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Supplemental material, SupplTableAndAppendixRev3Jan25-2018 for Reducing High-Users’ Visits to the Emergency Department by a Primary Care Intervention for the Uninsured: A Retrospective Study by Meng-Han Tsai, Sudha Xirasagar, Scott Carroll, Charles S. Bryan, Pamela J. Gallagher, Kim Davis, and Edward C. Jauch in INQUIRY: The Journal of Health Care Organization, Provision, and Financing

Supplemental material, Appendix for Alteplase for the treatment of acute ischemic stroke in patients with low National Institutes of Health Stroke Scale and not clearly disabling deficits (Potential of rtPA for Ischemic Strokes with Mild Symptoms PRISMS): Rationale and design by Sharon D Yeatts, Joseph P Broderick, Anjan Chatterjee, Edward C Jauch, Steven R Levine, Jose G Romano, Jeffrey L Saver, Achala Vagal, Barbara Purdon, Jenny Devenport and Pooja Khatri in International Journal of Stroke

INTRODUCTION: In studies on aneurysmal subarachnoid hemorrhage (SAH), substantial variability exists in the use and timing of outcomes and endpoints, which complicates interpretation and comparison of results between studies. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke/National Library of Medicine Unruptured Intracranial Aneurysm (UIA) and SAH common data elements (CDE) Project was to provide a common structure for future UIA and SAH research. METHODS: This article summarizes the recommendations of the UIA and SAH CDE Outcomes and Endpoints subgroup, which consisted of an international and multidisciplinary ad hoc panel of experts in clinical outcomes after SAH. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the SAH literature. Recommendations for CDEs were classified by priority into "Core," "Supplemental-Highly Recommended," "Supplemental," and "Exploratory." RESULTS: The subgroup identified over 50 outcomes measures and template case report forms (CRFs) to be included as part of the UIA and SAH CDE recommendations. None was classified as "Core". The modified Rankin Scale score and Montreal Cognitive Assessment were considered the preferred outcomes and classified as Supplemental-Highly Recommended. Death, Glasgow Outcome Scale score, and Glasgow Outcome Scale-extended were classified as Supplemental. All other outcome measures were categorized as "Exploratory". We propose outcome assessment at 3 months and at 12 months for studies interested in long-term outcomes. We give recommendations for standardized dichotomization. CONCLUSION: The recommended outcome measures and CRFs have been distilled from a broad pool of potentially useful CDEs, scales, instruments, and endpoints. The adherence to these recommendations will facilitate the comparison of results across studies and meta-analyses of individual patient data.

Treatment for acute ischemic stroke must be initiated within hours of stroke symptom onset, and the sooner it is administered, the better. In South Carolina, 76% of the population can access expert stroke care, and rural hospitals may provide specialized treatment using telemedicine, but many stroke sufferers seek care too late to achieve full benefit. Using a community-engaged approach in a southern rural community, we explored barriers and facilitators to early stroke care and implications for improvement. The Community-Engaged Assessment to facilitate Stroke Elimination (CEASE) study was guided by a community advisory group to ensure community centeredness and local relevance. In a qualitative descriptive study, eight focus groups were conducted including 52 individuals: recent stroke survivors, family members, emergency medical personnel, hospital emergency department staff, primary care providers, and community leaders. From analysis of focus group transcripts came six themes: lack of trust in healthcare system and providers; weak relationships fueled by poor communication; low health literacy; financial limitations related to health care; community-based education; and faith as a message of hope. A hierarchy model for improving early community-based stroke care was developed through consensus dialogue by community representatives and the research team. This model can be used to inform a community-partnered, stakeholder-informed intervention to improve stroke care in a rural southern community with the goal of improving stroke education, care, and outcome. © 2016 Wiley Periodicals, Inc.

