A prospective cluster-randomized trial to implement the Canadian CT Head Rule in emergency departments.

BACKGROUND: The Canadian CT Head Rule was developed to allow physicians to be more selective when ordering computed tomography (CT) imaging for patients with minor head injury. We sought to evaluate the effectiveness of implementing this validated decision rule at multiple emergency departments. METHODS: We conducted a matched-pair cluster-randomized trial that compared the outcomes of 4531 patients with minor head injury during two 12-month periods (before and after) at hospital emergency departments in Canada, six of which were randomly allocated as intervention sites and six as control sites. At the intervention sites, active strategies, including education, changes to policy and real-time reminders on radiologic requisitions were used to implement the Canadian CT Head Rule. The main outcome measure was referral for CT scan of the head. RESULTS: Baseline characteristics of patients were similar when comparing control to intervention sites. At the intervention sites, the proportion of patients referred for CT imaging increased from the "before" period (62.8%) to the "after" period (76.2%) (difference +13.3%, 95% CI 9.7%-17.0%). At the control sites, the proportion of CT imaging usage also increased, from 67.5% to 74.1% (difference +6.7%, 95% CI 2.6%-10.8%). The change in mean imaging rates from the "before" period to the "after" period for intervention versus control hospitals was not significant (p = 0.16). There were no missed brain injuries or adverse outcomes. INTERPRETATION: Our knowledge-translation-based trial of the Canadian CT Head Rule did not reduce rates of CT imaging in Canadian emergency departments. Future studies should identify strategies to deal with barriers to implementation of this decision rule and explore more effective approaches to knowledge translation. (ClinicalTrials.gov trial register no. NCT00993252).

Aminophylline in bradyasystolic cardiac arrest: a randomised placebo-controlled trial.

BACKGROUND: Endogenous adenosine might cause or perpetuate bradyasystole. Our aim was to determine whether aminophylline, an adenosine antagonist, increases the rate of return of spontaneous circulation (ROSC) after out-of-hospital cardiac arrest. METHODS: In a double-blind trial, we randomly assigned 971 patients older than 16 years with asystole or pulseless electrical activity at fewer than 60 beats per minute, and who were unresponsive to initial treatment with epinephrine and atropine, to receive intravenous aminophylline (250 mg, and an additional 250 mg if necessary) (n=486) or placebo (n=485). The patients were enrolled between January, 2001 and September, 2003, from 1886 people who had had cardiac arrests. Standard resuscitation measures were used for at least 10 mins after the study drug was administered. Analysis was by intention-to-treat. This trial is registered with the ClinicalTrials.gov registry with the number NCT00312273. FINDINGS: Baseline characteristics and survival predictors were similar in both groups. The median time from the arrival of the advanced life-support paramedic team to study drug administration was 13 min. The proportion of patients who had an ROSC was 24.5% in the aminophylline group and 23.7% in the placebo group (difference 0.8%; 95% CI -4.6% to 6.2%; p=0.778). The proportion of patients with non-sinus tachyarrhythmias after study drug administration was 34.6% in the aminophylline group and 26.2% in the placebo group (p=0.004). Survival to hospital admission and survival to hospital discharge were not significantly different between the groups. A multivariate logistic regression analysis showed no evidence of a significant subgroup or interactive effect from aminophylline. INTERPRETATION: Although aminophylline increases non-sinus tachyarrhythmias, we noted no evidence that it significantly increases the proportion of patients who achieve ROSC after bradyasystolic cardiac arrest.

Tissue plasminogen activator in cardiac arrest with pulseless electrical activity.

BACKGROUND: Coronary thrombosis and pulmonary thromboembolism are common causes of cardiac arrest. We assessed whether the administration of tissue plasminogen activator (t-PA) during cardiopulmonary resuscitation would benefit patients with cardiac arrest and pulseless electrical activity of unknown or presumed cardiovascular cause. METHODS: Patients who were older than 16 years of age and who had more than one minute of pulseless electrical activity that was unresponsive to initial therapy outside the hospital or in the emergency department were eligible. Patients were randomly assigned to receive 100 mg of t-PA or placebo intravenously over a 15-minute period in a double-blind fashion. Standard resuscitation was then continued for at least 15 minutes. The primary outcome was survival to hospital discharge. RESULTS: During the study period, 1583 patients with cardiac arrest were treated and 233 patients were enrolled (117 in the t-PA group and 116 in the placebo group). The characteristics of the patients in the two groups were similar. One patient in the t-PA group survived to hospital discharge, as compared with none in the placebo group (absolute difference between groups, 0.9; 95 percent confidence interval, -2.6 to 4.8; P=0.99). The proportion of patients with return of spontaneous circulation was 21.4 percent in the t-PA group and 23.3 percent in the placebo group (absolute difference between groups, -1.9; 95 percent confidence interval, -12.6 to 8.8; P=0.85). CONCLUSIONS: We found no evidence of a beneficial effect of fibrinolysis in patients with cardiac arrest and pulseless electrical activity of unknown or presumed cardiovascular cause. Our study had limited statistical power, and it remains unknown whether there is a small treatment effect or whether selected subgroups may benefit.

