The effects of prehospital TXA on mortality and neurologic outcomes in patients with traumatic intracranial hemorrhage: a subgroup analysis from the prehospital TXA for TBI trial.

BACKGROUND: In the Prehospital Tranexamic Acid (TXA) for TBI Trial, TXA administered within two hours of injury in the out-of-hospital setting did not reduce mortality in all patients with moderate/severe traumatic brain injury (TBI). We examined the association between TXA dosing arms, neurologic outcome, and mortality in patients with intracranial hemorrhage (ICH) on computed tomography (CT). METHODS: This was a secondary analysis of the Prehospital Tranexamic Acid for TBI Trial (ClinicalTrials.gov [NCT01990768]) that randomized adults with moderate/severe TBI (Glasgow Coma Scale<13) and systolic blood pressure > =90 mmHg within two hours of injury to a 2-gram out-of-hospital TXA bolus followed by an in-hospital saline infusion, a 1-gram out-of-hospital TXA bolus/1-gram in-hospital TXA infusion, or an out-of-hospital saline bolus/in-hospital saline infusion (placebo). This analysis included the subgroup with ICH on initial CT. Primary outcomes included 28-day mortality, 6-month Glasgow Outcome Scale-Extended (GOSE) < = 4, and 6-month Disability Rating Scale (DRS). Outcomes were modeled using linear regression with robust standard errors. RESULTS: The primary trial included 966 patients. Among 541 participants with ICH, 28-day mortality was lower in the 2-gram TXA bolus group (17%) compared to the other two groups (1-gram bolus/1-gram infusion 26%, placebo 27%). The estimated adjusted difference between the 2-gram bolus and placebo groups was -8·5 percentage points (95% CI, -15.9 to -1.0) and between the 2-gram bolus and 1-gram bolus/1-gram infusion groups was -10.2 percentage points (95% CI, -17.6 to -2.9). DRS at 6 months was lower in the 2-gram TXA bolus group than the 1-gram bolus/1-gram infusion (estimated difference -2.1 [95% CI, -4.2 to -0.02]) and placebo groups (-2.2 [95% CI, -4.3, -0.2]). Six-month GOSE did not differ among groups. CONCLUSIONS: A 2-gram out-of-hospital TXA bolus in patients with moderate/severe TBI and ICH resulted in lower 28-day mortality and lower 6-month DRS than placebo and standard TXA dosing. LEVEL OF EVIDENCE: Therapeutic/Care Management, Level II.

The effects of timing of prehospital tranexamic acid on outcomes after traumatic brain injury: Subanalysis of a randomized controlled trial.

BACKGROUND: Tranexamic acid (TXA) is an antifibrinolytic that has shown some promise in improving outcomes in traumatic brain injury (TBI), but only when given early after injury. We examined the association between timing of prehospital TXA administration and outcomes in patients with moderate to severe TBI. METHODS: Patients enrolled in the multi-institutional, double-blind randomized prehospital TXA for TBI trial with blunt or penetrating injury and suspected TBI (Glasgow Coma Scale score ≤ 12, SBP ≥90) who received either a 2-g TXA bolus or a 1-g bolus plus 1 g 8 hour infusion within 2 hours of injury were analyzed. Outcomes were compared between early administration (<45 minutes from injury) and late administration ≥45 minutes from injury) using a χ 2 , Fischer's exact test, t test, or Mann-Whitney U test as indicated. Logistic regression examined time to drug as an independent variable. A p value less than 0.05 was considered significant. RESULTS: Six hundred forty-nine patients met inclusion criteria (354 early and 259 late). Twenty-eight-day and 6-month mortalities, 6-month Glasgow Outcome Scale-Extended, and disability rating scale scores were not different between early and late administration. Late administration was associated with higher rates of deep venous thrombosis (0.8 vs. 3.4%, p = 0.02), cerebral vasospasm (0% vs. 2%, p = 0.01), as well as prolonged EMS transport and need for a prehospital airway ( p < 0.01). CONCLUSION: In patients with moderate or severe TBI who received TXA within 2 hours of injury, no mortality benefit was observed in those who received treatment within 45 minutes of injury, although lower rates of select complications were seen. These results support protocols that recommend TXA administration within 45 minutes of injury for patients with suspected TBI. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study.

