RESUMO
BACKGROUND: The effect of a liberal transfusion strategy as compared with a restrictive strategy on outcomes in critically ill patients with traumatic brain injury is unclear. METHODS: We randomly assigned adults with moderate or severe traumatic brain injury and anemia to receive transfusion of red cells according to a liberal strategy (transfusions initiated at a hemoglobin level of ≤10 g per deciliter) or a restrictive strategy (transfusions initiated at ≤7 g per deciliter). The primary outcome was an unfavorable outcome as assessed by the score on the Glasgow Outcome Scale-Extended at 6 months, which we categorized with the use of a sliding dichotomy that was based on the prognosis of each patient at baseline. Secondary outcomes included mortality, functional independence, quality of life, and depression at 6 months. RESULTS: A total of 742 patients underwent randomization, with 371 assigned to each group. The analysis of the primary outcome included 722 patients. The median hemoglobin level in the intensive care unit was 10.8 g per deciliter in the group assigned to the liberal strategy and 8.8 g per deciliter in the group assigned to the restrictive strategy. An unfavorable outcome occurred in 249 of 364 patients (68.4%) in the liberal-strategy group and in 263 of 358 (73.5%) in the restrictive-strategy group (adjusted absolute difference, restrictive strategy vs. liberal strategy, 5.4 percentage points; 95% confidence interval, -2.9 to 13.7). Among survivors, a liberal strategy was associated with higher scores on some but not all the scales assessing functional independence and quality of life. No association was observed between the transfusion strategy and mortality or depression. Venous thromboembolic events occurred in 8.4% of the patients in each group, and acute respiratory distress syndrome occurred in 3.3% and 0.8% of patients in the liberal-strategy and restrictive-strategy groups, respectively. CONCLUSIONS: In critically ill patients with traumatic brain injury and anemia, a liberal transfusion strategy did not reduce the risk of an unfavorable neurologic outcome at 6 months. (Funded by the Canadian Institutes of Health Research and others; HEMOTION ClinicalTrials.gov number, NCT03260478.).
Assuntos
Anemia , Lesões Encefálicas Traumáticas , Transfusão de Eritrócitos , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anemia/sangue , Anemia/etiologia , Anemia/terapia , Lesões Encefálicas Traumáticas/sangue , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/diagnóstico , Lesões Encefálicas Traumáticas/terapia , Estado Terminal , Depressão/etiologia , Transfusão de Eritrócitos/efeitos adversos , Transfusão de Eritrócitos/métodos , Escala de Resultado de Glasgow , Hemoglobinas/análise , Qualidade de VidaRESUMO
BACKGROUND: Trauma significantly impacts Tanzanian healthcare. Lacking standardized hospital-based minimal trauma data sets places further challenges for policymakers. In other resource-limited countries, implementing trauma systems and registries has reduced injury mortalities. In 2013, we introduced an electronic trauma registry, iTRAUMATM at the Tanzanian Muhimbili Orthopedic Institute (MOI) but noted several drawbacks. In 2023, we introduced a robust web-based trauma registry platform. This study assesses the feasibility and utility of implementing the platform at MOI and summarizes challenges, lessons, and results compared to existing systems. METHODS: This prospective observational study involved clinicians collecting data directly on the platform at the point-of-care, following specific training. Semi-structured interviews with local stakeholders identified challenges and areas for improvement. Data were reported from July to December 2023. RESULTS: Data from 2930 patients showed 59% of injuries were from road traffic collisions (RTCs), with 43% of patients arriving at MOI by non-ambulances. Our findings show that non-ambulance arrivals were associated with higher injury severity (p < 0.026), mortalities (p < 0.017), and delayed hospital arrival (p < 0.004), underscoring the critical role of prompt transport in trauma management. The new platform identified trauma care gaps, with a mean arrival-to-care time of 29.89 min, prompting trauma training at MOI to enhance clinician capacities. It also demonstrated superiority over existing systems by improving data completeness, timeliness, and usability. Challenges included gaining support for the platform's functionality, technology integration, and navigating administrative changes. With continued communication, stakeholder acceptance and support were achieved. CONCLUSION: The web-based platform has become MOI's standard trauma database, demonstrating its feasibility and utility. It overcame the existing challenges of data completeness, timeliness, and usability for policymaking. Positive feedback has prompted plans to expand the platform to other hospitals, benefiting clinical benchmarking and trauma preventive efforts. Ensuring sustainability requires involvement from the Ministry of Health, ongoing training, functionality enhancements, and strengthened global partnerships.
