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PDF - 133KB, Covariance matrix for currently screened subgroup (n=3,498).

PDF - 133KB, Covariance matrix for overdue subgroup (n=418).

PDF - 134KB, Covariance matrix for never screened subgroup (n=1,277).

Background: Few studies have examined the psychometric properties and invariance of scales measuring constructs relevant to colorectal cancer screening (CRCS). We sought to: (i) evaluate the factorial validity of four core constructs associated with CRCS (benefits, barriers, self-efficacy, and optimism); and (ii) examine measurement invariance by screening status (currently screened, overdue, never screened).Methods: We used baseline survey data from a longitudinal behavioral intervention trial to increase CRCS among U.S. veterans. Respondents were classified as currently screened (n = 3,498), overdue (n = 418), and never screened (n = 1,277). The measurement model was developed using a random half of the sample and then validated with the second half of the sample and the full baseline sample (n = 5,193). Single- and multi-group confirmatory factor analysis was used to examine measurement invariance by screening status.Results: The four-factor measurement model demonstrated good fit. Factor loadings, item intercepts, and residual item variance and covariance were invariant when comparing participants never screened and overdue for CRCS, indicating strict measurement invariance. All factor loadings were invariant among the currently screened and overdue groups. Only the benefits scale was invariant across current screeners and never screeners. Non-invariant items were primarily from the barriers scale.Conclusion: Our findings provide additional support for the construct validity of scales of CRCS benefits, barriers, self-efficacy, and optimism. A greater understanding of the differences between current and never screeners may improve measurement invariance.Impact: Measures of benefits, barriers, self-efficacy, and optimism may be used to specify intervention targets and effectively assess change pre- and post-intervention across screening groups. Cancer Epidemiol Biomarkers Prev; 22(12); 2295–302. ©2013 AACR.

Background Quantification of medical interventions administered during prolonged field care (PFC) is necessary to inform training and planning. Materials and methods Retrospective cohort study of Department of Defense Trauma Registry casualties with maximum Abbreviated Injury Scale (MAIS) score of 2 or greater and prehospital records during combat operations 2007 to 2015; US military nonsurvivors were linked to Armed Forces Medical Examiner System data. Medical interventions administered to survivors of 4 hours to 72 hours of PFC and nonsurvivors who died prehospital were compared by frequency-matching on mechanism (explosive, firearm, other), injury type (penetrating, blunt) and injured body regions with MAIS score of 3 or greater. Covariates for adjustment included age, sex, military Service, shock, Glasgow Coma Scale, transport team, MAIS and Injury Severity Score (ISS). Sensitivity analysis focused on US military subgroup with AIS/ISS assigned to nonsurvivors after autopsy. Results The total inception cohort included 16,202 casualties (5,269 US military, 10,809 non-US military), 64% Afghanistan, 36% Iraq. Of US military, 734 deaths occurred within 30 days, nearly 90% occurred within 4 hours of injury. There were 3,222 casualties (1,111 US military, 2,111 non-US military) documented for prehospital care and died prehospital (691) or survived 4 hours to 72 hours of PFC (2,531). Twenty-five percent (815/3,222) received advanced airway, 18% (583) ventilatory support, 9% (281) tourniquet. Twenty-three percent (725) received blood transfusions within 24 hours. Of the matched cohort (1,233 survivors, 490 nonsurvivors), differences were observed in care (survivors received more warming, intravenous fluids, sedation, mechanical ventilation, narcotics, antibiotics; nonsurvivors received more intubations, tourniquets, intraosseous fluids, cardiopulmonary resuscitation). Sensitivity analysis focused on US military (732 survivors, 379 nonsurvivors) showed no significant differences in prehospital interventions. Without autopsy information, the ISS of nonsurvivors significantly underestimated injury severity. Conclusion Tourniquets, blood transfusion, airway, and ventilatory support are frequently required interventions for the seriously injured. Prolonged field care should direct resources, technology, and training to field technology for sustained resuscitation, airway, and breathing support in the austere environment. Level of evidence Prognostic, Level III.

Objective To address the clinical and regulatory challenges of optimal primary endpoints for bleeding patients by developing consensus-based recommendations for primary clinical outcomes for pivotal trials in patients within 6 categories of significant bleeding, (1) traumatic injury, (2) intracranial hemorrhage, (3) cardiac surgery, (4) gastrointestinal hemorrhage, (5) inherited bleeding disorders, and (6) hypoproliferative thrombocytopenia. Background A standardized primary outcome in clinical trials evaluating hemostatic products and strategies for the treatment of clinically significant bleeding will facilitate the conduct, interpretation, and translation into clinical practice of hemostasis research and support alignment among funders, investigators, clinicians, and regulators. Methods An international panel of experts was convened by the National Heart Lung and Blood Institute and the United States Department of Defense on September 23 and 24, 2019. For patients suffering hemorrhagic shock, the 26 trauma working-group members met for almost a year, utilizing biweekly phone conferences and then an in-person meeting, evaluating the strengths and weaknesses of previous high quality studies. The selection of the recommended primary outcome was guided by goals of patient-centeredness, expected or demonstrated sensitivity to beneficial treatment effects, biologic plausibility, clinical and logistical feasibility, and broad applicability. Conclusions For patients suffering hemorrhagic shock, and especially from truncal hemorrhage, the recommended primary outcome was 3 to 6-hour all-cause mortality, chosen to coincide with the physiology of hemorrhagic death and to avoid bias from competing risks. Particular attention was recommended to injury and treatment time, as well as robust assessments of multiple safety related outcomes.

Background This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature–stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. Methods A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality. Results In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature–stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature– and cold-stored up to 7 days arm was 75 ml (95% CI, −220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, −1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature– and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature–stored platelets. Conclusions This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients. Editor’s Perspective What We Already Know about This Topic What This Article Tells Us That Is New

Study objective The transfusion of older packed RBCs may be harmful in critically ill patients. We seek to determine the association between packed RBC age and mortality among trauma patients requiring massive packed RBC transfusion. Methods We analyzed data from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios trial. Subjects in the parent trial included critically injured adult patients admitted to 1 of 12 North American Level I trauma centers who received at least 1 unit of packed RBCs and were predicted to require massive blood transfusion. The primary exposure was volume of packed RBC units transfused during the first 24 hours of hospitalization, stratified by packed RBC age category: 0 to 7 days, 8 to 14 days, 15 to 21 days, and greater than or equal to 22 days. The primary outcome was 24-hour mortality. We evaluated the association between transfused volume of each packed RBC age category and 24-hour survival, using random-effects logistic regression, adjusting for total packed RBC volume, patient age, sex, race, mechanism of injury, Injury Severity Score, Revised Trauma Score, clinical site, and trial treatment group. Results The 678 patients included in the analysis received a total of 8,830 packed RBC units. One hundred patients (14.8%) died within the first 24 hours. On multivariable analysis, the number of packed RBCs greater than or equal to 22 days old was independently associated with increased 24-hour mortality (adjusted odds ratio [OR] 1.05 per packed RBC unit; 95% confidence interval [CI] 1.01 to 1.08): OR 0.97 for 0 to 7 days old (95% CI 0.88 to 1.08), OR 1.04 for 8 to 14 days old (95% CI 0.99 to 1.09), and OR 1.02 for 15 to 21 days old (95% CI 0.98 to 1.06). Results of sensitivity analyses were similar only among patients who received greater than or equal to 10 packed RBC units. Conclusion Increasing quantities of older packed RBCs are associated with increased likelihood of 24-hour mortality in trauma patients receiving massive packed RBC transfusion (≥10 units), but not in those who receive fewer than 10 units.

