Jean Luciano - Academia.edu (original) (raw)
Papers by Jean Luciano
Stroke, 2018
Introduction: Poor medication adherence and insufficient stroke related knowledge may contribute ... more Introduction: Poor medication adherence and insufficient stroke related knowledge may contribute to worse outcomes. Hypothesis: A relationship-based attending nurse (AN) model of inpatient care for stroke patients will enhance medication adherence, stroke-related knowledge, and QOL after hospital discharge. Methods: We performed a pseudo-randomized trial of AN + standard care vs. standard care at a single comprehensive stroke center (CSC). We enrolled patients with ischemic stroke, TIA, or ICH. The AN intervention consisted of a dedicated nurse focused on individual patient goals, expectations, and disease related knowledge deficits. After discharge, subjects were consented and assessed via structured telephone interviews using the Morisky Medication Adherence Scale (MMAS-4), Stroke Patient Education Retention tool (SPER), and Stroke Impact Scale (SIS). Results: We randomly allocated 278 subjects to AN and 392 to standard models of care; 47% and 43% consented to participate, respect...
Stroke
Introduction: The impact of anxiety, depression, and PTSD on outcome after stroke is incompletely... more Introduction: The impact of anxiety, depression, and PTSD on outcome after stroke is incompletely understood. We aim to evaluate the prevalence of these disorders after stroke and evaluate associations with outcomes including healthcare utilization, medication adherence, return to work, and quality of life. Methods: We performed telephone surveys on stroke patients discharged to home or acute rehabilitation 6-12 months after discharge from a comprehensive stroke center. Patients with preexisting psychiatric disease, prior stroke, and those unable to communicate were excluded. Demographics, including education, relationship status, and household size were recorded. Stroke etiology, location, and severity (NIHSS) were abstracted from medical records. Surveys included: employment status, the Hospital Anxiety and Depression Scale, PTSD Checklist-Stressor Specific Version (PCL-S), Stanford Healthcare Utilization Survey, Morisky Medication Adherence Scale, modified Rankin Scale (mRS) and ...
The online version of this article, along with updated information and services, is located on the
Neuroepidemiology, 2003
Background and Relevance: Atherosclerotic stenosis of the major intracranial arteries is an impor... more Background and Relevance: Atherosclerotic stenosis of the major intracranial arteries is an important cause of transient ischemic attack (TIA) or stroke. Of the 900,000 patients who suffer a TIA or stroke each year in the USA, intracranial stenosis is responsible for approximately 10%, i.e. 90,000 patients. There have been no prospective trials evaluating antithrombotic therapies for preventing recurrent vascular events in these patients. The main objective of this trial is to compare warfarin [International Normalized Ratio (INR) 2–3] with aspirin (1,300 mg/day) for preventing stroke (ischemic and hemorrhagic) and vascular death in patients presenting with TIA or stroke caused by stenosis of a major intracranial artery. Study Design: Prospective, randomized, double-blind, multicenter trial. The sample sizerequired will be 403 patients per group, based on stroke and vascular death rates of 33% per 3 years in the aspirin group vs. 22% per 3 years in the warfarin group, a p value of 0.05, power of 80%, a 24% rate of ‘withdrawal of therapy’, and a 1% rate of ‘lost to follow-up’. Conduct of Trial: Patients with TIA or nondisabling stroke caused by ≧50% stenosis of a major intracranial artery documented by catheter angiography are randomized to warfarin or aspirin. Patients are contacted monthly by phone and examined every 4 months until a common termination date. Mean follow-up in the study is expected to be 3 years. Conclusion: This study will determine whether warfarin or aspirin is superior for patients with symptomatic intracranial arterial stenosis. Furthermore, it will identify patients whose rate of ischemic stroke in the territory of the stenotic intracranial artery on best medical therapy is sufficiently high to justify a subsequent trial comparing intracranial angioplasty/stenting with best medical therapy in this subset of patients.
