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.

High Levels of Satisfaction and Adequate Patient-Reported Outcomes After Operative Reconstruction of Multiligament Knee Injury With Allograft Among Patients Aged 40 Years and Older.

Purpose: To describe injury characteristics and patient-reported outcomes (PROs) among patients aged 40 years and older who underwent allograft reconstruction for multiligament knee injury (MLKI). Methods: Records of patients aged 40 years and older who underwent allograft multiligament knee reconstruction at a single institution between 2007 and 2017 with a minimum of 2 years of follow-up were retrospectively reviewed. Demographic information, concomitant injuries, patient satisfaction, and PROs including International Knee Documentation Committee and Marx activity scores were obtained. Results: Twelve patients were included with a minimum follow-up time of 2.3 years (mean, 6.1; range, 2.3-10.1 years) and a mean age at surgery of 49.8 years. Seven patients were male, and the most common mechanism of injury was sport-related. The most frequently reconstructed MLKIs were anterior cruciate ligament and medial collateral ligament (4), anterior cruciate ligament and posterolateral corner (2), and posterior cruciate ligament and posterolateral corner (2). The majority of patients reported satisfaction with their treatment (11). Median International Knee Documentation Committee and Marx scores were 73 (interquartile range, 45.5-88.0) and 3 (interquartile range 0-5), respectively. Conclusions: Patients aged 40 years and older can expect a high level of satisfaction and adequate PROs at 2-years follow-up after operative reconstruction for a MLKI with allograft. This demonstrates that allograft reconstruction for a MLKI in older patients may have clinical utility. Level of Evidence: IV, therapeutic case series.

Revision Soft-Tissue Allograft Anterior Cruciate Ligament Reconstruction Is Associated With Lower Patient-Reported Outcomes Compared With Primary Anterior Cruciate Ligament Reconstruction in Patients Aged 40 and Older.

PURPOSE: To evaluate patient-reported outcomes (PROs) and graft failure rates in revision allograft anterior cruciate ligament reconstruction (ACLR) in patients aged 40 and older and compare them with primary ACLRs. METHODS: Patients aged 40 and older who underwent arthroscopic soft-tissue allograft ACLR between 2005 and 2016 with a minimum 2-year follow-up were retrospectively reviewed. Patients were grouped based on revision versus primary ACLR. The rate of achieving an International Knee Documentation Committee (IKDC) patient acceptable symptom state (PASS) score was recorded. Patient satisfaction, PROs, and graft failure were compared between groups using the χ2 test, Fisher exact test, and Mann-Whitney U test. RESULTS: We identified 32 patients who underwent revision ACLR and 201 patients who underwent primary ACLR aged 40 and older who met inclusion criteria with a mean follow-up of 6.2 and 6.9 years, respectively (P = .042). There was a lower rate of concomitant meniscal repair in the primary ACLR group (6% vs 21.9%, P = .007) There were no other differences in chondral injuries, mechanism of injury, or meniscal injuries between groups. The median IKDC score was greater in the primary ACLR group as compared with the revision ACLR group (83.9 vs 70.6, P < .001). Patients who underwent revision ACLR were less likely to achieve the IKDC PASS threshold (82.5% vs 56.3%, P = .001) and were less likely to report satisfaction as compared with patients who underwent primary ACLR (90.5% vs 78.1%, P =.038). No difference in graft failure rates was identified between groups (8% vs 15.6%, P = .180). CONCLUSIONS: Revision allograft ACLR in patients aged 40 and older was associated with lower PROs compared with primary ACLR. Patients who underwent revision ACLR failed to meet the IKDC PASS threshold more often and were dissatisfied with procedure results more than twice as often as patients that underwent primary ACLR. LEVEL OF EVIDENCE: III, retrospective cohort study.

Delayed presentation of a pneumatic nail gun injury to the right ventricle without circulatory compromise.

Delayed presentation of penetrating cardiac injuries is exceedingly rare due to the observed near 100% pre-hospital mortality. We describe a case of a patient who presented for evaluation nearly 24 h after sustaining a self-inflicted pneumatic nail gun injury to the right ventricular outflow tract. Remarkably, the patient had no evidence of hemodynamic compromise. This case highlights the importance of maintaining a high index of suspicion for cardiac injury with penetrating trauma to the cardiac box regardless of presenting signs and symptoms, and the value of adhering to advanced trauma life support principles.

