Pub Date : 2024-07-04eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001436
Joseph L Fracasso, Nasim Ahmed
Research indicates that specialized trauma centers, especially those of level I and II designation, can generate revenue if financial support is provided, and most importantly provide better outcomes for an injured patient by reducing length of stay and mortality when compared with treatment at hospitals without trauma center designation. Costs associated with trauma center operation have risen over the past few years in association with growing patient volumes and inflation. Documentation regarding costs for trauma center operations is sparse, and there exists a large variance between reported numbers based on their region. In most cases, the greatest proportion of funds are spent on clinical personnel while the smallest fraction is dedicated to educational and prevention programs. Studies confirm that as a product of these rising costs and a lack of state and federal funding that trauma centers remain uniquely financially vulnerable. Multiple strategies have been implemented to mitigate these costs but have proven insufficient. Legislations providing patients with expanded access to healthcare such as the Affordable Healthcare Act have failed to deliver on their intended purposes, and managed care organizations have moved to protect their own interest at the expense of trauma patient mortality. In lieu of concerted federal support, states and municipalities have explored solutions to support trauma centers such as small fees added to fines or encouraging charitable donations, although these programs have not seen ubiquitous implementation. Most trauma centers have begun incorporating activation costs to recoup losses from their low reimbursement rate, but these have continued to inflate, and pose a growing burden on vulnerable patients. Lack of funding from external sources such as state or federal appropriations poses a tangible threat to trauma centers for closure, and with multiple trauma centers acting as critical pillars of healthcare infrastructure for disadvantaged communities as well as the impact of this lack of funding being so broad and systemic, multiple 'trauma deserts' may emerge, leaving communities-especially disadvantaged communities which rely on the safety-net function of many high designation trauma centers-deprived of an essential treatment resource and increasing annual mortalities that could have otherwise been averted.
{"title":"Trauma centers: an underfunded but essential asset to the community.","authors":"Joseph L Fracasso, Nasim Ahmed","doi":"10.1136/tsaco-2024-001436","DOIUrl":"10.1136/tsaco-2024-001436","url":null,"abstract":"<p><p>Research indicates that specialized trauma centers, especially those of level I and II designation, can generate revenue if financial support is provided, and most importantly provide better outcomes for an injured patient by reducing length of stay and mortality when compared with treatment at hospitals without trauma center designation. Costs associated with trauma center operation have risen over the past few years in association with growing patient volumes and inflation. Documentation regarding costs for trauma center operations is sparse, and there exists a large variance between reported numbers based on their region. In most cases, the greatest proportion of funds are spent on clinical personnel while the smallest fraction is dedicated to educational and prevention programs. Studies confirm that as a product of these rising costs and a lack of state and federal funding that trauma centers remain uniquely financially vulnerable. Multiple strategies have been implemented to mitigate these costs but have proven insufficient. Legislations providing patients with expanded access to healthcare such as the Affordable Healthcare Act have failed to deliver on their intended purposes, and managed care organizations have moved to protect their own interest at the expense of trauma patient mortality. In lieu of concerted federal support, states and municipalities have explored solutions to support trauma centers such as small fees added to fines or encouraging charitable donations, although these programs have not seen ubiquitous implementation. Most trauma centers have begun incorporating activation costs to recoup losses from their low reimbursement rate, but these have continued to inflate, and pose a growing burden on vulnerable patients. Lack of funding from external sources such as state or federal appropriations poses a tangible threat to trauma centers for closure, and with multiple trauma centers acting as critical pillars of healthcare infrastructure for disadvantaged communities as well as the impact of this lack of funding being so broad and systemic, multiple 'trauma deserts' may emerge, leaving communities-especially disadvantaged communities which rely on the safety-net function of many high designation trauma centers-deprived of an essential treatment resource and increasing annual mortalities that could have otherwise been averted.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001436"},"PeriodicalIF":2.1,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-04eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2023-001307
Randi N Smith, Mari Freedberg, Joanelle Bailey, Marc DeMoya, Amy Goldberg, Kristan Staudenmayer
Acute care surgery (ACS) encompasses five major pillars - trauma, surgical critical care, emergency general surgery, elective general surgery and surgical rescue. The specialty continues to evolve and due to high-acuity, high-volume and around-the-clock care, the workload can be significant leading to workforce challenges such as rightsizing of staff, work-life imbalance, surgeon burnout and more. To address these challenges and ensure a stable workforce, ACS as a specialty must be deliberate and thoughtful about how it manages workload and workforce going forward. In this article, we address the importance, benefits and challenges of defining full-time equivalence for ACS as a method to establish a stable ACS workforce for the future.