The Canadian C-spine rule versus the NEXUS low-risk criteria in patients with trauma.

BACKGROUND: The Canadian C-Spine (cervical-spine) Rule (CCR) and the National Emergency X-Radiography Utilization Study (NEXUS) Low-Risk Criteria (NLC) are decision rules to guide the use of cervical-spine radiography in patients with trauma. It is unclear how the two decision rules compare in terms of clinical performance. METHODS: We conducted a prospective cohort study in nine Canadian emergency departments comparing the CCR and NLC as applied to alert patients with trauma who were in stable condition. The CCR and NLC were interpreted by 394 physicians for patients before radiography. RESULTS: Among the 8283 patients, 169 (2.0 percent) had clinically important cervical-spine injuries. In 845 (10.2 percent) of the patients, physicians did not evaluate range of motion as required by the CCR algorithm. In analyses that excluded these indeterminate cases, the CCR was more sensitive than the NLC (99.4 percent vs. 90.7 percent, P<0.001) and more specific (45.1 percent vs. 36.8 percent, P<0.001) for injury, and its use would have resulted in lower radiography rates (55.9 percent vs. 66.6 percent, P<0.001). In secondary analyses that included all patients, the sensitivity and specificity of CCR, assuming that the indeterminate cases were all positive, were 99.4 percent and 40.4 percent, respectively (P<0.001 for both comparisons with the NLC). Assuming that the CCR was negative for all indeterminate cases, these rates were 95.3 percent (P=0.09 for the comparison with the NLC) and 50.7 percent (P=0.001). The CCR would have missed 1 patient and the NLC would have missed 16 patients with important injuries. CONCLUSIONS: For alert patients with trauma who are in stable condition, the CCR is superior to the NLC with respect to sensitivity and specificity for cervical-spine injury, and its use would result in reduced rates of radiography.

Comparison of the Canadian CT Head Rule and the New Orleans Criteria in patients with minor head injury.

CONTEXT: Current use of cranial computed tomography (CT) for minor head injury is increasing rapidly, highly variable, and inefficient. The Canadian CT Head Rule (CCHR) and New Orleans Criteria (NOC) are previously developed clinical decision rules to guide CT use for patients with minor head injury and with Glasgow Coma Scale (GCS) scores of 13 to 15 for the CCHR and a score of 15 for the NOC. However, uncertainty about the clinical performance of these rules exists. OBJECTIVE: To compare the clinical performance of these 2 decision rules for detecting the need for neurosurgical intervention and clinically important brain injury. DESIGN, SETTING, AND PATIENTS: In a prospective cohort study (June 2000-December 2002) that included 9 emergency departments in large Canadian community and university hospitals, the CCHR was evaluated in a convenience sample of 2707 adults who presented to the emergency department with blunt head trauma resulting in witnessed loss of consciousness, disorientation, or definite amnesia and a GCS score of 13 to 15. The CCHR and NOC were compared in a subgroup of 1822 adults with minor head injury and GCS score of 15. MAIN OUTCOME MEASURES: Neurosurgical intervention and clinically important brain injury evaluated by CT and a structured follow-up telephone interview. RESULTS: Among 1822 patients with GCS score of 15, 8 (0.4%) required neurosurgical intervention and 97 (5.3%) had clinically important brain injury. The NOC and the CCHR both had 100% sensitivity but the CCHR was more specific (76.3% vs 12.1%, P<.001) for predicting need for neurosurgical intervention. For clinically important brain injury, the CCHR and the NOC had similar sensitivity (100% vs 100%; 95% confidence interval [CI], 96%-100%) but the CCHR was more specific (50.6% vs 12.7%, P<.001), and would result in lower CT rates (52.1% vs 88.0%, P<.001). The kappa values for physician interpretation of the rules, CCHR vs NOC, were 0.85 vs 0.47. Physicians misinterpreted the rules as not requiring imaging for 4.0% of patients according to CCHR and 5.5% according to NOC (P = .04). Among all 2707 patients with a GCS score of 13 to 15, the CCHR had sensitivities of 100% (95% CI, 91%-100%) for 41 patients requiring neurosurgical intervention and 100% (95% CI, 98%-100%) for 231 patients with clinically important brain injury. CONCLUSION: For patients with minor head injury and GCS score of 15, the CCHR and the NOC have equivalent high sensitivities for need for neurosurgical intervention and clinically important brain injury, but the CCHR has higher specificity for important clinical outcomes than does the NOC, and its use may result in reduced imaging rates.

