Shirley M. Frederiksen

Multicenter prospective validation of prehospital clinical spinal clearance criteria.

BACKGROUND Spine immobilization is one of the most frequently performed prehospital procedures. If trauma patients without significant risk for spine injury complications can be identified, spine immobilization could be selectively performed. The purpose of this study was to evaluate five prehospital clinical criteria-altered mental status, neurologic deficit, spine pain or tenderness, evidence of intoxication, or suspected extremity fracture-the absence of which identify prehospital trauma patients without a significant spine injury. METHODS Prospectively collected emergency medical services data items included the above-listed criteria. Outcome data include spine fracture or cord injury, and also the level and management of injuries. RESULTS A total of 295 patients with spine injuries were present in 8,975 (3.3%) cases. Spine injury was identified by the prehospital criteria in 280 of 295 (94.9%) injured patients. The criteria missed 15 patients. Thirteen of 15 had stable injuries, the majority of which were stable compression or vertebral process injuries. The remaining two would have been captured by more accurate prehospital evaluation. CONCLUSION Absence of the study criteria may form the basis of a prehospital protocol that could be used to identify trauma patients who may safely have rigid spine immobilization withheld. Evaluation of such a protocol in practice should be performed.

Health status, not head injury, predicts concussion symptoms after minor injury.

OBJECTIVE Postconcussion (PC) syndrome etiology remains poorly understood. We sought to examine predictors of persistent PC symptoms after minor injury. METHODS Health status, symptom, and injury information were obtained on a sample of patients presenting to the emergency department after minor injury. Postconcussion and cognitive symptoms were assessed at 1, 3, and 12 months. RESULTS Among 507 patients enrolled, 339 had head injury. Repeated-measures logistic regression modeling of PC and cognitive symptom presence across time indicated that baseline mental health status and physical health status were most predictive of persistent symptoms. In contrast, head injury presence did not predict persistent PC syndrome. DISCUSSION Baseline mental health status and physical health status were associated with persistent PC syndrome after minor injury, but head injury status was not. Further studies of PC syndrome pathogenesis are needed.

Prevalence of Atrial Fibrillation and Antithrombotic Prophylaxis in Emergency Department Patients

Background and Purpose— The emergency department (ED), as the point of first medical contact for many complaints referable to atrial fibrillation (AF) and a common source of primary care, occupies a unique position to identify AF patients at risk of stroke. This study evaluates that potential by determining the prevalence of AF in an ED population and assessing antithrombotic use in those patients with recurrent AF. Methods— This was a multicenter, retrospective, cross-sectional study of consecutive records of ED patients with AF identified by ECG between January and June 1998. American Heart Association and modified Stroke Prevention in Atrial Fibrillation criteria established high-risk patients and contraindications to anticoagulation, respectively. Results— We identified 866 records with ECG-proven AF in 78 787 patient visits for an estimated prevalence of 1.10% (95% CI, 1.03 to 1.17). We found that 556 records had a prior history of AF; of these, 221 (40%) used warfarin alone, 155 (28%) had antiplatelet therapy alone, 28 (5%) used both, and 152 (27%) had no antithrombotic therapy identified. Sixty-eight patients (12%; 95% CI, 0.10 to 0.15) were warfarin eligible and without antithrombotic therapy. An additional 64 (12%; 95% CI, 0.09 to 0.14) had antiplatelet therapy alone. In warfarin-eligible patients, no differences were identified between the anticoagulated and nonanticoagulated groups on the basis of age, sex, or race. Of patients on warfarin with a measured international normalized ratio, 61% (95% CI, 0.55 to 0.67) were outside the AHA-recommended range of 2.0 to 3.0. Conclusions— AF is a common finding in an ED population. Many are warfarin eligible and untreated or undertreated. Methods to increase anticoagulant use in this at-risk population warrant further investigation.

