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Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.

ABSTRACT: Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study.The CC/PD was guided by the four bioethical principles. We used a multimedia approach, including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County's population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (eg, Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT study website.A total of 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost more than $84,000.The CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.

SUBMITTER: Chin TL

PROVIDER: S-EPMC4261038 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.

Chin Theresa L TL Moore Ernest E EE Coors Marilyn E ME Chandler James G JG Ghasabyan Arsen A Harr Jeffrey N JN Stringham John R JR Ramos Christopher R CR Ammons Sarah S Banerjee Anirban A Sauaia Angela A

Surgery 20141014 1

<h4>Background</h4>Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study.<h4> ...[more]

PMID: 25444222

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Project description:Importance:Although the Afghanistan and Iraq conflicts have the lowest US case-fatality rates in history, no comprehensive assessment of combat casualty care statistics, major interventions, or risk factors has been reported to date after 16 years of conflict. Objectives:To analyze trends in overall combat casualty statistics, to assess aggregate measures of injury and interventions, and to simulate how mortality rates would have changed had the interventions not occurred. Design, Setting, and Participants:Retrospective analysis of all available aggregate and weighted individual administrative data compiled from Department of Defense databases on all 56 763 US military casualties injured in battle in Afghanistan and Iraq from October 1, 2001, through December 31, 2017. Casualty outcomes were compared with period-specific ratios of the use of tourniquets, blood transfusions, and transport to a surgical facility within 60 minutes. Main Outcomes and Measures:Main outcomes were casualty status (alive, killed in action [KIA], or died of wounds [DOW]) and the case-fatality rate (CFR). Regression, simulation, and decomposition analyses were used to assess associations between covariates, interventions, and individual casualty status; estimate casualty transitions (KIA to DOW, KIA to alive, and DOW to alive); and estimate the contribution of interventions to changes in CFR. Results:In aggregate data for 56 763 casualties, CFR decreased in Afghanistan (20.0% to 8.6%) and Iraq (20.4% to 10.1%) from early stages to later stages of the conflicts. Survival for critically injured casualties (Injury Severity Score, 25-75 [critical]) increased from 2.2% to 39.9% in Afghanistan and from 8.9% to 32.9% in Iraq. Simulations using data from 23 699 individual casualties showed that without interventions assessed, CFR would likely have been higher in Afghanistan (15.6% estimated vs 8.6% observed) and Iraq (16.3% estimated vs 10.1% observed), equating to 3672 additional deaths (95% CI, 3209-4244 deaths), of which 1623 (44.2%) were associated with the interventions studied: 474 deaths (12.9%) (95% CI, 439-510) associated with the use of tourniquets, 873 (23.8%) (95% CI, 840-910) with blood transfusion, and 275 (7.5%) (95% CI, 259-292) with prehospital transport times. Conclusions and Relevance:Our analysis suggests that increased use of tourniquets, blood transfusions, and more rapid prehospital transport were associated with 44.2% of total mortality reduction. More critically injured casualties reached surgical care, with increased survival, implying improvements in prehospital and hospital care.

Project description:Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families.Epidemiologic, level III.

Project description:BACKGROUND:Severe traumatic injury continues to present challenges to healthcare systems around the world, and post-traumatic bleeding remains a leading cause of potentially preventable death among injured patients. Now in its fifth edition, this document aims to provide guidance on the management of major bleeding and coagulopathy following traumatic injury and encourages adaptation of the guiding principles described here to individual institutional circumstances and resources. METHODS:The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma was founded in 2004, and the current author group included representatives of six relevant European professional societies. The group applied a structured, evidence-based consensus approach to address scientific queries that served as the basis for each recommendation and supporting rationale. Expert opinion and current clinical practice were also considered, particularly in areas in which randomised clinical trials have not or cannot be performed. Existing recommendations were re-examined and revised based on scientific evidence that has emerged since the previous edition and observed shifts in clinical practice. New recommendations were formulated to reflect current clinical concerns and areas in which new research data have been generated. RESULTS:Advances in our understanding of the pathophysiology of post-traumatic coagulopathy have supported improved management strategies, including evidence that early, individualised goal-directed treatment improves the outcome of severely injured patients. The overall organisation of the current guideline has been designed to reflect the clinical decision-making process along the patient pathway in an approximate temporal sequence. Recommendations are grouped behind the rationale for key decision points, which are patient- or problem-oriented rather than related to specific treatment modalities. While these recommendations provide guidance for the diagnosis and treatment of major bleeding and coagulopathy, emerging evidence supports the author group's belief that the greatest outcome improvement can be achieved through education and the establishment of and adherence to local clinical management algorithms. CONCLUSIONS:A multidisciplinary approach and adherence to evidence-based guidance are key to improving patient outcomes. If incorporated into local practice, these clinical practice guidelines have the potential to ensure a uniform standard of care across Europe and beyond and better outcomes for the severely bleeding trauma patient.

Project description:BackgroundSevere trauma represents a major global public health burden and the management of post-traumatic bleeding continues to challenge healthcare systems around the world. Post-traumatic bleeding and associated traumatic coagulopathy remain leading causes of potentially preventable multiorgan failure and death if not diagnosed and managed in an appropriate and timely manner. This sixth edition of the European guideline on the management of major bleeding and coagulopathy following traumatic injury aims to advise clinicians who care for the bleeding trauma patient during the initial diagnostic and therapeutic phases of patient management.MethodsThe pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma included representatives from six European professional societies and convened to assess and update the previous version of this guideline using a structured, evidence-based consensus approach. Structured literature searches covered the period since the last edition of the guideline, but considered evidence cited previously. The format of this edition has been adjusted to reflect the trend towards concise guideline documents that cite only the highest-quality studies and most relevant literature rather than attempting to provide a comprehensive literature review to accompany each recommendation.ResultsThis guideline comprises 39 clinical practice recommendations that follow an approximate temporal path for management of the bleeding trauma patient, with recommendations grouped behind key decision points. While approximately one-third of patients who have experienced severe trauma arrive in hospital in a coagulopathic state, a systematic diagnostic and therapeutic approach has been shown to reduce the number of preventable deaths attributable to traumatic injury.ConclusionA multidisciplinary approach and adherence to evidence-based guidelines are pillars of best practice in the management of severely injured trauma patients. Further improvement in outcomes will be achieved by optimising and standardising trauma care in line with the available evidence across Europe and beyond.

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Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.

Publications

Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.

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