An executive summary of the National Trauma Research Action Plan.

ABSTRACT: The National Trauma Research Action Plan project successfully engaged multidisciplinary experts to define opportunities to advance trauma research and has fulfilled the recommendations related to trauma research from the National Academies of Sciences, Engineering and Medicine report. These panels identified more than 4,800 gaps in our knowledge regarding injury prevention and the optimal care of injured patients and laid out a priority framework and tools to support researchers to advance this field. Trauma research funding agencies and researchers can use this executive summary and supporting manuscripts to strategically address and close the highest priority research gaps. Given that this is the most significant public health threat facing our children, young adults, and military service personnel, we must do better in prioritizing these research projects for funding and providing grant support to advance this work. Through the Coalition for National Trauma Research, the trauma community is committed to a coordinated, collaborative approach to address these critical knowledge gaps and ultimately reduce the burden of morbidity and mortality faced by our patients.

Community of trauma care partnering with stakeholders to improve injury outcomes: focus group analysis.

Introduction: Engaging trauma survivors/caregivers results in research findings that are more relevant to patients' needs and priorities. Although their perspectives increase research significance, there is a lack of understanding about how best to incorporate their insights. We aimed to capture stakeholder perspectives to ensure research is meaningful, respectful, and relevant to the injured patient and their caregivers. Methods: A multiphase, inductive exploratory qualitative study was performed, the first phase of which is described here. Virtual focus groups to elicit stakeholder perspectives and preferences were conducted across 19 trauma centers in the USA during 2022. Discussion topics were chosen to identify patients' motivation to join research studies, preferences regarding consent, suggestions for increasing diversity and access, and feelings regarding outcomes, efficacy, and exception from informed consent. The focus groups were audio recorded, transcribed, coded, and analyzed to identify the range of perspectives expressed and any common themes that emerged. Results: Ten 90-minute focus groups included patients/caregiver (n=21/1) and researchers (n=14). Data analysis identified common themes emerging across groups. The importance of trust and preexisting relationships with the clinical care team were the most common themes across all groups. Conclusion: Our findings reveal common themes in preferences, motivations, and best practices to increase patient/caregiver participation in trauma research. The project's next phases are distribution of a vignette-based survey to establish broad stakeholder consensus; education and dissemination activities to share strategies that increase research engagement and relevance for patients; and the formation of a panel of patients to support future research endeavors. Level of evidence: Level IV.

Developing a National Trauma Research Action Plan: Results from the regulatory challenges Delphi survey.

BACKGROUND: In 2016, the National Academies of Sciences, Engineering, and Medicine issued a report calling for a National Trauma Research Action Plan (NTRAP) requiring a resourced, coordinated, joint approach to trauma care research. The National Academies of Sciences, Engineering, and Medicine report recommended the identification of regulatory barriers to trauma research. The NTRAP Regulatory Challenges Panel of trauma researchers and regulatory professionals was convened to identify the most challenging aspects of regulatory processes involved in conducting research. METHODS: Trauma researchers and regulatory experts were recruited to identify and rate challenging regulatory issues in 2021 to 2022. Challenge statements were developed from a comprehensive scoping review. Panelists rated the challenge level for each statement on a 9-point Likert scale. The Delphi survey was conducted over three online rounds. Consensus was defined a priori as ≥60% agreement. Results of the Delphi survey were presented to the panel during a webinar. Panel participants then participated in breakout sessions to strategize solutions, share lessons learned, and identify where more regulatory guidance is needed. RESULTS: Thirty-eight subject matter experts rated 175 regulatory challenges, of which 141 (81%) reached the consensus threshold. Of the consensus-reaching challenge statements, 42 had a challenge rating of 6 or higher. Among the highest-rated challenges were issues pertaining to conducting prehospital research, exception from informed consent, mistrust of research among various racial and ethnic groups, and issues specific to conducting pediatric trauma research. CONCLUSION: This Delphi survey rated challenges culled from a regulatory literature scoping review. The panel identified the most challenging aspects of human subjects protection while conducting trauma research and recommended strategies and best practices to address them. The findings from this study were used to develop the NTRAP Investigator Toolkit, which is available on the internet as a resource for trauma researchers. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Research priorities in venous thromboembolism after trauma: Secondary analysis of the National Trauma Research Action Plan.

