Enhancing trauma care through innovative trauma and disaster team response training: A blended learning approach in Tanzania.

BACKGROUND: In Tanzania, inadequate infrastructures and shortages of trauma-response training exacerbate trauma-related fatalities. McGill University's Centre for Global Surgery introduced the Trauma and Disaster Team Response course (TDTR) to address these challenges. This study assesses the impact of simulation-based TDTR training on care providers' knowledge/skills and healthcare processes to enhance patient outcomes. METHODS: The study used a pre-post-interventional design. TDTR, led by Tanzanian instructors at Muhimbili Orthopedic Institute from August 16-18, 2023, involved 22 participants in blended online and in-person approaches with simulated skills sessions. Validated tools assessed participants' knowledge/skills and teamwork pre/post-interventions, alongside feedback surveys. Outcome measures included evaluating 24-h emergency department patient arrival-to-care time pre-/post-TDTR interventions, analyzed using parametric and non-parametric tests based on data distributions. RESULTS: Participants' self-assessment skills significantly improved (median increase from 34 to 58, p < 0.001), along with teamwork (median increase from 44.5 to 87.5, p < 0.003). While 99% of participants expressed satisfaction with TDTR meeting their expectations, 97% were interested in teaching future sessions. The six-month post-intervention arrival-to-care time significantly decreased from 29 to 13 min, indicating a 55.17% improvement (p < 0.004). The intervention led to fewer ward admissions (35.26% from 51.67%) and more directed to operating theaters (29.83% from 16.85%), suggesting improved patient management (p < 0.018). CONCLUSION: The study confirmed surgical skills training effectiveness in Tanzanian settings, highlighting TDTR's role in improving teamwork and healthcare processes that enhanced patient outcomes. To sustain progress and empower independent trauma educators, ongoing refresher sessions and expanding TDTR across low- and middle-income countries are recommended to align with global surgery goals.

Repeat imaging increases detection of delayed pseudoaneurysms in patients with high-grade solid organ injury following abdominal trauma.

BACKGROUND: Nonoperative management of abdominal trauma can be complicated by the development of delayed pseudoaneurysms. Early intervention reduces the risk of rupture and decreases mortality. The objective of this study is to determine the utility of repeat computed tomography (CT) imaging in detecting delayed pseudoaneurysms in patients with abdominal solid organ injury. METHODS: A retrospective cohort study reviewing Montreal General Hospital registry between 2013 and 2019. Patients with The American Association for the Surgery of Trauma (AAST) grade 3 or higher solid organ injury following abdominal trauma were identified. A chart review was completed, and demographics, mechanism of injury, Injury Severity Score (ISS) score, AAST injury grade, CT imaging reports, and interventions were collected. Descriptive analysis and logistic regression model were completed. RESULTS: We identified 195 patients with 214 solid organ injuries. The average age was 38.6 years; 28.2% were female, 90.3% had blunt trauma, and 9.7% had penetrating trauma. The average ISS score was 25.4 (SD 12.8) in patients without pseudoaneurysms and 19.5 (SD 8.6) in those who subsequently developed pseudoaneurysms. The initial management was nonoperative in 57.0% of the patients; 30.4% had initial angioembolization, and 12.6% went to the operating room. Of the cohort, 11.7% had pseudoaneurysms detected on repeat CT imaging within 72 h. Grade 3 represents the majority of the injuries at 68.0%. The majority of these patients underwent angioembolization. CONCLUSIONS: In patients with high-grade solid organ injury following abdominal trauma, repeat CT imaging within 72 h enabled the detection of delayed development of pseudoaneurysms in 11.7% of injuries. The majority of the patients were asymptomatic.

Predictors of clinical deterioration and intensive care unit admission in trauma patients transferred from northern Quebec to a level 1 trauma centre: a retrospective cohort study.

BACKGROUND: Trauma care in Nunavik, Quebec, is highly challenging. Geographic distances and delays in transport can translate into precarious patient transfers to tertiary trauma care centres. The objective of this study was to identify predictors of clinical deterioration during transport and eventual intensive care unit (ICU) admission for trauma patients transferred from Nunavik to a tertiary trauma care centre. METHODS: This is a retrospective cohort study using the Montreal General Hospital (MGH) trauma registry. All adult trauma patients transferred from Nunavik and admitted to the MGH from 2010 to 2019 were included. Main outcomes of interest were hemodynamic and neurologic deterioration during transport and ICU admission. RESULTS: In total, 704 patients were transferred from Nunavik and admitted to the MGH during the study period. The median age was 33 (interquartile range [IQR] 23-47) years and the median Injury Severity Score was 10 (IQR 5-17). On multiple regression analysis, transport time from site of injury to the MGH (odds ratio [OR] 1.04, 95% confidence interval [CI] 1.01-1.06), thoracic injuries (OR 1.75, 95% CI 1.03-2.99), and head and neck injuries (OR 3.76, 95% CI 2.10-6.76) predicted clinical deterioration during transfer. Injury Severity Score (OR 1.04, 95% CI 1.01-1.08), abnormal local Glasgow Coma Scale score (OR 2.57, 95% CI 1.34-4.95), clinical deterioration during transfer (OR 4.22, 95% CI 1.99-8.93), traumatic brain injury (OR 2.44, 95% CI 1.05-5.68), and transfusion requirement at the MGH (OR 4.63, 95% CI 2.35-9.09) were independent predictors of ICU admission. CONCLUSION: Our study identified several predictors of clinical deterioration during transfer and eventual ICU admission for trauma patients transferred from Nunavik. These factors could be used to refine triage criteria in Nunavik for more timely evacuation and higher level care during transport.

