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Introduction As female active duty populations increase in all military environments, it is critical that women's health be addressed in a comprehensive manner. The study's results will be utilized to assist Navy health care leaders in addressing female force readiness policies, treatment gaps, and training specific to women's mental health. Materials and Methods In total, 212 active duty participants were recruited from the Navy's mental health specialties. The survey was hosted on the U.S. Government's MAX.gov survey website and received Institutional Review Board and Survey Review Board approval per Navy and Defense Health Agency requirements. Participants recorded their experiences with various patient presentations using Likert scale assessments, indicated their comfort in prescribing medication to patients with 11 distinct presenting concerns, and responded to six questions regarding their training and clinical experience in the field of women's mental health. Results Differences were noted for provider gender, treatment setting, patient sex, provider rank, and years of independent practice. Female providers were more likely than males to report that their female patients presented with 15 of the 21 measured issues. Providers located at MTFs were significantly more likely than providers in operational billets to report female patients presenting with certain conditions and reported being more comfortable prescribing medication. Eighty percent of respondents authorized to prescribe medicine rated themselves as very or extremely comfortable prescribing medications to their patients for all specified conditions except two: women who are breastfeeding and women who are pregnant. Senior officers reported the most comfort prescribing medication to women who are planning to become pregnant and women who have experienced perinatal loss. Only a minority of providers (20%, female; 33%, males) reported receiving women's mental health education during their training. Of those who did receive training, it was limited to post-partum and pregnancy. Most participants (93%) agreed that women's mental health should be incorporated into training programs for military providers. Conclusions This exploratory study highlights that provider variables impact assessment and treatment of and for patients. The study highlights the interplay of gender, treatment setting, experiences, and level of comfort are associated with provider assessment of presenting concerns. The authors hope this study will help in prioritizing women's mental health practices, mental health training, and research, and in informing policy and decision-making. [ABSTRACT FROM AUTHOR]

Introduction Training for mass casualty incident (MCI) response is critical to ensure that resource allocation and treatment priorities limit preventable mortality. Previous research has investigated the use of immersive virtual environments as an alternative to high fidelity MCI training, which is expensive and logistically challenging to implement. While these have demonstrated positive early results, they still require complex technology deployment, dedicated training facilities, and significant time from instructors and facilitators. This study explores the feasibility of a smartphone-based application for trauma care training and MCI triage to fill the gap between classroom learning and high-fidelity simulation. The goals of this investigation were to evaluate clinician perceptions of a virtual MCI training simulator's usability, acceptability, fidelity, functionality, and pacing. Materials and Methods This study used a smartphone-based training simulation called Extensible Field and Evacuation Care Training in a Virtual Environment (EFECTIVE), which presents virtual patient scenarios in a gamified, but visually high-fidelity environment. A total of 21 participants were recruited as a convenience sample of medical students, paramedics, nurses, and emergency medicine resident and attending physicians at University of Massachusetts Memorial Medical Center, an urban tertiary care medical center. Participants completed a brief tutorial and then performed a series of virtual patient scenarios and 1 MCI scenario on the simulator, each of which was 5 minutes in duration. Then, each participant completed a survey assessing the perceived usability, acceptability, fidelity, functionality, and pacing of the virtual training simulator. The research protocol was approved by the University of Massachusetts Chan Medical School Institutional Review Board. Results 48% of participants disagreed that a virtual simulator could completely replace live MCI training, though 71% agreed that app-based simulations could effectively supplement live MCI training and 67% felt that they could be used to learn how to order medical interventions in care under fire scenarios. 80% of participants agreed that the simulation could be used to practice MCI triage and to gain experience with coordinating movement of casualties to casualty collection points. 67% of participants believed that use of virtual simulators would increase their MCI preparedness. 76% agreed that the clinical cases depicted were medically realistic and that the clinical cases presented accurately represented the scenarios described. In addition, despite being presented on a smartphone as opposed to virtual reality, 62% of participants rated the experience immersive. Conclusions This study provides encouraging evidence that easy to deploy smartphone–based simulations may be an effective way to supplement MCI and care under fire training. Although the study is limited by a small sample size, there was strong agreement among participants from a wide variety of emergency medicine roles that such a simulation could train core topics associated with MCI triage. Because app-based simulations are easily deployable and can be executed quickly and frequently, they could be used as a more flexible training model compared to large scale live or virtual reality–based simulations. The results of this investigation also indicate that a sufficient level of medical realism can be achieved without live simulation. [ABSTRACT FROM AUTHOR]

Introduction Musculoskeletal injuries (MSKIs) among active duty soldiers result in more than 10 million limited duty days each year and account for more than 70% of the medically nondeployable population. Overuse injuries in lower limbs from running, foot marching long distances with heavy loads, and lifting heavy objects are the most common types of injuries in the military. Physical training and rehabilitation exercises for greater resiliency through aerobic, muscle strength, endurance, and agility conditioning programs can prevent or reduce the effects of MSKIs if Soldiers adhere to proper biomechanics and training techniques. We are introducing a three-dimensional (3D) camera-based platform for Optical Screening and Conditioning for Injury Resilience (OSCIR) that is designed to identify and correct high-risk movement patterns based on quantifiable biomechanical measurements in clinical or field settings. Our goal is to improve resilience to MSKI by offering greater access to quality of movement skills in warfighters through an autonomous device that can be used in Sports Medicine and Reconditioning Team (SMART) clinics and High-Intensity Tactical Training (HITT) sites. Materials and Methods OSCIR fuses four pairs of Kinect Azure cameras into a concise footprint to achieve suitable sampling rates and an unobstructed field of view for accurate dynamic movement tracking using a custom point cloud solution. We designed a unique multistage 3D joint tracking algorithm architecture to methodically isolate the human body point cloud from the background, identify individual limb segments, and perform iterative joint optimization at the global and local joint levels. We evaluated the feasibility of our prototype system among N  = 12 control participants (6 M/6 F; 21-37 years) in compliance with the Western Institutional Review Board (Tracking #20225920, approved on November 4, 2022). Five task-specific MSKI outcome metrics identified by end-user physical therapists and athletic trainers as indicators for movement quality were assessed across 7 lower-extremity exercises derived from standardized MSK assessment/conditioning batteries used in the military. Data were recorded concurrently by OSCIR and a reference standard Vicon motion capture system for validating system accuracy. Results Task-specific MSKI indicators for knee flexion and hip flexion range of motion achieved an average error of 4.05 ± 2.34°, while 3D position-based postural outcomes of left-right foot distance, left-right hand distance, and step length obtained mean absolute errors of 2.58 ± 2.30 cm. Results support the feasibility of our system in achieving outcomes that are comparable to currently accepted laboratory standards. Conclusions Our study describes the integration process for a 3D camera-based clinical system for MSKI conditioning and rehabilitation. The impact of our system will enable key stakeholders in the military to manage MSKIs in warfighters by automating key assessment and rehabilitation test batteries; making tests more readily accessible, and interpretations more accurate by providing objective biomechanical measures. OSCIR is undergoing turn-key design features to serve as a screening tool for warfighters to readily assess susceptibility to MSKI or as a training platform to help guide exercise techniques to achieve resiliency against future injuries. [ABSTRACT FROM AUTHOR]