{"title":"The importance and benefits of defining full-time equivalence in the field of acute care surgery.","authors":"Randi N Smith, Mari Freedberg, Joanelle Bailey, Marc DeMoya, Amy Goldberg, Kristan Staudenmayer","doi":"10.1136/tsaco-2023-001307","DOIUrl":"10.1136/tsaco-2023-001307","url":null,"abstract":"<p><p>Acute care surgery (ACS) encompasses five major pillars - trauma, surgical critical care, emergency general surgery, elective general surgery and surgical rescue. The specialty continues to evolve and due to high-acuity, high-volume and around-the-clock care, the workload can be significant leading to workforce challenges such as rightsizing of staff, work-life imbalance, surgeon burnout and more. To address these challenges and ensure a stable workforce, ACS as a specialty must be deliberate and thoughtful about how it manages workload and workforce going forward. In this article, we address the importance, benefits and challenges of defining full-time equivalence for ACS as a method to establish a stable ACS workforce for the future.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001307"},"PeriodicalIF":2.1,"publicationDate":"2024-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11227842/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001509
Randi N Smith, Patrice Sarumi, Christine Castater
{"title":"Addressing social determinants of health may improve emergency department utilization after firearm violence.","authors":"Randi N Smith, Patrice Sarumi, Christine Castater","doi":"10.1136/tsaco-2024-001509","DOIUrl":"10.1136/tsaco-2024-001509","url":null,"abstract":"","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001509"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11217995/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141493574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2023-001283
Jonelle T Campbell, Amber Brandolino, Jessica L Prom, Hamsitha Karra, Nana Danso, Elise A Biesboer, Colleen M Trevino, Susan E Cronn, Terri A deRoon-Cassini, Mary E Schroeder
Background: This project analyzed risk factors for emergency department (ED) utilization without readmission within 2 weeks post-discharge for survivors of gun violence.
Methods: A hundred gun violence survivors admitted to a Level 1 trauma center were surveyed. Descriptive analyses and group comparisons were conducted between patients who did and did not use the ED. Factors analyzed are rooted in social determinants of health and clinical care related to the index hospitalization.
Results: Of the 100 patients, 31 had an ED visit within 6 weeks, although most (87.1%) returned within 2 weeks of discharge. Factors significantly associated (p≤0.05) with a return ED visit included: not having an identified primary care provider, not having friends or family to count on for help, not having enough money to support themselves before return to work, and not feeling able to read discharge instructions.
Conclusion: Lack of a primary care provider, low health literacy and social support were associated with increased ED visits without readmission post-discharge.
Level of evidence: Level III, Prognostic and Epidemiological.
