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Erratum: Reaching back to enhance the future: the American Association for the Surgery of Trauma Diversity, Equity and Inclusion Pipeline Program. 勘误:回溯过去,提升未来:美国创伤外科协会多元化、公平与包容管道计划。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-08 eCollection Date: 2024-01-01 DOI: 10.1136/tsaco-2023-001339Corr1

[This corrects the article DOI: 10.1136/tsaco-2023-001339.].

[This corrects the article DOI: 10.1136/tsaco-2023-001339.].
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引用次数: 0
Using microfluidic shear to assess transfusion requirements in trauma patients. 利用微流体剪切力评估创伤患者的输血需求。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-05 eCollection Date: 2024-01-01 DOI: 10.1136/tsaco-2024-001403
Leslie H Vuoncino, Anamaria J Robles, Ashli C Barnes, James T Ross, Leonardo W Graeff, Taylor L Anway, Nico T Vincent, Nithya Tippireddy, Kimi M Tanaka, Randi J Mays, Rachael A Callcut

Background: Viscoelastic assays have widely been used for evaluating coagulopathies but lack the addition of shear stress important to in vivo clot formation. Stasys technology subjects whole blood to shear forces over factor-coated surfaces. Microclot formation is analyzed to determine clot area (CA) and platelet contractile forces (PCFs). We hypothesize the CA and PCF from this novel assay will provide information that correlates with trauma-induced coagulopathy and transfusion requirements.

Methods: Blood samples were collected on adult trauma patients from a single-institution prospective cohort study of high-level activations. Patient and injury characteristics, transfusion data, and outcomes were collected. Thromboelastography, coagulation studies, and Stasys assays were run on paired samples collected at admission. Stasys CA and PCFs were quantified as area under the curve calculations and maximum values. Normal ranges for Stasys assays were determined using healthy donors. Data were compared using Kruskal-Wallis tests and simple linear regression.

Results: From March 2021 to January 2023, 108 samples were obtained. Median age was 37.5 (IQR 27.5-52) years; patients were 77% male. 71% suffered blunt trauma, 26% had an Injury Severity Score of ≥25. An elevated international normalized ratio significantly correlated with decreased cumulative PCF (p=0.05), maximum PCF (p=0.05) and CA (p=0.02). Lower cumulative PCF significantly correlated with transfusion of any products at 6 and 24 hours (p=0.04 and p=0.05) as well as packed red blood cells (pRBCs) at 6 and 24 hours (p=0.04 and p=0.03). A decreased maximum PCF showed significant correlation with receiving any transfusion at 6 (p=0.04) and 24 hours (p=0.02) as well as transfusion of pRBCs, fresh frozen plasma, and platelets in the first 6 hours (p=0.03, p=0.03, p=0.03, respectively).

Conclusions: Assessing coagulopathy in real time remains challenging in trauma patients. In this pilot study, we demonstrated that microfluidic approaches incorporating shear stress could predict transfusion requirements at time of admission as well as requirements in the first 24 hours.

Level of evidence: Level II.

背景:粘弹性测定法已广泛用于评估凝血病症,但缺乏对体内凝块形成非常重要的剪切应力。Stasys 技术使全血在因子涂层表面受到剪切力。对微凝块的形成进行分析,以确定凝块面积(CA)和血小板收缩力(PCF)。我们假设这种新型检测方法得出的凝块面积(CA)和血小板收缩力(PCF)将提供与创伤引起的凝血病症和输血需求相关的信息:方法:我们从一个单一机构的高水平激活前瞻性队列研究中收集了成年创伤患者的血样。收集了患者和损伤特征、输血数据和结果。对入院时采集的配对样本进行血栓弹性成像、凝血研究和 Stasys 检测。Stasys CA 和 PCF 以曲线下面积计算值和最大值的形式进行量化。Stasys 检测的正常范围由健康供体确定。使用 Kruskal-Wallis 检验和简单线性回归对数据进行比较:从 2021 年 3 月到 2023 年 1 月,共获得 108 份样本。中位年龄为 37.5(IQR 27.5-52)岁;77% 的患者为男性。71%的患者遭受钝性创伤,26%的患者受伤严重程度评分≥25。国际标准化比率升高与累积 PCF 降低(p=0.05)、最大 PCF 降低(p=0.05)和 CA 降低(p=0.02)显著相关。累积 PCF 的降低与 6 小时和 24 小时内输注任何产品(p=0.04 和 p=0.05)以及 6 小时和 24 小时内输注包装红细胞(pRBCs)(p=0.04 和 p=0.03)明显相关。最大 PCF 下降与 6 小时(p=0.04)和 24 小时(p=0.02)接受任何输血以及前 6 小时输注 pRBC、新鲜冰冻血浆和血小板(分别为 p=0.03、p=0.03 和 p=0.03)有显著相关性:结论:实时评估创伤患者的凝血功能仍具有挑战性。在这项试验性研究中,我们证明了结合剪切应力的微流控方法可以预测入院时的输血需求以及最初 24 小时内的输血需求:证据级别:二级。
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引用次数: 0
Women working in violence intervention and outreach: providing space for emotional vulnerability and empathy. 从事暴力干预和外联工作的妇女:为情感脆弱和移情提供空间。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-05 eCollection Date: 2024-01-01 DOI: 10.1136/tsaco-2024-001477
Grace Keegan, LaCrisha Jones, Collette Sholi, Paige-Ashley Campbell, Tanya L Zakrison, Lea E Hoefer

