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    Neurology Outcomes Research: Current Science and Future Directions ... Neurology Outcomes Research: Current Science and Future Directions ... Document Transcript

    • Abstracts: Poster Session 3. Early Carotid Endarterectomy After Acute Ischemic Stroke Gary L. Bernardini, Antonio Sparano, Anthony J. Santiago, R. Clement Darling, and Dhiraj M. Shah; Albany, NY1. Discrepancy Between Physician Knowledge andPractices in the Evaluation of Coagulopathies in Carotid endarterectomy (CEA) is recommended for symp-Ischemic Stroke Patients tomatic high-grade carotid stenosis, but the timing of CEACheryl Bushnell and Larry B. Goldstein; Durham, NC after acute stroke remains controversial. We report outcome in patients with early CEA following acute stroke. Symptom-Coagulopathy is a rare cause of ischemic stroke. Prior studies atic patients with high-grade carotid stenosis may benefitdemonstrate that testing for coagulopathies in ischemic from CEA. Appropriate timing of CEA after acute stroke re-stroke patients is not optimal. We sought to determine neu- mains unknown; a 4- to 6-week waiting period after stroke isrologists’ views regarding their use of specialized coagulation often recommended before CEA. Risk of recurrent stroketesting and the frequency with which they believed these may approach 9.5% during this waiting period. No studiestests influenced their patient management. Surveys (n 79) have evaluated the outcome of early CEA after acute infarct.with multiple-choice and open-ended questions were sent to We retrospectively reviewed vascular surgery patients admit-26 neurology faculty, 26 residents/fellows, and 29 practitio- ted from February 1996 to November 2000 with CEA andners; 56 (71%) were completed (faculty 69%, in-training diagnosis of stroke. CEA was performed for symptomatic ip-88%, and private practice 59%). The most commonly re- silateral carotid stenosis of 60% or greater. Only patientsported factors influencing test ordering were patient age with CEA performed within 10 days of infarct were studied.(75%), history of thrombosis (48%) or miscarriages (37%), Time to CEA after stroke, preoperative and postoperativeand few traditional stroke risk factors (33%). These tests NIHSS score, stroke risk factors, and postoperative compli-were thought to infrequently influence stroke management cations were assessed in each patient. Twenty-five patients( 25% of the time for 83%, and never for 12% of respon- (mean age, 64.9 12.9 years) had CEA within 10 days ofdents). Most (88%) would order specialized coagulation tests infarct. Mean time from stroke to CEA was 4.9 3.1 days.for a hypothetical young patient with no known stroke risk There was no significant difference between preoperative ver-factors, none for a patient with atrial fibrillation, and 14% sus postoperative NIHSS scores (5.2 1.9 vs 5.8 2.9,for a patient with other stroke risk factors. These appropriate respectively; p 0.19). No patient died in the immediatereported practices differ from studies in which more indis- postoperative period. Postoperative neurological complica-criminant test ordering was observed. These data suggest that tions occurred in 6 of 25 (24%) patients with worsened pre-improved application of physician’s current knowledge to existing deficits but did not change the NIHSS score (4.8their test-ordering practices could optimize diagnostic testing 2.3 preoperative vs 6.2 1.8 postoperative; p 0.17). Onefor coagulopathies in ischemic stroke patients. patient had hemorrhagic conversion of bland infarct. Two Supported by an Agency for Healthcare Research and patients required intravenous antihypertensive medication forQuality training grant. elevated blood pressure after surgery. Disposition was to home (n 15), acute rehabilitation (n 7), nursing home (n 1), or hospital transfer (n 2). Selected patients with acute ischemic stroke and significant carotid artery disease2. Physician Attitudes About Risk Reduction: can safely undergo early CEA. A 4- to 6-week waiting periodThe Knowledge–Effectiveness Divide prior to CEA may not necessarily ensure optimal patientJohn Castaldo, Tamara Masiado, Jane Nester, care.Thomas Wasser, Janelle Thomas, and Lawrence Kleinman;Allentown, PA 4. Hypothesis Accounting for the Effect ofReducing risk factors in patients with vascular disease can Glucocorticoids in Closed-Head Traumareduce the subsequent incidence of stroke. Studies indicate Mark K. Borsody and Michael Coco;that little time is spent counseling patients about risk reduc- Atlanta, GA, and Chicago, ILtion. To identify whether physicians felt confident in theirknowledge and effectiveness regarding counseling patients to Because of disagreement between clinical studies, the Amer-reduce risk, we mailed surveys to 509 physicians affiliated ican College of Neurological Surgeons’ (ACNS) most recentwith an academic community hospital. Nonrespondents were recommendation ( Joint Section on Neurotrauma and Criti-sent reminders and a second survey. Comparisons were made cal Care. Guidelines for the management of severe brain in-using 2 analysis. A total of 205 surveys were returned jury. J Neurotrauma 1996;13:641–734) is that glucocorti-(41%). Results indicated that 36% of physicians felt knowl- coids not be used in the treatment of closed head traumaedgeable about weight management techniques, compared (CHT). The current research reviews clinical studies of glu-with 3% who were confident that they succeeded in their cocorticoids and CHT in order to examine what factorspractice (p 0.001). Similar patterns were found for to- might have accounted for the inconsistent results leading tobacco cessation (62% vs 14%; p 0.001), alcohol reduction the ACNS’s recommendation. A careful analyses of these(46% vs 7%; p 0.001), stress management (35% vs 5%; studies reveals that, contrary to the ACNS’s sweeping con-p 0.001), exercise (53% vs 10%; p 0.001), nutrition clusion, the available data support the use of glucocorticoids(36% vs 8%; p 0.001), diabetes management (48% vs for patients with CHT but only in specific cases. Of the nine23%; p 0.001), blood pressure management (57% vs controlled studies that have examined the use of glucocorti-43%; p 0.001), and lipid management (59% vs 38%; p coids in CHT patients, three studies with reported intracra-0.001). We identified a discordance between physician con- nial hemorrhage rates of less than 25% found a significantfidence in their knowledge about risk factor counseling and benefit of glucocorticoid treatment. Conversely, five studiestheir effectiveness at providing counseling in their office. Al- with reported intracranial hemorrhage rates greater than 30%ternate settings for risk factor reduction may be useful for found no benefit or a worsened outcome in glucocorticoid-stroke prevention. treated CHT patients. Thus, glucocorticoids may be benefi-S72 Annals of Neurology Supplement 1 2001