{"title":"Analysis of social determinants of health on emergency department utilization by gunshot wound survivors after level 1 trauma center discharge.","authors":"Jonelle T Campbell, Amber Brandolino, Jessica L Prom, Hamsitha Karra, Nana Danso, Elise A Biesboer, Colleen M Trevino, Susan E Cronn, Terri A deRoon-Cassini, Mary E Schroeder","doi":"10.1136/tsaco-2023-001283","DOIUrl":"10.1136/tsaco-2023-001283","url":null,"abstract":"<p><strong>Background: </strong>This project analyzed risk factors for emergency department (ED) utilization without readmission within 2 weeks post-discharge for survivors of gun violence.</p><p><strong>Methods: </strong>A hundred gun violence survivors admitted to a Level 1 trauma center were surveyed. Descriptive analyses and group comparisons were conducted between patients who did and did not use the ED. Factors analyzed are rooted in social determinants of health and clinical care related to the index hospitalization.</p><p><strong>Results: </strong>Of the 100 patients, 31 had an ED visit within 6 weeks, although most (87.1%) returned within 2 weeks of discharge. Factors significantly associated (p≤0.05) with a return ED visit included: not having an identified primary care provider, not having friends or family to count on for help, not having enough money to support themselves before return to work, and not feeling able to read discharge instructions.</p><p><strong>Conclusion: </strong>Lack of a primary care provider, low health literacy and social support were associated with increased ED visits without readmission post-discharge.</p><p><strong>Level of evidence: </strong>Level III, Prognostic and Epidemiological.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001283"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11216043/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141477477","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001439
Veronica Layrisse-Landaeta, Gabriela R Dincheva, Shahenda Khedr, Andrew Geng, Michele Schombs, Kazi Maisha, Steven Y Chao, Chun-Cheng Chen
Background: The relationship between English proficiency (EP), Glasgow Coma Scale (GCS) and traumatic brain injury (TBI) is not well characterized. We aimed to understand the impact of limited English proficiency (LEP) on the evaluation and outcomes of TBI.
Methods: Retrospective comparative study in a single institution of patients aged ⪰65 who presented to the emergency department after a fall with head strike between January 2018 and December 2021. TBI was defined as documented loss of consciousness or intracranial hemorrhage (ICH). Relationships between EP, GCS, and TBI were analyzed with multivariable and propensity score-matched models.
Results: Of the 2905 included, 1233 (42%) had LEP. Most LEP patients were Asian (60%) while the majority of EP patients were non-Hispanic Caucasians (72%). In a univariate analysis, LEP had higher incidence of decreased GCS and was strongly correlated with risk of TBI (OR 1.47, CI 1.26 to 1.71). After adjusting for multiple covariates including race, LEP did not have a significantly increased risk for GCS score <13 (OR 1.66, CI 0.99 to 2.76) or increased risk of TBI. In the matched analysis, LEP had a small but significantly higher risk of GCS score <13 (OR 1.03, CI 1.02 to 1.05) without an increased risk in TBI. Decreased GCS remained strongly correlated with presence of ICH in LEP patients in the adjusted model (OR 1.39, CI 1.30 to 1.50).
Conclusions: LEP correlated with lower GCS in geriatric patients with TBI. This association weakened after adjusting for factors like race, suggesting racial disparities may have more influence than language differences. Moreover, GCS remained effective for predicting ICH in LEP individuals, highlighting its value with suitable translation resources.
Level of evidence: This is a Level III evidence restrospective comparative study.