Assuntos
Internet , Sistema de Registros , Ferimentos e Lesões , Humanos , Tanzânia/epidemiologia , Ferimentos e Lesões/terapia , Estudos Prospectivos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Estudos de Viabilidade , Países em Desenvolvimento , Adolescente , Adulto Jovem , Recursos em Saúde/estatística & dados numéricos , Região de Recursos LimitadosRESUMO
BACKGROUND: Digitizing surgical data infrastructure is critical for policymakers to make informed decisions. The implementation of the first web-based operating theater (OT) recordings at Muhimbili Orthopedic Institute (MOI) represents significant advancements in data management for Tanzania. This study aims to share post-platform implementation outcomes, challenges, and insights gained offering guidance to settings facing similar data repository challenges. METHODS: In July 2023, after training clinicians, the platform was deployed at MOI operating theaters (OTs) to facilitate prospective data entry following procedures, ensuring timely updates of perioperative outcomes. Semi-structured interviews were conducted with key stakeholders to gather insights into the platform's functionality and efficient data management systems. We presented data from August 2023 to February 2024 along with platform insights. RESULTS: Over 4449 procedures were conducted, comprising 1321 emergencies and 3128 electives, with orthopedics/trauma accounting for the majority (3606). Trauma-related emergencies (921) predominate among interventions. General anesthesia was prevalent; 60.56% in emergencies and 44.51% in electives. Orthopedics/trauma utilized 90.91% of assigned operating days in electives, while neurosurgery utilized 93.39% (p < 0.011). The cancellation rate was 7.5%, primarily due to emergency interferences (32%). Of procedures, 96.76% were discharged, while 2.81% died. Challenges encountered during platform implementation included securing local support, integrating technology, and navigating administrative adjustments. Lessons learned emphasized continuous communication for stakeholder buy-in and training for platform familiarity. CONCLUSION: The web-based OT recordings at MOI succeeded with local support and showed promise for wider scalability. To ensure sustainability, ongoing follow-up, monitoring of platform functionality, local funding establishment, and strengthening global partnerships are recommended.
Assuntos
Salas Cirúrgicas , Adulto , Feminino , Humanos , Masculino , Países em Desenvolvimento , Salas Cirúrgicas/economia , Salas Cirúrgicas/organização & administração , Estudos Prospectivos , Região de Recursos Limitados , Procedimentos Cirúrgicos Operatórios , TanzâniaRESUMO
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.
Assuntos
Traumatismos Abdominais , Falso Aneurisma , Ferimentos não Penetrantes , Humanos , Feminino , Adulto , Masculino , Estudos Retrospectivos , Falso Aneurisma/diagnóstico por imagem , Falso Aneurisma/etiologia , Falso Aneurisma/terapia , Baço/lesões , Traumatismos Abdominais/complicações , Traumatismos Abdominais/diagnóstico por imagem , Traumatismos Abdominais/terapia , Ferimentos não Penetrantes/complicações , Ferimentos não Penetrantes/diagnóstico por imagem , Ferimentos não Penetrantes/terapia , Escala de Gravidade do FerimentoRESUMO
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.
Assuntos
Competência Clínica , Equipe de Assistência ao Paciente , Tanzânia , Humanos , Equipe de Assistência ao Paciente/organização & administração , Masculino , Feminino , Treinamento por Simulação/métodos , Traumatologia/educação , Adulto , Ferimentos e Lesões/terapiaRESUMO
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.
Assuntos
Deterioração Clínica , Centros de Traumatologia , Adulto , Humanos , Adulto Jovem , Pessoa de Meia-Idade , Estudos Retrospectivos , Quebeque/epidemiologia , Unidades de Terapia Intensiva , Escala de Gravidade do FerimentoRESUMO
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 = 10â¯940) to small-volume tubes (n = 10â¯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 21â¯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 = 27â¯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.
Assuntos
Anemia , Coleta de Amostras Sanguíneas , Transfusão de Sangue , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Anemia/etiologia , Anemia/terapia , Cuidados Críticos , Hemoglobinas/análise , Unidades de Terapia Intensiva , Coleta de Amostras Sanguíneas/métodosRESUMO
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.
Assuntos
Internato e Residência , Estudantes de Medicina , Humanos , Competência Clínica , Simulação por Computador , Aprendizagem , Simulação de PacienteRESUMO
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.
