Diffusion of surgical innovations, patient safety, and minimally invasive radical prostatectomy

Abstract

Importance: 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.

Objective: To investigate associations of patient safety with the diffusion of minimally invasive radical prostatectomy (MIRP) resulting from the development of the da Vinci robot.

Design, setting, and participants: A cohort study of 401 325 patients in the Nationwide Inpatient Sample who underwent radical prostatectomy during MIRP diffusion between January 1, 2003, and December 31, 2009.

Main outcomes and measures: We used Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs), which measure processes of care and surgical provider performance. We estimated the prevalence of MIRP among all prostatectomies and compared PSI incidence between MIRP and open radical prostatectomy in each year during the study. We also collected estimates of MIRP incidence attributed to the manufacturer of the da Vinci robot.

Results: Patients who underwent MIRP were more likely to be white (P = .004), have fewer comorbidities (P = .02), and have undergone surgery in higher-income areas (P = .005). The incidence of MIRP was substantially lower than da Vinci manufacturer estimates. Rapid diffusion onset occurred in 2006, when MIRP accounted for 10.4% (95% CI, 10.2-10.7) of all radical prostatectomies in the United States. In 2005, MIRP was associated with an increased adjusted risk for any PSI (adjusted odds ratio, 2.0; 95% CI, 1.1-3.7; P = .02) vs open radical prostatectomy. Stratification by hospital status demonstrated similar patterns: rapid diffusion onset among teaching hospitals occurred in 2006 (11.7%; 95% CI, 11.3-12.0), with an increased risk for PSI for MIRP in 2005 (adjusted odds ratio, 2.7; 95% CI, 1.4-5.3; P = .004), and onset among nonteaching hospitals occurred in 2008 (27.1%; 95% CI, 26.6-27.7), with an increased but nonsignificant risk for PSI in 2007 (adjusted odds ratio, 2.0; 95% CI, 0.8-5.2; P = .14).

Conclusions and relevance: During its initial national diffusion, MIRP 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.

Figure 1. National Estimated Frequencies of Open Radical Retropubic Prostatectomy and Minimally Invasive Radical Prostatectomy by Year

Estimates are based on a 20% sample of the Nationwide Inpatient Sample, with applied weighting with 95% CIs provided for estimate.

Figure 2. Likelihood Rates for Patient Safety Indicators

The likelihood of any Patient Safety Indicator occurring by year comparing minimally invasive radical prostatectomy with open radical prostatectomy for teaching hospitals (A) and nonteaching hospitals (B). Adjusted odds ratios (ORs) greater than 1.0 indicate a higher probability of any Patient Safety Indicator occurring in association with minimally invasive radical prostatectomy. The model includes the following variables: year by surgery interaction term, age, Charlson Comorbidity Index score, number of eligible Patient Safety Indicators, and year. The tipping point denotes the first year during which the prevalence of minimally invasive radical prostatectomy prevalence equaled or exceeded 10%.