Vascular access complications associated with resuscitative endovascular balloon occlusion of the aorta in adult trauma patients: A systematic review and meta-analysis.

BACKGROUND: Resuscitative endovascular balloon occlusion of the aorta (REBOA) is gaining popularity worldwide for managing hypotensive trauma patients. Vascular access complications related to REBOA placement have been reported, with some cases resulting in permanent morbidity. We aim to capitalize on the increase in literature to further describe and estimate the incidence of REBOA-associated vascular access complications in adult trauma patients. METHODS: We searched Medline, EMBASE, Scopus, and CINAHL for studies reporting vascular access complications of REBOA in adult trauma patients from inception to October 14, 2021. Studies reporting data from adult trauma patients who underwent REBOA insertion were eligible. Exclusion criteria included patients 15 years and younger, nontrauma patients, non-REBOA use, non-vascular access complications and patient duplication. Study data was abstracted using the PRISMA checklist and verified independently by three reviewers. Meta-analysis of proportions was performed using a random effects model with Freeman-Turkey double-arcsine transformation. Post hoc meta-regression by year of publication, sheath-size, and geographic region was also performed. The incidence of vascular access complications from REBOA insertion was the primary outcome of interest. Subgroup analysis was performed by degree of bias, sheath size, technique of vascular access, provider specialty, geographical region, and publication year. RESULTS: Twenty-four articles were included in the systematic review and the meta-analysis, for a total of 675 trauma patients who underwent REBOA insertion. The incidence of vascular access complications was 8% (95% confidence interval, 5%-13%). In post hoc meta-regression adjusting for year of publication and geographic region, the use of a smaller (7-Fr) sheath was associated with a decreased incidence of vascular access complications (odds ratio, 0.87; 95% confidence interval, 0.75-0.99; p = 0.046; R 2 = 35%; I 2 = 48%). CONCLUSION: This study provides a benchmark for quality of care in terms of vascular access complications related to REBOA insertion in adult trauma patients. Smaller sheath size may be associated with a decrease in vascular access complications. LEVEL OF EVIDENCE: Systematic Review and Meta-Analysis; Level III.

Surgical, trauma and telehealth capacity in Indigenous communities in Northern Quebec: a cross-sectional survey.

BACKGROUND: Delivering trauma and surgical care to Northern Quebec presents unique challenges owing to the region's remoteness, extreme weather and limited transport; the expansion of telehealth could help address these difficulties. We aimed to evaluate current surgical, trauma and telemedicine capacity in Nunavik, Quebec. METHODS: We used validated assessment tools, including the Personnel, Infrastructure, Procedures, Equipment and Supplies survey, the International Assessment of Capacity for Trauma index and the Maryland Health Care Commission Telemedicine Readiness tool to evaluate surgical, trauma and telemedicine capacity, respectively. We adapted these tools to the Northern Quebec context through discussions with local leadership. Data were collected in 2 regional hospitals - the Ungava Tulattavik Health Centre (UTHC) and the Inuulitsivik Health Centre (IHC) - and 12 Centres locaux de services communautaires (CLSCs; local community services centres) in 6 villages along the Hudson Bay coast and 6 villages along the Ungava Bay coast through iterative discussions with 4 chief nurses from each regional hospital and set of CLSCs; resources were confirmed through on-site evaluation by the respondents. We performed a descriptive analysis of the data. RESULTS: Surgical capacity was highest in the IHC (6.76) and lowest in the Ungava Bay CLSCs (5.52). Personnel (0%-0%) and procedures (13%-33%) were the least available resources. Trauma capacity was highest in the IHC (7.25) and lowest in the Hudson Bay CLSCs (5.58). Although equipment (90%-100%) and supplies (100%-100%) were readily available, personnel (0%-0%) and procedures (25%-56%) were lacking. The UTHC was most prepared for telehealth (67.80%), and the Ungava Bay CLSCs achieved a lower score (51.13%). Underdeveloped telehealth criteria included funding, administrative support, quality improvement and physical spaces (all 33%-67%). CONCLUSION: Acute care capacity in Nunavik appears heterogeneous, with readily available equipment and supplies, but a lack of personnel capable of performing lifesaving procedures. To address the need for telemedicine, future initiatives should focus on improving funding, administrative support, physical spaces and quality-improvement initiatives.

Small-Volume Blood Collection Tubes to Reduce Transfusions in Intensive Care: The STRATUS Randomized Clinical Trial.