Disparities in national and state estimates of COVID-19 vaccination receipt and intent to vaccinate by race/ethnicity, income, and age group among adults ≥ 18 years, United States.

INTRODUCTION: COVID-19 morbidity and mortality has disproportionately affected vulnerable populations such as minority racial/ethnic groups. Understanding disparities in vaccine intentions and reasons for vaccine hesitancy are important for developing effective strategies for ameliorating racial/ethnic COVID-19 inequities. METHODS: Using six waves of the large, nationally representative Census Bureau's Household Pulse Survey data from January 6-March 29, 2021 (n = 459,235), we examined national and state estimates for vaccination intent, defined as receipt of ≥ 1 dose of the COVID-19 vaccine or definite intent to be vaccinated, by race/ethnicity with stratification by household income and age group. In separate logistic regression models, we also examined the interaction between race/ethnicity and household income, and race/ethnicity and age group, and its association with vaccination intent. Lastly, we examined reasons for not vaccinating by race/ethnicity. RESULTS: Vaccination intent differed by racial/ethnic group, household income, and age group nationally and by Health and Human Services (HHS) region and state. A significant interaction was observed between race/ethnicity and household income (F(8,72) = 4.50, p < 0.001), and race/ethnicity and age group (F(8,72) = 15.66, p < 0.001). Non-Hispanic Black adults with lower income (<$35,000) and younger age (18-49 years) were least likely to intend to vaccinate. Similar disparities across racial/ethnic groups were seen across most HHS regions and states. Concerns about possible side effects and effectiveness were significantly higher among all minority groups compared to non-Hispanic White adults. CONCLUSION: Disparities in vaccination intent by racial/ethnic groups underscore the need for interventions and recommendations designed to improve vaccination coverage and confidence in underserved communities, such as younger and lower income racial/ethnic minority groups. Efforts to reduce disparities and barriers to vaccination are needed to achieve equity in vaccination coverage, and ultimately, to curb COVID-19 transmission.

Patient reported outcomes 6 to 12 months after interpersonal violence: A multicenter cohort study.

PURPOSE: Violence continues to be a significant public health burden, but little is known about the long-term outcomes of these patients. Our goal was to determine the impact of violence-related trauma on long-term functional and psychosocial outcomes. METHODS: We identified trauma patients with moderate to severe injuries (Injury Severity Score, ≥9) treated at one of three level 1 trauma centers. These patients were asked to complete a survey over the phone between 6 and 12 months after injury evaluating both functional and psychosocial outcomes (12-item Short Form Survey, Trauma Quality of Life, posttraumatic stress disorder [PTSD] screen, chronic pain, return to work). Patients were classified as having suffered a violent injury if the mechanism of injury was a stab, gunshot, or assault. Self-inflicted wounds were excluded. Adjusted logistic regression models were built to determine the association between a violent mechanism of injury and long-term outcomes. RESULTS: A total of 1,050 moderate to severely injured patients were successfully followed, of whom 176 (16.8%) were victims of violence. For the victims of violence, mean age was 34.4 years (SD, 12.5 years), 85% were male, and 57.5% were Black; 30.7% reported newly needing help with at least one activity of daily living after the violence-related event. Fifty-nine (49.2%) of 120 patients who were working before their injury had not yet returned to work; 47.1% screened positive for PTSD, and 52.3% reported chronic pain. On multivariate analysis, a violent mechanism was significantly associated with PTSD (odds ratio, 2.57; 95% confidence interval, 1.59-4.17; p < 0.001) but not associated with chronic pain, return to work, or functional outcomes. CONCLUSION: The physical and mental health burden after violence-related trauma is not insignificant. Further work is needed to identify intervention strategies and social support systems that may be beneficial to reduce this burden. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Long-term patient-reported outcomes and patient-reported outcome measures after injury: the National Trauma Research Action Plan (NTRAP) scoping review.