Journal of Stroke and Cerebrovascular Diseases, 1999
International Journal of Stroke, 2009
The National Institutes of Health Stroke Scale (NIHSS) is a well known, reliable and valid stroke... more The National Institutes of Health Stroke Scale (NIHSS) is a well known, reliable and valid stroke deficit scale. The NIHSS is simple, quick, and has shown significant reliability in diverse groups, settings, and languages. The NIHSS also contains items with poor reliability and redundancy. Recent investigations (include assessing a new training DVD, analyzing web-based or videotape certifications, and testing foreign language versions) have further detailed reliability issues. Items recurrently shown to have poor reliability include Level of Consciousness, Facial Palsy, Limb Ataxia, and Dysarthria. The modified NIHSS (mNIHSS) minimizes redundancy and eliminates poorly reliable items. The mNIHSS shows greater reliability in multiple settings and cohorts, including scores abstracted from records, when used via telemedicine, and when used in clinical trials. In a validation of the mNIHSS against the NIHSS, the number of elements with excellent agreement increased from 54% to 71%, while...
Stroke, 2001
; and the NINDS rtPA Stroke Study Group Background and Purpose-The National Institutes of Health ... more ; and the NINDS rtPA Stroke Study Group Background and Purpose-The National Institutes of Health Stroke Scale (NIHSS) is accepted widely for measuring acute stroke deficits in clinical trials, but it contains items that exhibit poor reliability or do not contribute meaningful information. To improve the scale for use in clinical research, we used formal clinimetric analyses to derive a modified version, the mNIHSS. We then sought to demonstrate the validity and reliability of the new mNIHSS. Methods-The mNIHSS was derived from our prior clinimetric studies of the NIHSS by deleting poorly reproducible or redundant items (level of consciousness, face weakness, ataxia, dysarthria) and collapsing the sensory item into 2 responses. Reliability of the mNIHSS was assessed with the certification data originally collected to assess the reliability of investigators in the National Institute of Neurological Disorders and Stroke (NINDS) rtPA (recombinant tissue plasminogen activator) Stroke Trial. Validity of the mNIHSS was assessed with the outcome results of the NINDS rtPA Stroke Trial. Results-Reliability was improved with the mNIHSS: the number of scale items with poor coefficients on either of the certification tapes decreased from 8 (20%) to 3 (14%) with the mNIHSS. With the use of factor analysis, the structure underlying the mNIHSS was found identical to the original scale. On serial use of the scale, goodness of fit coefficients were higher with the mNIHSS. With data from part I of the trial data, the proportion of patients who improved Ն4 points within 24 hours after treatment was statistically significantly increased by tPA (odds ratio, 1.3; 95% confidence limits, 1.0, 1.8; Pϭ0.05). Likewise, the odds ratio for complete/nearly complete resolution of stroke symptoms 3 months after treatment was 1.7 (95% confidence limits, 1.2, 2.6) with the mNIHSS. Other outcomes showed the same agreement when the mNIHSS was compared with the original scale. The mNIHSS showed good responsiveness, ie, was useful in differentiating patients likely to hemorrhage or have a good outcome after stroke. Conclusions-The mNIHSS appears to be identical clinimetrically to the original NIHSS when the same data are used for validation and reliability. Power appears to be greater with the mNIHSS with the use of 24-hour end points, suggesting the need for fewer patients in trials designed to detect treatment effects comparable to rtPA. The mNIHSS contains fewer items and might be simpler to use in clinical research trials. Prospective analysis of reliability and validity, with the use of an independently collected cohort, must be obtained before the mNIHSS is used in a research setting. (Stroke. 2001; 32:1310-1317.) Key Words: outcome Ⅲ outcome assessment Ⅲ stroke Ⅲ stroke assessment T he ideal stroke scale should be valid, reliable, and simple to administer. While no current scale satisfies all these requirements, 1-5 introducing a new scale is a formidable undertaking, given the expense associated with rigorous clinimetric scale design. 6 To improve the usefulness of a currently used scale, the National Institutes of Health Stroke Scale (NIHSS), we conducted several investigations of reliability, validity and internal structure. 7,8 The NIHSS is