Background Death from uncontrolled hemorrhage occurs rapidly, particularly among combat casualties. The US military has used warm fresh whole blood during combat operations owing to clinical and operational exigencies, but published outcomes data are limited. We compared early mortality between casualties who received warm fresh whole blood versus no warm fresh whole blood. Methods Casualties injured in Afghanistan from 2008 to 2014 who received ≥2 red blood cell containing units were reviewed using records from the Joint Trauma System Role 2 Database. The primary outcome was 6-hour mortality. Patients who received red blood cells solely from component therapy were categorized as the non–warm fresh whole blood group. Non– warm fresh whole blood patients were frequency-matched to warm fresh whole blood patients on identical strata by injury type, patient affiliation, tourniquet use, prehospital transfusion, and average hourly unit red blood cell transfusion rates, creating clinically unique strata. Multilevel mixed effects logistic regression adjusted for the matching, immortal time bias, and other covariates. Results The 1,105 study patients (221 warm fresh whole blood, 884 non–warm fresh whole blood) were classified into 29 unique clinical strata. The adjusted odds ratio of 6-hour mortality was 0.27 (95% confidence interval 0.13–0.58) for the warm fresh whole blood versus non–warm fresh whole blood group. The reduction in mortality increased in magnitude (odds ratio = 0.15, P = .024) among the subgroup of 422 patients with complete data allowing adjustment for seven additional covariates. There was a dose-dependent effect of warm fresh whole blood, with patients receiving higher warm fresh whole blood dose (>33% of red blood cell–containing units) having significantly lower mortality versus the non–warm fresh whole blood group. Conclusion Warm fresh whole blood resuscitation was associated with a significant reduction in 6-hour mortality versus non–warm fresh whole blood in combat casualties, with a dose-dependent effect. These findings support warm fresh whole blood use for hemorrhage control as well as expanded study in military and civilian trauma settings.

Background Colorectal cancer (CRC) screening (CRCS) facilitates early detection and lowers CRC mortality. Objectives To increase CRCS in a randomized trial of stepped interventions. Step 1 compared three modes of delivery of theory-informed minimal cue interventions. Step 2 was designed to more intensively engage those not completing CRCS after Step 1. Methods Recruitment packets (60,332) were mailed to a random sample of individuals with a record of U.S. military service during the Vietnam-era. Respondents not up-to-date with CRCS were randomized to one of four Step 1 groups: automated telephone, telephone, letter, or survey-only control. Those not completing screening after Step 1 were randomized to one of three Step 2 groups: automated motivational interviewing (MI) call, counselor-delivered MI call, or Step 2 control. Intention-to-treat (ITT) analyses assessed CRCS on follow-up surveys mailed after each step. Results After Step 1 (n = 1784), CRCS was higher in the letter, telephone, and automated telephone groups (by 1%, 5%, 7%) than in survey-only controls (43%), although differences were not statistically significant. After Step 2 (n = 516), there were nonsignificant increases in CRCS in the two intervention groups compared with the controls. CRCS following any combination of stepped interventions overall was 7% higher (P = 0.024) than in survey-only controls (55.6%). Conclusions In a nationwide study of Veterans, CRCS after each of two stepped interventions of varying modes of delivery did not differ significantly from that in controls. However, combined overall, the sequence of stepped interventions significantly increased CRCS.

Overtransfusion of packed red blood cells is known to increase the risk of death in stable patients. With the delineation of minimum transfusion ratios in hemorrhaging patients complete, attention must be turned to the other end of the massive transfusion spectrum-that of defining the maximum transfusion of packed red blood cells. We aimed to define the ideal hemoglobin range 24 hours after anatomic hemostasis associated with the lowest mortality.Massive-transfusion patients (≥10 units packed red blood cells within 24 hours) were reviewed from 2010-2013. The hemoglobin 24 ± 6 hours after anatomic hemostasis was used to stratify patients into undertransfusion (8.0 g/dL), hemoglobin transfusion target (8.0-11.9 g/dL), and overtransfusion (12.0 g/dL) groups; patients not surviving to 24 hours were excluded.We identified 418 patients (351 [84%] in the hemoglobin transfusion target group, 38 [9%] in the undertransfusion group, and 29 [7%] in the overtransfusion group) with an overall mortality of 18%. Undertransfusion patients had the greatest risk of death (odds ratio 3.3; 95% confidence interval 1.6-6.7) followed by overtransfusion patients (odds ratio 2.5; 95% confidence interval 1.1-5.6). Though pretransfusion hemoglobin was similar (9.5 ± 2.2 g/dL vs 9.5 ± 2.3 g/dL), overtransfusion patients had greater hemoglobin values during massive transfusion (8.3 ± 3.0 g/dL vs 6.9 ± 1.4 g/dL), persisting until hospital dismissal/death (11.4 ± 2.3 g/dL vs 9.6 ± 1.1 g/dL). In total, 657.4 excess packed red blood cell units were transfused (1.9 ± 1.5 per patient).Overtransfusion patients had increased mortality, comparable to undertransfusion patients, despite younger age and fewer comorbidities. Shorter massive transfusion durations foster a scenario in which patients are at greater risk of overtransfusion.

BackgroundMedication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial’s conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration.MethodsThe Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial was a Phase III multi-site, randomized trial to compare the effectiveness and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with a 1:1:2 ratio. In this trial, these three types of blood products were to be transfused in a pre-defined order that differed by treatment arm. In this paper, we present approaches from the PROPPR trial that we used to define and calculate the occurrence of out of order blood transfusion errors. We applied the proposed method to calculate protocol adherence to the specified order of transfusion in each treatment arm.ResultsUsing our proposed method, protocol adherence was greater in the 1:1:1 group than in the 1:1:2 group (96% vs 93%) (p

Background The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial has demonstrated that damage-control resuscitation, a massive transfusion strategy targeting a balanced delivery of plasma-platelet-red blood cell in a ratio of 1:1:1, results in improved survival at 3 hours and a reduction in deaths caused by exsanguination in the first 24 hours compared with a 1:1:2 ratio. In light of these findings, we hypothesized that patients receiving 1:1:1 ratio would have improved survival after emergency laparotomy. Methods Severely injured patients predicted to receive a massive transfusion admitted to 12 Level I North American trauma centers were randomized to 1:1:1 versus 1:1:2 as described in the PROPPR trial. From these patients, the subset that underwent an emergency laparotomy, defined previously in the literature as laparotomy within 90 minutes of arrival, were identified. We compared rates and timing of emergency laparotomy as well as postsurgical survival at 24 hours and 30 days. Results Of the 680 enrolled patients, 613 underwent a surgical procedure, 397 underwent a laparotomy, and 346 underwent an emergency laparotomy. The percentages of patients undergoing emergency laparotomy were 51.5% (174 of 338) and 50.3% (172 of 342) for 1:1:1 and 1:1:2, respectively (p = 0.20). Median time to laparotomy was 28 minutes in both treatment groups. Among patients undergoing an emergency laparotomy, the proportions of patients surviving to 24 hours and 30 days were similar between treatment arms; 24-hour survival was 86.8% (151 of 174) for 1:1:1 and 83.1% (143 of 172) for 1:1:2 (p = 0.29), and 30-day survival was 79.3% (138 of 174) for 1:1:1 and 75.0% (129 of 172) for 1:1:2 (p = 0.30). Conclusion We found no evidence that resuscitation strategy affects whether a patient requires an emergency laparotomy, time to laparotomy, or subsequent survival. Level of evidence Therapeutic study, level IV.