    • cial in the treatment of CHT uncomplicated by intracranial iate model. Elevation in WBC count at the time of ischemichemorrhage. A randomized trial comparing the effect of glu- stroke is predictive of the 5-year risk of recurrent stroke,cocorticoid treatment in head trauma patients with and with- myocardial infarction, or death. Chronic infection or inflam-out intracranial hemorrhage is proposed. mation could account for this association, and modification of inflammatory pathways may provide a novel approach to improving prognosis after stroke.5. The Impact of a Rapid Response Team on Tissue Supported by AHA SDG 9930178N, CDC U50/Plasminogen Activator Administration for Acute Stroke CCU216543, and NINDS R01 27517.in a Community HospitalJ. Castaldo, D. Jenny, and C. Mathiesen; Allentown, PA 7. Variability in Stroke Outcome in the NSLIJ HealthAfter a decade of thrombolytic use in stroke and treating less Systemthan 1% of patients, it was apparent that a process change John J. Halperin, Sanjay Mittal, andwas needed. We created a rapid response team (RRT) to the NSLIJHS Stroke Study Group; Manhasset, NYbuild a systematic approach to stroke assessment, diagnosis,and intervention. The RRT was developed using recommen- The objective of this study was to refine our previously de-dations from the American Stroke Association. Using a scribed statistical model of stroke outcome to improve stroketrauma center model, we built an acute stroke center by es- care. The NSLIJ Health System includes nine acute care hos-tablishing clear internal communication, emergency depart- pitals and treats more than 2,000 patients with stroke annu-ment protocols, and emergency medical system/community ally. Previously presented analysis of data in the system’seducation. Data on door-to-needle (DTN) time, door-to-CT administrative database identified seven independent risk fac-scan (DTCT) time, and mean time to physician evaluation tors that predicted outcome. Since our previous analysis(MTPE) were collected and analyzed. During 1996 –1999, demonstrated that outcomes differed from predicted at three20 patients received tissue plasminogen activator; from 2000 hospitals, we reviewed a representative sample of medicalto the present, 13 have been treated. MTPE improved from records (1) by neurologists to verify discharge coding and20 minutes to 7 minutes, DTCT time improved from 25 to assess stroke severity (Oxfordshire classification) and (2) by a20 minutes, DTN went from 47 to 140 minutes to 60 to 92 research nurse to assess additional risk factors and treatmentminutes, and length of stay improved by 2 days. Outcomes variation (61 variables). The sample consisted of all patientsvalidate the effectiveness of a RRT in the community setting. who died, plus 1 randomly selected surviving patient withCritical allocation of resources aimed toward brain recovery stroke at each hospital. Rate of coding errors varied widelyenhances ability to intervene. Continued efforts should focus among hospitals (0 –33%), as did stroke type and severity,on increasing public awareness on early access, improvements but neither accounted for differences in outcome. On mul-in stroke management, and ongoing evaluation of care pro- tiple exploratory univariate analyses, other variables associ-cesses. ated with differences in outcome included days not fed, ini- Supported by the Dorothy Rider Pool Healthcare Trust. tiation of physical therapy, smoking, and initiation of treatment with warfarin, subcutaneous heparin, aspirin, and clopidogrel. A multivariate analysis is in progress. We have6. White Blood Cell Count Predicts Outcome After further refined our model of stroke outcome and will nextStroke: The Northern Manhattan Stroke Study adapt the conclusions for prospective study.Mitchell S. Elkind, Jianfeng Cheng, Tanja Rundek,Bernadette Boden-Albala, and Ralph L. Sacco; New York, NY 8. Predictors of Nursing Home Admission AfterAtherosclerosis is an inflammatory condition. Leukocyte Stroke: Results from a Nationally Representative Sample(WBC) count predicts prognosis after myocardial infarction, of US Elderlybut few data are available on its relation to outcome after Susan L. Hickenbottom, Kenneth M. Langa,ischemic stroke. We hypothesized that WBC count at the Mohammed U. Kabeto, A. Regula Herzog,time of incident ischemic stroke is associated with long-term Mary Beth Ofstedal, and A. Mark Fendrick; Ann Arbor, MIprognosis. Data on demographics, medical history, andstroke were collected on incident stroke patients in northern As the population ages, the prevalence of stroke and henceManhattan, and patients were prospectively followed up for the need for long-term care will increase. We sought to iden-5 years for recurrent stroke, myocardial infarction, or death. tify independent predictors of nursing home admissionKaplan-Meier curves and Cox proportional hazard models (NHA) after stroke. We used data from the first three waveswere constructed to estimate hazard ratios and 95% CI after (1993, 1995, 1998) of the Asset and Health Dynamicsadjusting for other potential risk factors. Incident ischemic Study, a longitudinal, nationally representative survey of USstroke patients (N 655) were enrolled (mean age, 69.7 elderly born before 1923 (N 7,443). Respondents were12.7 years; 45% male; 51% Hispanic, 28% black, and 19% classified as having “no stroke,” “stroke without stroke-white). Seventy percent of WBC samples were drawn within related health problems” (SRHPs), or “stroke with SRHP.”24 hours of stroke. Mean WBC count at admission was A Cox proportional hazards model was used to determine9.1 4.7 109/L (median, 8.0; interquartile range, 6.5– the effect of stroke on NHA during 6 years of follow-up,10.4). The rate of all outcome events at 30 days, and 1, 2, adjusting for sociodemographic variables, disability with ac-and 3 years was 7.2%, 21.8%, 29.8%, and 36.7%, respec- tivities of daily living (ADLs), and other chronic health con-tively. Over 5 years, WBC count was a significant indepen- ditions. Of 7,443 respondents, 1,798 (24%) died after 6dent predictor of all events in an unadjusted model (hazard years of follow-up, and 232 (3%) were excluded for missingratio, 1.04; 95% CI, 1.02–1.06) and after adjusting for age, data. The proportional hazards model showed that NHA wassex, race/ethnicity, other risk factors, and stroke severity 1.58 times more likely for those with stroke and SRHPs(hazard ratio, 1.03; 95% CI, 1.01–1.05). Age over 70, atrial (95% CI, 1.05–2.39; p 0.05), adjusting for all covariatesfibrillation, hypertension, and stroke severity were also sig- except disability with ADLs. When disability was included innificant independent predictors of outcome in the multivar- the model, the hazard for those with stroke and SRHPs Program and Abstracts, Neurology Outcomes Research S73
