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1.
Clin Pract Cases Emerg Med ; 7(1): 49-50, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36859328

ABSTRACT

CASE PRESENTATION: We describe a case of epipericardial fat necrosis. DISCUSSION: Epipericardial fat necrosis is an inflammatory condition in which the pericardial fat pad necrotizes resulting in surrounding inflammation. This condition mimics more ominous pathology in clinical presentation and radiographic findings. Management is supportive with oral analgesics.

2.
Am J Emerg Med ; 58: 148-153, 2022 08.
Article in English | MEDLINE | ID: mdl-35689961

ABSTRACT

BACKGROUND/OBJECTIVE: Contrast-enhanced magnetic resonance imaging (MRI) is the preferred imaging modality for diagnosing pyogenic spinal infection (PSI), but it is not always available. Our objective was to describe pyogenic spinal infection imaging characteristics in patients presenting to a community emergency department (ED) and estimate the computed tomography (CT) sensitivity for these infections. METHODS: We examined the MRI reports from a cohort of 88 PSI patients whom we enrolled in a prospective cohort study and report the prevalence of each PSI type (spinal epidural abscess/infection, vertebral osteomyelitis/discitis, septic facet, and paravertebral abscess/infection) according to contemporary nomenclature. In a 14 patient subcohort who underwent both CT and MRI studies, we report the sensitivity for each PSI from a post hoc blinded overread of the CT imaging by a single neuroradiologist. RESULTS: Of the 88 PSI patients, the median age was 55 years, and 31% were female. The PSI prevalence included: spinal epidural abscess/infection (SEA) in 61(69%), vertebral osteomyelitis/discitis (VO/D) in 54 (61%), septic facet (SF) in 15 (17%), and paravertebral abscess/infection (PVA) in 53 (60%). Of the SEAs, 82% (50/61) were associated with other spinal infections, while 18% (11/61) were isolated SEAs. The overall CT sensitivity in a masked overread was 79% (11/14) for any PSI, 83% (10/12) for any infection outside the spinal canal, and only 18% (2/11) for SEA. CONCLUSION: Patients found to have vertebral osteomyelitis/discitis, septic facet, and paravertebral infections frequently had a SEA coinfection. CT interpretation by a neuroradiologist had moderate sensitivity for infections outside the spinal canal but had low sensitivity for SEA.


Subject(s)
Discitis , Epidural Abscess , Osteomyelitis , Discitis/complications , Discitis/diagnostic imaging , Epidural Abscess/complications , Epidural Abscess/diagnostic imaging , Female , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Osteomyelitis/diagnostic imaging , Prospective Studies , Tomography, X-Ray Computed
3.
West J Emerg Med ; 22(5): 1156-1166, 2021 Aug 30.
Article in English | MEDLINE | ID: mdl-34546893

ABSTRACT

INTRODUCTION: Patients with pyogenic spinal Infection (PSI) are often not diagnosed at their initial presentation, and diagnostic delay is associated with increased morbidity and medical-legal risk. We derived a decision tool to estimate the risk of spinal infection and inform magnetic resonance imaging (MRI) decisions. METHODS: We conducted a two-part prospective observational cohort study that collected variables from spine pain patients over a six-year derivation phase. We fit a multivariable regression model with logistic coefficients rounded to the nearest integer and used them for variable weighting in the final risk score. This score, SIRCH (spine infection risk calculation heuristic), uses four clinical variables to predict PSI. We calculated the statistical performance, MRI utilization, and model fit in the derivation phase. In the second phase we used the same protocol but enrolled only confirmed cases of spinal infection to assess the sensitivity of our prediction tool. RESULTS: In the derivation phase, we evaluated 134 non-PSI and 40 PSI patients; median age in years was 55.5 (interquartile range [IQR] 38-70 and 51.5 (42-59), respectively. We identified four predictors for our risk score: historical risk factors; fever; progressive neurological deficit; and C-reactive protein (CRP) ≥ 50 milligrams per liter (mg/L). At a threshold SIRCH score of ≥ 3, the predictive model's sensitivity, specificity, and positive predictive value were, respectively, as follows: 100% (95% confidence interval [CI], 100-100%); 56% (95% CI, 48-64%), and 40% (95% CI, 36-46%). The area under the receiver operator curve was 0.877 (95% CI, 0.829-0.925). The SIRCH score at a threshold of ≥ 3 would prompt significantly fewer MRIs compared to using an elevated CRP (only 99/174 MRIs compared to 144/174 MRIs, P <0.001). In the second phase (49 patient disease-only cohort), the sensitivities of the SIRCH score and CRP use (laboratory standard cut-off 3.5 mg/L) were 92% (95% CI, 84-98%), and 98% (95% CI, 94-100%), respectively. CONCLUSION: The SIRCH score provides a sensitive estimate of spinal infection risk and prompts fewer MRIs than elevated CRP (cut-off 3.5 mg/L) or clinician suspicion.