BACKGROUND: Lumbar spinal stenosis (LSS) is a common degenerative condition that contributes to back and back-related leg pain in older adults. Most patients with symptomatic LSS initially receive non-operative care before surgical consultation. However, there is a scarcity of data regarding prognosis for patients seeking non-surgical care. The overall goal of this project is to develop and evaluate a clinically useful model to predict long-term physical function of patients initiating non-surgical care for symptomatic LSS. METHODS: This is a protocol for an inception cohort study of adults 50 years and older who are initiating non-surgical care for symptomatic LSS in a secondary care setting. We plan to recruit up to 625 patients at two study sites. We exclude patients with prior lumbar spine surgeries or those who are planning on lumbar spine surgery. We also exclude patients with serious medical conditions that have back pain as a symptom or limit walking. We are using weekly, automated data pulls from the electronic health records to identify potential participants. We then contact patients by email and telephone within 21 days of a new visit to determine eligibility, obtain consent, and enroll participants. We collect data using telephone interviews, web-based surveys, and queries of electronic health records. Participants are followed for 12 months, with surveys completed at baseline, 3, 6, and 12 months. The primary outcome measure is the 8-item PROMIS Physical Function (PF) Short Form. We will identify distinct phenotypes using PROMIS PF scores at baseline and 3, 6, and 12 months using group-based trajectory modeling. We will develop and evaluate the performance of a multivariable prognostic model to predict 12-month physical function using the least absolute shrinkage and selection operator and will compare performance to other machine learning methods. Internal validation will be conducted using k-folds cross-validation. DISCUSSION: This study will be one of the largest cohorts of individuals with symptomatic LSS initiating new episodes of non-surgical care. The successful completion of this project will produce a cross-validated prognostic model for LSS that can be used to tailor treatment approaches for patient care and clinical trials.

Tranexamic acid is not inferior to placebo with respect to adverse events in suspected traumatic brain injury patients not in shock with a normal head computed tomography scan: A retrospective study of a randomized trial.

BACKGROUND: A 2-g bolus of tranexamic acid (TXA) has been shown to reduce 28-day mortality in a randomized controlled trial. This study investigates whether out-of-hospital TXA use is associated with adverse events or unfavorable outcomes in suspected traumatic brain injury (TBI) when intracranial hemorrhage (ICH) is absent on initial computed tomography. METHODS: This study used data from a 2015 to 2017, multicenter, randomized trial studying the effect of the following TXA doses on moderate to severe TBI: 2-g bolus, 1-g bolus plus 1-g infusion over 8 hours, and a placebo bolus with placebo infusion. Of the 966 participants enrolled, 395 with an initial computed tomography negative for ICH were included in this analysis. Fifteen adverse events (28-day incidence) were studied: myocardial infarction, deep vein thrombosis, seizure, pulmonary embolism, acute respiratory distress syndrome, cardiac failure, liver failure, renal failure, cerebrovascular accident, cardiac arrest, cerebral vasospasm, "any thromboembolism," hypernatremia, acute kidney injury, and infection. Other unfavorable outcomes analyzed include mortality at 28 days and 6 months, Glasgow Outcome Scale-Extended score of ≤4 at discharge and 6 months, intensive care unit-free days, ventilator-free days, hospital-free days, and combined unfavorable outcomes. In both study drug groups, the incidence of dichotomous outcomes and quantity of ordinal outcomes were compared with placebo. RESULTS: No statistically significant increase in adverse events or unfavorable outcomes was found between either TXA dosing regimen and placebo. Demographics and injury scores were not statistically different other than two methods of injury, which were overrepresented in the 1-g TXA bolus plus 1-g TXA infusion. CONCLUSION: Administration of either a 2-g TXA bolus or a 1-g TXA bolus plus 1-g TXA 8-hour infusion in suspected TBIs without ICH is not associated with increased adverse events or unfavorable outcomes. Because the out-of-hospital 2-g bolus is associated with a mortality benefit, it should be administered in suspected TBI. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level II.

Patient, Provider, and Clinic Characteristics Associated with Opioid and Non-Opioid Pain Prescriptions for Patients Receiving Low Back Imaging in Primary Care.

BACKGROUND: To describe characteristics of patients, providers, and clinics associated with opioid or non-opioid pain medication prescribing patterns for patients who received lower spine imaging in primary care clinics. METHODS: In these secondary analyses of the Lumbar Imaging with Reporting of Epidemiology (LIRE) study, a randomized controlled trial conducted in 4 health systems in the United States, we evaluated characteristics associated with receipt of pain medication prescriptions. The outcomes were receipt of prescriptions for opioid or, separately, non-opioid pain medications within 90 days after imaging. Among patients who received opioid or non-opioid prescriptions, we evaluated receipt of multiple prescriptions in the year following imaging. Mixed models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs). RESULTS: Compared with whites, patients identified as Asian (OR, 0.53; 95% CI, 0.51-0.56), Native Hawaiian/Pacific Islander (OR, 0.73; 95% CI, 0.64-0.83), multiracial (OR, 0.84; 95% CI, 0.71-0.98) or Black (OR, 0.92; 95% CI, 0.89-0.96) had significantly reduced odds for receiving prescriptions for opioids within 90 days. Patients identified as Native American/Alaska Native had greater odds for receiving prescriptions for non-opioid pain medications within 90 days (OR, 1.12; 95% CI, 1.01-1.24). Receipt of pain prescriptions 120 days before imaging was strongly predictive of subsequent receipt of pain prescriptions across all categories. CONCLUSIONS: After adjusting for factors that could affect prescribing, the strongest differences observed in pain-medication prescribing were across racial categories and for patients with previous pain prescriptions. Further research is needed to understand these differences and to optimize prescribing.