Annals of Emergency Medicine, 2005
Stroke, 2008
Background and Purpose-Multiple approaches are being studied to enhance the rate of thrombolysis ... more Background and Purpose-Multiple approaches are being studied to enhance the rate of thrombolysis for acute ischemic stroke. Treatment of myocardial infarction with a combination of a reduced-dose fibrinolytic agent and a glycoprotein (GP) IIb/IIIa receptor antagonist has been shown to improve the rate of recanalization versus fibrinolysis alone. The combined approach to lysis utilizing eptifibatide and recombinant tissue-type plasminogen activator (rt-PA) (CLEAR) stroke trial assessed the safety of treating acute ischemic stroke patients within 3 hours of symptom onset with this combination. Methods-The CLEAR trial was a National Institutes of Health/National Institute of Neurological Disorders and Stroke-funded multicenter, double-blind, randomized, dose-escalation and safety study. Patients were randomized 3:1 to either low-dose rt-PA (tier 1ϭ0.3 mg/kg, tier 2ϭ0.45 mg/kg) plus eptifibatide (75 g/kg bolus followed by 0.75 g/kg per min infusion for 2 hours) or standard-dose rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracerebral hemorrhage within 36 hours. Secondary analyses were performed regarding clinical efficacy. Results-Ninety-four patients (40 in tier 1 and 54 in tier 2) were enrolled. The combination group of the 2 dose tiers (nϭ69) had a median age of 71 years and a median baseline National Institutes of Health Stroke Scale (NIHSS) score of 14, and the standard-dose rt-PA group (nϭ25) had a median age of 61 years and a median baseline NIHSS score of 10 (Pϭ0.01 for NIHSS score). Fifty-two (75%) of the combination treatment group and 24 (96%) of the standard treatment group had a baseline modified Rankin scale score of 0 (Pϭ0.04). There was 1 (1.4%; 95% CI, 0% to 4.3%) symptomatic intracranial hemorrhage in the combination group and 2 (8.0%; 95% CI, 0% to 19.2%) in the rt-PA-only arm (Pϭ0.17). During randomization in tier 2, a review by the independent data safety monitoring board demonstrated that the safety profile of combination therapy at the tier 2 doses was such that further enrollment was statistically unlikely to indicate inadequate safety for the combination treatment group, the ultimate outcome of the study. Thus, the study was halted. There was a trend toward increased clinical efficacy of standard-dose rt-PA compared with the combination treatment group. Conclusions-The safety of the combination of reduced-dose rt-PA plus eptifibatide justifies further dose-ranging trials in acute ischemic stroke.
The online version of this article, along with updated information and services, is located on the
Frontiers in Neurology, Nov 2, 2018
Background: Stroke patients are known to be at risk of developing anxiety, depression, and post-t... more Background: Stroke patients are known to be at risk of developing anxiety, depression, and post-traumatic stress disorder (PTSD). Objective: To determine the overlap between anxiety, depression, and PTSD in patients after stroke and to determine the association between these disorders and quality of life, functional status, healthcare utilization, and return to work. Methods: A cross-sectional telephone survey was conducted to assess for depression, anxiety, PTSD, and health-related outcomes 6-12 months after first ischemic stroke in patients without prior psychiatric disease at a single stroke center. Results: Of 352 eligible subjects, 55 (16%) completed surveys. Seven subjects (13%) met criteria for probable anxiety, 6 (11%) for PTSD, and 11 for depression (20%). Of the 13 subjects (24%) who met criteria for any of these disorders, 6 (46%) met criteria for more than one, and 5 (39%) met criteria for all three. There were no significant differences in baseline characteristics, including stroke severity or neurologic symptoms, between those with or without any of these disorders. Those who had any of these disorders were less likely to be independent in their activities of daily living (ADLs) (54 vs. 95%, p < 0.001) and reported significantly worse quality of life (score of 0-100, median score of 50 vs. 80, p < 0.001) compared to those with none of these disorders. Conclusions: Anxiety, depression, and PTSD are common after stroke, have a high degree of co-occurrence, and are associated with worse outcomes, including quality of life and functional status.
