Abstract WMP66: Enrollment in a Pre-hospital Stroke Trial: Common Reasons for Patient Non- Enrollment

Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Randy Sanoff ◽  
Samantha B Cherin ◽  
Joan Krause ◽  
Fiona Chatfield ◽  
Nerses Sanossian ◽  
...  
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Outcome Evaluation ◽  
Phase 3 ◽  
Stroke Treatment ◽  
Spanish Speaking ◽  
Promising Strategy ◽  
Stroke Trial

Background: Enrolling patients in the field is a promising strategy to facilitate entry of subjects within the first 1 to 2 hours after symptom onset into clinical trials for acute stroke treatment. The Field Administration of Stroke Therapy Magnesium (FAST-MAG) Trial is the first multicenter study to implement eliciting informed consent by cell phone between patients or their legally authorized representatives (LARs) and off- site enrolling physician-investigators. Call yield and profile of screen failures observed over the course of the study are reported. Methods: FAST-MAG is a phase 3 trial to evaluate field-initiated magnesium sulfate as a neuroprotective agent to improve the long-term functional outcome in acute stroke. The outcomes of these attempted enrollment calls from 362 participating ambulances to the eight central English and Spanish-speaking enrolling physician-investigators were tracked prospectively from 1/2012 to 1/2005. Results: Over seven years, 3,726 calls were made to enrolling physicians. Of these, 1478 (40%) resulted in trial enrollments. Among 2248 non-enrollment calls, the five most common reasons for were: physician’s determination of last known well time was longer than two hours (19%), pre-existing condition which could confound outcome evaluation (18%), patient deemed not competent to provide informed consent and no LAR available (12%), rapidly improving neurological deficit (9%), patient not English or Spanish speaking (6%). Phone connection difficulties accounted for only 2.7% of screen failures, whereas 4.2% were competent patients and 11% were LARs refusing participation. Yearly enrollment yeilds did not change significantly throughout the study Conclusion: Two of every five calls from the field to FM enrolling physicians resulted in trial enrollment. Enrollment yields were consistent throughout the study.

Abstract 70: Importance of Both Self-consent and Proxy- consent Enrollments to Avoid Bias in Acute Stroke Randomized Trials

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Kristina Shkirkova ◽  
Nelson Wu ◽  
Sidney Starkman ◽  
Nerses Sanossain ◽  
Scott Hamilton ◽  
...  
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Randomized Trials ◽  
Proxy Consent ◽  
Long Term Outcomes ◽  
Stroke Population ◽  
Acute Cerebral Ischemia ◽  
Hemorrhage Volume ◽  
Artery Disease

Background: Informed consent options for acute stroke randomized trials include self-consent from patients with retained competency, proxy consent from a legally authorized representative (LAR), and exception from informed consent in emergency circumstances (EFIC). Mechanisms other than self-consent trespass upon the ethical principle of autonomy (respect for persons), and should be used only if self-consent alone would bias the patient population. Methods: We analyzed acute stroke patients enrolled within 2h of symptom onset in the NIH Phase 3 Field Administration of Stroke Therapy - Magnesium (FAST-MAG) trial, comparing entry characteristics and outcomes with different consent mechanisms. Results: Among 1700 patients, median time from onset to study entry was 45 min (IQR 35-62). Overall, 60% of patients were competent and provided self-consent, 39% noncompetent and enrolled by proxy consent from an on-scene LAR, and 1% noncompetent enrolled using EFIC/delayed consent. Compared to self-consented patients, proxy-consented patients were: older, 73.8 vs 66.5, p<0.001; more often female, 47% vs 40%, p<0.02; and a higher frequency of several vascular risk factors, including hypertension, 81% vs 76%, p<0.05, diabetes, 26% vs20%, p<0.01, atrial fibrillation, 29% vs 17%, p<0.001, and coronary artery disease, 24% vs 19%, p<0.01. Proxy consent patients had more severe initial stroke deficits, prehospital LAMS, 4.1 vs 3.5, p<0.001. Proxy consent patients with acute cerebral ischemia had more advanced initial ischemic stroke lesions, ASPECTS 8.3 vs 9.3, p<0.001, and received tPA more often, 35% vs 20%, p<0.001. Proxy consent patients with intracerebral hemorrhage patient had larger initial hemorrhage volume (cc), 42.2 vs 22.6, p<0.001. Proxy consent patients had worse final outcomes, with freedom from disability (mRS 0-1) at 90d, 23.6% vs 44.3%, p<0.001. Conclusions: Proxy-informed consent patients differ systematically from self-consent patients, with older age, more comorbidities, more severe deficits, and worse long term outcomes. To ensure that acute stroke trial cohorts are representative of the general stroke population, it is important that enrollment mechanisms include proxy and/or deferred consent.

