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dc.contributor.authorSavitz, Sean I.
dc.contributor.authorBenatar, Michael
dc.contributor.authorSaver, Jeffrey L.
dc.contributor.authorFisher, Marc
dc.date2022-08-11T08:09:28.000
dc.date.accessioned2022-08-23T16:31:37Z
dc.date.available2022-08-23T16:31:37Z
dc.date.issued2008-06-19
dc.date.submitted2010-03-24
dc.identifier.citationCerebrovasc Dis. 2008;26(2):156-62. Epub 2008 Jun 17. <a href="http://dx.doi.org/10.1159/000139663">Link to article on publisher's site</a>
dc.identifier.issn1015-9770 (Linking)
dc.identifier.doi10.1159/000139663
dc.identifier.pmid18560219
dc.identifier.urihttp://hdl.handle.net/20.500.14038/37691
dc.description.abstractBACKGROUND: Thrombolysis remains the only proven therapy to benefit acute ischemic stroke (AIS) patients. Recent studies have introduced more sensitive outcome measures such as the shift analysis to detect a treatment effect in AIS trials and are also including imaging as a surrogate of injury. METHODS: We conducted a cross-sectional, internet-based survey of academic neurologists regarding their attitudes, choices and understanding of various outcome measures in clinical trial design for AIS. The survey population consisted of neurologists who specialize in the care of stroke patients and are on faculty at university-affiliated hospitals in the USA. RESULTS: 152 of 300 neurologists completed the survey. There were 79% men and 21% women. Among commonly used outcome scales in acute stroke, the most frequent ones selected for use as trial primary endpoints were the global statistic (59%), modified Rankin scale (mRS) (52%), and NIHSS (30%). When given choices about which outcome on the mRS would justify a therapeutic intervention, 54% chose a shift analysis of change in the distribution of outcomes and 39% chose a dichotomized outcome (mRS CONCLUSION: The majority of respondents accepted an analysis of the entire distribution of the mRS scores as an appropriate endpoint analytic technique in AIS trials and did not require the traditional dichotomized outcome to demonstrate a treatment effect; however, a better understanding of the shift strategy is needed. Our data also support the importance of incorporating mismatch imaging into future neuroprotection trials.
dc.language.isoen_US
dc.relation<a href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&list_uids=18560219&dopt=Abstract">Link to Article in PubMed</a>
dc.relation.urlhttp://dx.doi.org/10.1159/000139663
dc.subject*Attitude of Health Personnel
dc.subject*Choice Behavior
dc.subject*Clinical Trials as Topic
dc.subjectComprehension
dc.subjectCross-Sectional Studies
dc.subjectData Interpretation, Statistical
dc.subjectEndpoint Determination
dc.subjectFemale
dc.subject*Health Knowledge, Attitudes, Practice
dc.subjectHospitals, University
dc.subjectHumans
dc.subjectInternet
dc.subjectMale
dc.subjectNeuroprotective Agents
dc.subjectPatient Selection
dc.subjectSeverity of Illness Index
dc.subjectStroke
dc.subjectTreatment Outcome
dc.subjectUnited States
dc.subjectNeurology
dc.subjectNeuroscience and Neurobiology
dc.titleOutcome analysis in clinical trial design for acute stroke: physicians' attitudes and choices
dc.typeJournal Article
dc.source.journaltitleCerebrovascular diseases (Basel, Switzerland)
dc.source.volume26
dc.source.issue2
dc.identifier.legacycoverpagehttps://escholarship.umassmed.edu/neuro_pp/366
dc.identifier.contextkey1242238
html.description.abstract<p>BACKGROUND: Thrombolysis remains the only proven therapy to benefit acute ischemic stroke (AIS) patients. Recent studies have introduced more sensitive outcome measures such as the shift analysis to detect a treatment effect in AIS trials and are also including imaging as a surrogate of injury.</p> <p>METHODS: We conducted a cross-sectional, internet-based survey of academic neurologists regarding their attitudes, choices and understanding of various outcome measures in clinical trial design for AIS. The survey population consisted of neurologists who specialize in the care of stroke patients and are on faculty at university-affiliated hospitals in the USA.</p> <p>RESULTS: 152 of 300 neurologists completed the survey. There were 79% men and 21% women. Among commonly used outcome scales in acute stroke, the most frequent ones selected for use as trial primary endpoints were the global statistic (59%), modified Rankin scale (mRS) (52%), and NIHSS (30%). When given choices about which outcome on the mRS would justify a therapeutic intervention, 54% chose a shift analysis of change in the distribution of outcomes and 39% chose a dichotomized outcome (mRS </p> <p>CONCLUSION: The majority of respondents accepted an analysis of the entire distribution of the mRS scores as an appropriate endpoint analytic technique in AIS trials and did not require the traditional dichotomized outcome to demonstrate a treatment effect; however, a better understanding of the shift strategy is needed. Our data also support the importance of incorporating mismatch imaging into future neuroprotection trials.</p>
dc.identifier.submissionpathneuro_pp/366
dc.contributor.departmentDepartment of Neurology
dc.source.pages156-62


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