{"id":"https://openalex.org/W2280417974","doi":"https://doi.org/10.1161/str.44.suppl_1.a162","title":"Abstract 162: The Challenges of Decision-making Regarding Futility in a Randomized Trial: The IMS III Experience","display_name":"Abstract 162: The Challenges of Decision-making Regarding Futility in a Randomized Trial: The IMS III Experience","publication_year":2013,"publication_date":"2013-02-01","ids":{"openalex":"https://openalex.org/W2280417974","doi":"https://doi.org/10.1161/str.44.suppl_1.a162","mag":"2280417974"},"language":"en","primary_location":{"id":"doi:10.1161/str.44.suppl_1.a162","doi":"https://doi.org/10.1161/str.44.suppl_1.a162","is_oa":false,"landing_page_url":"https://doi.org/10.1161/str.44.suppl_1.a162","pdf_url":null,"source":{"id":"https://openalex.org/S62532593","display_name":"Stroke","issn_l":"0039-2499","issn":["0039-2499","1524-4628"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Stroke","raw_type":"journal-article"},"volume":null,"type":"conference-abstract","is_traditional":false,"indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5033233067","display_name":"Sharon D. Yeatts","orcid":"https://orcid.org/0000-0001-9235-0670","observed_orcids":["https://orcid.org/0000-0001-9235-0670"]},"institutions":[{"id":"https://openalex.org/I153297377","display_name":"Medical University of South Carolina","ror":"https://ror.org/012jban78","country_code":"US","type":"education","lineage":["https://openalex.org/I153297377"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Sharon D Yeatts","raw_affiliation_strings":["Med Univ of South Carolina, Charleston, SC","Sharon D Yeatts"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Med Univ of South Carolina, Charleston, SC","institution_ids":["https://openalex.org/I153297377"]},{"raw_affiliation_string":"Sharon D Yeatts","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5101527520","display_name":"Renee Martin","orcid":"https://orcid.org/0000-0002-9589-681X","observed_orcids":["https://orcid.org/0000-0002-9589-681X"]},"institutions":[{"id":"https://openalex.org/I153297377","display_name":"Medical University of South Carolina","ror":"https://ror.org/012jban78","country_code":"US","type":"education","lineage":["https://openalex.org/I153297377"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Renee\u2019 H Martin","raw_affiliation_strings":["Med Univ of South Carolina, Charleston, SC","Renee' H Martin"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Med Univ of South Carolina, Charleston, SC","institution_ids":["https://openalex.org/I153297377"]},{"raw_affiliation_string":"Renee' H Martin","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084475391","display_name":"Lydia D. Foster","orcid":"https://orcid.org/0000-0001-6856-5583","observed_orcids":["https://orcid.org/0000-0001-6856-5583"]},"institutions":[{"id":"https://openalex.org/I153297377","display_name":"Medical University of South Carolina","ror":"https://ror.org/012jban78","country_code":"US","type":"education","lineage":["https://openalex.org/I153297377"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lydia D Foster","raw_affiliation_strings":["Med Univ of South Carolina, Charleston, SC","Lydia D Foster"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Med Univ of South Carolina, Charleston, SC","institution_ids":["https://openalex.org/I153297377"]},{"raw_affiliation_string":"Lydia D Foster","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5111641382","display_name":"Robert F. Woolson","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I153297377","display_name":"Medical University of South Carolina","ror":"https://ror.org/012jban78","country_code":"US","type":"education","lineage":["https://openalex.org/I153297377"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Robert F Woolson","raw_affiliation_strings":["Med Univ of South Carolina, Charleston, SC","Robert F Woolson"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Med Univ of South Carolina, Charleston, SC","institution_ids":["https://openalex.org/I153297377"]},{"raw_affiliation_string":"Robert F Woolson","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083232394","display_name":"Joseph P. Broderick","orcid":"https://orcid.org/0000-0002-7323-7709","observed_orcids":["https://orcid.org/0000-0002-7323-7709"]},"institutions":[{"id":"https://openalex.org/I63135867","display_name":"University