Expected Organizational Costs for Inserting Prevalence Information Into Lumbar Spine Imaging Reports.

BACKGROUND: Modifying physician behavior to more closely align with guideline-based care can be challenging. Few effective strategies resulting in appropriate spine-related health care have been reported. The Lumbar Imaging With Reporting of Epidemiology (LIRE) intervention did not result in reductions in spine care but did in opioid prescriptions written. OBJECTIVES: To estimate organizational resource needs and costs associated with implementing a pragmatic, decision support-type intervention that inserted age- and modality-matched prevalence information for common lumbar spine imaging findings, using site-based resource use data from the LIRE trial. RESEARCH DESIGN: Time and cost estimation associated with implementing the LIRE intervention in a health organization. SUBJECTS: Providers and patients assessed in the LIRE trial. MEASURES: Expected personnel costs required to implement the LIRE intervention. RESULTS: Annual salaries were converted to daily average per person costs, ranging from $400 to $2,200 per day (base case) for personnel (range: $300-$2,600). Estimated total average cost for implementing LIRE was $5,009 (range: $2,651-$12,020), including conducting pilot testing with providers. Costs associated with a small amount of time for a radiologist (6-12 hours) and imaging-ordering providers (1-8 hours each) account for approximately 75% of the estimated total cost. CONCLUSIONS: The process of implementing an intervention for lumbar spine imaging reports containing age- and modality-appropriate epidemiological benchmarks for common imaging findings required radiologists, imaging-ordering providers, information technology specialists, and limited testing and monitoring. The LIRE intervention seems to be a relatively low-cost, evidence-based, complementary tool that can be easily integrated into the reporting of spine imaging.

Effects of Including Epidemiologic Data in Lumbar Spine Imaging Reports on Prescribing Non-Opioid Medications for Pain.

BACKGROUND: Information on the prevalence of common imaging findings among patients without back pain in spine imaging reports might affect pain medication prescribing for patients with back pain. Prior research on inserting this text suggested a small reduction in opioid prescribing. OBJECTIVE: To evaluate the effect of epidemiologic information in spine imaging reports on non-opioid pain medication prescribing for primary care patients with back pain. DESIGN: Post hoc analysis of the Lumbar Imaging with Reporting of Epidemiology cluster-randomized trial. PARTICIPANTS: A total of 170,680 patients aged ≥ 18 years from four healthcare systems who received thoracolumbar, lumbar, or lumbosacral spine imaging from 2013 to 2016 and had not received a prescription for non-opioid pain medication in the preceding 120 days. INTERVENTION: Text of age- and modality-specific epidemiologic benchmarks indicating the prevalence of common findings in people without back pain inserted into thoracolumbar, lumbar, or lumbosacral spine imaging reports at intervention clinics. MAIN MEASURES: Primary outcomes: any non-opioid prescription within 90 days after index imaging, overall, and by sub-class (skeletal muscle relaxants, NSAIDs, gabapentinoids, tricyclic antidepressants, benzodiazepines, duloxetine). SECONDARY OUTCOMES: count of non-opioid prescriptions within 90 days, overall, and by sub-class. KEY RESULTS: The intervention was not associated with the likelihood of patients receiving at least one prescription for new non-opioid pain-related medications, overall (adjusted OR, 1.02; 95% CI, 0.97-1.08) or by sub-class. The intervention was not associated with the number of prescriptions for any non-opioid medication (adjusted incidence rate ratio [IRR], 1.02; 95% CI, 0.99-1.04). However, the intervention was associated with more new prescriptions for NSAIDs (IRR, 1.12) and tricyclic antidepressants (IRR, 1.11). CONCLUSIONS: Inserting epidemiologic text in spine imaging reports had no effect on whether new non-opioid pain-related medications were prescribed but was associated with the number of new prescriptions for certain non-opioid sub-classes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02015455.

Providing Epidemiological Data in Lumbar Spine Imaging Reports Did Not Affect Subsequent Utilization of Spine Procedures: Secondary Outcomes from a Stepped-Wedge Randomized Controlled Trial.

