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1.
Ann Surg ; 279(1): 17-23, 2024 01 01.
Article in English | MEDLINE | ID: mdl-37747970

ABSTRACT

OBJECTIVE: To identify and refer patients at high risk for the psychological sequelae of traumatic injury, the American College of Surgeons Committee on Trauma now requires that trauma centers have in-place protocols. No investigations have documented reductions in utilization and associated potential cost savings associated with trauma center mental health interventions. BACKGROUND: The investigation was a randomized clinical trial analysis that incorporated novel 5-year emergency department (ED)/inpatient health service utilization follow-up data. METHODS: Patients were randomized to a mental health intervention, targeting the psychological sequelae of traumatic injury (n = 85) versus enhanced usual care control (n = 86) conditions. The intervention included case management that coordinated trauma center-to-community care linkages, psychotropic medication consultation, and psychotherapy elements. Mixed model regression was used to assess intervention and control group utilization differences over time. An economic analysis was also conducted. RESULTS: Over the course of the 5-year intervention, patients demonstrated significant reductions in ED/inpatient utilization when compared with control patients [ F (19,3210) = 2.23, P = 0.009]. Intervention utilization reductions were greatest at 3 to 6 months (intervention 15.5% vs control 26.7%, relative risk = 0.58, 95% CI: 0.34, 1.00) and 12 to 15 months (intervention 16.5% vs control 30.6%, relative risk = 0.54, 95% CI: 0.32, 0.91) postinjury time points. The economic analysis suggested potential intervention cost savings. CONCLUSIONS: Mental health intervention is associated with significant reductions in ED and inpatient utilization, as well as potential cost savings. These findings could be productively integrated into future American College of Surgeons Committee on Trauma policy discussions.


Subject(s)
Mental Health , Trauma Centers , Humans , Inpatients , Cost Savings , Emergency Service, Hospital , Disease Progression
2.
Ann Emerg Med ; 2024 Feb 05.
Article in English | MEDLINE | ID: mdl-38323952

ABSTRACT

Extracorporeal cardiopulmonary resuscitation (ECPR) is a form of intensive life support that has seen increasing use globally to improve outcomes for patients who experience out-of-hospital cardiac arrest (OHCA). Hospitals with advanced critical care capabilities may be interested in launching an ECPR program to offer this support to the patients they serve; however, to do so, they must first consider the significant investment of resources necessary to start and sustain the program. The existing literature describes many single-center ECPR programs and often focuses on inpatient care and patient outcomes in hospitals with cardiac surgery capabilities. However, building a successful ECPR program and using this technology to support an individual patient experiencing refractory cardiac arrest secondary to a shockable rhythm depends on efficient out-of-hospital and emergency department (ED) management. This article describes the process of implementing 2 intensivist-led ECPR programs with limited cardiac surgery capability. We focus on emergency medical services and ED clinician roles in identifying patients, mobilizing resources, initiation and management of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) in the ED, and ongoing efforts to improve ECPR program quality. Each center experienced a significant learning curve to reach goals of arrest-to-flow times of cannulation for ECPR. Building consensus from multidisciplinary stakeholders, including out-of-hospital stakeholders; establishing shared expectations of ECPR outcomes; and ensuring adequate resource support for ECPR activation were all key lessons in improving our ECPR programs.

3.
Crit Care Med ; 51(2): 182-211, 2023 02 01.
Article in English | MEDLINE | ID: mdl-36661448

ABSTRACT

Surgical science has driven innovation and inquiry across adult and pediatric disciplines that provide critical care regardless of location. Surgically originated but broadly applicable knowledge has been globally shared within the pages Critical Care Medicine over the last 50 years.


Subject(s)
Critical Care , General Surgery , Science , Child , Humans , Adult
4.
Prehosp Emerg Care ; 27(1): 38-45, 2023.
Article in English | MEDLINE | ID: mdl-35191799

