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OBJECTIVE: Dimethylsulfoxide-cryopreserved platelets are being evaluated for treatment of acute hemorrhage in patients with thrombocytopenia or platelet dysfunction when liquid stored platelets are unavailable. Patients undergoing cardiac surgery with cardiopulmonary bypass with risk factors for significant bleeding represent a population for which determining efficacy and safety of cryopreserved platelets is ideal in the clinical trial setting. The primary objective is to compare blood loss in cardiopulmonary bypass patients receiving cryopreserved platelets or liquid stored platelets. METHODS: In patients undergoing cardiac surgery utilizing cardiopulmonary bypass, a standardized algorithm with transfusion triggers will be used to guide the intra- and postoperative administration of study platelets, either cryopreserved platelets or liquid stored platelets, based on the clinical presentation. The primary efficacy end point was the volume of blood loss from completion of chest closure (time 0) until the time chest tubes were removed or 24 hours after chest closure, whichever is earlier. RESULTS: This design article describes an ongoing multicenter, randomized, blinded trial to evaluate noninferiority or superiority of cryopreserved platelets with liquid stored platelets in controlling blood loss in patients undergoing cardiopulmonary bypass surgery. CONCLUSIONS: Frozen storage could substantially safely extend the shelf life of stored platelets. If efficacy and safety were demonstrated in this trial, current constraints on platelet use in low resource military and civilian settings would be relieved.

Supplemental Digital Content is available in the text., Introduction: Overutilization of point-of-care (POC) testing may reduce the overall value of care due to high-cost cartridges, need for staff training, and quality assurance requirements. Methods: The Diagnostic Stewardship group at Cincinnati Children’s Hospital Medical Center assembled a multidisciplinary team to reduce the use of POC blood gas testing by 20% in the pediatric intensive care unit (PICU). Key drivers of test overutilization included poor knowledge of cost, concern with testing turnaround time, and a lack of a standard definition of when a POC test was appropriate. We calculated weekly the outcome measure of POC blood gas tests per PICU patient-day and a balancing measure of blood gas result turnaround time using data extracted from the electronic medical record. Interventions focused on staff education, the establishment of a standard practice guideline for the use of POC testing, and improving turnaround time for laboratory blood gas testing. Results: Over the baseline period starting July 2016, a median of 0.94 POC blood gas tests per PICU patient-day was ordered. After initial staff training, the rate was reduced to 0.60 tests per PICU patient-day and further reduced to 0.41 tests per PICU patient-day after a formal policy change was adopted. We have sustained this rate for 15 months through June 2018. Institutional direct cost savings were estimated to be $19,000 per year. Conclusions: Our improvement initiative was associated with a significant and rapid reduction in the use of POC testing in the PICU. Interventions focused on cost awareness, and a formal guideline helped establish a consensus around appropriate utilization.

Introduction: The purpose of this study was to compare the following three treatments of upper limb motor impairment in chronic moderate/severely impaired stroke survivors: 1) Customized whole limb motor learning (Whole ML), including shoulder/elbow robotics (ROB) and functional electrical stimulation (FES); 2) prescribed shoulder/elbow ROB + motor learning (S/E ROB ML); and 3) prescribed wrist/hand FES + ML (W/H FES ML). Methods: Subjects with chronic stroke were stratified according to relative level of impairment (Fugl-Meyer coordination Test) in wrist/hand versus shoulder/elbow. Their stratification category dictated the treatment group to which they were allocated, as follows: 1) WHOLE ML (n=18), equal distal and proximal impairment; 2) S/E ROB ML (n=10 ), greater shoulder/elbow impairment; and 3) FES ML (n=8), greater wrist/hand impairment. Treatment was 5 days/wk, 5 hrs/day, 60 sessions. Primary measure was the Arm Motor Assessment Tool, 13 complex tasks, Functional Scale (AMAT-F), acquired at baseline and at follow-up, 3 months after last treatment. Secondary measures were subscales, AMAT-F Shoulder/Elbow (AMAT-F S/E) and AMAT Wrist/Hand (AMAT-F W/H). Statistical analyses were Kruskal Wallace model to account for group size differences; group comparisons and within-group pre-/follow-up comparisons were analyzed (and multiple comparisons corrections). Results: All three groups had significant within-group gain for AMAT-F (p=.0007; p=.039; p=.047, respectively; similar results were shown for AMAT S/E subscale. Only the Whole ML group had significant gain in AMAT W/H (p=.007). Gain for all three groups exceeded the threshold for clinically significant gain in AMAT-F (.21 points), as follows: Whole ML (.66 points, 3 x’s the threshold); S/E ROB ML (.53 points, 2.5 x’s); W/H FES ML (.46 points, 2 x’s). Conclusion: For the customized whole limb motor learning group there was greater improvement in upper limb function versus the two groups that received prescribed, focused training for either shoulder/elbow or wrist/hand, according to the AMAT-F clinically significant threshold and according to the AMAT-F W/H subscale.

