of the radiology film room attending who commonly sat in a dark office in the basement of the hospital. You would go down there with your team of residents, students, and attending and looks through the films and discuss face to face who has pneumonia and who was fluid overloaded, etc. Once we went digital, that whole interaction disappeared for better or worse. As a funny recollection, the other key staff down there when I was a resident were the guys organizing the film library—once a day you had to give them a list of cases to pull from the stacks. They were your friends and could make you look good at conference time. As I recall, once we went digital that job when away quickly. Seems like many of them found employment at our local airport as TSA security agents. I guess the experience with x-rays was a good prerequisite.

John W. Davis, MD, FACS
Associate Editor, BJUI

Image 2: Key Slide. The latter point of digitization of health care is the next point of emphasis, following pressure to deliver high value care.

BAUS 2018 Highlights Day Two

June 27, 2018/2 Comments/by John Davis

BAUS Day 2. The Multidisciplinary Team Debate. Which way are you headed?

BAUS is certainly a UK-centric meeting. But we all share most of the same challenges in healthcare, and as an international urologist in attendance, the learning experience is often gaining insight into how different health systems tackle common problems with solutions and evolutions.

During day 2 prime time, the agenda tackled the current and future situation with MDTs in cancer treatment—multidisciplinary team meetings. For the USA, we might use the term Tumor Board. At MD Anderson we just say, “Urological Multidisciplinary Case Conference.” So yes, MDT is much more efficient.

The goals are straightforward in principle: 1) increase the quality and standardization of care, 2) improve access to expert imaging/pathology, 3) provide a “group” decision which may be more experienced than any 1 person. In the United States, each center is left on its own how to organize and conduct MDTs, although there may be requirements for inclusion as an NIH designated comprehensive cancer center. In the UK, it appears that MDTs are more of a compulsory element. Another key decision is what patients will be presented—all or selected. In the UK, it appears the goal has been to present everyone.

The first speaker was Hashim Ahmed who showed how the “present everything” model has increasingly become impossible, as half of all cases are presented/discussed in < 2 minutes and few go beyond 3 minutes. A national strategy is being discussed and likely piloted in prostate cancer whereby “routine” cases might be listed as a statistic but not discussed; and time reserved for more complicated cases where discussion might be more fruitful. This model will require the MDT chair to spend more pre-meeting time triaging the meeting agenda.

Jo Cresswell expanded the topic by compiling the UK real world experience with MDTs in terms of what has worked well and where it has been lacking.

The “good” might include:

Building working relationships with colleagues
Mentorship interactions
Challenging old practices—evolving from eminence based to evidence based decisions
Calling out bad practice/minimize rouge decision making
Comforting patients that their case has been heard by a group—sort of a free 2^nd opinion

The “bad” or “Pet Hates” list is interesting:

The cost of running the MDTs—actual and effort
Reduced ownership of the patient—notes where the plan just reads “refer to MDT”
Waiting on the MDT
MDT Tennis—i.e. referring back and forth between different MDTs
Fatigue—going through 120 cases in a session—is anyone awake at the end? Some providers have to attend multiple MDTs per week
Loud voices can overrule others (queue the photo of Trump)
Agenda effect—if you always present in the same order then whoever goes last on the agenda probably gets less quality discussion.

What is the best middle ground? Again,the concept of discussion reserved for complex cases, and routine cases are under the MDT but not given time.

The final speaker was Bill Dunsmuir. He started by challenging the assumption that the MDT make up of 10-20 experts in oncology will produce wiser decisions than any single provider. Case and point was the 1996 climbing expedition to Mount Everest where the group decision making of expert climbers led to the deaths of the many. Maybe group thinking is not so wise? Problems might include group thought with the same ideas, hierarchy that minimizes dissent, and false debates.

From the Emperor of All Maladies book, he channeled the similar questions, “What is Cancer, why does cancer kill?” One trainee responded in a survey “A cancer killed because they were unfortunate enough to have their cases discussed at an MDT.” So why do we have MDTs?

His proposal was to consider MDTs as not only dedicated to group decisions, which may or may not always be right. Rather consider them as multidisciplinary professional education. As an example, if the group encounters a specific problem, there would be a pool of short video clips to review the evidence and guidelines—and then discussion could flow off of these standardized points. Ambitious for sure and would need funding and buy in.

