Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.

Background: The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.

Methods: This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States.

A Systematic Review: The Impact of COVID-19 Policy Flexibilities on SNAP and WIC Programmatic Outcomes.

In response to the coronavirus disease 2019 (COVID-19) public health emergency (PHE), the federal government deployed policy flexibilities in food and nutrition assistance programs including the Supplemental Nutrition Assistance Program (SNAP) and Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) to meet the needs those experiencing economic hardship. Emergent literature evaluates the impact of these flexibilities on program outcomes. The objective of this study was to explore the impact of policy flexibilities deployed during the COVID-19 PHE on access, enrollment/retention, benefit utilization, and perceptions of SNAP and WIC.

Human placental stem cell-based therapies for prevention of abdominal adhesions: A prospective randomized preclinical trial.

Background: Abdominal adhesions are networks of fibrotic tissues that form between organs postoperatively. Current prophylactic strategies do not reproducibly prevent adhesive small bowel obstruction across the entire abdomen. Human placental-derived stem cells produce an anti-inflammatory secretome that has been applied to multiple fibrosing diseases.

Longitudinal stability and predictive value of socio/emotional/behavioral screening in an Outpatient Pediatric Network.

Background: In 2022, the American Academy of Pediatrics recommended annual social/emotional/behavioral (SEB) screening at preventive pediatric visits. Numerous SEB screeners have considerable empirical support for children of all ages. However, few studies inform the longitudinal use of SEB screeners in pediatrics.

Preparing the future combat surgeon: a survey of the military general surgery trainee GME experience.

Introduction: Graduate medical education (GME) lacks a standardized military training program for general surgery residents, and concern exists that they may not be prepared to serve as combat surgeons on training completion. The purpose of this study was to assess military surgery trainee satisfaction with their programs. Our hypothesis was that military residents were not completely confident to care for combat casualties on completion of current GME training.

'Golden day' is a myth: rethinking medical timelines and risk in large scale combat operations.

The evolving landscape of battlefield medicine forces medical planners to prepare for large-scale combat operations (LSCO) against peer adversaries, requiring reassessment of recent medical strategies. Despite lacking medical backing, the term 'golden day' has been used by senior military leaders to link the resuscitative benefits of the 'golden hour' to prolonged medical care through similar nomenclature. Pseudomedical terminology can easily enter the lexicon of commanders as attractive soundbites.

Hyperfibrinolysis: a crucial phenotypic abnormality of posttraumatic fibrinolytic dysfunction.

Background: Traumatic fibrinolytic dysfunction is often categorized into 3 phenotypes based on the result of thromboelastography (TEG) lysis at 30 minutes (LY30): fibrinolysis shutdown, physiologic fibrinolysis, and hyperfibrinolysis. However, the molecular pathophysiology of fibrinolytic dysfunction and the association with clinical outcomes have not been fully evaluated.

Objectives: To assess whether posttraumatic fibrinolysis phenotypes identified by TEG correlate with levels of key fibrinolysis-related serum markers and with risk of mortality and hospital complications.

The Emergence of MOVES SLC Life-Support System Equipment for En-Route Trauma Care in Ukraine During a Qualitative Assessment.

Introduction: Ukraine's health and trauma system has been detrimentally impacted since the Russian Federation invasion in February 2022. The number and extent of injuries experienced in Ukraine because of trench warfare and high-intensity large-scale combat operations has not been seen in recent conflicts. Understanding attitudes and perceptions around the use of devices and products including MOVES (monitor, oxygen concentrator, ventilator, and suction system) and its use in the large-scale combat operation environment can inform lessons learned for improved prehospital care in Ukraine, as well as in other future conflicts.

A Scoping Review of Animal Models for Development of Abdominal Adhesion Prevention Strategies.

Introduction: Abdominal adhesions represent a chronic postsurgical disease without reliable prophylaxis. Animal modeling has been a cornerstone of novel therapeutic development but has not produced reliable clinical therapies for prevention of adhesive small bowel obstruction. The purpose of this scoping review is to analyze animal models for abdominal adhesion generation by key considerations of external validity (i.

Blood biodistribution and vector shedding of valoctocogene roxaparvovec in people with severe hemophilia A.

Following systemically administered adeno-associated virus gene therapy, vector particles are widely distributed, raising concerns about horizontal or germline vector transmission. Characterization of biodistribution and kinetics of vector DNA in body fluids can address these concerns and provide insights into vector behavior in accessible samples. We investigated biodistribution and vector shedding profile of valoctocogene roxaparvovec in men with severe hemophilia A enrolled in the phase 3 GENEr8-1 trial.

Who needs a tourniquet? And who does not? Lessons learned from a review of tourniquet use in the Russo-Ukrainian war.

Background: Extremity tourniquets have proven to be lifesaving in both civilian and military settings and should continue to be used by first responders for trauma patients with life-threatening extremity bleeding. This is especially true in combat scenarios in which both the casualty and the first responder may be confronted by the imminent threat of death from hostile fire as the extremity hemorrhage is being treated. Not every extremity wound, however, needs a tourniquet.

Complexities of autonomy in military medical ethics: A brief report.

The first Fallen Surgeons Military Educational Symposium was convened in conjunction with the the American Association for the Surgery of Trauma (AAST) 23 meeting, under the guidance of the AAST Military Liaison Committee. The daylong session included a 1.5-hour segment on military medical ethics in combat and its unique challenges.

The thin red line: Blood planning factors and the enduring need for a robust military blood system to support combat operations.

Battlefield lessons learned are forgotten; the current name for this is the Walker Dip. Blood transfusion and the need for a Department of Defense Blood Program are lessons that have cycled through being learned during wartime, forgotten, and then relearned during the next war. The military will always need a blood program to support combat and contingency operations.

Interactive Media-Based Approach for an Exception From Informed Consent Trial Involving Patients With Trauma.

Importance: Exception From Informed Consent (EFIC) research requires community consultation (CC) and public disclosure (PD). Traditional methods of conducting CC and PD are slow, expensive, and labor intensive.

Objective: To describe the feasibility and reach of a novel interactive, media-based approach to CC and PD and to identify the similarities and differences between trial sites in website views, survey responses, online community forum attendance, and opt-out requests.

Diagnostic performance of the ABC score in the PROPPR trial.

Introduction: The Assessment of Blood Consumption (ABC) score is used to predict massive transfusions (MT). However, its diagnostic performance has not been widely examined, especially when used as an objective tool to enroll patients in multi-center clinical trials. The purpose of this study was to evaluate the performance of the ABC score in enrolling patients in the Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial.

Red line the red line: Optimizing emergency medicine physicians and surgeons collaborative roles on trauma teams.

It has long been the standard for surgical and EM teams to both be present upon patient arrival and work together for the sickest trauma patients, yielding improved outcomes. It is important to dismantle divisive perceptions, confront system constraints, and promote new strategies that optimize the engagement of trauma team members. The focus should be on the patient, whose injury care starts with prevention and extends seamlessly through prehospital, hospital and rehabilitation.