Importance: Blood collection for laboratory testing in intensive care unit (ICU) patients is a modifiable contributor to anemia and red blood cell (RBC) transfusion. Most blood withdrawn is not required for analysis and is discarded. Objective: To determine whether transitioning from standard-volume to small-volume vacuum tubes for blood collection in ICUs reduces RBC transfusion without compromising laboratory testing procedures. Design, Setting, and Participants: Stepped-wedge cluster randomized trial in 25 adult medical-surgical ICUs in Canada (February 5, 2019 to January 21, 2021). Interventions: ICUs were randomized to transition from standard-volume (n = 10 940) to small-volume tubes (n = 10 261) for laboratory testing. Main Outcomes and Measures: The primary outcome was RBC transfusion (units per patient per ICU stay). Secondary outcomes were patients receiving at least 1 RBC transfusion, hemoglobin decrease during ICU stay (adjusted for RBC transfusion), specimens with insufficient volume for testing, length of stay in the ICU and hospital, and mortality in the ICU and hospital. The primary analysis included patients admitted for 48 hours or more, excluding those admitted during a 5.5-month COVID-19-related trial hiatus. Results: In the primary analysis of 21 201 patients (mean age, 63.5 years; 39.9% female), which excluded 6210 patients admitted during the early COVID-19 pandemic, there was no significant difference in RBC units per patient per ICU stay (relative risk [RR], 0.91 [95% CI, 0.79 to 1.05]; P = .19; absolute reduction of 7.24 RBC units/100 patients per ICU stay [95% CI, -3.28 to 19.44]). In a prespecified secondary analysis (n = 27 411 patients), RBC units per patient per ICU stay decreased after transition from standard-volume to small-volume tubes (RR, 0.88 [95% CI, 0.77 to 1.00]; P = .04; absolute reduction of 9.84 RBC units/100 patients per ICU stay [95% CI, 0.24 to 20.76]). Median decrease in transfusion-adjusted hemoglobin was not statistically different in the primary population (mean difference, 0.10 g/dL [95% CI, -0.04 to 0.23]) and lower in the secondary population (mean difference, 0.17 g/dL [95% CI, 0.05 to 0.29]). Specimens with insufficient quantity for analysis were rare (≤0.03%) before and after transition. Conclusions and Relevance: Use of small-volume blood collection tubes in the ICU may decrease RBC transfusions without affecting laboratory analysis. Trial Registration: ClinicalTrials.gov Identifier: NCT03578419.

Virtual trauma patient simulation design using the McGill Simulation Complexity Score (MSCS): a breakthrough in trauma education.

BACKGROUND: Virtual patient simulations are interactive, computer-based cases. We designed scenarios based on the McGill Simulation Complexity Score (MSCS), a previously described objective complexity score. We aimed to establish validity of the MSCS and introduce a novel learning tool in trauma education at our institution. METHODS: After design of an easy and difficult patient scenario, we randomized medical students and residents to each perform 1 of the 2 scenarios. We conducted a 2-way analysis of variance of training level (medical student, resident) and scenario complexity (easy, difficult) to assess their effects on virtual time, the number of steps taken in the scenario, beneficial and harmful actions, and the ratio of beneficial over harmful actions. RESULTS: Virtual patient scenarios were successfully designed using the MSCS. Twenty-four medical students and 12 residents participated in the easy scenario (MSCS = 3), and 27 medical students and 12 residents did the difficult scenario (MSCS = 18). Though beneficial actions were similar between students and residents, sudents performed more harmful actions, particularly when the scenario was difficult. One virtual patient died in the easy scenario and 3 died in the difficult one (all medical students). Performance varied with level of complexity and there was significant interaction between level of training and number of steps, as well as with number of harmful actions. Decreasing performance with increasing level of complexity, as defined by the MSCS, suggests this score can accurately quantify difficulty. CONCLUSION: We established validity of the MSCS and showed its successful application on virtual patient scenario design.

The McGill Simulation Complexity Score (MSCS): a novel complexity scoring system for simulations in trauma.

BACKGROUND: In medical education, simulation can be defined as an activity in which an individual demonstrates skills, procedures and critical thinking using interactive mannequins in a setting closely resembling the clinical environment. To our knowledge, the complexity of trauma simulations has not previously been assessed. We aimed to develop an objective trauma simulation complexity score and assess its interrater reliability. METHODS: The McGill Simulation Complexity Score (MSCS) was designed to address the need for objective evaluation of the complexity of trauma scenarios. Components of the score reflected the Advanced Trauma Life Support approach to trauma. The score was developed to take into account the severity of trauma injuries and the complexity of their management. We assessed interrater reliability at 5 high-fidelity simulation events. Interrater reliability was calculated using the Pearson correlation coefficient (PCC) and the intraclass correlation coefficient (ICC). RESULTS: The MSCS has 5 categories: airway, breathing, circulation, disability, and extremities or exposure. The scale has 5 levels for each category, from 0 to 4; level increases with complexity, with 0 corresponding to normal or absent. Cases designed to lead to cardiac arrest, regardless of whether or not the trainee has the ability to resuscitate the simulated patient and regardless of the level of each category, are automatically assigned the maximum score. Between 3 and 9 raters used the MSCS to grade the level of complexity of 26 scenarios at the 5 events. The mean MSCS was 10.2 (range 3.0-20.0). Mean PCC and ICC values were both above 0.7 and therefore statistically significant. CONCLUSION: The MSCS for trauma is an innovative scoring system with high interrater reliability.