In conclusion, this was a well-done session, and highlights the natural history, so to speak, of compulsory MDTs including all patients. At MD Anderson, we went the other way: select presentations. Each case takes 10-20 minutes, so we usually only get through 3-5 in an hour session. Attendance is optional and there tends to emerge faculty personalities who like MDT interaction, and some who never go. Cases are nominated by a fellow or faculty and you would probably be criticized for presenting a patient where we already have a treatment protocol in placed, i.e. “put them on the protocol, next case.” As a fellow in 2001-2002 I observed there are 3 popular categories of MDT case presentation that are always worthwhile:

I dare you to operate on this patient (co-morbidity, prior surgery, obesity etc.)
How to manage multiple cancers
Look what they screwed up on the outside. Now what?

Please use our comment section—where do you stand on MDTs at your center and what is in the future?

John W. Davis, MD, FACS

Associated Editor, BJUI

Figures: Slide highlights on current and future of MDTs

The 5th BJUI Social Media Awards

May 17, 2017/1 Comment/by Declan Murphy

It’s hard to believe that we have been doing the BJUI Social Media Awards for five years now! I recall vividly our inaugural BJUI Social Media Awards in 2013, as the burgeoning social media community in urology gathered in the back of an Irish Bar in San Diego to celebrate all things social. At that time, many of us had only got to know each other through Twitter, and it was certainly fun going around the room putting faces with twitter handles for the first time. That spirit continues today as the “uro-twitterati” continues to grow, and the BJUI Awards, (or the “Cult” Awards as our Editor-in-Chief likes to call them), remains a fun annual focus for the social-active urology community to meet up in person.

As you may know, we alternate the Awards between the annual congresses of the American Urological Association (AUA) and of the European Association of Urology (EAU). Last year, we descended on Munich, Germany to join the 13,000 or so other delegates attending the EAU Annual Meeting and to enjoy all the wonderful Bavarian hospitality on offer. This year, we set sail for the #AUA17 Annual Congress in Boston, MA, along with over 16,000 delegates from 100 different countries. What a great few days in beautiful Boston and a most welcome return for the AUA to this historic city. Hopefully it will have a regular spot on the calendar, especially with the welcome dumping of Anaheim and Orlando as venues for the Annual Meeting.

Awards

On therefore to the Awards. These took place on Saturday 13^th May 2017 in the City Bar of the Westin Waterfront Boston. Over 80 of the most prominent uro-twitterati from all over the world turned up to enjoy the hospitality of the BJUI and to hear who would be recognised in the 2017 BJUI Social Media Awards. We actually had to shut the doors when we reached capacity so apologies to those who couldn’t get in! Individuals and organisations were recognised across 12 categories including the top gong, The BJUI Social Media Award 2017, awarded to an individual, organization, innovation or initiative who has made an outstanding contribution to social media in urology in the preceding year. The 2013 Award was won by the outstanding Urology Match portal, followed in 2014 by Dr Stacy Loeb for her outstanding individual contributions, and in 2015 by the #UroJC twitter-based journal club. Last year’s award went to the #ilooklikeaurologist social media campaign which we continue to promote.

This year our Awards Committee consisted of members of the BJUI Editorial Board – Declan Murphy, Prokar Dasgupta, Matt Bultitude, Stacy Loeb, John Davis, as well as BJUI Managing Editor Scott Millar whose team in London (Max and Clare) drive the content across our social platforms. The Committee reviewed a huge range of materials and activity before reaching their final conclusions.

The full list of winners is as follows:

Most Read Blog@BJUI – “The optimal treatment of patients with localized prostate cancer: the debate rages on”. Dr Chris Wallis, Toronto, Canada

Most Commented Blog@BJUI – “It’s not about the machine, stupid”. Dr Declan Murphy, Melbourne, Australia

Most Social Paper – “Novel use of Twitter to disseminate and evaluate adherence to clinical guidelines by the European Association of Urology”. Accepted by Stacy Loeb on behalf of herself and her colleagues.

Best BJUI Tube Video – “Combined mpMRI Fusion and Systematic Biopsies Predict the Final Tumour Grading after Radical Prostatectomy”. Dr Angela Borkowetz, Dresden, Germany

Best Urology Conference for Social Media – #USANZ17 – The Annual Scientific Meeting of the Urological Association of Australia & New Zealand (USANZ) 2017. Accepted by Dr Peter Heathcote, Brisbane, Australia. President of USANZ.

Best Urology App – The EAU Guidelines App. Accepted by Dr Maria Ribal, Barcelona, Spain, on behalf of the EAU.

Innovation Award – BJUI Urology Ontology Hashtags keywords. Accepted by Dr Matthew Bultitude, London, UK, on behalf of the BJUI.

#UroJC Award – Dr Brian Stork, Michigan, USA. Accepted by Dr Henry Woo of Brian’s behalf.