Endotheliopathy of trauma is characterized by breakdown of the endothelial glycocalyx. Elevated biomarkers of endotheliopathy, such as serum syndecan-1 (Synd-1) ≥ 40 ng/mL, have been associated with increased need for transfusions, complications, and mortality. We hypothesized that severely injured trauma patients who exhibit elevated Synd-1 levels shortly after admission have an increased likelihood of developing sepsis.We analyzed a subset of patients from the Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial who survived at least 72 hours after hospital admission, and we determined elevated Synd-1 levels (≥ 40 ng/mL) 4 hours after hospital arrival. Sepsis was defined a priori as meeting systemic inflammatory response criteria and having a known or suspected infection. Univariate analysis was performed to identify variables associated with elevated Synd-1 levels and sepsis. Significant variables at a value of p0.2 in the univariate analysis were chosen by purposeful selection and analyzed in a mixed effects multivariate logistic regression model to account for the 12 different study sites.We included 512 patients. Of these, 402 (79%) had elevated Synd-1 levels, and 180 (35%) developed sepsis. Median Synd-1 levels at 4 hours after admission were 70 ng/dL (interquartile range [IQR] 36 to 157 ng/dL) in patients who did not develop sepsis, and 165 ng/dL [IQR 67 to 336 ng/dL] in those who did (p0.001). Adjusting for treatment arm and site, multivariable analyses revealed that elevated Synd-1 status, Injury Severity Score (ISS), and total blood transfused were significantly associated with an increased likelihood of developing sepsis.Elevated Synd-1 levels 4 hours after admission in severely injured adult trauma patients who survived the initial 72 hours after hospital admission are associated with subsequent sepsis.

Background Previously, a model to predict massive transfusion protocol (MTP) (activation) was derived using a single-institution data set. The PRospective, Observational, Multicenter, Major Trauma Transfusion database was used to externally validate this model's ability to predict both MTP activation and massive transfusion (MT) administration using multiple MT definitions. Methods The app model was used to calculate the predicted probability of MTP activation or MT delivery. The five definitions of MT used were: (1) 10 units packed red blood cells (PRBCs) in 24 hours, (2) Resuscitation Intensity score ≥ 4, (3) critical administration threshold, (4) 4 units PRBCs in 4 hours; and (5) 6 units PRBCs in 6 hours. Receiver operating curves were plotted to compare the predicted probability of MT with observed outcomes. Results Of 1,245 patients in the data set, 297 (24%) met definition 1, 570 (47%) met definition 2, 364 (33%) met definition 3, 599 met definition 4 (49.1%), and 395 met definition 5 (32.4%). Regardless of the outcome (MTP activation or MT administration), the predictive ability of the app model was consistent: when predicting activation of the MTP, the area under the curve for the model was 0.694 and when predicting MT administration, the area under the curve ranged from 0.695 to 0.711. Conclusion Regardless of the definition of MT used, the app model demonstrates moderate ability to predict the need for MT in an external, homogenous population. Importantly, the app allows the model to be iteratively recalibrated ("machine learning") and thus could improve its predictive capability as additional data are accrued. Level of evidence Diagnostic test study/Prognostic study, level III.

Objective The current study leveraged data from the Early Whole Blood (EWB) trial to explore the effects of modified whole blood (mWB) versus component (COMP) transfusions on coagulation parameters over time using longitudinal statistical methods. Study design and methods The EWB study was a single-center randomized controlled trial, approved by the local IRB. Adult patients at highest-level trauma activations were randomized into mWB or COMP groups. Coagulation status was evaluated (at times 0, 3, 6, 12, and 24 h postadmission) using thrombelastography, platelet aggregometry, and calibrated automated thrombograms. Longitudinal statistical analyses with generalized estimating equations (GEE) were used to evaluate the effects of group, time, transfusion types, and their respective interactions on changes in measured coagulation markers. Results A total of 59 patients were enrolled and adhered to protocol in the EWB trial, 25 in the mWB group, and 34 in the COMP group. Patients in both the mWB and COMP groups demonstrated a significant decline in their thrombelastography parameters during the first 3-6 h, specifically K-time, α-angle, maximum amplitude, G, and LY30. Patients receiving mWB exhibited improved thrombin potential than those receiving COMP. Platelet count and function declined over time in both mWB and COMP groups; however, platelet aggregation in response to ristocetin in the mWB group was significantly improved at 12 h compared with the COMP group. The longitudinal GEE model revealed significant group-time interactive effects on the changes in coagulation markers and significant effect of platelet transfusions on improvements in coagulation profile. Conclusions We observed significant interactive group-time effects, indicating that the types of transfusion as well as the time of transfusion significantly affect the patient's coagulation status. Our pilot data suggest that there is an improvement in platelet function with mWB, but further studies are needed. Regardless, platelet transfusions were associated with improvements in coagulation over time in both the groups.

In comparative effectiveness studies of multicomponent, sequential interventions like blood product transfusion (plasma, platelets, red blood cells) for trauma and critical care patients, the timing and dynamics of treatment relative to the fragility of a patient’s condition is often overlooked and underappreciated. While many hospitals have established massive transfusion protocols to ensure that physiologically optimal combinations of blood products are rapidly available, the period of time required to achieve a specified massive transfusion standard (e.g. a 1:1 or 1:2 ratio of plasma or platelets:red blood cells) has been ignored. To account for the time-varying characteristics of transfusions, we use semiparametric rate models for multivariate recurrent events to estimate blood product ratios. We use latent variables to account for multiple sources of informative censoring (early surgical or endovascular hemorrhage control procedures or death). The major advantage is that the distributions of latent variables and the dependence structure between the multivariate recurrent events and informative censoring need not be specified. Thus, our approach is robust to complex model assumptions. We establish asymptotic properties and evaluate finite sample performance through simulations, and apply the method to data from the PRospective Observational Multicenter Major Trauma Transfusion study.

Background Positive Focused Assessment with Sonography in Trauma examination and hypotension often indicate urgent surgery. An abdomen/pelvis computed tomography (apCT) may allow less invasive management but the delay may be associated with adverse outcomes. Methods Patients in the Prospective Observational Multicenter Major Trauma Transfusion study with hypotension and a positive Focused Assessment with Sonography in Trauma (HF+) examination who underwent a CT (apCT+) were compared with those who did not. Results Of the 92 HF+ identified, 32 (35%) underwent apCT during initial evaluation and apCT was associated with decreased odds of an emergency operation (odds ratio .11, 95% confidence interval .001 to .116) and increased odds of angiographic intervention (odds ratio 14.3, 95% confidence interval 1.5 to 135). There was no significant difference in 30-day mortality or need for dialysis. Conclusions An apCT in HF+ patients is associated with reduced odds of emergency surgery, but not mortality. Select HF+ patients can safely undergo apCT to obtain clinically useful information.