of Cincinnati","ror":"https://ror.org/01e3m7079","country_code":"US","type":"education","lineage":["https://openalex.org/I63135867"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Joseph P Broderick","raw_affiliation_strings":["Univ of Cincinnati, Cincinnati, OH","Joseph P Broderick"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Univ of Cincinnati, Cincinnati, OH","institution_ids":["https://openalex.org/I63135867"]},{"raw_affiliation_string":"Joseph P Broderick","institution_ids":[]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5002815959","display_name":"Yuko Y. Palesch","orcid":"https://orcid.org/0000-0003-3434-8550","observed_orcids":["https://orcid.org/0000-0003-3434-8550"]},"institutions":[{"id":"https://openalex.org/I153297377","display_name":"Medical University of South Carolina","ror":"https://ror.org/012jban78","country_code":"US","type":"education","lineage":["https://openalex.org/I153297377"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Yuko Y Palesch","raw_affiliation_strings":["Med Univ of South Carolina, Charleston, SC","Yuko Y Palesch"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Med Univ of South Carolina, Charleston, SC","institution_ids":["https://openalex.org/I153297377"]},{"raw_affiliation_string":"Yuko Y Palesch","institution_ids":[]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":2,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":2,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":"44","issue":"suppl_1","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9872999787330627,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},"topics":[{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.9872999787330627,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10227","display_name":"Acute Ischemic Stroke Management","score":0.006000000052154064,"subfield":{"id":"https://openalex.org/subfields/2728","display_name":"Clinical Neurology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10582","display_name":"Ethics in Clinical Research","score":0.0013000000035390258,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/futility-analysis","display_name":"futility analysis","score":0.5630000233650208},{"id":"https://openalex.org/keywords/conditional-power","display_name":"conditional power","score":0.9079999923706055},{"id":"https://openalex.org/keywords/interim-analysis","display_name":"interim analysis","score":0.8560000061988831},{"id":"https://openalex.org/keywords/data-and-safety-monitoring-board","display_name":"data safety monitoring board","score":0.7979999780654907},{"id":"https://openalex.org/keywords/acute-ischemic-stroke","display_name":"acute ischemic stroke","score":0.828000009059906},{"id":"https://openalex.org/keywords/intravenous-tpa","display_name":"intravenous tPA","score":0.8289999961853027},{"id":"https://openalex.org/keywords/intra-arterial-therapy","display_name":"intra-arterial therapy","score":0.7760000228881836},{"id":"https://openalex.org/keywords/trial-termination","display_name":"trial termination","score":0.5230000019073486},{"id":"https://openalex.org/keywords/trial-design","display_name":"trial design","score":0.41200000047683716}],"concepts":[{"id":"https://openalex.org/C2776957806","wikidata":"https://www.wikidata.org/wiki/Q4895105","display_name":"Interim","level":2,"score":0.8755719661712646},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8599740266799927},{"id":"https://openalex.org/C61943457","wikidata":"https://www.wikidata.org/wiki/Q6046661","display_name":"Interim analysis","level":3,"score":0.6315252780914307},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.619697630405426},{"id":"https://openalex.org/C5465570","wikidata":"https://www.wikidata.org/wiki/Q5326898","display_name":"Early stopping","level":3,"score":0.495008647441864},{"id":"https://openalex.org/C65409693","wikidata":"https://www.wikidata.org/wiki/Q425265","display_name":"Statistical significance","level":2,"score":0.4508282542228699},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.23711830377578735},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.21629852056503296},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.19031530618667603},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.10982593894004822},{"id":"https://openalex.org/C166957645","wikidata":"https://www.wikidata.org/wiki/Q23498","display_name":"Archaeology","level":1,"score":0.0},{"id":"https://openalex.org/C50644808","wikidata":"https://www.wikidata.org/wiki/Q192776","display_name":"Artificial