Definitions, rates and associated mortality of ICU-acquired pneumonia: A multicenter cohort study.

INTRODUCTION: We aimed to analyze intensive care unit (ICU)-acquired pneumonia according to 7 definitions, estimating associated hospital mortality. METHODS: This cohort study was nested within an international randomized trial, evaluating the effect of probiotics on ICU-acquired pneumonia in 2650 mechanically ventilated adults. Each clinically suspected pneumonia was adjudicated by two physicians blinded to allocation and center. The primary outcome was ventilator-associated pneumonia (VAP) informed by ventilation for ≥2 days, new, progressive or persistent infiltrate plus 2 of: temperature > 38 °C or < 36 °C; leukopenia (<3 × 10(Fernando et al., 20206)/L) or leukocytosis (>10 × 10(Fernando et al., 20206)/L); and purulent sputum. We also used 6 other definitions estimating the risk of hospital mortality. RESULTS: The frequency of ICU-acquired pneumonia varied by definition: the trial primary outcome VAP (21.6%), Clinical Pulmonary Infection Score (CPIS) (24.9%), American College Chest Physicians (ACCP) (25.0%), International Sepsis Forum (ISF) (24.4%), Reducing Oxidative Stress Study (REDOXS) (17.6%), Centers for Disease Control (CDC) (7.8%), and invasively microbiologically confirmed (1.9%). The trial primary outcome VAP (HR 1.31 [1.08, 1.60]), ISF (HR 1.32 [1.09,1.60]), CPIS (HR 1.30 [1.08,1.58]) and ACCP definitions (HR 1.22 [1.00,1.47]) were associated with hospital mortality. CONCLUSIONS: Rates of ICU-acquired pneumonia vary by definition and are associated with differential increased risk of death.

Factors associated with bicycle helmet use and proper fit: a cross-sectional survey of Montreal cyclists during the COVID-19 pandemic.

OBJECTIVES: With increased bicycle use during the COVID-19 pandemic and growing availability of bicycle-sharing programs in Montreal, we hypothesize helmet use has decreased. The aim of this study was to evaluate helmet use and proper fit among Montreal cyclists during the pandemic relative to historical data. METHODS: Nine observers collected data on bike type, gender, helmet use, and ethnicity using the iHelmet© app at 18 locations across the island of Montreal from June to September 2021. Proper helmet wear was assessed at one busy location. Multiple logistic regression was used to identify factors associated with helmet wear and results were compared to a historical study. RESULTS: Of the 2200 cyclists observed, 1109 (50.4%) wore a helmet. Males (OR = 0.78, 95%CI = 0.65-0.95), young adults (OR = 0.65, 95%CI = 0.51-0.84), visible minorities (OR = 0.38, 95%CI = 0.28-0.53), and bike-share users (OR = 0.21, 95%CI = 0.15-0.28) were less likely to be wearing a helmet, whereas children (OR = 3.92, 95%CI = 2.17-7.08) and cyclists using racing bicycles (OR = 3.84, 95%CI = 2.62-5.62) were more likely to be wearing a helmet. The majority (139/213; 65.3%) of assessed cyclists wore properly fitting helmets. Children had the lowest odds of having a properly fitted helmet (OR = 0.13, 95%CI = 0.04-0.41). Compared to 2011, helmet use during the pandemic increased significantly (1109/2200 (50.4%) vs. 2192/4789 (45.8%); p = 0.032). CONCLUSION: Helmet use among Montreal cyclists was associated with age, gender, ethnicity, and type of bicycle. Children were least likely to have a properly fitted helmet. The recent increase in popularity of cycling and expansion of bicycle-sharing programs reinforce the need for bicycle helmet awareness initiatives, legislation, and funding prioritization.

RéSUMé: OBJECTIF: Avec la popularité grandissante du vélo durant la pandémie COVID-19 et l'expansion du vélopartage à Montréal, nous croyons que le port du casque a diminué. L'objectif de cette étude était d'évaluer l'utilisation du casque et le port adéquat parmi les cyclistes montréalais et de comparer nos résultats avec des données historiques. MéTHODE: Neuf observateurs, stationnés à 18 emplacements, ont recueilli les informations suivantes en utilisant l'application mobile iHelmet© : type de vélo, sexe, origine ethnique et port du casque. Le port adéquat du casque a été observé à un endroit. L'association de chaque variable avec le port et le port adéquat a été fait par régression multivariable et comparé à des données historiques. RéSULTATS: Des 2 200 cyclistes observés, 1 109 (50,4 %) portaient un casque. Les enfants (OR = 3,92, IC95% = 2,17­7,08) et les cyclistes de performance (OR = 3,84, IC95% = 2,62­5,62) portaient le casque plus fréquemment tandis que les hommes (OR = 0,78, IC95% = 0,65­0,95), les jeunes adultes (OR = 0,65, IC95% = 0,51­0,84), les minorités visibles (OR = 0,38, IC95% = 0,28­0,53), et les utilisateurs de vélopartage (OR = 0,21, IC95% = 0,15­0,28) le portaient moins. La majorité (139/213; 65,3 %) des casques étaient portés adéquatement. Les enfants étaient plus à risque de porter un casque mal ajusté (OR = 0,13, IC95% = 0,04­0,41). L'utilisation d'un casque chez les cyclistes montréalais a augmenté significativement depuis 2011 (1 109/2 200 (50,4 %) c. 2 192/4 789 (45,8 %); p = 0,032). CONCLUSION: Le port du casque à vélo à Montréal est associé à l'âge, le sexe, l'origine ethnique et le type de vélo. Les enfants sont plus à risque de mal porter un casque. Des stratégies de promotion ainsi que la législation peuvent favoriser des comportements sécuritaires à vélo.