Most Social Trainee – Dr Chris Wallis, Toronto, Canada

Best Urology Journal for Social Media –Journal of Urology/Urology Practice. Accepted by Dr Angie Smith, Chapel Hill, USA, on behalf of the AUA Publications Committee.

Best Urology Organisation – Canadian Urological Association. Accepted by Dr Mike Leveridge, Vice-President of Communications for CUA.

The BJUI Social Media Award 2017 – The Urology Green List, accepted by Dr Henry Woo, Sydney, Australia.

All the Award winners (except Dr Brian Stork who had to get home to work), were present to collect their awards themselves. A wonderful spread of socially-active urology folk from all over the world, pictured here with BJUI Editor-in-Chief, Prokar Dasgupta.

A special thanks to our outstanding BJUI team at BJUI in London, Scott Millar, Max Cobb and Clare Dunne, who manage our social media and website activity as well as the day-to-day running of our busy journal.

See you all in Copenhagen for #EUA18 where we will present the 6th BJUI Social Media Awards ceremony!

Declan Murphy

Peter MacCallum Cancer Centre, Melbourne, Australia

Associate Editor, BJUI

@declangmurphy

The USPSTF Changes Course: a “C” rating for PSA screening in ages 55-69. I did not see this coming.

April 11, 2017/5 Comments/by John Davis

It should surprise no one that I never agreed with the 2012 United States Preventive Services Task Force to give PSA a “D” rating that has led to decreases in U.S. rates of PSA testing, biopsies, and diagnosis of low- through high-risk cancer. I take care of men with prostate cancer in a multidisciplinary clinic at a dedicated cancer hospital. I perform robotic surgeries and manage over a 1,000 men on active surveillance. If you search the BJUI blogs, you can find the often viewed (>80K) “Melbourne Consensus Statement on Prostate Cancer Testing” that included 15 authors who produced 5 consensus statements on the topic. There are 62 comments—comment #5 is a fairly famous one that equates the panel to “a group of 10 pig-farmers telling us we should eat more bacon.” So yes, I think I count as a pig farmer here. My maternal grandfather and great uncle farmed pigs in Western Tennessee, so it does run in the family.

Figure 1: It was either this or robotics

That said, it always seemed odd, that as a large country and major healthcare market, we rolled out PSA screening in the 1990s with wild enthusiasm and without data on benefit, only to then try and roll it back in when faced with two conflicting level 1 evidence studies. Meanwhile, the American Urological Association guidelines recommended PSA screening (with the “shared decision making caveat”)—mostly mirroring the European study—for men ages 55-69 (also consensus statement 1 from the Melbourne consensus). However, a recent fact struck me during a conference talk—Urologists in the U.S. are estimated to order <10% of all PSA tests, and a vast majority are from primary care physicians. So in essence it doesn’t matter as much what we think of one guideline versus another, it’s what the primary care specialties think that matters. As the USPSTF is targeted at primary care, their D rating did have an effect—fewer PSA tests, biopsies, and diagnosis of all grades of cancer (not just Gleason 6). We have heard stories over the years that specialty exams in primary care were starting to feature PSA screening questions, and the “don’t screen” answer was the one you got credit for. But I was also never convinced that most primary care physicians were comfortable with abandoning screening either. They must have seen what we saw—real cancers presenting later stage.

Some memorable quotes along these years of debate:

“There is no evidence prostate carcinogenesis has declined.” Joel Nelson, J Urol 2015

“I believe the USPSTF recommendations have created confusion at the patient and primary physician level, and that this confusion did not likely result in more informed, shared decision making, but instead avoidance of the issue.” Samir Taneja, J Urol.

Amen. So now it’s 2017 and the USPSTF has looked at the data again. They’ve had their “analysis” methods on the web for a while so we know something was planned. I can’t find authorship credits anywhere—we always complained that no prostate cancer experts were involved in the past, and now wondering who is driving this ship. The take home messages are:

Offer PSA screening to ages 55-69 with shared decision making. The narrative is not “do screening.” It’s a full paragraph with the often told caveats of individualized decisions, potential harms and benefits. It’s limited to the reduction in mortality way of thinking, i.e. no thought to preventing metastatic progression, palliative care, etc.
Don’t screen in men ages 70 and older. From an evidence standpoint—hard to argue and the AUA guidelines are similar. The Melbourne Consensus is at least polite enough to point out that not all men over age 70 are going to drop dead any minute, and maybe some of them should be screened if very healthy (level of evidence = CS for common sense).
We recognized that men with a family history of prostate cancer or African American race are higher risk, but we don’t have evidence to support a different screening policy. Again—hard to argue with the evidence and the AUA says the same.