Blunt hollow viscus injury (HVI) is uncommon. No sufficiently large series has studied the prevalence of these injuries in blunt trauma patients. This study defines the prevalence of blunt HVI, in addition to the associated morbidity and mortality rates for this diagnosis on the basis of a series of over 275,000 trauma admissions.Patients with blunt small bowel injury (SBI) were identified from the registries of 95 trauma centers for a 2-year period (1998-1999). Each HVI patient (case) was matched by age and Injury Severity Score with a blunt trauma patient receiving an abdominal workup who did not have HVI (control). Patient level data were abstracted by individual chart review. Institution level data were collected on total numbers for trauma admission demographics and on total diagnostic examinations performed.From 275,557 trauma admissions, 227,972 blunt injury patients were identified. HVI was rare, with 2,632 patients identified from this group. Perforating small bowel injury accounted for less than 0.3% of blunt admissions. Mortality and morbidity were high for HVI. Controlling for injury severity, patients with HVI were usually at higher risk of death than non-HVI patients.HVI is a rare but deadly phenomenon. The high mortality rates reflect the severity of the HVI and associated injuries. HVI patients should be carefully monitored for related injuries and complications.

Intensive gait training can produce improvements in gait and function (6 months after stroke); however, findings are mixed for enhanced life-role participation. Therefore, it is unclear if improved gait and function translate into life-role participation gain. Our objective was to evaluate whether intensive gait therapy can produce improvements in life-role participation for chronic-stroke survivors, according to a comprehensive measure dedicated to life-role participation.In conjunction with a clinical gait-training trial, we conducted a secondary analysis for a 44-member cohort with stroke (6 months). Gait-training interventions included functional neuromuscular stimulation, body-weight supported treadmill training, over-ground gait training and exercise for 1.5 hours/day, 4 days/week for 12 weeks. Study measures included Tinetti Gait (gait impairment), Functional Independence Measure (FIM, function), Stroke Impact Scale subscale of life-role participation (SIS part) and Craig Handicap Assessment and Reporting Technique (CHART, life-role participation). Analysis included Wilcoxon signed rank test and polytomous universal regression model.Gait interventions produced significant improvement in CHART (p = 0.020), SIS part (p = 0.011), FIM (p0.0001), and Tinetti Gait (p0.0001). Age, gender and time since stroke did not predict response to treatment.Intensive gait therapy resulted in significant gain in life-role participation, according to a comprehensive measure, so dedicated.