OBJECTIVE: To evaluate the effect of inserting epidemiological information into lumbar spine imaging reports on subsequent nonsurgical and surgical procedures involving the thoracolumbosacral spine and sacroiliac joints. DESIGN: Analysis of secondary outcomes from the Lumbar Imaging with Reporting of Epidemiology (LIRE) pragmatic stepped-wedge randomized trial. SETTING: Primary care clinics within four integrated health care systems in the United States. SUBJECTS: 238,886 patients ≥18 years of age who received lumbar diagnostic imaging between 2013 and 2016. METHODS: Clinics were randomized to receive text containing age- and modality-specific epidemiological benchmarks indicating the prevalence of common spine imaging findings in people without low back pain, inserted into lumbar spine imaging reports (the "LIRE intervention"). The study outcomes were receiving 1) any nonsurgical lumbosacral or sacroiliac spine procedure (lumbosacral epidural steroid injection, facet joint injection, or facet joint radiofrequency ablation; or sacroiliac joint injection) or 2) any surgical procedure involving the lumbar, sacral, or thoracic spine (decompression surgery or spinal fusion or other spine surgery). RESULTS: The LIRE intervention was not significantly associated with subsequent utilization of nonsurgical lumbosacral or sacroiliac spine procedures (odds ratio [OR] = 1.01, 95% confidence interval [CI] 0.93-1.09; P = 0.79) or any surgical procedure (OR = 0.99, 95 CI 0.91-1.07; P = 0.74) involving the lumbar, sacral, or thoracic spine. The intervention was also not significantly associated with any individual spine procedure. CONCLUSIONS: Inserting epidemiological text into spine imaging reports had no effect on nonsurgical or surgical procedure utilization among patients receiving lumbar diagnostic imaging.

The Effect of Including Benchmark Prevalence Data of Common Imaging Findings in Spine Image Reports on Health Care Utilization Among Adults Undergoing Spine Imaging: A Stepped-Wedge Randomized Clinical Trial.

Importance: Lumbar spine imaging frequently reveals findings that may seem alarming but are likely unrelated to pain. Prior work has suggested that inserting data on the prevalence of imaging findings among asymptomatic individuals into spine imaging reports may reduce unnecessary subsequent interventions. Objective: To evaluate the impact of including benchmark prevalence data in routine spinal imaging reports on subsequent spine-related health care utilization and opioid prescriptions. Design, Setting, and Participants: This stepped-wedge, pragmatic randomized clinical trial included 250 401 adult participants receiving care from 98 primary care clinics at 4 large health systems in the United States. Participants had imaging of their backs between October 2013 and September 2016 without having had spine imaging in the prior year. Data analysis was conducted from November 2018 to October 2019. Interventions: Either standard lumbar spine imaging reports (control group) or reports containing age-appropriate prevalence data for common imaging findings in individuals without back pain (intervention group). Main Outcomes and Measures: Health care utilization was measured in spine-related relative value units (RVUs) within 365 days of index imaging. The number of subsequent opioid prescriptions written by a primary care clinician was a secondary outcome, and prespecified subgroup analyses examined results by imaging modality. Results: We enrolled 250 401 participants (of whom 238 886 [95.4%] met eligibility for this analysis, with 137 373 [57.5%] women and 105 497 [44.2%] aged >60 years) from 3278 primary care clinicians. A total of 117 455 patients (49.2%) were randomized to the control group, and 121 431 patients (50.8%) were randomized to the intervention group. There was no significant difference in cumulative spine-related RVUs comparing intervention and control conditions through 365 days. The adjusted median (interquartile range) RVU for the control group was 3.56 (2.71-5.12) compared with 3.53 (2.68-5.08) for the intervention group (difference, -0.7%; 95% CI, -2.9% to 1.5%; P = .54). Rates of subsequent RVUs did not differ between groups by specific clinical findings in the report but did differ by type of index imaging (eg, computed tomography: difference, -29.3%; 95% CI, -42.1% to -13.5%; magnetic resonance imaging: difference, -3.4%; 95% CI, -8.3% to 1.8%). We observed a small but significant decrease in the likelihood of opioid prescribing from a study clinician within 1 year of the intervention (odds ratio, 0.95; 95% CI, 0.91 to 1.00; P = .04). Conclusions and Relevance: In this study, inserting benchmark prevalence information in lumbar spine imaging reports did not decrease subsequent spine-related RVUs but did reduce subsequent opioid prescriptions. The intervention text is simple, inexpensive, and easily implemented. Trial Registration: ClinicalTrials.gov Identifier: NCT02015455.

Effect of Out-of-Hospital Tranexamic Acid vs Placebo on 6-Month Functional Neurologic Outcomes in Patients With Moderate or Severe Traumatic Brain Injury.

