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

BackgroundRobotic technology disseminated into urological practice without robust comparative effectiveness data.ObjectiveTo review the diffusion of robotic surgery into urological practiceMethodsWe performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomyResultsRobotic 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.ConclusionsEvidence-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.

[1]  S. Lipsitz,et al.  Hospital volume, utilization, costs and outcomes of robot-assisted laparoscopic radical prostatectomy. , 2012, The Journal of urology.

[2]  J. Cadeddu DO THE OUTCOMES AND COST JUSTIFY THE MARKETING , 2010 .

[3]  Amul Shah,et al.  Pathologic outcomes during the learning curve for robotic-assisted laparoscopic radical prostatectomy. , 2008, International braz j urol : official journal of the Brazilian Society of Urology.

[4]  E. Jordan,et al.  Review of a decision by the Medical Services Advisory Committee based on health technology assessment of an emerging technology: The case for remotely assisted radical prostatectomy , 2007, International Journal of Technology Assessment in Health Care.

[5]  A. Vickers,et al.  Low annual caseloads of United States surgeons conducting radical prostatectomy. , 2009, The Journal of urology.

[6]  Joshua R. Ehrlich,et al.  A comparison of postoperative complications in open versus robotic cystectomy. , 2010, European urology.

[7]  M. Menon,et al.  Safety profile of robot-assisted radical prostatectomy: a standardized report of complications in 3317 patients. , 2011, European urology.

[8]  M. Menon,et al.  Nerve‐sparing robot‐assisted radical cystoprostatectomy and urinary diversion , 2003, BJU international.

[9]  S. Bhayani,et al.  Robot-assisted partial nephrectomy: evaluation of learning curve for an experienced renal surgeon. , 2010, Journal of endourology.

[10]  Jim C Hu,et al.  Overcoming the learning curve for robotic-assisted laparoscopic radical prostatectomy. , 2010, The Urologic clinics of North America.

[11]  D. Chang,et al.  Patient safety and the diffusion of surgical innovations: a national analysis of laparoscopic partial nephrectomy , 2013, Surgical Endoscopy.

[12]  E. Wallen,et al.  Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. , 2010, European urology.

[13]  G. Barbash,et al.  New technology and health care costs--the case of robot-assisted surgery. , 2010, The New England journal of medicine.

[14]  Guy Vallancien,et al.  Robotically Assisted Laparoscopic Radical Prostatectomy: Feasibility Study in Men , 2001, European Urology.

[15]  Jamie E. Anderson,et al.  Hospital costs and length of stay related to robot-assisted versus open radical and partial nephrectomy for kidney cancer in the USA , 2012, Journal of Robotic Surgery.

[16]  John D Seigne,et al.  The cost of learning robotic-assisted prostatectomy. , 2008, Urology.

[17]  Ashutosh Tewari,et al.  Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. , 2002, The Journal of urology.

[18]  M. Kattan,et al.  The surgical learning curve for prostate cancer control after radical prostatectomy , 2008 .

[19]  J. Binder,et al.  Robotically‐assisted laparoscopic radical prostatectomy , 2001, BJU international.

[20]  L. Feldman,et al.  Evaluation and stages of surgical innovations , 2009, The Lancet.

[21]  J Kellogg Parsons,et al.  The first national examination of outcomes and trends in robotic surgery in the United States. , 2012, Journal of the American College of Surgeons.

[22]  Philipp Dahm,et al.  Low quality of evidence for robot-assisted laparoscopic prostatectomy: results of a systematic review of the published literature. , 2010, European urology.

[23]  J. Eastham,et al.  Systematic review and meta-analysis of perioperative outcomes and complications after robot-assisted radical prostatectomy. , 2012, European urology.

[24]  Eric L Eisenstein,et al.  Local cost structures and the economics of robot assisted radical prostatectomy. , 2005, The Journal of urology.

[25]  Thomas R. Miller,et al.  What would be the effect of referral to high-volume hospitals in a largely rural state? , 2004, The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association.

[26]  M. Menon,et al.  Disparities in access to care at high‐volume institutions for uro‐oncologic procedures , 2012, Cancer.

[27]  V. Laudone,et al.  Comprehensive standardized report of complications of retropubic and laparoscopic radical prostatectomy. , 2010, European urology.

[28]  A. Tewari,et al.  Learning curve for robotic assisted laparoscopic prostatectomy: a multi-institutional study of 3794 patients. , 2011, Minerva urologica e nefrologica = The Italian journal of urology and nephrology.

[29]  M. Sangalli,et al.  Impact of the learning curve on perioperative outcomes in patients who underwent robotic partial nephrectomy for parenchymal renal tumours. , 2010, European urology.