BACKGROUND Nonoperative multidisciplinary management for severe (American Association for the Surgery of Trauma Grades IV and V) liver injury has been used for two decades. We have previously shown that Damage Control Resuscitation (DCR) using low-volume, balanced resuscitation improves survival of severely injured trauma patients; however, little attention has been paid to organ-specific outcomes. We wanted to determine if implementation of DCR has improved survival and successful nonoperative management after severe blunt liver injury. METHODS A retrospective study was performed on all adult trauma patients with severe blunt liver injury who were admitted from 2005 to 2011. Patients were divided into pre-DCR (2005-2008) and DCR (2009-2011) groups. Patients who died before leaving the emergency department (ED) were excluded. Outcomes (resuscitation products used, survival, and length of stay) were then compared by univariate and multivariate analyses. RESULTS Between 2005 and 2011, 29,801 adult trauma patients were admitted, and 1,412 (4.7%) experienced blunt liver injury. Of these, 244 (17%) sustained Grade IV and V injuries, with 206 patients surviving to leave the ED. The pre-DCR group (2005-2008) was composed of 108 patients, and the DCR group (2009-2011) had 98 patients. The groups were not different in demographics as well as prehospital and ED vital signs or Injury Severity Score (ISS). No change in operative or interventional radiology techniques occurred in this time frame. The DCR cohort had an increase in successful nonoperative management (from 54% to 74%, p < 0.01) as well as a reduction in initial 24-hour packed red blood cell (median, from 13 U to 6.5 U; p < 0.01), plasma (median, from 13 U to 8 U; p < 0.01), and crystalloid (median, from 5,800 mL to 4,100 mL; p < 0.01) administration. The DCR treatment was associated with improved survival, from 73% to 94% (p < 0.01). CONCLUSION In patients with severe blunt liver injury, DCR was associated with less crystalloid and blood product use, a higher successful nonoperative management rate, and improved survival. Resuscitation technique may improve outcomes after severe liver injury. LEVEL OF EVIDENCE Therapeutic/care management, level III.

Importance Prehospital blood product transfusion in trauma care remains controversial due to poor-quality evidence and cost. Sequential expansion of blood transfusion capability after 2012 to deployed military medical evacuation (MEDEVAC) units enabled a concurrent cohort study to focus on the timing as well as the location of the initial transfusion. Objective To examine the association of prehospital transfusion and time to initial transfusion with injury survival. Design, Setting, and Participants Retrospective cohort study of US military combat casualties in Afghanistan between April 1, 2012, and August 7, 2015. Eligible patients were rescued alive by MEDEVAC from point of injury with either (1) a traumatic limb amputation at or above the knee or elbow or (2) shock defined as a systolic blood pressure of less than 90 mm Hg or a heart rate greater than 120 beats per minute. Exposures Initiation of prehospital transfusion and time from MEDEVAC rescue to first transfusion, regardless of location (ie, prior to or during hospitalization). Transfusion recipients were compared with nonrecipients (unexposed) for whom transfusion was delayed or not given. Main Outcomes and Measures Mortality at 24 hours and 30 days after MEDEVAC rescue were coprimary outcomes. To balance injury severity, nonrecipients of prehospital transfusion were frequency matched to recipients by mechanism of injury, prehospital shock, severity of limb amputation, head injury, and torso hemorrhage. Cox regression was stratified by matched groups and also adjusted for age, injury year, transport team, tourniquet use, and time to MEDEVAC rescue. Results Of 502 patients (median age, 25 years [interquartile range, 22 to 29 years]; 98% male), 3 of 55 prehospital transfusion recipients (5%) and 85 of 447 nonrecipients (19%) died within 24 hours of MEDEVAC rescue (between-group difference, −14% [95% CI, −21% to −6%];P = .01). By day 30, 6 recipients (11%) and 102 nonrecipients (23%) died (between-group difference, −12% [95% CI, −21% to −2%];P = .04). For the 386 patients without missing covariate data among the 400 patients within the matched groups, the adjusted hazard ratio for mortality associated with prehospital transfusion was 0.26 (95% CI, 0.08 to 0.84,P = .02) over 24 hours (3 deaths among 54 recipients vs 67 deaths among 332 matched nonrecipients) and 0.39 (95% CI, 0.16 to 0.92,P = .03) over 30 days (6 vs 76 deaths, respectively). Time to initial transfusion, regardless of location (prehospital or during hospitalization), was associated with reduced 24-hour mortality only up to 15 minutes after MEDEVAC rescue (median, 36 minutes after injury; adjusted hazard ratio, 0.17 [95% CI, 0.04 to 0.73],P = .02; there were 2 deaths among 62 recipients vs 68 deaths among 324 delayed transfusion recipients or nonrecipients). Conclusions and Relevance Among medically evacuated US military combat causalities in Afghanistan, blood product transfusion prehospital or within minutes of injury was associated with greater 24-hour and 30-day survival than delayed transfusion or no transfusion. The findings support prehospital transfusion in this setting.

Background Ultrasound is widely considered the initial diagnostic imaging modality for trauma. Preliminary studies have explored the use of trauma ultrasound in the prehospital setting, but the accuracy and potential utility is not well understood. Objective We sought to determine the accuracy of trauma ultrasound performed by helicopter emergency medical service (HEMS) providers. Methods Trauma ultrasound was performed in flight on adult patients during a 7-month period. Accuracy of the abdominal, cardiac, and lung components was determined by comparison to the presence of injury, primarily determined by computed tomography, and to required interventions. Results HEMS providers performed ultrasound on 293 patients during a 7-month period, completing 211 full extended Focused Assessment with Sonography for Trauma (EFAST) studies. HEMS providers interpreted 11% of studies as indeterminate. Sensitivity and specificity for hemoperitoneum was 46% (95% confidence interval [CI] 27.1%–94.1%) and 94.1% (95% CI 89.2%–97%), and for laparotomy 64.7% (95% CI 38.6%–84.7%) and 94% (95% CI 89.2%–96.8%), respectively. Sensitivity and specificity for pneumothorax were 18.7% (95% CI 8.9%–33.9%) and 99.5% (95% CI 98.2%–99.9%), and for thoracostomy were 50% (95% CI 22.3%–58.7%) and 99.8% (98.6%–100%), respectively. The positive likelihood ratio for laparotomy was 10.7 (95% CI 5.5–21) and for thoracostomy 235 (95% CI 31−1758), and the negative likelihood ratios were 0.4 (95% CI 0.2–0.7) and 0.5 (95% CI 0.3–0.8), respectively. Of 240 cardiac studies, there was one false-positive and three false-negative interpretations (none requiring intervention). Conclusions HEMS providers performed EFAST with moderate accuracy. Specificity was high and positive interpretations raised the probability of injury requiring intervention. Negative interpretations were predictive, but sensitivity was not sufficient for ruling out injury.

Recent studies suggest there are gender-specific differences in injury response that may be related to coagulation. The objective of this study was to test the hypothesis that rapid thrombelastography (rTEG) coagulation profiles differ by gender.Adult trauma patients were prospectively followed at 3 level 1 trauma centers over a 14-month period. rTEG was obtained upon arrival and serially at several time points during the hospital stay. Female patients were stratified into premenopausal (≤50 years) and postmenopausal (50 years) age groups with age-matched male cohorts. Values were analyzed using a repeated-measures multilevel linear model to evaluate the effect of gender on coagulation.A total of 795 patients had serial rTEG data (24% female and 76% male). Compared with age-matched males, premenopausal females were more hypercoagulable by rTEG on admission (P.001) and for the first 12 hours after arrival. Gender was an effect modifier for alpha angle (P = .02) and maximum amplitude (P = .04). Controlling for Injury Severity Score and mechanism of injury, age-matched males had a4-fold increased risk of hypercoagulable complications than premenopausal females (odds ratio, 4.7; P = .038).This prospective, multicenter study demonstrates that premenopausal females are relatively hypercoagulable compared with age-matched males early after injury. However, this did not translate into higher thromboembolic complications.