ABSTRACT

OBJECTIVES: The Field Triage Guidelines (FTG) are used across North America to identify seriously injured patients for transport to appropriate level trauma centers, with a goal of under-triaging no more than 5% and over-triaging between 25% and 35%. Our objective was to systematically review the literature on under-triage and over-triage rates of the FTG. METHODS: We conducted a systematic review of the FTG performance. Ovid Medline, EMBASE, and the Cochrane databases were searched for studies published between January 2011 and February 2021. Two investigators dual-reviewed eligibility of abstracts and full-text. We included studies evaluating under- or over-triage of patients using the FTG in the prehospital setting. We excluded studies not reporting an outcome of under- or over-triage, studies evaluating other triage tools, or studies of triage not in the prehospital setting. Two investigators independently assessed the risk of bias for each included article. The primary accuracy measures to assess the FTG were under-triage, defined as seriously injured patients transported to non-trauma hospitals (1-sensitivity), and over-triage, defined as non-injured patients transported to trauma hospitals (1-specificity). Due to heterogeneity, results were synthesized qualitatively. RESULTS: We screened 2,418 abstracts, reviewed 315 full-text publications, and identified 17 studies that evaluated the accuracy of the FTG. Among eight studies evaluating the entire FTG (steps 1-4), under-triage rates ranged from 1.6% to 72.0% and were higher for older (≥55 or ≥65 years) adults (20.1-72.0%) and pediatric (<15 years) patients (15.9-34.8%) compared to all ages (1.6-33.8%). Over-triage rates ranged from 9.9% to 87.4% and were higher for all ages (12.2-87.4%) compared to older (≥55 or ≥65 years) adults (9.9-48.2%) and pediatric (<15 years) patients (28.0-33.6%). Under-triage was lower in studies strictly applying the FTG retrospectively (1.6-34.8%) compared to as-practiced (10.5-72.0%), while over-triage was higher retrospectively (64.2-87.4%) compared to as-practiced (9.9-48.2%). CONCLUSIONS: Evidence suggests that under-triage, while improved if the FTG is strictly applied, remains above targets, with higher rates of under-triage in both children and older adults.


Subject(s)
Emergency Medical Services , Wounds and Injuries , Humans , Child , Aged , Triage , Emergency Medical Services/methods , Retrospective Studies , Trauma Centers , Hospitals , Wounds and Injuries/diagnosis , Wounds and Injuries/therapy
5.
Ann Surg ; 275(2): e520-e526, 2022 02 01.
Article in English | MEDLINE | ID: mdl-33064384

ABSTRACT

OBJECTIVE: To describe the current use of the ER-REBOA catheter and associated outcomes and complications. INTRODUCTION: Noncompressible truncal hemorrhage is the leading cause of potentially preventable death in trauma patients. Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a novel strategy to obtain earlier temporary hemorrhage control, supporting cardiac, and cerebral perfusion before definitive hemostasis. METHODS: Prospective, observational study conducted at 6 Level 1 Trauma Centers over 12-months. Inclusion criteria were age >15 years of age with evidence of truncal hemorrhage below the diaphragm and decision for emergent hemorrhage control intervention within 60 minutes of arrival. REBOA details, demographics, mechanism of injury, complications, and outcomes were collected. RESULTS: A total of 8166 patients were screened for enrollment. In 75, REBOA was utilized for temporary hemorrhage control. Blunt injury occurred in 80% with a median injury severity score (ISS) 34 (21, 43). Forty-seven REBOAs were placed in Zone 1 and 28 in Zone 3. REBOA inflation increased systolic blood pressure from 67 (40, 83) mm Hg to 108 (90, 128) mm Hg 5 minutes after inflation (P = 0.02). Cardiopulmonary resuscitation was ongoing during REBOA insertion in 17 patients (26.6%) and 10 patients (58.8%) had return of spontaneous circulation after REBOA inflation. The procedural complication rate was 6.6%. Overall mortality was 52%. CONCLUSION: REBOA can be used in blunt and penetrating trauma patients, including those in arrest. Balloon inflation uniformly improved hemodynamics and was associated with a 59% rate of return of spontaneous circulation for patients in arrest. Use of the ER-REBOA catheter is technically safe with a low procedural complication rate.


Subject(s)
Balloon Occlusion , Hemorrhage/therapy , Resuscitation/methods , Adult , Emergency Treatment , Female , Humans , Male , Middle Aged , Prospective Studies , Torso , Trauma Centers , United States
6.
Transfusion ; 62(9): 1699-1705, 2022 09.
Article in English | MEDLINE | ID: mdl-35815552

ABSTRACT

BACKGROUND: Whole blood (WB) is an attractive product for prehospital treatment of hemorrhagic shock and for initial in-hospital resuscitation of patients likely to require massive transfusion. Neither our regional blood provider nor our hospital blood bank had recent experience collecting or using WB, so we developed a stepwise process to gather experience with WB in clinical practice. METHODS: When our Transfusion Committee suggested a WB program, we worked with our regional blood provider to collect cold-stored, leukoreduced, low-titer anti-A, and anti-B group O RhD positive WB (low-titer group O WB [LTOWB]) and worked with our city Fire Department to integrate it into prehospital care. This work required planning, development of protocols, writing software for blood bank and electronic medical records, changes in paramedic scope of practice, public information, training of clinicians, and close clinical follow-up. RESULTS: Between June 2019 and December 2021, we received 2269 units of LTOWB and transfused 2220 units; 24 (1%) were wasted, two were withdrawn, and 23 were in stock at the end of that time. Most (89%) were transfused to trauma patients. Usage has grown from 48 to 120 units/month, covers all 5 Fire Districts in the county, and represents about » of all hospital trauma blood product use. CONCLUSIONS: Developing a WB program is complex but can be started slowly, including both pre-hospital and hospital elements, and expanded as resources and training progress. The investments of time, effort, and funding involved can potentially improve care, save blood bank and nursing effort, and reduce patient charges.