BACKGROUND: Venous thromboembolism (VTE) is a significant cause of morbidity and mortality during recovery from injury and can result in significant health care costs. Despite advances in the past several decades in our approach to VTE prophylaxis after injury, opportunities exist to improve the delivery and implementation of optimal VTE prophylaxis. Here, we aim to identify consensus research questions related to VTE across all National Trauma Research Action Plan (NTRAP) Delphi expert panels to further guide the research agenda aimed at preventing VTE after injury. METHODS: This is a secondary analysis of consensus-based research priorities that were collected using a Delphi methodology by 11 unique NTRAP panels that were charged with unique topic areas across the spectrum of injury care. The database of questions was queried for the keywords "VTE," "venous thromboembo," and "DVT" and then grouped into relevant topic areas. RESULTS: There were 86 VTE-related research questions identified across 9 NTRAP panels. Eighty-five questions reached consensus with 24 rated high priority; 60, medium priority; and 1, low priority. Questions related to the timing of VTE prophylaxis (n = 17) were most common, followed by questions related to risk factors for the development of VTE (n = 16), the effects of tranexamic acid on VTE (n = 11), the approach to dosing of pharmacologic prophylaxis (n = 8), and the pharmacologic prophylactic medication choice for optimal VTE prophylaxis (n = 6). CONCLUSION: National Trauma Research Action Plan panelists identified 85 consensus-based research questions that should drive dedicated extramural research funding opportunities to support quality studies aimed at optimizing VTE prophylaxis after injury. LEVEL OF EVIDENCE: Prognostic and Epidemiological; Level IV.

Access to trauma center care: A statewide system-based approach.

BACKGROUND: Timely access to specialized trauma care is a vital element in patient outcome after severe and critical injury requiring the skills of trauma teams in levels I and II trauma centers to avoid preventable mortality. We used system-based models to estimate timely access to care. METHODS: Trauma system models consisted of ground emergency medical services, helicopter emergency medical services, and designated levels I to V trauma centers were constructed for five states. These models incorporated geographic information systems along with traffic data and census block group data to estimate population access to trauma care within the "golden hour." Trauma systems were further analyzed to identify the optimal location for an additional level I or II trauma center that would provide the greatest increase in access. RESULTS: The population of the states studied totaled 23 million people, of which 20 million (87%) had access to a level I or II trauma center within 60 minutes. Statewide-specific access ranged from 60% to 100%. Including levels III to V trauma centers, access within 60 minutes increased to 22 million (96%), ranging from 95% to 100%. The addition of a levels I and II trauma center in an optimized location in each state would provide timely access to a higher trauma capability for an additional 1.1 million, increasing total access to approximately 21.1 million people (92%). CONCLUSION: This analysis demonstrates that nearly universal access to trauma care is present in these states when including levels I to V trauma centers. However, concerning gaps remain in timely access to levels I and II trauma centers. This study provides an approach to determine more robust statewide estimates of access to care. It highlights the need for a national trauma system, one in which all components of state-managed trauma systems are assembled in a national data set to accurately identify gaps in care. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Regulatory challenges in conducting human subjects research in emergency settings: the National Trauma Research Action Plan (NTRAP) scoping review.