    • dropped to 1.04 (95% CI, 0.67–1.16). These data suggest occurring within 30 days of admission. Measures to reduceSRHPs are an important predictor of NHA; disability with pneumonia incidence following stroke are warranted.ADLs drives NHA after stroke. Supported by Aging for Healthcare Research and Quality.9. Can the Mini-Mental State Examination and the 11. Diabetes, Blood Glucose, and Outcome AfterAlzheimer’s Disease Assessment Scale (Cognitive) Be Ischemic StrokeConverted Directly? Evidence Based on Predictions Brett Kissela, Jane Khoury, Daniel Woo, Rosie Miller,of Patient Disability Kathleen Alwell, Jerzy Szaflarski, James Gebel,K. J. Ishak, A. Ward, K. Migliaccio-Walle, J. Caro, and Charles Moomaw, and Joseph Broderick; Cincinnati, OH,K. Torfs; Dorval, Quebec, Canada, Concord, MA, and and Pittsburgh, PABeerse, Belgium We investigated the influence of diabetes, blood glucose, andWhile the Mini-Mental State Examination (MMSE) is com- other factors on ischemic stroke outcome in our population-monly used in clinical practice, in research the cognitive part based stroke study in greater Cincinnati and Northern Ken-of the Alzheimer’s Disease Assessment Scale (ADAS-cog) pre- tucky from January 1993 and June 1994. Ischemic strokesdominates. Despite wide variation in patient scores, direct and transient ischemic attacks were identified by ICD-9conversions of one to the other have been proposed. The codes and medical records abstracted by study nurses. Casesobjective of this study was to examine how well MMSE val- were included if admission glucose value was measuredues converted to ADAS-cog to predict disability with activi- within 24 hours of symptom onset. In total, 2,385 of 3,714ties of daily living (ADLs) compared to actual MMSE values. cases were analyzed. A multivariable logistic regression anal-Data were obtained from patients with mild to moderate ysis was performed, including age, prestroke modifiedAlzheimer’s disease (N 1,286) on the two scales and Dis- Rankin score, and stroke severity as measured by level ofability Assessment for Dementia (DAD). The DAD mea- consciousness (alert vs not) and weakness (normal strength vssures the proportion of 46 ADLs attempted and successfully abnormal in any limb). The model predicts discharge out-completed in the preceding 2 weeks. Disability predicted di- come: good (modified Rankin score, 0 –1) versus poor (mod-rectly using the MMSE and other patient characteristics was ified Rankin score, 2). Outcome was related to age, pre-compared with prediction based on ADAS-cog scores con- stroke modified Rankin score, and stroke severity. Afterverted from MMSE scores. We found close agreement be- controlling for these factors, admission glucose ( 120, 120 –tween the two. For example, a patient with an MMSE of 20 140, 141–180, 181–200, or 200) and history of hyperten-was predicted to complete 86.4% of activities whereas the sion, but not diabetes, were significantly associated with poorconverted ADAS-cog score of 23 yields a prediction of outcome. We conclude that hypertension and blood glucose85.9%. Within the mild to moderate range, the maximum levels on admission, but not diabetes, are associated withdiscrepancy was no more than three percentage points, outcome after ischemic stroke. It is possible that diabetes isequivalent to less than a single activity on the DAD. It was undiagnosed in many patients with elevated glucose, thatconcluded that conversion of MMSE to ADAS-cog values glucose may be a surrogate for stroke severity, or that highappears to yield reasonably accurate estimates of disability. glucose causes increased brain injury during stroke. Supported by an unrestricted grant from Janssen Research Supported by R01 NS36078.Foundation. 12. The Effect of Stroke on Outcome of Acute Aortic10. The Effect of Pneumonia on 30-Day Mortality for Dissection: Results from the International RegistryMedicare Patients Hospitalized for Acute Stroke of Aortic DissectionIrene L. Katzan, Randall D. Cebul, Scott S. Husek, J. S. Kutcher, S. L. Hickenbottom, R. H. Mehta,Neal V. Dawson, and David W. Baker; Cleveland, OH J. V. Cooper, D. E. Smith, E. M. Kline-Rogers, K. A. Eagle, and L. A. Pape, for the IRAD Investigators; Ann Arbor, MIPneumonia is an important and often avoidable complica-tion of acute stroke. The purpose of this study was to deter- Acute aortic dissection occurs with an incidence of approxi-mine the effect of pneumonia on 30-day mortality rate in mately 2,000 cases per year in the United States. Stroke ispatients hospitalized for acute stroke. Subjects were 11,286 one possible presenting clinical sign of aortic dissection andMedicare patients admitted for ischemic or hemorrhagic is also a known complication of aortic dissection or its sur-stroke to 27 greater Cleveland hospitals between 1991 and gical treatment. We sought to describe the rate of stroke as a1997. Clinical data were obtained from chart abstraction and presenting feature of acute aortic dissection, as well as thewas merged with MEDPAR files to obtain 30-day mortality rate of stroke as a complication of the dissection itself or itsrates. A predicted mortality model (C statistic 0.73) and treatment. We used data from the prospective Internationalpropensity score for pneumonia (C statistic 0.832) were Registry of Aortic Dissection (N 878). At the time ofused to adjust for severity and selection bias, respectively, in presentation, 43 (4.9%) of patients had an acute clinicallogistic regression analyses. Pneumonia occurred in 5.6% stroke. Of these, 20 (46.5%) had an aortic root dissection(n 635) patients and was more frequent in patients with (p 0.001). Stroke was found to be significantly associatedgreater admission severity (predicted mortality, 13.2% vs with in-hospital mortality (37.2% mortality with stroke com-6.0%; p 0.001) and in men (7.6% vs 4.1%; p 0.001). pared with 22.8% without stroke, p 0.045). In-hospitalCrude 30-day mortality rates were 26.9% for patients with complication rates were reported for 783 patients. Of thesepneumonia and 4.4% for those without (p 0.001). Risk- patients, 33 (4.2%) had preoperative stroke and an addi-adjusted odds ratio for 30-day death in pneumonia patients tional 39 (5.0%) had postoperative stroke. These prospectivewas 3.3 (2.6 – 4.2). After adjustment, 11.4% of 30-day data demonstrate an increased risk of mortality in aortic dis-deaths were attributable to pneumonia. In this large section patients presenting with stroke and illustrate the sig-community-wide risk-adjusted study of stroke patients, nificance of stroke as a complication of aortic dissection andpneumonia accounted for a significant proportion of deaths its surgical treatment.S74 Annals of Neurology Supplement 1 2001