{"title":"Impact of English proficiency on use of Glasgow Coma Scale in geriatric patients with traumatic brain injury.","authors":"Veronica Layrisse-Landaeta, Gabriela R Dincheva, Shahenda Khedr, Andrew Geng, Michele Schombs, Kazi Maisha, Steven Y Chao, Chun-Cheng Chen","doi":"10.1136/tsaco-2024-001439","DOIUrl":"10.1136/tsaco-2024-001439","url":null,"abstract":"<p><strong>Background: </strong>The relationship between English proficiency (EP), Glasgow Coma Scale (GCS) and traumatic brain injury (TBI) is not well characterized. We aimed to understand the impact of limited English proficiency (LEP) on the evaluation and outcomes of TBI.</p><p><strong>Methods: </strong>Retrospective comparative study in a single institution of patients aged ⪰65 who presented to the emergency department after a fall with head strike between January 2018 and December 2021. TBI was defined as documented loss of consciousness or intracranial hemorrhage (ICH). Relationships between EP, GCS, and TBI were analyzed with multivariable and propensity score-matched models.</p><p><strong>Results: </strong>Of the 2905 included, 1233 (42%) had LEP. Most LEP patients were Asian (60%) while the majority of EP patients were non-Hispanic Caucasians (72%). In a univariate analysis, LEP had higher incidence of decreased GCS and was strongly correlated with risk of TBI (OR 1.47, CI 1.26 to 1.71). After adjusting for multiple covariates including race, LEP did not have a significantly increased risk for GCS score <13 (OR 1.66, CI 0.99 to 2.76) or increased risk of TBI. In the matched analysis, LEP had a small but significantly higher risk of GCS score <13 (OR 1.03, CI 1.02 to 1.05) without an increased risk in TBI. Decreased GCS remained strongly correlated with presence of ICH in LEP patients in the adjusted model (OR 1.39, CI 1.30 to 1.50).</p><p><strong>Conclusions: </strong>LEP correlated with lower GCS in geriatric patients with TBI. This association weakened after adjusting for factors like race, suggesting racial disparities may have more influence than language differences. Moreover, GCS remained effective for predicting ICH in LEP individuals, highlighting its value with suitable translation resources.</p><p><strong>Level of evidence: </strong>This is a Level III evidence restrospective comparative study.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001439"},"PeriodicalIF":2.1,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11217998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141493575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-25eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2023-001288
Vanessa P Ho, Christopher W Towe, Wyatt P Bensken, Elizabeth Pfoh, Jarrod Dalton, Alfred F Connors, Jeffrey A Claridge, Adam T Perzynski
Background: The decision to undertake a surgical intervention for an emergency general surgery (EGS) condition (appendicitis, diverticulitis, cholecystitis, hernia, peptic ulcer, bowel obstruction, ischemic bowel) involves a complex consideration of factors, particularly in older adults. We hypothesized that identifying variability in the application of operative management could highlight a potential pathway to improve patient survival and outcomes.
Methods: We included adults aged 65+ years with an EGS condition from the 2016-2017 National Inpatient Sample. Operative management was determined from procedure codes. Each patient was assigned a propensity score (PS) for the likelihood of undergoing an operation, modeled from patient and hospital factors: EGS diagnosis, age, gender, race, presence of shock, comorbidities, and hospital EGS volumes. Low and high probability for surgery was defined using a PS cut-off of 0.5. We identified two model-concordant groups (no surgery-low probability, surgery-high probability) and two model-discordant groups (no surgery-high probability, surgery-low probability). Logistic regression estimated the adjusted OR (AOR) of in-hospital mortality for each group.
Results: Of 375 546 admissions, 21.2% underwent surgery. Model-discordant care occurred in 14.6%; 5.9% had no surgery despite a high PS and 8.7% received surgery with low PS. In the adjusted regression, model-discordant care was associated with significantly increased mortality: no surgery-high probability AOR 2.06 (1.86 to 2.27), surgery-low probability AOR 1.57 (1.49 to 1.65). Model-concordant care showed a protective effect against mortality (AOR 0.83, 0.74 to 0.92).
Conclusions: Nearly one in seven EGS patients received model-discordant care, which was associated with higher mortality. Our study suggests that streamlined treatment protocols can be applied in EGS patients as a means to save lives.