The complexity of the care environment, the emergent nature, and the severity of patient injury make conducting clinical trauma research challenging. These challenges hamper the ability to investigate potentially life-saving research that aims to deliver pharmacotherapeutics, test medical devices, and develop technologies that may improve patient survival and recovery. Regulations intended to protect research subjects impede scientific advancements needed to treat the critically ill and injured and balancing these regulatory priorities is challenging in the acute setting. This scoping review attempted to systematically identify what regulations are challenging in conducting trauma and emergency research. A systematic search of PubMed was performed to identify studies published between 2007 and 2020, from which 289 articles that address regulatory challenges in conducting research in emergency settings were included. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. The review is reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. Most articles identified were editorial/commentary (31%) and published in the USA (49%). Regulatory factors addressed in the papers were categorized under 15 regulatory challenge areas: informed consent (78%), research ethics (65%), institutional review board (55%), human subjects protection (54%), enrollment (53%), exception from informed consent (51%), legally authorized representative (50%), patient safety (41%), community consultation (40%), waiver of informed consent (40%), recruitment challenges (39%), patient perception (30%), liability (15%), participant incentives (13%), and common rule (11%). We identified several regulatory barriers to conducting trauma and emergency research. This summary will support the development of best practices for investigators and funding agencies.

Timing of venous thromboembolism prophylaxis initiation after injury: Findings from the consensus conference to implement optimal VTE prophylaxis in trauma.

ABSTRACT: Optimizing prophylaxis against venous thromboembolic events (VTEs) is a critical issue in the care of injured patients. Although these patients are at significant risk of developing VTE, they also present competing concerns related to exacerbation of bleeding from existing injuries. Especially after high-risk trauma, including injuries to the abdominal solid organs, brain, and spine, trauma providers must delineate the time period in which VTE prophylaxis successfully reduces VTE rates without encouraging bleeding. Although existing data are primarily retrospective in nature and further study is required, literature supports early VTE chemoprophylaxis initiation even for severely injured patients. Early initiation is most frequently defined as <48 hours from admission but varies from <24 hours to 72 hours and occasionally refers to time from initial trauma. Prior to chemical VTE prophylaxis initiation in patients at risk for bleeding, an observation period is necessary during which injuries must show themselves to be hemostatic, either clinically or radiographically. In the future, prospective examination of optimal timing of VTE prophylaxis is necessary. Further study of specific subsets of trauma patients will allow for development of effective VTE mitigation strategies based upon collective risks of VTE and hemorrhage progression.

Novel therapeutic medications for venous thromboembolism prevention in trauma patients: Findings from the Consensus Conference to Implement Optimal Venous Thromboembolism Prophylaxis in Trauma.

ABSTRACT: Trauma patients are at high risk for venous thromboembolism (VTE). Despite evidence-based guidelines and concerted efforts in trauma centers to implement optimal chemoprophylaxis strategies, VTE remains a frequent diagnosis in trauma patients. Current chemoprophylaxis strategies largely focus on the subcutaneous injection of low-molecular-weight heparin, which is administered twice daily. Novel approaches to pharmacologic VTE prophylaxis have the potential to reduce VTE rates by improving patient compliance through oral administration or through their ability to target alternative pathways that mediate thrombosis. While novel pharmacologic VTE prophylaxis strategies have been studied in nontrauma patients, there is a paucity of literature in trauma patients where the risk of thrombosis versus hemorrhage must be carefully considered. As a component of the 2022 Consensus Conference to Implement Optimal VTE Prophylaxis in Trauma, this review provides an update of the novel chemoprophylaxis agents for potential use in trauma patients. Here, we will consider the relative risks and benefits related to the use of these drugs, evaluate the current literature in nontrauma patients, and consider future directions that could potentially improve posttrauma VTE prophylaxis.

Approaches for optimizing venous thromboembolism prevention in injured patients: Findings from the consensus conference to implement optimal venous thromboembolism prophylaxis in trauma.

