Stella Boukas

Trauma care regionalization: a process-outcome evaluation.

BACKGROUND Regionalization of trauma care services in our region was initiated in 1993 with the designation of four tertiary trauma centers. The process continued in 1995 with the implementation of patient triage and transfer protocols. Since 1995, the network of trauma care has been expanded with the designation of 33 secondary, 30 primary, and 32 stabilization trauma centers. In addition, during this period emergency medical personnel have been trained to assess and triage trauma victims within minimal prehospital time. The objective of the present study was to evaluate the impact of trauma care regionalization on the mortality of major trauma patients. METHODS This was a prospective study in which patients were entered at the time of injury and were followed to discharge from the acute-care hospital. The patients were identified from the Quebec Trauma Registry, a review of the records of acute-care hospitals that treat trauma, and records of the emergency medical services in the region. The study sample consisted of all patients fulfilling the criteria of a major trauma, defined as death, or Injury Severity Score (ISS) > 12, or Pre-Hospital Index > 3, or two or more injuries with Abbreviated Injury Scale scores > 2, or hospital stay of more than 3 days. Data collection took place between April 1, 1993, and March 31, 1998. During this period, four distinct phases of trauma care regionalization were defined: pre-regionalization (phase 0), initiation (phase I), intermediate (phase II), and advanced (phase III). RESULTS A total of 12,208 patients were entered into the study cohort, and they were approximately evenly distributed over the 6 years of the study. During the study period, there was a decline in the mean age of patients from 54 to 46 years, whereas the male/female ratio remained constant at 2:1. There was also an increase in the mean ISS, from 25.5 to 27.5. The proportion of patients injured in motor vehicle collisions increased from less than 45% to more than 50% (p < 0.001). The mortality rate during the phases of regionalization were: phase 0, 52%; phase I, 32%; phase II, 19%; and phase III, 18%. These differences were clinically important and statistically significant (p < 0.0001). Stratified analysis showed a significant decline in mortality among patients with ISS between 12 and 49. The change in mortality for patients with fatal injuries (ISS > or = 50) was not significant. During the study period, the mean prehospital time decreased significantly, from 62 to 44 minutes. The mean time to admission after arrival at the hospital decreased from 151 to 128 minutes (p < 0.001). The latter decrease was primarily attributable to changes at the tertiary centers. The proportion of patients with ISS between 12 and 24 and between 25 and 49 who were treated at tertiary centers increased from 56 to 82% and from 36 to 84%, respectively (p < 0.001). Compared with the secondary and primary centers, throughout the course of the study the mortality rate in the secondary and tertiary centers showed a consistent decline (p < 0.001). In addition, the mortality rate in the tertiary centers remained consistently lower (p < 0.001). The results of multivariate analyses showed that after adjusting for injury severity and patient age, the primary factors contributing to the reduced mortality were treatment at a tertiary center, reduced prehospital time, and direct transport from the scene to tertiary centers. CONCLUSION This study produced empirical evidence that the integration of trauma care services into a regionalized system reduces mortality. The results showed that tertiary trauma centers and reduced prehospital times are the essential components of an efficient trauma care system.

Ineffectiveness of on-site intravenous lines: is prehospital time the culprit?