Subject(s)
Back Pain/diagnostic imaging , Decision Support Systems, Clinical , Emergency Service, Hospital/statistics & numerical data , Hospitalization/statistics & numerical data , Magnetic Resonance Imaging/methods , Adult , Aged , Back Pain/microbiology , C-Reactive Protein/analysis , Delayed Diagnosis , Humans , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Sensitivity and Specificity
4.
Med J (Ft Sam Houst Tex) ; (PB 8-21-04/05/06): 20-31, 2021.
Article in English | MEDLINE | ID: mdl-34251661

ABSTRACT

Damage control resuscitation (DCR) simultaneously tackles hemorrhage control and balanced resuscitation in complex multisystem trauma patients. This technique can improve patient outcomes. This review outlines the importance of DCR with hemorrhage control and administration of fresh whole blood or component therapy if not available and avoiding crystalloid administration. Additionally, administration of tranexamic acid and calcium prove beneficial in critically ill trauma patients. Avoidance of acidosis, hypothermia, and coagulopathy remains a key but challenging goal of DCR.


Subject(s)
Blood Coagulation Disorders , Goals , Blood Coagulation Disorders/therapy , Crystalloid Solutions , Hemorrhage/prevention & control , Humans , Resuscitation
5.
Cureus ; 12(7): e9278, 2020 Jul 19.
Article in English | MEDLINE | ID: mdl-32821621

ABSTRACT

Aortic dissection carries a high mortality of up to 40% at the time of initial dissection and an additional 1% per hour the dissection is untreated. Patients with acute aortic dissection most commonly present with chest or back pain. Less frequently, it manifests without pain with predominant neurologic symptoms secondary to an acute stroke. We present the case of a 53-year-old male presenting with acute onset aphasia and right-sided weakness. Incidentally, CT angiography of his neck revealed a carotid artery dissection, which was found an extension of a Stanford type A acute aortic dissection resulting in a large vessel occlusion stroke. The patient's concomitant pathologies resulted in uncertainty as to the priority of management between the interventional neurology and cardiothoracic surgery services, ultimately resulting in the transfer of the patient to an aorta specialist at an outside facility. This case highlights several areas of difficulty in the management of patients with presenting with both large vessel occlusion stroke and acute aortic dissection and the need for consideration of acute aortic dissection in patients presenting with symptoms consistent with large vessel occlusion stroke. Optimal blood pressure control is unknown, as is the ideal timing of aortic repair and the potential for endovascular therapy for large vessel occlusion stroke in the setting of acute aortic dissection. Emergency physicians must rapidly engage with neurology, interventional neurology, and cardiothoracic surgery to determine appropriate interventions and timing of operative repair. The emergency physician must consider acute aortic dissection in patients presenting with signs and symptoms concerning for large vessel occlusion stroke, even if they have no complaint of chest pain, as administration of thrombolytics in these patients may be deadly.