Subject(s)
Shock, Hemorrhagic , Wounds and Injuries , Blood Banks , Blood Transfusion/methods , Hospitals , Humans , Resuscitation/methods , Shock, Hemorrhagic/therapy
7.
Transfusion ; 62(6): 1218-1229, 2022 06.
Article in English | MEDLINE | ID: mdl-35470898

ABSTRACT

BACKGROUND: Early transfusion can prolong life in injured patients awaiting definitive hemorrhage control. We conducted a community resources assessment of blood product availability at hospitals within the Washington State (WA) Regional Trauma System, with the expectation that a minority of Level IV and V centers would have blood products routinely available for use in resuscitation. METHODS: We designed a questionnaire soliciting information on routinely available unit quantities of red blood cells (RBC), plasma, platelets, cryoprecipitate, and/or whole blood and submitted this questionnaire electronically to the 82 WA designated trauma centers (Levels I-V). Non-responders were contacted directly by telephone. The study was conducted in September and October 2021. US 2020 census data were used to correlate results with local population densities. RESULTS: First-round contact netted responses from 57 (70%) centers; the remaining centers provided information via telephone, for a 100% final response. Packed RBC were available in 79 of the 82 centers (96%; range 6-220 units); plasma, 62 centers (76%, range 1-100 units); platelets, 40 centers (49%, range 1-8 units); cryoprecipitate, 45 centers (55%, range 1-20 units). Whole blood was only available at the Level I center. Three Level V centers, located in 2 of the 8 WA state trauma regions, reported no routine blood availability. The two trauma regions affected represent 12% of the state's population and more than a third of its geographic area. CONCLUSIONS: Within the WA regional trauma system, blood products are wide, if unevenly, available. Large urban/rural disparities in availability exist that should be explored.


Subject(s)
Trauma Centers , Wounds and Injuries , Blood Transfusion , Hemorrhage , Humans , Resuscitation/methods , Washington , Wounds and Injuries/therapy
8.
J Surg Res ; 276: 340-346, 2022 08.
Article in English | MEDLINE | ID: mdl-35427912

ABSTRACT

INTRODUCTION: Predicting failure of nonoperative management (NOM) in splenic trauma remains elusive. Shock index (SI) is an indicator of physiologic burden in an injury but is not used as a prediction tool. The purpose of this study was to determine if elevated SI would be predictive of failure of NOM in patients with a blunt splenic injury. METHODS: Adult patients admitted to a level-1 trauma center from January 2011 to April 2017 for NOM of splenic injury were reviewed. Patients were excluded if they underwent a procedure (angiography or surgery) prior to admission. The primary outcome was requiring intervention after an initial trial of noninterventional management (NIM). An SI > 0.9 at admission was considered a high risk. Univariate and multivariate analyses were used to identify predicators of the failure of NOM. Findings were subsequently verified on a validation cohort of patients. RESULTS: Five hundred and eighty-five patients met inclusion criteria; 7.4% failed NIM. On an univariate analysis, findings of pseudoaneurysm or extra-arterial contrast on computed tomography did not differentiate successful NIM versus failure (8.1% versus 14.0%, P = 0.18). Age, the American Association for the Surgery of Trauma injury grade, and elevated SI were included in multivariate modeling. Grade of injury (OR 3.49, P = 0.001), age (OR 1.02, P = 0.009), and high SI (OR 3.49, P = 0.001) were each independently significant for NIM failure. The risk-adjusted odds of failure were significantly higher in patients with a high risk SI (OR 2.35, P < 0.001). Validation of these findings was confirmed for high SI on a subsequent 406 patients with a c-statistic of 0.71 (95% CI 0.62-0.80). CONCLUSIONS: Elevated SI is an independent risk factor for failure of NIM in those with splenic injury. SI along with age and computed tomography findings may aid in predicting the failure of NIM. Trauma providers should incorporate SI into decision-making tools for splenic injury management.