So really that’s it—3 main concepts. This is likely to be a significant impact in the U.S., depending upon whether or not primary care physicians change practice (and their exam questions are the same with a different correct answer).

Probably what is on your mind now is “why the change.” It does not appear to be one thing—not even recent publications revealing a more significant pattern of PSA contamination in the PLCO trial. The checklist seems to include: 1) PCLO “issues”, 2) more data from ERSPC and its subsets, 3) more data on treatment benefit, and 4) increased use of active surveillance in low-risk disease. So the balance tipped in favor of a “C” although they state the benefits and harms are still close. Fair enough.

As I re-read the 2013 Melbourne Consensus and compare to the 2017 USPSTF statement, there is a lot of overlap now. So congrats to the Melbourne group for getting it right in the first place. I, myself, did not see this coming—just another example of why I don’t invest in individual stocks or otherwise pretend to know the future.

I apologize as I re-read this, as I realize we Americans think the world revolves around us. Many of you certainly live in countries that are against routine screening and manage to get by. By all means, please sound off on what you think this means for the international picture of men’s health.

Figure 2: Scenic Melbourne at dusk

John W. Davis is BJUI Associate Editor for oncology. @jdhdavis

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April Editorial: The BJUI’s clinical trials initiative

April 3, 2017/by John Davis

The BJUI supports clinical trials. Plain, simple, and with some new strategies.

Randomised clinical trials (RCTs) are the highest level of evidence-based medicine. We know this to be true, but we also know that RCTs are a challenge to fund, accrue patients, execute, and follow to endpoints. From a statistician’s point of view, RCTs provide unbiased estimates of the effects of different treatments. From a clinician’s point of view, RCTs provide the grandest of experiments in nature – a true test of option A vs option B. We are thrilled when one option beats the other. We can be satisfied if the options are equivalent, at least knowing the matter is settled and move on to the next question. Either way, the story lines can be rich with ongoing debate, drama, and analysis: were the cohorts truly equivalent? Was the study population generalisable? Were the treatments contemporary? Were there unintended harms/toxicities?

Allow us to illustrate some examples of what we propose to our readers. In 2003, Thompson et al. [1] published the famous Prostate Cancer Prevention Trial in the New England Journal of Medicine: ‘The influence of finasteride on the development of prostate cancer’. This landmark study has been cited 2541 times, according to Google Scholar. Looking further at impact, one can go to the www.swog.org site and query the protocol ‘SWOG-9217’ and see that over 150 publications have been produced using this dataset (16 in 2016!). Several publications pre-dated the primary endpoint paper and discussed trial design, the dilemma of chemoprevention, and updates to trial progress. Post primary endpoint, publications have looked at multiple strategies – costs, the high-grade findings, longer-term follow-up, biopsy findings from the placebo arm, etc. Just last year, the UK made its mark on the prostate cancer world with the landmark Prostate Testing for Cancer and Treatment (ProtecT) study [2]. Again, we see the primary endpoint paper in the New England Journal of Medicine, but secondary endpoint papers, such as the quality-of-life outcomes are in the BJUI [3], and a mortality outcome analysis for trial screen failures in European Urology [4].

The BJUI can support clinical trial efforts through multiple pathways. Certainly, we would love to receive a primary endpoint paper from an important RCT in urology. We can also have impact by featuring important secondary endpoint papers, trial design papers (preferably ones that read like a good review article, with the trial proposed as the ‘answer’ to the dilemma), as well as smaller/early phase I–II trials that are stand-alone pieces of key knowledge. Figure 1 shows a possible flow chart of a RCT with each box representing possible publication points. In addition to content in the BJUI, our webpage Blogs section has a ‘rapid response team’ to start immediate dialogue on important RCTs published in other journals. For example with the recent Yaxley et al. [5] trial in the Lancet, our blogs section, led by Declan Murphy, had over 10 000 views and over 50 follow-up comments. So clearly, our readers care about RCTs.

Figure 1. A possible flow chart of a randomised clinical trial (RCT) with each box representing possible publication points. QOL, quality of life; f/u, follow-up.

Finally, the BJUI can help with RCTs in two more ways. For the reader, we will highlight RCT-related papers in their native sections (i.e. oncology, functional, education) with a special ‘Trials’ headline, and will invite experts to comment on the significance of the study. For reviewers and authors, we will be critical on RCT design, such that flaws are identified, and papers not given inflated significance. It is frustrating to receive papers that lack adequate reporting on what researchers did, RCT-related papers submitted to the BJUI frequently fail to adhere to the 2010 Consolidated Standards of Reporting Trials (CONSORT) guidance for reporting RCTs, which potentially leads to major revisions, if not outright rejection. The CONSORT requirements are on our author submission guidelines, but ideally these are read and adhered to in advance, as many are not possible to correct after the fact. Recently, we have also added that all RCTs must be registered (i.e. clinicaltrials.gov or similar) before the first patient is enrolled.