Introduction Rotating shiftwork schedules are known to disrupt sleep in a manner that can negatively impact safety. Consumer sleep technologies (CSTs) may be a useful tool for sleep tracking, but the standard feedback provided by CSTs may not be salient to shift-working populations. SleepTank is an app that uses the total sleep time data scored by a CST to compute a percentage that equates hours of sleep to the fuel in a car and warns the user to sleep when the "tank" is low. Royal Australian Navy aircraft maintenance workers operating on a novel rotational shift schedule were given Fitbit Versa 2s to assess sleep timing, duration, and efficiency across a 10-week period. Half of the participants had access to just the Fitbit app while the other half had access to Fitbit and the SleepTank app. The goal of this study was to evaluate differences in sleep behavior between shifts using an off-the-shelf CST and to investigate the potential of the SleepTank app to increase sleep duration during the 10-week rotational shift work schedule. Materials and Methods Royal Australian Navy volunteers agreed to wear a Fitbit Versa 2 with the SleepTank app (SleepTank condition), or without the SleepTank app (Controls), for up to 10 weeks from May to July 2023 during the trial of a novel shift rotation schedule. Participants from across 6 units worked a combination of early (6:00 AM to 2:00 PM), day (7:30 AM to 4:30 PM), late (4:00 PM to 12:00 AM), and night shifts (12:00 AM to 6:00 AM) or stable day shifts (6:00 AM to 4:00 PM). Differences in sleep behavior (time in bed, total sleep time, bedtime, wake time, sleep efficiency [SE]) between conditions and shift types were tested using Analysis of Variance. This study was approved by the Australian Departments of Defence and Veterans' Affairs Human Research Ethics Committee. Results Thirty-four participants completed the full study (n  = 17 Controls; n  = 17 SleepTank). There was a significant effect of shift type on 24-hour time in bed (TIB24; F(4,9) = 8.15, P  < .001, η2 = 0.15) and total sleep time (TST24; F(4,9) = 8.54, P  < .001, η2 = 0.18); both were shorter in early shifts and night shifts compared to other shift types. TIB24 and TST24 were not significantly different between conditions, but there was a trend for greater SE in the SleepTank condition relative to Controls (F(1,9) = 2.99, P  = .08, η2 = 0.11). Conclusions Sleep data collected by Fitbit Versa 2s indicated shorter sleep duration (TIB24, TST24) for Royal Australian Navy workers during early and late shifts relative to stable day shifts. Access to the SleepTank app did not greatly influence measures of sleep duration but may be protective against fatigue by affecting SE. Further research is needed to evaluate the utility of the SleepTank app as a means of improving sleep hygiene in real-world, shift-working environments. [ABSTRACT FROM AUTHOR]

Introduction Recovering from neuromuscular injuries or conditions can be a challenging journey that involves complex surgeries and extensive physical rehabilitation. During this process, individuals often rely on orthotic devices to support and enable movement of the affected limb. However, users have criticized current commercially available powered orthotic devices for their bulky and heavy design. To address these limitations, we developed a novel powered myoelectric elbow orthosis. Materials and Methods The orthosis incorporates 3 mechanisms: a solenoid brake, a Bowden cable-powered constant torque elbow mechanism, and an extension limiter. The device controller and battery are in a backpack to reduce the weight on the affected arm. We performed extensive calculations and testing to ensure that the orthosis could withstand at least 15 Nm of elbow torque. We developed a custom software effectively control the orthosis, enhancing its usability and functionality. A certified orthotist fitted a subject who had undergone a gracilis free functioning muscle transfer surgery with the device. We studied the subject under Mayo clinic IRB no. 20-006849 and obtained objective measurements to assess the orthosis's impact on upper extremity functionality during daily activities. Results The results are promising since the orthosis significantly improved elbow flexion range of motion by 40° and reduced compensatory movements at the shoulder (humerothoracic joint) by 50°. Additionally, the subject was able to perform tasks which were not possible before, such as carrying a basket with weights, highlighting the enhanced functionality provided by the orthosis. Conclusion In brief, by addressing the limitations of existing devices, this novel powered myoelectric elbow orthosis offers individuals with neuromuscular injuries/conditions improved quality of life. Further research will expand the patient population and control mechanisms. [ABSTRACT FROM AUTHOR]

Introduction Musculoskeletal injuries are one of the primary causes of Soldiers' inability to be medically ready, comprising over 80% of such causes. The electronic profile (e-Profile) is the way that musculoskeletal injuries are documented so that commanders will know the type of injury as well as the length of the time that the Soldier will need limited duty. A previous study of e-Profiles in an Army MTF Integrated Pain Management Center showed that the median length of an e-Profile was 30 days. It is in the best interest of the Army to have the Soldier out of the fight the minimum amount of time for recovery to ensure the unit readiness. The goal of this study was to utilize e-Profile data to see if a machine learning model can be developed to determine the appropriate time a Soldier needs to be on profile for a given diagnoses. Materials and Methods Institutional Review Board approval was obtained from the USAMRDC (protocol #M-10966). The initial dataset provided to the research team consisted of a single pipe delimited ("|") text file containing 2.9 million rows of e-Profile data. Linear regression, decision trees, and random forests (RFs) were evaluated to see which model would best predict the number of days needed for an e-Profile. Results Linear regression had an adjusted R-squared of 0.165. The positive predictive value of decision trees (0-to-30-day range of e-Profiles) was 73.6%, and the negative predictive value (30-90 days) was 60.9% with an area under the receiver operating characteristic curve (AUC) of 0.694 for the model. The positive predictive value of RFs was 85.3% (for the 0-30 range), and the negative predictive value was 58.7% (for the 30-90 range) with an AUC of 0.794. An AUC that approaches 1 indicates a more accurate prediction. Conclusions The 3 models (linear regression, decision trees, and RF) studied as part of this project did not predict the days on e-Profile with a high degree of certainty. Future research will focus on adding additional data to the e-Profile dataset in order to improve model accuracy. [ABSTRACT FROM AUTHOR]

Introduction The DoD has prioritized programs to optimize readiness by enhancing resilience of its service members. Problematic anger in the military is an issue that impacts psychological well-being and resilience. Leader support is a potential tactic for reducing anger and its effects. Currently military resilience training is focused on individual level resilience. A gap exists in such training and there is a need to train leaders to provide mental health and resilience support to their subordinates. The present study developed and tested a theory-based training aimed at platoon leaders that focused on how to engage in proactive and responsive mental health and resilience-supportive behaviors through guided discussion, scenarios, and computer-based training with embedded quizzes. Materials and Methods We conducted an Institutional Review Board–approved cluster randomized controlled trial to test the effects of a leadership training with Army platoon leaders (n  = 99) and soldiers (n  = 276) in 2 brigades at an active duty military installation in the USA. Training was conducted in person with a computer-based component. Soldiers completed online surveys 1 month prior and again 3 months after the leader training. Results Post-training results demonstrated significant leader learning effects (Cohen's d  = 1.56) and leader positive reactions to the training information, with leaders reporting the information as useful and relevant to their work. Service members in the treatment group reported significantly lower levels of anger at time 2 (b  = −0.18, SE  = 0.06, P  = .002, pseudo Δ R 2 = 0.01; d  = 0.27) compared to the control group. We also found an indirect effect of the intervention on increased life satisfaction at time 2 via decreased anger (b  = 0.035, SE  = 0.023, 95% CI = [0.004-0.24]). Conclusions This study provides an initial evaluation of training for platoon leaders that educates them on proactive and responsive behavioral strategies to support the mental health and resilience of their service members via decreased problematic anger and increased well-being. Further adaptations and evaluations should be conducted with other military branches and civilian occupations, as the benefits of the relatively brief and noninvasive training could be widespread. [ABSTRACT FROM AUTHOR]