Objective. Earlier use of plasma and red blood cells (RBCs) has been associated with improved survival in trauma patients with substantial hemorrhage. We hypothesized that prehospital transfusion (PHT) of thawed plasma and/or RBCs would result in improved patient coagulation status on admission and survival. Methods. Adult trauma patient records were reviewed for patient demographics, shock, coagulopathy, outcomes, and blood product utilization from September 2011 to April 2013. Patients arrived by either ground or two different helicopter companies. All patients transfused with blood products (either pre- or in-hospital) were included in the study. One helicopter system (LifeFlight, LF) had thawed plasma and RBCs while the other air (OA) and ground transport systems used only crystalloid resuscitation. Patients receiving PHT were compared with all other patients meeting entry criteria to the study cohort. All comparisons were adjusted in multilevel regression models. Results. A total of 8,536 adult trauma patients were admitted during the 20-month study period, of which 1,677 met inclusion criteria. They represented the most severely injured patients (ISS = 24 and mortality = 26%). There were 792 patients transported by ground, 716 by LF, and 169 on OA. Of the LF patients, 137 (19%) received prehospital transfusion. There were 942 units (244 RBCs and 698 plasma) placed on LF helicopters, with 1.9% wastage. PHT was associated with improved acid-base status on hospital admission, decreased use of blood products over 24 hours, a reduction in the risk of death in the sickest patients over the first 6 hours after admission, and negligible blood products wastage. In this small single-center pilot study, there were no differences in 24-hour (odds ratio 0.57, p = 0.117) or 30-day mortality (odds ratio 0.71, p = 0.441) between LF and OA. Conclusions. Prehospital plasma and RBC transfusion was associated with improved early outcomes, negligible blood products wastage, but not an overall survival advantage. Similar to the data published from the ongoing war, improved early outcomes are associated with placing blood products prehospital, allowing earlier infusion of life-saving products to critically injured patients.

Background Overtriage not only wastes resources but also displaces the patient from their community and causes delay of treatment for the more seriously injured. This study aimed to validate the Random Forest computer model (RFM) as means of better triaging trauma patients to level 1 trauma centers. Methods Adult trauma patients with “medium activation” presenting via helicopter to a level 1 trauma center from May 2007 to May 2009 were included. The “medium activation” trauma patient is alert and hemodynamically stable on scene but has either subnormal vital signs or accumulation of risk factors that may indicate a potentially serious injury. Variables included in the RFM analysis were demographics, mechanism of injury, prehospital fluid, medications, vitals, and disposition. Statistical analysis was performed via the Random Forest algorithm to compare our institutional triage rate to rates determined by the RFM. Results A total of 1653 patients were included in this study, of which 496 were used in the testing set of the RFM. In our testing set, 33.8% of patients brought to our level 1 trauma center could have been managed at a level 3 trauma center, and 88% of patients who required a level 1 trauma center were identified correctly. In the testing set, there was an overtriage rate of 66%, whereas using the RFM, we decreased the overtriage rate to 42% (P The RFM predicted patient disposition with a sensitivity of 89%, specificity of 42%, negative predictive value of 92%, and positive predictive value of 34%. Conclusions Although prospective validation is required, it appears that computer modeling potentially could be used to guide triage decisions, allowing both more accurate triage and more efficient use of the trauma system.

In the United States, ultrasound has rarely been incorporated into prehospital care, and scant descriptions of the processes used to train prehospital providers are available.Our objective was to evaluate the effectiveness of an extended focused assessment with sonography for trauma (EFAST) training curriculum that incorporated multiple educational modalities. We also aimed to determine if certain demographic factors predicted successful completion.All aeromedical prehospital providers (APPs) for a Level I trauma center took a 25-question computer-based test to ascertain baseline knowledge. Questions were categorized by content and format. Training over a 2-month period included a didactic course, a hands-on training session, proctored scanning sessions in the Emergency Department, six Internet-based training modules, pocket flashcards, a review session, and remedial training. At the conclusion of the training curriculum, the same test and an objective structured clinical examination were administered to evaluate knowledge gained.Thirty-three of 34 APPs completed training. The overall pre-test and post-test means and all content and format subsets showed significant improvement (p0.0001 for all). No APP passed the pre-test, and 28 of 33 passed the post-test with a mean score of 78%. No demographic variable predicted passing the post-test. Twenty-seven of 33 APPs passed the objective structured clinical examination, and the only predictive variable was passing the post-test (odds ratio 1.21, 95% confidence interval 1.00-1.25, p = 0.045).The implementation of a multifaceted EFAST prehospital training program is feasible. Significant improvement in overall and subset testing scores suggests that the test instrument was internally consistent and sufficiently sensitive to capture knowledge gained as a result of the training. Demographic variables were not predictive of test success.

Background: Few studies have examined the psychometric properties and invariance of scales measuring constructs relevant to colorectal cancer screening (CRCS). We sought to: (i) evaluate the factorial validity of four core constructs associated with CRCS (benefits, barriers, self-efficacy, and optimism); and (ii) examine measurement invariance by screening status (currently screened, overdue, never screened). Methods: We used baseline survey data from a longitudinal behavioral intervention trial to increase CRCS among U.S. veterans. Respondents were classified as currently screened (n = 3,498), overdue (n = 418), and never screened (n = 1,277). The measurement model was developed using a random half of the sample and then validated with the second half of the sample and the full baseline sample (n = 5,193). Single- and multi-group confirmatory factor analysis was used to examine measurement invariance by screening status. Results: The four-factor measurement model demonstrated good fit. Factor loadings, item intercepts, and residual item variance and covariance were invariant when comparing participants never screened and overdue for CRCS, indicating strict measurement invariance. All factor loadings were invariant among the currently screened and overdue groups. Only the benefits scale was invariant across current screeners and never screeners. Non-invariant items were primarily from the barriers scale. Conclusion: Our findings provide additional support for the construct validity of scales of CRCS benefits, barriers, self-efficacy, and optimism. A greater understanding of the differences between current and never screeners may improve measurement invariance. Impact: Measures of benefits, barriers, self-efficacy, and optimism may be used to specify intervention targets and effectively assess change pre- and post-intervention across screening groups. Cancer Epidemiol Biomarkers Prev; 22(12); 2295–302. ©2013 AACR.