John W. Davis, Associate Editor, Urological Oncology* and

Graeme MacLennan, Consulting Editor, Statistics and Trials†

*MD Anderson Cancer Center, Houston, TX, USA and †University of Aberdeen, Aberdeen, UK

References

1 Thompson IM, Goodman PJ, Tangen CM et al. The inﬂuence of ﬁnasteride on the development of prostate cancer. N Engl J Med 2003; 349: 215–24

2 Donovan JL, Hamdy FC, Lane A et al. Patient-reported outcomes after monitoring, surgery, or radiotherapy for prostate cancer. N Engl J Med 2016; 375: 1425–37

3 Lane A, Metcalfe C, Young GJ et al. Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life. BJU Int 2016; 118: 869–79

4 Johnston TJ, Shaw GL, Lamb AD et al. Mortality among men with advanced prostate cancer excluded from the ProtecT trial. Eur Urol 2017; 71: 381–8

5 Yaxley JW, Coughlin GD, Chambers SK et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet 2016; 388: 1057–66

How to Cite this article

Davis, J. W. and MacLennan, G. (2017), The BJUI‘s clinical trials initiative. BJU International, 119: 503. doi: 10.1111/bju.13837

Immunotherapy in urological malignancies: can you take your knowledge to the next level?

October 12, 2016/by John Davis

In this month’s issue of the BJUI, we highlight the evolving era of immunotherapy in solid tumour therapy. As urological surgeons, we spend a large portion of our time working with anatomy, instruments, and robots – things we can see, touch, and control. Immunotherapy is a different conversation – cartoon pathways, process blockades, molecular expression levels, combination therapies, and treatment resistance. Curing a patient with a successful operation is a major draw to our field, but we know our limitations when faced with lethal variant prostate cancer, and high-grade/high-stage bladder and kidney cancers in particular. Systemic therapies have been around for decades and are part of our guidelines – so why all the excitement over immunotherapy?

Our highlighted articles are a review from Mataraza and Gotwals [1] and a comment from Elhage et al. [2]. I urge you to start with the review article [1] and give it a full line-by-line read. You may need to pull out pen and paper, and practice spelling and pronouncing a number of new compounds. They may sound as awkward as abiraterone did the first time you heard of it years ago but will eventually become familiar and attached to yet another catchy trade name from pharma. Here is a quick list/homework assignment: ipilimumab, nivolumab, pembrolizumab, pidilizumab, atezolizumab. Another 20 or more are in development. Challenge yourself to write out their pathways, and you may re-learn a thing or two about familiar agents like sipuleucel-T, interferon α, and interleukin 2.

A major theme in both articles is the experience with immunotherapy in advanced melanoma. The enticing message is that a cohort of patients with metastatic melanoma treated with ipilimumab survived 3 years and the Kaplan–Meier curves plateau out to 10 years. This observation sparks different possible futures such as immune ‘memory’, durable response, and ultimately the word we like to use in surgery – cure.

The picture in urological cancers is not entirely as rosy as the melanoma Kaplan–Meier curve. Multiple trials are highlighted by our review with familiar themes of single agent trials, combination immunotherapies, and combined immunotherapy plus anti-angiogenesis agents. Many trials enrol heavily pre-treated populations with limited remaining options. Many endpoints still observe responses followed by resistance patterns. An important theme to follow is the coupling of biomarkers that link expression to treatment response (i.e. predictive vs prognostic), and the USA Food and Drug Administration (FDA) has approved such a biomarker for nivolumab response. However, even this story line is perplexing, as drug response is not always linked to the marker, and immune cell expression may be ‘inducible and dynamic’ [1].

Last step – re-read the review and comment articles and see if you can write down some key agenda items for future immunotherapy. How are checkpoint inhibitors different from vaccines? How do we generate a durable immune response? What is the ‘abscopal effect’? What are three major areas of research and development in immunotherapy?

If you can spend the time on these articles and ponder these challenging questions, you will move up to the next level of understanding and enjoy a greater appreciation of the next abstract you hear at a major meeting. In closing, I am reminded of the oft-repeated words from the hit television show Game of Thrones (based on the novels of George R.R. Martin) from the House Stark: ‘Winter is Coming’. In urological oncology, ‘Immunotherapy is Coming’, so be prepared!