Background and Purpose—Early identification of stroke patients in need of rehabilitation or long-... more Background and Purpose—Early identification of stroke patients in need of rehabilitation or long-term nursing facility (NF) care may promote more efficient use of health care resources and lead to better outcomes. The NIH Stroke Scale (NIHSS) is an attractive candidate predictor of disposition because it is widely used, is easily learned, and can be performed rapidly on admission. Methods—We present
Stroke, 1999
Background and Purpose —The aim of our study was to determine whether the National Institutes of ... more Background and Purpose —The aim of our study was to determine whether the National Institutes of Health Stroke Scale (NIHSS) can be estimated retrospectively from medical records. The NIHSS is a quantitative measure of stroke-related neurological deficit with established reliability and validity for use in prospective clinical research. Recently, retrospective observational studies have estimated NIHSS scores from medical records for quantitative outcome analysis. The reliability and validity of estimation based on chart review has not been determined. Methods —Thirty-nine patients were selected because their NIHSS scores were formally measured at admission and discharge. Handwritten notes from medical records were abstracted and NIHSS scores were estimated by 6 raters who were blinded to the actual scores. Estimated scores were compared among raters and with the actual measured scores. Results —Interrater reliability was excellent, with an intraclass correlation coefficient of 0.82...
Neurology, 2009
Background: Despite the high incidence of acute stroke, only a minority of patients are enrolled ... more Background: Despite the high incidence of acute stroke, only a minority of patients are enrolled in acute stroke treatment trials. We aimed to identify factors associated with participation in clinical trials of novel therapeutic agents for acute stroke. Methods: Prospective survey of patients with acute stroke Ͻ72 hours from onset. A structured interview was administered to the patient or primary decision-maker. If offered participation in an actual acute treatment trial, questions focused on decisions about that trial; otherwise a similar mock trial was proposed. The primary outcome was whether the subject agreed to participate in the proposed trial. Results: A total of 200 subjects (47% patients, 53% proxies) completed the survey: mean age 63 Ϯ 14 years, 47% women, 44% white, 50% black. A real acute trial was offered to 22%; others were offered a mock trial. Overall, 57% (95% confidence interval: 50%-64%) of respondents stated they would participate in the proposed acute treatment trial. There were no differences with respect to age, sex, race, educational level, self-assessed stroke severity or stroke type, vascular risk factors, or comorbidities. Misconceptions about key research concepts were found in 50% but did not impact participation. Participation was associated with the perceived risk of the proposed trial intervention (p Ͻ 0.001), prior general attitudes about research (p Ͻ 0.001), and influences attributed to family, religion, and other personal beliefs (p Ͻ 0.001). Patients were more likely to participate than proxy decision-makers (p ϭ 0.04). Conclusions: Demographic factors, clinical factors, and prior knowledge about research have little impact on the decision to participate in acute stroke clinical trials. Preexisting negative attitudes and external influences about research strongly inhibit participation. Patients are more inclined to participate than their proxy decision-makers.
Neurology, 2005
... Steven R. Messé, MD, Brett Cucchiara, MD, Jeanie Luciano, NP and Scott E. Kasner, MD ... to D... more ... Steven R. Messé, MD, Brett Cucchiara, MD, Jeanie Luciano, NP and Scott E. Kasner, MD ... to Dr. Steven R. Messé, Department of Neurology, Comprehensive Stroke Center, University of Pennsylvania Medical Center, 3W Gates Building, 3400 Spruce Street, Philadelphia, PA ...