To determine whether resuscitation of severely injured patients with modified whole blood (mWB) resulted in fewer overall transfusions compared with component (COMP) therapy.For decades, whole blood (WB) was the primary product for resuscitating patients in hemorrhagic shock. After dramatic advances in blood banking in the 1970s, blood donor centers began supplying hospitals with individual components [red blood cell (RBC), plasma, platelets] and removed WB as an available product. However, no studies of efficacy or hemostatic potential in trauma patients were performed before doing so.Single-center, randomized trial of severely injured patients predicted to large transfusion volume. Pregnant patients, prisoners, those younger than 18 years or with more than 20% total body surface area burns (TBSA) burns were excluded. Patients were randomized to mWB (1 U mWB) or COMP therapy (1 U RBC+ 1 U plasma) immediately on arrival. Each group also received 1 U platelets (apheresis or prepooled random donor) for every 6 U of mWB or 6 U of RBC + 6 U plasma. The study was performed under the Exception From Informed Consent (Food and Drug Administration 21 code of federal regulations [CFR] 50.24). Primary outcome was 24-hour transfusion volumes.A total of 107 patients were randomized (55 mWB, 52 COMP therapy) over 14 months. There were no differences in demographics, arrival vitals or laboratory values, injury severity, or mechanism. Transfusions were similar between groups (intent-to-treat analysis). However, when excluding patients with severe brain injury (sensitivity analysis), WB group received less 24-hour RBC (median 3 vs 6, P = 0.02), plasma (4 vs 6, P = 0.02), platelets (0 vs 3, P = 0.09), and total products (11 vs 16, P = 0.02).Compared with COMP therapy, WB did not reduce transfusion volumes in severely injured patients predicted to receive massive transfusion. However, in the sensitivity analysis (patients without severe brain injuries), use of mWB significantly reduced transfusion volumes, achieving the prespecified endpoint of this initial pilot study.

Background The trauma transfusion literature has yet to resolve which is more important for hemorrhaging patients: transfusing plasma and platelets along with red blood cells (RBCs) early in resuscitation or gradually balancing blood product ratios. In a previous report of PROMMTT results, we found 1) plasma and platelet:RBC ratios increased gradually over the 6 hours following admission, and 2) patients achieving ratios >1:2 (relative to ratios

BACKGROUNDThere are few clinical data to guide the use of cryoprecipitate in severely injured trauma patients. Cryoprecipitate is a rich source of fibrinogen and has been associated with improved survival in animal as well as limited human studies. Our objectives were to identify patterns and predic

BACKGROUND: The Focused Assessment with Sonography for Trauma (FAST) examination is an important variable in many retrospective trauma studies. The purpose of this study was to devise an imputation method to overcome missing data for the FAST examination. Owing to variability in patients' injuries and trauma care, these data are unlikely to be missing completely at random, raising concern for validity when analyses exclude patients with missing values. METHODS: Imputation was conducted under a less restrictive, more plausible missing-at-random assumption. Patients with missing FAST examinations had available data on alternate, clinically relevant elements that were strongly associated with FAST results in complete cases, especially when considered jointly. Subjects with missing data (32.7%) were divided into eight mutually exclusive groups based on selected variables that both described the injury and were associated with missing FAST values. Additional variables were selected within each group to classify missing FAST values as positive or negative, and correct FAST examination classification based on these variables was determined for patients with nonmissing FAST values. RESULTS: Severe head/neck injury (odds ratio [OR], 2.04), severe extremity injury (OR, 4.03), severe abdominal injury (OR, 1.94), no injury (OR, 1.94), other abdominal injury (OR, 0.47), other head/neck injury (OR, 0.57), and other extremity injury (OR, 0.45) groups had significant ORs for missing data; the other group's OR was not significant (OR, 0.84). All 407 missing FAST values were imputed, with 109 classified as positive. Correct classification of nonmissing FAST results using the alternate variables was 87.2%. CONCLUSION: Purposeful imputation for missing FAST examinations based on interactions among selected variables assessed by simple stratification may be a useful adjunct to sensitivity analysis in the evaluation of imputation strategies under different missing data mechanisms. This approach has the potential for widespread application in clinical and translational research, and validation is warranted. Language: en

Background Several predictive models have been developed to identify trauma patients who have had severe hemorrhage (SH) and may need a massive transfusion protocol (MTP). However, almost all these models define SH as the transfusion of ≥10 units of red blood cells (RBCs) within 24 hours of ED admission (aka massive transfusion, MT). This definition excludes some patients with SH, especially those who die before a 10th unit of RBCs could be transfused, which calls the validity of these prediction models into question. We show how a latent class model could improve the accuracy of identifying the SH patients.

Introduction Focused assessment with sonography for trauma (FAST) is commonly used to facilitate the timely diagnosis of life-threatening hemorrhage in injured patients. Most patients with positive findings on FAST require laparotomy. Although it is assumed that an increasing time to operation (T-OR) leads to higher mortality, this relationship has not been quantified. This study sought to determine the impact of T-OR on survival in patients with a positive FAST who required emergent laparotomy. Methods We retrospectively analyzed patients from the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study who underwent laparotomy within 90 minutes of presentation and had a FAST performed. Cox proportional hazards models including Injury Severity Score (ISS), age, base deficit, and hospital site were created to examine the impact of increasing T-OR on in-hospital survival at 24 hours and 30 days. The impact of time from the performance of the FAST examination to operation (TFAST-OR) on in-hospital mortality was also examined using the same model. Results One hundred fifteen patients met study criteria and had complete data. Increasing T-OR was associated with increased in-hospital mortality at 24 hours (hazard ratio [HR], 1.50 for each 10-minute increase in T-OR; confidence interval [CI], 1.14-1.97; p = 0.003) and 30 days (HR, 1.41; CI, 1.18-2.10; p = 0.002). Increasing TFAST-OR was also associated with higher in-hospital mortality at 24 hours (HR, 1.34; CI, 1.03-1.72; p = 0.03) and 30 days (HR, 1.40; CI, 1.06-1.84; p = 0.02). Conclusion In patients with a positive FAST who required emergent laparotomy, delay in operation was associated with increased early and late in-hospital mortality. Delays in T-OR in trauma patients with a positive FAST should be minimized.

Acute lung injury following trauma resuscitation remains a concern despite recent advances. With the use of the PROMMTT study population, the risk of hypoxemia and potential modifiable risk factors are studied.Patients with survival for 24 hours or greater with at least one intensive care unit day were included in the analysis. Hypoxemia was categorized using the Berlin definition for adult respiratory distress syndrome: none (PaO₂-to-FIO₂ ratio [P/F]300 mm Hg), mild (P/F, 201-300 mm Hg), moderate (P/F, 101-200 mm Hg) or severe (P/F ≤ 100 mm Hg). The cohort was dichotomized into those with none or mild hypoxemia and those with moderate or severe injury. Early resuscitation was defined as that occurring 0 hour to 6 hours from arrival; late resuscitation was defined as that occurring 7 hours to 24 hours. Multivariate logistic regression models were developed controlling for age, sex, mechanisms of injury, arrival physiology, individual Abbreviated Injury Scale (AIS) scores, blood transfusions, and crystalloid administration.Of the patients 58.7% (731 of 1,245) met inclusion criteria. Hypoxemia occurred in 69% (mild, 24%; moderate, 28%; severe, 17%). Mortality was highest (24%) in the severe group. During early resuscitation (0-6 h), logistic regression revealed age (odd ratio [OR], 1.02; 95% confidence interval [CI], 1.00-1.04), chest AIS score (OR, 1.31; 95% CI, 1.10-1.57), and intravenously administered crystalloid fluids given in 500 mL increments (OR, 1.12; 95% CI, 1.01-1.25) as predictive of moderate or severe hypoxemia. During late resuscitation, age (OR, 1.02; 95% CI, 1.00-1.04), chest AIS score (OR, 1.33; 95% CI, 1.11-1.59), and crystalloids given during this period (OR, 1.05; 95% CI, 1.01-1.10) were also predictive of moderate-to-severe hypoxemia. Red blood cell, plasma, and platelet transfusions (whether received during early or late resuscitation) failed to demonstrate an increased risk of developing moderate/severe hypoxemia.Severe chest injury, increasing age, and crystalloid-based resuscitation, but not blood transfusions, were associated with increased risk of developing moderate-to-severe hypoxemia following injury.