{"title":"Mortality burden from variation in provision of surgical care in emergency general surgery: a cohort study using the National Inpatient Sample.","authors":"Vanessa P Ho, Christopher W Towe, Wyatt P Bensken, Elizabeth Pfoh, Jarrod Dalton, Alfred F Connors, Jeffrey A Claridge, Adam T Perzynski","doi":"10.1136/tsaco-2023-001288","DOIUrl":"10.1136/tsaco-2023-001288","url":null,"abstract":"<p><strong>Background: </strong>The decision to undertake a surgical intervention for an emergency general surgery (EGS) condition (appendicitis, diverticulitis, cholecystitis, hernia, peptic ulcer, bowel obstruction, ischemic bowel) involves a complex consideration of factors, particularly in older adults. We hypothesized that identifying variability in the application of operative management could highlight a potential pathway to improve patient survival and outcomes.</p><p><strong>Methods: </strong>We included adults aged 65+ years with an EGS condition from the 2016-2017 National Inpatient Sample. Operative management was determined from procedure codes. Each patient was assigned a propensity score (PS) for the likelihood of undergoing an operation, modeled from patient and hospital factors: EGS diagnosis, age, gender, race, presence of shock, comorbidities, and hospital EGS volumes. Low and high probability for surgery was defined using a PS cut-off of 0.5. We identified two model-concordant groups (no surgery-low probability, surgery-high probability) and two model-discordant groups (no surgery-high probability, surgery-low probability). Logistic regression estimated the adjusted OR (AOR) of in-hospital mortality for each group.</p><p><strong>Results: </strong>Of 375 546 admissions, 21.2% underwent surgery. Model-discordant care occurred in 14.6%; 5.9% had no surgery despite a high PS and 8.7% received surgery with low PS. In the adjusted regression, model-discordant care was associated with significantly increased mortality: no surgery-high probability AOR 2.06 (1.86 to 2.27), surgery-low probability AOR 1.57 (1.49 to 1.65). Model-concordant care showed a protective effect against mortality (AOR 0.83, 0.74 to 0.92).</p><p><strong>Conclusions: </strong>Nearly one in seven EGS patients received model-discordant care, which was associated with higher mortality. Our study suggests that streamlined treatment protocols can be applied in EGS patients as a means to save lives.</p><p><strong>Level of evidence: </strong>III.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001288"},"PeriodicalIF":2.1,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11202721/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141459513","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-25eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001465
John M Lorence, Jack K Donohue, Nidhi Iyanna, Francis X Guyette, Elizabeth Gimbel, Joshua B Brown, Brian J Daley, Brian J Eastridge, Richard S Miller, Raminder Nirula, Brian G Harbrecht, Jeffrey A Claridge, Herb A Phelan, Gary Vercruysse, Terence O'Keeffe, Bellal Joseph, Matthew D Neal, Jason L Sperry
Background: The reporting of adverse events (AEs) is required and well defined in the execution of clinical trials, but is poorly characterized particularly in prehospital trials focusing on traumatic injury. In the setting of prehospital traumatic injury trials, no literature currently exists analyzing the clinical implications of AEs and their associations with mortality and morbidity. We sought to analyze AEs from three prehospital hemorrhagic shock trials and characterize their time course, incidence, severity, associated clinical outcomes, and relatedness.
Methods: We performed a secondary analysis of three prehospital randomized clinical trials. We analyzed AEs at both the patient level as well as the individual AE level. We categorized patients who had no AEs, a single documented AE and those with multiple events (>1 AE). We characterized AE timing, severity, relatedness and attributable mortality outcomes.
Results: We included 1490 patients from the three harmonized clinical trials, with 299 (20.1%) individual patients having at least a single AE documented with 529 AEs documented overall as a proportion of patients had multiple events. Over 44% of patients had a death-related misclassified AE. Patients with at least a single documented AE had a significantly higher 28-day mortality (log-rank χ2=81.27, p<0.001) compared with those without an AE documented. Patients with a single AE had a significant higher mortality than those with multiple AEs, potentially due to survival bias (log-rank χ2=11.80, p=0.006). When relatedness of each individual AE was characterized, over 97% of AEs were classified as 'definitely not related' or 'probably not related' to the intervention.
Conclusions: AEs in hemorrhagic shock trials are common, occur early and are associated with mortality and survival bias. The potential for inaccurate reporting exists, and education and training remain essential for appropriate treatment arm comparison. The current results have important relevance to injury-related clinical trials.
Trial registration numbers: NCT01818427, NCT02086500 and NCT03477006.