Implementation of the Canadian C-Spine Rule: prospective 12 centre cluster randomised trial.

OBJECTIVE: To evaluate the effectiveness of an active strategy to implement the validated Canadian C-Spine Rule into multiple emergency departments. DESIGN: Matched pair cluster randomised trial. SETTING: University and community emergency departments in Canada. Participants 11 824 alert and stable adults presenting with blunt trauma to the head or neck at one of 12 hospitals. INTERVENTIONS: Six hospitals were randomly allocated to the intervention and six to the control. At the intervention sites, active strategies were used to implement the Canadian C-Spine Rule, including education, policy, and real time reminders on radiology requisitions. No specific intervention was introduced to alter the behaviour of doctors requesting cervical spine imaging at the control sites. MAIN OUTCOME MEASURE: Diagnostic imaging rate of the cervical spine during two 12 month before and after periods. RESULTS: Patients were balanced between control and intervention sites. From the before to the after periods, the intervention group showed a relative reduction in cervical spine imaging of 12.8% (95% confidence interval 9% to 16%; 61.7% v 53.3%; P=0.01) and the control group a relative increase of 12.5% (7% to 18%; 52.8% v 58.9%; P=0.03). These changes were significant when both groups were compared (P<0.001). No fractures were missed and no adverse outcomes occurred. CONCLUSIONS: Implementation of the Canadian C-Spine Rule led to a significant decrease in imaging without injuries being missed or patient morbidity. Final imaging rates were much lower at intervention sites than at most US hospitals. Widespread implementation of this rule could lead to reduced healthcare costs and more efficient patient flow in busy emergency departments worldwide. TRIAL REGISTRATION: Clinical trials NCT00290875.

The Canadian C-spine rule performs better than unstructured physician judgment.

STUDY OBJECTIVES: We compare the predictive accuracy of emergency physicians' unstructured clinical judgment to the Canadian C-Spine rule. METHODS: This prospective multicenter cohort study was conducted at 10 Canadian urban academic emergency departments. Included in the study were alert, stable, adult patients with a Glasgow Coma Scale score of 15 and trauma to the head or neck. This was a substudy of the Canadian C-Spine and CT Head Study. Eligible patients were prospectively evaluated before radiography. Physicians estimated the probability of unstable cervical spine injury from 0% to 100% according to clinical judgment alone and filled out a data form. Interobserver assessments were done when feasible. Patients underwent cervical spine radiography or follow-up to determine clinically important cervical spine injuries. Analyses included comparison of areas under the receiver operating characteristic (ROC) curve with 95% confidence intervals (CIs) and the kappa coefficient. RESULTS: During 18 months, 6265 patients were enrolled. The mean age was 36.6 years (range 16 to 97 years), and 50.1% were men. Sixty-four (1%) patients had a clinically important injury. The physicians' kappa for a 0% predicted probability of injury was 0.46 (95% CI 0.28 to 0.65). The respective areas under the ROC curve for predicting cervical spine injury were 0.85 (95% CI 0.80 to 0.89) for physician judgment and 0.91 (95% CI 0.89 to 0.92) for the Canadian C-Spine rule (P <.05). With a threshold of 0% predicted probability of injury, the respective indices of accuracy for physicians and the Canadian C-Spine rule were sensitivity 92.2% versus 100% (P <.001) and specificity 53.9% versus 44.0% (P <.001). CONCLUSION: Interobserver agreement of unstructured clinical judgment for predicting clinically important cervical spine injury is only fair, and the sensitivity is unacceptably low. The Canadian C-Spine rule was better at detecting clinically important injuries with a sensitivity of 100%. Prospective validation has recently been completed and should permit widespread use of the Canadian C-Spine rule.