BACKGROUND: The aim of this scoping review is to identify and summarize patient-reported outcome measures (PROMs) that are being used to track long-term patient-reported outcomes (PROs) after injury and can potentially be included in trauma registries. METHODS: Online databases were used to identify studies published between 2013 and 2019, from which we selected 747 articles that involved survivors of acute physical traumatic injury aged 18 years or older at time of injury and used PROMs to evaluate recovery between 6 months and 10 years postinjury. Data were extracted and summarized using descriptive statistics and a narrative synthesis of the results. RESULTS: Most studies were observational, with relatively small sample sizes, and predominantly on traumatic brain injury or orthopedic patients. The number of PROs assessed per study varied from one to 12, for a total of 2052 PROs extracted, yielding 74 unique constructs (physical health, 25 [34%]; mental health, 27 [37%]; social health, 12 [16%]; cognitive health, 7 [10%]; and quality of life, 3 [4%]). These 74 constructs were assessed using 355 different PROMs. Mental health was the most frequently examined outcome domain followed by physical health. Health-related quality of life, which appeared in more than half of the studies (n = 401), was the most common PRO evaluated, followed by depressive symptoms. Physical health was the domain with the highest number of PROMs used (n = 157), and lower-extremity functionality was the PRO that contributed most PROMs (n = 33). CONCLUSION: We identified a wide variety of PROMs available to track long-term PROs after injury in five different health domains: physical, mental, social, cognitive, and quality of life. However, efforts to fully understand the health outcomes of trauma patients remain inconsistent and insufficient. Defining PROs that should be prioritized and standardizing the PROMs to measure them will facilitate the incorporation of long-term outcomes in national registries to improve research and quality of care. LEVEL OF EVIDENCE: Systematic Reviews & Meta-analyses, Level IV.

Reduced chronic pain: Another benefit of recovery at an inpatient rehabilitation facility over a skilled nursing facility?

BACKGROUND: We sought to compare outcomes 6-12 months post-injury between patients discharged to an inpatient rehabilitation facility (IRF) and a skilled nursing facility (SNF). METHODS: Trauma patients admitted to 3 Level-I trauma centers were interviewed to evaluate the presence of daily pain requiring medication, functional outcomes, and physical and mental health-related quality-of-life at 6-12 months post-injury. Inverse-probability-of-treatment-weighting (IPTW)-adjusted analyses were performed to compare outcomes between patients who were discharged to IRF vs SNF. RESULTS: A total of 519 patients were included: 389 discharged to IRFs and 130 to SNFs. In adjusted analyses, IRF was associated with a significant reduction in the likelihood of chronic pain after injury (28.3% vs. 44.7%; OR:0.49; 95% CI, 0.26-0.91; P = .02). However, there were no significant differences in functional outcome or SF-12 composite scores between groups. CONCLUSION: Our findings suggest that injured patients discharged to an IRF as compared to a SNF had less chronic pain and analgesic use.

The Cost-Effectiveness of Silver-Impregnated Occlusive Dressings for Infection Prevention After Total Joint Arthroplasty.

BACKGROUND: Prosthetic joint infection (PJI) is a catastrophic complication after total joint arthroplasty that exacts a substantial economic burden on the health-care system. This study used break-even analysis to investigate whether the use of silver-impregnated occlusive dressings is a cost-effective measure for preventing PJI after primary total knee arthroplasty (TKA) and total hip arthroplasty (THA). METHODS: Baseline infection rates after TKA and THA, the cost of revision arthroplasty for PJI, and the cost of a silver-impregnated occlusive dressing were determined based on institutional data and the existing literature. A break-even analysis was then conducted to calculate the minimal absolute risk reduction needed for cost-effectiveness. RESULTS: The use of silver-impregnated occlusive dressings would be economically viable at an infection rate of 1.10%, treatment costs of $25,692 for TKA PJI, and $31,753 for THA PJI and our institutional dressing price of $38.05 if it reduces infection rates after TKA by 0.15% (the number needed to treat [NNT] = 676) and THA by 0.12% (NNT = 835). The absolute risk reduction needed to maintain cost-effectiveness did not change with varying initial infection rates and remained less than 0.40% (NNT = 263) for infection treatment costs as low as $10,000 and less than 0.80% (NNT = 129) for dressing prices as high as $200. CONCLUSION: The use of silver-impregnated occlusive dressings is a cost-effective measure for infection prophylaxis after TKA and THA.

Hospital Stays and Medical Expenses Increase Nationwide Among Patients With Septic Arthritis of the Shoulder Who Inject Drugs.