Percutaneous Tracheostomy With a Demistifier Canopy in the COVID-19 Era: A Safe Technique in the Intensive Care Unit.

BACKGROUND: Endoscopic percutaneous tracheostomy (PT) is a safe technique that is performed frequently by otolaryngologists and intensivists. New challenges have been identified in order to maintain the safety of this procedure during the COVID-19 pandemic. A novel approach, using a modified demistifier canopy, was developed during the first wave of the pandemic and implemented for 17 consecutive percutaneous tracheostomies in order to enhance procedural safety. METHODS: A protocol was developed after performing a literature review of tracheostomy in COVID-19 patients. A multidisciplinary tracheostomy team was established, including the departments of otolaryngology, critical care, and respiratory therapy. Simulation was performed prior to each PT, and postoperative debriefings were done. RESULTS: A protocol and technical description of PT using a modified demistifier canopy covering was written and video documented. Data were collected on 17 patients who underwent this procedure safely in our tertiary care hospital. There were no procedure-related complications, and no evidence of COVID-19 transmission to any member of the health care team during the study period. CONCLUSION: As patients continue to recover from COVID-19, their need for tracheostomy will increase. The technique described provides a safe, multidisciplinary method of performing PT in COVID-19 patients.

Cost-effectiveness of remdesivir plus usual care versus usual care alone for hospitalized patients with COVID-19: an economic evaluation as part of the Canadian Treatments for COVID-19 (CATCO) randomized clinical trial.

BACKGROUND: The role of remdesivir in the treatment of hospitalized patients with COVID-19 remains ill-defined. We conducted a cost-effectiveness analysis alongside the Canadian Treatments for COVID-19 (CATCO) open-label, randomized clinical trial evaluating remdesivir. METHODS: Patients with COVID-19 in Canadian hospitals from Aug. 14, 2020, to Apr. 1, 2021, were randomly assigned to receive remdesivir plus usual care versus usual care alone. Taking a public health care payer's perspective, we collected in-hospital outcomes and health care resource utilization alongside estimated unit costs in 2020 Canadian dollars over a time horizon from randomization to hospital discharge or death. Data from 1281 adults admitted to 52 hospitals in 6 Canadian provinces were analyzed. RESULTS: The total mean cost per patient was $37 918 (standard deviation [SD] $42 413; 95% confidence interval [CI] $34 617 to $41 220) for patients randomly assigned to the remdesivir group and $38 026 (SD $46 021; 95% CI $34 480 to $41 573) for patients receiving usual care (incremental cost -$108 [95% CI -$4953 to $4737], p > 0.9). The difference in proportions of in-hospital deaths between remdesivir and usual care groups was -3.9% (18.7% v. 22.6%, 95% CI -8.3% to 1.0%, p = 0.09). The difference in proportions of incident invasive mechanical ventilation events between groups was -7.0% (8.0% v. 15.0%, 95% CI -10.6% to -3.4%, p = 0.006), whereas the difference in proportions of total mechanical ventilation events between groups was -5.7% (16.4% v. 22.1%, 95% CI -10.0% to -1.4%, p = 0.01). Remdesivir was the dominant intervention (but only marginally less costly, with mildly lower mortality) with an incalculable incremental cost effectiveness ratio; we report results of incremental costs and incremental effects separately. For willingness-to-pay thresholds of $0, $20 000, $50 000 and $100 000 per death averted, a strategy using remdesivir was cost-effective in 60%, 67%, 74% and 79% of simulations, respectively. The remdesivir costs were the fifth highest cost driver, offset by shorter lengths of stay and less mechanical ventilation. INTERPRETATION: From a health care payer perspective, treating patients hospitalized with COVID-19 with remdesivir and usual care appears to be preferrable to treating with usual care alone, albeit with marginal incremental cost and small clinical effects. The added cost of remdesivir was offset by shorter lengths of stay in the intensive care unit and less need for ventilation. STUDY REGISTRATION: ClinicalTrials. gov, no. NCT04330690.

Health economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): a cost-effectiveness analysis.