The purpose of the present study was to test the association between on-site intravenous fluid replacement and mortality in patients with severe trauma. The effect of prehospital time on this association was also evaluated. The design was that of an observational quasi-experimental study comparing 217 patients who had on-site intravenous fluid replacement (IV group) with an equal number of matched patients for whom this intervention was not performed (no-IV group). The patients were individually matched on their Prehospital Index obtained at the scene and were included in the study if they had an on-site Prehospital Index score > 3 and were transported alive to the hospital. The outcome measure of interest was mortality because of injury. The patients in the IV group had a significantly lower mean age (37 vs. 45 years; p < 0.001) and higher incidence of injuries to the head or neck (46 vs. 32%; p = 0.004), chest (34 vs. 17%; p < 0.001), and abdomen (28 vs. 12%; p < 0.001). The IV group also had a higher proportion of patients injured by motor vehicle crashes (41 vs. 27%; p = 0.003), firearms (9 vs. 2%; p = 0.001), and stabbing (20 vs. 9%; p = 0.001). The rate of extremity injuries (38 vs. 59%; p < 0.001) and falls (12 vs. 40%; p < 0.001) was lower for the IV group. In addition, the mean Injury Severity Score was significantly higher for the IV group (15 vs. 9; p < 0.001). The mortality rates for the IV and no-IV groups were 23 and 6% (p < 0.001). Logistic regression analysis showed that after adjusting for patient age, gender, Injury Severity Score, mechanism of injury, and prehospital time, the use of on-site intravenous fluid replacement was associated with a significant increase in the risk of mortality (adjusted odds ratio = 2.3; 95% confidence interval = 1.02-5.28; p = 0.04). To further evaluate the effect of prehospital time on the association between on-site IV use and mortality, the analysis was repeated separately for the following time strata: 0 to 30 minutes, 31 to 60 minutes, and >60 minutes. The adjusted odds ratios (95% confidence interval) for these strata were 1.05 (0.08-14.53; p = 0.97), 3.38 (0.84-13.62; p = 0.08), and 8.40 (1.27-54.69; p = 0.03). These results show that for prehospital times of less than 30 minutes, the use of on-site intravenous fluid replacement provides no benefit, and that for longer times, this intervention is associated with significant increases in the risk of mortality. The results of this observational study have shown that the use of on-site intravenous fluid replacement is associated with an increase in mortality risk and that this association is exacerbated by, but is not solely the result of, increased prehospital times. Our findings are consistent with the hypothesis that early intravenous fluid replacement is harmful because it disrupts the normal physiologic response to severe bleeding. Although this evidence is against the implementation of on-site intravenous fluid replacement for severely injured patients, further studies including randomized controlled trials are required to provide a definitive answer to this question.

Preventable death evaluation of the appropriateness of the on-site trauma care provided by Urgences-Santé physicians.

The study is based on 44 preventable deaths occurring in a cohort of 360 patients with major trauma. These cases were reviewed by a committee of nine experts. The mean Injury Severity Score (ISS) was 28, and most cases had injuries to the head/neck (68%) and chest (64%). The mean (+/- SD) observed prehospital times, and those considered the maximum allowable by the committee, were 40.6 +/- 12.0 minutes for head/neck injuries and 23.9 +/- 12.2 minutes for chest injuries (p < 0.05). Intravenous (i.v.) lines were started in 38 (86%) of the patients. The committee classified this procedure as harmful for 16 (42%) and neutral for 19 (50%). Among the 18 (46%) that were intubated, this intervention was considered harmful for 17% and neutral for 39%. In two of the three patients for whom a pneumatic antishock garment was applied, this procedure was considered harmful. Of the 34 patients that required direct transport at a level I trauma center, 50% were transferred to such a hospital. These results show significant prehospital delays and high rates of inappropriate IV line initiation and intubation in trauma patients receiving on-site care by physicians. We conclude that prehospital care protocols for trauma patients should emphasize prompt transport and specific on-site care algorithms.

Preventable death classification: interrater reliability and comparison with ISS-based survival probability estimates

The purpose of the study was to compare the injury-related threat to survival estimated by the Injury Severity Score (ISS) and a committee of experts. The charts of 116 (73 fatalities and 43 survivors) patients with severe injuries were reviewed. A committee of nine clinicians classified each case as survivable, potentially survivable, and nonsurvivable based on anatomical descriptors, mechanism of injury, and patients age. Majority was used to determine the final committee classification. Based on the ISS values, cases were classified as survivable (9-24), potentially survivable (25-49), and nonsurvivable (> 49). The results showed poor interrater reliability among the nine clinicians with an overall intraclass correlation coefficient of 0.43. The ISS-based classification had high agreement with the final committee classification (overall weighted kappa = 0.71). Lower agreement was observed for falls and with increasing number of injuries. This study has demonstrated no additional benefit for using a committee to classify injury severity on the basis of anatomical damage over applying ISS-based survival probabilities. The continued use of the ISS is supported.

Efficacy and tolerability of ezetimibe 10 mg/day coadministered with statins in patients with primary hypercholesterolemia who do not achieve target LDL-C while on statin monotherapy: A Canadian, multicentre, prospective study--the Ezetrol Add-On Study.