ABSTRACT: Venous thromboembolism (VTE) is a major issue in trauma patients. Without prophylaxis, the rate of deep venous thrombosis approaches 60% and even with chemoprophylaxis may be nearly 30%. Advances in VTE reduction are imperative to reduce the burden of this issue in the trauma population. Novel approaches in VTE prevention may include new medications, dosing regimens, and extending prophylaxis to the postdischarge phase of care. Standard dosing regimens of low-molecular-weight heparin are insufficient in trauma, shifting our focus toward alternative dosing strategies to improve prophylaxis. Mixed data suggest that anti-Xa-guided dosage, weight-based dosing, and thromboelastography are among these potential strategies. The concern for VTE in trauma does not end upon discharge, however. The risk for VTE in this population extends well beyond hospitalization. Variable extended thromboprophylaxis regimens using aspirin, low-molecular-weight heparin, and direct oral anticoagulants have been suggested to mitigate this prolonged VTE risk, but the ideal approach for outpatient VTE prevention is still unclear. As part of the 2022 Consensus Conference to Implement Optimal Venous Thromboembolism Prophylaxis in Trauma, a multidisciplinary array of participants, including physicians from multiple specialties, pharmacists, nurses, advanced practice providers, and patients met to attack these issues. This paper aims to review the current literature on novel approaches for optimizing VTE prevention in injured patients and identify research gaps that should be investigated to improve VTE rates in trauma.

Developing a National Trauma Research Action Plan: Results from the trauma systems and informatics panel Delphi survey.

BACKGROUND: The National Academies of Sciences, Engineering, and Medicine 2016 report on the trauma care system recommended establishing a National Trauma Research Action Plan to strengthen and guide future trauma research. To address this recommendation, the Department of Defense funded a study to generate a comprehensive research agenda spanning the trauma and burn care continuum. Panels were created to conduct a gap analysis and identify high-priority research questions. The National Trauma Research Action Plan panel reported here addressed trauma systems and informatics. METHODS: Experts were recruited to identify current gaps in trauma systems research, generate research questions, and establish the priorities using an iterative Delphi survey approach from November 2019 through August 2020. Panelists were identified to ensure heterogeneity and generalizability, including military and civilian representation. Panelists were encouraged to use a PICO format to generate research questions: patient/population, intervention, compare/control, and outcome. In subsequent surveys, panelists prioritized each research question on a 9-point Likert scale, categorized as low-, medium-, and high-priority items. Consensus was defined as ≥60% agreement. RESULTS: Twenty-seven subject matter experts generated 570 research questions, of which 427 (75%) achieved the consensus threshold. Of the consensus reaching questions, 209 (49%) were rated high priority, 213 (50%) medium priority, and 5 (1%) low priority. Gaps in understanding the broad array of interventions were identified, including those related to health care infrastructure, technology products, education/training, resuscitation, and operative intervention. The prehospital phase of care was highlighted as an area needing focused research. CONCLUSION: This Delphi gap analysis of trauma systems and informatics research identified high-priority research questions that will help guide investigators and funding agencies in setting research priorities to continue to work toward Zero Preventable Deaths after trauma. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level IV.

Proceedings from the 2022 Consensus Conference to Implement Optimal Venous Thromboembolism Prophylaxis in Trauma.

ABSTRACT: On May 4 and 5, 2022, a meeting of multidisciplinary stakeholders in the prevention and treatment of venous thromboembolism (VTE) after trauma was convened by the Coalition for National Trauma Research, funded by the National Heart, Lung, and Blood Institute of the National Institutes of Health, and hosted by the American College of Surgeons in Chicago, Illinois. This consensus conference gathered more than 40 in-person and 80 virtual attendees, including trauma surgeons, other physicians, thrombosis experts, nurses, pharmacists, researchers, and patient advocates. The objectives of the meeting were twofold: (1) to review and summarize the present state of the scientific evidence regarding VTE prevention strategies in injured patients and (2) to develop consensus on future priorities in VTE prevention implementation and research gaps.To achieve these objectives, the first part of the conference consisted of talks from physician leaders, researchers, clinical champions, and patient advocates to summarize the current state of knowledge of VTE pathogenesis and prevention in patients with major injury. Video recordings of all talks and accompanying slides are freely available on the conference website ( https://www.nattrauma.org/research/research-policies-templates-guidelines/vte-conference/ ). Following this curriculum, the second part of the conference consisted of a series of small-group breakout sessions on topics potentially requiring future study. Through this process, research priorities were identified, and plans of action to develop and undertake future studies were defined.The 2022 Consensus Conference to Implement Optimal VTE Prophylaxis in Trauma answered the National Trauma Research Action Plan call to define a course for future research into preventing thromboembolism after trauma. A multidisciplinary group of clinical champions, physicians, scientists, and patients delineated clear objectives for future investigation to address important, persistent key knowledge gaps. The series of papers from the conference outlines the consensus based on the current literature and a roadmap for research to answer these unanswered questions.

