Potential Pitfalls of the Rapid Uptake of New Technology in Surgery: Can Comparative Effectiveness Research Help?

Most of us are aware of the ever-increasing health care costs in the United States and of the ongoing battle taking place in Washington to address this issue. There is a need and demand for comparative effectiveness research (CER) to find more cost-efficient and evidencebased care for our patients. If done correctly, CER can have significant impacts on health care decisions. In 1999, the Institute of Medicine composed a list of 100 priority topics for CER, and one topic on that list was to “compare the effectiveness of robotic assistance surgery and conventional surgery for common operations.” Wright et al report the results of their CER regarding robotic versus laparoscopic hysterectomy for endometrial cancer in the article that accompanies this editorial. Their meritorious article provides important information using a validated method and database. I agree with the authors’ conclusions that their findings highlight the potential pitfalls of the rapid uptake of new technology; however, there are equally as many pitfalls with conclusions drawn from premature CER studies. Although their report provides important cost information for the learning curve of a complex new surgical technology, it is difficult to extrapolate beyond that. The 2009 Institute of Medicine report called for a comparison of robotic assistance to conventional surgery. At that time, the standard, or conventional, surgery for endometrial cancer was not laparoscopy but laparotomy. The Gynecologic Oncology Group published the results of a large randomized trial comparing laparoscopy with the standard approach of laparotomy (LAP2) at the end of 2009. Gynecologic Oncology Group LAP2 confirmed that a laparoscopic approach was superior to laparotomy with the increased operative times greatly outweighed by the benefits of decreased complications and improved quality of life. Despite the many reported benefits of laparoscopy, it is still not the standard, or conventional, approach for the majority of hysterectomies performed in the United States. Laparoscopic approaches for hysterectomy have been available for 20 years. There were 518,828 hysterectomies recorded in the 2005 National Inpatient Sample, a national database sponsored by the Agency for Healthcare Research and Quality, of which only 14% were performed via a laparoscopic technique. There are many reasons for the limited adoption of laparoscopy. Perhaps the primary reason is that laparoscopy is difficult to learn and to perform proficiently. There are expert laparoscopists who can perform remarkable tasks with standard laparoscopy, and their skills cannot be minimized. But such experts are not common, and the majority of women will therefore never have the opportunity to benefit from a minimally invasive hysterectomy. I was trained in laparoscopy by expert laparoscopists. I was not, nor were those who trained me, comfortable in offering minimally invasive approaches for certain patients and procedures. The robotic platform has changed this. So how valid or relevant is comparing the cost of robotics to an approach that is infrequently used and mostly used in select, “easier” situations by the majority of gynecologists? And what of the cost associated with learning laparoscopy? The Perspective database described by Wright et al samples more than 500 acute-care hospitals. The presented data from their analysis seems to confirm the limited use of laparoscopy. There were only 1,027 laparoscopic hysterectomies performed during an 18month period, for an average of 57 per month distributed among more than 500 hospitals. There was little variation in the number of laparoscopic hysterectomies performed monthly throughout the entire study period. Similarly, only 1,437 robotic hysterectomies were performed, for an average of 80 per month among 500 hospitals. However, the number of robotic hysterectomies per month more than doubled from 48 in October 2008 to 99 in March 2010. The experience among these hospitals is sparse at best regarding either approach. It would have been interesting if the authors had also reported how many hysterectomies were performed via laparotomy during the same time period. This would help determine whether the introduction of robotics into these hospitals actually led to a reduction in the overall rate of laparotomy. The next question would then be: “Was there a cost effect by reducing the number of laparotomies?” Laparotomy is associated with a longer length of stay, greater pain and need for narcotics, and more complications. All of these things contribute significantly to the cost of delivering care. The authors report that if all 1,680 minimally invasive hysterectomies performed in 2009 were done robotically, the direct costs would have increased by more than $2.5 million, estimating that the robotic hysterectomies would have cost a median of $1,513 each over laparoscopy. This statement assumes that all of the robotic hysterectomies would have been done laparoscopically instead. A similarly reasonable, and possibly more likely, assumption is that the robotic hysterectomies would have been performed via laparotomy. Assuming that each postoperative day in the hospital as well as the management of complications is associated with significant costs, this striking $2.5 million of increased cost for robotics postulated by the authors may actually be entirely negated or perhaps even reversed in favor of robotics. Any new surgical device is associated with a learning curve. Often omitted from argument are the countless added hours needed to learn to perform laparoscopy over laparotomy. Any conscientious surgeon will take the extra time to learn to use any new instrument or technology. Increased operative time increases cost. The majority of the cost differences noted in the Perspective database would most likely be generated from operative times and/or disposable instrument use given that length of stays and complications were the same and Editorials