BACKGROUND For patients who have above-target low-density lipoprotein cholesterol (LDL-C) levels while on statin monotherapy, coadministration of a cholesterol absorption inhibitor with the statin may decrease serum LDL-C levels and improve overall lipid profiles. OBJECTIVES To assess the effectiveness and safety of ezetimibe 10 mg/day coadministered with a statin in patients with primary hypercholesterolemia who have higher than recommended LDL-C levels while on statin monotherapy. METHODS A six-week, prospective, multicentre study of eligible patients who had above-target LDL-C levels while on monotherapy with any statin, regardless of dose, for a minimum of four weeks. All patients were treated for six weeks with 10 mg ezetimibe daily coadministered with their current statins. RESULTS A total of 1141 patients were screened, 953 (83.5%) fulfilled the study inclusion criteria and 837 (87.8%) completed the study. Reasons for withdrawal included: lost to follow-up (50 patients [5.2%]); protocol violations (45 patients [4.7%]); adverse events (19 patients [2.0%]); and withdrawal of consent (two patients [0.2%]). After six weeks of treatment, statistically significant (P = 0.001) mean reductions were observed in LDL-C (30.05%), total cholesterol (20.84%), triglycerides (10.16%), apolipoprotein B (19.84%) and the total cholesterol to high-density lipoprotein cholesterol ratio (19.88%). At six weeks, 674 patients (80.5%) achieved target LDL-C levels. Fifty predominantly mild, nonserious adverse events related to ezetimibe were reported by 32 patients (3.4%). Frequently reported adverse events included constipation (n = 7 [0.7% of patients]), diarrhea (n = 4 [0.4%]) and dizziness (n = 4 [0.4%]). CONCLUSION Ezetimibe coadministered with statins is effective in reducing LDL-C in patients who do not attain target LDL-C levels while on statin monotherapy.

Effectiveness and tolerability of ezetimibe co-administered with statins versus statin dose-doubling in high-risk patients with persistent hyperlipidemia: The EZE(STAT)2 trial.

Introduction When a standard dose of statins fails to achieve lipid control in patients at high risk for coronary artery disease (CAD), increasing the statin dosage or co-administration of additional agents is recommended. The aim of this study was to compare the safety and lipid-lowering efficacy of doubling the standard statin dose (STAT2) to that of co-administering ezetimibe 10 mg/day (EZE+statin) in Canadian patients at high CAD risk with persistent hyperlipidemia upon statin treatment. Material and methods Six-week, open-label, randomized, multicentre study. The primary outcome was the change in plasma LDL-C and secondary measures included the change in additional lipid parameters. Safety was assessed with the incidence of emergent adverse events (AEs). Results Eight hundred eighty-five patients (EZE+statin, n=586; STAT2, n=299) completed the study. The mean (SD) percent change in low-density lipoprotein cholesterol (LDL-C) was – 30.9% (18.2) for the EZE+statin group and –18.4% (19.0) for the STAT2 group (p=0.001). Percent and absolute decreases in total cholesterol (TC), triglycerides and the TC to high-density lipoprotein cholesterol ratio (TC/HDL-C) were significantly greater for the EZE+statin group (p = 0.001). After 6 weeks of treatment, 70% of the patients in the EZE+statin group and 48% of patients in the STAT2 group (OR=2.45, p<0.001) achieved target LDL-C levels of<2.5 mmol/l. Incidence of AEs was similar between groups, with the exception of a higher incidence of muscle disorders in the STAT2 group. Conclusions In patients at high CAD risk who are above the LDL-C target while on statin monotherapy, co-administration of ezetimibe is well tolerated and more effective in improving the lipid profile compared to doubling the existing statin dose.

Reduction in Estimated Risk for Coronary Artery Disease After Use of Ezetimibe with a Statin