Subject(s)
Abdominal Injuries , Injury Severity Score , Shock , Spleen , Wounds, Nonpenetrating , Abdominal Injuries/complications , Abdominal Injuries/diagnosis , Abdominal Injuries/diagnostic imaging , Abdominal Injuries/therapy , Adult , Humans , Retrospective Studies , Shock/diagnosis , Shock/etiology , Shock/therapy , Spleen/diagnostic imaging , Spleen/injuries , Splenectomy , Trauma Centers , Treatment Failure , Treatment Outcome , Wounds, Nonpenetrating/complications , Wounds, Nonpenetrating/diagnosis , Wounds, Nonpenetrating/diagnostic imaging , Wounds, Nonpenetrating/therapy
9.
World J Surg ; 46(5): 1059-1066, 2022 05.
Article in English | MEDLINE | ID: mdl-35128569

ABSTRACT

BACKGROUND: We aimed to identify and describe demand-side factors that have been used to support ATLS global promulgation, as well as current gaps in demand-side incentives. METHODS: We performed a cross-sectional survey about demand-side factors that influence the uptake and promulgation of ATLS and other trauma-related CME courses. The survey was sent to each of the four global ATLS region chiefs and 80 ATLS country directors. Responses were described and qualitative data were analyzed using a content analysis framework. RESULTS: Representatives from 30 countries and each region chief responded to the survey (40% response rate). Twenty of 30 country directors (66%) reported that there were some form of ATLS verification requirements. ATLS completion, not current verification, was often the benchmark. Individual healthcare systems were the most common agency to require ATLS verification (37% of countries) followed by medical/surgical accreditation boards (33%), governments (23%), training programs (27%), and professional societies (17%). Multiple credentialing frameworks were reported including making ATLS verification a requirement for: emergency unit or trauma center designation (40%), contract renewal or promotion (37%); professional licensing (37%); training program graduation (37%); and increases in remuneration (3%). Unique demand-side incentives were reported including expansion of ATLS to non-physician cadre credentialing and use of subsidies. CONCLUSION: ATLS region chiefs and country directors reported a variety of demand-side incentives that may facilitate the promulgation of ATLS. Actionable steps include: (i) shift incentivization from ATLS course completion to maintenance of verification; (ii) develop an incentive toolkit of best practices to support implementation; and (iii) engage leadership stakeholders to use demand-side incentives to improve the training and capabilities of the providers they oversee to care for the injured.


Subject(s)
Advanced Trauma Life Support Care , Wounds and Injuries , Cross-Sectional Studies , Humans , Motivation , Surveys and Questionnaires , Wounds and Injuries/therapy
10.
J Med Syst ; 46(4): 21, 2022 Mar 09.
Article in English | MEDLINE | ID: mdl-35260929

ABSTRACT

Current trauma registries suffer from inconsistent collection of data needed to assess health equity. To identify barriers/facilitators to collecting accurate equity-related data elements, we assessed perspectives of national stakeholders, Emergency Department (ED) registration, and Trauma Registry staff. We conducted a Delphi process with experts in trauma care systems and key informant interviews and focus groups with ED patient registration and trauma registry staff at a regional Level I trauma center. Topics included data collection process, barriers/facilitators for equity-related data collection, electronic health record (EHR) entry, trauma registry abstraction, and strategies to overcome technology limitations. Responses were qualitatively analyzed and triangulated with observations of ED and trauma registry staff workflow. Expert-identified barriers to consistent data collection included lack of staff investment in changes and lack of national standardization of data elements; facilitators were simplicity, quality improvement checks, and stakeholder investment in modifying existing technology to collect equity elements. ED staff reported experiences with patients reacting suspiciously to queries regarding race and ethnicity. Cultural resonance training, a script to explain equity data collection, and allowing patients to self-report sensitive items using technology were identified as potential facilitators. Trauma registry staff reported lack of discrete fields, and a preference for auto-populated and designated EHR fields. Identified barriers and facilitators of collection and abstraction of equity-related data elements from multiple stakeholders provides a framework for improving data collection. Successful implementation will require standardized definitions, staff training, use of existing technology for patient self-report, and discrete fields for added elements.


Subject(s)
Health Equity , Data Collection , Electronic Health Records , Humans , Registries , Trauma Centers
11.
Clin Infect Dis ; 73(11): e4592-e4598, 2021 12 06.
Article in English | MEDLINE | ID: mdl-33151283

ABSTRACT

BACKGROUND: ß-Hemolytic streptococci are frequently implicated in necrotizing soft-tissue infections (NSTIs). Clindamycin administration may improve outcomes in patients with serious streptococcal infections. However, clindamycin resistance is growing worldwide, and resistance patterns in NSTIs and their impact on outcomes are unknown. METHODS: Between 2015 and 2018, patients with NSTI at a quaternary referral center were followed up for the outcomes of death, limb loss, and streptococcal toxic shock syndrome. Surgical wound cultures and resistance data were obtained within 48 hours of admission as part of routine care. Risk ratios for the association between these outcomes and the presence of ß-hemolytic streptococci or clindamycin-resistant ß-hemolytic streptococci were calculated using log-binomial regression, controlling for age, transfer status, and injection drug use-related etiology. RESULTS: Of 445 NSTIs identified, 85% had surgical wound cultures within 48 hours of admission. ß-Hemolytic streptococci grew in 31%, and clindamycin resistance was observed in 31% of cultures. The presence of ß-hemolytic streptococci was associated with greater risk of amputation (risk ratio, 1.80; 95% confidence interval, 1.07-3.01), as was the presence of clindamycin resistance among ß-hemolytic streptococci infections (1.86; 1.10-3.16). CONCLUSIONS: ß-Hemolytic streptococci are highly prevalent in NSTIs, and in our population clindamycin resistance was more common than previously described. Greater risk of limb loss among patients with ß-hemolytic streptococci-particularly clindamycin-resistant strains-may portend a more locally aggressive disease process or may represent preexisting patient characteristics that predispose to both infection and limb loss. Regardless, these findings may inform antibiotic selection and surgical management to maximize the potential for limb salvage.