Background: Spasticity can prevent productive practice of skilled movement that should occur during neurorehabilitation of coordinated arm movements after stroke. Studies showed that spasticity could be reduced following an intervention that inhibited activation of the contralesional primary motor region (M1) using non-invasive transcranial magnetic or electric stimulation. However, there is little understanding of how the mitigation of spasticity might be controlled by the multiple sensorimotor control brain regions. Therefore, the aim of this study was to evaluate the change in activation patterns of multiple sensorimotor regions that predict the mitigation of spasticity, in response to intensive upper limb neurrehabiltiation. Methods: Twenty three stroke subjects (>6 months after stroke) with persistent arm motor deficits were treated with intensive upper extremity rehabilitation (5 hours/day, 5 days/week for 12 weeks). Baseline and post-rehab evaluation consisted of three measures: 1) functional magnetic resonance imaging (fMRI) during a shoulder/elbow reach task for the paretic arm, 2) a skilled motor function (Arm Motor Assessment test (AMAT)), and 3) spasticity (Modified Ashworth Scale(MAS)). Volume of brain activation (voxel count) during the reach task was calculated for sensory and motor control regions using SPM05 (London, UK) and in-house software in MATLAB (Natick, MA). Paired t-test analysis was conducted for pre- vs post-treatment comparisons. Multiple linear regression analysis was conducted, where post-rehab AMAT was the dependent variable, the co-variate was pre-rehab score, and the predictors were change from pre- to post-rehab in voxel count in bilateral M1, somatosensory (SS), posterior parietal (PP), lateral premotor (LPM) and supplementary motor (SMA) areas. Results: Subject characteristics were as follows: mean age, 56.3 ±12.8years; 41%, female; and 1.8±1.1 years after first ever stroke. Change in the activation pattern in a number of regions significantly predicted mitigated spasticity (R2=.86). Specifically, in response to treatment, increased activation, in ipsilesional SMA (p=.002) and contralesional M1 (p=.002), predicted mitigated spasticity. Reduction in activation volume, in ipsilesional PP region (p=.0009), contralesional SS (p=.008) and SMA (p=.006), predicted mitigated spasticity. AMAT score improved from 1636.63±668.41 to 1213.67±6643.79 seconds (p Conclusions: A specific pattern of functional brain change across multiple regions predicted mitigation of spasticity following neurorehabilitation; skill functional recovery occurred, as well. This information could be used in constructing study design for future research that would investigate brain training to mitigate spasticity and improve skilled functional task performance.

Effective combat trauma management strategies depend on an understanding of the epidemiology of death on the battlefield, resulting in evidence-based equipment, training, and research requirements.All Special Operations Forces (SOF) fatalities (combat and noncombat) in Operation Iraqi Freedom/Operation Enduring Freedom (OEF/OIF) from October 2001 until November 2004 were reviewed. All available autopsy and treatment records and photographs were used. In most cases, the immediate tactical situation was unknown. The review was performed by a multidisciplinary group including forensic pathologists, an SOF combat medic, and trauma surgeons. Fatalities were classified as having wounds that were either nonsurvivable or potentially survivable with existing training, equipment, and expertise on the battlefield. A structured review was performed evaluating the need for new equipment, training, or research requirements. Results were compared to autopsy data from Vietnam and modern civilian trauma center data. The study was approved by the Institutional Review Boards of the Armed Forces Institute of Pathology and the US Army Institute of Surgical Research.During the study period, 82 SOF fatalities were identified. Autopsies were performed on 77 Soldiers. Five casualties died secondary to aircraft crash, their bodies were not recovered from the ocean. For the purposes of this study they were considered nonsurvivable. Eighty-five percent (n = 70) of the fatalities sustained wounds that were nonsurvivable, while the remaining 15% (n = 12) had wounds that were potentially survivable. Injury Severity Score (ISS) was higher in the nonsurvivable group (p0.05). Truncal hemorrhage accounted for 47% of deaths while extremity hemorrhage accounted for 33%. One casualty was noted at autopsy to have a tension pneumothorax as well as multiple sources of internal hemorrhage, one suffered an airway death, while another died of sepsis 56 days after injury. Of those casualties deemed to be nonsurvivable, there were 31 patients with 40 Abbreviated Injury Score (AIS) 6 injuries (p = .0011), and 53 patients with 104 AIS 5 injuries. Among the 12 deaths deemed to be potentially survivable, there were only 8 AIS 5 injuries. Deaths were largely caused by explosions (n = 35), gunshot wounds (n = 23), and aircraft accidents (n = 19). No new training or equipment needs were identified for 53% of the potentially survivable deaths while improved methods of truncal hemorrhage control need to be developed for the remainder. The review panel concluded that 85% of the deaths would not have been prevented at a civilian Level I facility. Available records, in most cases, did not contain information about the use of body armor, time to death after injury, or the ongoing tactical situation.The majority of deaths on the modern battlefield are nonsurvivable. Current results are not different from previous conflicts. In Vietnam, reported potentially preventable death rates range from 5% to 35% and civilian data reports potentially preventable death rates ranging from 12% to 22%. Military munitions cause multiple lethal injuries. Current trauma training and equipment is sufficient to care for 53% of the potentially survivable deaths. Improved methods of intravenous or intracavitary noncompressible hemostasis combined with rapid surgery are required for the remaining 47% of the decedents.