Introduction Modern warfare operations are volatile, highly complex environments, placing immense physiological, psychological, and cognitive demands on the warfighter. To maximize cognitive performance and warfighter resilience and readiness, training must address psychological stress to enhance performance. Resilience in the face of adversity is fundamentally rooted in an individual's psychophysiological stress response and optimized through decreased susceptibility to the negative impact of trauma exposure. The current project aims to optimize warfighter expertise, resilience, adaptability, and performance by utilizing a validated Full Dive Virtual Reality (FDVR) training platform to provide high-fidelity, safe, and scalable, controlled stress exposure in highly realistic simulated training scenarios with the most advanced, immersive technology available. Materials and Methods Following Institutional Review Board approval and consent, 2 operators were fitted with high-fidelity virtual reality headsets with hand and eye tracking, full-body haptic feedback suits, a 360° omnidirectional treadmill, and Food and Drug Administration (FDA) cleared biometric monitors. Following acclimation, operators were placed in an industrial fire scenario and instructed to respond as a firefighter and paramedic, to search for and resuscitate any casualties, extinguish the fire, and exfiltrate safely. Following initial acclimation and after each demonstration (n  = 2), 3 semistructured interviews asked operators their perceptions and experiences related to FDVR, focusing on usability, feasibility, and safety. Biometric data were continuously recorded using the Caretaker Medical VitalStream. Results Proof-of-concept (POC) testing proved that the FDVR training platform is usable, safe, and feasible. It creates an immersive environment with physiological responses to mimic realistic Mass Casualty Events (MCEs). Using a case study approach, transcript data were analyzed using thematic analysis. Three major themes emerged: Sensory deficits reduced realism, but sensory feedback improved fidelity, vestibular discord affected the virtual reality experience but only when the system did not respond naturally to operator movement after acclimation, and movement accommodations were made by operators to enhance usability, especially for fine motor movements. Biometric data analysis correlated timestamps from the VitalStream unit with operator responses to stress-inducing events (i.e. explosions, fires, and a deceased victim). Both operators exhibited significant physiological responses, including elevated heart rate, systolic blood pressure, and mean arterial pressure, particularly following explosions, encountering fire, and encountering the deceased victim within the training environment. Conclusions The FDVR training platform overcomes the obstacles of in-person simulation training and provides the closest to real-life experience available. It will allow warfighters to train with their teams in immersive environments that replicate the conditions in which they are expected to perform their duties. The POC demonstrated that physiological responses can be mapped to scenario events to allow tracking of stress responses, cognitive load, as well as performance, and decision-making of the warfighter. The POC only involved 2 operators, but served to prove that the platform was safe and effective. Future testing plans to include 200 warfighters in operational teams of 10 to 12 to further validate the training effectiveness of the FDVR platform. [ABSTRACT FROM AUTHOR]

Introduction Military fighter aircrew report high rates of cervical pain and injury. There is currently no consensus regarding the best training methods for this population. Eglin Air Force Base (AFB) and Luke AFB have multidisciplinary teams specializing in aircrew training, performance, and injury mitigation. All student pilots (SPs) completing Basic Course training at these locations engage in an 8-week Spine Training Program (STP). The STP originated at Luke AFB in 2020 and was expanded to Eglin AFB in 2022. The primary aim of this study was to assess whether the STP led to significant changes in the performance measure studied, Cervical Endurance Hold (CEH). Further, this study aimed to determine if the CEH training effect was independent of location of STP administration. We hypothesized that SPs would exhibit statistically significant CEH training adaptations irrespective of base location. Materials and Methods Air Force F-16 and F-35 SPs from Luke AFB and Eglin AFB were actively enrolled in the Basic Course and participated in the standardized STP from 2020 to 2023. The CEH test was administered prior to (intake) and following (exit) the 8-week STP. SPSS for Windows version 29 software (IBM, Armonk, NY) was used to retrospectively analyze the data from this study. Participants were excluded if they were unable to perform the CEH test at intake or exit. The study was approved by the Air Force Research Laboratory Institutional Review Board and was performed in accordance with the ethical standards of the Declaration of Helsinki. Results One hundred and ninety-eight SPs (Luke AFB, males n  = 170, females n  = 12; Eglin AFB, males n  = 16) completed the STP program. There was no significant difference between intake and exit concerning age, height, weight, % body fat, and fat-free mass at Luke AFB or Eglin AFB (P  < 0.05). Statistically significant improvements in CEH were observed within all groups from intake to exit (P  < 0.001). When considering all participants collectively, there was a notable 33.6% increase in CEH from intake to exit (P  < 0.001) with an overall effect size of d  = 1.14. When analyzing specific subgroups, females from Luke AFB experienced a significant 20.4% increase in CEH (P  < 0.001, d  = 1.14), males from Luke AFB exhibited a significant 34.5% increase (P  < 0.001, d  = 1.09), and males from Eglin AFB demonstrated a significant increase of 55.7% in CEH (P  < 0.001, d  = 1.97). Conclusions This retrospective analysis showed significant improvements in the CEH across all groups following the completion of the STP. Furthermore, CEH results from both bases exhibited a large effect size indicating a meaningful change was found between intake and exit regardless of training location. These preliminary study results should be interpreted with caution as a control group was unable to be established. In the future, a randomized control trial should be performed to test the STP used in this study against other STP programs. This may better inform experts on the best spine training methods for fighter aircrew. [ABSTRACT FROM AUTHOR]

Introduction Current standards for hemoglobin monitoring during air transports of U.S. combat wounded are invasive and intermittent. Fielded pulse co-oximeters can noninvasively measure total hemoglobin, but this parameter is not currently utilized. The primary objective of this study was to assess the percentage of vital sign measurements with successful capture of total noninvasive hemoglobin measurement using spectrophotometry-based technology for Hb (SpHb) measurements in healthy participants during training flights. Secondary objectives were to assess the feasibility of a novel electronic data capture mechanism from usual patient movement items and perform a pilot analysis of SpHb changes in healthy participants during transitions from ground to air transport. Methods We conducted a feasibility study enrolling healthy participants who had hemodynamic monitoring during usual U.S. Air Force Critical Care Air Transport (CCAT) flight training exercises from 2022 to 2023. Usual CCAT monitoring equipment and currently used Masimo Rainbow® pulse co-oximeters had the capability to measure SpHb. After each training exercise, the study team wirelessly downloaded case files from patient monitors utilizing the Battlefield Assisted Trauma Distributed Observation Kit (BATDOKTM) Case Downloader application. We then calculated point and precision estimates for the percentage of time for successful SpHb capture during the exercise and compared this to pulse oximetry (SpO2) capture. An a priori precision analysis for percentage of flight-time with successful SpHb data capture and descriptive statistics were performed. This study received Exempt Determination by the 59th Medical Wing IRB. Results We analyzed 26 records with mean monitoring durations of 94.5 [59.3-119.9] minutes during ground phases and 78.0 [59.9-106.5] minutes during flight phases. SpHb measures were successfully captured for 97.7% (n  = 4,620) of possible ground measurements and 97.2% (n  = 3,973) of possible in-flight measurements compared to 99.5% ground and 98.2% in-flight capture for SpO2. Mean intervals of missing SpHb data were 2 ± 5 minutes on the ground and 4 ± 6 minutes in-flight. Mean SpHb increased by 0.93 ± 0.96 g/dL during the ground phase, but had minimal changes during ascent, cruising altitude or descent. The BATDOKTM Case downloader completed transfer for all files. Conclusion Masimo Rainbow® SpHb pulse co-oximeters reliably captured continuous, noninvasive hemoglobin measurements using usual CCAT patient movement items in healthy participants during both ground and flight training. The BATDOKTM Case Downloader successfully imported case files from CCAT patient monitors. Mean SpHb measures had a small increase during the ground phase of monitoring followed by minimal changes when transitioning to flight altitude. [ABSTRACT FROM AUTHOR]

Introduction Prolonged Casualty Care (PCC) is a military adaptation aimed at providing pre-hospital care in austere settings when evacuation is delayed or even impossible. Current lack of standardized medical equipment and size/weight restrictions of military packs during dismounted operations hinder effective PCC. We sought to design a standardized, practical, and effective prolonged field care kit (PFAK) to enable widespread implementation of PCC. Materials and Methods We reviewed Joint Trauma System Clinical Practice Guidelines to generate a list of potential contents of the PFAK. We obtained Institutional Review Board (IRB) exemption and then conducted stakeholder surveys of combat casualty care experts across the Joint Trauma System using a modified Delphi survey approach. We established a civil–military working group that provided in-depth qualitative feedback on the PFAK contents and provided an initial design of a long-range medical rucksack (LMR) to house it. Responses were analyzed using mean rank scores to help determine initial components of the PFAK. Tactical subject-matter experts tested and evaluated the PFAK and LMR prototype in austere conditions to refine the design. Results Review of the PCC Clinical Practice Guidelines generated 49 medications and 301 potential supplies as potential PFAK contents. The first Delphi survey was sent to 100 stakeholders (overall response rate of 60%). After the first survey, contents were narrowed to a list of the most essential 27 medications and 105 other components. Iterative prototypes of the PFAK and LMR were tested to determine ergonomics, portability, flexibility, and equipment compartmentalization to facilitate use in emergencies. The prototype was optimized to address the clinical, logistical, and tactical requirements of PCC across a variety of platforms and environmental conditions. Conclusions Given the changing battlefield environment, efficient and effective PCC will play an increasingly important role in the management of combat trauma. The PFAK can meet this need by providing a practical and standardized resuscitation kit generated by expert military and trauma personnel consensus, carried conveniently in the LMR. [ABSTRACT FROM AUTHOR]