Subject(s)
Soft Tissue Infections , Streptococcal Infections , Anti-Bacterial Agents/pharmacology , Anti-Bacterial Agents/therapeutic use , Clindamycin/pharmacology , Clindamycin/therapeutic use , Humans , Soft Tissue Infections/drug therapy , Soft Tissue Infections/epidemiology , Streptococcal Infections/complications , Streptococcal Infections/drug therapy , Streptococcal Infections/epidemiology , Streptococcus
12.
Ann Surg ; 273(6): 1051-1059, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33378302

ABSTRACT

The emergence of coronavirus disease 2019 (COVID-19) that is caused by the SARS-CoV-2 virus has led to an overwhelming strain on healthcare delivery. This pandemic has created a sustained stress on the modern healthcare system, with unforeseen and potential drastic effects. Although the initial focus during this pandemic has been preparedness and response directed to the pandemic itself, traumatic injury has continued to remain a common problem that requires immediate evaluation and care to provide optimal outcomes. The State of Washington had the first reported case and death related to COVID-19 in the United States. Harborview Medical Center, which serves as the sole Level-1 adult and pediatric trauma center for the state, was rapidly affected by COVID-19, but still needed to maintain preparedness and responses to injured patients for the region. Although initially the focus was on the emerging pandemic on institutional factors, it became obvious that sustained efforts for regional trauma care required a more global focus. Because of these factors, Harborview Medical Center was quickly entrusted to serve as the coordinating center for the regions COVID-19 response, while also continuing to provide optimal care for injured patients during the pandemic. This response allowed the care of injured patients to be maintained within designated trauma centers during this pandemic. This present report summarizes the evolution of trauma care delivery during the first phase of this pandemic and provides informative recommendations for sustained responses to the care of injured patients during the pandemic based on lessons learned during the initial response.


Subject(s)
COVID-19/epidemiology , Delivery of Health Care/trends , Disaster Planning , Pneumonia, Viral/epidemiology , Trauma Centers/organization & administration , Humans , Pandemics , Pneumonia, Viral/virology , SARS-CoV-2 , United States/epidemiology , Washington/epidemiology
13.
Ann Surg ; 274(6): 962-970, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34784664

ABSTRACT

SUMMARY BACKGROUND/OBJECTIVE: To describe the current literature regarding long-term physical, mental, and social outcomes of firearm injury survivors in the United States. METHODS: We systematically searched the PubMed/MEDLINE and Embase databases for articles published from 2013 to 2019 that involved survivors of acute physical traumatic injury aged 18 or older and reported health outcomes between 6 months and 10 years postinjury. Out of 747 articles identified, seven reported outcomes on United States-based civilian patients whose mechanism of injury involved firearms. We extended our publication date criteria from 1995 to 2020 and expanded the search strategy to include medical subject headings terms specific for firearm injury outcomes. Ultimately, ten articles met inclusion criteria. RESULTS: When studied, a significant proportion of patients surviving firearm injury screened positive for posttraumatic stress disorder (49%-60%) or were readmitted (13%-26%) within 6 months postinjury. Most studies reported worse long-term outcomes for firearm injury survivors when compared both to similarly injured motor vehicle collision survivors and to the United States general population, including increased chronic pain, new functional limitations, and reduced physical health composite scores. Studies also reported high rates of posttraumatic stress disorder, reduced mental health composite scores, lower employment and return to work rates, poor social functioning, increased alcohol, and substance abuse. CONCLUSIONS: Research on the long-term health impact of firearm injury is scant, and heterogeneity in available studies limits the ability to fully characterize the outcomes among these patients. A better understanding of the long-term health impact of firearm injury would support systematic change in policy and patient care to improve outcomes.