Meaningful delays occurred in the Interventional Management of Stroke (IMS) III trial. Analysis of the work flow will identify factors contributing to the in-hospital delays.In the endovascular arm of the IMS III trial, the following time intervals were calculated: stroke onset to emergency department arrival; emergency department to computed tomography (CT); CT to intravenous tissue plasminogen activator start; intravenous tissue plasminogen activator start to randomization; randomization to groin puncture; groin puncture to thrombus identification; thrombus identification to start of endovascular therapy; and start of endovascular therapy to reperfusion. The effects of enrollment time, CT angiography use, interhospital transfers, and intubation on work flow were evaluated. Delays occurred notably in the time intervals from intravenous tissue plasminogen activator initiation to groin puncture (median 84 minutes) and start of endovascular therapy to reperfusion (median 85 minutes). The CT to groin puncture time was significantly shorter during working hours than after. Times from emergency department to reperfusion and groin puncture to reperfusion decreased over the trial period. Patients with CT angiography had shorter emergency department to reperfusion and onset to reperfusion times. Transfer of patients resulted in a longer onset to reperfusion time compared with those treated in the same center. Age, sex, National Institutes of Health Stroke Scale score, and intubation did not affect delays.Important delays were identified before reperfusion in the IMS III trial. Delays decreased as the trial progressed. Use of CT angiography and endovascular treatment in the same center were associated with time savings. These data may help in optimizing work flow in current and future endovascular trials.http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Stroke is the fourth leading cause of death in the United States, and its incidence is especially high in South Carolina. Recombinant tissue plasminogen activator (rtPA) has been given to patients with acute ischemic stroke since 1996 and has shown overall improved outcomes relative to patients who are not treated with rtPA.A 1998 study by Fagan and colleagues reported the economic impact of the use of rtPA. The purpose of this current article is to present an updated economic analysis of the impact of rtPA.In the current analysis, an updated estimate of the economic and health benefits of treatment with rtPA in South Carolina was provided using estimates of cost, incidence, and course of treatment from several data sources. The Markov model in the 1998 study was used as a guide in this current study; we sought to replicate the methodology, while providing updated economic figures and applying it to the state of South Carolina. We estimated the costs per 1000 patients who are eligible for treatment with rtPA compared with 1000 untreated patients, as well as routine medical practice and outcomes of quality-adjusted life-years (QALYs) and economic costs based on whether a patient was treated with rtPA or not. We calculated the number of stroke cases that would be treated with rtPA if the rate were to increase from 3% to 20%, using the most recent number of strokes in South Carolina and prorating for 5 years to estimate the total expected cost-savings with increased rtPA use.The results indicate that the use of rtPA in South Carolina accounts for a cost-savings of $3454 per treated patient over a 6-year period. The model estimates an increase of 0.425 QALYs (or 5.1 quality-adjusted months) of survival per patient treated with rtPA. Over the lifetime of a treated patient, the estimated cost-savings are $4084, with an accrued health benefit of 0.692 QALYs (or 8.3 quality-adjusted months). For every 100 patients treated with rtPA, there is a gain of 69.17 QALYs and of $408,419 over the lifetime of 100 treated patients with acute ischemic stroke. We calculated that the cost-savings gained by increasing the rtPA treatment rate in a state with a high incidence of stroke from the current 3% rate to an achievable 20% rate over a 5-year period would be $16,615,723.This new analysis demonstrates a significant savings associated with the use of rtPA for patients with stroke and provides great support for the increased systematic use of rtPA in the state of South Carolina for patients with acute ischemic stroke. For every additional 100 patients who are treated with rtPA in South Carolina, a robust savings supports the wider economic benefit that would be gained with an increased use of rtPA.

Sex is suggested to be an important determinant of ischemic stroke risk factors, etiology, and outcome. However, the basis for this remains unclear. The Y chromosome is unique in males. Genes expressed in males on the Y chromosome that are associated with stroke may be important genetic contributors to the unique features of males with ischemic stroke, which would be helpful for explaining sex differences observed between men and women.We compared Y chromosome gene expression in males with ischemic stroke and male controls.Blood samples were obtained from 40 male patients ≤3, 5, and 24 hours after ischemic stroke and from 41 male controls (July 2003-April 2007). RNA was isolated from blood and was processed using Affymetrix Human U133 Plus 2.0 expression arrays (Affymetrix Inc., Santa Clara, California). Y chromosome genes differentially expressed between male patients with stroke and male control subjects were identified using an ANCOVA adjusted for age and batch. A P0.05 and a fold change1.2 were considered significant.Seven genes on the Y chromosome were differentially expressed in males with ischemic stroke compared with controls. Five of these genes (VAMP7, CSF2RA, SPRY3, DHRSX, and PLCXD1) are located on pseudoautosomal regions of the human Y chromosome. The other 2 genes (EIF1AY and DDX3Y) are located on the nonrecombining region of the human Y chromosome. The identified genes were associated with immunology, RNA metabolism, vesicle fusion, and angiogenesis.Specific genes on the Y chromosome are differentially expressed in blood after ischemic stroke. These genes provide insight into potential molecular contributors to sex differences in ischemic stroke.

The pivotal National Institute of Neurological Disorders and Stroke recombinant tissue plasminogen activator trials excluded patients with ischemic stroke with specific minor presentations or rapidly improving symptoms. The recombinant tissue plasminogen activator product label notes that its use for minor neurological deficit or rapidly improving stroke symptoms has not been evaluated. As a result, patients with low National Institutes of Health Stroke Scale scores are not commonly treated in clinical practice. We sought to further characterize the patients with minor stroke who were included in the National Institute of Neurological Disorders and Stroke trials.Minor strokes were defined as National Institutes of Health Stroke Scale score ≤ 5 at baseline for this retrospective analysis, because this subgroup is most commonly excluded from treatment in clinical practice and trials. Clinical stroke syndromes were defined based on prespecified National Institutes of Health Stroke Scale item score clusters. Clinical outcomes were reviewed generally and within these cluster subgroups.Only 58 cases had National Institutes of Health Stroke Scale scores of 0 to 5 in the National Institute of Neurological Disorders and Stroke trials (42 recombinant tissue plasminogen activator and 16 placebo), and 2971 patients were excluded from the trials due to "rapidly improving" or "minor symptoms" as the primary reason. No patients were enrolled with isolated motor symptoms, isolated facial droop, isolated ataxia, dysarthria, isolated sensory symptoms, or with only symptoms/signs not captured by the National Institutes of Health Stroke Scale score (ie, National Institutes of Health Stroke Scale=0). There were ≤ 3 patients with each of the other isolated deficits enrolled in the trial.The National Institute of Neurological Disorders and Stroke trials excluded a substantial number of strokes with minor presentations, those that were included were small in number, and conclusions about outcomes based on specific syndromes cannot be drawn. Further prospective, systematic study of this subgroup is needed.