The authors determined the proportion of patients nationwide with septic arthritis of the shoulder who inject drugs, evaluated differences in hospitalization outcomes and charges between patients with and without injection drug use (IDU), and quantified demographic trends among patients with IDU from 2000 to 2013. Nationally representative data of patients with a principal discharge diagnosis of shoulder septic arthritis were obtained from the Nationwide Inpatient Sample 2000-2013. Using published algorithms, the authors classified septic arthritis of the shoulder as related or unrelated to IDU. They compared length of stay, leaving against medical advice, number of procedures, and mortality rates between the 2 groups, using regression models to control for age, sex, and race. Fifteen percent (95% confidence interval [CI], 13.6%-16.5%) of septic arthritis cases were associated with IDU. From 2000 to 2013, shoulder septic arthritis associated with IDU increased 4-fold. After controlling for age, sex, and race, individuals who inject drugs stayed in the hospital for 3.7 more days (95% CI, 2.4-5.0), incurred an average of $13,250 more charges for medical care (95% CI, $2635-$23,866), and were 5.54 times more likely (95% CI, 3.22-9.55) to leave against medical advice than those without IDU. From 2000 to 2013, there was an increase in the proportion of patients with IDU-related septic arthritis of the shoulder between 35 and 54 years old and 55 and 64 years old, and an increase in the proportion who were white. Injection drug use-related shoulder septic arthritis is linked to suboptimal inpatient outcomes and greater resource use. [Orthopedics. 2020;43(4):e270-e277.].

Injection Drug Use in Patients With Spinal Epidural Abscess: Nationwide Data, 2000 to 2013.

STUDY DESIGN: Retrospective review of the Healthcare Cost and Utilization Project National Inpatient Sample, 2000 to 2013. OBJECTIVE: To determine the proportion of spinal epidural abscess (SEA) cases that were related to injection drug use (IDU) and to compare length of stay, leaving against medical advice, paralysis, cauda equina syndrome, radiculitis, and in-hospital mortality between SEA cases with and without IDU. SUMMARY OF BACKGROUND DATA: The US opioid epidemic impacts all aspects of healthcare, including spinal surgeons. Although injection drug use (IDU) is a risk factor for spinal epidural abscess (SEA), IDU among SEA patients and its effect on clinical outcomes is not well understood. METHODS: Cases aged 15 to 64 with principal diagnosis of SEA were classified as IDU-related (IDU-SEA) or non-IDU-related (non-IDU-SEA) using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes for illicit drug use and hepatitis C. We determined the proportion of SEA patients with IDU and compared length of stay, leaving against medical advice, paralysis, cauda equina syndrome, radiculitis, and in-hospital mortality between IDU-SEA and non-IDU-SEA patients. RESULTS: From 2000 to 2013, there were 20,425 admissions with a principal diagnosis of SEA (95% confidence interval (CI), 19,281-21,568); 19.1% were associated with IDU (95% CI, 17.7%-20.5%). The proportion of white IDU-SEA cases increased by 2.4 percentage points annually (95% CI, 1.4-3.4). After adjusting for age, sex, and race, IDU-SEA patients stayed a mean of 6.7 more days in the hospital (95% CI, 5.1-8.2) and were 4.8 times more likely to leave against medical advice (95% CI, 2.9-8.0). Mean hospital charges for IDU-SEA patients were $31,603 higher (95% CI: $20,721-$42,485). Patients with IDU-SEA were less likely to have cauda equina syndrome (adjusted odds ratio, 0.48, 95% CI, 0.26-0.87). CONCLUSION: IDU-SEA patients stay in the hospital longer and more often leave against medical advice. Providers and hospitals may benefit from exploring how to better facilitate completion of inpatient treatment and achieve superior outcomes. LEVEL OF EVIDENCE: 3.

Treatment Outcomes in Septic Arthritis of the Foot and Ankle in People Who Inject Drugs.

BACKGROUND: Although injection drug use (IDU) is a known risk factor for septic arthritis (SA) of the foot and ankle (F&A), disease and hospitalization outcomes are poorly characterized. We evaluated national trends, demographic characteristics, and hospitalization outcomes of SA of the F&A in people who inject drugs vs those who do not. METHODS: Using the Nationwide Inpatient Sample, we identified all patients aged 15-64 with a principal discharge diagnosis of SA of the F&A from 2000 to 2013 and evaluated if they were related or unrelated to IDU. We assessed differences in demographic characteristics and in-hospital outcomes in these groups. RESULTS: From 2000 to 2013, there were an estimated 14,198 hospitalizations for SA of the F&A in the United States, and 11% were associated with IDU (SA-IDU). Compared to SA unrelated to IDU, people with SA-IDU were significantly more likely to be younger, black, and have Medicaid or no insurance. People with SA-IDU were significantly more likely to leave against medical advice (9.7% vs 1.4%, P < .001), have a longer length of stay (9.2 vs 6.8 days, P < .001), and incur increased hospital charges ($58 628 vs $38 876, P = .005). People with SA-IDU were significantly less likely to receive an arthroscopy (1.5% vs 6.5%, P < .001) or arthrotomy (2.2% vs 11.0%, P < .001) of the foot. CONCLUSION: People with SA-IDU of the F&A had suboptimal hospitalization outcomes with greater costs. Recognizing risk factors and proactively addressing potential complications of substance use disorder in the hospital should be prioritized by the orthopedic community. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Development and validation of a revised trauma-specific quality of life instrument.