Subject(s)
Stress Disorders, Post-Traumatic/epidemiology , Survivors/psychology , Wounds, Gunshot/epidemiology , Wounds, Gunshot/psychology , Humans , Injury Severity Score , United States/epidemiology
14.
Ann Surg ; 274(4): e364-e369, 2021 10 01.
Article in English | MEDLINE | ID: mdl-34225296

ABSTRACT

OBJECTIVE: To describe the demographic, injury-related, and mental health characteristics of firearm injury patients and trace firearm weapon carriage and PTSD symptoms over the year after injury. SUMMARY AND BACKGROUND DATA: Based on the increasing incidence of firearm injury and need for novel injury prevention strategies, hospital-based violence intervention programs are being implemented in US trauma centers. There is limited data on the long-term outcomes and risk behaviors of firearm injury survivors to guide this work. METHODS: We conducted a secondary analysis of a pragmatic 25-trauma center randomized trial (N = 635). Baseline characteristics of firearm-injured patients (N = 128) were compared with other trauma patients. Mixed model regression was used to identify risk factors for postinjury firearm weapon carriage and PTSD symptoms. RESULTS: Firearm injury patients were younger and more likely to be black, male and of lower socioeconomic status, and more likely to carry a firearm in the year before injury. Relative to preinjury, there was a significant drop in firearm weapon carriage at 3- and 6-months postinjury, followed by a return to preinjury levels at 12-months. Firearm injury was significantly and independently associated with an increased risk of postinjury firearm weapon carriage [relative risk = 2.08, 95% confidence interval (1.34, 3.22), P < 0.01] and higher PTSD symptom levels [Beta = 3.82, 95% confidence interval (1.29, 6.35), P < 0.01]. CONCLUSIONS: Firearm injury survivors are at risk for firearm carriage and high PTSD symptom levels postinjury. The significant decrease in the high-risk behavior of firearm weapon carriage at 3-6 months postinjury suggests that there is an important postinjury "teachable moment" that should be targeted with preventive interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02655354.


Subject(s)
Firearms , Social Behavior , Stress Disorders, Post-Traumatic/epidemiology , Survivors/psychology , Trauma Centers , Wounds, Gunshot/psychology , Adult , Female , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Stress Disorders, Post-Traumatic/therapy , United States , Violence , Wounds, Gunshot/epidemiology , Young Adult
15.
Ann Surg ; 273(3): 395-401, 2021 03 01.
Article in English | MEDLINE | ID: mdl-33065652

ABSTRACT

OBJECTIVE: To address the clinical and regulatory challenges of optimal primary endpoints for bleeding patients by developing consensus-based recommendations for primary clinical outcomes for pivotal trials in patients within 6 categories of significant bleeding, (1) traumatic injury, (2) intracranial hemorrhage, (3) cardiac surgery, (4) gastrointestinal hemorrhage, (5) inherited bleeding disorders, and (6) hypoproliferative thrombocytopenia. BACKGROUND: A standardized primary outcome in clinical trials evaluating hemostatic products and strategies for the treatment of clinically significant bleeding will facilitate the conduct, interpretation, and translation into clinical practice of hemostasis research and support alignment among funders, investigators, clinicians, and regulators. METHODS: An international panel of experts was convened by the National Heart Lung and Blood Institute and the United States Department of Defense on September 23 and 24, 2019. For patients suffering hemorrhagic shock, the 26 trauma working-group members met for almost a year, utilizing biweekly phone conferences and then an in-person meeting, evaluating the strengths and weaknesses of previous high quality studies. The selection of the recommended primary outcome was guided by goals of patient-centeredness, expected or demonstrated sensitivity to beneficial treatment effects, biologic plausibility, clinical and logistical feasibility, and broad applicability. CONCLUSIONS: For patients suffering hemorrhagic shock, and especially from truncal hemorrhage, the recommended primary outcome was 3 to 6-hour all-cause mortality, chosen to coincide with the physiology of hemorrhagic death and to avoid bias from competing risks. Particular attention was recommended to injury and treatment time, as well as robust assessments of multiple safety related outcomes.


Subject(s)
Clinical Trials as Topic , Hemostasis, Surgical/methods , Outcome Assessment, Health Care , Shock, Hemorrhagic/etiology , Shock, Hemorrhagic/prevention & control , Consensus , Evidence-Based Medicine , Hemostatics/therapeutic use , Humans , Patient-Centered Care , Shock, Hemorrhagic/mortality
16.
Med Care ; 59(Suppl 4): S379-S386, 2021 08 01.
Article in English | MEDLINE | ID: mdl-34228020

