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Article 1
Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp Trial Collaborators. N Engl J Med. 2016 Sep 22;375(12):1119-30.
The RESCUEicp study (Randomised Evaluation of Surgery with Craniectomy for Uncontrollable Elevation of Intracranial Pressure) was a 10-year prospective randomized clinical trial (RCT). The RCT assigned those with refractory intracranial hypertension after traumatic brain injury (TBI) to two arms, as follows: 1) continued medical management or 2) decompressive craniectomy. Main inclusion criteria consisted of A) TBI patients with age between 10 and 65, B) intracranial pressure (ICP) > 25 mm Hg despite protocolized ICP management. Main exclusion criteria consisted of A) fixed and dilated pupils, B) bleeding disorder, or C) being moribund. The primary outcome was the 6-month eight-tiered Extended Glasgow Outcome Scale (GOSE). Decompressive craniectomy resulted in lower mortality (GOSE 1), but also higher rates of vegetative state (GOSE 2), lower severe disability (GOSE 3), and upper severe disability (GOSE 4).
Compared to the DECRA RCT, the RESCUEicp multicenter (52 centers), international (20 countries) RCT conducted from 2004 to 2014 assessed the effectiveness of decompressive craniectomy (of any type) as a last-tier treatment in 409 patients; the median time from randomization to craniectomy was 2.2 hours. The medical group had at least 37% treatment failure requiring crossover into surgical decompression, albeit late. A priori and unconventionally, the trialists decided that upper-severe-disability (GOSE 4) would be included in the definition of favorable outcome, when the GOSE was analyzed dichotomously in a sensitivity analysis. This RCT left the type of craniectomy up to the surgeon and allowed patients with intracranial hematoma (Marshall Class V and VI). Similar to the DECRA RCT, the RESCUEicp increased disability among survivors.
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Article 2
Impact of Volume Change Over Time on Trauma Mortality in the United States. Brown JB, Rosengart MR, Kahn JM, Mohan D, Zuckerbraun BS, Billiar TR, Peitzman AB, Angus DC, Sperry JL. Ann Surg. 2017 Jul;266(1):173-178.
This 13-year retrospective cohort derived from the National Trauma Databank (NTDB) explored the association of volume change over time with mortality of severely injured patients at a trauma center level. Particularly among Level I or II centers, increasing patient volume was associated with improving outcomes, whereas decreasing patient volume was associated with worsening outcomes. Volume change came before outcome change, and on average, improvements resulted 3 years later. This unique study shows a temporal association between volume and outcome in trauma.
From 2000 to 2012, a total of 839,809 patients were included from 287 US Trauma centers. Centers must have contributed more than 50 patients per year, and have at least 1 year of data from 2000-2006 and 2007-2012 in the NTDB. At the trauma center level, a ratio of observed to expected deaths (i.e., standardized mortality ratio, SMR) was created. Expected deaths were adjusted for age, admission hypotension, admission heart rate (i.e., pulseless, bradycardia, normal, or tachycardia), admission Glasgow Coma Scale, Injury Severity Score (ISS>15 only), mechanical ventilation, and mechanism of injury. Advanced statistical models were used to study annual SMR as a function of the annual percent volume change over time, while controlling for ISS by center. Ultimately, this outstanding clinical database study overcame the past limitations of cross-sectional analysis regarding volume-outcomes associations in trauma mortality, and has important implications for trauma system planning and designation.
Article 3
The Effect of a Golden Hour Policy on the Morbidity and Mortality of Combat Casualties. Kotwal RS, Howard JT, Orman JA, Tarpey BW, Bailey JA, Champion HR, Mabry RL, Holcomb JB, Gross KR. JAMA Surg. 2016 Jan;151(1):15-24.
This study is a retrospective descriptive analysis of battlefield data that compares morbidity and mortality outcomes for casualties before and after a 2009 golden-hour policy mandate by the Secretary of Defense. The mandate required a prehospital helicopter transport of critically injured combat casualty of 60 minutes or less. The investigators show that the 2009 golden-hour mandate reduced the time between combat injury and receiving definitive care, and represents an important factor in combat injury survival.