6.
CJEM ; 22(6): 836-843, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32538336

ABSTRACT

OBJECTIVES: The aim of this study was to describe the sensitivity of various C-reactive protein (CRP) cut-off values to identify patients requiring magnetic resonance imaging evaluation for pyogenic spinal infection among emergency department (ED) adults presenting with neck or back pain. METHODS: We prospectively enrolled a convenience series of adults presenting to a community ED with neck or back pain in whom ED providers had concern for pyogenic spinal infection in a derivation cohort from 2004 to 2010 and a validation cohort from 2010 to 2018. The validation cohort included only patients with pyogenic spinal infection. We analysed diagnostic test characteristics of various CRP cut-off values. RESULTS: We enrolled 232 patients and analysed 201 patients. The median age was 55 years, 43.8% were male, 4.0% had history of intravenous drug use, and 20.9% had recent spinal surgery. In the derivation cohort, 38 (23.9%) of 159 patients had pyogenic spinal infection. Derivation sensitivity and specificity of CRP cut-off values were > 3.5 mg/L (100%, 24.8%), > 10 mg/L (100%, 41.3%), > 30 mg/L (100%, 61.2%), and > 50 mg/L (89.5%, 69.4%). Validation sensitivities of CRP cut-off values were > 3.5 mg/L (97.6%), > 10 mg/L (97.6%), > 30 mg/L (90.4%), and > 50 mg/L (85.7%). CONCLUSIONS: CRP cut-offs beyond the upper limit of normal had high sensitivity for pyogenic spinal infection in this adult ED population. Elevated CRP cut-off values of 10 mg/L and 30 mg/L require validation in other settings.


Subject(s)
C-Reactive Protein , Infections , Back Pain , C-Reactive Protein/analysis , Emergency Service, Hospital , Female , Humans , Male , Middle Aged , Sensitivity and Specificity
7.
Am J Emerg Med ; 38(3): 491-496, 2020 03.
Article in English | MEDLINE | ID: mdl-31128933

ABSTRACT

OBJECTIVE: To identify clinical characteristics associated with pyogenic spinal infection among adults presenting to a community emergency department (ED) with neck or back pain. A secondary objective was to describe the frequency of these characteristics among patients with spinal epidural abscess (SEA). METHODS: We conducted a prospective cohort study in a community ED enrolling adults with neck or back pain in whom the ED provider had clinical concern for pyogenic spinal infection. Study phase 1 (Jan 2004-Mar 2010) included patients with and without pyogenic spinal infection. Phase 2 (Apr 2010-Aug 2018) included only patients with pyogenic spinal infection. We performed univariate and multivariate analyses for association of clinical characteristics with pyogenic spinal infection. RESULTS: We enrolled 232 and analyzed 223 patients, 89 of whom had pyogenic spinal infection. The median age was 55 years and 102 patients (45.7%) were male. The clinical characteristics associated with pyogenic spinal infection on multivariate analysis of study phase 1 included recent soft tissue infection or bacteremia (OR 13.5, 95% CI 3.6 to 50.7), male sex (OR 5.0, 95% CI 2.5 to 10.0), and fever in the ED or prior to arrival (OR 2.8, 95% CI 1.3 to 6.0). Among patients with SEA (n = 61), 49 (80.3%) had at least one historical risk factor, 12 (19.7%) had fever in the ED, and 8 (13.1%) had a history of intravenous drug use. CONCLUSION: Male sex, fever, and recent soft tissue infection or bacteremia were associated with pyogenic spinal infection in this prospective ED cohort.