    • 13. Long-Term Outcome After Childhood Lead 15. Validation of the 11-Point Pain Scale in thePoisoning Measurement of Migraine Headache PainT. I. Lidsky, P. Gunser, and J. S. Schneider; Dev S. Pathak, W. Jackie Kwong, and Alice S. Batenhorst;Staten Island and Yonkers, NY, and Philadelphia, PA Columbus, OH, and Research Triangle Park, NCAlthough childhood lead poisoning impairs cognitive devel- Although the 11-point pain scale is commonly used to eval-opment, the long-term prognosis is not clear. The present uate pain, the 4-point pain scale (none, mild, moderate, se-research, describing 7 case histories, indicates that at least vere) is considered the gold standard in assessing migraine pain. The objectives of this study were to validate the 11-some lead-poisoned children exhibit considerable cognitive point pain scale using the 4-point pain scale, and to comparedeterioration as they grow older. The subjects, currently 16 the responsiveness of the two scales in detecting clinicallyto 21 years of age, had been poisoned by lead between the meaningful change. Migraine clinic patients (N 179) wereages of 2 and 3 years (mean blood lead, 18 –29 g/dl). An sent home with a questionnaire to be completed during theIQ battery was administered to each subject as well as a com- next migraine attack. Patients rated migraine pain intensityprehensive evaluation of neuropsychological functioning. before treatment and at 2 and 4 hours after treatment usingGeneral level of cognitive functioning before the age of 9 both pain scales. Functional and emotional disability wereyears was determined from school records and from previous also assessed using 4- and 5-point categorical scales. Fourevaluations. Each of the subjects were impaired in three do- hours after taking medication, patients were asked whethermains: visual memory, attention, and fine motor function- their migraine condition had improved, remained the same,ing. Individual subjects had additional impairments in other or deteriorated. At each time point, correlations between thecognitive domains as well. However, 3 of the subjects were 4-point and 11-point scales (r 0.75–0.94) were signifi-distinctive in showing very severe impairments in virtually all cantly higher than with functional/emotional disability rat-of the tested neuropsychological domains and in exhibiting ings (r 0.14–0.32; p 0.05), supporting the construct validity of the 11-point scale. Although both pain scales de-clear evidence that their level of cognitive functioning had tected statistically significant differences between patients re-significantly deteriorated since they were evaluated as chil- ported to be “improved/deteriorated” and “remained thedren. Recent evidence indicates that there are genetic influ- same,” effect size of the 11-point scale was larger than theences associated with the toxicokinetics of lead as well as dif- 4-point scale (1.748 vs 1.127). The 11-point scale demon-ferential outcome after brain injury. It remains to be strated validity in measuring migraine pain intensity and wasdetermined if these, or other variables, contributed to the 55% more responsive than the 4-point scale in detectingfindings reported here. clinically meaningful change. Supported by NYS Office of Mental Retardation and De- Supported by Glaxo Wellcome, Inc.velopmental Disabilities. 16. Development and Independent Validation of Prospective Mortality Risk-Adjustment Models for Alzheimer’s Disease and Related Dementias Based14. Risk Factors Associated With Symptomatic on Automated Pharmacy and Medical Claims DataHemorrhagic Conversion in Acute Ischemic Jean-Francois Ricci, Marc D. Silverstein, and ¸Stroke Bradley C. Martin; Research Triangle Park, NC,M. Moonis, N. Selvaraj, S. Nanjundaswamy, A. Ahmed, Charleston, SC, and Athens, GAT. Kovats, and S. Baker; Worcester, MA, and Risk-adjusted survival using administrative data is needed forBudapest, Hungary outcomes research. Incident cases of Alzheimer’s dementia from Georgia and North Carolina Medicaid data from 1990Although the overall risk of early recurrent stroke (RS) in to 1997 were studied. ICD-9-CM diagnoses and drug expo-acute ischemic stroke is low (2–2.2%), patients with cardio- sure in the year prior to the Alzheimer’s dementia diagnosisembolic stroke may be at higher risk (4.5– 8%). In this sub- were used to predict 6-month and 1- and 2-year survival rates.group, early anticoagulation with unfractionated intravenous Logistic regression models using drug data, ICD-9-CM codes,heparin (UFIH) may reduce the risk of RS. Use of UFIH is and both drug and ICD-9-CM codes were tested. Risk factorslimited by projected high risk of symptomatic hemorrhagic were reviewed by a panel of clinicians and then validated inconversion (SHC). In the absence of any single large study of the North Carolina sample. A total of 4,986 Georgia andUFIH, this inference is based on small retrospective studies 5,000 North Carolina Medicaid Alzheimer’s dementia patientswith variable results. To address this issue, we performed a were studied. Mortality rates were 14%, 21%, and 34% at 6large retrospective study using our stroke database. During months and 1 and 2 years, respectively. Opiates, cardiac andthe past 12 years (1988 –2000), we identified 2,543 patients respiratory drugs, tumors/cancers, cardiac diseases, and weightwith acute ischemic stroke. The overall incidence of SHC loss were each associated with increased odds of death of atwas 1.84%. Almost 18% had received UFIH without an ini- least 25% (p 0.05). Conversely, nonorganic psychotic dis-tial bolus. Stepwise logistic regression with correction for orders and alcohol abuse reduced the odds of death (p 0.05). The Georgia prospective models were valid when testedmultiple comparisons revealed SHC to be correlated with on the North Carolina sample (C statistics, 0.65– 0.67). Drugearly radiological signs of infarction (within 24 hours of on- models performed as well as ICD-9-CM models. We concludeset) on CT scan (p 0.024). Patients with histories of car- that prospective risk-adjusted models using Medicaid claimsdiac disorders were more likely to have SHC (p 0.043). and drug data are valid predictors of post-Alzheimer’s demen-UFIH was not a significant association. Based on our results, tia diagnosis survival and can be readily used in quality im-the risk of SHC with UFIH seem to be overstated. A com- provement programs and outcomes research.parative analysis with other studies of UFIH is in progress Supported by University of Georgia Research Assistant-and will be discussed. ship. Program and Abstracts, Neurology Outcomes Research S75