Developing a National Trauma Research Action Plan: Results from the postadmission critical care research gap Delphi survey.

INTRODUCTION: The 2016 National Academies of Science, Engineering and Medicine report included a proposal to establish a National Trauma Research Action Plan. In response, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care from prehospital care to rehabilitation as part of an overall strategy to achieve zero preventable deaths and disability after injury. The Postadmission Critical Care Research panel was 1 of 11 panels constituted to develop this research agenda. METHODS: We recruited interdisciplinary experts in surgical critical care and recruited them to identify current gaps in clinical critical care research, generate research questions, and establish the priority of these questions using a consensus-driven Delphi survey approach. The first of four survey rounds asked participants to generate key research questions. On subsequent rounds, we asked survey participants to rank the priority of each research question on a 9-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as ≥60% of panelists agreeing on the priority category. RESULTS: Twenty-five subject matter experts generated 595 questions. By Round 3, 249 questions reached ≥60% consensus. Of these, 22 questions were high, 185 were medium, and 42 were low priority. The clinical states of hypovolemic shock and delirium were most represented in the high-priority questions. Traumatic brain injury was the only specific injury pattern with a high-priority question. CONCLUSION: The National Trauma Research Action Plan critical care research panel identified 22 high-priority research questions, which, if answered, would reduce preventable death and disability after injury. LEVEL OF EVIDENCE: Diagnostic Tests or Criteria; Level IV.

Developing a National Trauma Research Action Plan: Results from the long-term outcomes research gap Delphi survey.

BACKGROUND: In the National Academies of Sciences, Engineering, and Medicine 2016 report on trauma care, the establishment of a National Trauma Research Action Plan to strengthen and guide future trauma research was recommended. To address this recommendation, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. We describe the gap analysis and high-priority research questions generated from the National Trauma Research Action Plan panel on long-term outcomes. METHODS: Experts in long-term outcomes were recruited to identify current gaps in long-term trauma outcomes research, generate research questions, and establish the priority for these questions using a consensus-driven, Delphi survey approach from February 2021 to August 2021. Panelists were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability including both military and civilian representation. Panelists were encouraged to use a PICO format to generate research questions: Patient/Population, Intervention, Compare/Control, and Outcome model. On subsequent surveys, panelists were asked to prioritize each research question on a 9-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as ≥60% of panelists agreeing on the priority category. RESULTS: Thirty-two subject matter experts generated 482 questions in 17 long-term outcome topic areas. By Round 3 of the Delphi, 359 questions (75%) reached consensus, of which 107 (30%) were determined to be high priority, 252 (70%) medium priority, and 0 (0%) low priority. Substance abuse and pain was the topic area with the highest number of questions. Health services (not including mental health or rehabilitation) (64%), mental health (46%), and geriatric population (43%) were the topic areas with the highest proportion of high-priority questions. CONCLUSION: This Delphi gap analysis of long-term trauma outcomes research identified 107 high-priority research questions that will help guide investigators in future long-term outcomes research. LEVEL OF EVIDENCE: Diagnostic Tests or Criteria; Level IV.

Developing a National Trauma Research Action Plan: Results from the injury prevention research gap Delphi survey.