Subject(s)
Back Pain/etiology , Neck Pain/etiology , Spinal Cord Diseases/diagnosis , Adult , Aged , Bacteremia/complications , Emergency Service, Hospital/statistics & numerical data , Epidural Abscess/epidemiology , Epidural Abscess/microbiology , Female , Fever/etiology , Humans , Male , Middle Aged , Prospective Studies , Risk Factors , Sex Factors , Soft Tissue Infections/complications , Spinal Cord Diseases/epidemiology , Spinal Cord Diseases/etiology , Spinal Cord Diseases/microbiology
9.
J Trauma ; 66(4 Suppl): S112-9, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19359954

ABSTRACT

OBJECTIVES: Military casualties with vascular injuries often present with severe acidosis and coagulopathy that can negatively influence limb salvage decisions. We previously reported the value of a damage control resuscitation (DCR) strategy that can correct physiologic shock during simultaneous vascular reconstruction. The effect of recombinant factor VIIa (rFVIIa) on the repair of injured vessels and vascular grafts when used as an adjunctive therapy during DCR is unclear in the setting of wartime vascular injuries. The primary aim of this study was to assess the effect of rFVIIa use during DCR for vascular trauma and the impact on vessel repair. METHODS: A retrospective two cohort case control study was performed using the Joint Theater Trauma Registry to identify patients with major vascular injury and DCR. Group 1 (n = 12) had DCR and repair of the injured vessels. Group 2 (n = 41) included early rFVIIa as an adjunctive therapy with DCR to control bleeding and perform simultaneous vascular reconstruction. RESULTS: Age, injury severity score, presenting physiology, and operative time were similar between groups. Postoperative data show that early physiologic recovery from acidosis, coagulopathy, and anemia was associated with rFVIIa and DCR. Extremity graft failures in groups 1 and 2 (follow-up range, 10-26 months) were either from early thrombosis (1 vs. 5 p = 1), graft dehiscence (1 vs. 2 p = 0.55), or infection (1 vs. 1 p = 0.41) and were the result of inadequate soft tissue coverage or technical factors that eventually resulted in eight (15%) amputations. All cause mortality (group 1: 0% vs. group 2: 7.3%, p = 1) and amputation rates (group 1: 25% vs. groups 2: 12.2%, p = 0.36) were similar between the two groups. CONCLUSIONS: DCR using rFVIIa is effective for controlling hemorrhage and reversing coagulopathy for severe vascular injuries. Early graft failures seem unrelated to rFVIIa use in the setting of wartime vascular injuries. No differences in amputation rate or mortality were seen. Although rFVIIa may be a useful damage control adjunct during vessel repair, the overall impact of this strategy on long-term outcomes such as mortality and limb salvage remains to be determined.


Subject(s)
Blood Vessels/injuries , Coagulants/therapeutic use , Factor VIIa/therapeutic use , Hemorrhage/therapy , Military Personnel , Wounds, Penetrating/complications , Acidosis/blood , Acidosis/etiology , Adolescent , Adult , Case-Control Studies , Female , Hemorrhage/blood , Hemorrhage/etiology , Humans , Iraq War, 2003-2011 , Limb Salvage , Male , Practice Guidelines as Topic , Recombinant Proteins/therapeutic use , Registries , Retrospective Studies , Trauma Centers , Vascular Surgical Procedures/rehabilitation , Young Adult
10.
Prehosp Emerg Care ; 13(1): 50-2, 2009.
Article in English | MEDLINE | ID: mdl-19145524

ABSTRACT

BACKGROUND: Previous literature has shown the ability of ultrasonography technology to accurately assess orthopedic pathology. Over the past two decades, the use of ultrasound in the prehospital setting has become an important tool for triage, diagnosis, and treatment, especially in austere and remote environments that lack appropriate radiography capability and logistical support. The purpose of our study was to assess the accuracy of ultrasound in the austere, combat environment for diagnosis of orthopedic fracture. METHODS: We conducted a longitudinal, prospective, observational study on patients presenting with suspected closed fractures using a digital handheld ultrasound device. All patients presenting with suspected fracture underwent an ultrasound examination by a board-certified emergency medicine physician credentialed in emergency ultrasonography. Patients were then categorized into ultrasound-positive and ultrasound-negative groups. RESULTS: A total of 44 subjects underwent ultrasound examination for suspected fractures. There were initially 12 (27%) positive and 32 (73%) negative scans. Of the initial 12 positive scans, ten had a true fracture verified by plain radiography. Ultrasonography yielded an overall sensitivity of 100% and a specificity of 94%. Only four patients with an initial negative ultrasound scan continued to have clinical symptoms for more than three days and were found to have no evidence of fracture by radiograph. CONCLUSIONS: Our data show that use of ultrasound by an experienced clinician in the austere environment can be performed accurately and can possibly prevent unnecessary evacuations for suspected fractures requiring radiographic verification. The purpose of our study was to assess the accuracy of ultrasound examination in the austere, combat environment for diagnosis of orthopedic fracture.


