Tag Archive for: PIVOT

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The Flaws of the PIVOT Study of Radical Prostatectomy versus Observation; Don’t Give up on PSA Just Yet.

A recent editorial in the BMJ by Christopher Parker (Treating prostate cancer. BMJ 2012; 345: e5122) uses the “best available evidence” from the PIVOT study (Wilt TJ, et al) to argue the case for watchful waiting for low risk prostate cancer and question the need to diagnose the condition at all. Unfortunately the PIVOT trial was marred by a number of serious flaws that should make us doubt its conclusions.

The original design of the PIVOT trial included a randomisation of 2000 patients to surgery or observation (Prostate cancer, uncertainty and a way forward. NEJM 2012; 367: 270-1). Unfortunately, this goal was not achieved; the design was modified to justify a randomization goal of only 740 patients. Median survival was assumed to be 15 years in the original study design and 10 years in the updated version. If the median survival of 12 years in the study’s observation group is taken and 7 years for enrollment and 8 years of follow-up assumed, the sample requires 1200 patients in order to detect a 25% relative reduction in mortality with 90% power and a two-sided alpha level of 0.05. With an actual enrollment of only 731 patients, the study was consequently underpowered to detect this relatively large clinical effect. The wide 95% confidence interval around the hazard ratio for death in the treatment group illustrates this point. A relative increase of 8% to a relative reduction of 29% in the risk of death in the prostatectomy group, as compared with the observation group, cannot be excluded with 95% confidence. Only 15% of the deaths were attributed to prostate cancer or its treatment.

Although a “life expectancy of at least 10 years” was an entry criterion, by 10 years almost half the participants had died, leaving only 176 men in the surgery group and 187 in the observation cohort, and by 15 years only 30% were alive. The investigators therefore did not recruit healthy men who would be the normal candidates for surgery and randomize them to observation; instead they recruited elderly and co-morbid men with very limited life expectancy and randomised them to surgery (with one fatality!). Furthermore, the finding that one fifth of patients did not adhere to the assigned treatment further reduces the ability of the trial to discern a treatment effect.

Prostate cancer is a slowly progressive condition which eventually, and after many years, results in a painful death from metastases in a significant number of patients, unless mortality from other causes supervenes. Radical prostatectomy, now usually performed minimally invasively with robotic assistance (Goldstraw MA, et al), prevents disease progression in >80% of well-selected cases. We appear to manage localised prostate cancer in a much more holistic way than our American colleagues and MDT decision-making and robust active surveillance programmes have enhanced this. Others were also outraged by the Parker editorial and the intrinsically flawed results of the PIVOT study should definitely not encourage us to turn our backs on a disease that kills more than 10,000 men per annum in the UK and hundreds of thousands more worldwide.

 

Roger Kirby, Ben Challacombe and Prokar Dasgupta
The Prostate Centre, London W1G 8GT and Guy’s Hospital, King’s College London, King’s Health Partners

 

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International Urology Journal Club on Twitter

International Urology Journal Club on Twitter: The Beginnings of a New Application of Social Media in Urology CME

The International Urology Journal Club on Twitter almost came about by accident, although the formation of such was an inevitability. Over the course of 2012, a number of research papers have been the subjects of discussion amongst urologists on Twitter.

The standout paper as example for discussion in 2012 was the PIVOT study. This generated comments that were difficult to follow unless you were following all of the many participants. Although one could find the majority of the tweets in chronological order by doing a search under the tab “Discover”, it was still dependent upon whether the term PIVOT was used in the tweet or not – it was quite often the case that a comment was made without the term PIVOT being used and these would be missed by a search for PIVOT. In essence, a form of journal club was already happening although there was no organized manner by which all comments could be filed or arranged to provide context. When limited to 140 characters, a tweet can easily lose context if it cannot be connected to other tweets it may refer to or be in reply to. The use of a hashtag provides a filing system for related tweets and had all participants in the PIVOT study discussion used the hashtag #PIVOT, a search under that term would have enabled easy following and review of the discussion pertaining to that topic. The use of a hashtag does require general agreement by contributors that this will be the agreed filing (this is what I call it even though it is not a universal way of describing it) system for the tweets. It also meant that inclusion of long twitter handle names such as @cooperberg_ucsf would not eat into the precious 140 character limit to which we wish to make comment – as we are a tolerant, respectful and good humoured community, we of course continue to tolerate this blight on our character count. (I have incidentally shortened my Twitter name from @DrHenryWoo to @DrHWoo as a donation of 4 precious characters to those who wish to engage me on Twitter).