John W. Davis

BJUI Associate Editor Urological Oncology

References

1 Mataraza JM, Gotwals P. Recent advances in immuno-oncology and its application to urological cancers. BJU Int 2016; 118: 506– 14

2 Elhage O, Galustian C , Dasgupta P. Immune checkpoint blockade – a treatment for urological cancers? BJU Int 2016; 118: 498–505

Video: Step-By-Step: Extended PLND – Creating the Spaces

January 13, 2016/by John Davis

Sequencing robot-assisted extended pelvic lymph node dissection prior to radical prostatectomy: a step-by-step guide to exposure and efficiency

Stephen B. Williams, Yasar Bozkurt , Mary Achim, Grace Achim and John W. Davis

Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA

Read the full article

OBJECTIVE

To describe a novel, step-by-step approach to robot-assisted extended pelvic lymph node dissection (ePLND) at the time of robot-assisted radical prostatectomy (RARP) for intermediate–high risk prostate cancer.

PATIENTS AND METHODS

The sequence of ePLND is at the beginning of the operation to take advantage of greater visibility of the deeper hypogastric planes. The urachus is left intact for an exposure/retraction point. The anatomy is described in terms of lymph nodes (LNs) that are easily retrieved vs those that require additional manipulation of the anatomy, and a determined surgeon. A representative cohort of 167 RARPs was queried for representative metrics that distinguish the ePLND: 146 primary cases and 21 with neoadjuvant systemic therapy.

RESULTS

The median (interquartile range, IQR) LN yield was 22 (16–28) for primary surgeries and 21 (16–23) for neoadjuvant cases. The percentage of cases with positive LNs (pN1) was 16.4% for primary and 29% for neoadjuvant. The hypogastric LNs were involved in 75% of pN1 primary cases and uniquely positive in 33%. Each side of ePLND took the attending surgeon a median (IQR) of 16 (13–20) min and trainees 25 (24–38) min.

CONCLUSIONS

Robot-assisted ePLND before RARP provides an anatomical approach to surgical extirpation mimicking the open approach. We think this sequence offers efficiency and efficacy advantages in high-risk and select intermediate-risk patients with prostate cancer undergoing RARP.

Clever surgeons and challenging study endpoints

August 18, 2015/by John Davis

Intraoperative in vivo tracking of a periprostatic nerve with multiphoton microscopy in rat model.

In the last 6 months, the BJUI editorial team has evaluated an average of 59 urological oncology papers per month with an average acceptance rate of 16%. We receive additional papers for our ‘Translational Science’ section. Studies with high-quality methods are given the highest priority. Other papers compete well if they are highly applicable to clinical practice (i.e. comparative, multicentre, multi-surgeon design) and/or show us new ideas in surgical technique, re-designed study endpoints, or explore new sources of data. For translational science, the best candidates are studies that look at new diagnostic tests in humans and beyond simple immunostaining techniques. We want to evaluate biomarkers likely to be validated and translated into a clinical test. Clinical impact will be even higher if a biomarker is linked to a therapy outcome rather than just a risk estimate. We want our papers to guide us to better outcomes for our patients, hopefully control healthcare costs, and, yes, be well-cited in the literature.

Our review process is tough but fair, and we congratulate and highlight three authorship groups for acceptance into this month’s issue of BJUI. The theme of ‘clever surgeons and challenging study endpoints’ is well illustrated by all three groups. Zargar et al. [1] report on an exclusive database of high-volume minimally invasive surgeons who have tackled the partial nephrectomy option for small renal masses. The comparison is simple in concept and retrospective in design, but what they have done is to significantly increase the outcome measures into a ‘trifecta’ concept in perioperative outcomes (previously reported) with an even more stringent ‘optimal outcome’ endpoint that includes renal function preservation. With a database of 1185 robotic and 646 laparoscopic cases, the robotic procedures showed superior trifecta results (70% vs 33%), complication rates (14.8% vs 20.9%), positive surgical margin rates (3.2% vs 9.7%), and warm ischaemia time (18 vs 26 min). The optimal outcome endpoint included a minimum 90% estimated GFR (eGFR) preservation and no chronic kidney disease upstaging. Only the robotic cohort had sufficient data available and the rate was 38.5%. The latter figure is an interesting challenge, as defining such a high threshold for success challenges surgical technique and allows more room to identify incremental advancement. This may be the largest study of its kind, but non-randomised and with limitations discussed in peer review such as the learning curve influence, use of eGFR as an endpoint with two kidneys, and incomplete data. The definitions used are of interest and the field could use some uniformity moving forward in measuring perioperative and long-term benchmarks of quality.