BACKGROUND: In its 2016 report on trauma care, the National Academies of Sciences, Engineering, and Medicine called for the establishment of a National Trauma Research Action Plan to strengthen and guide future trauma research. To address this recommendation, the Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. We describe the gap analysis and high priority research questions generated from the National Trauma Research Action Plan panel on injury prevention. METHODS: Experts in injury prevention research were recruited to identify current gaps in injury prevention research, generate research questions and establish the priority of these questions using a consensus-driven Delphi survey approach from December 2019 through September 2020. Participants were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability with both military and civilian representatives. Participants were encouraged, but not required, to use a Patient/Population, Intervention, Comparison, and Outcome format to generate research questions: Patient/Population; Intervention; Compare/Control; Outcome model. On subsequent surveys, participants were asked to rank the priority of each research question on a nine-point Likert scale, categorized to represent low-, medium-, and high-priority items. Consensus was defined as 60% or greater of panelists agreeing on the priority category. RESULTS: Twenty-eight subject matter experts generated 394 questions in 12 topic areas. By round 3 of the Delphi, 367 (93.1%) questions reached consensus, of which 169 (46.1%) were determined to be high priority, 196 (53.4%) medium priority, and 2 (0.5%) low priority. Among the 169 high priority questions, suicide (29.6%), firearm violence (20.1%), and violence prevention (18.3%) were the most prevalent topic areas. CONCLUSION: This Delphi gap analysis of injury prevention research identified 169 high priority research questions that will help guide investigators in future injury prevention research. Funding agencies and researchers should consider these gaps when they prioritize future research. LEVEL OF EVIDENCE: Therepeutic/Care Management; Level IV.

Developing a National Trauma Research Action Plan: Results from the acute resuscitation, initial patient evaluation, imaging, and management research gap Delphi survey.

BACKGROUND: Injury is the leading cause of death in patients aged 1 to 45 years and contributes to a significant public health burden for individuals of all ages. To achieve zero preventable deaths and disability after injury, the National Academies of Science, Engineering and Medicine called for the development of a National Trauma Research Action Plan to improve outcomes for military and civilian trauma patients. Because rapid resuscitation and prompt identification and treatment of injuries are critical in achieving optimal outcomes, a panel of experts was convened to generate high-priority research questions in the areas of acute resuscitation, initial evaluation, imaging, and definitive management on injury. METHODS: Forty-three subject matter experts in trauma care and injury research were recruited to perform a gap analysis of current literature and prioritize unanswered research questions using a consensus-driven Delphi survey approach. Four Delphi rounds were conducted to generate research questions and prioritize them using a 9-point Likert scale. Research questions were stratified as low, medium, or high priority, with consensus defined as ≥60% of panelists agreeing on the priority category. Research questions were coded using a taxonomy of 118 research concepts that were standard across all National Trauma Research Action Plan panels. RESULTS: There were 1,422 questions generated, of which 992 (69.8%) reached consensus. Of the questions reaching consensus, 327 (33.0%) were given high priority, 621 (62.6%) medium priority, and 44 (4.4%) low priority. Pharmaceutical intervention and fluid/blood product resuscitation were most frequently scored as high-priority intervention concepts. Research questions related to traumatic brain injury, vascular injury, pelvic fracture, and venous thromboembolism prophylaxis were highly prioritized. CONCLUSION: This research gap analysis identified more than 300 high-priority research questions within the broad category of Acute Resuscitation, Initial Evaluation, Imaging, and Definitive Management. Research funding should be prioritized to address these high-priority topics in the future.

Developing a National Trauma Research Action Plan: Results from the geriatric research gap Delphi survey.

BACKGROUND: Treating older trauma patients requires a focus on the confluence of age-related physiological changes and the impact of the injury itself. Therefore, the primary way to improve the care of geriatric trauma patients is through the development of universal, systematic multidisciplinary research. To achieve this, the Coalition for National Trauma Research has developed the National Trauma Research Action Plan that has generated a comprehensive research agenda spanning the continuum of geriatric trauma care from prehospital to rehabilitation. METHODS: Experts in geriatric trauma care and research were recruited to identify current gaps in clinical geriatric research, generate research questions, and establish the priority of these questions using a consensus-driven Delphi survey approach. Participants were identified using established Delphi recruitment guidelines ensuring heterogeneity and generalizability. On subsequent surveys, participants were asked to rank the priority of each research question on a nine-point Likert scale, categorized to represent low-, medium-, and high-priority items. The consensus was defined as more than 60% of panelists agreeing on the priority category. RESULTS: A total of 24 subject matter experts generated questions in 109 key topic areas. After editing for duplication, 514 questions were included in the priority ranking. By round 3, 362 questions (70%) reached 60% consensus. Of these, 161 (44%) were high, 198 (55%) medium, and 3 (1%) low priority. CONCLUSION: Among the questions prioritized as high priority, questions related to three types of injuries (i.e., rib fracture, traumatic brain injury, and lower extremity injury) occurred with the greatest frequency. Among the 25 highest priority questions, the key topics with the highest frequency were pain management, frailty, and anticoagulation-related interventions. The most common types of research proposed were interventional clinical trials and comparative effectiveness studies, outcome research, and health care systems research.