    • 17. Comparison of Adverse Reaction Reports for relation between stroke severity measured by JSS and lesionRivastigmine and Donepezil Using the FDA’s Adverse volume assessed by T2WI 3 days after onset, indicating theEvent Reporting System tissue viability of the lesion detected by DWI MRI. JSS isJohn A. Rizzo, Sobin Chang, and Aaryn Cohen; proved to be a reliable and quantitative scale to assess theColumbus, OH, and East Hanover, NJ severity among patients with acute cerebral infarction com- pared with NIHSS.Clinical trials have shown similar types yet differing frequen-cies of adverse reactions for Alzheimer’s patients taking cho-linesterase inhibitors. This study is the first to compare theadverse reaction reports of cholinesterase inhibitors using 19. To What Degree Does Cognitive Impairmentreal-world data (2000 FDA Quarterly Data from the Adverse in Alzheimer’s Disease Predict Dependence of PatientsEvent Reporting System [AERS]). Total prescription and on Caregivers?sales data for rivastigmine and donepezil were used to deter- A. J. Ward, K. Ishak, J. Caro, and K. Torfs; Concord, MA,mine the number of patients taking each drug. Adverse drug Montreal, Quebec, Canada, and Beerse, Belgiumreaction measurements as a proportion of users of each drug Patients with Alzheimer’s disease experience a progressive cog-were then obtained. Analyses tested differences in propor- nitive loss leading to progressively shorter periods when theytions. The most frequent common adverse reactions were can be safely left alone. To investigate the relationship of cog-nausea and malaise for rivastigmine and drug interactions nitive function to dependence on caregivers, data were ob-and convulsions for donepezil. Results show no statistically tained on 1,286 patients diagnosed with mild to moderatesignificant differences in total rate of adverse reactions and Alzheimer’s disease studied in clinical trials. Cognition was as-serious adverse drug reactions (as defined by FDA) between sessed using the cognitive part of the Alzheimer’s Disease As-rivastigmine and donepezil. In contrast, the rate of common sessment Scale (ADAS-cog). Patients were considered to haveadverse events found in donepezil was significantly higher become dependent on caregivers if they required at least 12compared with its product labeling (p 0.05). Adverse hours of supervision each day. The odds ratio of dependenceevents from drug interactions was significantly higher for was significantly higher with worse cognitive impairment, in-donepezil (p 0.05). As indicated from the FDA’s AERS, creasing with each ADAS-cog point, adjusting for age, sex, andsimilar rates of adverse events and serious adverse events for use of antipsychotic medication. For example, a 4-point wors-rivastigmine and donepezil were found. Efficacy and con- ening of the ADAS-cog score was associated with an increasecomitant medication usage should be considerations when in the adjusted odds for dependence of 15% (95% CI, 10 –selecting therapies for Alzheimer’s disease. 19) and of 27% (95% CI, 19 – 44) for an 8-point increase. An Supported by Novartis Pharmaceuticals. important marker of disease progression for both patients and their families is a patient’s ability to independently perform daily activities. Patients with mild to moderate Alzheimer’s18. Correlation Between Stroke Severity and Early disease who experience relatively small reductions in their cog-Ischemic Lesion Volume on Diffusion-Weighted nitive function are at increased risk of becoming dependent.Imaging: Comparison of Japan Stroke Scale Supported by an unrestricted grant from Janssen Researchand NIH Stroke Scale Foundation.Yasuo Terayama, Fumio Gotoh, Takahiro Amano, andMasahiro Yamamoto; Tokyo and Yokohama, JapanA novel weighted stroke scale ( Japan Stroke Scale [JSS]) has 20. Results of Percutaneous Patent Foramen Ovalebeen developed by the Japan Stroke Society for quantifica- Closure With Prospective Neurologist Follow-Uption of the severity of stroke. The aim of the present study is Quanwei Zhang, Huifang Zhai, Seemant Chaturvedi,to examine its validity by applying this scale to correlate with Thomas Forbes, Bradley S. Jacobs, and Steven R. Levine;early ischemic lesion volume on diffusion-weighted imaging Detroit, MI(DWI) and T2-weighted imaging (T2WI). The result wascompared with the assessment using the NIH Stroke Scale A patent foramen ovale (PFO) is found in up to 50% of pa-(NIHSS). A total of 45 patients with nonlacunar ischemic tients with cryptogenic stroke. Percutaneous PFO closure maystroke in the anterior circulation composed the subject pop- be useful to prevent recurrent stroke. Our objective was toulation. A DWI MRI was performed on admission (mean, define the outcomes in patients seen before and after percuta-6.7 2.3 hours after onset) and T2WI MRI was performed neous PFO closure by stroke neurologists. Consecutive case3 days (mean 74.5 7.2 hours) after onset. The stroke se- series of 12 patients from a university medical center were ex-verity of each of the patients was scored both by JSS and amined. A single interventional cardiologist implanted 11 Car-NIHSS on admission and 3 days after admission. Volume of dioseal devices and one angel wing occluder following trans-lesion assessed with both DWI and T2WI was compared esophageal echocardiography. Patients were referred over a 37-with each of the stroke scale scores. JSS score is a weighted month period. The median age of the patients was 43.5 yearsstroke severity scale, which varies from 26.5 (worst) to 0.38 (range, 16 – 69 years). Acquired or hereditary hypercoagulable(best). The correlation between JSS score and volume of le- states were present in 50% of patients. Before PFO closure,sion assessed with DWI on admission was not significant, 58% of patients were taking antiplatelet agents and 42% werewhere correlation between JSS score and volume of lesion receiving anticoagulation. One patient with cancer-related hy-assessed by T2WI performed 3 days after onset was signifi- percoagulability had multiple strokes after PFO closure but allcant (p 0.002). Among the patients with no remarkable of the remaining patients were free of stroke/death at 30 days.difference of lesion volume between DWI and T2WI, JSS Over a mean follow-up of 10.7 months, 1 patient died, butscore showed significant correlation with volume of lesion. the remaining patients were stroke-free. Two patients requiredCorrelation between NIHSS score and lesion volume showed chronic anticoagulation. We conclude that in patients withoutthe same pattern as the JSS study, but correlation between fulminant hypercoagulability, percutaneous PFO closure canNIHSS score and lesion volume assessed 3 days after onset be achieved with low morbidity, although larger studies arewere poor. The present study demonstrates a significant cor- needed to confirm this finding. Percutaneous PFO closureS76 Annals of Neurology Supplement 1 2001