A multilevel intervention to increase community hospital use of alteplase for acute stroke (INSTINCT): a cluster-randomised controlled trial

BACKGROUND Use of alteplase improves outcome in some patients with stroke. Several types of barrier frequently prevent its use. We assessed whether a standardised, barrier-assessment, multicomponent intervention could increase alteplase use in community hospitals in Michigan, USA. METHODS In a cluster-randomised controlled trial, we selected adult, non-specialty, acute-care community hospitals in the Lower Peninsula of Michigan, USA. Eligible hospitals discharged at least 100 patients who had had a stroke per year, had less than 100 000 visits to the emergency department per year, and were not academic comprehensive stroke centres. Using a computer-generated randomisation sequence, we selected 12 matched pairs of eligible hospitals. Within pairs, the hospitals were allocated to intervention or control groups with restricted randomisation in January, 2007. Between January, 2007, and December, 2007, intervention hospitals implemented a multicomponent intervention that included qualitative and quantitative assessment of barriers to alteplase use and ways to address the findings, and provided additional support. The primary outcome was change in alteplase use in patients with stroke in emergency departments between the pre-intervention period (January, 2005, to December, 2006) and the post-intervention period (January, 2008, to January, 2010). Physicians in participating hospitals and the coordinating centre could not be masked to group assignment, but were masked to progress made in paired control hospitals. External medical reviewers who were masked to group assignment assessed outcomes. We did intention-to-treat (ITT) and target-population (without one pair that was excluded after randomisation) analyses. This trial is registered at ClinicalTrials.gov, number NCT00349479. FINDINGS All 24 hospitals completed the study. Overall, 745 of 40 823 patients with stroke received intravenous alteplase treatment. In the ITT analysis, the proportion of patients with stroke who were admitted and treated with alteplase increased between the pre-intervention and post-intervention periods in intervention hospitals (89 [1·25%] of 7119 patients to 235 [2·79%] of 8419) to a greater extent than in control hospitals (99 [1·25%] of 7946 to 194 [2·10%] of 9222), but the difference between groups was not significant (relative risk [RR] 1·37, 95% CI 0·96-1·93; p=0·08). In the target-population analysis, the increase in alteplase use in intervention hospitals (59 [1·00%] of 5882 to 191 [2·62%] of 7288) was significantly greater than in control hospitals (65 [1·09%] of 5957 to 120 [1·72%] of 6989; RR 1·68, 95% CI 1·09-2·57; p=0·02), but was still clinically modest. INTERPRETATION The intervention did not significantly increase alteplase use in patients with ischaemic stroke. The increase in use of alteplase in the target population was significant, but smaller than the effect to which the study was powered. Additional strategies to increase acute stroke treatment are needed. FUNDING National Institutes of Health National Institute of Neurological Disorders and Stroke.

Provider perceptions of barriers to the emergency use of tPA for Acute Ischemic Stroke: A qualitative study

BackgroundOnly 1-3% of ischemic stroke patients receive thrombolytic therapy. Provider barriers to adhering with guidelines recommending tPA delivery in acute stroke are not well known. The main objective of this study was to describe barriers to thrombolytic use in acute stroke care.MethodsTwenty-four hospitals were randomly selected and matched into 12 pairs. Barrier assessment occurred at intervention sites only, and utilized focus groups and structured interviews. A pre-specified taxonomy was employed to characterize barriers. Two investigators independently assigned themes to transcribed responses. Seven facilitators (three emergency physicians, two nurses, and two study coordinators) conducted focus groups and interviews of emergency physicians (65), nurses (62), neurologists (15), radiologists (12), hospital administrators (12), and three others (hospitalists and pharmacist).ResultsThe following themes represented the most important external barriers: environmental and patient factors. Important barriers internal to the clinician included familiarity with and motivation to adhere to the guidelines, lack of self-efficacy and outcome expectancy. The following themes were not substantial barriers: lack of awareness of the existence of acute stroke guidelines, presence of conflicting guidelines, and lack of agreement with the guidelines.ConclusionsHealthcare providers perceive environmental and patient-related factors as the primary barriers to adherence with acute stroke treatment guidelines. Interventions focused on increasing physician familiarity with and motivation to follow guidelines may be of highest yield in improving adherence. Improving self-efficacy in performing guideline concordant care may also be useful.Trial RegistrationClinicalTrials.gov identifier: NCT00349479

An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project.

