Global observational survey verifying surgeon utilization of the Validated Intraoperative Bleeding (VIBe) scale for use in clinical practice

Abstract

Based on US-FDA guidelines to create tools for development and evaluation of medical devices in non-clinical and clinical studies, the Validated Intraoperative Bleeding (VIBe) Scale was developed. The current investigation expands upon the earlier validation study with multi-specialty surgeons to further corroborate these findings and establish feasibility to implement VIBe SCALE into clinical practice and surveys degree of anticipated bleeding across common procedures in multiple surgical disciplines. Following online didactic VIBe SCALE training, participating surgeons graded bleeding in ten porcine model videos corresponding to the original validation study. Surgeon and practice information were collected along with percentage of hemostatic product utilization in surgical procedures, the top three surgical procedures performed in their specialty, together with self-reported percentage of bleeding per VIBe SCALE bleeding grade typically encountered in those procedures. Using a web-based interface, survey data were collected from 585 participating surgeons; 339 (58%) participants were from academic or university setting, 170 (29%) had >20 years of surgical experience, 217 (37%) performed 11-20 surgeries per month. Overall, 125 (21%) surgeons reported conducting up to 10% minimally invasive surgeries in their practice. Total, 334 (57%) participants considered patient's coagulation status while selecting intraoperative adjunctive hemostatic product, if required; majority (n=552 [94%]) considered bleeding intensity important when selecting a hemostatic product intraoperatively. Interobserver concordance for VIBe SCALE of 0.89 (perfect concordance=1.0) as a measure of reproducibility, was achieved. This survey strengthens the findings of the earlier validation study and provides human factors verification of the VIBe SCALE as a relevant tool to evaluate and assess bleeding severity across multiple surgical specialties, while demonstrating the useability in contemporary clinical practice and may facilitate hemostatic product choice.