Importance: Traumatic brain injury (TBI) is the leading cause of death and disability due to trauma. Early administration of tranexamic acid may benefit patients with TBI. Objective: To determine whether tranexamic acid treatment initiated in the out-of-hospital setting within 2 hours of injury improves neurologic outcome in patients with moderate or severe TBI. Design, Setting, and Participants: Multicenter, double-blinded, randomized clinical trial at 20 trauma centers and 39 emergency medical services agencies in the US and Canada from May 2015 to November 2017. Eligible participants (N = 1280) included out-of-hospital patients with TBI aged 15 years or older with Glasgow Coma Scale score of 12 or less and systolic blood pressure of 90 mm Hg or higher. Interventions: Three interventions were evaluated, with treatment initiated within 2 hours of TBI: out-of-hospital tranexamic acid (1 g) bolus and in-hospital tranexamic acid (1 g) 8-hour infusion (bolus maintenance group; n = 312), out-of-hospital tranexamic acid (2 g) bolus and in-hospital placebo 8-hour infusion (bolus only group; n = 345), and out-of-hospital placebo bolus and in-hospital placebo 8-hour infusion (placebo group; n = 309). Main Outcomes and Measures: The primary outcome was favorable neurologic function at 6 months (Glasgow Outcome Scale-Extended score >4 [moderate disability or good recovery]) in the combined tranexamic acid group vs the placebo group. Asymmetric significance thresholds were set at 0.1 for benefit and 0.025 for harm. There were 18 secondary end points, of which 5 are reported in this article: 28-day mortality, 6-month Disability Rating Scale score (range, 0 [no disability] to 30 [death]), progression of intracranial hemorrhage, incidence of seizures, and incidence of thromboembolic events. Results: Among 1063 participants, a study drug was not administered to 96 randomized participants and 1 participant was excluded, resulting in 966 participants in the analysis population (mean age, 42 years; 255 [74%] male participants; mean Glasgow Coma Scale score, 8). Of these participants, 819 (84.8%) were available for primary outcome analysis at 6-month follow-up. The primary outcome occurred in 65% of patients in the tranexamic acid groups vs 62% in the placebo group (difference, 3.5%; [90% 1-sided confidence limit for benefit, -0.9%]; P = .16; [97.5% 1-sided confidence limit for harm, 10.2%]; P = .84). There was no statistically significant difference in 28-day mortality between the tranexamic acid groups vs the placebo group (14% vs 17%; difference, -2.9% [95% CI, -7.9% to 2.1%]; P = .26), 6-month Disability Rating Scale score (6.8 vs 7.6; difference, -0.9 [95% CI, -2.5 to 0.7]; P = .29), or progression of intracranial hemorrhage (16% vs 20%; difference, -5.4% [95% CI, -12.8% to 2.1%]; P = .16). Conclusions and Relevance: Among patients with moderate to severe TBI, out-of-hospital tranexamic acid administration within 2 hours of injury compared with placebo did not significantly improve 6-month neurologic outcome as measured by the Glasgow Outcome Scale-Extended. Trial Registration: ClinicalTrials.gov Identifier: NCT01990768.

The impact of increased chest compression fraction on survival for out-of-hospital cardiac arrest patients with a non-shockable initial rhythm.

OBJECTIVE: We evaluated the effect of chest compression fraction (CCF) on survival to hospital discharge and return of spontaneous circulation (ROSC) in out-of-hospital cardiac arrest (OHCA) patients with non-shockable rhythms. METHODS: This is a retrospective analysis (completed in 2016) of a prospective cohort study which included OHCA patients from ten U.S. and Canadian sites (Resuscitation Outcomes Consortium Epistry and PRIMED study (2007-2011)). We included all OHCA victims of presumed cardiac aetiology, not witnessed by emergency medical services (EMS), without automated external defibrillator shock prior to EMS arrival, receiving > 1 min of CPR with CPR process measures available, and initial non-shockable rhythm. We measured CCF using the first 5 min of electronic CPR records. RESULTS: Demographics of 12,928 adult patients were: mean age 68; male 59.9%; public location 8.5%; bystander witnessed 35.2%; bystander CPR 39.3%; median interval from 911 to defibrillator turned on 10 min:04 s; initial rhythm asystole 64.8%, PEA 26.0%, other non-shockable 9.2%; compression rate 80-120/min (69.1%); median CCF 74%; ROSC 25.6%; survival to hospital discharge 2.4%. Adjusted odds ratio (OR); 95% confidence intervals (95%CI) of survival for each CCF category were: 0-40% (2.00; 1.16, 3.32); 41-60% (0.83; 0.54, 1.24); 61-80% (1.02; 0.77, 1.35); and 81-100% (reference group). Adjusted (OR; 95%CI) of ROSC for each CCF category were: 0-40% (1.02; 0.79, 1.30); 41-60% (0.83; 0.72, 0.95); 61-80% (0.85; 0.77, 0.94); and 81-100% (reference group). CONCLUSIONS: We observed an incremental benefit from higher CCF on the incidence of ROSC, but not survival, among non-shockable OHCA patients with CCF higher than 40%.