Background Clinical research in trauma patients poses multiple challenges in study design. These reflect the heterogeneity of injury and treatment, the paucity of acceptable study endpoints aside from mortality, and the difficulties inherent in obtaining informed consent in acutely ill populations. A current example of this problem is the study of recombinant factor VIIa (rFVIIa), which has attracted considerable interest as a systemic procoagulant agent for use in trauma patients with exsanguinating hemorrhage. Purpose To report on the implementation of an international trial — CONTROL — intended to assess the efficacy and safety of rFVIIa in trauma, and discuss trauma research study design in light of this experience. Methods The CONTROL trial international steering committee confronted a number of barriers in the design of the CONTROL trial. They addressed methodologies for (1) standardizing entry criteria for trauma patients suffering inherently heterogeneous injuries, (2) obtaining informed consent in an acutely injured population with altered levels of consciousness, (3) avoiding futile care, while recruiting subjects with incompletely diagnosed injuries, (4) standardizing trauma intensive care across different investigating sites and countries, and (5) establishing study endpoints that were both clinically relevant and convincing to regulatory authorities. The resulting study methodology is reported. Results The CONTROL trial began active recruitment in October 2005, and was halted on June 11, 2008 because the observed mortality in the 576 enrolled patients was so far below expectations that the study would lack sufficient statistical power at the planned number of subjects to demonstrate a benefit. The utility of the endpoints selected for study will not be known until completion of data analysis. Limitations Any clinical trial in trauma patients must cope with the urgency of care required, issues of patient heterogeneity, standardization of care across multiple centers, and the difficulties of obtaining informed consent. Conclusion Research in acutely hemorrhaging trauma patients presents numerous scientific and ethical challenges. The methodology of the CONTROL study is presented as an example of how some of these challenges can be approached and managed, and of the pitfalls that may arise. Clinical Trials 2009; 6: 467—479. http://ctj.sagepub.com

Discusses the Constitutional responsibilities of the US Federal Government for public schools. Citing “control follows funding”, argues that control should remain with the states and school boards. Offers suggestions for reorganizing educational spending and improving educational programmes and school standards. Details important ways for the Federal Government to contribute without taking control.

Discusses the concept of “the reaching mind”. Makes the case that successful learning has to involve the learner as a willing partner in the process and discusses areas where improvements can be made to benefit the learning process.

Emphasizes the need to save public education in America as being essential to the “American way of life”. Pinpoints the lack of a generally accepted goal, the designing of school programmes to suit teachers, not the students, and the movement of state and federal government further into the leadership and day‐to‐day operation of schools, as the factors which have had a detrimental effect on public schools during the past generation. Lists a 12‐point agenda for getting the public schools back on course and advocates a study of public education to identify what the public wants, followed by a plan to implement a suitable education programme.

When the Radix Anchor apex was allowed to engage the bottom of the prepared channel, very high apical stresses were generated within the supporting structure. When the coronal flanges engaged the occlusal portion of the model, high lateral stresses occurred in the coronal portion of the channel. These stress concentrations can be avoided by installing the dowel so that only the retentive threads engage dentin. This may be accomplished by "backing off" one half turn when slight resistance to dowel threading is encountered. The Radix endodontic dowel system was more retentive than cemented dowels and less retentive than another dowel which threads into the dentin of the channel wall. The Radix Anchor was more retentive when both diameter and length of imbedment were increased simultaneously.