PURPOSE: We sought to compare the cost-effectiveness of probiotics and usual care with usual care without probiotics in mechanically ventilated, intensive care unit patients alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (PROSPECT). METHODS: We conducted a health economic evaluation alongside the PROSPECT randomized control trial (October 2013-March 2019). We adopted a public healthcare payer's perspective. Forty-four intensive care units in three countries (Canada/USA/Saudi Arabia) with adult critically ill, mechanically ventilated patients (N = 2,650) were included. Interventions were probiotics (Lactobacillus rhamnosus GG) vs placebo administered enterally twice daily. We collected healthcare resource use and estimated unit costs in 2019 United States dollars (USD) over a time horizon from randomization to hospital discharge/death. We calculated incremental cost-effectiveness ratios (ICERs) comparing probiotics vs usual care. The primary outcome was incremental cost per ventilator-associated pneumonia (VAP) event averted; secondary outcomes were costs per Clostridioides difficile-associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD), and mortality averted. Uncertainty was investigated using nonparametric bootstrapping and sensitivity analyses. RESULTS: Mean (standard deviation [SD]) cost per patient was USD 66,914 (91,098) for patients randomized to probiotics, with a median [interquartile range (IQR)] of USD 42,947 [22,239 to 76,205]. By comparison, for those not receiving probiotics, mean (SD) cost per patient was USD 62,701 (78,676) (median [IQR], USD 41,102 [23,170 to 75,140]; incremental cost, USD 4,213; 95% confidence interval [CI], -2,269 to 10,708). Incremental cost-effectiveness ratios for VAP or AAD events averted, probiotics were dominated by usual care (more expensive, with similar effectiveness). The ICERs were USD 1,473,400 per CDAD event averted (95% CI, undefined) and USD 396,764 per death averted (95% CI, undefined). Cost-effectiveness acceptability curves reveal that probiotics were not cost-effective across wide ranges of plausible willingness-to-pay thresholds. Sensitivity analyses did not change the conclusions. CONCLUSIONS: Probiotics for VAP prevention among critically ill patients were not cost-effective. Study registration data www. CLINICALTRIALS: gov (NCT01782755); registered 4 February 2013.

RéSUMé: OBJECTIF: Nous avons cherché à comparer le rapport coût-efficacité d'un traitement avec probiotiques ajoutés aux soins habituels avec des soins habituels prodigués sans probiotiques chez les patients des soins intensifs sous ventilation mécanique dans le cadre de l'étude PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial). MéTHODE: Nous avons réalisé une évaluation de l'économie de la santé parallèlement à l'étude randomisée contrôlée PROSPECT (octobre 2013-mars 2019). Nous avons adopté le point de vue d'un payeur public de services de santé. Quarante-quatre unités de soins intensifs dans trois pays (Canada/États-Unis/Arabie saoudite) prenant soin de patients adultes gravement malades sous ventilation mécanique (n = 2650) ont été inclus. Les interventions ont été les suivantes : probiotiques (Lactobacillus rhamnosus GG) vs placebo administrés par voie entérale deux fois par jour. Nous avons recueilli les données concernant l'utilisation des ressources en soins de santé et estimé les coûts unitaires en dollars américains (USD) de 2019 sur un horizon temporel allant de la randomisation au congé de l'hôpital / décès. Nous avons calculé des rapports coût-efficacité différentiels (RCED) en comparant les probiotiques vs les soins habituels. Le critère d'évaluation principal était le coût différentiel par événement évité de pneumonie associée au ventilateur (PAV); les critères d'évaluation secondaires étaient les coûts par diarrhée associée au Clostridioides difficile (DACD), diarrhée associée aux antibiotiques (DAA) et mortalité évitées. L'incertitude a été étudiée à l'aide d'analyses d'amorçage et de sensibilité non paramétriques. RéSULTATS: Le coût moyen (écart type [ÉT]) par patient était de 66 914 (91 098) USD pour les patients randomisés au groupe probiotiques, avec une médiane [écart interquartile (ÉIQ)] de 42 947 USD [22 239 à 76 205]. En comparaison, pour ceux ne recevant pas de probiotiques, le coût moyen (ÉT) par patient était de 62 701 USD (78 676) (médiane [ÉIQ], 41 102 USD [23 170 à 75 140]; coût différentiel, 4213 USD; intervalle de confiance [IC] à 95%, -2269 à 10 708). En matière de rapports coût-efficacité différentiels pour les événements de PAV ou DAA évités, les probiotiques étaient dominés par les soins habituels (plus coûteux, avec une efficacité similaire). Les RCED étaient de 1 473 400 USD par événement de DACD évitée (IC 95 %, non défini) et de 396 764 USD par décès évité (IC 95 %, non défini). Les courbes d'acceptabilité coût-efficacité révèlent que les probiotiques n'étaient pas rentables dans de larges gammes de seuils plausibles de volonté de payer. Les analyses de sensibilité n'ont pas modifié les conclusions. CONCLUSION: Les probiotiques utilisés pour prévenir la PAV chez les patients gravement malades n'étaient pas rentables. Enregistrement de l'étude : www.clinicaltrials.gov (NCT01782755); enregistrée le 4 février 2013.

Haemoglobin transfusion threshold in traumatic brain injury optimisation (HEMOTION): a multicentre, randomised, clinical trial protocol.