Missing data are inherent in clinical research and may be especially problematic for trauma studies. This study describes a sensitivity analysis to evaluate the impact of missing data on clinical risk prediction algorithms. Three blood transfusion prediction models were evaluated using an observational trauma data set with valid missing data.The PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study included patients requiring one or more unit of red blood cells at 10 participating US Level I trauma centers from July 2009 to October 2010. Physiologic, laboratory, and treatment data were collected prospectively up to 24 hours after hospital admission. Subjects who received 10 or more units of red blood cells within 24 hours of admission were classified as massive transfusion (MT) patients. Correct classification percentages for three MT prediction models were evaluated using complete case analysis and multiple imputation. A sensitivity analysis for missing data was conducted to determine the upper and lower bounds for correct classification percentages.PROMMTT study enrolled 1,245 subjects. MT was received by 297 patients (24%). Missing percentage ranged from 2.2% (heart rate) to 45% (respiratory rate). Proportions of complete cases used in the MT prediction models ranged from 41% to 88%. All models demonstrated similar correct classification percentages using complete case analysis and multiple imputation. In the sensitivity analysis, correct classification upper-lower bound ranges per model were 4%, 10%, and 12%. Predictive accuracy for all models using PROMMTT data was lower than reported in the original data sets.Evaluating the accuracy clinical prediction models with missing data can be misleading, especially with many predictor variables and moderate levels of missingness per variable. The proposed sensitivity analysis describes the influence of missing data on risk prediction algorithms. Reporting upper-lower bounds for percent correct classification may be more informative than multiple imputation, which provided similar results to complete case analysis in this study.

BACKGROUND: The classic definition of massive transfusion, 10 or more units of red blood cells (RBCs) in 24 hours, has never been demonstrated as a valid surrogate for severe hemorrhage and can introduce survival bias. In addition, the definition fails to capture other products that the clinician may have immediately available, and may use, during the initial resuscitation. Assuming that units of resuscitative fluids reflect patient illness, our objective was to identify a rate of resuscitation intensity (RI) that could serve as an early surrogate of sickness for patients with substantial bleeding after injury. METHODS: Adult patients surviving at least 30 minutes after admission and receiving one or more RBCs within 6 hours of admission from 10 US Level 1 trauma centers were enrolled in the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study. Total fluid units were calculated as the sum of the number of crystalloid units (1 L = 1 U), colloids (0.5 L = 1 U), and blood products (1 RBC = 1 U, 1 plasma = 1 U, 6 pack platelets = 1 U). Univariable and multivariable logistic regressions were used to evaluate associations between RI and 6-hour mortality, adjusting for age, center, penetrating injury, weighted Revised Trauma Score (RTS), and Injury Severity Score (ISS). RESULTS: A total of 1,096 eligible patients received resuscitative fluids within 30 minutes, including 620 transfused with blood products. Despite varying products used, the total fluid RI was similar across all sites (3.2T 2.5 U). Patients who received four or more units of any resuscitative fluid had a 6-hour mortality rate of 14.4% versus 4.5% in patients who received less than 4 U. The adjusted odds ratio of 6-hour mortality for patients receiving 4 U or more within 30 minutes was 2.1 (95% confidence interval, 1.2Y3.5). CONCLUSION: Resuscitation with four or more units of any fluid was significantly associated with 6-hour mortality. This study suggests that early RI regardless of fluid type can be used as a surrogate for sickness and mortality in severely bleeding patients. ( JT rauma Acute Care Surg. 2013;74: S16YS23. Copyright * 2013 by Lippincott Williams & Wilkins) LEVEL OF EVIDENCE: Epidemiologic/prognostic study, level III.

Early predictors of massive transfusion (MT) would prevent undertriage of patients likely to require MT. This study validates triggers using the Prospective Observational Multicenter Major Trauma Transfusion (PROMMTT) study.All enrolled patients in PROMMTT were analyzed. The initial emergency department value for each trigger (international normalized ratio [INR], systolic blood pressure, hemoglobin, base deficit, positive result for Focused Assessment for the Sonography of Trauma examination, heart rate, temperature, and penetrating injury mechanism) was compared for patients receiving MT (≥ 10 U of packed red blood cells in 24 hours) versus no MT. Adjusted odds ratios (ORs) for MT are reported using multiple logistic regression. If all triggers were known, a Massive Transfusion Score (MTS) was created, with 1 point assigned for each met trigger.A total of 1,245 patients were prospectively enrolled with 297 receiving an MT. Data were available for all triggers in 66% of the patients including 67% of the MTs (199 of 297). INR was known in 87% (1,081 of 1,245). All triggers except penetrating injury mechanism and heart rate were valid individual predictors of MT, with INR as the most predictive (adjusted OR, 2.5; 95% confidence interval, 1.7-3.7). For those with all triggers known, a positive INR trigger was seen in 49% receiving MT. Patients with an MTS of less than 2 were unlikely to receive MT (negative predictive value, 89%). If any two triggers were present (MTS ≥ 2), sensitivity for predicting MT was 85%. MT was present in 33% with an MTS of 2 greater compared with 11% of those with MTS of less than 2 (OR, 3.9; 95% confidence interval, 2.6-5.8; p0.0005).Parameters that can be obtained early in the initial emergency department evaluation are valid predictors for determining the likelihood of MT.Diagnostic, level II.

Transfusion research seeks to improve survival for severely injured and hemorrhaging patients using optimal plasma and platelet ratios over red blood cells (RBCs). However, most published studies comparing different ratios are plagued with serious bias and ignore time-varying effects. We applied joint recurrent event frailty models to increase validity and clinical utility.Using the PRospective Observational Multicenter Major Trauma Transfusion study data, our joint random-effects models estimated the association of (1) clinical covariates with transfusion rate intensities and (2) varying plasma:RBC and platelet:RBC ratios with survival over the 24 hours after hospital admission. Along with survival time, baseline patient vital signs, laboratory values, and longitudinal data on types and volumes of transfusions were included.Baseline systolic blood pressure, heart rate, pH, and hemoglobin were significantly associated with RBC transfusion rates. Increased transfusion rates (per hour) of plasma (P = 0.05), platelets (P 0.001), or RBCs were associated with increased 24-hour mortality. Higher ratios of plasma:RBC (P = 0.107) and platelet:RBC (P 0.001) were associated with reduced mortality in a time-varying pattern (P 0.001).The proposed joint analysis of transfusion rates and ratios offers a more valid statistical approach to evaluate survival effects in the presence of informative censoring by early death.