Introduction Suicidal ideation and attempts are considered to be graduated risks for suicide, yet they remain under studied. Suicide is among the leading causes of death in the U.S. for all individuals between the ages of 10 and 64 years. Suicide is a critical problem in the U.S. Military. The U.S. Army suicide rates surpassed civilian rates in 2008 and continue to climb steadily; with U.S. Army soldiers at more than twice the risk than U.S. civilians, and enlisted personnel at more than twice the risk of officers. Suicidal ideation and attempts are routinely reported within U.S. Army brigades using suicide-related serious incident reports (SR-SIRs). These reports could form a useful source of information for prevention planning, but to date there have been no efforts to summary these reports. This paper analyzes SR-SIRs among enlisted personnel for a 4-year period for 1 Army brigade, to test the usefulness of this information and to explore whether risk factors for attempts compared to ideation can be identified. Materials and Methods This report analyzes 130 de-identified reports of suicidal ideation (n  = 102) and suicide attempts (n  = 28) reported as SR-SIRs from August 2018 to June 2022 among enlisted personnel in an airborne infantry brigade combat team (BCT) outside the continental U.S. Analysis of de-identified data was not considered research by brigade and university human subject/IRB authorities. Fourteen soldier characteristics and context factors were examined to determine if they differentiate the two types of incidents, suicidal ideations and suicide attempts. Results Unit location and alcohol use at the time of the incident were strongly associated with suicide attempts compared to ideation. Attempts occurred disproportionately during off duty hours, and attempters were more likely to have had prior contact with behavioral health services than ideators; however, these differences did not attain conventional statistical significance. Conclusions The study can help inform unit-specific suicide prevention and intervention strategies. Off duty hours and alcohol use are risk factors for attempts, particularly among soldiers who have sought behavioral health care. Plans to engage and support soldiers who have sought behavioral health care during off duty hours, and information regarding the risks of alcohol use, could meaningfully reduce their risk. This is the first known attempt to examine active duty U.S. Army brigade combat team SR-SIRs, and they are a potentially valuable source of health and mental health-related information. [ABSTRACT FROM AUTHOR]

Introduction The primary objective of this study was to evaluate the association between the U.S. Air Force Critical Care Air Transport (CCAT) provider operational experience with compliance for lung protective ventilation (LPV) volumes recommended by Acute Respiratory Distress Syndrome Clinical Network guidelines. Materials and Methods We performed a retrospective cohort study of CCAT providers transporting combat casualties requiring mechanical ventilation from the Middle East to Germany from 2007 to 2012. We reviewed CCAT medical records from 2007 to 2012 for the total number of patient transports by CCAT physicians and respiratory care practitioners (RCPs). Center for Sustainment of Trauma and Readiness Skills Cincinnati process improvement questionnaire data described provider demographics and clinical backgrounds. We linked these data to patient demographics and in-flight ventilation management from a prior CCAT cohort study. Patient inclusion criteria included transport by CCAT from the Middle East to Germany for traumatic injury requiring mechanical ventilation between 2007 and 2012. We excluded patients with no documented height or tidal volume. LPV compliance was defined as tidal volumes ≤8 mL/kg of predicted body weight during en route critical care transport. We performed a logistic regression analysis. This study was reviewed and approved by the 59th Medical Wing institutional review board (IRB). Results We analyzed 491 patient transports conducted by 71 (RCPs and 84 physicians. Patients had a median age of 25 years (IQR 22-30), 98% were male, median injury severity score was 24 (IQR 17-34), and median preflight PaO2/FiO2 was 285 (IQR 220-365). Median experience was 26 missions (IQR 13-40) for RCPs and 23 missions (IQR 12-38) for physicians. All in-flight tidal volumes were LPV compliant in 58.3% of missions. Unadjusted analysis showed higher LPV compliance for RCPs with in-garrison critical care experience. Multivariate models did not find an association between missions flown and LPV compliance but did demonstrate a positive association with physician specialty of medical intensivist (OR 3.0, 95% CI 1.6-5.7) and a negative association with flights in 2008 (OR 0.4, 95% CI 0.2-0.7) for LPV compliance. Conclusion No association was found between number of missions flown by CCAT providers and lung protective tidal volume compliance. Linkage of multiple data sources enabled investigation of clinical and operational currency associations with a care quality metric compliance in the combat en route care environment. Future studies should evaluate the impact of ongoing CCAT training and quality improvement interventions on LPV compliance. [ABSTRACT FROM AUTHOR]

Introduction Soldiers on the battlefield are affected by heavy body armor and excessive march load. It is well known, but the long-term effects of this extra weight on the musculoskeletal system of military veterans, specifically the lumbar spine, are unclear. In Iraq and Afghanistan, most body armors weighed over 33 pounds (15 kg). These armors were 3 times heavier than those used in Vietnam. Chiropractors at the Fargo VA Hospital are seeing more young veterans with non-traumatic lower back pain. This article presents a perspective on the impact of body armor weight and excessive carry load on lumbosacral disc herniation with radicular pain in military veterans. Materials and Methods This study is a retrospective case series. We used a convenient sampling method. We selected the first 10 military veterans who came to a Fargo VA chiropractor in late fall 2023. Each veteran filled out a VA Form 10-5345 to give us permission to access their electronic health records. All 10 veterans also completed a survey. The survey asked about their active combat status, the type and weight of their body armor, how long they wore the armor each day, how much weight they carried, and their opinion on the cause of their lower back pain (service related or not). The Fargo VA does not require an institutional review board for a case series. Results This study found that military veterans experience lower back pain at an average age of 35 years. This is at least 5 years earlier than non-service men. Lower back pain with disc herniation typically occurs at the L4-L5 and L5-S1 disc levels. All 10 veterans in the study believe that their lower back pain is related to their service. Sixty percent of the participants in the study have a service-connected disability because of back pain. Conclusions For military veterans, onset of lower back pain from a disc herniation at a young age may be linked to carrying heavy body armor and loads. However, the small sample size of this case series limits causal relationship inferences. [ABSTRACT FROM AUTHOR]

Introduction A US Naval hospital in the remote Pacific region has developed interfacility transfer (IFT) teams staffed by active duty personnel out of necessity due to a large percentage of critically ill patients requiring IFT and a lack of local resources. The IFT program underwent significant improvements in training and quality assurance in 2017. We sought to assess patient safety when transport was performed by our locally sourced and trained IFT teams. En route care (ERC) is a recognized critical capability gap in the US Navy requiring clinicians with current knowledge and skills to maintain competency. IFT programs may be a viable skill sustainment program for ERC clinicians. Materials and Methods A database was created as part of the quality assurance program to collate information on patient demographics, level of care provided, reason for transport, and interventions provided by the transporting team. A retrospective review of these data was conducted with emphasis on the appropriateness of patient management and skill sustainment for active duty personnel. The project was deemed institutional review board exempt. Results Of the 1,193 patient care reports reviewed, interventions were required in 128 (10.7%) of patients and 58 (4.9%) required ventilator management. Medical deterioration occurred during 22 (1.8%) of the transports, with 20 (90.9%) of the deterioration episodes managed appropriately. No patient harm occurred. Conclusions IFT teams with local training were able to safely transport critically ill patients with no adverse outcomes, defined as direct harm to the patients as a result of transport. Patient care during transports included routine interventions, ventilator management, and troubleshooting of patient deteriorations. Our data further suggest IFT programs may be a viable skill sustainment platform for ERC clinicians. [ABSTRACT FROM AUTHOR]

