INNOVATIVE MEDICAL DEVICE DESIGN SIGNIFICANTLY REDUCES SURGEON INTRA-PROCEDURAL STRESS LEVELS (IPSL)

Author(s)

MacDonald M, Lombard J, Sutton N, Hinoul P, Ilie B
Johnson & Johnson Medical Devices, Somerville, NJ, USA

OBJECTIVES: This pilot study was designed to non-invasively measure surgeon perceived and biologically expressed stress levels during two simulated hernia repairs performed in an animal model. METHODS: One repair was done using traditional suture methods and flat mesh, and the other using new open hernia repair products, ETHICON SECURESTRAP® Open and ETHICON PHYSIOMESH™ Open. Eight surgeons experienced with mechanical and suture fixation performed the two procedures in a randomized order. Outcomes of Interest:
  • Procedure fixation times
  • Surgeon stress level, evaluated using salivary biomarkers (cortisol and amylase) at multiple time points including before, during, and at 5 and 20 minutes post-procedure
  • Task load questionnaire, SURG-TLX, administered to establish perceived stress levels, including the following domains: mental demands, physical demands, temporal demands, task complexity, situational stress and distractions.
The median difference in procedure time, task load and change in stress level between the procedures (SECURESTRAP® Open with PHYSIOMESH™ Open minus Suture fixation with PROCEED®) is reported. RESULTS: The median differences in procedure fixation time and overall task load questionnaire score (weighted for task importance as identified by surgeons) were -23.64 (95%CI: -27.15 to -6.58) minutes and -49.5 (95%CI: -114.0 to -16.0) points respectively, favoring procedures performed using PHYSIOMESH™ Open with SECURESTRAP® Open. The median differences in the maximum change from baseline for sAA and salivary cortisol favored the new product combination of PHYSIOMESH™ Open fixated with SECURESTRAP® Open (sAA: -81.02, 97.5% CI: -291.92 to 131.36 U/mL), (cortisol: -0.0275, 97.5%CI: -0.33 to 0.11 ug/dL) . CONCLUSIONS: In addition to dramatic time savings, use of these new products was associated with convincing evidence of reduced perceived stress levels. Additionally, salivary hormone levels may provide a valuable objective measure of surgeons’ intraoperative experience. Measurement of IPSL can provide objective measures of reduced surgical stress which has been associated with reduced surgical errors and improved outcomes.

Conference/Value in Health Info

2016-10, ISPOR Europe 2016, Vienna, Austria

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PHP192

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Health Care Research

Disease

Geriatrics, Multiple Diseases, Reproductive and Sexual Health

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×