    • may allow most patients to be treated without long-term an- 23. Quality of Life Following Stroke: Insightsticoagulation. from Qualitative Research Philippa Clarke and Sandra E. Black; Toronto, Ontario, Canada21. Quetiapine in the Treatment of Psychosis in Clinical trials and cohort studies are the typical methodsPatients With Parkinson’s Disease and Dementia used to gather data on stroke outcomes. In contrast, this(Lewy Body Disease Variant) study used qualitative methodological strategies (in-depth in-M. Parsa, H. Greenaway, and B. Bastiani; terviews) to investigate quality of life (QOL) after stroke.Beechwood and Cleveland, OH Subjects were selected from community-dwelling stroke sur-The objective of this study was to assess the efficacy and vivors age over 60 years with various levels of residual im-safety of quetiapine in the treatment of psychosis in patients pairment and disability. Eight cognitively intact stroke sur-with Lewy body disease (LBD) and Parkinson’s disease. We vivors were interviewed (3 males; age, 60 – 81 years; 7enrolled 10 patients (5 male) with dementia and parkinson- infarctions, 1 hemorrhage). Time since stroke ranged from 7ism who met the LBD criteria in a 52-week trial of open- months to 9 years. Throughout the interviews, survivors in-label, dose-flexible quetiapine (25–300 mg/d). All patients dicated the considerable effect of a stroke on their QOL,had significant psychosis and required treatment. PET per- particularly if residual disabilities constrained their participa-fusion scan of the brain showed bitemporoparietal hypoac- tion in self-defining activities. However, socioeconomic re-tivity in the patients. Psychotic symptoms were measured by sources (social supports and finances) and health services (re-Brief Psychiatric Rating Scale (BPRS). Motor function was habilitation programs) facilitated adaptation strategies thatassessed by the Unified Parkinson’s Disease Rating Scale, enabled people to find a way to return to valued life activi-Simpson-Angus Scale, and Abnormal Involuntary Movement ties, even in a modified form, to improve their QOL. InScale. Mini-Mental State Examination evaluated cognitive comparison with quantitative data from the Canadian Studystatus. All patients showed a marked improvement in psy- of Health and Aging, the greater nuances and complexitieschosis as measured by the BPRS, with no significant wors- revealed in these qualitative patient accounts generate infor-ening in motor function or cognitive status. Quetiapine is an mation that help to inform the provision of care to strokeeffective treatment for psychosis associated with LBD. survivors. By identifying the patient’s self-defining activitiesQuetiapine is well tolerated by patients with LBD, despite and supporting adaptive strategies that result in a return totheir extreme sensitivity to extrapyramidal and anticholin- such activities, QOL can be enhanced after stroke.ergic side effects associated with other antipsychotic agents.Further studies are needed to confirm these pilot data. Supported by AstraZeneca. 24. Reliability and Validity of the Assessment22. Shared and Unique Psychosocial Contributions to of Functioning and Well-Being of PatientsMarital and Nonmarital Well-Being in Brain Tumor With Ischemic StrokePatients and Their Spouses L. B. Goldstein, P. Lyden, S. D. Mathias, S. S. Colman,Nicole D. Anderson, Warren P. Mason, D. J. Pasta, and A. Rylander, for the CLASS-I Investigators;Rosemary L. Cashman, Mary E. Elliott, and Durham, NC, San Diego and San Francisco, CA, andGerald M. Devins; Toronto, Ontario, Canada Sodertalje, SwedenLittle research has examined the impact of brain tumors and Stroke patients and their family caregivers (N 76 pairs) andtheir treatment on patients’ and spouses’ quality of life an additional 30 caregivers of patients who had an ischemic(QOL) or on the marital relationship. We investigated psy- stroke within the previous 12 months were evaluated with achosocial effects of the disease, including illness intrusiveness telephone version of the HUI2/3 twice within 10 days. Dis-(disruptions to QOL), cognitive self-efficacy (beliefs about ability was assessed with the Barthel Index (BI; 0 –55 severe,one’s cognitive abilities), and memory self-efficacy (beliefs 60 – 85 moderate, 90 –100 mild). For the HUI2, completeabout one’s memory abilities) in 25 patients and their data were available for 22% of patients and 28% of caregiversspouses. Hierarchical regression analyses (p 0.01) tested (all four evaluations available in 15%); for the HUI3, the pro-the hypothesis that the psychosocial effects of the disease on portions were 30%, 36%, and 19%. For patient-caregivermarital satisfaction, emotional distress, and psychological pairs, 27% had no HUI2 responses, 51% had partial re-well-being would be significant for both partners but greater sponses, and 22% had complete responses; for the HUI3, thefor patients than spouses. Cognitive self-efficacy and illness- proportions were 19%, 52%, and 29%. Based on availableintrusiveness into marital life predicted marital satisfaction data, test-retest reliability for patients (ICC 0.76 for HUI2;similarly for patients and their spouses, but memory self- 0.75 for HUI3) and caregivers (ICC 0.91 and 0.89) wereefficacy predicted only patients’ marital satisfaction. Cogni- excellent. Mild and moderate patients reported different over-tive self-efficacy and illness intrusiveness into nonmarital life all HUI2 (p 0.011) and HUI3 (p 0.001) scores, butpredicted emotional distress similarly for patients and there were no differences between moderate and severe pa-spouses. Illness intrusiveness into nonmarital life predicted tients. The same pattern was found for caregivers. The highpsychological well-being similarly for patients and spouses. proportions of missing data for both patients and caregiversOther recent life strains and social support did not signifi- limit the use of the telephone-administered HUI2/3. Thecantly modify these relationships. Hence, the psychosocial ef- HUI2/3 appears to be reliable and to have at least limitedfects of brain tumors impose shared and unique influences validity based on the available data.on marital and nonmarital well-being, and these are remark- L. B. Goldstein and P. Lyden received research funds andably similar for both patients and spouses. That fact that consulting fees from AstraZeneca; S. D. Mathias, S. S. Col-memory self-efficacy has a unique impact on patients’ marital man, and D. J. Pasta are employees of the Lewin Group,happiness highlights the importance of memory rehabilita- which was paid by AstraZeneca to perform this research; andtion in neurooncology. A. Rylander is an employee of AstraZeneca. Program and Abstracts, Neurology Outcomes Research S77