Subject(s)
Emergency Medical Services , Fractures, Closed/diagnostic imaging , Military Personnel , Point-of-Care Systems , Triage , Humans , Longitudinal Studies , Retrospective Studies , Sensitivity and Specificity , Ultrasonography/instrumentation
11.
Int J Cardiol ; 134(3): 417-8, 2009 May 29.
Article in English | MEDLINE | ID: mdl-18353463

ABSTRACT

For Emergency Department (ED) patients presenting with acute chest pain, troponin-I (TnI) is reported not just as negative or positive, but also within an "indeterminate range". We reviewed 150 patients with a first-drawn ED TnI level in the indeterminate range (0.08-0.79 ng/dL) and compared outcomes to 150 control patients with a negative TnI. An initial ED indeterminate TnI yielded a statistically significant association with a composite adverse outcome (44% vs. 24%; OR=2.49; CI=1.52-4.08). Indeterminate TnI also showed a significantly increased risk of both an acute myocardial infarction and of the need for an invasive cardiac procedure during the admission. Our study further supports the hypothesis that any detectable level of TnI increases risk of cardiovascular events during acute hospitalization.


Subject(s)
Emergency Service, Hospital , Troponin I/physiology , Aged , Biomarkers/blood , Chest Pain/blood , Chest Pain/diagnosis , Cohort Studies , Female , Humans , Male , Middle Aged , Retrospective Studies , Troponin I/blood
12.
J Trauma ; 65(1): 1-9, 2008 Jul.
Article in English | MEDLINE | ID: mdl-18580508

ABSTRACT

BACKGROUND: Hemorrhage from extremity wounds is a leading cause of potentially preventable death during modern combat operations. Optimal management involves rapid hemostasis and reversal of metabolic derangements utilizing damage control principles. The traditional practice of damage control surgery favors a life over limb approach and discourages elaborate, prolonged vascular reconstructions. We hypothesized that limb preservation could be successful when the damage control approach combines advanced resuscitative strategies and modern vascular techniques. METHODS: Trauma Registry records at a Combat Support Hospital from April to June 2006 were retrospectively reviewed. Patients with life-threatening hemorrhage (defined as >4 units of packed red blood cells) who underwent simultaneous revascularization for a pulseless extremity were included. Data collection included the initial physiologic parameters in the emergency department (ED), total and 24-hour blood product requirements, and admission physiology and laboratory values in the intensive care unit (ICU). Outcome measures were survival, graft patency, and amputation rate at 7 days. RESULTS: Sixteen patients underwent 20 vascular reconstructions for upper (3) or lower extremity (17) wounds. Patients were hypotensive (blood pressure 105/60 +/- 29/18), acidotic (pH 7.27 +/- 0.1; BD -7.50 +/- 5.5), and coagulopathic (international normalized ratio 1.3 +/- 0.4) on arrival to the ED and essentially normal upon admission to the ICU, 4 hours later. Vein grafts (19/20, 95%) were used preferentially. Prosthetic grafts (1), shunting and delayed repair (4) or amputation (1) were infrequent. Heparin was not used or limited to a half dose (5/20, 25%). Tourniquets (12/16, 75%) and fasciotomies (13/16, 81%) were routine. Most (75%) received recombinant factor VIIa in the ED and in the operating room. All survived with normalized physiology on arrival in the ICU. Twenty-four-hour crystalloid use averaged 7.1 +/- 3.2 L, whereas packed red blood cells averaged 23 +/- 18 units, and 88% were massively transfused. Median operative time was 4.5 hours (range, 1.7-8.4 hours). CONCLUSIONS: Aggressive damage control resuscitation maneuvers in critically injured casualties successfully permitted prolonged, complex extremity revascularization with excellent early limb salvage and graft patency. Recombinant VIIa and liberal resuscitation with fresh whole blood, plasma, platelets and cryoprecipitate, while minimizing crystalloid, allowed limb salvage and did not result in early graft failures.