ABSTRACT

BACKGROUND: The expedient translation of research findings into sustainable intervention procedures is a longstanding health care system priority. The Patient-Centered Outcomes Research Institute (PCORI) has facilitated the development of "research done differently," with a central tenet that key stakeholders can be productively engaged throughout the research process. Literature review revealed few examples of whether, as originally posited, PCORI's innovative stakeholder-driven approach could catalyze the expedient translation of research results into practice. OBJECTIVES: This narrative review traces the historical development of an American College of Surgeons Committee on Trauma (ACS/COT) policy guidance, facilitated by evidence supplied by the PCORI-funded studies evaluating the delivery of patient-centered care transitions. Key elements catalyzing the guidance are reviewed, including the sustained engagement of ACS/COT policy stakeholders who have the capacity to invoke system-level implementation strategies, such as regulatory mandates linked to verification site visits. Other key elements, including the encouragement of patient stakeholder voice in policy decisions and the incorporation of end-of-study policy summits in pragmatic comparative effectiveness trial design, are discussed. CONCLUSIONS: Informed by comparative effectiveness trials, ACS/COT policy has expedited introduction of the patient-centered care construct into US trauma care systems. A comparative health care systems conceptual framework for transitional care which incorporates Research Lifecycle, pragmatic clinical trial and implementation science models is articulated. When combined with Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE), employed as a targeted implementation strategy, this approach may accelerate the sustainable delivery of high-quality patient-centered care transitions for US trauma care systems.


Subject(s)
Emergency Medical Services , Health Plan Implementation/methods , Patient Outcome Assessment , Transitional Care , Translational Research, Biomedical/methods , Comparative Effectiveness Research , Delivery of Health Care , Health Policy , Humans , Patient-Centered Care , Stakeholder Participation , United States
17.
Transfusion ; 61(11): 3139-3149, 2021 11.
Article in English | MEDLINE | ID: mdl-34632587

ABSTRACT

BACKGROUND: Advanced trauma care demands the timely availability of hemostatic blood products, posing special challenges for regional systems in geographically diverse areas. We describe acute trauma blood use by transfer status and injury characteristics at a large regional Level 1 trauma center. STUDY DESIGN AND METHODS: We reviewed Harborview Medical Center (HMC) Trauma Registry, Transfusion Service, and electronic medical records on acute trauma patients for demographics, injury patterns, blood use, and in-hospital mortality, 2011-2019. RESULTS: Among 47,471 patients (mean age 45.2 ± 23.0 years; 68.3% male; Injury Severity Score 12.6 ± 11.1), 4.7% died and 8547 (18%) received at least one blood component through HMC. Firearms injuries were the most often transfused (690/2596, 26.6%) and the most urgently (39.9% ≥3 units in <1 h; 40.6% ≥5 units in <4 h), and had the highest mortality (case-fatality, 12.2%) (all p < .001). From-scene patients were younger than transfers (42.9 ± 21.0 vs. 47.2 ± 24.4), predominated among firearms injuries (68.2% from-scene vs. 31.8% transfers), were more likely to receive blood (18.5% vs. 17.6%) more urgently (≥3 units first hour, 24.4% vs. 7.7%; ≥5 units first 4 h: 25.6% vs. 8.2%), were more likely to die of hemorrhage (15.5% vs. 4.3%) and from firearms injuries (310/1360, 22.8%) (all p < .001). DISCUSSION: Early blood use, firearms injuries, and mortality were all greater among from-scene patients, and firearms injuries had worse outcomes despite greater and more urgent blood use, but the role of survivor bias for transfer patients must be clarified. Future research must identify strategies for providing local hemostatic transfusion support, particularly for firearms injuries.


Subject(s)
Hemostatics , Wounds and Injuries , Adult , Aged , Blood Component Transfusion , Female , Hemorrhage/etiology , Hemorrhage/therapy , Humans , Injury Severity Score , Male , Middle Aged , Retrospective Studies , Trauma Centers , Wounds and Injuries/epidemiology , Wounds and Injuries/therapy , Young Adult
18.
Prehosp Emerg Care ; 25(2): 221-234, 2021.
Article in English | MEDLINE | ID: mdl-32286899

ABSTRACT

Introduction: Multiple national organizations have identified a need to incorporate more evidence-based medicine in emergency medical services (EMS) through the creation of evidence-based guidelines (EBGs). Tools like the Appraisal of Guidelines for Research and Evaluation (AGREE) II and criteria outlined by the National Academy of Medicine (NAM) have established concrete recommendations for the development of high-quality guidelines. While many guidelines have been created that address topics within EMS medicine, neither the quantity nor quality of prehospital EBGs have been previously reported. Objectives: To perform a systematic review to identify existing EBGs related to prehospital care and evaluate the quality of these guidelines using the AGREE II tool and criteria for clinical guidelines described by the NAM. Methods: We performed a systematic search of the literature in MEDLINE, EMBASE, PubMED, Trip, and guidelines.gov, through September 2018. Guideline topics were categorized based on the 2019 Core Content of EMS Medicine. Two independent reviewers screened titles for relevance and then abstracts for essential guideline features. Included guidelines were appraised with the AGREE II tool across 6 domains by 3 independent reviewers and scores averaged. Two additional reviewers determined if each guideline reported the key elements of clinical practice guidelines recommended by the NAM via consensus. Results: We identified 71 guidelines, of which 89% addressed clinical aspects of EMS medicine. Only 9 guidelines scored >75% across AGREE II domains and most (63%) scored between 50 and 75%. Domain 4 (Clarity of Presentation) had the highest (79.7%) and domain 5 (Applicability) had the lowest average score across EMS guidelines. Only 38% of EMS guidelines included a reporting of all criteria identified by the NAM for clinical practice guidelines, with elements of a systematic review of the literature most commonly missing. Conclusions: EBGs exist addressing a variety of topics in EMS medicine. This systematic review and appraisal of EMS guidelines identified a wide range in the quality of these guidelines and variable reporting of key elements of clinical guidelines. Future guideline developers should consider established methodological and reporting recommendations to improve the quality of EMS guidelines.