Durand et al. [2] give us a glimpse into the future of surgery, a science fiction world of prostate surgery where nerves and prostatic glands can be colour coded and seen at a microscopic level in real time. The pictures stand for themselves, especially Fig. 1. If such imaging can be integrated into technique decisions, and perhaps future instrument designs, then perhaps we will have a whole new wave of studies possible on linking surgical technique to improved functional and oncological outcomes after radical prostatectomy. The paper has a nice depth in detail, methods, results, as well as narratives in solving technical problems with novel technology.

This issue’s ‘Article of the Month’ by Gavin et al. [3] is a different look at the question of morbidity after localised prostate cancer treatments, specific to long-term care at >2 years from treatment. The database is from a cancer registry and they have an impressive 54% response rate from a population that is 2–18 years from diagnosis. Rather than Likert-like scales of symptom severity, they simply look at ‘current’ vs ‘ever had’ symptoms and look at the total burden including multiple/overlapping symptoms. Although this may not be as robust and validated as the Expanded Prostate Cancer Index Composite (EPIC) instrument, the simple phrasing of ‘current’ vs ‘ever had’ is probably capturing a very high proportion of symptoms rather than dismissing them if minor or in the past. Again, we see more erectile dysfunction after radical prostatectomy and radiation with hormonal therapy, and more bowel symptoms after radiation therapy. Hormone therapy patients have hot flashes and fatigue, and watchful-waiting patients have some advantages but are certainly not free of symptoms. The burden of symptoms is interesting, nine of 10 reported at least one of seven key symptoms at some point and three of four are current. Therefore, as the authors indicate, ≈75% of prostate cancer survivors will have ongoing symptoms needing follow-up care. This is a significant database resource adding to our understanding of long-term outcomes of patients with prostate cancer and supporting the significance of the Durand et al. [2] study that may show the way forward towards reducing such burdens of disease treatment.

References

1 Zargar H, Al laf ME, Bhayani S et al. Trifecta and optimal perioperative outcomes of robotic and laparoscopic partial nephrectomy in surgical treatment of small renal masses: a multi-institutional study. BJU Int 2015; 407–14

2 Durand M, Jain M, Aggarwal A et al. Real-time in vivo periprostatic nerve tracking using multiphoton microscopy in a rat survival surgery model: a promising pre-clinical study for enhanced nerve-sparing surgery. BJU Int 2015; 478–86

3 Gavin AT, Drummond FJ, Donnelly C, O’Leary E, Sharp L, Kinnear HR. Patient-reported ‘ever had’ and ‘current’ long-term physical symptoms after prostate cancer treatments. BJU Int 2015; 397–406

John W. Davis, MD
Associate Editor, BJUI

5 Questions with Per-Anders Abrahamsson and Gopal Badlani

June 23, 2014/by John Davis

Secretary Generals to the big Spring Meetings, European Association of Urology and the American Urological Association

Every Spring, thousands of urologists gather in big cities with mega-venues to attend one or both of the annual congresses of the EAU and the AUA. These are big events with respect to release of the latest scientific trials, instructional courses, plenary sessions, and of course multiple ways to see and interact with advances in industry partners. But who orchestrates these massive events occurring over multiple days? Of course it requires a full team of expert staff members, and in both groups, they employ an outstanding Urologist to a multi-year contract to serve as secretary and be a principle organizer of the annual meeting. We asked each secretary general to share their perspectives with 5 questions.

Gopal Badlani–Secretary to the AUA 2011-2015. The New Orleans AUA will be Prof. Badlani’s last as AUA and will certainly be an exciting meeting and fitting celebration to an excellent term of service and creative updates to the annual meeting.

1) What excites you about your meeting format and location?

PAA: Stockholm of course is a major draw, but we don’t know if it will be Spring or Winter at the time. Forty percent of our draw is from beyond Europe—Latin America, China, and India. We know that Stockholm is an exotic city worth the trip, but hopefully they find the meeting and the quality of education worth the trip. Stockholm is recognized as one of the best venues, and our office staff knows venues across Europe. The problem here is that the Swedish economy is booming and its one of the most expensive cities in the world. We were able to downsize the hotel prices, but its very expensive. In addition, Pharma support for attendees has dropped from 80% to 60%. The weather has been rather decent.

GB: We changed our format this year to incorporate Friday as the first official day of the AUA Annual Meeting, showcasing a full day of research programs and a highly successful Crossfires: Controversies in Urology program. It certainly generated “buzz” and continued discussions surrounding such controversies throughout the meeting.

2) What about high impact studies being presented?