Subject(s)
Arm Injuries/surgery , Emergency Service, Hospital , Hospitals, Military , Leg Injuries/surgery , Limb Salvage , Warfare , Adult , Arm Injuries/complications , Cohort Studies , Hemostatic Techniques , Humans , Iraq , Leg Injuries/complications , Retrospective Studies , Tourniquets , Treatment Outcome , United States
13.
J Trauma ; 64(2 Suppl): S99-106; discussion S106-7, 2008 Feb.
Article in English | MEDLINE | ID: mdl-18376180

ABSTRACT

OBJECTIVES: Major vascular injury is a leading cause of potentially preventable hemorrhagic death in modern combat operations. An optimal resuscitation approach for military trauma should offer both rapid hemorrhage control and early reversal of metabolic derangements. The objective of this report is to establish the use and effectiveness of a damage control resuscitation (DCR) strategy in the setting of wartime vascular injury. METHODS: A retrospective two-cohort case control study was performed using the Joint Theater Trauma Registry to identify patients with an extremity vascular injury treated at two different points in time: group 1 (n = 16) from April to June 2006 when DCR concepts were put into practice and group 2 (n = 24) 1 year later in a period when DCR strategies were not employed. RESULTS: Baseline demographics, injury severity, admission physiology, and operative details were similar between groups 1 and 2. Group 1 patients received more total blood products (23 vs. 12 units, p < 0.05), fresh frozen plasma (16 vs. 7 units, p < 0.01), cryoprecipitate (11 vs. 1.2 units, p < 0.05), whole blood (19% vs. 0%, p = 0.06), and early recombinant factor VIIa (75% vs. 0%, p < 0.001) than group 2 patients. Group 1 patients had a more complete early physiologic recovery after vascular reconstruction (heart rate: 38 vs. 12, p < 0.001; systolic blood pressure, 39 vs. 14, p < 0.001; base deficit: 7.36 vs. 2.72, p < 0.001; International Normalized Ratio, 0.3 vs. 0.1, p < 0.001). There was no significant difference in early amputation rates (group 1: 6.2% vs. group 2: 4.2%) or 7-day mortality (0% in both groups). CONCLUSIONS: This study was the first to use the Joint Theater Trauma Registry for follow-up on an established clinical practice guideline. DCR goals appear now to be met during the management of acute wartime vascular injuries with effective correction of physiologic shock. The overall impact of this resuscitation strategy on long-term outcomes such as limb salvage and mortality remains to be determined.


Subject(s)
Arm Injuries/therapy , Blood Transfusion , Hemostatic Techniques , Iraq War, 2003-2011 , Leg Injuries/therapy , Practice Guidelines as Topic , Adolescent , Adult , Arteries/injuries , Cohort Studies , Female , Guideline Adherence , Humans , Male , Middle Aged , Retrospective Studies , Treatment Outcome , United States , Veins/injuries
14.
J Trauma ; 64(2): 286-93; discussion 293-4, 2008 Feb.
Article in English | MEDLINE | ID: mdl-18301188