scholarly journals Young women’s stroke etiology differs from that in young men: an analysis of 511 patients

2013 ◽  
Vol 5 (3) ◽  
pp. 12 ◽  
Author(s):  
Emily Nakagawa ◽  
Michael Hoffmann
Keyword(s):  
Acute Stroke ◽  
Small Vessel Disease ◽  
Stroke Treatment ◽  
Stroke Registry ◽  
Stroke Etiology ◽  
Scale Scores ◽  
Acute Stroke Treatment ◽  
Undetermined Etiology ◽  
Toast Classification

Women are known to have particular heterogeneity in stroke etiology related to childbearing and hormonal factors. Although there are continued acute stroke treatment advances focusing on clot dissolution or extraction, effective secondary prevention of stroke, however, is dependent on an accurate etiological determination of the stroke. Otherwise, more strokes are likely to follow. Analysis of young women’s stroke etiology in a large stroke registry incorporating contemporary neurovascular and parenchymal imaging and cardiac imaging. Young people (18-49 years old) with stroke were consecutively accrued over a 4 year period and an investigative protocol prospectively applied that incorporated multimodality magnetic resonance imaging, angiography, cardiac echo and stroke relevant blood investigations. All patients were classified according to an expanded Trial of Org 10172 in Acute Stroke Treatment − TOAST − classification and neurological deficit by the National Institute of Health stroke admission scores. In 511 registry derived, young stroke patients (mean age 39.8 years, 95% confidence interval: 39.1; 40.7 years), gender (women n=269, 53%) the etiological categories (women; men) included: i) small vessel disease (30/55;25/55), ii) cardioembolic (16/42;26/42), iii) large vessel cervical and intracranial disease (24/43;19/43), the <em>other category</em> (132/226; 91/226), which included, iv) substance abuse (15/41; 26/41, 4.6), v) prothrombotic states (22/37;15/37), vi) dissection (11/30;19/30), vii) cerebral venous thrombosis (15/19; 4/19, 12.4), viii) vasculitis (8/12; 4/12), ix) migraine related (10/11, 1/11) and x) miscellaneous vasculopathy (38/52;14/52). The latter entities comprised of aortic arch atheroma, vessel redundancy syndrome, vertebrobasilar hypoplasia, arterial fenestrations and dolichoectasia. Some conditions occurred solely in women, such as eclampsia (5), Call Fleming syndrome (4), fibromuscular dysplasia (3) and Moya Moya syndrome (2). Categories aside from bland infarction included: ii) intracerebral hemorrhage (43/106; 63/106) and xiii) stroke of undetermined etiology (6/10; 4/10). Admission mean National Institute of Health Stroke Scale scores differed significantly between women and men (4.7; 6.0 t=1.8, P=0.03). Young women’s stroke is significantly different from men in 7/12 stroke etiological categories in addition to 4 unique subtypes that require specific management.

Abstract TP289: Legal Authorized Representative Feedback on the use of Smartphone Platform for Electronic Informed Consent in an Acute Stroke Trial

Stroke ◽  
2019 ◽  
Vol 50 (Suppl_1) ◽  
Author(s):  
Diogo C Haussen ◽  
Leah Craft ◽  
Shannon Doppelheuer ◽  
Kiva Schindler ◽  
Gabriel M Rodrigues ◽  
...  
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Stroke Trial

scholarly journals Deferred Consent in an Acute Stroke Trial from a Patient, Proxy, and Physician Perspective: A Cross-Sectional Survey

2021 ◽  
Author(s):  
Inez Koopman ◽  
Dagmar Verbaan ◽  
W. Peter Vandertop ◽  
Rieke van der Graaf ◽  
Erwin J. O. Kompanje ◽  
...  
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Acute Care ◽  
Scientific Research ◽  
Future Research ◽  
Willingness To Participate ◽  
Deferred Consent ◽  
Consent Procedure ◽  
Trust In Physicians ◽  
Stroke Trial