So how did the International Urology Journal Club on Twitter come about? It all started with Canadian urologist Michael Leveridge sending a few live tweets from his local journal club and nominally used the hastag #quroljc, which stood for Queens Urology Journal Club. A number of urology colleagues around the world, including myself, were intrigued by this.

Following an exchange of tweets, we came to realization that we were effectively engaging in a Twitter urology journal club. We soon realized that in order to do this effectively, we needed a hashtag to which we could all tweet our journal club responses and the hastag #urojc was born.

According to the exchange of tweets above, we can credit Michael Leveridge for coining the hashtag #urojc. On Twitter, it does not take long for the message to spread.

To administer Journal Club, an administrative account @iurojc and specific blog account was established. You will note that the administrative account is @iurojc and not @urojc since the latter had already been taken by another urologist. The #urojc blog carries information about the journal club as well as the tweet logs from the discussions.

In short, a recently published manuscript is selected for each month’s discussion. Such manuscripts are usually those that have been published online ahead of print in order to offer the most cutting edge research discussion. Discussions occur on the first Sunday or Monday of each month depending on which time zone you are in. Tweet discussion is carried out in an asynchronous manner over the course of 48 hours. Since commencing in November 2012, there has been a truly global engagement and with the amplification effect of Social Media, we have seen in excess of 50,000 impressions (a Twitter metric of reach). A novel approach to this format of journal club is the invitation and participation of the lead author and/or corresponding author associated with the paper for discussion – there is no question that this significantly enhances the value of the discussion.

Prior to the commencement of the first #urojc discussion, it was suggested that there should be a prize for the best tweet. This has now been instituted and a #urojc Hall of Fame is now in the making. With the Best Tweet prize for November 2012 being awarded to Ben Davies, it has only fueled his belief that he is indeed the urological King of Twitter. He is, however, the inaugural prize winner and at the top of the list of the #urojc Twitter Hall of Fame. The winner of the December Best Tweet Prize was another Ben, namely Ben Jackson. We thank Urology Match and Nature Reviews in Urology for donating the prizes for November and December respectively. Whilst there were suggestions of a Ben conspiracy, we cannot promise that the January Best Tweet Prize, which has been donated by the Urological Society of Australia and New Zealand (USANZ) will be awarded to a non-Ben participant.

It is our belief that the #urojc is the first truly international clinical journal club discussion taking place on Twitter in an organized manner. Whilst there are local real time Twitter journal club chats and similar discussions in non-clinical areas of health care, this is again a demonstration of how urologists lead the way with the embracement of technology to advance health care. For now, the discussions are on a monthly basis with a focus on uro-oncology. As interest grows, the plan is to expand to twice monthly with the mid-month discussion being on topics such as endourology or voiding dysfunction or female urology or any other area of interest. Do follow @iurojc and put forward your suggestions for papers to discuss. Again remember that the Twitter user name is slightly different to the hashtag, which is #urojc.

We look forward to having you join us for the next #urojc. 

 

Henry Woo is an Associate Professor of Surgery at the Sydney Adventist Hospital Clinical School of the University of Sydney in Australia. He has been appointed as the inaugural BJUI CME Editor. He is currently the coordinator of the International Urology Journal Club on Twitter. Follow him on Twitter @DrHWoo

 

January #urojc paper will be on PHI by @LoebStacy jurology.com/article/S0022-… ncbi.nlm.nih.gov/pubmed/23206426

 

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Ten stories of 2012, part I

It is now my turn to welcome you to the BJUI blog. We [the editorial team] hope that you will be as excited as we are about the future. For my first blog posts, I decided to recap the year 2012 in ten stories. These are topics that caught my attention in 2012, and are certainly not representative of what others might think as ‘important’. Nonetheless, I hope that you will find this curated collection of some interest, and maybe stir a little controversy or two. Happy 2013!