ABSTRACT

BACKGROUND: The majority of patients with potentially survivable combat-related injuries die from hemorrhage. Our objective was to determine whether the use of recombinant activated factor VII (rFVIIa) decreased mortality in combat casualties with severe trauma who received massive transfusions and if its use was associated with increased severe thrombotic events. METHODS: We retrospectively reviewed a database of combat casualty patients with severe trauma (Injury Severity Score [ISS] >15) and massive transfusion (red blood cell [RBCs] >/=10 units/24 hours) admitted to one combat support hospital in Baghdad, Iraq, between December 2003 and October 2005. Admission vital signs and laboratory data, blood products, ISS, 24-hour and 30-day mortality, and severe thrombotic events were compared between patients who received rFVIIa (rFVIIa) and did not receive rFVIIa (rFVIIa). RESULTS: Of 124 patients in this study, 49 patients received rFVIIa and 75 did not. ISS, laboratory values, and admission vitals did not differ between rFVIIa and rFVIIa groups, except for systolic blood pressure (mm Hg) 105 +/- 33 and 92 +/- 28, p = 0.02 and temperature ( degrees F) 96.3 +/- 2.1 and 95.2 +/- 2.4, p = 0.03, respectively. Interactions between all vital signs and laboratory values measured upon admission, to include systolic blood pressure and temperature, were not significant when measured between rFVIIa use and 30-day mortality. Twenty-four-hour mortality was 7 of 49 (14%) in rFVIIa and 26 of 75 (35%) in rFVIIa, (p = 0.01); 30-day mortality was 15 of 49 (31%) and 38 of 75 (51%), (p = 0.03). Death from hemorrhage was 8 of 14 (57%) for rFVIIa patients compared with 29 of 37 (78%) for rFVIIa patients, (p = 0.12). The incidence of severe thrombotic events was similar in both groups. CONCLUSIONS: The early use of rFVIIa was associated with decreased 30-day mortality in severely injured combat casualties requiring massive transfusion, but was not associated with increased risk of severe thrombotic events.


Subject(s)
Blood Transfusion , Factor VIIa/therapeutic use , Hemorrhage/drug therapy , Military Personnel , Wounds and Injuries/mortality , Cause of Death , Databases, Factual , Factor VIIa/adverse effects , Hemorrhage/etiology , Humans , Injury Severity Score , Kaplan-Meier Estimate , Military Medicine , Recombinant Proteins/adverse effects , Recombinant Proteins/therapeutic use , Retrospective Studies , Thrombosis/etiology , United States , Warfare , Wounds and Injuries/classification , Wounds and Injuries/therapy
18.
Acad Emerg Med ; 12(11): 1120-6, 2005 Nov.
Article in English | MEDLINE | ID: mdl-16264083

ABSTRACT

Informed consent in military research shares many of the same fundamental principles and regulations that govern civilian biomedical research. In fact, much of modern research ethics is grounded in events that occurred in the context of war or government-sponsored research. Despite these similarities and common origins, research in the military has additional requirements designed to preserve service members' informed consent rights. The special nature of the superior-subordinate relationship in the military necessitates careful protections to avoid perceptions of coercion or undue influence on a military subject. Additionally, current legal and regulatory requirements for advanced informed consent significantly restrict the flexibility of the military to conduct research using waiver of consent. This has implications on the ability of the nation to develop effective medical treatments for the global war on terrorism. Nevertheless, work is under way to realign defense research policy with the norms of civilian biomedical practice. Future directions include the adoption of waivers for military emergency research, and the cautious introduction of human subject studies on the battlefield. This paper discusses historical background, regulatory differences, and concerns and challenges of some of these regulatory differences for research personnel that apply to informed consent and waiver of said informed consent for emergency research conducted by the U.S. military.


Subject(s)
Informed Consent/ethics , Military Medicine/ethics , Government Regulation/history , History, 18th Century , History, 19th Century , History, 20th Century , Humans , Informed Consent/history , Informed Consent/legislation & jurisprudence , Military Medicine/legislation & jurisprudence , Military Medicine/trends , Patient Selection/ethics , Public Opinion , Terrorism/prevention & control , United States
19.
Ann Emerg Med ; 41(2): 276-7, 2003 Feb.
Article in English | MEDLINE | ID: mdl-12548281
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