Flint, Isaac

ABSTRACT Introduction Expected future delays in evacuation during near-peer conflicts in remote locales are expected to require extended care including prolonged field care over hours to days. Such delays can increase potential complications, such as insufficient blood flow (shock), bloodstream infection (sepsis), internal bleeding (hemorrhage), and require more complex treatment beyond stabilization. The Trauma Triage Treatment and Training Decision Support (4TDS) system is a real-time decision support system to monitor casualty health and identify such complications. The 4TDS software prototype operates on an Android smart phone or tablet configured for use in the DoD Nett Warrior program. It includes machine learning models to evaluate trends in six vital signs streamed from a sensor placed on a casualty to identify shock probability, internal hemorrhage risk, and need for a massive transfusion. Materials and Methods The project team used a mixed methods approach to create and evaluate the system including literature review, rapid prototyping, design requirements review, agile development, an algorithm “silent test,” and usability assessments with novice to expert medics from all three services. Results Both models, shock (showing an accuracy of 0.83) and hemorrhage/massive transfusion protocol, were successfully validated using externally collected data. All usability assessment participants completed refresher training scenarios and were able to accurately assess a simulated casualty’s condition using the phone prototype. Mean responses to statements on evaluation criteria [e.g., fit with Tactical Combat Casualty Care (TCCC), ease of use, and decision confidence] fell at five or above on a 7-point scale, indicating strong support. Conclusions Participatory design ensured 4TDS and machine learning models reflect medic and clinician mental models and work processes and built support among potential users should the system transition to operational use. Validation results can support 4TDS readiness for FDA 510k clearance as a Class II medical device.

ABSTRACT Objectives The objectives of this study were to test in real time a Trauma Triage, Treatment, and Training Decision Support (4TDS) machine learning (ML) model of shock detection in a prospective silent trial, and to evaluate specificity, sensitivity, and other estimates of diagnostic performance compared to the gold standard of electronic medical records (EMRs) review. Design We performed a single-center diagnostic performance study. Patients and setting A prospective cohort consisted of consecutive patients aged 18 years and older who were admitted from May 1 through September 30, 2020 to six Mayo Clinic intensive care units (ICUs) and five progressive care units. Measurements and main results During the study time, 5,384 out of 6,630 hospital admissions were eligible. During the same period, the 4TDS shock model sent 825 alerts and 632 were eligible. Among 632 hospital admissions with alerts, 287 were screened positive and 345 were negative. Among 4,752 hospital admissions without alerts, 78 were screened positive and 4,674 were negative. The area under the receiver operating characteristics curve for the 4TDS shock model was 0.86 (95% CI 0.85-0.87%). The 4TDS shock model demonstrated a sensitivity of 78.6% (95% CI 74.1-82.7%) and a specificity of 93.1% (95% CI 92.4-93.8%). The model showed a positive predictive value of 45.4% (95% CI 42.6-48.3%) and a negative predictive value of 98.4% (95% CI 98-98.6%). Conclusions We successfully validated an ML model to detect circulatory shock in a prospective observational study. The model used only vital signs and showed moderate performance compared to the gold standard of clinician EMR review when applied to an ICU patient cohort.