The analysis included over 21K combat casualties from September 11, 2001 through March 31, 2014. Casualties (excluding those with minor wounds) who underwent prehospital helicopter transport were evaluated for flight time (<60 minutes vs. >60 minutes), overall mortality, killed in action (KIA), and died of wounds (DOW). Secondary outcomes measured included amputation, cardiac arrest, coagulopathy, and shock. Treatment related variables included massive transfusion (MT), non-massive transfusion (NMT), prehospital transfusion (PHT), and type of initial receiving treatment facility. Limitations of this study include the use of historical controls for pre and post comparisons, post hoc analysis of non-randomized data, variance in data capture and collection, transfusion-related survivor bias, and use of the Injury Severity Score to estimate complex battlefield wounds.
The investigators found for all casualty data that after the mandate, there was an increase in percentage return to duty (33.5% to 47.3%, p<0.001), a decrease in percentage KIA (16% to 9.9%, p<0.001) and decrease percentage case fatality rate (13.7% to 7.6%, p<0.001). There were 4552 casualties who underwent further individual level study of which 89.9% survived and 67.1% underwent helicopter evacuation in 60 minutes or less. When comparing before and after implementation of the mandate, there was a decrease in median transport time by 52% (90 minutes vs. 43 minutes, p<0.001) and increase in number of missions achieving transport in under 60 minutes (25% vs. 75%, p<0.001). The percentage of casualties who received MT, NMT, and PHT significantly increased after the mandate, as did the likelihood that these casualties had transport times of 60 minutes or less. The percentage of patients delivered to a combat casualty hospital also increased. Data also demonstrated there was no difference in mortality, increase in KIA, decrease in DOW, increase in amputations, and decrease in coagulopathy after the mandate. In summary, battlefield casualty survival depends on prehospital transport time and treatment capability.
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Article 4
Immediate total-body CT scanning versus conventional imaging and selective CT scanning in patients with severe trauma (REACT-2): a randomised controlled trial. Sierink JC, Treskes K, Edwards MJ, Beuker BJ, den Hartog D, Hohmann J, Dijkgraaf MG, Luitse JS, Beenen LF, Hollmann MW, Goslings JC; REACT-2 study group. Lancet. 2016 Aug 13;388(10045):673-83.
This is a multicenter, Randomized study of Early Assessment by CT Scanning in Severely Injured Trauma Patients (REACT-2) conducted at five European hospitals to assess the effect of immediate total body computerized tomography (CT) versus standard work-up with selective imaging on in-hospital mortality after severe trauma. The trial showed no difference in direct medical costs or in-hospital mortality, while radiation dosing modestly favored a selective approach, however, their times for imaging and diagnosis favored total body CT.
The REACT-2 randomized clinical trial (RCT) inclusion criteria were vital sign abnormalities, clinical suspicion of severe injury or significant mechanism (fall from height >10 feet, ejection from vehicle, death or severe injury of occupant in same vehicle, or entrapment of chest/abdomen). Exclusion criteria were minors, known pregnancy, transfer from another hospital, stab wounds to one body region, low-energy trauma with blunt mechanism, and patients that were too unstable to undergo CT. Randomization was 1:1 to either total body CT or selective imaging, under temporary exception from informed consent. Limitations of this study include unmasked randomization, non-US trauma hospital systems, and ultimately ~1/3 of this RCT cohort had an Injury Severity Score (ISS)<16, albeit ISS being a retrospective database determined parameter, which was not part of the prospective eligibility criteria. The authors aptly state, "The trial reflects the realities of daily practice and the difficulties in preventing over-triage or under-triage, but possibly <lower ISS> confounds the association between survival and total-body CT scanning."
There were 1403 patients randomized in the REACT-2 study. Exclusions after allocation consisted of 203 patients and 118 patients declined participation and/or had language barriers. In-hospital mortality was similar between groups (CT 16% vs selective imaging 16%; p=0.92), as was subgroup analyses in patients with polytrauma or traumatic brain injury. Median radiation exposure was statistically significantly higher in the CT arm, but only by 0.3 mSv (i.e, less than a mammogram). In the selective imaging arm, 46% received serial scans that were equivalent to whole body CT. Surprisingly, there were only modest differences in median time to imaging completion and diagnosis of life threatening injuries (7 and 8 min, respectively), all favoring total body CT. Results were unaltered using a per-protocol analysis (i.e., excluding 24 cross-over patients). This is the first international multicenter RCT examining total body CT versus selective imaging after major trauma; this may be viewed as complementary or contradictory to the recently published NICE guidelines for major trauma, which advocate use of immediate total body CT (except in pediatric patients).
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