Comparison of Natural Language Processing Rules-based and Machine-learning Systems to Identify Lumbar Spine Imaging Findings Related to Low Back Pain.

RATIONALE AND OBJECTIVES: To evaluate a natural language processing (NLP) system built with open-source tools for identification of lumbar spine imaging findings related to low back pain on magnetic resonance and x-ray radiology reports from four health systems. MATERIALS AND METHODS: We used a limited data set (de-identified except for dates) sampled from lumbar spine imaging reports of a prospectively assembled cohort of adults. From N = 178,333 reports, we randomly selected N = 871 to form a reference-standard dataset, consisting of N = 413 x-ray reports and N = 458 MR reports. Using standardized criteria, four spine experts annotated the presence of 26 findings, where 71 reports were annotated by all four experts and 800 were each annotated by two experts. We calculated inter-rater agreement and finding prevalence from annotated data. We randomly split the annotated data into development (80%) and testing (20%) sets. We developed an NLP system from both rule-based and machine-learned models. We validated the system using accuracy metrics such as sensitivity, specificity, and area under the receiver operating characteristic curve (AUC). RESULTS: The multirater annotated dataset achieved inter-rater agreement of Cohen's kappa > 0.60 (substantial agreement) for 25 of 26 findings, with finding prevalence ranging from 3% to 89%. In the testing sample, rule-based and machine-learned predictions both had comparable average specificity (0.97 and 0.95, respectively). The machine-learned approach had a higher average sensitivity (0.94, compared to 0.83 for rules-based), and a higher overall AUC (0.98, compared to 0.90 for rules-based). CONCLUSIONS: Our NLP system performed well in identifying the 26 lumbar spine findings, as benchmarked by reference-standard annotation by medical experts. Machine-learned models provided substantial gains in model sensitivity with slight loss of specificity, and overall higher AUC.

Prehospital traumatic cardiac arrest: Management and outcomes from the resuscitation outcomes consortium epistry-trauma and PROPHET registries.

BACKGROUND: Traumatic arrests have historically had poor survival rates. Identifying salvageable patients and ideal management is challenging. We aimed to (1) describe the management and outcomes of prehospital traumatic arrests; (2) determine regional variation in survival; and (3) identify Advanced Life Support (ALS) procedures associated with survival. METHODS: This was a secondary analysis of cases from the Resuscitation Outcomes Consortium Epistry-Trauma and Prospective Observational Prehospital and Hospital Registry for Trauma (PROPHET) registries. Patients were included if they had a blunt or penetrating injury and received cardiopulmonary resuscitation. Logistic regression analyses were used to determine the association between ALS procedures and survival. RESULTS: We included 2,300 patients who were predominately young (Epistry mean [SD], 39 [20] years; PROPHET mean [SD], 40 [19] years), males (79%), injured by blunt trauma (Epistry, 68%; PROPHET, 67%), and treated by ALS paramedics (Epistry, 93%; PROPHET, 98%). A total of 145 patients (6.3%) survived to hospital discharge. More patients with blunt (Epistry, 8.3%; PROPHET, 6.5%) vs. penetrating injuries (Epistry, 4.6%; PROPHET, 2.7%) survived. Most survivors (81%) had vitals on emergency medical services arrival. Rates of survival varied significantly between the 12 study sites (p = 0.048) in the Epistry but not PROPHET (p = 0.14) registries.Patients in the PROPHET registry who received a supraglottic airway insertion or intubation experienced decreased odds of survival (adjusted OR, 0.27; 95% confidence interval, 0.08-0.93; and 0.37; 95% confidence interval, 0.17-0.78, respectively) compared to those receiving bag-mask ventilation. No other procedures were associated with survival. CONCLUSIONS: Survival from traumatic arrest may be higher than expected, particularly in blunt trauma and patients with vitals on emergency medical services arrival. Although limited by confounding and statistical power, no ALS procedures were associated with increased odds of survival. LEVEL OF EVIDENCE: Prognostic study, level IV.

Lumbar Imaging With Reporting Of Epidemiology (LIRE)--Protocol for a pragmatic cluster randomized trial.