Abstract Background In some acute care trials, immediate informed consent is not possible, but deferred consent is often considered problematic. We investigated the opinions of patients, proxies, and physicians about deferred consent in an acute stroke trial to gain insight into its acceptability and effects. Methods Paper-based surveys were sent to patients who were randomly assigned in the Ultra-early Tranexamic Acid After Subarachnoid Hemorrhage (ULTRA) trial between 2015 and 2018 in two tertiary referral centers and to physicians of centers who agreed or declined to participate. The primary outcome measure was the proportion of respondents who agreed with deferral of consent in the ULTRA trial. Secondary outcomes included respondents’ preferred consent procedure for the ULTRA trial, the effect of deferred consent on trust in physicians and scientific research, and the willingness to participate in future research. Results Eighty-nine of 135 (66%) patients or proxies and 20 of 30 (67%) physicians completed the survey. Of these, 82 of 89 (92%) patients or proxies and 14 of 20 (70%) physicians agreed with deferral of consent in the ULTRA trial. When asked for their preferred consent procedure for the ULTRA trial, 31 of 89 (35%) patients or proxies indicated deferred consent, 15 of 89 (17%) preferred immediate informed consent, and 32 of 89 (36%) had no preference. None of the patients’ or proxies’ trust in physicians or scientific research had decreased because of the deferred consent procedure. Willingness to participate in future studies remained the same or increased in 84 of 89 (94%) patients or proxies. Conclusions A large majority of the surveyed patients and proxies and a somewhat smaller majority of the surveyed physicians agreed with deferred consent in the ULTRA trial. Deferred consent may enable acute care trials in an acceptable manner without decreasing trust in medicine. Future research should investigate factors facilitating the responsible use of deferred consent, such as in-depth interviews, to study the minority of participants who agreed with deferred consent but still preferred immediate informed consent.

Effects of Candesartan in Acute Stroke on Vascular Events during Long-Term Follow-up: Results from the Scandinavian Candesartan Acute Stroke Trial (SCAST)

2015 ◽  
Vol 10 (6) ◽  
pp. 830-835 ◽  
Author(s):  
Astrid G. Hornslien ◽  
Else C. Sandset ◽  
Jannicke Igland ◽  
Andreas Terént ◽  
Gudrun Boysen ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Vascular Events ◽  
Long Term Follow Up ◽  
Stroke Trial

Long-term neurological, vascular, and mortality outcomes after stroke

2018 ◽  
Vol 13 (8) ◽  
pp. 787-796 ◽  
Author(s):  
Ravinder-Jeet Singh ◽  
Shuo Chen ◽  
Aravind Ganesh ◽  
Michael D Hill
Keyword(s):  
Acute Stroke ◽  
Recurrent Stroke ◽  
Intravenous Thrombolysis ◽  
Stroke Recurrence ◽  
Stroke Survivors ◽  
Acute Stroke Care ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Stroke Treatment

Background Despite improved survival and short-term (90-day) outcomes of ischemic stroke patients, only sparse data exist describing the sustained benefits of acute stroke care interventions and long-term prognosis of stroke survivors. Aim We review the contemporary literature assessing long-term (5 years or more) outcomes after stroke and acute stroke treatment. Summary of review Acute stroke unit care and intravenous thrombolysis have sustained benefits over longer follow-up, but few data exist on the long-term outcome after endovascular thrombectomy (EVT). A large proportion of stroke survivors face challenges of residual disability and neuropsychiatric sequelae (especially affective disorders and epilepsy) which affects their quality of life and is associated with poorer prognosis due to increase in stroke recurrences/mortality. Nearly, a quarter of stroke survivors have a recurrent stroke at 5 years, and nearly double that at 10 years. Mortality after recurrent stroke is high, and half of the stroke survivors are deceased at 5 years after stroke and three fourth at 10 years. Long-term all-cause mortality is largely due to conditions other than stroke. Both stroke recurrence and long-term mortality are affected by several modifiable risk factors, and thus amenable to secondary prevention strategies. Conclusions There is a need for studies reporting longer term effects of acute interventions, especially EVT. Better preventive strategies are warranted to reduce the vascular and non-vascular mortality long after stroke.

scholarly journals Physiologic imaging in acute stroke: Patient selection

2015 ◽  
Vol 21 (4) ◽  
pp. 499-510 ◽  
Author(s):  
Clinton D Morgan ◽  
Marcus Stephens ◽  
Scott L Zuckerman ◽  
Magarya S Waitara ◽  
Peter J Morone ◽  
...  
Keyword(s):  
Acute Stroke ◽  
Imaging Techniques ◽  
Treatment Decision ◽  
Imaging Findings ◽  
Patient Benefit ◽  
Stroke Treatment ◽  
Treatment Decision Making ◽  
Stroke Imaging ◽  
Tissue Plasminogen