Developing a National Trauma Research Action Plan: Results from the Pediatric Research Gap Delphi Survey.

BACKGROUND: In 2016, the National Academies of Sciences, Engineering, and Medicine trauma report recommended a National Trauma Research Action Plan to "strengthen trauma research and ensure that the resources available for this research are commensurate with the importance of injury and the potential for improvement in patient outcomes." With a contract from the Department of Defense, the Coalition for National Trauma Research created 11 expert panels to address this recommendation, with the goal of developing a comprehensive research agenda, spanning the continuum of trauma and burn care. This report outlines the work of the group focused on pediatric trauma. METHODS: Experts in pediatric trauma clinical care and research were recruited to identify gaps in current clinical pediatric trauma research, generate research questions, and establish the priority of these questions using a consensus-driven Delphi survey approach. Using successive surveys, participants were asked to rank the priority of each research question on a 9-point Likert scale categorized to represent priority. Consensus was defined as >60% agreement within the priority category. Priority questions were coded based on a dictionary of 118 National Trauma Research Action Plan taxonomy concepts in 9 categories to support comparative analysis across all panels. RESULTS: Thirty-seven subject matter experts generated 625 questions. A total of 493 questions (79%) reached consensus on priority level. Of those reaching consensus, 159 (32%) were high, 325 (66%) were medium, and 9 (2%) were low priority. The highest priority research questions related to surgical interventions for traumatic brain injury (intracranial pressure monitoring and craniotomy); the second highest priority was hemorrhagic shock. The prehospital setting was the highest priority phase of care. CONCLUSION: This diverse panel of experts determined that most significant pediatric trauma research gaps were in traumatic brain injury, hemorrhagic shock, and the prehospital phase of care. These research domains should be top priorities for funding agencies. LEVEL OF EVIDENCE: Therapeutic / Care Management; Level IV.

Core outcome measures for research in traumatic injury survivors: The National Trauma Research Action Plan modified Delphi consensus study.

BACKGROUND: Until recently, survival has been the main outcome measure for injury research. Given the impact of injury on quality of life, the National Academies of Science, Engineering, and Medicine has called for advancing the science of research evaluating the long-term outcomes of trauma survivors. This is necessary so that treatments and interventions can be assessed for their impact on a trauma patients' long-term functional and psychosocial outcomes. We sought to propose a set of core domains and measurement instruments that are best suited to evaluate long-term outcomes after traumatic injury with a goal for these measures to be adopted as a national standard. METHODS: As part of the development of a National Trauma Research Action Plan, we conducted a two-stage, five-round modified online Delphi consensus process with a diverse panel of 50 key stakeholders including clinicians, researchers, and trauma survivors from more than 9 professional areas across the United States. Before voting, panelists reviewed the results of a scoping review on patient-reported outcomes after injury and standardized information on measurement instruments following the Consensus-based Standards for the Selection of Health Measurement Instruments guidelines. RESULTS: The panel considered a preliminary list of 74 outcome domains (patient-reported outcomes) and ultimately reached the a priori consensus criteria for 29 core domains that encompass aspects of physical, mental, social, and cognitive health. Among these 29 core domains, the panel considered a preliminary list of 199 patient-reported outcome measures and reached the a priori consensus criteria for 14 measures across 13 core domains. Participation of panelists ranged from 65% to 98% across the five Delphi rounds. CONCLUSION: We developed a core outcome measurement set that will facilitate the synthesis, comparison, and interpretation of long-term trauma outcomes research. These measures should be prioritized in all future studies in which researchers elect to evaluate long-term outcomes of traumatic injury survivors. LEVEL OF EVIDENCE: Diagnostic Test or Criteria, Level IV.