BACKGROUND: Diagnostic imaging is often the first step in evaluating patients with back pain and likely functions as a "gateway" to a subsequent cascade of interventions. However, lumbar spine imaging frequently reveals incidental findings among normal, pain-free individuals suggesting that treatment of these "abnormalities" may not be warranted. Our prior work suggested that inserting the prevalence of imaging findings in patients without back pain into spine imaging reports may reduce subsequent interventions. We are now conducting a pragmatic cluster randomized clinical trial to test the hypothesis that inserting this prevalence data into lumbar spine imaging reports for studies ordered by primary care providers will reduce subsequent spine-related interventions. METHODS/DESIGN: We are using a stepped wedge design that sequentially randomizes 100 primary care clinics at four health systems to receive either standard lumbar spine imaging reports, or reports containing prevalence data for common imaging findings in patients without back pain. We capture all outcomes passively through the electronic medical record. Our primary outcome is spine-related intervention intensity based on Relative Value Units (RVUs) during the following year. Secondary outcomes include subsequent prescriptions for opioid analgesics and cross-sectional lumbar spine re-imaging. DISCUSSION: If our study shows that adding prevalence data to spine imaging reports decreases subsequent back-related RVUs, this intervention could be easily generalized and applied to other kinds of testing, as well as other conditions where incidental findings may be common. Our study also serves as a model for cluster randomized trials that are minimal risk and highly pragmatic.

A controlled resuscitation strategy is feasible and safe in hypotensive trauma patients: results of a prospective randomized pilot trial.

BACKGROUND: Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS: Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) of 90 mm Hg or lower. CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater. The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival. RESULTS: A total of 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. The mean (SD) crystalloid volume administered during the study period was 1.0 L (1.5) in the CR group and 2.0 L (1.4) in the SR group, a difference of 1.0 L (95% confidence interval [CI], 0.6-1.4). Intensive care unit-free days, ventilator-free days, renal injury, and renal failure did not differ between the groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio, 0.39; 95% CI, 0.12-1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03-0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19-19.17). CONCLUSION: CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted. LEVEL OF EVIDENCE: Therapeutic study, level I.

Understanding traumatic shock: out-of-hospital hypotension with and without other physiologic compromise.

BACKGROUND: Among trauma patients with out-of-hospital hypotension, we evaluated the predictive value of systolic blood pressure (SBP) with and without other physiologic compromise for identifying trauma patients requiring early critical resources. METHODS: This was a secondary analysis of a prospective cohort of injured patients 13 years or older with out-of-hospital hypotension (SBP ≤ 90 mm Hg) who were transported by 114 emergency medical service agencies to 56 Level I and II trauma centers in 11 regions of the United States and Canada from January 1, 2010, through June 30, 2011. The primary outcome was early critical resource use, defined as blood transfusion of 6 U or greater, major nonorthopedic surgery, interventional radiology, or death within 24 hours. RESULTS: Of 3,337 injured patients with out-of-hospital hypotension, 1,094 (33%) required early critical resources and 1,334 (40%) had serious injury (Injury Severity Score [ISS] ≥ 16). Patients with isolated hypotension required less early critical resources (14% vs. 52%), had less serious injury (20% vs. 61%), and had lower mortality (24 hours, 1% vs. 26%; in-hospital, 3% vs. 34%). The standardized probability of requiring early critical resources was lowest among patients with blunt injury and isolated moderate hypotension (0.12; 95% confidence interval, 0.09-0.15) and steadily increased with additional physiologic compromise, more severe hypotension, and penetrating injury (0.94; 95% confidence interval, 0.90-0.98). CONCLUSION: A minority of trauma patients with isolated out-of-hospital hypotension require early critical resuscitation resources. However, hypotension accompanied by additional physiologic compromise or penetrating injury markedly increases the probability of requiring time-sensitive interventions. LEVEL OF EVIDENCE: Prognostic study, level II.

A comparison of prehospital lactate and systolic blood pressure for predicting the need for resuscitative care in trauma transported by ground.