Introduction: There is a growing presence of violence intervention workers who identify as women, yet their unique strengths and challenges have not been described previously. The purpose of this study was to characterize the intersections of gender and violence intervention work.

Methods: We conducted a qualitative study of women working in violence intervention via focus groups. Perceived strengths and risks were explored using a semistructured interviewing technique. Focus groups were transcribed and coded by two separate evaluators. Grounded theory methodology was used for thematic analysis.

Results: 17 violence intervention and outreach specialists who identify as women were included in three focus groups. Common challenges include a sense of powerlessness when faced with inequitable structural limitations and vicarious trauma. When discussing the role of their gender identity in the work, the women reported that men seem more willing to be emotionally vulnerable with women, including disclosures of a history of sexual abuse. Women also experience a lack of respect personally and professionally in their role related to gender. The women revealed a need for leadership opportunities to leverage their strengths and for enhanced training, especially for male colleagues who may benefit from the insights of colleagues who are women.

Conclusions: Women bring unique strengths to roles as violence intervention specialists to deal with trauma and prevent future violence. These findings suggest a need for specific curricula to support women working in violence intervention and further studies that explore the intersectional role of race as well as gender in violence intervention work.

Level of evidence: 6.

导言:越来越多的暴力干预工作者将自己定位为女性,但她们所具有的独特优势和面临的挑战却从未被描述过。本研究旨在描述性别与暴力干预工作的交叉点:我们通过焦点小组对从事暴力干预工作的女性进行了定性研究。我们采用半结构式访谈技术探讨了她们认为的优势和风险。焦点小组由两名不同的评估人员进行誊写和编码。采用基础理论方法进行主题分析:17 名女性暴力干预和外联专家参加了三个焦点小组。共同面临的挑战包括面对不公平的结构性限制时的无力感和替代性创伤。在讨论她们的性别认同在工作中的作用时,妇女们报告说,男性似乎更愿意在情感上对女性表现得脆弱,包括披露性虐待史。此外,女性还在个人和职业角色中体验到与性别有关的不尊重。妇女们表示需要领导机会来发挥她们的优势,并需要加强培训,特别是对男性同事的培训,因为他们可能会从女性同事的见解中受益:结论:作为暴力干预专家,女性在处理创伤和预防未来暴力方面具有独特的优势。这些发现表明,有必要为从事暴力干预工作的女性提供专门的课程支持,并进一步开展研究,探讨种族和性别在暴力干预工作中的交叉作用:6.
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引用次数: 0
Trauma centers: an underfunded but essential asset to the community. 创伤中心:资金不足但却是社区的重要资产。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-04 eCollection Date: 2024-01-01 DOI: 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.