PAA: One coming up is the PREVAIL study with Enzalutamide “Pre-chemo”. We also have our own Swedish national cancer registry and there are some data coming out favoring early treatment of prostate cancer. This is one of the oldest in the world. Peter Wiklund will present this. Another that will be updated Tuesday is the European randomized screening trial. The principal investigator after Fritz Schroeder is Jonas Hugosson from Gothenberg. He got permission from Lancet to update the Swedish arm of that trial. You will find differences between centers and there will be an update with longer follow-up.

GB: Our plenary sessions highlighted late-breaking news, new AUA clinical guidelines and the latest advances in urologic medicine. It was in this forum, we heard from Dr. Anthony Fauci on ending the HIV/AIDS pandemic and its lifecycle from scientific advances to public health implementation.

It was also where attendees heard from Dr. Ajay Nangia about the adverse effects of common medications on male fertility to outstanding sessions on benign disease, the challenges in managing spinal cord injury patients with neurogenic bladder as well as mesh use for urinary incontinence (Drs. Flynn and Rovner).

Our International Prostate Forum more than tripled anticipated attendance. Dr. Andrew Schally, a recipient of the Nobel Prize in Medicine, as well as a number of experts from around the world, provided global perspectives on prostate cancer.

Eight debates on today’s hottest topics in urology were showcased through our standing-room only Crossfire-Controversies in Urology event. Our Town Hall transported attendees into the future of simulated surgical training and imaging. This session included presentations from experts and pioneers in 3D and molecular imaging as well as surgical simulation.

3) What are key metrics of the meeting?

PAA: We have 120 countries represented. Registration is about 700 off from Milan last year, but are pleased overall given the expense noted, and sponsorship from Pharma continues to decrease.

GB: Our meeting continues to attract over 15,000 attendees from over 120 countries. More than 2,200 abstracts were presented and more than 2,500 speakers.

4) What are key trends important to Urologists attending your meeting? Why do they attend?

PAA: There is a need for meetings like this for people to meet and to start up multi-institutional trials, even trans-Atlantic. We hope to facilitate translational research. For example, we facilitated the first ever World Chinese meeting—Taiwan, Hong Kong, and Mainland—all together, and very difficult to organize from a political viewpoint. We were very pleased with this and left politics aside.

GB: There are a number of major concerns affecting American urologists, including issues affecting fair and appropriate payment (e.g., the sustainable growth rate, or SGR, the formula which is used to set Medicare payments for U.S. physicians), certain provisions under the Affordable Care Act (such as the 90-day grace period for recipients of advanced payments in the large group health insurance market places) and the impact that unfunded mandates such as prior authorizations, required accreditations, etc., have on our practices. All of these issues are compounded by the fact that our U.S. physician workforce is shrinking and, unless significant steps are taken to fundamentally reform graduate medical education, the country will have an insufficient supply of physicians to adequately meet patients’ needs in a timely manner. This shortage is of specific note to urology, since we have the second-oldest surgical subspecialty workforce, and limits on funding for urology residency programs make it extremely difficult to get more medical students into urology residencies.

5) What are your impressions of the venue and city?

PAA: Honestly I was not involved in that decision-making. We have 70 people working full time in our office in Holland. We had our own congress consultants working, looking at new venues. We have mainly concentrated our annual congress to limited venues—Madrid, Barcelona, Paris, Vienna, Milan, London in the future, and in Germany Munich and Berlin. Scandinavia so far its only been Stockholm as we can take care of 15,000 people here and we have a good congress venue. In the future it will be Copenhagen as they have a new congress venue that is closer to Europe. So we are going to rotate between these venues. We have not been able to find a venue in Eastern Europe that accommodates that many people.

GB: We enjoyed being in sunny, warm Orlando in May. Orlando has a good mix of hotels to offer to our attendees – from an impressive full service Ritz Carlton to a few lower cost options such as the Days Inn and Marriott Courtyard. Overall, I think the Orlando Convention Center worked well for us. Looking forward, the excitement is in the air surrounding next year’s location, New Orleans May 15-20, 2015. Program planning begins this summer!

So there you have it. While most of us run around these meetings trying to figure out which session suits our interest, or where we have to moderate/speak next, the secretaries have a very different perspective. They worry about meeting formats, costs, weather, who will show up, what will they think. I was also impressed that while most of us tend to network on the fly by just walking around the venue and bumping into colleagues, the secretaries have very tight schedules run by their staff. I appreciate the time both gave to us. Note that the answers may flow differently as Per-Anders did a sit down interview with an iPhone recorder running, while Gopal gave me typed answers after the meeting.

Thank you to both secretaries on strong annual congresses.

John W. Davis, MD, FACS
Associate Editor, BJUI