Introduction Congenital heart disease (CHD) has an incidence of 0.8% to 1.2% worldwide, making it the most common birth defect. Researchers have compared high-volume to low-volume hospitals and found significant hospital-level variation in major complications, health resource utilization, and mortality after CHD surgery. In addition, researchers found critical CHD patients at low-volume/non-teaching facilities to be associated with higher odds of inpatient mortality when compared to CHD patients at high-volume/teaching hospitals (odds ratio 1.76). We examined the effects of high-quality hospital (HQH) use on health care outcomes and health care costs in pediatric CHD care using an instrumental variable (IV) approach. Materials and Methods Using nationwide representative claim data from the United States Military Health System from 2016 to 2020, TRICARE beneficiaries with a diagnosis of CHD were tabulated based on relevant ICD-10 (International Classification of Diseases, 10th revision) codes. We examined the relationships between annual readmissions, annual emergency room (ER) use, and mortality and HQH use. We applied both the naive linear probability model (LPM), controlling for the observed patient and hospital characteristics, and the two-stage least squares (2SLS) model, accounting for the unobserved confounding factors. The differential distance between the patient and the closest HQH at the index date and the patient and nearest non-HQH was used as the IV. This protocol was approved by the Institutional Review Board at the University of Maryland, College Park (Approval Number: 1576246-2). Results The naive LPM indicated that HQH use was associated with a higher probability of annual readmissions (marginal effect, 18%; 95% CI, 0.12 to 0.23). The naive LPM indicated that HQH use was associated with a higher probability of mortality (marginal effect, 2.2%; 95% CI, 0.01 to 0.03). Using the differential distance of closest HQH and non-HQH, we identified a significant association between HQH use and annual ER use (marginal effect, −14%; 95% CI, −0.24 to −0.03). Conclusions After controlling for patient-level and facility-level covariates and adjusting for endogeneity, (1) HQH use did not increase the probability of more than one admission post 1-year CHD diagnosis, (2) HQH use lowered the probability of annual ER use post 1-year CHD diagnosis, and (3) HQH use did not increase the probability of mortality post 1-year CHD diagnosis. Patients who may have benefited from utilizing HQH for CHD care did not, alluding to potential barriers to access, such as health insurance restrictions or lack of patient awareness. Although we used hospital quality rating for congenital cardiac surgery as reported by the Society of Thoracic Surgeons, the contributing data span a 4-year period and may not reflect real-time changes in center performance. Since this study focused on inpatient care within the first-year post-initial CHD diagnosis, it may not reflect the full range of health system utilization. It is necessary for clinicians and patient advocacy groups to collaborate with policymakers to promote the development of an overarching HQH designation authority for CHD care. Such establishment will facilitate access to HQH for military beneficiary populations suffering from CHD. [ABSTRACT FROM AUTHOR]

Introduction While previous studies have analyzed military surgeon experience within military–civilian partnerships (MCPs), there has never been an assessment of how well military providers are integrated within an MCP. The Center for Sustainment of Trauma and Readiness Skills, Cincinnati supports the Critical Care Air Transport Advanced Course and maintains the clinical skills of its staff by embedding them within the University of Cincinnati Medical Center. We hypothesized that military trauma surgeons are well integrated within University of Cincinnati Medical Center and that they are exposed to a similar range of complex surgical pathophysiology as their civilian partners. Materials and Methods After Institutional Review Board approval, Current Procedural Terminology (CPT) codes were abstracted from billing data for trauma surgeons covering University of Cincinnati Hospitals in 2019. The number of trauma resuscitations and patient acuity metrics were abstracted from the Trauma Registry and surgeon Knowledge, Skills, and Abilities clinical activity (KSA-CA) scores were calculated using their CPT codes. Finally, surgeon case distributions were studied by sorting their CPT codes into 23 categories based on procedure type and anatomic location. Appropriate, chi-squared or Mann–Whitney U-tests were used to compare these metrics between the military and civilian surgeon groups and the metrics were normalized by the group's full-time equivalent (FTE) to adjust for varying weeks on service between groups. Results Data were available for two active duty military and nine civilian staff. The FTEs were significantly lower in the military group: military 0.583-0.583 (median 0.583) vs. civilian 0.625-1.165 (median 1.0), P  = 0.04. Per median FTE and surgeon number, both groups performed a similar number of trauma resuscitations (civilian 214 ± 54 vs. military 280 ± 13, P  = 0.146) and KSA-CA points (civilian 55,629 ± 25,104 vs. military 36,286 ± 11,267; P  = 0.582). Although the civilian surgeons had a higher proportion of hernia repairs (P  < 0.001) and laparoscopic procedures (P  = 0.006), the CPT code categories most relevant to combat surgery (those relating to solid organ, hollow viscus, cardiac, thoracic, abdominal, and tissue debridement procedures) were similar between the surgeon groups. Finally, patient acuity metrics were similar between groups. Conclusion This is the first assessment of U.S. Air Force trauma surgeon integration relative to their civilian partners within an MCP. Normalized by FTE, there was no difference between the two groups' trauma experience to include patient acuity metrics and KSA-CA scores. The proportion of CPT codes that was most relevant to expeditionary surgery was similar between the military and civilian partners, thus optimizing the surgical experience for the military trauma surgeons within University of Cincinnati Medical Center. The methods used within this pilot study can be generalized to any American College of Surgeons verified Trauma Center MCP, as standard databases were used. [ABSTRACT FROM AUTHOR]

The use of patient‐reported outcome measures (PROMs) is increasingly common in routine clinical practice. As tools to quantify symptoms and health status, PROMs play an important role in focusing health care on outcomes that matter to patients. The uses of PROM data are myriad, ranging from clinical care to survey‐based research and quality improvement. Discerning the boundaries between these use cases can be challenging for institutional review boards (IRBs). In this article, we provide a framework for classifying the three primary PROM use cases (clinical care, human subjects research, and quality improvement) and discuss the level of IRB oversight (if any) necessary for each. One of the most important considerations for IRB staff is whether PROMs are being used primarily for clinical care and thus do not constitute human subjects research. We discuss characteristics of PROMs implemented primarily for clinical care, focusing on: data platform; survey location; questionnaire length; patient interface; and clinician interface. We also discuss IRB oversight of projects involving the secondary use of PROM data that were collected during the course of clinical care, which span human subjects research and quality improvement. This framework provides practical guidance for IRB staff as well as clinicians who use PROMs as communication aids in routine clinical practice. [ABSTRACT FROM AUTHOR]

Introduction Dialectical behavior therapy (DBT) is a multimodal evidence-based suicide prevention psychotherapy with barriers to full implementation. This study qualitatively examined barriers and facilitators to the DBT skills group treatment mode, which can be implemented as a stand-alone intervention. Using data from a national mixed-methods program evaluation of DBT in the Veterans Health Administration (VHA), this is the first article to examine barriers and facilitators to DBT skills groups implemented with a DBT consultation team or as a stand-alone intervention. Materials and Methods A subset of data from semi-structured telephone interviews of six clinicians and three administrators (n  = 9 respondents) was analyzed to provide complementarity and expansion on prior quantitative findings. The data were coded using an iterative process based on content analysis and a codebook based on the Promoting Action on Research Implementation in Health Services framework. The study was approved by the institutional review board for the Palo Alto VA Health Care System. Results Barriers and facilitators were organized by Promoting Action on Research Implementation in Health Services domains of evidence, context, and facilitation. Results showed how reduced leadership support and low receptivity to providing DBT skills groups functioned as barriers and also identified a barrier not described earlier in the literature: the perception that this group could conflict with expanding access to care for more veterans. The results showed how leadership supported implementation, including by mapping clinic grids and supporting training, and also revealed how a supportive culture among providers facilitated division of labor between skills group providers, and how offering a treatment that filled a gap in services supported the group. At some sites, a provider with prior DBT experience was instrumental in starting DBT skills groups or developing ongoing training. Conclusions Qualitatively analyzed barriers and facilitators to a group-delivered suicide prevention intervention, DBT skills groups, expanded on quantitative findings on the importance of leadership support, culture, and training as facilitators. Future work implementing DBT skills group as a stand-alone treatment will need to address the barrier of receptivity and perceived barriers about access to care. [ABSTRACT FROM AUTHOR]