INTRODUCTION: Traumatic brain injury (TBI) is the leading cause of mortality and long-term disability in young adults. Despite the high prevalence of anaemia and red blood cell transfusion in patients with TBI, the optimal haemoglobin (Hb) transfusion threshold is unknown. We undertook a randomised trial to evaluate whether a liberal transfusion strategy improves clinical outcomes compared with a restrictive strategy. METHODS AND ANALYSIS: HEMOglobin Transfusion Threshold in Traumatic Brain Injury OptimizatiON is an international pragmatic randomised open label blinded-endpoint clinical trial. We will include 742 adult patients admitted to an intensive care unit (ICU) with an acute moderate or severe blunt TBI (Glasgow Coma Scale ≤12) and a Hb level ≤100 g/L. Patients are randomly allocated using a 1:1 ratio, stratified by site, to a liberal (triggered by Hb ≤100 g/L) or a restrictive (triggered by Hb ≤70 g/L) transfusion strategy applied from the time of randomisation to the decision to withdraw life-sustaining therapies, ICU discharge or death. Primary and secondary outcomes are assessed centrally by trained research personnel blinded to the intervention. The primary outcome is the Glasgow Outcome Scale extended at 6 months. Secondary outcomes include overall functional independence measure, overall quality of life (EuroQoL 5-Dimension 5-Level; EQ-5D-5L), TBI-specific quality of life (Quality of Life after Brain Injury; QOLIBRI), depression (Patient Health Questionnaire; PHQ-9) and mortality. ETHICS AND DISSEMINATION: This trial is approved by the CHU de Québec-Université Laval research ethics board (MP-20-2018-3706) and ethic boards at all participating sites. Our results will be published and shared with relevant organisations and healthcare professionals. TRIAL REGISTRATION NUMBER: NCT03260478.

Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. Objective: To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. Design, Setting, and Participants: This parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. Interventions: Patients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. Main Outcomes and Measures: Main outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle. Results: A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Low-dose trimethoprim-sulfamethoxazole for the treatment of Pneumocystis jirovecii pneumonia (LOW-TMP): protocol for a phase III randomised, placebo-controlled, dose-comparison trial.

INTRODUCTION: Pneumocystis jirovecii pneumonia (PJP) is an opportunistic infection of immunocompromised hosts with significant morbidity and mortality. The current standard of care, trimethoprim-sulfamethoxazole (TMP-SMX) at a dose of 15-20 mg/kg/day, is associated with serious adverse drug events (ADE) in 20%-60% of patients. ADEs include hypersensitivity reactions, drug-induced liver injury, cytopenias and renal failure, all of which can be treatment limiting. In a recent meta-analysis of observational studies, reduced dose TMP-SMX for the treatment of PJP was associated with fewer ADEs, without increased mortality. METHODS AND ANALYSIS: A phase III randomised, placebo-controlled, trial to directly compare the efficacy and safety of low-dose TMP-SMX (10 mg/kg/day of TMP) with the standard of care (15 mg/kg/day of TMP) among patients with PJP, for a composite primary outcome of change of treatment, new mechanical ventilation, or death. The trial will be undertaken at 16 Canadian hospitals. Data will be analysed as intention to treat. Primary and secondary outcomes will be compared using logistic regression adjusting for stratification and presented with 95% CI. ETHICS AND DISSEMINATION: This study has been conditionally approved by the McGill University Health Centre; Ethics approval will be obtained from all participating centres. Results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT04851015.

Penn State equation versus indirect calorimetry for nutritional assessment in patients with traumatic brain injury.

BACKGROUND: Nutritional assessment can be challenging in patients with traumatic brain injury (TBI), and indirect calorimetry may be a more suitable method than predictive equations. We compared the Penn State equation versus the gold standard of indirect calorimetry for the nutritional assessment of patients with TBI, and quantified the difference between nutritional requirements and actual patient intake. METHODS: This single-centre, prospective cohort study included patients with moderate (Glasgow Coma Scale score 9-12) and severe (Glasgow Coma Scale score 3-8) TBI admitted to the Montreal General Hospital intensive care unit (ICU) between June 2018 and March 2019. Penn State equation estimates and indirect calorimetry measurements were collected, and actual intake was drawn from medical records. We compared the 2 assessment methods using a Spearman correlation coefficient. RESULTS: Twenty-three patients with TBI (moderate in 7 and severe in 16) were included in the study. Overall, there was a moderate positive correlation between the Penn State equation estimate and indirect calorimetry readings (correlation coefficient 0.457, p = 0.03); however, the correlation was weaker in severe TBI (correlation coefficient 0.174, p = 0.5) than in moderate TBI (correlation coefficient 0.929, p = 0.003). When compared to indirect calorimetry assessment, patients received 5.4% (p = 0.5) of required intake on the first day and 43.9% (p = 0.8) of required daily intake throughout their ICU stay. CONCLUSION: Patients with moderate or severe TBI in the ICU received less than 50% of their nutritional requirements. The difference between the Penn State equation and indirect calorimetry assessments was most noticeable for patients with severe TBI, which indicates that indirect calorimetry may be a more suitable tool for assessment of nutritional needs in this population.

Resuscitative endovascular balloon occlusion of the aorta in Canada: a context-specific position paper from the Canadian Collaborative for Urgent Care Surgery (CANUCS).

