{"id":"https://openalex.org/W2417618181","doi":null,"title":"What can we learn from design faults in the Women's Health Initiative randomized clinical trial?","display_name":"What can we learn from design faults in the Women's Health Initiative randomized clinical trial?","publication_year":2009,"publication_date":"2009-01-01","ids":{"openalex":"https://openalex.org/W2417618181","mag":"2417618181","pmid":"https://pubmed.ncbi.nlm.nih.gov/19583558"},"language":"en","primary_location":{"id":"pmid:19583558","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/19583558","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Bulletin of the NYU hospital for joint diseases","raw_type":"Journal Article"},"volume":null,"type":"article","indexed_in":["pubmed"],"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/A5038686564","display_name":"Tan O","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I57206974","display_name":"New York University","ror":"https://ror.org/0190ak572","country_code":"US","type":"education","lineage":["https://openalex.org/I57206974"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Orkun Tan","raw_affiliation_strings":["Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA","institution_ids":["https://openalex.org/I57206974"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5012321322","display_name":"S. Mitchell Harman","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"S Mitchell Harman","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5030184373","display_name":"Frederick Nicholas Naftolin","orcid":"https://orcid.org/0000-0002-9447-6266","observed_orcids":["https://orcid.org/0000-0002-9447-6266"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Frederick Naftolin","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":1.3722,"has_fulltext":false,"cited_by_count":17,"citation_normalized_percentile":{"value":0.83468649,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":97},"biblio":{"volume":"67","issue":"2","first_page":"226","last_page":"9"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10694","display_name":"Menopause: Health Impacts and Treatments","score":0.9965999722480774,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10694","display_name":"Menopause: Health Impacts and Treatments","score":0.9965999722480774,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.0007999999797903001,"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/T13252","display_name":"Sex and Gender in Healthcare","score":0.0003000000142492354,"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/women-s-health-initiative","display_name":"Women's Health Initiative","score":0.9950000047683716},{"id":"https://openalex.org/keywords/trial-design-flaws","display_name":"trial design flaws","score":0.7360000014305115},{"id":"https://openalex.org/keywords/hormone-replacement-therapy","display_name":"hormone replacement therapy","score":0.968999981880188},{"id":"https://openalex.org/keywords/cardioprotection","display_name":"cardioprotection","score":0.9359999895095825},{"id":"https://openalex.org/keywords/cardiovascular-events","display_name":"cardiovascular events","score":0.6010000109672546},{"id":"https://openalex.org/keywords/menopause","display_name":"menopause","score":0.5860000252723694},{"id":"https://openalex.org/keywords/trial-recruitment","display_name":"trial recruitment","score":0.3019999861717224},{"id":"https://openalex.org/keywords/treatment-timing","display_name":"treatment timing","score":0.3050000071525574},{"id":"https://openalex.org/keywords/regulatory-guidance","display_name":"regulatory guidelines","score":0.5360000133514404},{"id":"https://openalex.org/keywords/postmenopausal-women","display_name":"postmenopausal women","score":0.6420000195503235}],"concepts":[{"id":"https://openalex.org/C2779676291","wikidata":"https://www.wikidata.org/wiki/Q25325349","display_name":"Cardioprotection","level":3,"score":0.9004417657852173},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8554040789604187},{"id":"https://openalex.org/C23131810","wikidata":"https://www.wikidata.org/wiki/Q818574","display_name":"Observational study","level":2,"score":0.7357996106147766},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.6958091259002686},{"id":"https://openalex.org/C2778562196","wikidata":"https://www.wikidata.org/wiki/Q177708","display_name":"Menopause","level":2,"score":0.6168882846832275},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6032408475875854},{"id":"https://openalex.org/C2780733421","wikidata":"https://www.wikidata.org/wiki/Q1451732","display_name":"Women's Health Initiative","level":3,"score":0.5478588342666626},{"id":"https://openalex.org/C27415008","wikidata":"https://www.wikidata.org/wiki/Q7256382","display_name":"Psychological intervention","level":2,"score":0.5046716928482056},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.4756048619747162},{"id":"https://openalex.org/C2777267654","wikidata":"https://www.wikidata.org/wiki/Q3519023","display_name":"Test (biology)","level":2,"score":0.4621172249317169},{"id":"https://openalex.org/C1862650","wikidata":"https://www.wikidata.org/wiki/Q186005","display_name":"Physical therapy","level":1,"score":0.4266775846481323},{"id":"https://openalex.org/C177713679","wikidata":"https://www.wikidata.org/wiki/Q679690","display_name":"Intensive care medicine","level":1,"score":0.36186695098876953},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.21095088124275208},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.15618658065795898},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.06773167848587036},{"id":"https://openalex.org/C151730666","wikidata":"https://www.wikidata.org/wiki/Q7205","display_name":"Paleontology","level":1,"score":0.0},{"id":"https://openalex.org/C541997718","wikidata":"https://www.wikidata.org/wiki/Q188151","display_name":"Ischemia","level":2,"score":0.0},{"id":"https://openalex.org/C86803240","wikidata":"https://www.wikidata.org/wiki/Q420","display_name":"Biology","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D000367","descriptor_name":"Age Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D001291","descriptor_name":"Attitude