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Health See other Health Articles Title: Early Adoption Robotic Prostatectomy Associated With Patient Harm? During the early adoption phase of robotic prostatectomy, there was a 2-fold increase in adverse events with this technique compared with traditional open radical prostatectomy (ORP) for prostate cancer, a new analysis has found. The study, published online July 2 in JAMA Surgery, shows that the rapid introduction of a new surgical technology can result in patient harm, say the authors. "The current system in the United States by which surgical innovations are introduced into community practice is flawed in that there are no standardized procedures to ensure their safe adoption," lead author J. Kellogg Parsons, MD, MHS, a urologic oncologist at the University of California, San Diego School of Medicine, told Medscape Medical News. However, an accompanying commentary questions the conclusions and points out that there was a significant difference between adverse events reported with the 2 surgical techniques only for 1 year, the year prior to the "tipping point." For the other years, the risk of adverse events was similar, suggesting that the new technique of robotic prostatectomy was comparable with open surgery even during its early adoption. Rapid Adoption of New Technique In their study, Dr. Parsons and colleagues focussed on the years between 2003 and 2009, the period during which robotic surgery for prostatectomy was enthusiastically taken up in the United States. There were 617 such procedures in 2003 and 37,753 by 2009. The team identified the "tipping point" (at which time more than 10% of all procedures are carried out with the new technology) as occurring in 2006 at teaching hospitals and in 2008 at nonteaching hospitals. The researchers then analyzed data on Patient Safety Indicators (PSI) from the Agency for Healthcare Research and Quality, which provided information on potential adverse events occurring in the hospital setting. The data for teaching hospitals showed that patients undergoing minimally invasive robotic prostatectomy (MIRP) were more than 2 times likely to experience an adverse event compared with patients undergoing ORP (adjusted odds ratio [OR], 2.7; 95% confidence interval, 1.1 - 3.67) in 2005, the year before the tipping point at teaching hospitals. When data were reviewed for nonteaching hospitals, a similar observation was noted—the adjusted OR for risk of PSI was 2.02 in 2007, again the year prior to the tipping point for these hospitals. These differences were significant; however, the data for other years showed no significant difference in adverse events reported with the 2 different surgical procedures. Dr. Parsons and colleagues say the higher risk of PSI prior to the tipping point suggests a need to develop standardized training and monitoring systems to oversee wider adoption by the surgical community. Importantly, they imply that if there had been a national, independent monitoring system in place, problems encountered during the dissemination phase in teaching hospitals could have been identified and corrected before its use spread to community hospitals. The team also contends that prior estimates of MIRP adoption — provided solely by the da Vinci robot manufacturer and reported widely in the popular press and scientific literature — substantially overestimated the rapidity with which it spread. They report that prevalence rates for MIRP use as published by the da Vinci robot manufacturer were consistently and substantially higher compared with rates computed from the Nationwide Inpatient Sample (NIS) — the largest publicly available database in the United States. Between 2004 and 2008, MIRP rates estimated by the manufacturer were 2 to 5 times higher than the NIS rate. According to the authors, if manufacturer estimates of device use are the primary information source, it may potentially influence initial surgeon and public perception of the device despite lack of "published comparative safety effectiveness research." "This is a thought-provoking study and emphasizes the importance of the safe adoption of a new surgical procedure," Mohamad E. Allaf, MD, associate professor of urology and oncology, and a director of minimally invasive and robotic surgery, at Johns Hopkins, told Medscape Medical News. In the accompanying commentary he coauthored with colleague Alan Partin, MD, they write that "designing a new adoption system that ensures quality of care is a laudable but formidable task. Such a system must remove industry influence on surgeons and hospitals and allow procedures to stand on their own and be objectively tested before widespread use." However, although conceding that in 2005 patients undergoing MIRP were twice as likely to experience an adverse event compared with patients undergoing ORP, Dr. Allaf emphasized that in other years adverse events between the 2 groups were not significantly different. But Dr. Parsons told Medscape Medical News: "That was exactly the point of the paper. The problem manifested only during the rapid integration of the technology into the surgical community. Rapid integration, therefore, is the crucial time point which the healthcare system should target for reform." Speaking with Medscape Medical News, Dr. Allaf said, "In the adoption of any new technology, there is a learning curve. In the dissemination of any technology there should never be a year when it is associated with an increased incidence of adverse events. The fact that issues associated with MIRP in 1 year were fixed so quickly speaks to mechanisms in place that corrected and fixed the problem." The commentary also questioned the clinical significance of the adverse event risk, as only 2% of all patients reported a safety event. However, Dr. Parsons took issue with this. "Ascertainment of 'clinical significance' in this context implies the occurrence of an 'acceptable' or 'tolerable' number of preventable adverse safety events occurring in hospitalized patients — a concept we respectfully reject," Dr. Parsons told Medscape Medical News. "Every single PSI is clinically significant because it denotes a preventable adverse patient safety event." However, Dr. Allaf said that the data did not address important issues such as cancer and quality-of-life outcomes, such as erectile dysfunction and incontinence rates, which are of paramount importance to patients. Dr. Parsons commented that the robotic surgery system, itself, is not inherently dangerous and PSI are not likely to be caused by a robotic malfunction. David C. Chang, PhD, MPH, MBA, director of outcomes research at UC San Diego School of Medicine and the paper's senior author, told Medscape Medical News: "A new surgical innovation does not work equally well in all hospitals and in the hands of all surgeons. That is why surveillance of surgical safety should be ongoing, much like the Centers for Disease Control monitor changes in trends of infectious diseases across the country." The authors have reported no relevant financial relationships. JAMA Surgery. Published online July 2, 2014 Abstract Commentary extract Post Comment Private Reply Ignore Thread
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