Stroke, 2018
Introduction: Poor medication adherence and insufficient stroke related knowledge may contribute ... more Introduction: Poor medication adherence and insufficient stroke related knowledge may contribute to worse outcomes. Hypothesis: A relationship-based attending nurse (AN) model of inpatient care for stroke patients will enhance medication adherence, stroke-related knowledge, and QOL after hospital discharge. Methods: We performed a pseudo-randomized trial of AN + standard care vs. standard care at a single comprehensive stroke center (CSC). We enrolled patients with ischemic stroke, TIA, or ICH. The AN intervention consisted of a dedicated nurse focused on individual patient goals, expectations, and disease related knowledge deficits. After discharge, subjects were consented and assessed via structured telephone interviews using the Morisky Medication Adherence Scale (MMAS-4), Stroke Patient Education Retention tool (SPER), and Stroke Impact Scale (SIS). Results: We randomly allocated 278 subjects to AN and 392 to standard models of care; 47% and 43% consented to participate, respect...
Stroke
Introduction: The impact of anxiety, depression, and PTSD on outcome after stroke is incompletely... more Introduction: The impact of anxiety, depression, and PTSD on outcome after stroke is incompletely understood. We aim to evaluate the prevalence of these disorders after stroke and evaluate associations with outcomes including healthcare utilization, medication adherence, return to work, and quality of life. Methods: We performed telephone surveys on stroke patients discharged to home or acute rehabilitation 6-12 months after discharge from a comprehensive stroke center. Patients with preexisting psychiatric disease, prior stroke, and those unable to communicate were excluded. Demographics, including education, relationship status, and household size were recorded. Stroke etiology, location, and severity (NIHSS) were abstracted from medical records. Surveys included: employment status, the Hospital Anxiety and Depression Scale, PTSD Checklist-Stressor Specific Version (PCL-S), Stanford Healthcare Utilization Survey, Morisky Medication Adherence Scale, modified Rankin Scale (mRS) and ...
The online version of this article, along with updated information and services, is located on the
Neuroepidemiology, 2003
Background and Relevance: Atherosclerotic stenosis of the major intracranial arteries is an impor... more Background and Relevance: Atherosclerotic stenosis of the major intracranial arteries is an important cause of transient ischemic attack (TIA) or stroke. Of the 900,000 patients who suffer a TIA or stroke each year in the USA, intracranial stenosis is responsible for approximately 10%, i.e. 90,000 patients. There have been no prospective trials evaluating antithrombotic therapies for preventing recurrent vascular events in these patients. The main objective of this trial is to compare warfarin [International Normalized Ratio (INR) 2–3] with aspirin (1,300 mg/day) for preventing stroke (ischemic and hemorrhagic) and vascular death in patients presenting with TIA or stroke caused by stenosis of a major intracranial artery. Study Design: Prospective, randomized, double-blind, multicenter trial. The sample sizerequired will be 403 patients per group, based on stroke and vascular death rates of 33% per 3 years in the aspirin group vs. 22% per 3 years in the warfarin group, a p value of 0.05, power of 80%, a 24% rate of ‘withdrawal of therapy’, and a 1% rate of ‘lost to follow-up’. Conduct of Trial: Patients with TIA or nondisabling stroke caused by ≧50% stenosis of a major intracranial artery documented by catheter angiography are randomized to warfarin or aspirin. Patients are contacted monthly by phone and examined every 4 months until a common termination date. Mean follow-up in the study is expected to be 3 years. Conclusion: This study will determine whether warfarin or aspirin is superior for patients with symptomatic intracranial arterial stenosis. Furthermore, it will identify patients whose rate of ischemic stroke in the territory of the stenotic intracranial artery on best medical therapy is sufficiently high to justify a subsequent trial comparing intracranial angioplasty/stenting with best medical therapy in this subset of patients.