BACKGROUND: The National Academies of Science has called for routine collection of long-term outcomes after injury. One of the main barriers for this is the lack of practical trauma-specific tools to collect such outcomes. The only trauma-specific long-term outcomes measure that applies a biopsychosocial view of patient care, the Trauma Quality-of-Life (T-QoL), has not been adopted because of its length, lack of composite scores, and unknown validity. Our objective was to develop a shorter version of the T-QoL measure that is reliable, valid, specific, and generalizable to all trauma populations. METHODS: We used two random samples selected from a prospective registry developed to follow long-term outcomes of adult trauma survivors (Injury Severity Score ≥9) admitted to three level I trauma centers. First, we validated the original T-QoL instrument using the 12-Item Short-Form Health Survey (SF-12) version 2.0 and Breslau post-traumatic stress disorder screening (B-PTSD) tools. Second, we conducted a confirmatory factor analysis to reduce the length of the original T-QoL instrument, and using a different sample, we scored and performed internal consistency and validity assessments of the revised T-QoL (RT-QoL) components. RESULTS: All components of the original T-QoL were significantly correlated negatively with the B-PTSD and positively with the SF-12 mental and physical composite scores. After confirmatory factor analysis, a three-component structure using 18 items (six items/component) most appropriately represented the data. Each component in the revised instrument demonstrated a high level of internal consistency (Cronbach's α ≥0.8) and correlated negatively with the B-PTSD and positively with the SF-12, demonstrating concurrent validity. In addition, each of the RT-QoL components was able to distinguish between individuals based on their work status, with those who have returned to work reporting better health. CONCLUSION: This more practical RT-QoL measure greatly increases the ability to evaluate long-term outcomes in trauma more efficiently and meaningfully, without sacrificing the validity and psychometric properties of the original instrument. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.

Lower education and income predict worse long-term outcomes after injury.

BACKGROUND: Lower socioeconomic status (SES) is known to be associated with higher morbidity and mortality following injury. However, the impact of individual SES on long-term outcomes after trauma is unknown. The objective of this study was to determine the impact of educational level and income on long-term outcomes after injury. METHODS: Trauma patients with moderate to severe injuries admitted to three Level-I trauma centers were contacted 6 months to 12 months after injury to evaluate functional status, return to work/school, chronic pain, and posttraumatic stress disorder (PTSD). Lower SES status was determined by educational level and income. Adjusted logistic regression models were built to determine the association between educational level and income (lowest vs. highest quartile determined by census-tract area) on each of the long-term outcomes. A sensitivity analysis was performed using the national median household income ($57,617) as threshold for defining low versus high income. RESULTS: A total of 1,516 patients were followed during a 36-month period. Forty-nine percent had a low educational level, and 26% were categorized in the low-income group. Mean (SD) age and injury severity score were 60 (21.5) and 14.3 (7.3), respectively, with most patients (94%) having blunt injuries. After adjusting for confounders, low educational level was associated with poor long-term outcomes: functional limitation [odds ratio (OR), 1.78 (95% confidence interval (CI), 1.41-2.26)], has not yet returned to work/school [OR, 2.48 (95% CI, 1.70-3.62)], chronic pain [OR, 1.63 (95% CI, 1.27-2.10)], and PTSD [OR, 2.23 (95% CI, 1.60-3.11)]. Similarly, low-income level was associated with not yet return to work/school [OR, 1.97 (95% CI, 1.09-3.56)], chronic pain [OR,1.70 (95% CI, 1.14-2.53)], and PTSD [OR, 2.20 (95% CI, 1.21-3.98)]. In sensitivity analyses, there were no significant differences in long-term outcomes between income levels. CONCLUSION: Low educational level is strongly associated with worse long-term outcomes after injury. However, although household income is associated with long-term outcomes, it matters where the threshold is. The impact of different socioeconomic measures on long-term outcomes after trauma cannot be assumed to be interchangeable. LEVEL OF EVIDENCE: Prognostic and epidemiological, level III.