Background: The aim of lipid-lowering treatment is to reduce the risk for cardiovascular events. Patients not at target lipid levels while on hydroxymethylglutaryl coenzyme A reductase inhibitors (statin) monotherapy are at increased cardiovascular risk. Objective: To describe the impact of coadministration of ezetimibe with a statin on the estimated 10 year risk for coronary artery disease (E-RCAD) in patients with hypercholesterolemia and above-target low-density lipoprotein cholesterol (LDL-C) levels after statin monotherapy. Methods: Post hoc analysis was conducted of a prospective, open-label, single-cohort, multicenter Canadian study of 953 patients who were treated for 6 weeks with ezetimibe 10 mg/day coadministered with their current statin at an unaltered dose. For each patient, E-RCAD at baseline and at 6 weeks was calculated using the Framingham model. The primary outcome measure of the analysis was the change in E-RCAD. Results: A total of 825 patients with data at baseline and 6 weeks were included in the analysis. There were 423 (51.3%) patients with hypertension, 107 (13.0%) with diabetes mellitus but not metabolic syndrome, 160 (19.4%) with metabolic syndrome but not diabetes mellitus, and 235 (28.5%) with both diabetes mellitus and metabolic syndrome. After 6 weeks of ezetimibe coadministration with statin therapy, mean E-RCAD was reduced by 4.1% from 15.6% to 11.5%, which is equivalent to a 25.3% risk reduction (p < 0.001). Of the 225 (27.3%) patients with high E-RCAD (≥20.1%) at baseline, 144 (64.0%) converted to a lower E-RCAD category (p < 0.001). Patients with both diabetes mellitus and metabolic syndrome experienced the highest mean percent reduction in E-RCAD of –29.4% (p < 0.001). Conclusions: For patients with above-target LDL-C levels while on statin monotherapy, coadministration of ezetimibe with the statin is effective in significantly reducing the E-RCAD.

Effectiveness of Ezetimibe in Reducing the Estimated Risk for Fatal Cardiovascular Events in Hypercholesterolaemic Patients with Inadequate Lipid Control While on Statin Monotherapy as Measured by the SCORE Model

Objectives. The aim of this prospective cohort, multicentre study was to assess the effect of coadministrating ezetimibe 10 mg/day with an ongoing statin on the estimated risk for Cardiovascular (CVD) mortality in patients with persistently elevated LDL-C after statin monotherapy. Methods. The Systematic Coronary Risk Evaluation (SCORE) function was used to estimate the 10-year risk for cardiovascular mortality at baseline and 6 weeks. Primary outcome measures were absolute and percent changes in estimated Coronary Heart Disease (CHD) Mortality Risk, and general CVD Mortality Risk (Total CVD Mortality Risk). Results. 825 patients were included in the analysis. Mean (SD) age was 62 (10.5) years and 62.3% were males. The mean (SD) estimated Total CVD Mortality Risk decreased from 0.068 (0.059) at baseline to 0.053 (0.046) at 6 weeks (RR = 0.77; 95% CI:0.689–0.867), while the estimated CHD Mortality Risk decreased from 0.047 (0.040) at baseline to 0.034 (0.029) at 6 weeks (RR = 0.72; 95% CI:0.624–0.826). Conclusions. Co-administration of ezetimibe with a statin is effective in significantly reducing the estimated risk for cardiovascular mortality as measured by the SCORE model.

A Randomized Trial Assessing the Effectiveness of Ezetimibe in South Asian Canadians with Coronary Artery Disease or Diabetes: The INFINITY Study

Background. There is a paucity of data regarding the effectiveness and safety of lipid-lowering treatments among South-Asian patients. Methods. Sixty-four South-Asian Canadians with coronary artery disease or diabetes and persistent hypercholesterolemia on statin therapy, were randomized to ezetimibe 10 mg/day co-administered with statin therapy (EZE + Statin) or doubling their current statin dose (STAT2). Primary outcome was the proportion of patients achieving target LDL-C (<2.0 mmol/L) after 6 weeks. Secondary outcomes included the change in lipid profile and the incidence of treatment-emergent adverse events through 12 weeks. Exploratory markers for vascular inflammation were assessed at baseline and 12 weeks. Results. At 6 weeks, the primary outcome was significantly higher among the EZE + Statin patients (68% versus 36%; P = 0.031) with an OR (95% CI) of 3.97 (1.19, 13.18) upon accounting for baseline LDL-C and adjusting for age. At 12 weeks, 76% of EZE + Statin patients achieved target LDL-C compared to 48% (P = 0.047) of the STAT2 patients (adjusted OR (95% CI) = 3.31 (1.01,10.89)). No significant between-group differences in exploratory markers were observed with the exception of CRP. Conclusions. Patients receiving ezetimibe and statin were more likely to achieve target LDL-C after 6 and 12 weeks compared to patients doubling their statin dose. Ezetimibe/statin combination therapy was well tolerated among this cohort of South-Asian Canadians, without safety concerns.