Introduction: Preservation of life, preservation of limb, and preservation of eyesight are the priorities for military medical personnel when attending to casualties. The incidences of eye injuries in modern warfare have increased significantly, despite personal eye equipment for service members. Serious eye injuries are often overlooked or discovered in a delayed fashion because they accompany other life- and limb-threatening injuries, which are assigned a higher priority. Prehospital military ocular trauma care is to shield the eye and evacuate the casualty to definitive ophthalmic care as soon as possible, with exceptions for treatment of ocular chemical injury and orbital compartment syndrome. Retrospective analysis of eye injuries in recent conflicts identified gaps in clinical capabilities with up to 96% of ocular injuries being suboptimally managed. Ocular compartment syndrome (OCS) is a complication associated with orbital hemorrhage, where significant morbidity occurs as a result of increasing intracompartment pressure. The ischemic tolerance of the retina and optic nerve is approximately 90 minutes, so OCS must be rapidly diagnosed and aggressively treated through lateral canthotomy/cantholysis (LC/C) to prevent permanent vision loss. LC/C procedures consist of using hemostats to crush the lateral canthal fold and cutting the lateral canthal tendon from the inferior crus to relieve increasing intracompartment pressure. The purpose of this study was to examine the baseline capabilities of military physicians and surgeons to accurately and independently perform the LC/C procedures and identify performance gaps that could be closed through focused professional development activities.Materials and Methods: This study received institutional review board approval at our institution. A total of 60 subjects voluntarily participated in the study from emergency medicine (15), general surgery (28), and ophthalmology (17). All procedural assessments were performed 1:1 by expert faculty ocular trauma specialists using a high-reliability eye trauma simulator (Sonalysts, Inc.). The competency standard was set at independent and accurate completion of all procedural components and all critical procedural components. Analyses were performed using descriptive statistics and analysis of variance to examine between-group differences (P < 0.05).Results: There was a significant difference between the total score performance and the critical score performance for the three groups (P < 0.001). Outcomes indicate a significant linear relationship between the expertise level of the clinical provider and the procedural performance of LC/C. Outcomes demonstrate the baseline surgical capabilities of the general surgeons transferred to LC/C performance; however, they were unfamiliar with the anatomy and the procedural techniques and requirements. The group of emergency medicine participants demonstrated performance gaps not only in the same areas as the general surgeons but also in their baseline surgical abilities. This suggests that different professional development activities are necessary for surgeons and physicians tasked with performing LC/V procedures.Conclusions: We identified significant performance gaps among emergency medicine physicians, general surgeons, and ophthalmologists in their abilities to recognize and treat OCS through LC/C procedures. These sight-saving procedures are a critical competency for forward-situated clinicians in expeditionary contexts. We identified the need for targeted approaches to professional development for closing the performance gaps for both emergency medicine physicians and general surgeons. [ABSTRACT FROM AUTHOR]

Research studies involving human participants must be approved by the organization's Institutional Review Board before data collection can begin. To a frustrated novice researcher who is struggling to obtain approval, this process can, at times, feel excessively rigorous. Inhumane and unethical experiments from the past have driven the evolution of research ethics regulations. Understanding the past and present requirements of ethical research helps novice and seasoned researchers alike to better appreciate the process. This paper will briefly introduce the history, landmark reports, current regulations, and ethical issues when conducting and publishing research that includes human subjects. [ABSTRACT FROM AUTHOR]

Parental consent poses challenges to needed research with adolescents who identify as lesbian, gay, bisexual, transgender, queer and/or questioning (LGBTQ+) and are at heightened risk for negative health outcomes. Obtaining parental consent in studies focused on LGBTQ+ issues can prove arduous if adolescents have not yet disclosed their identity or have unsupportive guardians. Institutional Review Boards (IRBs) may be hesitant to grant waivers of parental consent, yet research suggests that studies requiring parental consent deter the participation of adolescents who identify as LGBTQ+. In this article, ethical considerations regarding waivers of parental consent in the context of the American Psychological Association's (APA) general ethical principles are reviewed and recommendations for psychological researchers seeking waivers of parental consent are offered. A vignette is used to demonstrate a question-and-answer guide to help determine if a waiver of parental consent is ethically justified. [ABSTRACT FROM AUTHOR]

This study explores how qualitative health researchers navigate the demands of medical research ethics committees in Germany where qualitative research is subject to approval only when it is conducted in medical contexts. We present the results of a grounded theory study to investigate qualitative health researchers' experiences with procedural ethics and the strategies they adopt to navigate its demands. Our analysis revealed six dimensions of experience and three strategies adopted by researchers to navigate the demands of medical research ethics committees. All participants agreed that research ethics is of high importance in qualitative health research, but strategies to navigate the demands of medical research ethics committees ranged from avoiding, and adapting, to transforming the procedures of ethics review. Based on our findings, we provide recommendations for improving the ethics review of qualitative health research. [ABSTRACT FROM AUTHOR]

IntroductionDespite the pressing need for primary care-based suicide prevention initiatives and growing acknowledgement of recruitment difficulties and Institutional Review Board (IRB) challenges in suicide research, we are aware of no illustrative examples describing how IRB decisions in the design of a primary care trial can compound recruitment challenges.MethodsThe CDC-funded trial (NCT02986113) of Men and Providers Preventing Suicide aimed to examine the effects of a tailored computer program encourage men with suicidal thoughts (n = 304, ages 35-64) to discuss suicide with a primary care clinician and accept treatment. Before a visit, participants viewed MAPS or a non-tailored control video. Post-visit, both arms were offered telephone collaborative care, as mandated by the institutional review board (IRB). We previously showed that exposure to MAPs led to improvements in communication about suicide in a primary care visit. In this paper, we report data on the study's primary outcome, suicide preparatory behaviors.ResultsAfter screening nearly 4100 men, 48 enrolled. Recruitment challenges, which were exacerabted by an IRB mandate narrowing post-intervention patient management differences between trial arms, limited detection of the effects of MAPS on suicide preparatory behaviors.ConclusionsWhile primary care settings are key sites for suicide prevention trials, issues such as recruitment difficulties and overly restrictive IRB requirements may limit their utility. Methodological innovation to improve recruitment and ethical guidance to inform IRB decision-making are needed.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year‐long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB. [ABSTRACT FROM AUTHOR]

This nurse-led, institutional review board-approved pilot study describes basic nursing research from the phenomenon of interest through institutional review board submission and approval process, study protocol development, study execution, and reporting both qualitative and quantitative finding. This study is underpinned with a novel nursing theory, The Steel Jacket: Antecedents of Trauma , inspired by the work of physicist David Bohm and nursing theorist Martha Rogers. The study involved 2 distinct sets of subject: nurses and trauma patients. Nurses were recruited to participate in a prestudy and poststudy of The Steel Jacket Theory. Trauma patients were interviewed to understand their lived experience of the meaning of trauma 1 year after the event. One hundred acute care nurses in a level 1 trauma center were emailed a survey about their level of empathic care and existential nursing approaches toward trauma patients. The intervention included a short module on The Steel Jacket Theory and an accompanying original 6-minute video. Simple statistics were used to tabulate findings. The second set of subjects were trauma patients who were consented and participated in 30-minute interviews. Spielberg's Phenomenological framework was used to describe themes from trauma patient's lived experiences: feeling lost, engaging in self-blame, internally fighting vulnerability and fear, marshalling inner resources to survive, and knowing that a moment in time changed their life forever. Trauma patients can benefit from Trauma Survivorship clinics and nurses need protected time to appreciate and cultivate the space to listen for what is said, perceive what is not said, and co-create a path of healing. [ABSTRACT FROM AUTHOR]