    • 25. Effect of Botulinum Toxin Type A on Health- aggressive case management in LOVAR improves the QOLRelated Quality of Life in Stroke Patients With for patients after a vascular event.Spasticity Supported by the Dorothy Rider Pool Health Care Trust.Chris M. Kozma, Steven P. Burch, Martin K. Childers, andRich Barron; Research Triangle Park, NC, Columbia, MO,and Irvine, CA 27. Cognitive Dysfunction and Quality of Life After Subarachnoid HemorrhageThe objective of this study was to compare the effect of bot- Stephan A. Mayer, Kurt T. Kreiter, Noeleen Ostapkovich,ulinum toxin type A (Botox) and placebo on health-related Juan R. Carhuapoma, Adam Mednick, Shelly Peery, andquality of life (HRQOL) in stroke patients with spasticity. E. Sander Connolly; New York, NYWe assessed four phase II randomized, dose-ranging clinicaltrials comparing the safety, efficacy, and HRQOL of botuli- The impact of cognitive dysfunction on quality of lifenum toxin type A to placebo. Although these studies were (QOL) among survivors of subarachnoid hemorrhage (SAH)not specifically designed or powered to detect improvements is poorly defined. To evaluate the relationship between cog-in HRQOL, these exploratory data were useful for identifi- nitive dysfunction and QOL after SAH, we prospectively ex-cation of HRQOL domains that warrant further investiga- amined a multiethnic cohort of 113 patients 3 months aftertion. HRQOL data were evaluated from 111 stroke patients SAH (mean age, 49 years; 68% female). We assessed globalwith upper and lower limb spasticity. The SF-36 was admin- cognitive function (GCF) with the Telephone Interview ofistered at baseline and 6 weeks after treatment. Treatment Cognitive Status (TICS) and administered neuropsychologi-and placebo groups were compared using analysis of covari- cal tests (two per domain) to assess visual memory, verbalance with baseline score, age, sex, and race as covariates. Im- memory, motor function, reaction time, executive function,provements of greater than 5 points, generally considered to visuospatial function, and language. Domains were coded asbe clinically meaningful on the SF-36, were reported for vi- “impaired” if any test score fell 2 or more SD below norma-tality (5.31 points; p 0.0176) and social functioning (8.74 tive reference values. Outcome measures included the ex-points; p 0.0048). We concluded that botulinum toxin tended GOS (global outcome), the Lawton IADL scale (dis-type A use in the treatment of spasticity following stroke ability), and the Sickness Impact Profile (SIP) and Medicalmay result in improved social functioning and vitality at Outcomes Study-Short Form 36 (SF-36) (QOL). We used tclinically significant levels. tests to evaluate differences in outcome measures between Allergan, Inc, funded this study: C. M. Kozma and S. P. impaired and unimpaired patients within each cognitive do-Burch are currently employees of Strategic Outcomes Services main. Significance was set at p 0.0055, with Bonferroniof CareScience Inc (SOS), which provides statistical analysis correction within each domain. Cognitive dysfunction wasand reporting services for Allergan, Inc; M. K. Childers served associated with significantly reduced SIP scores in all but oneas an author-consultant for Allergan, Inc, on this study; and R. of the domains tested. By contrast, the relationship betweenBarron is currently an employee of Allergan, Inc. cognitive dysfunction and reduced SF-36 scores was weak and inconsistent. Impaired GCF was the only domain asso- ciated with significantly reduced scores in every outcome measure, and the strength of association between impaired GCF and QOL exceeded that of the more specific cognitive26. Aggressive Case Management in the Lowering of domains. We conclude that cognitive dysfunction is associ-Vascular Atherosclerotic Risk Study Improves Quality ated with significantly impaired QOL after SAH. The SIP isof Life for Patients Who Have Suffered Ischemic Events superior to the SF-36 for assessing QOL after SAH becauseTamara Masiado, John Castaldo, Janelle Thomas, it is more sensitive to these effects. The TICS is particularlyJane Nester, Thomas Wasser, Kim Sterk, and well suited to assess cognitive status after SAH, because it isLawrence Kleinman; Allentown, PA broadly applicable, easy to use, and better correlated with QOL than more detailed neuropsychological tests.It is well known that quality of life (QOL) deteriorates in Supported by an American Heart Association grant-in-aid.patients at risk for stroke and myocardial infarction, espe-cially after an ischemic event. We set out to determinewhether aggressive case management can positively affect 28. Are Proxy Ratings Valid for Assessing QualityQOL. Lowering of Vascular Atherosclerotic Risk Study of Life After Subarachnoid Hemorrhage?(LOVAR) is a prospective cohort study providing inten- Noeleen Ostapkovich, Kurt Kreiter, Shelley Perry,sive case management, a multidisciplinary risk factor reduc- E. Sander Connolly, and Stephan A. Mayer; New York, NYtion/behavior modification program, discussions with pri-mary care physicians, and alternating telephone and office The Sickness Impact Profile (SIP) is a widely used instru-follow-up every 3 months (or every 6 months for controls). ment for assessing health-related quality of life (QOL). InQOL was assessed using the Medical Outcome Study Short severely ill patients, the assessment can be obtained from aForm-36 (SF-36). Of 379 subjects enrolled in the first 2 surrogate. However, the validity of substituting a surrogateyears, 34 control patients and 56 intervention patients have assessment needs to be established. The objective of thisreached the first year of follow-up for evaluation. SF-36 study was to evaluate the agreement between patient and sur-scores were nearly identical at baseline. Year 1 scores for the rogate SIP scores among survivors of subarachnoid hemor-intervention group significantly improved in general health rhage (SAH). We prospectively enrolled 326 consecutive pa-(p 0.007); physical functioning, physical role, emotional tients (mean age, 54 years; 64% female). Three months afterrole (all p 0.000); social functioning (p 0.001); and SAH, patients and families were independently given thevitality (p 0.006); and showed trends in bodily pain (p SIP. Using the SIP physical and psychosocial aggregate and0.066) and mental health (p 0.409). The control group overall scores stratified by outcome (Rankin 0 –1 vs Rankinshowed deterioration in physical functioning, bodily pain, 2– 4) the percentage variation between scores was calculated.and vitality, and showed a significant improvement only in A total of 248 patients were alive at 3-month follow-up. SIPsocial functioning (p 0.033). SF-36 provides evidence that scores were obtained from 158 patients, 119 surrogates, andS78 Annals of Neurology Supplement 1 2001