Randomized clinical trials, which aim to determine the efficacy and safety of drugs and medical devices, are a complex enterprise with myriad challenges, stakeholders, and traditions. Although the primary goal is scientific discovery, clinical trials must also fulfill regulatory, clinical, and ethical requirements. Innovations in clinical trials methodology have the potential to improve the quality of knowledge gained from trials, the protection of human subjects, and the efficiency of clinical research. Adaptive clinical trial methods represent a broad category of innovations intended to address a variety of long-standing challenges faced by investigators, such as sensitivity to previous assumptions and delayed identification of ineffective treatments. The implementation of adaptive clinical trial methods, however, requires greater planning and simulation compared with a more traditional design, along with more advanced administrative infrastructure for trial execution. The value of adaptive clinical trial methods in exploratory phase (phase 2) clinical research is generally well accepted, but the potential value and challenges of applying adaptive clinical trial methods in large confirmatory phase clinical trials are relatively unexplored, particularly in the academic setting. In the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) project, a multidisciplinary team is studying how adaptive clinical trial methods could be implemented in planning actual confirmatory phase trials in an established, National Institutes of Health-funded clinical trials network. The overarching objectives of ADAPT-IT are to identify and quantitatively characterize the adaptive clinical trial methods of greatest potential value in confirmatory phase clinical trials and to elicit and understand the enthusiasms and concerns of key stakeholders that influence their willingness to try these innovative strategies.

Attitudes and Beliefs of Michigan Emergency Physicians Toward Tissue Plasminogen Activator Use in Stroke Baseline Survey Results From the INcreasing Stroke Treatment through INteractive behavioral Change Tactic (INSTINCT) Trial Hospitals

Objective To determine baseline proportion of emergency physicians with favorable attitudes and beliefs toward IV tPA use in a cohort of randomly selected Michigan hospitals.Background and Purpose— The objective of this study was to determine the baseline proportion of emergency physicians with favorable attitudes and beliefs toward intravenous tissue plasminogen activator (tPA) use in a cohort of randomly selected Michigan hospitals. Methods— Two hundred seventy-eight emergency physicians from 24 hospitals were surveyed. A confidential, self-administered, pilot-tested survey assessing demographics, practice environment, attitudes, and beliefs regarding tPA use in stroke was used. Main outcome measures assessed belief in a legal standard of care, likelihood of use in an ideal setting, comfort in use without a specialist consultation, and belief that science on tPA use is convincing. ORs with robust 95% CIs (adjusted for clustering) were calculated to quantify the association between responses and physician- and hospital-level characteristics. Results— One hundred ninety-nine surveys completed (gross response rate 71.6%). Ninety-nine percent (95% CI: 97.8 to 100) indicated use of tPA in eligible patients represented either acceptable or ideal patient care. Twenty-seven percent (95% CI: 21.7 to 32.3) indicated use of tPA represented a legal standard of care. Eighty-three percent (95% CI: 78.5 to 87.5) indicated they were “likely” or “very likely” to use tPA given an ideal setting. When asked about using tPA without a consultation, 65% (95% CI: 59.3 to 70.7) indicated they were uncomfortable. Forty-nine percent (95% CI: 43.0 to 55.0) indicated the science regarding use of tPA in stroke is convincing with 30% remaining neutral. Characteristics associated with favorable attitudes included non-emergency medicine board certification; older age, and a smaller hospital practice environment. Conclusions— In this cohort, emergency physician attitudes and beliefs toward intravenous tPA use in stroke are considerably more favorable than previously reported.

Baseline Predictors of Fatigue 1 Year After Mild Head Injury

OBJECTIVE To compare reports of fatigue 12 months after minor trauma by participants with mild head injury (MHI) with those with other injury, and identify injury and baseline predictors of fatigue. DESIGN An inception cohort study of participants with MHI and other nonhead injuries recruited from and interviewed at the emergency department (ED), with a follow-up telephone interview at 12 months. SETTING Level II community hospital ED. PARTICIPANTS Participants (n=58) with MHI and loss of consciousness (LOC) of 30 minutes or less and/or posttraumatic amnesia (PTA) less than 24 hours, 173 with MHI but no PTA/LOC, and 128 with other mild nonhead injuries. INCLUSION CRITERIA age 18 years or older, within 24 hours of injury, Glasgow Coma Scale score of 13 or higher, and discharge from the ED. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURE Medical Outcomes Study 36-Item Short-Form Health Survey Vitality subscale. RESULTS Significant predictors of fatigue severity at 12 months were baseline fatigue, having seen a counselor for a mental health issue, medical disability, marital status, and in some stage of litigation. Injury type was not a significant predictor. CONCLUSIONS Fatigue severity 12 months after injury is associated with baseline characteristics and not MHI. Clinicians should be cautious about attributing persisting fatigue to MHI without comprehensive consideration of other possible etiologic factors.