The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers' regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem. [ABSTRACT FROM AUTHOR]

Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

Problem: As community-engaged research (CER) methods evolve, Institutional Review Boards (IRBs) must adapt policies to facilitate CER research. This paper describes a novel collaboration between hospital-based therapy dog volunteer teams (CERs), academic faculty, and an IRB. Subjects: CER volunteers delivered a canine-assisted intervention to hospitalized adults in a clinical trial. Methods: IRB members and faculty developed a human subjects protections training tailored to the volunteer handlers' role as study interventionists including an interactive video- and discussion-based training with a knowledge assessment. Findings: Fourteen volunteer handlers were trained. The expedited IRB review period was similar to national average rates (18 days.) Volunteer handlers have conducted 107 research visits with little patient attrition. Conclusion: Tailored human subjects trainings facilitate research with interventions delivered by people who are not typically involved in research. Bespoke CER human subjects training requires collaboration between researchers and IRBs and flexibility in IRB policy regarding CER. [ABSTRACT FROM AUTHOR]

The ethics review of qualitative health research poses various challenges that are due to a mismatch between the current practice of ethics review and the nature of qualitative methodology. The process of obtaining ethics approval for a study by a research ethics committee before the start of a research study has been described as "procedural ethics" and the identification and handling of ethical issues by researchers during the research process as "ethics in practice." While some authors dispute and other authors defend the use of procedural ethics in relation to qualitative health research, there is general agreement that it needs to be supplemented with ethics in practice. This article aims to provide an illustration of research ethics in practice by reflecting on the ways in which we identified and addressed ethical and methodological issues that arose in the context of an interview study with mental health service users and relatives. We describe the challenges we faced and the solutions we found in relation to the potential vulnerability of research participants, the voluntariness of consent, the increase of participant access and the heterogeneity of the sample, the protection of privacy and internal confidentiality, and the consideration of personal and contextual factors. [ABSTRACT FROM AUTHOR]

Медицинская этика – это попытка определить надлежащее поведение врачей в сложных клинических и исследовательских сценариях. Это не просто теоретический вопрос, поскольку врачи и медицинские работники сталкиваются с ситуациями, когда им приходится принимать решения, касающиеся ухода за пациентами, во время исследований и повседневной практики. Хотя многие ситуации диктуют четкий курс действий, некоторые случаи представляют собой двусмысленность, требующую всестороннего понимания этического анализа. Актуальность медицинской этики сохраняется и сегодня, поскольку продолжают происходить нарушения фундаментальных этических принципов. Несмотря на принятие Хельсинкской декларации 59 лет назад, в которую каждое десятилетие вносятся обновления для решения новых проблем, нарушения основных принципов медицинской этики продолжаются, особенно среди молодых ученых и врачей-исследователей в странах, где область науки все еще развивается.

The Institutional Review Board (IRB) is fundamental to conducting ethical research involving human subjects. IRB applications require detailed descriptions of the research and specific indications of how the research will be implemented. This can be difficult for inexperienced researchers. Preparing the application is a significant time commitment, even for experienced researchers. In order to lighten the administrative burden on busy clinical professionals, this software application will automatically generate a draft human subject research protocol (the most laborious element of an IRB application) based on responses to a short form. This technology uses generative AI and a custom literature search plug-in to draft the protocol from succinct, user-provided details. User inputs include a brief description of the research, including the hypothesis, inclusion/exclusion criteria, and the study design type (e.g., randomized clinical trial). This tool can expedite the IRB application creation process, provide additional consistency for reviewers, and may reduce clinician researcher burnout through a reduction in clerical work thereby facilitating participation in meaningful research.

Background COVID-19 is a highly challenging infectious disease. Research ethics committees (RECs) have challenges reviewing research on this new pandemic disease under a tight timeline and public pressure. This study aimed to assess RECs’ responses and review during the outbreak in seven Asian countries where the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) networks are active. Methods The online survey was conducted in seven Asian countries from April to August 2021. Two sets of online questionnaires were developed, one set for the chairs/secretaries and another set for the REC members. The REC profiles obtained from the REC members are descriptive in nature. Data from the chairs/secretaries were compared between the RECs with external quality assessment (SIDCER-Recognized RECs, SR-RECs) and non-external quality assessment (Non-SIDCER-Recognized RECs, NSR-RECs) and analyzed using a Chi-squared test. Results A total of 688 REC members and 197 REC chairs/secretaries participated in the survey. Most RECs have standard operating procedures (SOPs), and have experience in reviewing all types of protocols, but 18.1% had no experience reviewing COVID-19 protocols. Most REC members need specific training on reviewing COVID-19 protocols (93%). In response to the outbreak, RECs used online reviews, increased meeting frequency and single/central REC. All SR-RECs had a member composition as required by the World Health Organisation ethics guidelines, while some NSR-RECs lacked non-affiliated and/or layperson members. SR-RECs reviewed more COVID-related product development protocols and indicated challenges in reviewing risk/benefit and vulnerability (0.010), informed consent form (0.002), and privacy and confidentiality (P = 0.020) than NSR-RECs. Conclusions Surveyed RECs had a general knowledge of REC operation and played a significant role in reviewing COVID-19-related product development protocols. Having active networks of RECs across regions to share updated information and resources could be one of the strategies to promote readiness for future public health emergencies.

Abstract Background Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value

ObjectiveThe Miami Heart Study (MiHeart) at Baptist Health South Florida is an ongoing, community-based, prospective cohort study aimed at characterizing the prevalence, characteristics, and prognostic value of diverse markers of early subclinical coronary atherosclerosis and of various potential demographic, psychosocial, and metabolic risk factors. We present the study objectives, detailed research methods, and preliminary baseline results of MiHeart.MethodsMiHeart enrolled 2,459 middle-aged male and female participants from the general population of the Greater Miami Area. Enrollment occurred between May 2015 and September 2018 and was restricted to participants aged 40-65 years free of clinical cardiovascular disease (CVD). The baseline examination included assessment of demographics, lifestyles, medical history, and a detailed evaluation of psychosocial characteristics; a comprehensive physical exam; measurement of multiple blood biomarkers including measures of inflammation, advanced lipid testing, and genomics; assessment of subclinical coronary atherosclerotic plaque and vascular function using coronary computed tomography angiography, the coronary artery calcium score, carotid intima-media thickness, pulse wave velocity, and peripheral arterial tonometry; and other tests including 12-lead electrocardiography and assessment of pulmonary function. Blood samples were biobanked to facilitate future ancillary research.ResultsMiHeart enrolled 1,261 men (51.3%) and 1,198 women (48.7%). Mean age was 53 years, 85.6% participants were White and 47.4% were of Hispanic/Latino ethnicity. The study included 7% individuals with diabetes, 33% with hypertension, and 15% used statin therapy at baseline. Overweight or obese participants comprised 72% of the population and 3% were smokers. Median 10-year estimated atherosclerotic CVD risk using the Pooled Cohort Equations was 4%.ConclusionMiHeart will provide important, novel insights into the pathophysiology of early subclinical atherosclerosis and further our understanding of its role in the genesis of clinical CVD. The study findings will have important implications, further refining current cardiovascular prevention paradigms and risk assessment and management approaches moving forward.