Subject(s)
Emergency Medical Services , Consensus , Evidence-Based Medicine , Humans , Practice Guidelines as Topic
19.
Ann Surg ; 272(3): 469-478, 2020 09 01.
Article in English | MEDLINE | ID: mdl-32657946

ABSTRACT

BACKGROUND AND OBJECTIVE: Reltecimod, a CD 28 T-lymphocyte receptor mimetic, inhibits T-cell stimulation by an array of bacterial pathogens. A previous phase 2 trial demonstrated improved resolution of organ dysfunction after NSTI. We hypothesized that early administration of reltecimod would improve outcome in severe NSTI. METHODS: Randomized, double-blind, placebo-controlled trial of single dose reltecimod (0.5 mg/kg) administered within 6 hours of NSTI diagnosis at 65 of 93 study sites. Inclusion: surgical confirmation of NSTI and organ dysfunction [modified Sequential Organ Failure Assessment Score (mSOFA) score ≥3]. Primary analysis was modified Intent-to-Treat (mITT), responder analysis using a previously validated composite endpoint, necrotizing infection clinical composite endpoint, defined as: alive at day 28, ≤3 debridements, no amputation beyond first operation, and day 14 mSOFA ≤1 with ≥3 point reduction (organ dysfunction resolution). A prespecified, per protocol (PP) analysis excluded 17 patients with major protocol violations before unblinding. RESULTS: Two hundred ninety patients were enrolled, mITT (Reltecimod 142, Placebo 148): mean age 55 ±â€Š15 years, 60% male, 42.4% diabetic, 28.6% perineal infection, screening mSOFA mean 5.5 ±â€Š2.4. Twenty-eight-day mortality was 15% in both groups. mITT necrotizing infection clinical composite endpoint success was 48.6% reltecimod versus 39.9% placebo, P = 0.135 and PP was 54.3% reltecimod versus 40.3% placebo, P = 0.021. Resolution of organ dysfunction was 65.1% reltecimod versus 52.6% placebo, P = 0.041, mITT and 70.9% versus 53.4%, P = 0.005, PP. CONCLUSION: Early administration of reltecimod in severe NSTI resulted in a significant improvement in the primary composite endpoint in the PP population but not in the mITT population. Reltecimod was associated with improved resolution of organ dysfunction and hospital discharge status.


Subject(s)
CD28 Antigens/administration & dosage , Debridement/methods , Fasciitis, Necrotizing/therapy , Dose-Response Relationship, Drug , Double-Blind Method , Drug Administration Schedule , Female , Humans , Immunologic Factors/administration & dosage , Male , Middle Aged , Treatment Outcome
20.
J Extra Corpor Technol ; 52(3): 237-241, 2020 Sep.
Article in English | MEDLINE | ID: mdl-32981962

ABSTRACT

The deleterious effects of high serum lipid content on the membrane lung (ML) during extracorporeal membrane oxygenation (ECMO) are sparsely documented, and the threshold of lipemia-induced membrane failure is poorly described. We present a case of a patient on venovenous ECMO who developed ML failure after 7 days due to moderate to severe hypertriglyceridemia (700-800 mg/dL). ML failure was exhibited by impaired gas exchange and high transmembrane pressures, and there was notable lipemic layering in the circuit immediately after decannulation. This case demonstrates that in addition to patients with extreme lipemia, ML failure can also occur in patients with moderate to severe hypertriglyceridemia. Hypertriglyceridemia should be suspected in patients with high transmembrane pressures and ML failure not attributable to thrombosis, and these patients may require frequent ML changes if a prolonged ECMO run is required.


Subject(s)
Extracorporeal Membrane Oxygenation , Hypertriglyceridemia , Respiratory Insufficiency , Thrombosis , Humans , Hypertriglyceridemia/complications , Hypertriglyceridemia/therapy
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