Assuntos
Educação Médica , Internato e Residência , Humanos , Reprodutibilidade dos TestesRESUMO
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.
Assuntos
Atenção à Saúde , Telemedicina , Humanos , Quebeque , Estudos Transversais , HospitaisRESUMO
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.
Assuntos
Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Antivirais/administração & dosagem , Tratamento Farmacológico da COVID-19 , Mortalidade Hospitalar , Tempo de Internação/estatística & dados numéricos , Monofosfato de Adenosina/administração & dosagem , Monofosfato de Adenosina/efeitos adversos , Idoso , Alanina/administração & dosagem , Alanina/efeitos adversos , Antivirais/efeitos adversos , COVID-19/epidemiologia , COVID-19/mortalidade , Canadá/epidemiologia , Comorbidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Pandemias , Respiração Artificial/estatística & dados numéricos , SARS-CoV-2RESUMO
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.
Assuntos
Pneumonia Associada à Ventilação Mecânica , Probióticos , Adulto , Humanos , Análise Custo-Benefício , Estado Terminal , Probióticos/uso terapêutico , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Diarreia/prevenção & controleRESUMO
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.
Assuntos
Lesões Encefálicas Traumáticas , Avaliação Nutricional , Lesões Encefálicas Traumáticas/complicações , Lesões Encefálicas Traumáticas/diagnóstico , Calorimetria Indireta/métodos , Humanos , Necessidades Nutricionais , Estudos ProspectivosRESUMO
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.
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Oclusão com Balão , Procedimentos Endovasculares , Choque Hemorrágico , Assistência Ambulatorial , Aorta/lesões , Aorta/cirurgia , Oclusão com Balão/métodos , Canadá , Procedimentos Endovasculares/métodos , Humanos , Ressuscitação/métodos , Choque Hemorrágico/cirurgiaRESUMO
INTRODUCTION: Incisional negative pressure wound therapy (iNPWT) may reduce surgical site infections (SSI), which can have devastating consequences after incisional hernia repair. Few comparative studies investigate the effectiveness of this wound management strategy in this population. The objective of this study is to determine the effect of iNPWT on the incidence of SSI after complex incisional hernia repair. METHODS: All adult patients undergoing open incisional hernia repair at a single center from 2016 to 2019 were reviewed. A commercial iNPWT dressing was used at the discretion of the surgeon. Patients were grouped by type of dressing; iNPWT and standard sterile dressings (SSD). Coarsened exact matching was used to create balanced cohorts for comparison using age, sex, American Society of Anesthesiologists classification, wound classification, and surgical urgency. The primary outcome was the composite incidence of superficial and deep SSI within 30 days. Secondary outcomes included non-infectious surgical site occurrences (SSO), overall complications, length of stay (LOS), emergency department visits, and readmission at 30 days. RESULTS: 134 patients underwent complex hernia repair, with 114 patients included after matching (34 iNPWT, 51 SSD). Composite incidence of superficial and deep SSI was 19.3% (11.8% vs. 27.5%, p = 0.107), with significantly lower rates of deep SSI in patients receiving iNPWT (2.9% vs. 17.6%, p = 0.045). After accounting for residual differences between groups, iNPWT was associated with decreased incidence of composite SSI (RR 0.36, 95% CI [0.16, 0.87]). Median LOS was longer in patients with iNPWT (7 vs. 5 days, p = 0.001). There were no differences in SSO, overall complications, readmission, or emergency department visits. CONCLUSION: In patients undergoing incisional hernia repair, the use of iNPWT was associated with a lower incidence of SSI at 30 days. Future studies should focus on cost effectiveness of iNPWT, its impact on long-term hernia recurrences, and the identification of patient selection criteria in this population.