Background: Institutional review boards (IRBs) are formally designated to review, approve, and monitor biomedical research. They are responsible for ensuring that researchers comply with the ethical guidelines concerning human research participants. Given that IRBs might face different obstacles that cause delays in their processes or conflicts with investigators, this study aims to report the functions, roles, resources, and review process of IRBs in Saudi Arabia. Method: This was a cross-sectional self-reported survey conducted from March 2021 to March 2022. The survey was sent to 53 IRB chairpersons and the administration directors (or secretary) across the country through email after receiving verbal consent. The validated survey consisted of eight aspects: (a) organizational aspects, (b) membership and educational training, (c) submission arrangements and materials, (d) minutes, (e) review procedures, (f) communicating a decision, (g) continuing review, and (h) research ethics committee (REC) resources. A total of 200 points indicated optimal IRB functions. Results: Twenty-six IRBs across Saudi Arabia responded to the survey. Overall, the IRBs in this study scored a total of 150/200 of the points on the self-assessment tool. Relatively newer IRBs (established less than ten years ago) conducted meetings at least once in a month, had annual funding, had more balanced gender representation, tended to score higher than older IRBs. The organizational aspect score was the lowest among all items in the survey (14.3 score difference, p-value < 0.01). The average turnaround time for expedited research from proposal submission to final decision was 7 days, while it was 20.5 days for the full committee review. Conclusion: Saudi IRBs performed generally well. However, there is room for focused improvement with respect to extra resources and organizational issues that require closer evaluation and guidance from the regulatory bodies. [ABSTRACT FROM AUTHOR]

The study and the practice of collaborative research between university researchers and community entities of various types have generally focused on the organizational conditions that facilitate community partners to make use of research knowledge. In this article, we propose a conceptual innovation that absorptive capacity – the ability to identify helpful new information and to absorb and apply it in new ways – is important not only for community entities but also for universities. Using our experience of collaborating at the University of California Berkeley between scholars engaged in collaborative research and Institutional Review Board (IRB) analysts, we examine the dimensions of absorptive capacity – prior knowledge, communication pathways, strategic knowledge leadership, and resources – in the university context. The analysis generates insights that recommend 1) further research into the conditions and the processes of organizational learning for collaborative research in universities and 2) strategies for practitioners of collaborative research to strengthen and improve universities' capacity to engage in it. [ABSTRACT FROM AUTHOR]

Medical ethics is an endeavor to define appropriate conduct for doctors in complex clinical and research scenarios. It is not merely theoretical, as physicians and healthcare professionals encounter situations where they must make decisions concerning patient care during research and routine practice. While many situations dictate clear courses of action, some instances present ambiguity, requiring a comprehensive understanding of ethical analysis. The relevance of medical ethics persists today, as violations of fundamental ethical principles continue to occur. The publication is presented as a literature review using integrated search in PubMed, Scopus, Web of Science and Google Scholar databases. Search queries related to bioethics, public health and medicine were mainly used. The search depth was 10 years. Despite the issuance of the Declaration of Helsinki 59 years ago, with updates every decade to address new challenges, violations of basic medical ethics principles persist, particularly among young scientists and physician-researchers in countries where the field of science is still developing. [ABSTRACT FROM AUTHOR]

Institutional Review Boards (IRBs) are federally mandated to include both nonscientific and unaffiliated representatives in their membership. Despite this, there is no guidance or policy on the selection of unaffiliated or non-scientist members and reports indicate a lack of clarity regarding members' roles. In the present study we sought to explore processes of recruitment, training, and the perceived roles for unaffiliated and non-scientist members of IRBs. We distributed a self-administered REDCap survey of members of the Association for the Accreditation of Human Research Protection Programs familiar with IRB member recruitment. The survey included closed and open-ended questions regarding: the operation of the HRPP/IRB(s), how unaffiliated and non-scientist members are recruited, whether they had faced challenges recruiting for these roles, and training and mentorship offered. The survey also collected information regarding the perceived value and roles of unaffiliated and non-scientist members. 76 responses were included in the analysis (38% completion rate). The most common approach for recruitment was referral from current IRB members, with almost half of respondents indicating challenges recruiting unaffiliated members. Over 75% indicated no additional training was provided to unaffiliated or non-scientist members compared to affiliated or scientist members. Most common supports provided were travel/parking expenses and honoraria. Commonly perceived roles were to provide an independent voice from the participant perspective, notably regarding consent processes and materials. Respondents indicated challenges in defining unaffiliated and non-scientist members and limited practices toward recruitment and support. Future work should more closely examine the challenges in defining these roles and applying the definitions in practice, as well as strategies that may improve recruitment and retention of unaffiliated and non-scientist members. [ABSTRACT FROM AUTHOR]

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Humans are frequently exposed to Quaternary Ammonium Compounds (QACs). QACs are ubiquitously used in medical settings, restaurants, and homes as cleaners and disinfectants. Despite their prevalence, nothing is known about the health effects associated with chronic low-level exposure. Chronic QAC toxicity, only recently identified in mice, resulted in developmental, reproductive, and immune dysfunction. Cell based studies indicate increased inflammation, decreased mitochondrial function, and disruption of cholesterol synthesis. If these findings translate to human toxicity, multiple physiological processes could be affected. This study tested whether QAC concentrations could be detected in the blood of 43 human volunteers, and whether QAC concentrations influenced markers of inflammation, mitochondrial function, and cholesterol synthesis. QAC concentrations were detected in 80 % of study participants. Blood QACs were associated with increase in inflammatory cytokines, decreased mitochondrial function, and disruption of cholesterol homeostasis in a dose dependent manner. This is the first study to measure QACs in human blood, and also the first to demonstrate statistically significant relationships between blood QAC and meaningful health related biomarkers. Additionally, the results are timely in light of the increased QAC disinfectant exposure occurring due to the SARS-CoV-2 pandemic.Main findingsThis study found that 80 % of study participants contained QACs in their blood; and that markers of inflammation, mitochondrial function, and sterol homeostasis varied with blood QAC concentration.

IntroductionThe rapid expansion of artificial intelligence (AI) has produced many opportunities, but also new risks that must be actively managed, particularly in the health care sector with clinical practice to avoid unintended health, economic, and social consequences.MethodsGiven that much of the research and development (R&D) involving human subjects is reviewed and rigorously monitored by institutional review boards (IRBs), we argue that supplemental questions added to the IRB process is an efficient risk mitigation technique available for immediate use. To facilitate this, we introduce AI supplemental questions that provide a feasible, low-disruption mechanism for IRBs to elicit information necessary to inform the review of AI proposals. These questions will also be relevant to review of research using AI that is exempt from the requirement of IRB review. We pilot the questions within the Department of Veterans Affairs–the nation's largest integrated healthcare system–and demonstrate its efficacy in risk mitigation through providing vital information in a way accessible to non-AI subject matter experts responsible for reviewing IRB proposals. We provide these questions for other organizations to adapt to fit their needs and are further developing these questions into an AI IRB module with an extended application, review checklist, informed consent, and other informational materials.ResultsWe find that the supplemental AI IRB module further streamlines and expedites the review of IRB projects. We also find that the module has a positive effect on reviewers' attitudes and ease of assessing the potential alignment and risks associated with proposed projects.DiscussionAs projects increasingly contain an AI component, streamlining their review and assessment is important to avoid posing too large of a burden on IRBs in their review of submissions. In addition, establishing a minimum standard that submissions must adhere to will help ensure that all projects are at least aware of potential risks unique to AI and dialogue with their local IRBs over them. Further work is needed to apply these concepts to other non-IRB pathways, like quality improvement projects.

Objective: To map literature on research ethics committees, institutional review boards and ethics review framework in Pakistan to identify key insights during public health emergencies and normal times. Method: The systematic scoping review was conducted in April 22, and comprised literature search on PubMed, World Health Organisation Global Index Medicus and Summons databases for articles published between January 2005 and February 2022. Information extracted included authors’ names, year of publication, title, study methodology, and key insights under the heads of challenges and solutions. Due to data heterogeneity, key themes were identified and analysed. Results: Of the 2,190 studies initially identified, 21(0.95%) were subjected to full-text review, and, from among them, 9(45%) were analysed in detail. There were 4 key insights identified: research ethics committees and institutional review boards in Pakistan remain unregulated as they are currently not registered or accredited by a competent national-level authority; most members of such committees are not formally trained to implement the mandate; internal and external pressures hinder independent decision-making of such committees; and other issues hindering the functionality and performance of research ethics committees and institutional review boards. Conclusion: Despite existing publications calling for urgent policy and regulatory reforms, there is a dearth of literature and minimal policy actions underline the fact that ethics review remains a neglected area in Pakistan. Key Words: Ethics, Pakistan, Bioethics, Ethics committees, Institutional review board.