[30]  Prokar Dasgupta,et al.  The learning curve of robot-assisted radical cystectomy: results from the International Robotic Cystectomy Consortium. , 2010, European urology.

[31]  M. Menon,et al.  Retropubic, laparoscopic, and robot-assisted radical prostatectomy: a systematic review and cumulative analysis of comparative studies. , 2009, European urology.

[32]  J. Cadeddu,et al.  Robotic prostatectomy. , 2010, The Journal of urology.

[33]  David I. Lee,et al.  Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons. , 2009, The Journal of urology.

[34]  J. Parsons,et al.  Outcomes of retropubic, laparoscopic, and robotic-assisted prostatectomy. , 2008, Urology.

[35]  E. Castle,et al.  Positive surgical margins in robotic-assisted radical prostatectomy: impact of learning curve on oncologic outcomes. , 2006, European urology.

[36]  T. Ahlering,et al.  Successful transfer of open surgical skills to a laparoscopic environment using a robotic interface: initial experience with laparoscopic radical prostatectomy. , 2003, The Journal of urology.

[37]  S. Lipsitz,et al.  Comparative analysis of outcomes and costs following open radical cystectomy versus robot-assisted laparoscopic radical cystectomy: results from the US Nationwide Inpatient Sample. , 2012, European urology.

[38]  R. Brook,et al.  Disparities in the utilization of high-volume hospitals for complex surgery. , 2006, JAMA.

[39]  S. Lipsitz,et al.  Comparative effectiveness of minimally invasive vs open radical prostatectomy. , 2009, JAMA.

[40]  Herng‐Ching Lin,et al.  Comparison of 90‐day re‐admission rates between open retropubic radical prostatectomy (RRP), laparoscopic RP (LRP) and robot‐assisted laparoscopic prostatectomy (RALP) , 2012, BJU international.

[41]  Y. Horiguchi,et al.  Robotic versus open radical cystectomy: prospective comparison of perioperative and pathologic outcomes in Japan. , 2012, Japanese journal of clinical oncology.

[42]  E. Barret,et al.  Robot-assisted laparoscopic prostatectomy: a single-institutions learning curve. , 2008, Urology.

[43]  Charles B. Wilson Adoption of new surgical technology , 2006, BMJ : British Medical Journal.

[44]  A. Shalhav,et al.  Robotic radical prostatectomy learning curve of a fellowship-trained laparoscopic surgeon. , 2007, Journal of endourology.

[45]  A. Hoznek,et al.  [Remote laparoscopic radical prostatectomy carried out with a robot. Report of a case]. , 2000, Progres en urologie : journal de l'Association francaise d'urologie et de la Societe francaise d'urologie.

[46]  Georges-Pascal Haber,et al.  Robotic versus laparoscopic partial nephrectomy: a systematic review and meta-analysis. , 2012, European urology.

[47]  S Duke Herrell,et al.  Robotic-assisted laparoscopic prostatectomy: what is the learning curve? , 2005, Urology.

[48]  Mani Menon,et al.  Evolution of robotic radical prostatectomy , 2007, Cancer.

[49]  J. Kaouk,et al.  Robotic versus laparoscopic partial nephrectomy for complex tumors: comparison of perioperative outcomes. , 2012, European urology.

[50]  D. Meadows-Klue The Tipping Point: How Little Things Can Make a Big Difference , 2004 .

[51]  Yair Lotan,et al.  Cost comparison of robotic, laparoscopic, and open radical prostatectomy for prostate cancer. , 2010, European urology.

[52]  S. Lipsitz,et al.  Use, costs and comparative effectiveness of robotic assisted, laparoscopic and open urological surgery. , 2012, The Journal of urology.

[53]  J. Skinner,et al.  Adverse effects of robotic-assisted laparoscopic versus open retropubic radical prostatectomy among a nationwide random sample of medicare-age men. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[54]  Y. Lotan Is robotic surgery cost-effective: no , 2012, Current opinion in urology.

[55]  E. Rogers Diffusion of Innovations , 1962 .

[56]  J. Binder,et al.  Robotic-assisted laparoscopic radical prostatectomy: the Frankfurt technique , 2003, World Journal of Urology.

[57]  A. Weizer,et al.  Matched comparison of robotic-assisted and open radical cystectomy. , 2012, Urology.

[58]  J. Nelson Robotic-assisted radical prostatectomy: who is benefiting? , 2012, Oncology.

[59]  Stuart R. Lipsitz,et al.  Utilization and outcomes of minimally invasive radical prostatectomy. , 2008, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.