Diffusion of robotics into clinical practice in the United States: process, patient safety, learning curves, and the public health

Abstract

Robotic technology disseminated into urological practice without robust comparative effectiveness data. To review the diffusion of robotic surgery into urological practice. We performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomy. Robotic urologic surgery diffused in patterns typical of novel technology spreading among practicing surgeons. Robust evidence-based data comparing outcomes of robotic to open surgery were sparse. Although initial Level 3 evidence for robotic prostatectomy observed complication outcomes similar to open prostatectomy, subsequent population-based Level 2 evidence noted an increased prevalence of adverse patient safety events and genitourinary complications among robotic patients during the early years of diffusion. Level 2 evidence indicated comparable to improved patient safety outcomes for robotic compared to open partial nephrectomy and cystectomy. Learning curve recommendations for robotic urologic surgery have drawn exclusively on Level 4 evidence and subjective, non-validated metrics. The minimum number of cases required to achieve competency for robotic prostatectomy has increased to unrealistically high levels. Most comparative cost-analyses have demonstrated that robotic surgery is significantly more expensive than open or laparoscopic surgery. Evidence-based data are limited but suggest an increased prevalence of adverse patient safety events for robotic prostatectomy early in the national diffusion period. Learning curves for robotic urologic surgery are subjective and based on non-validated metrics. The urological community should develop rigorous, evidence-based processes by which future technological innovations may diffuse in an organized and safe manner.