OBJECTIVES Despite a national crisis of increased prevalence of obesity and type 2 diabetes mellitus in adolescents, especially among Hispanics, there is a paucity of data on health indicators among farmworker adolescents and their peers. The main aim of this study was to estimate the prevalence of cardiovascular disease risk factors in a population of Hispanic adolescent students in south Texas. The study also aimed to compare the prevalence of these risk factors between students enrolled in the Migrant Education Program (MEP) and other students, and between boys and girls. METHODS In partnership with the Weslaco (Texas) Independent School District and the Migrant Education Department, a cohort study was conducted from 2007 to 2010 to estimate the prevalence of overall obesity (body mass index ≥85th percentile for age and sex), abdominal obesity (waist circumference ≥75th percentile for age, sex, and ethnicity), acanthosis nigricans (AN), and high blood pressure (HBP; ≥90th percentile for age, height, and sex or systolic/diastolic BP ≥120/80 mm Hg) among MEP students compared with other students from two south Texas high schools. Multilevel logistic regression was used to assess the relation between sex and our main outcomes of interest while accounting for within-school nesting of participants. RESULTS Among 628 sampled students, 508 (80.9%) completed the consent procedure and participated in the study. Of these, 257 were MEP students and 251 were non-MEP peers. Approximately 96.7% of participants were Hispanic and 50.0% were boys. Analyses of data across the years comparing MEP students and non-MEP students show an average prevalence of 44.8% versus 47.7% for overall obesity, 43.2% versus 43.7% for abdominal obesity, 24.7% versus 24.7% for AN, and 29.2% versus 32.8% for HBP. Across recruitment and follow-up years, the prevalence of overall obesity, abdominal obesity, and HBP was 1.3 to 1.5, 1.2 to 1.8, and 2.9 to 4.6 times higher in boys than in girls, respectively. In contrast, the prevalence of AN varied little by sex. CONCLUSIONS The high prevalence of cardiovascular risk factors in both groups suggests a compelling need for comprehensive, culturally targeted interventions to prevent future cardiovascular diseases in these high-risk Hispanic adolescents, especially among boys. There were not, however, substantial differences between MEP students and other students. These findings also support the feasibility of conducting future epidemiologic studies among adolescent farmworkers and their families, as well as culturally appropriate school or community-based interventions.

This combined cross-sectional/cohort study addressed research gaps by estimating the rate of non-fatal occupational injury and identifying potential determinants among a population of adolescent farmworkers who are largely Hispanic and migrant.The cohort included 410 farmworkers (aged 13-19 years) attending high school in South Texas along the border with Mexico. Data collection involved a self-administered, Web-based survey that solicited information on demographics, farm work variables including person-time at risk, occupational injury, health status and health risk behaviours. Cox regression was used to identify potential risk factors for non-fatal injury events experienced during a 9-month recall period.Depending on the definition of injury, the rate of non-fatal injury ranged from 27.0-73.6/100 full time equivalents. Variables with an increased and statistically significant HR in an adjusted Cox model included: age groups15 years-old (5.82) and 16 years-old (4.47), usually sleeping8 h during the week (2.10), feeling tense, stressed or anxious sometimes/often (2.25), not watching TV (2.65), working around ditches (2.01) and detasseling (2.70).The high observed rates of non-fatal injury combined with the potential negative consequences and cost of these injuries signifies a compelling need for injury prevention efforts targeting adolescent, Hispanic, farmworkers.

Over the last 2 decades, early treatment for patients presenting with acute heart failure syndromes (AHFS) has changed very little. Despite strikingly different underlying disease pathophysiology, presenting signs and symptoms, and precipitants of AHFS, most patients are treated in a homogeneous manner with intravenous loop diuretics. Inhospital studies of new therapies have produced disappointingly neutral results at best. Patients continue to be enrolled in trials long after initial therapy, at a time when vital signs have improved, symptoms have changed, and initiating pathophysiologic processes, such as myocardial and renal injury, have already begun. The "one-size-fits-all" approach to inhospital AHFS trials have been recognized as one potential contributor to the disappointing trial results seen to date. Studies designed to tailor the therapeutic approach to ascertain which treatment modalities are most effective depending on patient phenotypes have not been previously conducted in AHFS because this objective is not traditional in clinical trial design. Utilizing Bayesian adaptive designs in trials of early AHFS provides an opportunity to personalize therapy within the constraints of clinical research. Bayesian adaptive design is increasingly recognized as an efficient method for obtaining valid clinical trial results. At its core, this approach uses existing information at the time of trial initiation, combined with data accumulating during the trial, to identify treatments most beneficial for specific patient subgroups. Based on accumulating evidence, the study then "adapts" its focus to critical differences between treatments within patient subgroups. Bayesian adaptive design is ideally suited for investigating complex, heterogeneous conditions such as AHFS and affords investigators the ability to study multiple treatment approaches and therapies in multiple patient phenotypes within a single trial, while maintaining a reasonable overall sample size. Identifying specific treatment approaches that safely improve symptoms and facilitate early discharge in patients who traditionally are admitted, often for prolonged periods of time, are necessary if we aim to reverse the disappointing trend in clinical trial results. In this study, AHFS clinical researchers and biostatisticians with expertise and experience in designing "personalized medicine" trials describe the development of a Bayesian adaptive design for an emergency department-based AHFS trial.

National and regional surgical meetings represent the key venue in which investigators present research results and a frequent source of continuing medical education for community and academic-based providers.1,2 Results from the presented research are often reprinted in the lay press, allowing results to reach thousands more nonattendees and in some cases, the public. Because of this potential for such “high-profile” dissemination, research selected for presentation should be of the highest scientific merit and research quality. Despite this, abstracts submitted to societal meetings typically do not undergo the same critical peer review as published manuscripts. Many academic societies do not have formal qualifications for abstract reviewers nor do they publish standardized reviewing or selection criteria. The most frequently used quality measure of a meeting’s scientific merit has been the number of abstracts presented that go on to peer-reviewed publication. A number of authors have described the publication rates for abstracts presented at national and international meetings, reporting proportions of 23% to 55% with publication delays of 12 months to 28 months.3–5 It is possible that these low publication rates indicate a lack of methodological quality in presented abstracts that do not ultimately stand up to peer review. Rather than basing abstract acceptance on methodological quality, other criteria, such as institutional affiliation and authorship, may play a role in selection. In addition, it is possible that particularly “hot” clinical topics are preferentially selected without particular attention to research methodology. A lack of methodological scrutiny can provide seriously flawed research the opportunity to attain a high-profile platform. It is also possible that such flaws are detected in manuscript review and result in the work not being published. We sought to describe the level of methodological detail reported in the abstracts presented at a major, national and international surgical meeting. We hypothesized that accepted abstracts would rate high on the key methodological factors selected and we further hypothesized that oral presentations would rate higher than poster presentations.

Aim Early death due to hemorrhage is a major consequence of traumatic injury. Transfusion practices differ among hospitals and it is unknown which transfusion practices improve survival. This report describes the experience of the PRospective Observational Multicenter Major Trauma Transfusion (PROMMTT) Study Data Coordination Center in designing and coordinating a study to examine transfusion practices at ten Level 1 trauma centers in the US. Methods PROMMTT was a multisite prospective observational study of severely injured transfused trauma patients. The clinical sites collected real-time information on the timing and amounts of blood product infusions as well as colloids and crystalloids, vital signs, initial diagnostic and clinical laboratory tests, life saving interventions and other clinical care data. Results Between July 2009 and October 2010, PROMMTT screened 12,561 trauma admissions and enrolled 1245 patients who received one or more blood transfusions within 6h of Emergency Department (ED) admission. A total of 297 massive transfusions were observed over the course of the study at a combined rate of 5.0 massive transfusion patients/week. Conclusion PROMMTT is the first multisite study to collect real-time prospective data on trauma patients requiring transfusion. Support from the Department of Defense and collaborative expertise from the ten participating centers helped to demonstrate the feasibility of prospective trauma transfusion studies. The observational data collected from this study will be an invaluable resource for research in trauma surgery and it will guide the design and conduct of future randomized trials.