neural network","level":2,"score":0.0},{"id":"https://openalex.org/C95457728","wikidata":"https://www.wikidata.org/wiki/Q309","display_name":"History","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1161/str.44.suppl_1.a162","doi":"https://doi.org/10.1161/str.44.suppl_1.a162","is_oa":false,"landing_page_url":"https://doi.org/10.1161/str.44.suppl_1.a162","pdf_url":null,"source":{"id":"https://openalex.org/S62532593","display_name":"Stroke","issn_l":"0039-2499","issn":["0039-2499","1524-4628"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-class-a","anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Stroke","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":0.8048999905586243,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2107331800","https://openalex.org/W2039690243","https://openalex.org/W3008510792","https://openalex.org/W2057099216","https://openalex.org/W2034456343","https://openalex.org/W2324869316","https://openalex.org/W185274233","https://openalex.org/W7100775248","https://openalex.org/W608649263","https://openalex.org/W4411212100"],"abstract_inverted_index":{"INTRODUCTION:":[0],"IMS":[1,117],"3":[2,35,73,118],"Trial":[3,119],"is":[4,169],"a":[5,155],"multicenter":[6],"randomized":[7],"study":[8,143,195,210],"to":[9,21,43,47,52,148,171,198],"compare":[10],"the":[11,14,22,59,88,93,100,112,116,124,132,139,142,145,152,164,182,191,194,199,205,208,213,216,220,230,238,243,250,257,260],"effectiveness":[12],"of":[13,37,61,70,108,134,141,159,190,193,219,228,232,252,259,264],"bridging":[15],"(IV":[16],"tPA":[17,24],"+":[18],"intra-arterial)":[19],"therapy":[20],"IV":[23],"only":[25],"treatment":[26],"in":[27,58,114,215,226,242,256],"patients":[28],"with":[29,63,151],"acute":[30],"ischemic":[31],"stroke":[32],"presenting":[33],"within":[34],"hours":[36],"symptom":[38],"onset.":[39],"The":[40,95,176,188],"trial":[41],"intended":[42],"enroll":[44],"900":[45],"subjects":[46,62,80],"ensure":[48],"adequate":[49],"statistical":[50,136,173],"power":[51,107,128],"detect":[53],"an":[54],"absolute":[55],"10%":[56,160],"difference":[57,158],"%":[60],"good":[64],"outcome,":[65],"defined":[66,130],"as":[67,131],"mRS":[68],"score":[69],"0-2":[71],"at":[72,138,181,237],"months.":[74],"In":[75],"April":[76],"2012,":[77],"after":[78],"656":[79],"were":[81],"randomized,":[82],"further":[83],"enrollment":[84],"was":[85,97,120,129,179],"terminated":[86],"by":[87,92,123],"NINDS":[89],"upon":[90],"recommendation":[91],"DSMB.":[94,125],"decision":[96],"based":[98],"on":[99],"pre-specified":[101],"criterion":[102],"for":[103],"futility":[104,177,200],"using":[105],"conditional":[106],"<20%.":[109],"We":[110],"describe":[111],"process":[113],"which":[115],"deemed":[121],"futile":[122],"METHOD:":[126],"Conditional":[127],"likelihood":[133],"finding":[135],"significance":[137],"end":[140],"given":[144],"accumulated":[146],"data":[147,221,239],"date":[149],"and":[150,212,245],"assumption":[153],"that":[154,196],"minimum":[156],"hypothesized":[157],"truly":[161],"exists":[162],"between":[163,207],"two":[165],"groups.":[166],"Hence,":[167],"it":[168],"akin":[170],"ordinary":[172],"power.":[174],"RESULTS:":[175],"boundary":[178],"crossed":[180],"Trial\u2019s":[183],"4":[184],"th":[185],"interim":[186,233,235],"analysis.":[187],"details":[189],"evolution":[192],"led":[197],"determination":[201],"are":[202],"presented,":[203],"including":[204,262],"interaction":[206],"unblinded":[209],"statisticians":[211],"DSMB":[214],"complex":[217],"deliberation":[218],"analysis":[222],"results.":[223],"CONCLUSION:":[224],"Even":[225],"spite":[227],"pre-specifying":[229],"parameters":[231],"analysis,":[234],"looks":[236],"pose":[240],"challenges":[241],"interpretation":[244],"decision-making.":[246],"It":[247],"therefore":[248],"underscores":[249],"importance":[251],"taking":[253],"utmost":[254],"care":[255],"design":[258],"study,":[261],"specification":[263],"objective":[265],"stopping":[266],"guidelines.":[267]},"counts_by_year":[{"year":2016,"cited_by_count":1},{"year":2014,"cited_by_count":1}],"updated_date":"2026-08-21T09:56:20.448147","created_date":"2016-06-24T00:00:00"}