研究表明,专科创伤中心,特别是那些被指定为一级和二级创伤中心的医院,如果得到财政支持,可以创造收入,最重要的是,与没有被指定为创伤中心的医院相比,可以缩短住院时间,降低死亡率,从而为受伤病人提供更好的治疗效果。在过去几年中,随着病人数量的增加和通货膨胀,与创伤中心运营相关的成本也在上升。有关创伤中心运营成本的文献资料很少,而且不同地区的报告数字也存在很大差异。在大多数情况下,最大一部分资金用于临床人员,而最小一部分用于教育和预防项目。研究证实,由于成本上升以及缺乏州政府和联邦政府的资金支持,创伤中心的财政状况依然十分脆弱。已经实施了多种策略来降低这些成本,但事实证明这些策略还不够。平价医疗法案》(Affordable Healthcare Act)等为患者提供更多医疗服务的立法未能实现其预期目的,管理性医疗机构为保护自身利益,不惜牺牲创伤患者的死亡率。在联邦的一致支持下,各州和各市探索了支持创伤中心的解决方案,如在罚款中加入小额费用或鼓励慈善捐款,尽管这些计划并未得到普遍实施。大多数创伤中心已开始纳入激活成本,以弥补因报销率低而造成的损失,但这些成本持续上升,给弱势病人造成了越来越大的负担。由于多个创伤中心是弱势社区医疗保健基础设施的重要支柱,而且缺乏资金的影响如此广泛和系统,可能会出现多个 "创伤沙漠",使社区(尤其是依赖于许多高指定创伤中心的安全网功能的弱势社区)失去重要的治疗资源,并增加原本可以避免的年度死亡率。
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引用次数: 0
The importance and benefits of defining full-time equivalence in the field of acute care surgery. 在急诊外科领域定义全职同等学历的重要性和益处。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-04 eCollection Date: 2024-01-01 DOI: 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.

急诊外科(ACS)包括五大支柱--创伤、外科重症监护、急诊普通外科、择期普通外科和外科抢救。该专科在不断发展,由于高危、高容量和全天候护理,其工作量可能会非常大,从而导致劳动力方面的挑战,如人员合理化、工作与生活失衡、外科医生倦怠等。为了应对这些挑战并确保稳定的员工队伍,作为一个专科,ACS 必须对今后如何管理工作量和员工队伍深思熟虑。在这篇文章中,我们将探讨定义 ACS 全职当量的重要性、益处和挑战,以此为未来建立一支稳定的 ACS 员工队伍。
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引用次数: 0
Addressing social determinants of health may improve emergency department utilization after firearm violence. 解决健康的社会决定因素可能会改善枪支暴力事件后急诊室的使用情况。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-01 eCollection Date: 2024-01-01 DOI: 10.1136/tsaco-2024-001509
Randi N Smith, Patrice Sarumi, Christine Castater
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引用次数: 0
Analysis of social determinants of health on emergency department utilization by gunshot wound survivors after level 1 trauma center discharge. 分析健康的社会决定因素对枪伤幸存者在一级创伤中心出院后使用急诊室的影响。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-01 eCollection Date: 2024-01-01 DOI: 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.

背景:该项目分析了枪支暴力幸存者出院后 2 周内使用急诊科(ED)但未再次入院的风险因素:该项目分析了枪支暴力幸存者在出院后 2 周内使用急诊科(ED)但未再次入院的风险因素:对 100 名入住一级创伤中心的枪支暴力幸存者进行了调查。对使用和未使用急诊室的患者进行了描述性分析和分组比较。所分析的因素源于健康的社会决定因素以及与指数住院相关的临床护理:在 100 名患者中,有 31 人在 6 周内到过急诊室,但大多数人(87.1%)在出院后 2 周内又回到了急诊室。与急诊室复诊明显相关(p≤0.05)的因素包括:没有确定的初级保健提供者、没有朋友或家人可以依靠、在重返工作岗位前没有足够的钱养活自己,以及感觉无法阅读出院说明:缺乏初级保健提供者、健康素养低和社会支持与出院后无再入院的急诊就诊次数增加有关:III级,预后和流行病学。
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引用次数: 0
Impact of English proficiency on use of Glasgow Coma Scale in geriatric patients with traumatic brain injury. 英语水平对老年脑外伤患者使用格拉斯哥昏迷量表的影响。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-07-01 eCollection Date: 2024-01-01 DOI: 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.

背景:英语熟练程度(EP)、格拉斯哥昏迷量表(GCS)和创伤性脑损伤(TBI)之间的关系尚不十分明确。我们旨在了解英语水平有限(LEP)对创伤性脑损伤评估和治疗结果的影响:在一家医疗机构对 2018 年 1 月至 2021 年 12 月间因摔倒致头部撞击而到急诊科就诊的 65 岁以上患者进行回顾性比较研究。有记录的意识丧失或颅内出血(ICH)即为创伤性脑损伤。采用多变量和倾向得分匹配模型分析了EP、GCS和TBI之间的关系:在纳入的 2905 例患者中,有 1233 例(42%)患有 LEP。大多数 LEP 患者为亚洲人(60%),而大多数 EP 患者为非西班牙裔白种人(72%)。在单变量分析中,LEP 的 GCS 下降发生率较高,并且与 TBI 风险密切相关(OR 1.47,CI 1.26 至 1.71)。在对包括种族在内的多个协变量进行调整后,LEP 并未显著增加 GCS 评分的风险:LEP与老年创伤性脑损伤患者较低的GCS相关。在对种族等因素进行调整后,这种相关性减弱,这表明种族差异的影响可能大于语言差异。此外,GCS 对预测 LEP 患者的 ICH 仍然有效,这凸显了其在适当翻译资源下的价值:这是一项 III 级证据的回顾性比较研究。
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引用次数: 0
Mortality burden from variation in provision of surgical care in emergency general surgery: a cohort study using the National Inpatient Sample. 普外科急诊手术护理服务差异造成的死亡率负担:利用全国住院病人样本进行的队列研究。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-06-25 eCollection Date: 2024-01-01 DOI: 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.