Treatment of acute stroke is changing, as endovascular intervention becomes an important adjunct to tissue plasminogen activator. An increasing number of sophisticated physiologic imaging techniques have unique advantages and applications in the evaluation, diagnosis, and treatment-decision making of acute ischemic stroke. In this review, we first highlight the strengths, weaknesses, and possible indications for various stroke imaging techniques. How acute imaging findings in each modality have been used to predict functional outcome is discussed. Furthermore, there is an increasing emphasis on using these state-of-the-art imaging modalities to offer maximal patient benefit through IV therapy, endovascular thrombolytics, and clot retrieval. We review the burgeoning literature in the determination of stroke treatment based on acute, physiologic imaging findings.

scholarly journals EXPRESS: Factors influencing the use of different methods of consent in a randomised acute stroke trial, the Third International Stroke Trial (IST-3)

2021 ◽  
pp. 174749302110371
Author(s):  
Richard Lindley ◽  
Ingrid Kane ◽  
Geoff Cohen ◽  
Peter Sandercock
Keyword(s):  
Informed Consent ◽  
Acute Stroke ◽  
Data Access ◽  
Stroke Onset ◽  
Neurological Deficits ◽  
Direct Result ◽  
The Third ◽  
Consent Procedure ◽  
Waiver Of Consent ◽  
Stroke Trial

Background Obtaining informed consent in people with acute stroke is complex since many, as a direct result of their stroke, lose capacity to make important decisions. Furthermore reperfusion interventions are time dependent necessitating rapid consent. We developed 4 different consent approaches to facilitate recruitment of a broad range of patients in the Third International Stroke Trial (IST-3). Aims To describe the clinical characteristics of patients recruited by different consent methods and the association between these methods and time from stroke onset to randomisation. Methods IST-3 was a randomised controlled trial of thrombolysis for acute ischaemic stroke. Clinicians could use one of four consent procedures: written consent, witnessed consent, assent, or a waiver of consent. We analysed the relationship between consent procedure and baseline variables. The effect of consent procedure on delay time from onset to randomisation was determined using analysis of variance to adjust for confounding effects. Results Of the 3035 patients recruited, the method of consent was known for 3034 (99.9%) and it was: written in 985 subjects (24%), witnessed verbal consent in 280 (9.2%), assent by relative in 1727 (56.9%), and waiver of consent in 42 subjects (1.4%). Assent was required in 63.4% for those presenting 0-3 hours from stroke onset (written consent in 25.3%). Patients with more severe neurological deficits (or with a non-lacunar hemispheric stroke syndrome) were less likely to give written consent. Mean delay between onset and randomisation varied significantly between consent types (one way anova : F=15.7 on 3 df, P<0.0001) (longest at 4.06 hours for signed consent and 3.46 hours for waiver of consent). Conclusions Acute stroke trials requiring written informed consent would result in substantial selection bias. Flexible consent methods will ensure a broad range of patients are recruited, enabling trial results to be widely generalisable. Registration The study is registered number ISRCTN25765518. Data access statement IST-3 Trial dataset is available on Edinburgh Data Share. https://datashare.ed.ac.uk/handle/10283/1931

Preparation And elemental analysis of ancient fibers

1987 ◽  
Vol 45 ◽  
pp. 410-411
Author(s):  
Allen Angel ◽  
Kathryn A. Jakes
Keyword(s):  
Cross Sections ◽  
Physical Structure ◽  
Energy Dispersive ◽  
Archaeological Sites ◽  
X Ray ◽  
Long Term Storage ◽  
Backscattered Electron ◽  
Electron Imaging

Fabrics recovered from archaeological sites often are so badly degraded that fiber identification based on physical morphology is difficult. Although diagenetic changes may be viewed as destructive to factors necessary for the discernment of fiber information, changes occurring during any stage of a fiber's lifetime leave a record within the fiber's chemical and physical structure. These alterations may offer valuable clues to understanding the conditions of the fiber's growth, fiber preparation and fabric processing technology and conditions of burial or long term storage (1).Energy dispersive spectrometry has been reported to be suitable for determination of mordant treatment on historic fibers (2,3) and has been used to characterize metal wrapping of combination yarns (4,5). In this study, a technique is developed which provides fractured cross sections of fibers for x-ray analysis and elemental mapping. In addition, backscattered electron imaging (BSI) and energy dispersive x-ray microanalysis (EDS) are utilized to correlate elements to their distribution in fibers.

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