In no particular order, part 1 of 2:

+ The re-election of Barack Obama

The bottom line is that the Patient Protection and Affordable Care Act, AKA Obamacare, will happen. What does this mean for American Urologists? Read the excellent review article by Kirk Keagan and Dave Penson on this sweeping piece of legislation aimed at addressing health care costs and disparities. From the paper: “Perhaps most germane to urologists, the ACA will restrain revenues generated from ancillary services, such as in-office imaging and via a bolstered Stark law that will prohibit physicians from referring Medicare patients to a hospital in which they have an investment or ownership interest.” Word on the street is that the AUA is not too happy. Is America ready for Cheesecake medicine?

+ Is robot-assisted radical prostatectomy really better?

Against a background of Jim Hu’s landmark JAMA paper, we learned new things with respect to the robot-assisted (RARP) vs. open RP (ORP) polemic. First, objective data shows that RARP has overtaken ORP as the main surgical approach for prostate cancer in the U.S (Link)(Link). Second, perioperative outcomes of RARP are better (Link)(Link)(Link). Third, RARP costs more. Fourth, nobody knows for functional outcomes (Link)(Link)(Link). Either way, some people really seem to hate robotic surgery, with a vengeance.

+ PSA screening – the controversy that refuses to die…

2012 will be forever (well, at least for nerdy urologists) remembered as the year the USPSTF downgraded PSA screening to a ‘D’ recommendation. In case you live in a cave, that means that “the science shows that more men will be harmed by PSA screening than will benefit. The expected harms are greater than the small potential benefit.” Nice rebuttal by Carlsson et al from MSKCC here. Nonetheless, primary care providers don’t seem to care, as up to 43.9% of men above the age of 74 were still getting screened in 2010. Conversely, in an article emphatically subtitled ‘Less is More’, the evidence shows that the incidence of prostate cancer is, for the first time in decades, decreasing. Prostatectomists, better find something else to do (just trolling, no hate mail please).

+ PSA screening – the Twitter Wars

2012 was a breakthrough year for social media in Urology. In the past year, Twitter has gained considerable traction in our field, thanks to the presence of Tweet (and real world) leaders such as Matt Cooperberg, Tony Finelli, Alex Kutikov, Mike Leveridge, Stacy Loeb, our own Declan Murphy, Dave Penson, Maxine Sun and the self-proclaimed King of Twitter himself, Ben Davies. That said, December hosted some lively exchanges on PSA screening. It started with a nicely-written-yet-a-little-oversimplistic blog post and accompanying tweet by @CBayneMD in favour of PSA screening, which led to some epic jostling between @cooperberg_ucsf (pro-screening) and @kennylinafp (against screening, wrote the evidence review for the USPSTF), amongst others. @daviesbj summary here. Oh yeah, be sure to follow me on Twitter as well as the BJUI itself.

+ The PIVOT trial

Timothy Wilt, of USPSTF fame, strikes again. Here’s one man who won’t be getting a Christmas card from an Urologist anytime soon. After representing the USPSTF at the 2012 AUA Town Hall  Meeting (brave), Wilt et al’s PIVOT trial demonstrated that “among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up.” Despite its many limitations and flaws (read Ian Thompson’s excellent accompanying editorial here), the lay press suggested in light of this trial that RP does not save lives.

Quoc-Dien Trinh
@qdtrinh

 

Quoc-Dien Trinh is a minimally-invasive urologist and co-director of the Cancer Prognostics and Health Outcomes Unit. His research focuses on patterns of care, costs and outcomes in prostate cancer treatment.

 

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