Journal of Stroke and Cerebrovascular Diseases, 1999
International Journal of Stroke, 2009
The National Institutes of Health Stroke Scale (NIHSS) is a well known, reliable and valid stroke... more The National Institutes of Health Stroke Scale (NIHSS) is a well known, reliable and valid stroke deficit scale. The NIHSS is simple, quick, and has shown significant reliability in diverse groups, settings, and languages. The NIHSS also contains items with poor reliability and redundancy. Recent investigations (include assessing a new training DVD, analyzing web-based or videotape certifications, and testing foreign language versions) have further detailed reliability issues. Items recurrently shown to have poor reliability include Level of Consciousness, Facial Palsy, Limb Ataxia, and Dysarthria. The modified NIHSS (mNIHSS) minimizes redundancy and eliminates poorly reliable items. The mNIHSS shows greater reliability in multiple settings and cohorts, including scores abstracted from records, when used via telemedicine, and when used in clinical trials. In a validation of the mNIHSS against the NIHSS, the number of elements with excellent agreement increased from 54% to 71%, while...
Stroke, 2001
; and the NINDS rtPA Stroke Study Group Background and Purpose-The National Institutes of Health ... more ; and the NINDS rtPA Stroke Study Group Background and Purpose-The National Institutes of Health Stroke Scale (NIHSS) is accepted widely for measuring acute stroke deficits in clinical trials, but it contains items that exhibit poor reliability or do not contribute meaningful information. To improve the scale for use in clinical research, we used formal clinimetric analyses to derive a modified version, the mNIHSS. We then sought to demonstrate the validity and reliability of the new mNIHSS. Methods-The mNIHSS was derived from our prior clinimetric studies of the NIHSS by deleting poorly reproducible or redundant items (level of consciousness, face weakness, ataxia, dysarthria) and collapsing the sensory item into 2 responses. Reliability of the mNIHSS was assessed with the certification data originally collected to assess the reliability of investigators in the National Institute of Neurological Disorders and Stroke (NINDS) rtPA (recombinant tissue plasminogen activator) Stroke Trial. Validity of the mNIHSS was assessed with the outcome results of the NINDS rtPA Stroke Trial. Results-Reliability was improved with the mNIHSS: the number of scale items with poor coefficients on either of the certification tapes decreased from 8 (20%) to 3 (14%) with the mNIHSS. With the use of factor analysis, the structure underlying the mNIHSS was found identical to the original scale. On serial use of the scale, goodness of fit coefficients were higher with the mNIHSS. With data from part I of the trial data, the proportion of patients who improved Ն4 points within 24 hours after treatment was statistically significantly increased by tPA (odds ratio, 1.3; 95% confidence limits, 1.0, 1.8; Pϭ0.05). Likewise, the odds ratio for complete/nearly complete resolution of stroke symptoms 3 months after treatment was 1.7 (95% confidence limits, 1.2, 2.6) with the mNIHSS. Other outcomes showed the same agreement when the mNIHSS was compared with the original scale. The mNIHSS showed good responsiveness, ie, was useful in differentiating patients likely to hemorrhage or have a good outcome after stroke. Conclusions-The mNIHSS appears to be identical clinimetrically to the original NIHSS when the same data are used for validation and reliability. Power appears to be greater with the mNIHSS with the use of 24-hour end points, suggesting the need for fewer patients in trials designed to detect treatment effects comparable to rtPA. The mNIHSS contains fewer items and might be simpler to use in clinical research trials. Prospective analysis of reliability and validity, with the use of an independently collected cohort, must be obtained before the mNIHSS is used in a research setting. (Stroke. 2001; 32:1310-1317.) Key Words: outcome Ⅲ outcome assessment Ⅲ stroke Ⅲ stroke assessment T he ideal stroke scale should be valid, reliable, and simple to administer. While no current scale satisfies all these requirements, 1-5 introducing a new scale is a formidable undertaking, given the expense associated with rigorous clinimetric scale design. 6 To improve the usefulness of a currently used scale, the National Institutes of Health Stroke Scale (NIHSS), we conducted several investigations of reliability, validity and internal structure. 7,8 The NIHSS is