Level of evidence: III.

背景:决定对急诊普外科(EGS)疾病(阑尾炎、憩室炎、胆囊炎、疝气、消化性溃疡、肠梗阻、缺血性肠道)进行手术干预涉及复杂的考虑因素,尤其是对老年人而言。我们假设,识别手术治疗应用中的变异性可以突出改善患者生存和预后的潜在途径:我们纳入了 2016-2017 年全国住院患者样本中 65 岁以上患有 EGS 病症的成年人。根据手术代码确定手术管理。根据患者和医院因素对每位患者进行手术的可能性进行倾向评分(PS):EGS 诊断、年龄、性别、种族、是否休克、合并症和医院 EGS 量。手术的低概率和高概率以 PS 0.5 为临界值。我们确定了两个模型一致组(无手术-低概率组、手术-高概率组)和两个模型不一致组(无手术-高概率组、手术-低概率组)。逻辑回归估算了各组的院内死亡率调整OR(AOR):在 375 546 例住院患者中,21.2% 接受了手术治疗。14.6%的患者接受了模式不一致的治疗;5.9%的患者尽管PS较高却没有接受手术,8.7%的患者接受了PS较低的手术。在调整回归中,模式不一致的护理与死亡率显著增加有关:不手术-高概率 AOR 2.06(1.86 至 2.27),手术-低概率 AOR 1.57(1.49 至 1.65)。模型一致的护理对死亡率有保护作用(AOR 0.83,0.74 至 0.92):结论:将近七分之一的 EGS 患者接受了模式不一致的治疗,这与较高的死亡率有关。结论:近七分之一的 EGS 患者接受了模式不一致的护理,这与较高的死亡率有关。我们的研究表明,EGS 患者可采用简化的治疗方案来挽救生命:证据等级:III。
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引用次数: 0
Characterization of adverse events in injured patients at risk of hemorrhagic shock: a secondary analysis of three harmonized prehospital randomized clinical trials. 有失血性休克风险的伤员不良事件的特征:对三项统一院前随机临床试验的二次分析。
IF 2.1 Q3 CRITICAL CARE MEDICINE Pub Date : 2024-06-25 eCollection Date: 2024-01-01 DOI: 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.

Level of evidence: II.

背景:不良事件(AEs)的报告在临床试验的执行过程中是必须的,也是有明确规定的,但在以创伤为重点的院前试验中却鲜有报道。在院前创伤试验中,目前还没有文献分析 AEs 的临床影响及其与死亡率和发病率的关系。我们试图分析三项院前失血性休克试验中的 AEs,并描述其时间过程、发生率、严重程度、相关临床结果和关联性:我们对三项院前随机临床试验进行了二次分析。我们从患者层面和单个 AE 层面对 AE 进行了分析。我们对无 AE、有记录的单个 AE 和有多个事件(>1 AE)的患者进行了分类。我们描述了AE发生的时间、严重程度、相关性和可归因的死亡率结果:我们纳入了来自三项统一临床试验的 1490 例患者,其中 299 例(20.1%)患者至少记录了一次 AE,总计记录了 529 次 AE,有一定比例的患者发生了多次 AE。超过 44% 的患者发生了与死亡相关的误分类 AE。至少有一次AE记录的患者28天死亡率明显较高(log-rank χ2=81.27,P2=11.80,P=0.006)。在对每个AE的相关性进行定性时,超过97%的AE被归类为与干预 "绝对无关 "或 "可能无关":结论:失血性休克试验中的AE很常见,发生较早,与死亡率和存活率偏差有关。报告不准确的可能性是存在的,教育和培训对于适当的治疗组比较仍然至关重要。目前的结果对与损伤相关的临床试验具有重要意义:试验登记号:NCT01818427、NCT02086500 和 NCT03477006:证据等级:II。
{"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}
引用次数: 0
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Trauma Surgery & Acute Care Open
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