of Health Personnel","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D002318","descriptor_name":"Cardiovascular Diseases","qualifier_ui":"Q000517","qualifier_name":"prevention & control","is_major_topic":true},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007722","descriptor_name":"Health Knowledge, Attitudes, Practice","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D011322","descriptor_name":"Primary Prevention","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D013997","descriptor_name":"Time Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015914","descriptor_name":"Estrogen Replacement Therapy","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015983","descriptor_name":"Selection Bias","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D016032","descriptor_name":"Randomized Controlled Trials as Topic","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D016387","descriptor_name":"Women's Health","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D017410","descriptor_name":"Practice Guidelines as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018401","descriptor_name":"Sample Size","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018579","descriptor_name":"Patient Selection","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D019317","descriptor_name":"Evidence-Based Medicine","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D032882","descriptor_name":"Comprehension","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":3,"locations":[{"id":"pmid:19583558","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/19583558","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Bulletin of the NYU hospital for joint diseases","raw_type":"Journal Article"},{"id":"pmh:oai:CiteSeerX.psu:10.1.1.663.9433","doi":null,"is_oa":false,"landing_page_url":"http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.663.9433","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"http://nyuhjdbulletin.org/Mod/Bulletin/V67N2/Docs/V67N2_25.pdf","raw_type":"text"},{"id":"mag:2417618181","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/19583558","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":1.0,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":11,"referenced_works":["https://openalex.org/W1593442063","https://openalex.org/W2002815810","https://openalex.org/W2058521038","https://openalex.org/W2089892151","https://openalex.org/W2094588318","https://openalex.org/W2110502449","https://openalex.org/W2117049071","https://openalex.org/W2124653687","https://openalex.org/W2131266318","https://openalex.org/W2290627980","https://openalex.org/W2352579400"],"related_works":["https://openalex.org/W7098523626","https://openalex.org/W2117049071","https://openalex.org/W2019647253","https://openalex.org/W2744162429","https://openalex.org/W7099089183","https://openalex.org/W2119641064","https://openalex.org/W1991394012","https://openalex.org/W2171636933","https://openalex.org/W1971893144","https://openalex.org/W2115341476"],"abstract_inverted_index":{"Design":[0],"faults":[1],"resulted":[2,62],"in":[3,63,84,97,122,130,148,215,221],"the":[4,7,17,38,57,60,76,103,111,123,131,139,149,162,167,187,213,216,229,244],"inability":[5],"of":[6,19,26,40,45,59,65,78,82,114,161,231,246],"Women's":[8],"Health":[9],"Initiative":[10],"(WHI)":[11],"randomized":[12],"clinical":[13],"trial":[14],"to":[15,52,102,128,141,174,190,210,223,242],"test":[16,243],"level":[18],"cardioprotection":[20,83,96,147,192],"conferred":[21],"by":[22,166],"timely":[23],"hormone":[24,181],"treatment":[25,88,100],"women":[27,121],"seeking":[28],"help":[29],"for":[30,73],"menopausal":[31,104,180,247],"complaints.":[32],"Adopting":[33],"a":[34,89,107,151,175],"design":[35,218],"constructed":[36],"around":[37,75],"avoidance":[39],"symptomatic":[41],"subjects":[42,47,68,85,98,115],"and":[43,170,193,202,206,219,228,235],"recruitment":[44,64],"older":[46],"who":[48,125],"were":[49,118,126],"more":[50,92],"likely":[51],"manifest":[53],"cardiovascular":[54],"events":[55],"during":[56],"life":[58],"WHI":[61,124,140,164,217],"older,":[66],"sicker":[67],"than":[69],"are":[70,197,240],"normally":[71],"treated":[72],"complaints":[74],"time":[77],"menopause.":[79],"The":[80],"lack":[81],"that":[86,134,143,153,196],"began":[87],"decade":[90],"or":[91],"after":[93,157],"menopause":[94],"diluted":[95],"starting":[99],"close":[101],"transition.":[105],"As":[106],"result,":[108],"despite":[109],"having":[110],"largest":[112],"number":[113],"ever,":[116],"there":[117,144],"not":[119],"enough":[120],"comparable":[127],"those":[129],"observational":[132],"trials":[133,239],"showed":[135],"cardioprotection.":[136,249],"This":[137,183],"led":[138,173],"report":[142],"was":[145],"no":[146],"trial,":[150],"position":[152],"has":[154],"been":[155],"qualified":[156],"further":[158],"analysis.":[159],"Misapprehension":[160],"initial":[163],"conclusions":[165,234],"media,":[168],"professionals,":[169],"regulatory":[171],"agencies":[172,205],"major":[176],"shift":[177],"away":[178],"from":[179],"treatment.":[182],"remains":[184],"problematic":[185],"since":[186],"evidence":[188],"continues":[189],"favor":[191],"other":[194],"benefits":[195],"denied":[198],"under":[199],"present":[200],"regulations":[201],"guidelines.":[203],"Regulatory":[204],"professional":[207],"organizations":[208],"need":[209],"better":[211],"understand":[212],"faws":[214],"results":[220,227],"order":[222],"properly":[224],"consider":[225],"its":[226],"sustainability":[230],"their":[232],"earlier":[233],"recommendations.":[236],"Additionally,":[237],"new":[238],"needed":[241],"validity":[245],"hormone-related":[248]},"counts_by_year":[{"year":2020,"cited_by_count":1},{"year":2019,"cited_by_count":3},{"year":2018,"cited_by_count":2},{"year":2016,"cited_by_count":3},{"year":2015,"cited_by_count":1},{"year":2013,"cited_by_count":1}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2016-06-24T00:00:00"}