Annals of Emergency Medicine, 2005
Stroke, 2008
Background and Purpose-Multiple approaches are being studied to enhance the rate of thrombolysis ... more Background and Purpose-Multiple approaches are being studied to enhance the rate of thrombolysis for acute ischemic stroke. Treatment of myocardial infarction with a combination of a reduced-dose fibrinolytic agent and a glycoprotein (GP) IIb/IIIa receptor antagonist has been shown to improve the rate of recanalization versus fibrinolysis alone. The combined approach to lysis utilizing eptifibatide and recombinant tissue-type plasminogen activator (rt-PA) (CLEAR) stroke trial assessed the safety of treating acute ischemic stroke patients within 3 hours of symptom onset with this combination. Methods-The CLEAR trial was a National Institutes of Health/National Institute of Neurological Disorders and Stroke-funded multicenter, double-blind, randomized, dose-escalation and safety study. Patients were randomized 3:1 to either low-dose rt-PA (tier 1ϭ0.3 mg/kg, tier 2ϭ0.45 mg/kg) plus eptifibatide (75 g/kg bolus followed by 0.75 g/kg per min infusion for 2 hours) or standard-dose rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracerebral hemorrhage within 36 hours. Secondary analyses were performed regarding clinical efficacy. Results-Ninety-four patients (40 in tier 1 and 54 in tier 2) were enrolled. The combination group of the 2 dose tiers (nϭ69) had a median age of 71 years and a median baseline National Institutes of Health Stroke Scale (NIHSS) score of 14, and the standard-dose rt-PA group (nϭ25) had a median age of 61 years and a median baseline NIHSS score of 10 (Pϭ0.01 for NIHSS score). Fifty-two (75%) of the combination treatment group and 24 (96%) of the standard treatment group had a baseline modified Rankin scale score of 0 (Pϭ0.04). There was 1 (1.4%; 95% CI, 0% to 4.3%) symptomatic intracranial hemorrhage in the combination group and 2 (8.0%; 95% CI, 0% to 19.2%) in the rt-PA-only arm (Pϭ0.17). During randomization in tier 2, a review by the independent data safety monitoring board demonstrated that the safety profile of combination therapy at the tier 2 doses was such that further enrollment was statistically unlikely to indicate inadequate safety for the combination treatment group, the ultimate outcome of the study. Thus, the study was halted. There was a trend toward increased clinical efficacy of standard-dose rt-PA compared with the combination treatment group. Conclusions-The safety of the combination of reduced-dose rt-PA plus eptifibatide justifies further dose-ranging trials in acute ischemic stroke.
The online version of this article, along with updated information and services, is located on the
Frontiers in Neurology, Nov 2, 2018
Background: Stroke patients are known to be at risk of developing anxiety, depression, and post-t... more Background: Stroke patients are known to be at risk of developing anxiety, depression, and post-traumatic stress disorder (PTSD). Objective: To determine the overlap between anxiety, depression, and PTSD in patients after stroke and to determine the association between these disorders and quality of life, functional status, healthcare utilization, and return to work. Methods: A cross-sectional telephone survey was conducted to assess for depression, anxiety, PTSD, and health-related outcomes 6-12 months after first ischemic stroke in patients without prior psychiatric disease at a single stroke center. Results: Of 352 eligible subjects, 55 (16%) completed surveys. Seven subjects (13%) met criteria for probable anxiety, 6 (11%) for PTSD, and 11 for depression (20%). Of the 13 subjects (24%) who met criteria for any of these disorders, 6 (46%) met criteria for more than one, and 5 (39%) met criteria for all three. There were no significant differences in baseline characteristics, including stroke severity or neurologic symptoms, between those with or without any of these disorders. Those who had any of these disorders were less likely to be independent in their activities of daily living (ADLs) (54 vs. 95%, p < 0.001) and reported significantly worse quality of life (score of 0-100, median score of 50 vs. 80, p < 0.001) compared to those with none of these disorders. Conclusions: Anxiety, depression, and PTSD are common after stroke, have a high degree of co-occurrence, and are associated with worse outcomes, including quality of life and functional status.
