Feasibility of conducting a military-relevant multicenter cohort study to assess outcomes of early trauma resuscitative interventions in a prolonged care civilian setting

Abstract

BACKGROUND The Epidemiology and Outcomes of Prolonged Trauma Care (EpiC) study is a 4-year, prospective, observational, large-scale epidemiologic study in South Africa. It will provide novel evidence on how early resuscitation impacts postinjury mortality and morbidity in patients experiencing prolonged care. A pilot study was performed to inform the main EpiC study. We assess outcomes and experiences from the pilot to evaluate overall feasibility of conducting the main EpiC study. METHODS The pilot was a prospective, multicenter, cohort study at four ambulance bases, four hospitals, and two mortuaries from March 25 to August 27, 2021. Trauma patients 18 years or older were included. Data were manually collected via chart review and abstraction from clinical records at all research sites and inputted into Research Electronic Data Capture. Feasibility metrics calculated were as follows: screening efficiency, adequate enrollment, availability of key exposure and outcome data, and availability of injury event date/time. RESULTS A total of 2,303 patients were screened. Of the 981 included, 70% were male, and the median age was 31.4 years. Six percent had one or more trauma relevant comorbidity. Fifty-five percent arrived by ambulance. Forty percent had penetrating injuries. Fifty-three percent were critically injured. Thirty-three percent had one or more critical interventions performed. Mortality was 5%. Four of the eight feasibility metrics exceed the predetermined threshold: screening ratio, monthly enrollment, percentage with significant organ failure, and missing injury date/time for emergency medical services patients. Two feasibility metrics were borderline: key exposure and primary outcome. Two feasibility metrics fell below the feasibility threshold, which necessitate changes to the main EpiC study: percentage with infections and missing injury date/time for walk-in patients. CONCLUSION The EpiC pilot study suggests that the main EpiC study is overall feasible. Improved data collection for infections and methods for missing data will be developed for the main study. LEVEL OF EVIDENCE Prognostic and Epidemiological; Level V.

Prolonged casualty care: Extrapolating civilian data to the military context

“…The authors reported that delayed transfer patients had higher SOFA scores. 32 While not a traditional trauma scoring tool, SOFA was selected in EpiC by a 20-member expert panel 33 as a trade-off between high feasibility of collecting the necessary clinical variables despite slightly lower performance characteristics compared with other trauma multiorgan failure scoring tools. 21,34 The correlation of critical interventions with organ failure scores and trends, especially as they pertain to prolonged periods of resuscitation and delays to care, will be an ongoing area of focus in the EpiC study.…”

“… 13 In EpiC, demographic and clinical data are collected on included patients, defined as patients with trauma (external application of force to the body) who are 18 years and older with a clinical encounter at 1 of the 10 study sites. Exclusion criteria include prisoners, injury onset exceeding 24 hours before arrival at the first study site, stings, other forms of envenomation, toxicologic injuries, drownings, patients who are found deceased on scene, and/or patients transported via private EMSs agency 13 . Data are collected by a team of trained research personnel using primary review of EMSs, hospital, and pathology records for each case.…”

“…The ongoing large-scale Epidemiology and Outcomes of Prolonged Trauma Care (EpiC) study in the Western Cape of South Africa has established that the Western Cape civilian and US military PCC settings have some similarities in care capabilities, injury profiles, resource limitations, and system configurations 13–15 . The EpiC study seeks to assess the effect of early trauma resuscitation on mortality and morbidity outcomes among severely injured adult patients.…”

“…Importantly, the median time from injury to definitive care, measured in the EpiC cohort, is 10 hours 14 . The EpiC study seeks to assess the effects of early resuscitation on postinjury mortality and morbidity in a civilian population with a high-prevalence of combat-relevant injuries 13 . Findings will help fill critical scientific gaps relevant to military and civilian populations requiring PCC 16,17 …”