Developing a National Trauma Research Action Plan: Results from the Neurotrauma Research Panel Delphi Survey.

BACKGROUND: In 2016, the National Academies of Science, Engineering and Medicine called for the development of a National Trauma Research Action Plan. The Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma and burn care. Given the public health burden of injuries to the central nervous system, neurotrauma was one of 11 panels formed to address this recommendation with a gap analysis and generation of high-priority research questions. METHODS: We recruited interdisciplinary experts to identify gaps in the neurotrauma literature, generate research questions, and prioritize those questions using a consensus-driven Delphi survey approach. We conducted four Delphi rounds in which participants generated key research questions and then prioritized the importance of the questions on a 9-point Likert scale. Consensus was defined as 60% or greater of panelists agreeing on the priority category. We then coded research questions using an National Trauma Research Action Plan taxonomy of 118 research concepts, which were consistent across all 11 panels. RESULTS: Twenty-eight neurotrauma experts generated 675 research questions. Of these, 364 (53.9%) reached consensus, and 56 were determined to be high priority (15.4%), 303 were deemed to be medium priority (83.2%), and 5 were low priority (1.4%). The research topics were stratified into three groups-severe traumatic brain injury (TBI), mild TBI (mTBI), and spinal cord injury. The number of high-priority questions for each subtopic was 46 for severe TBI (19.7%), 3 for mTBI (4.3%) and 7 for SCI (11.7%). CONCLUSION: This Delphi gap analysis of neurotrauma research identified 56 high-priority research questions. There are clear areas of focus for severe TBI, mTBI, and spinal cord injury that will help guide investigators in future neurotrauma research. Funding agencies should consider these gaps when they prioritize future research. LEVEL OF EVIDENCE: Diagnostic Test or Criteria, Level IV.

Developing a national trauma research action plan: Results from the Burn Research Gap Delphi Survey.

BACKGROUND: The 2016 National Academies of Science, Engineering and Medicine call for a national integrated, military-civilian trauma action plan to achieve zero preventable deaths and disability after injury included a proposal to establish a National Trauma Research Action Plan to "strengthen trauma research and ensure that the resources available for this research are commensurate with the importance of injury and the potential for improvement in patient outcomes." The Department of Defense funded the Coalition for National Trauma Research to generate a comprehensive research agenda spanning the continuum of trauma/burn care from prehospital to rehabilitation. The Burn/Reconstructive Surgery group represents one focus area for this research agenda development. METHODS: Experts in burn and reconstructive surgery research identified gaps in knowledge, generated research questions and prioritized questions using a consensus driven Delphi survey approach. Participants were identified using established Delphi recruitment guidelines to ensure heterogeneity and generalizability with military and civilian representatives. Literature reviews informed the panel. Panelists were encouraged to use a PICO format to generate research questions: Patient/Population; Intervention; Compare/Control; Outcome. Participants ranked the priority of each question on a nine-point Likert scale, which was categorized to represent low, medium, and high priority items. Consensus was defined based on ≥60% panelist agreement. RESULTS: Subject matter experts generated 949 research questions in 29 Burn & 26 Reconstruction topics. Five hundred ninety-seven questions reached consensus. Of these, 338 (57%) were high-priority, 180 (30%), medium-priority, and 78 (13%) low-priority questions. CONCLUSION: Many high-priority questions translate to complex wound management and outcomes. Panel recognition that significant gaps in knowledge exist in understanding functional outcomes after injury underscores the importance of long-term recovery metrics even when studying acute injury or interventions such as resuscitation or inhalation injury. Funding agencies and burn/reconstructive surgery researchers should consider these gaps when they prioritize future research. LEVEL OF EVIDENCE: Expert consensus, Level IV.