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European UrologyVolume 57, issue 6, pages e53-e68, June 2010
Reply from Authors re: Markus Graefen. Low Quality of Evidence for Robot-Assisted Laparoscopic Prostatectomy: A Problem Not Only in the Robotic Literature. Eur Urol 2010;57:938–40 and Vipul P. Patel. Low Quality of Evidence for Robot-Assisted Laparoscopic Prostatectomy: What About the Evidence for Open? Eur Urol 2010;57:941–2
Published online 5 March 2010, pages 943 - 944
Refers to article:
Low Quality of Evidence for Robot-Assisted Laparoscopic Prostatectomy: Results of a Systematic Review of the Published Literature
Accepted 14 January 2010
June 2010 (Vol. 57, Issue 6, pages 930 - 937)
Refers to article:
Low Quality of Evidence for Robot-Assisted Laparoscopic Prostatectomy: A Problem Not Only in the Robotic Literature
June 2010 (Vol. 57, Issue 6, pages 938 - 940)
Refers to article:
Low Quality of Evidence for Robot-Assisted Laparoscopic Prostatectomy: What About the Evidence for Open?
June 2010 (Vol. 57, Issue 6, pages 941 - 942)
We greatly appreciate the opportunity to publish our study , which provides a critical evaluation of the methodological and reporting quality of the robot-assisted laparoscopic prostatectomy (RALP) literature. Even more so, we welcome the healthy debate it has sparked, as demonstrated by the editorial comments of our colleagues Dr. Markus Graefen  from Germany and Dr. Vipul Patel  from the United States.
RALP has dramatically transformed the way we treat clinically localized prostate cancer. At most centers in the United States, and increasingly in Europe, RALP is displacing alternative surgical approaches such as radical retropubic prostatectomy (RRP), pure laparoscopic prostatectomy, and the time-honored perineal approach. As highlighted in our study , this trend was not the rational consequence of high-quality evidence supporting relative superiority with regard to critical oncologic and functional patient-important outcomes. Instead, it was brought about by a variety of factors including the intuitive appeal of a new technology to patients and urologists alike, the prospect of a shortened surgical learning curve necessary to master a complex laparoscopic procedure, and the promise of improved outcomes made by a visionary company by way of an aggressive marketing campaign.
Alas, as our study  and a prior study by Ficarra et al.  have illustrated, the evidence for improved outcomes is limited and does not pertain to those outcomes that we might consider most critical to clinical decision making , such as long-term oncologic outcomes (overall survival, disease-specific survival, and biochemical recurrence-free survival), functional outcomes (urinary and sexual function), and quality of life. Although most studies are fraught with methodological issues, the best evidence for an advantage of RALP over RRP relates to outcomes of lesser importance such estimated blood loss and length of hospital stay. It seems imperative that those benefits in the domain of noncritical outcomes are not achieved by compromising more critical outcomes. The few population-based studies that have compared the outcomes of RALP to alternative approaches at least raise that concern  and .
We wholeheartedly agree with Dr. Graefen  that the skills and experience of the operating surgeon are far more important than the tools he or she uses. The association of a surgeon's level of experience has been convincingly demonstrated in several studies, including the study by Vickers et al. , which Dr. Graefen cites. In the last 5–10 yr, hundreds of urologists have embarked on the surgical learning curve for RALP, thereby raising the additional concern of how the uptake and dissemination of new surgical technology can be organized in such a way that it generates more benefit than harm for our patients.
Dr. Patel raises the issue that the methodological quality of the literature for the open approaches is not better than the published RALP literature that we have critically appraised . We agree: The shortcomings of the urologic literature in terms of methodological and reporting quality have, in fact, been subject to several previous studies by our research team , , and . There is a clear need to raise the methodological standards of urologic research overall. Nevertheless, it strikes us as remarkable that the urologic community has chosen to believe the promises of a costly new technology and abandon the previously accepted gold standard approaches based on such limited evidence.
We agree with both editorial authors that robotic surgery is here to stay; however, the issue that our study  addresses is larger than that of RALP versus open prostatectomy and relates to the evidentiary standards that we, as the urologic community, should require before broadly endorsing a new technology outside the setting of well-designed studies. Although the application of robotic surgery to radical prostatectomy may withstand the test of time, the jury is still out on radical cystectomy and many other urologic procedures. It is not the conclusion of our study that RALP is not better than alternative open surgical approaches but that, based on the available evidence, it is impossible to draw that conclusion with any certainty. There are numerous examples of surgical technologies that were widely used initially but subsequently were shown to do more harm than good and ultimately were abandoned. It is in our patients’ best interest to avoid these dead ends in surgical innovation and to take a more critical approach toward technological advancement. Only high-quality evidence, be it from randomized controlled trials or well-designed observational studies (for which there is a substantial need), can provide us with the necessary guidance to make these judgments. Without this paradigm shift, the current pattern of trial and error in surgical innovation—oftentimes on the backs of the patients that we serve—will continue to repeat itself as new technology becomes available year after year.
Going forward, there is a critical need to raise the evidentiary standards for the development, assessment, and dissemination of new surgical innovations across surgical subspecialties. The interested reader is directed to the visionary work by the Balliol Collaboration, which has developed a model of how to replace the largely unregulated and variable process of surgical innovation with a more structured approach , , and , The IDEAL model proposes five stages of surgical innovation: It begins with the proof of concept (Idea), which moves through stages of development at a few selected centers (Development), is further refined at more centers for broader indications (Exploration), and is evaluated in large and robust studies (Assessment), and ultimately includes the study of long-term outcomes (Long-term study) .
Urology as a specialty has repeatedly been an innovator and leader in medicine. We urge the urologic community to consider the IDEAL model and to take the challenge of more rigorous surgical innovation head on. This evidence-based development invariably will not only benefit our patients but also further enhance the reputation of our specialty.
Conflicts of interest
The authors have nothing to disclose.
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-  M. Graefen. Low quality of evidence for robot-assisted laparoscopic prostatectomy: a problem not only in the robotic literature. Eur Urol. 2010;57:938-940 Abstract, Full-text, PDF, Crossref.
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Department of Urology, University of Florida, College of Medicine, Gainesville, Florida, USA
Corresponding author. Department of Urology, University of Florida, College of Medicine, Health Science Center, Box 100247, Room N2-15, Gainesville, FL 32610-0247, USA. Tel. +352 273 7936; Fax: +352 273 7515.
© 2010 European Association of Urology, Published by Elsevier B.V.
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