Safe Integration of Surgical Innovations Essential to Patient Safety: Study Evaluates Minimally-Invasive Radical Prostatectomy
In the introduction to a cohort study reported in JAMA Surgery, Parsons et al stated “Surgical innovations disseminate in the absence of coordinated systems to ensure their safe integration into clinical practice, potentially exposing patients to increased risk for medical error.” Their study showed that the initial dissemination of use of robotic minimally invasive radical prostatectomy in the United States was associated with reduced perioperative patient safety compared with open radical prostatectomy.
Study Details
The study involved 401,325 patients in the Nationwide Inpatient Sample who underwent radical prostatectomy during the period of minimally invasive radical prostatectomy diffusion into practice between January 2003 and December 2009. Of particular interest was the “tipping point” in the process of diffusion of the new practice, which is considered to occur early during diffusion when the prevalence of the innovation reaches approximately 10%. The incidence rates of Agency for Healthcare Research and Quality Patient Safety Indicators, which measure processes of care and surgical provider performance, were compared between the minimally invasive procedure and open radical prostatectomy.
Patient safety indicators experienced during the study consisted of anesthesia complications, death in low-mortality diagnosis-related groups, decubitus ulcer, failure to rescue, foreign body left during procedure, iatrogenic pneumothorax, infection due to medical care, hip fracture, hemorrhage or hematoma, physiologic and metabolic derangement, respiratory failure, pulmonary embolism/deep vein thrombosis, sepsis, wound dehiscence, accidental puncture or laceration, and transfusion reaction.
Pace of Diffusion
Patients who underwent the minimally invasive procedure were more likely to be white (P = .004), have fewer comorbidities (P = .02), and have undergone surgery in higher-income areas (P = .005). Use of the minimally invasive procedure increased form 6.20% and 5.56% in 2004 and 2005 to 10.41% in 2006, 13.93% in 2007, 27.65% in 2008, and 59.55% in 2009.
Incidence of Patient Safety Indicators
The overall prevalence of any patient safety indicator was higher with open radical prostatectomy than with the robotic minimally invasive procedure (1.8% vs 1.3%, although the difference was not significant on multivariate analysis (adjusted odds ratio [OR] = 1.01, P = .94). However, in 2005, the year prior to the onset of rapid diffusion for all hospitals (teaching and nonteaching combined), minimally invasive radical prostatectomy was associated with a significant twofold increase in risk of patient safety indicators (adjusted OR = 2.01, P = .02). In 2005, the year prior to the onset of rapid diffusion in teaching hospitals (11.7% prevalence in 2006), there was a 2.7-fold increased risk of patient safety indicators with the minimally invasive procedure in teaching hospitals (adjusted OR = 2.7, P = .004); in 2007, the year prior to onset of rapid diffusion in nonteaching hospitals (prevalence of 27.1% in 2008), the minimally invasive procedure was associated with a nonsignificant increased risk of patient safety indicators in nonteaching hospitals (adjusted OR = 2.02, P = .14). There was no association of minimally invasive radical prostatectomy with risk of patient safety indicators in any other year in teaching or nonteaching hospitals or with combined data.
The investigators concluded: “During its initial national diffusion, [minimally invasive radical prostatectomy] was associated with diminished perioperative patient safety. To promote safety and protect patients, the processes by which surgical innovations disseminate into clinical practice require refinement.”
J. Kellogg Parsons, MD, MHS, of University of California, San Diego, Moores Comprehensive Cancer Center, is the corresponding author for the JAMA Surgery article.
The authors reported no conflicts of interest.
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