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Hérnia Incisional , Tratamento de Ferimentos com Pressão Negativa , Adulto , Estudos de Coortes , Humanos , Hérnia Incisional/epidemiologia , Hérnia Incisional/etiologia , Hérnia Incisional/cirurgia , Recidiva Local de Neoplasia , Estudos Retrospectivos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controleRESUMO
Importance: Growing interest in microbial dysbiosis during critical illness has raised questions about the therapeutic potential of microbiome modification with probiotics. Prior randomized trials in this population suggest that probiotics reduce infection, particularly ventilator-associated pneumonia (VAP), although probiotic-associated infections have also been reported. Objective: To evaluate the effect of Lactobacillus rhamnosus GG on preventing VAP, additional infections, and other clinically important outcomes in the intensive care unit (ICU). Design, Setting, and Participants: Randomized placebo-controlled trial in 44 ICUs in Canada, the United States, and Saudi Arabia enrolling adults predicted to require mechanical ventilation for at least 72 hours. A total of 2653 patients were enrolled from October 2013 to March 2019 (final follow-up, October 2020). Interventions: Enteral L rhamnosus GG (1 × 1010 colony-forming units) (n = 1321) or placebo (n = 1332) twice daily in the ICU. Main Outcomes and Measures: The primary outcome was VAP determined by duplicate blinded central adjudication. Secondary outcomes were other ICU-acquired infections including Clostridioides difficile infection, diarrhea, antimicrobial use, ICU and hospital length of stay, and mortality. Results: Among 2653 randomized patients (mean age, 59.8 years [SD], 16.5 years), 2650 (99.9%) completed the trial (mean age, 59.8 years [SD], 16.5 years; 1063 women [40.1%.] with a mean Acute Physiology and Chronic Health Evaluation II score of 22.0 (SD, 7.8) and received the study product for a median of 9 days (IQR, 5-15 days). VAP developed among 289 of 1318 patients (21.9%) receiving probiotics vs 284 of 1332 controls (21.3%; hazard ratio [HR], 1.03 (95% CI, 0.87-1.22; P = .73, absolute difference, 0.6%, 95% CI, -2.5% to 3.7%). None of the 20 prespecified secondary outcomes, including other ICU-acquired infections, diarrhea, antimicrobial use, mortality, or length of stay showed a significant difference. Fifteen patients (1.1%) receiving probiotics vs 1 (0.1%) in the control group experienced the adverse event of L rhamnosus in a sterile site or the sole or predominant organism in a nonsterile site (odds ratio, 14.02; 95% CI, 1.79-109.58; P < .001). Conclusions and Relevance: Among critically ill patients requiring mechanical ventilation, administration of the probiotic L rhamnosus GG compared with placebo, resulted in no significant difference in the development of ventilator-associated pneumonia. These findings do not support the use of L rhamnosus GG in critically ill patients. Trial Registration: ClinicalTrials.gov Identifier: NCT02462590.
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Antibacterianos/uso terapêutico , Lacticaseibacillus rhamnosus , Pneumonia Associada à Ventilação Mecânica/prevenção & controle , Probióticos/uso terapêutico , Respiração Artificial , Idoso , Antibacterianos/efeitos adversos , Infecções Bacterianas/prevenção & controle , Diarreia/prevenção & controle , Feminino , Humanos , Unidades de Terapia Intensiva , Masculino , Pessoa de Meia-Idade , Respiração Artificial/efeitos adversos , Falha de TratamentoRESUMO
OBJECTIVES: To evaluate the effect of esophageal stimulation on nutritional adequacy in critically ill patients at risk for enteral feeding intolerance. DESIGN: A multicenter randomized sham-controlled clinical trial. SETTING: Twelve ICUs in Canada. PATIENTS: We included mechanically ventilated ICU patients who were given moderate-to-high doses of opioids and expected to remain alive and ventilated for an additional 48 hours and who were receiving enteral nutrition or expected to start imminently. INTERVENTIONS: Patients were randomly assigned 1:1 to esophageal stimulation via an esophageal stimulating catheter (E-Motion Tube; E-Motion Medical, Tel Aviv, Israel) or sham treatment. All patients were fed via these catheters using a standardized feeding protocol. MEASUREMENTS AND MAIN RESULTS: The co-primary outcomes were proportion of caloric and protein prescription received enterally over the initial 7 days following randomization. Among 159 patients randomized, the modified intention-to-treat analysis included 155 patients: 73 patients in the active treatment group and 82 in the sham treatment group. Over the 7-day study period, the percent of prescribed caloric intake (± SE) received by the enteral route was 64% ± 2 in the active group and 65% ± 2 in sham patients for calories (difference, -1; 95% CI, -8 to 6; p = 0.74). For protein, it was 57% ± 3 in the active group and 60% ± 3 in the sham group (difference, -3; 95% CI, -10 to 3; p = 0.30). Compared to the sham group, there were more serious adverse events reported in the active treatment group (13 vs 6; p = 0.053). Clinically important arrhythmias were detected by Holter monitoring in 36 out of 70 (51%) in the active group versus 22 out of 76 (29%) in the sham group (p = 0.006). CONCLUSIONS: Esophageal stimulation via a special feeding catheter did not improve nutritional adequacy and was associated with increase risk of harm in critically ill patients.