BACKGROUND: Reliance on prehospital trauma triage guidelines misses patients with serious injury. Lactate is a biomarker capable of identifying high-risk trauma patients. Our objective was to compare prehospital point-of-care lactate (P-LAC) with systolic blood pressure (SBP) for predicting the need for resuscitative care (RC) in trauma patients transported by ground emergency medical services. METHODS: This is a prospective observational study at nine sites within the Resuscitation Outcomes Consortium conducted from March 2011 to August 2012. Lactate was measured on patients with a prehospital SBP of 100 mm Hg or less who were transported by emergency medical services to a Level I or II trauma center. Patients were followed up for the need for RC, defined as any of the following within 6 hours of emergency department arrival: blood transfusion of 5 U or greater; intervention for hemorrhage including thoracotomy, laparotomy, pelvic fixation, or interventional radiology embolization; or death. RESULTS: A total of 387 patients had a lactate value and presented with SBP between 71 mm Hg and 100 mm Hg, and 70 (18%) required RC. With the use of a P-LAC decision rule (≥2.5 mmol/L) that yielded the same specificity as that of SBP of 90 mm Hg or less (48%), the observed sensitivities for RC were 93% (95% confidence interval [CI], 84-98%) for P-LAC of 2.5 mmol/L or greater and 67% (95% CI, 55-78%) for SBP of 90 mm Hg or less (McNemar's test, p < 0.001). P-LAC has an estimated area under the curve of 0.78 (95% CI, 0.73-0.83), which is statistically superior to that of SBP (0.59; 95% CI, 0.53-0.66) and shock index (heart rate / SBP) (0.66; 95% CI, 0.60-0.74). CONCLUSION: P-LAC obtained at the scene is associated with the need for RC. P-LAC is superior to other early surrogates for hypoperfusion (SBP and shock index) in predicting the need for RC in trauma patients with 70 mm Hg < SBP ≤ 100 mm Hg. LEVEL OF EVIDENCE: Prognostic study, level II.

Revisiting the "Golden Hour": An Evaluation of Out-of-Hospital Time in Shock and Traumatic Brain Injury.

STUDY OBJECTIVE: We evaluate patients with shock and traumatic brain injury who were previously enrolled in an out-of-hospital clinical trial to test the association between out-of-hospital time and outcome. METHODS: This was a secondary analysis of patients with shock and traumatic brain injury who were aged 15 years or older and enrolled in a Resuscitation Outcomes Consortium out-of-hospital clinical trial by 81 emergency medical services agencies transporting to 46 Level I and II trauma centers in 11 sites (May 2006 through May 2009). Inclusion criteria were systolic blood pressure less than or equal to 70 mm Hg or systolic blood pressure 71 to 90 mm Hg with pulse rate greater than or equal to 108 beats/min (shock cohort) and Glasgow Coma Scale score less than or equal to 8 (traumatic brain injury cohort); patients meeting both criteria were placed in the shock cohort. Primary outcomes were 28-day mortality (shock cohort) and 6-month Glasgow Outcome Scale-Extended score less than or equal to 4 (traumatic brain injury cohort). RESULTS: There were 778 patients in the shock cohort (26% 28-day mortality) and 1,239 patients in the traumatic brain injury cohort (53% 6-month Glasgow Outcome Scale-Extended score ≤4). Out-of-hospital time greater than 60 minutes was not associated with worse outcomes after accounting for important confounders in the shock cohort (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.77 to 2.62) or traumatic brain injury cohort (aOR 0.77; 95% CI 0.51 to 1.15). However, shock patients requiring early critical hospital resources and arriving after 60 minutes had higher 28-day mortality (aOR 2.37; 95% CI 1.05 to 5.37); this finding was not observed among a similar traumatic brain injury subgroup. CONCLUSION: Among out-of-hospital trauma patients meeting physiologic criteria for shock and traumatic brain injury, there was no association between time and outcome. However, the subgroup of shock patients requiring early critical resources and arriving after 60 minutes had higher mortality.

Interrater agreement in the evaluation of discrepant imaging findings with the Radpeer system.

OBJECTIVE: The Radpeer system is central to the quality assurance process in many radiology practices. Previous studies have shown poor agreement between physicians in the evaluation of their peers. The purpose of this study was to assess the reliability of the Radpeer scoring system. MATERIALS AND METHODS: A sample of 25 discrepant cases was extracted from our quality assurance database. Images were made anonymous; associated reports and identities of interpreting radiologists were removed. Indications for the studies and descriptions of the discrepancies were provided. Twenty-one subspecialist attending radiologists rated the cases using the Radpeer scoring system. Multirater kappa statistics were used to assess interrater agreement, both with the standard scoring system and with dichotomized scores to reflect the practice of further review for cases rated 3 and 4. Subgroup analyses were conducted to assess subspecialist evaluation of cases. RESULTS: Interrater agreement was slight to fair compared with that expected by chance. For the group of 21 raters, the kappa values were 0.11 (95% CI, 0.06-0.16) with the standard scoring system and 0.20 (95% CI, 0.13-0.27) with dichotomized scores. There was disagreement about whether a discrepancy had occurred in 20 cases. Subgroup analyses did not reveal significant differences in the degree of interrater agreement. CONCLUSION: The identification of discrepant interpretations is valuable for the education of individual radiologists and for larger-scale quality assurance and quality improvement efforts. Our results show that a ratings-based peer review system is unreliable and subjective for the evaluation of discrepant interpretations. Resources should be devoted to developing more robust and objective assessment procedures, particularly those with clear quality improvement goals.