Background and Purpose—Early identification of stroke patients in need of rehabilitation or long-... more Background and Purpose—Early identification of stroke patients in need of rehabilitation or long-term nursing facility (NF) care may promote more efficient use of health care resources and lead to better outcomes. The NIH Stroke Scale (NIHSS) is an attractive candidate predictor of disposition because it is widely used, is easily learned, and can be performed rapidly on admission. Methods—We present
Stroke, 1999
Background and Purpose —The aim of our study was to determine whether the National Institutes of ... more Background and Purpose —The aim of our study was to determine whether the National Institutes of Health Stroke Scale (NIHSS) can be estimated retrospectively from medical records. The NIHSS is a quantitative measure of stroke-related neurological deficit with established reliability and validity for use in prospective clinical research. Recently, retrospective observational studies have estimated NIHSS scores from medical records for quantitative outcome analysis. The reliability and validity of estimation based on chart review has not been determined. Methods —Thirty-nine patients were selected because their NIHSS scores were formally measured at admission and discharge. Handwritten notes from medical records were abstracted and NIHSS scores were estimated by 6 raters who were blinded to the actual scores. Estimated scores were compared among raters and with the actual measured scores. Results —Interrater reliability was excellent, with an intraclass correlation coefficient of 0.82...
Neurology, 2009
Background: Despite the high incidence of acute stroke, only a minority of patients are enrolled ... more Background: Despite the high incidence of acute stroke, only a minority of patients are enrolled in acute stroke treatment trials. We aimed to identify factors associated with participation in clinical trials of novel therapeutic agents for acute stroke. Methods: Prospective survey of patients with acute stroke Ͻ72 hours from onset. A structured interview was administered to the patient or primary decision-maker. If offered participation in an actual acute treatment trial, questions focused on decisions about that trial; otherwise a similar mock trial was proposed. The primary outcome was whether the subject agreed to participate in the proposed trial. Results: A total of 200 subjects (47% patients, 53% proxies) completed the survey: mean age 63 Ϯ 14 years, 47% women, 44% white, 50% black. A real acute trial was offered to 22%; others were offered a mock trial. Overall, 57% (95% confidence interval: 50%-64%) of respondents stated they would participate in the proposed acute treatment trial. There were no differences with respect to age, sex, race, educational level, self-assessed stroke severity or stroke type, vascular risk factors, or comorbidities. Misconceptions about key research concepts were found in 50% but did not impact participation. Participation was associated with the perceived risk of the proposed trial intervention (p Ͻ 0.001), prior general attitudes about research (p Ͻ 0.001), and influences attributed to family, religion, and other personal beliefs (p Ͻ 0.001). Patients were more likely to participate than proxy decision-makers (p ϭ 0.04). Conclusions: Demographic factors, clinical factors, and prior knowledge about research have little impact on the decision to participate in acute stroke clinical trials. Preexisting negative attitudes and external influences about research strongly inhibit participation. Patients are more inclined to participate than their proxy decision-makers.
Neurology, 2005
... Steven R. Messé, MD, Brett Cucchiara, MD, Jeanie Luciano, NP and Scott E. Kasner, MD ... to D... more ... Steven R. Messé, MD, Brett Cucchiara, MD, Jeanie Luciano, NP and Scott E. Kasner, MD ... to Dr. Steven R. Messé, Department of Neurology, Comprehensive Stroke Center, University of Pennsylvania Medical Center, 3W Gates Building, 3400 Spruce Street, Philadelphia, PA ...