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Estado Terminal/terapia , Terapia por Estimulação Elétrica/métodos , Nutrição Enteral/métodos , Esôfago/fisiologia , Motilidade Gastrointestinal/fisiologia , Refluxo Laringofaríngeo/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Unidades de Terapia Intensiva , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Estado Nutricional , Respiração Artificial , Adulto JovemRESUMO
Background: Acute care surgery (ACS) and emergency general surgery (EGS) services must provide timely care and intervention for patients who have some of the most challenging needs. Patients treated by ACS services are often critically ill and have both substantial comorbidities and poor physiologic reserve. Despite the widespread implemention of ACS/EGS services across North America, the true postoperative morbidity rates remain largely unknown. Methods: In this prospective study, inpatients at 8 high-volume ACS/EGS centres in geographically diverse locations in Canada who underwent operative interventions were followed for 30 days or until they were discharged. Readmissions during the 30-day window were also captured. Preoperative, intraoperative and postoperative variables were tracked. Standard statistical methodology was employed. Results: A total of 601 ACS/EGS patients were followed for up to 30 inpatient or readmission days after their index emergent operation. Fifty-one percent of patients were female, and the median age was 51 years. They frequently had substantial medical comorbidities (42%) and morbid obesity (15%). The majority of procedures were minimally invasive (66% laparoscopic). Median length of stay was 3.3 days and the early readmission (< 30 d) rate was 6%. Six percent of patients were admitted to the critical care unit. The overall complication and mortality rates were 34% and 2%, respectively. Cholecystitis (31%), appendicitis (21%), bowel obstruction (18%), incarcerated hernia (12%), gastrointestinal hemorrhage (7%) and soft tissue infections (7%) were the most common diagnoses. The morbidity and mortality rates for open surgical procedures were 73% and 5%, respectively. Conclusion: Nontrauma ACS/EGS procedures are associated with a high postoperative morbidity rate. This study will serve as a prospective benchmark for postoperative complications among ACS/EGS patients and subsequent quality improvement across Canada.
Contexte: Les services de chirurgie dans les unités de soins actifs (CSA) et de chirurgie générale dans les services d'urgence (CGSU) doivent fournir rapidement des soins et des interventions à des patients dont les besoins sont parmi les plus complexes. En effet, les patients pris en charge par les services de CSA sont souvent gravement malades et présentent des comorbidités sur fond de faible réserve physiologique. Même si les services de CSA/CGSU se sont répandus en Amérique du Nord, les taux réels de morbidité postopératoire demeurent pour une bonne part inconnus. Méthodes: Dans cette étude prospective, on a suivi pendant 30 jours ou jusqu'à leur congé, les patients hospitalisés pour des interventions chirurgicales dans 8 centres de CSA/CGSU achalandés de divers endroits au Canada. On a également tenu compte des réadmissions dans les 30 jours. Les paramètres pré-, per- et postopératoires ont été enregistrés. Une méthodologie statistique standard a été appliquée. Résultats: En tout, 601 patients de CSA/CGSU ont ainsi été suivis pendant une durée allant jusqu'à 30 jours d'hospitalisation ou de réadmission après leur intervention urgente initiale. Cinquante et un pour cent étaient de sexe féminin et l'âge moyen était de 51 ans. Ces patients étaient nombreux à présenter des comorbidités de nature médicale substantielles (42 %) et une obésité morbide (15 %). La majorité des interventions ont été minimalement effractives (66 % laparoscopiques). La durée médiane des séjours a été de 3,3 jours et le taux de réadmission précoce (< 30 j) a été de 6 %. Six pour cent des patients ont été admis aux soins intensifs. Les taux globaux de complications et de mortalité ont été respectivement de 34 % et de 2 %. Cholécystite (31 %), appendicite (21 %), obstruction intestinale (18 %), hernie incarcérée (12 %), hémorragie digestive (7 %) et infections des tissus mous (7 %) comptent parmi les diagnostics les plus fréquents. Les taux de morbidité et de mortalité dans les cas de chirurgies ouvertes ont été respectivement de 73 % et 5 %. Conclusion: Les interventions de CSA/CGSU non liées à la traumatologie sont associées à un taux de morbidité postopératoire élevé. Cette étude fournira un ensemble de valeurs de références pour l'étude prospective des complications chez les patients pris en charge par les services de CSA/CGSU et l'amélioration subséquente des soins partout au Canada.