Safety of Intravenous Thrombolytic Use in Four Emergency Departments Without Acute Stroke Teams

OBJECTIVES The objective was to evaluate safety of intravenous (IV) tissue plasminogen activator (tPA) delivered without dedicated thrombolytic stroke teams. METHODS This was a retrospective, observational study of patients treated between 1996 and 2005 at four southeastern Michigan hospital emergency departments (EDs) with a prospectively defined comparison to the National Institute of Neurological Disorders and Stroke (NINDS) tPA stroke study cohort. Main outcome measures were mortality, intracerebral hemorrhage (ICH), systemic hemorrhage, neurologic recovery, and guideline violations. RESULTS A total of 273 consecutive stroke patients were treated by 95 emergency physicians (EPs) using guidelines and local neurology resources. One-year mortality was 27.8%. Unadjusted Cox model relative risk (RR) of mortality compared to the NINDS tPA treatment and placebo groups was 1.20 (95% confidence interval [CI] = 0.87 to 1.64) and 1.04 (95% CI = 0.76 to 1.41), respectively. The rate of significant ICH by computed tomography (CT) criteria was 6.6% (odds ratio [OR] = 1.03, 95% CI = 0.56 to 1.90 compared to the NINDS tPA treatment group). The proportions of symptomatic ICH by two other prespecified sets of clinical criteria were 4.8 and 7.0%. The rate of any ICH within 36 hours of treatment was 9.9% (RR = 0.94, 95% CI = 0.58 to 1.51 compared to the NINDS tPA group). The occurrence of major systemic hemorrhage (requiring transfusion) was 1.1%. Functional recovery by the modified Rankin Scale score (mRS = 0 to 2) at discharge occurred in 38% of patients with a premorbid disability mRS < 2. Guideline deviations occurred in the ED in 26% of patients and in 25% of patients following admission. CONCLUSIONS In these EDs there was no evidence of increased risk with respect to mortality, ICH, systemic hemorrhage, or worsened functional outcome when tPA was administered without dedicated thrombolytic stroke teams. Additional effort is needed to improve guideline compliance.

Lack of association between hyperglycaemia at arrival and clinical outcomes in acute stroke patients treated with tissue plasminogen activator

Rationale Hyperglycaemia is associated with adverse outcomes in some studies of acute ischaemic stroke. Aims We hypothesised that in thrombolytic-treated stroke patients, hyperglycaemia would be independently associated with haemorrhagic transformation and unfavourable outcome. Design Consecutive rt-PA-treated acute ischaemic stroke patients presenting to four emergency departments were analysed. Associations of initial blood glucose and survival to hospital discharge, symptomatic intracerebral haemorrhage, any form of intracerebral haemorrhage, and disability at hospital discharge were determined. Potentially confounding factors of age, National Institutes of Health Stroke Scale, and smoking were analysed by univariate logistic regression and those with P<0·3 included in the multivariate model. Study Outcome In 268 patients, initial glucose values ranged from 62 to 507mg/dl (mean 131). Elevated glucose at arrival was not significantly associated with any adverse clinical outcomes. A trend towards higher mortality in hyperglycae-mic patients (odds ratio 1·71 per 100mg/dl increase in glucose, 95% confidence interval 0·92–3·13, P = 0·08) was seen, but is of unclear significance, and was not corroborated by effects on discharge disability, symptomatic intracerebral haemorrhage or intracerebral haemorrhage. Conclusions Thrombolytic-treated stroke patients with hyperglycaemia at presentation did not have significantly worse outcomes than others in this cohort. These data fail to confirm previously described associations seen in similarly sized studies. Further study of these associations and their magnitude are necessary to better define the relationship between serum glucose and outcome in thrombolytic-treated acute ischaemic stroke.