    • 85 pairs. Surrogates rated better health-related QOL of the the United States. A model (Assessment of Health Economicspatient in all three areas. The overall amount of disagree- in AD [AHEAD]) was developed with two components: anment is relatively small and the extent of bias is no greater in initial module based on randomized galantamine/placebo clin-the poorer outcome patients compared with the good out- ical trials and a subsequent module that uses regression equa-come patients. Percentage variation for psychosocial scores is tions to predict time until fulltime care (FTC) is needed or0.36 (Rankin 0 –1) compared with 0.43. Similarly, for phys- death occurs. Analyses of mild (MMSE 18) and moderateical scores, percentage variation is 0.40 (Rankin 0 –1) com- (MMSE 18) patients over a decade evaluated numberpared with 0.17 (Rankin 2– 4). Our results indicate good needed to treat (NNT) for 1-year delay in FTC, time in FTC,agreement for the two SIP subscales between patients and and costs from a payer perspective in 2000 US dollars. Wesurrogates even in severely impaired patients. Surrogate eval- found that 3.8 to 4.6 patients need to start treatment withuations of health-related QOL using the SIP is an acceptable galantamine to avoid 1 year of FTC. Savings are $2,374 tosubstitute if the subject is unavailable. $3,575 per treated patient. In mild AD, the NNT is 4.3, with Supported by an American Heart Association grant-in-aid. savings of $2,181 per treated patient, compared with 3.4 in moderate AD, with greater savings ($5,298). While time be- fore FTC is longer in mild disease, the delay achieved is29. Health and Economic Outcomes for Drugs That smaller. In addition to the proven clinical benefits of galan-Slow Multiple Sclerosis Disability Progression: tamine, its use in the management of AD in the United StatesImprovement in Prevalence Cohorts With is expected to lead to a delay in FTC and savings for bothMore Years Since Onset mild and moderate AD patients.Murray G. Brown, John D. Fisk, Chris Skedgel, Supported by an unrestricted grant from Janssen Pharma-Ingrida S. Sketris, and T. J. Murray; ceuticals.Halifax, Nova Scotia, CanadaTreatment efficacy for drugs that slow multiple sclerosis(MS) progression is demonstrated by increased time to pro-gression—measured by units of time, percent increased time 31. Neurocysticercosis: 469 Cases From Los Angelesto progression, or reduced probability of progression. Health County Medical Centerand economic outcomes improve in treated prevalence co- Abbas Mehdi, Christopher M. DeGiorgio, Iceland Houston,horts with more years-since-onset (YSO). Health outcomes Aniko Ponce Reegt, and David Y. Ko; Los Angeles, CAand (net) treatment costs (intention to treat) are simulated Here we report the largest series of neurocysticercosis (NC)for “scenarios” using Multiple Sclerosis Pharmaco Economic cases in United States affecting only a selective population.Evaluation Tool (MS PEET). Outcomes are measured by Caused by Taenia solium, NC is one of the most commondisability years avoided (DYA), quality adjusted life years parasitic diseases of human brain. When symptomatic, NC(QALY) gained, and percentage of disease burden avoided can have severe and long-term affects on morbidity and in-(DBA). Variables included disability (EDSS) progression by crease health care cost. This was a retrospective chart reviewMS subtype, analytic perspective (onset or prevalence), effi- of patients with the diagnosis of NC from 1995 to 1998 atcacy, compliance, treatment start by YSO, treatment dura- Los Angeles County and the USC Medical Center. Theretion, within disability stage progression, posttreatment re- were 469 cases of NC that were identified using neuroimag-gression, cost perspective (public, private, societal), discount ing as the main diagnostic criteria. Only inpatients with arate, and treatment eligibility/termination criteria. Data primary diagnosis of NC were included. Of 469 patients,included disability progression in relapsing-remitting and 264 (56%) were males. Mean age was 35 years. Two thirdsprimary-progressive MS onset cohorts, by sex, over 25 years; of the patients were in the second or third decade of life.efficacy; drug costs; and health-related quality of life and MS Nearly all the patients were Hispanic. Most common clinicalhealth costs (public, private, societal) by disability stage. Sim- presentations included seizures (192 patients, 40%) and signsulated health outcomes (DYA, QALY, DBA) and economic of increased intracranial pressure (126 patients, 26.8%), withoutcomes (C/DYA, C/QALY) improve in treated MS prev- 16% requiring surgical intervention. Other common presen-alence cohorts with more years since onset. Models are effi- tations were headaches (65 patients, 13.8%), meningitis (27cient tools for simulating health and economic outcomes for patients, 5.7%), stroke (15 patients, 3.1%), and psychosis (8treatment scenarios when direct evidence is not, and may patients, 1.7%). NC is one of the most known causes ofnever be, available. Results suggest refinements to treatment seizures in our institution. As compared with previous stud-eligibility and termination criteria. ies, the common presenting signs are similar, but more pa- Supported by AstraZeneca AB. tients with increased intracranial pressure required surgical intervention with shunt placement. Previous publications from our institution reported 127 cases of NC during 1970 –30. Economic Impact of Galantamine in Mild to 1980 (12.7 per year) and 238 cases during 1981–1986 (39.6Moderate Alzheimer’s Disease per year). This study of 469 cases from 1995 to 1998Jaime Caro, K. Migliaccio-Walle, K. J. Ishak, D. Getsios, (117.25 per year) indicates nearly a 10-fold increase of NCJ. A. O’Brien, and G. Papadopoulos, in Southern California in the past 30 years. NC is prevalentfor the AHEAD Study Group; Concord, MA, mostly in the Hispanic population that has emigrated fromMontreal, Quebec, Canada, and Titusville, NJ endemic areas. The numbers of new cases within Los AngelesWe evaluated the long-term economic impact of galantamine County are rising without exposure to these endemic areas,in patients with mild to moderate Alzheimer’s disease (AD) in suggesting spread within the United States. Program and Abstracts, Neurology Outcomes Research S79