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Emergências , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Operatórios/estatística & dados numéricos , Canadá/epidemiologia , Auditoria Clínica , Feminino , Humanos , Laparoscopia/estatística & dados numéricos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Estudos Prospectivos , Procedimentos Cirúrgicos Operatórios/efeitos adversosRESUMO
BACKGROUND: Management of the post-traumatic open abdomen (OA) using negative pressure wound therapy (NPWT) alone is associated with low rates of primary fascial closure. The abdominal reapproximation anchor (ABRA) system exerts dynamic medial fascial traction and may work synergistically with NPWT to facilitate primary fascial closure. METHODS: Patients with an OA following trauma laparotomy between 2009 and 2018 were identified from a prospectively maintained institutional database. Patients treated with ABRA in conjunction with NPWT (ABRA) versus NPWT alone (NPWT) were compared in terms of primary fascial closure rate, number of surgeries to closure, tracheostomy duration, length of stay and incidence of entero-atmospheric fistula. Multivariable linear regression was performed to identify predictors of tracheostomy duration. RESULTS: We identified 48 patients [ABRA, 12 and NPWT, 36]. The ABRA group was significantly younger (25 vs. 37 years, p = 0.027) and included a lower proportion of males (58% vs. 89%, p = 0.032). Groups were similar with respect to the incidence of hollow viscus injury, injury severity score and abdominal abbreviated injury score. Compared to the NPWT group, the ABRA group had a significantly higher rate of primary fascial closure (100% vs. 28%, p < 0.001), fewer surgeries to abdominal closure (2 vs. 2.5, p = 0.023) and shorter duration of tracheostomy (15.5 vs. 36 days, p = 0.008). There were no differences in length of stay or incidence of entero-atmospheric fistula. On multivariable linear regression, ABRA placement was an independent predictor of shorter tracheostomy duration, after adjusting for covariates (ß = - 0.294, p = 0.036). CONCLUSION: For the post-traumatic OA, ABRA coupled with NPWT achieves a higher rate of primary fascial closure compared to NPWT alone, while requiring fewer surgeries and a shorter duration of tracheostomy.
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Traumatismos Abdominais/cirurgia , Técnicas de Fechamento de Ferimentos Abdominais , Tratamento de Ferimentos com Pressão Negativa/métodos , Cavidade Abdominal/cirurgia , Adolescente , Adulto , Idoso , Fasciotomia/métodos , Feminino , Humanos , Fístula Intestinal/etiologia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias , Estudos Prospectivos , Fatores de Tempo , Tração/métodos , Adulto JovemRESUMO
BACKGROUND: Approximately 5 billion people do not have access to safe, timely, and affordable surgical and anesthesia care, with this number disproportionately affecting those from low-middle-income countries (LMICs). Perioperative mortality rates (POMRs) have been identified by the World Health Organization as a potential health metric to monitor quality of surgical care provided. The purpose of this systematic review was to evaluate published reports of POMR and suggest recommendations for its appropriate use as a health metric. METHODS: The protocol was registered a priori with PROSPERO. A peer-reviewed search strategy was developed adhering with the PRISMA guidelines. Relevant articles were identified through Medline, Embase, CENTRAL, CDSR, LILACS, PubMed, BIOSIS, Global Health, Africa-Wide Information, Scopus, and Web of Science databases. Two independent reviewers performed a primary screening analysis based on titles and abstracts, followed by a full-text screen. Studies describing POMRs of adult emergency abdominal surgeries in LMICs were included. RESULTS: A total of 7787 articles were screened of which 7466 were excluded based on title and abstract. Three hundred and twenty-one articles entered full-text screen of which 70 articles met the inclusion criteria. Variables including timing of POMR reporting, intraoperative mortality, length of hospital stay, complication rates, and disease severity score were collected. Complication rates were reported in 83% of studies and postoperative stay in 46% of studies. 40% of papers did not report the specific timing of POMR collection. 7% of papers reported on intraoperative death. Additionally, 46% of papers used a POMR timing specific to the duration of their study. Vital signs were discussed in 24% of articles, with disease severity score only mentioned in 20% of studies. CONCLUSION: POMR is an important health metric for quantifications of quality of care of surgical systems. Further validation and standardization are necessary to effectively use this health metric.