SummaryResuscitative endovascular balloon occlusion of the aorta (REBOA) is a well-described intervention for noncompressible torso hemorrhage. Several Canadian centres have included REBOA in their hemorrhagic shock protocols. However, REBOA has known complications and equipoise regarding its use persists. The Canadian Collaborative on Urgent Care Surgery (CANUCS) comprises surgeons who provide acute trauma care and leadership in Canada, with experience in REBOA implementation, use, education and research. Our goal is to provide evidence- and experience-based recommendations regarding institutional implementation of a REBOA program, including multidisciplinary educational programs, attention to device and care pathway logistics, and a robust quality assurance program. This will allow Canadian trauma centres to maximize patient benefits and minimize risks of this potentially life-saving technology.

Remdesivir for the treatment of patients in hospital with COVID-19 in Canada: a randomized controlled trial.

BACKGROUND: The role of remdesivir in the treatment of patients in hospital with COVID-19 remains ill defined in a global context. The World Health Organization Solidarity randomized controlled trial (RCT) evaluated remdesivir in patients across many countries, with Canada enrolling patients using an expanded data collection format in the Canadian Treatments for COVID-19 (CATCO) trial. We report on the Canadian findings, with additional demographics, characteristics and clinical outcomes, to explore the potential for differential effects across different health care systems. METHODS: We performed an open-label, pragmatic RCT in Canadian hospitals, in conjunction with the Solidarity trial. We randomized patients to 10 days of remdesivir (200 mg intravenously [IV] on day 0, followed by 100 mg IV daily), plus standard care, or standard care alone. The primary outcome was in-hospital mortality. Secondary outcomes included changes in clinical severity, oxygen- and ventilator-free days (at 28 d), incidence of new oxygen or mechanical ventilation use, duration of hospital stay, and adverse event rates. We performed a priori subgroup analyses according to duration of symptoms before enrolment, age, sex and severity of symptoms on presentation. RESULTS: Across 52 Canadian hospitals, we randomized 1282 patients between Aug. 14, 2020, and Apr. 1, 2021, to remdesivir (n = 634) or standard of care (n = 648). Of these, 15 withdrew consent or were still in hospital, for a total sample of 1267 patients. Among patients assigned to receive remdesivir, in-hospital mortality was 18.7%, compared with 22.6% in the standard-of-care arm (relative risk [RR] 0.83 (95% confidence interval [CI] 0.67 to 1.03), and 60-day mortality was 24.8% and 28.2%, respectively (95% CI 0.72 to 1.07). For patients not mechanically ventilated at baseline, the need for mechanical ventilation was 8.0% in those assigned remdesivir, and 15.0% in those receiving standard of care (RR 0.53, 95% CI 0.38 to 0.75). Mean oxygen-free and ventilator-free days at day 28 were 15.9 (± standard deviation [SD] 10.5) and 21.4 (± SD 11.3) in those receiving remdesivir and 14.2 (± SD 11) and 19.5 (± SD 12.3) in those receiving standard of care (p = 0.006 and 0.007, respectively). There was no difference in safety events of new dialysis, change in creatinine, or new hepatic dysfunction between the 2 groups. INTERPRETATION: Remdesivir, when compared with standard of care, has a modest but significant effect on outcomes important to patients and health systems, such as the need for mechanical ventilation. Trial registration: ClinicalTrials.gov, no. NCT04330690.

Management of vascular trauma across Canada: A cohort study with implications for practice.

BACKGROUND: The aim of this study was to provide a description of vascular trauma and its management at trauma centers across Canada. METHODS: This retrospective cohort study evaluated patients from 8 Canadian level 1 trauma centers (2011-2015). Medical records were queried to identify adult patients who survived to hospital with major vascular injury. Major vascular injury was defined as injury to named arterial or venous vessels in the legs, arms torso, and neck. Data collected included patient demographics, injury mechanism, injury details, management and clinical outcomes. RESULTS: A total of 1330 patients were included. Patients were 76% male with a mean age of 43 (SD 18.8). Reported injuries were 63% blunt, 36% penetrating, and the remainder mixed. The most common specific mechanisms of injury were motor vehicle collision (36%), stabbing (26%), and falls (16%), with gunshot injuries accounting for <5%. Pre-hospital tourniquets were applied in 27 patients (2%). The mean Injury Severity Score (ISS) was 24 (SD 14.5). We identified injuries to named vessels of the neck (32%), thorax (23%), abdomen and pelvis (27%), upper extremity (14%) and lower extremity (10%). Specific vascular injuries included transection (50%), complete occlusion (11%), partial occlusion (39%), and pseudoaneurysm formation (11%). Injuries were managed non-operatively in 32%, with definitive open surgical management (24%), endovascular management (9%) and with damage control techniques in the operating room (3%). Amputation occurred in 10% of lower extremity and 5% of upper extremity injuries. Responsibility for vascular injury management was undertaken by a wide variety of specialists (n = 17). Overall, in-hospital mortality was 13%, and 2% of patients underwent amputation. CONCLUSION: This study describes the nature and management of vascular injuries across Canada. The variability in injury mechanisms, management strategies, specialty responsible for management, and outcomes have important implications for practice change and knowledge translation.