{"title":"Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials.","authors":"John M Lorence, Jack K Donohue, Nidhi Iyanna, Francis X Guyette, Elizabeth Gimbel, Joshua B Brown, Brian J Daley, Brian J Eastridge, Richard S Miller, Raminder Nirula, Brian G Harbrecht, Jeffrey A Claridge, Herb A Phelan, Gary Vercruysse, Terence O'Keeffe, Bellal Joseph, Matthew D Neal, Jason L Sperry","doi":"10.1136/tsaco-2024-001465","DOIUrl":"10.1136/tsaco-2024-001465","url":null,"abstract":"<p><strong>Background: </strong>The reporting of adverse events (AEs) is required and well defined in the execution of clinical trials, but is poorly characterized particularly in prehospital trials focusing on traumatic injury. In the setting of prehospital traumatic injury trials, no literature currently exists analyzing the clinical implications of AEs and their associations with mortality and morbidity. We sought to analyze AEs from three prehospital hemorrhagic shock trials and characterize their time course, incidence, severity, associated clinical outcomes, and relatedness.</p><p><strong>Methods: </strong>We performed a secondary analysis of three prehospital randomized clinical trials. We analyzed AEs at both the patient level as well as the individual AE level. We categorized patients who had no AEs, a single documented AE and those with multiple events (>1 AE). We characterized AE timing, severity, relatedness and attributable mortality outcomes.</p><p><strong>Results: </strong>We included 1490 patients from the three harmonized clinical trials, with 299 (20.1%) individual patients having at least a single AE documented with 529 AEs documented overall as a proportion of patients had multiple events. Over 44% of patients had a death-related misclassified AE. Patients with at least a single documented AE had a significantly higher 28-day mortality (log-rank χ<sup>2</sup>=81.27, p<0.001) compared with those without an AE documented. Patients with a single AE had a significant higher mortality than those with multiple AEs, potentially due to survival bias (log-rank χ<sup>2</sup>=11.80, p=0.006). When relatedness of each individual AE was characterized, over 97% of AEs were classified as 'definitely not related' or 'probably not related' to the intervention.</p><p><strong>Conclusions: </strong>AEs in hemorrhagic shock trials are common, occur early and are associated with mortality and survival bias. The potential for inaccurate reporting exists, and education and training remain essential for appropriate treatment arm comparison. The current results have important relevance to injury-related clinical trials.</p><p><strong>Trial registration numbers: </strong>NCT01818427, NCT02086500 and NCT03477006.</p><p><strong>Level of evidence: </strong>II.</p>","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001465"},"PeriodicalIF":2.1,"publicationDate":"2024-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11202790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141459512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-18eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001510
Lawrence B Brown, Anthony D Douglas, Adam J Milam
{"title":"A pathway program to increase diversity in surgery: experience from the American Association for the Surgery of Trauma Diversity, Equity, and Inclusion Committee.","authors":"Lawrence B Brown, Anthony D Douglas, Adam J Milam","doi":"10.1136/tsaco-2024-001510","DOIUrl":"10.1136/tsaco-2024-001510","url":null,"abstract":"","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001510"},"PeriodicalIF":2.1,"publicationDate":"2024-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11191825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141443385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-17eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001495
Aaron Kleinertz, Kenrick Manswell, Kent Peterson, Colleen Flanagan, Melissa Drezdzon, Joshua Dilday, Patrick B Murphy
{"title":"Current approaches to treating acute appendicitis in the third trimester.","authors":"Aaron Kleinertz, Kenrick Manswell, Kent Peterson, Colleen Flanagan, Melissa Drezdzon, Joshua Dilday, Patrick B Murphy","doi":"10.1136/tsaco-2024-001495","DOIUrl":"10.1136/tsaco-2024-001495","url":null,"abstract":"","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001495"},"PeriodicalIF":2.0,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11184202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141421093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-06-13eCollection Date: 2024-01-01DOI: 10.1136/tsaco-2024-001456
Alexander Coomey Schwed
{"title":"Towards a truly multimodal pain regimen: putting locoregional analgesia in the acute care surgeon's toolkit.","authors":"Alexander Coomey Schwed","doi":"10.1136/tsaco-2024-001456","DOIUrl":"10.1136/tsaco-2024-001456","url":null,"abstract":"","PeriodicalId":23307,"journal":{"name":"Trauma Surgery & Acute Care Open","volume":"9 1","pages":"e001456"},"PeriodicalIF":2.1,"publicationDate":"2024-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11177767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141331854","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}