{"id":"https://openalex.org/W3087582330","doi":"https://doi.org/10.1002/pds.5117","title":"Assessing the impact of unmeasured confounders for credible and reliable real\u2010world evidence","display_name":"Assessing the impact of unmeasured confounders for credible and reliable real\u2010world evidence","publication_year":2020,"publication_date":"2020-09-14","ids":{"openalex":"https://openalex.org/W3087582330","doi":"https://doi.org/10.1002/pds.5117","mag":"3087582330","pmid":"https://pubmed.ncbi.nlm.nih.gov/32929830"},"language":"en","primary_location":{"id":"doi:10.1002/pds.5117","doi":"https://doi.org/10.1002/pds.5117","is_oa":false,"landing_page_url":"https://doi.org/10.1002/pds.5117","pdf_url":null,"source":{"id":"https://openalex.org/S140231191","display_name":"Pharmacoepidemiology and Drug Safety","issn_l":"1053-8569","issn":["1053-8569","1099-1557"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacoepidemiology and Drug Safety","raw_type":"journal-article"},"volume":null,"type":"review","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://osf.io/fe4gs/download","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5059480360","display_name":"Xiang Zhang","orcid":"https://orcid.org/0000-0002-5304-0482","observed_orcids":["https://orcid.org/0000-0002-5304-0482"]},"institutions":[{"id":"https://openalex.org/I168537998","display_name":"Eli Lilly (United States)","ror":"https://ror.org/01qat3289","country_code":"US","type":"company","lineage":["https://openalex.org/I168537998"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Xiang Zhang","raw_affiliation_strings":["Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA"],"raw_orcid":"https://orcid.org/0000-0002-5304-0482","affiliations":[{"raw_affiliation_string":"Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA","institution_ids":["https://openalex.org/I168537998"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072226527","display_name":"James D. Stamey","orcid":"https://orcid.org/0000-0002-3787-6490","observed_orcids":["https://orcid.org/0000-0002-3787-6490"]},"institutions":[{"id":"https://openalex.org/I157394403","display_name":"Baylor University","ror":"https://ror.org/005781934","country_code":"US","type":"education","lineage":["https://openalex.org/I157394403"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"James D. Stamey","raw_affiliation_strings":["Department of Statistics, Baylor University, Waco, Texas, USA"],"raw_orcid":"https://orcid.org/0000-0002-3787-6490","affiliations":[{"raw_affiliation_string":"Department of Statistics, Baylor University, Waco, Texas, USA","institution_ids":["https://openalex.org/I157394403"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5021906307","display_name":"Maya B. Mathur","orcid":"https://orcid.org/0000-0001-6698-2607","observed_orcids":["https://orcid.org/0000-0001-6698-2607"]},"institutions":[{"id":"https://openalex.org/I97018004","display_name":"Stanford University","ror":"https://ror.org/00f54p054","country_code":"US","type":"education","lineage":["https://openalex.org/I97018004"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Maya B. Mathur","raw_affiliation_strings":["Quantitative Sciences Unit, Stanford University, Stanford, California, USA"],"raw_orcid":"https://orcid.org/0000-0001-6698-2607","affiliations":[{"raw_affiliation_string":"Quantitative Sciences Unit, Stanford University, Stanford, California, USA","institution_ids":["https://openalex.org/I97018004"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":3,"corresponding_author_ids":["https://openalex.org/A5072226527"],"corresponding_institution_ids":["https://openalex.org/I157394403"],"apc_list":{"value":4500,"currency":"USD","value_usd":4500},"apc_paid":null,"fwci":0.7448,"has_fulltext":false,"cited_by_count":54,"citation_normalized_percentile":{"value":0.63768116,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":97,"max":100},"biblio":{"volume":"29","issue":"10","first_page":"1219","last_page":"1227"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10845","display_name":"Advanced Causal Inference Techniques","score":0.9994999766349792,"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/T10845","display_name":"Advanced Causal Inference Techniques","score":0.9994999766349792,"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/T14374","display_name":"Statistical Methods in Epidemiology","score":0.00019999999494757503,"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/T11235","display_name":"Statistical Methods in Clinical Trials","score":9.999999747378752e-05,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/unmeasured-confounding","display_name":"unmeasured confounding","score":1.0},{"id":"https://openalex.org/keywords/sensitivity-analysis","display_name":"sensitivity analysis","score":0.6880000233650208},{"id":"https://openalex.org/keywords/e-values","display_name":"E-value","score":0.9440000057220459},{"id":"https://openalex.org/keywords/real-world-evidence","display_name":"real-world evidence","score":0.8209999799728394},{"id":"https://openalex.org/keywords/non-interventional-study","display_name":"non-interventional study","score":0.906000018119812},{"id":"https://openalex.org/keywords/bias-assessment","display_name":"bias assessment","score":0.7329999804496765}],"concepts":[{"id":"https://openalex.org/C77350462","wikidata":"https://www.wikidata.org/wiki/Q1125472","display_name":"Confounding","level":2,"score":0.8343105316162109},{"id":"https://openalex.org/C21200559","wikidata":"https://www.wikidata.org/wiki/Q7451068","display_name":"Sensitivity (control systems)","level":2,"score":0.5175899267196655},{"id":"https://openalex.org/C94124525","wikidata":"https://www.wikidata.org/wiki/Q912550","display_name":"Categorization","level":2,"score":0.5169665217399597},{"id":"https://openalex.org/C158600405","wikidata":"https://www.wikidata.org/wiki/Q5054566","display_name":"Causal inference","level":2,"score":0.48211026191711426},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.47236424684524536},{"id":"https://openalex.org/C149782125","wikidata":"https://www.wikidata.org/wiki/Q160039","display_name":"Econometrics","level":1,"score":0.4669087529182434},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.338907390832901},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.3283851444721222},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.12344822287559509},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.09742012619972229},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C24326235","wikidata":"https://www.wikidata.org/wiki/Q126095","display_name":"Electronic engineering","level":1,"score":0.0},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.0}],"mesh":[{"descriptor_ui":"D003627","descriptor_name":"Data Interpretation, Statistical","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D012107","descriptor_name":"Research Design","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D015982","descriptor_name":"Bias","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015984","descriptor_name":"Causality","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D015986","descriptor_name":"Confounding Factors, Epidemiologic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":6,"locations":[{"id":"doi:10.1002/pds.5117","doi":"https://doi.org/10.1002/pds.5117","is_oa":false,"landing_page_url":"https://doi.org/10.1002/pds.5117","pdf_url":null,"source":{"id":"https://openalex.org/S140231191","display_name":"Pharmacoepidemiology and Drug Safety","issn_l":"1053-8569","issn":["1053-8569","1099-1557"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-2","poland-100","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pharmacoepidemiology and Drug Safety","raw_type":"journal-article"},{"id":"doi:10.31219/osf.io/fe4gs","doi":"https://doi.org/10.31219/osf.io/fe4gs","is_oa":true,"landing_page_url":"https://doi.org/10.31219/osf.io/fe4gs","pdf_url":"https://osf.io/fe4gs/download","source":{"id":"https://openalex.org/S4306401127","display_name":"OSF Preprints (OSF Preprints)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2799848540","host_organization_name":"Center for Open Science","host_organization_lineage":["https://openalex.org/I2799848540"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"posted-content"},{"id":"pmid:32929830","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/32929830","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":"Pharmacoepidemiology and drug safety","raw_type":"Journal Article"},{"id":"pmh:oai:RePEc:osf:osfxxx:fe4gs_v1","doi":null,"is_oa":false,"landing_page_url":"https://osf.io/download/5f778a9e39d7e301b4eb6272/","pdf_url":null,"source":{"id":"https://openalex.org/S4306401271","display_name":"RePEc: Research Papers in Economics","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I77793887","host_organization_name":"Federal Reserve Bank of St. Louis","host_organization_lineage":["https://openalex.org/I77793887"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"preprint"},{"id":"pmh:oai:share.osf.io:73ae9d3c-5488-4f0d-9b28-c1cbfd4d0cd6","doi":null,"is_oa":true,"landing_page_url":"https://osf.io/fe4gs","pdf_url":null,"source":{"id":"https://openalex.org/S4306401127","display_name":"OSF Preprints (OSF Preprints)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2799848540","host_organization_name":"Center for Open Science","host_organization_lineage":["https://openalex.org/I2799848540"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"Preprint"},{"id":"pmh:oai:share.osf.io:E01A4-0ED-A4F","doi":null,"is_oa":false,"landing_page_url":"http://doi.org/10.31219/OSF.IO/FE4GS","pdf_url":null,"source":{"id":"https://openalex.org/S4306401127","display_name":"OSF Preprints (OSF Preprints)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2799848540","host_organization_name":"Center for Open Science","host_organization_lineage":["https://openalex.org/I2799848540"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"","raw_type":"preprint"}],"best_oa_location":{"id":"doi:10.31219/osf.io/fe4gs","doi":"https://doi.org/10.31219/osf.io/fe4gs","is_oa":true,"landing_page_url":"https://doi.org/10.31219/osf.io/fe4gs","pdf_url":"https://osf.io/fe4gs/download","source":{"id":"https://openalex.org/S4306401127","display_name":"OSF Preprints (OSF Preprints)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I2799848540","host_organization_name":"Center for Open Science","host_organization_lineage":["https://openalex.org/I2799848540"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":null,"raw_type":"posted-content"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.6240000128746033,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W3087582330.pdf","grobid_xml":"https://content.openalex.org/works/W3087582330.grobid-xml"},"referenced_works_count":69,"referenced_works":["https://openalex.org/W200863923","https://openalex.org/W1593442063","https://openalex.org/W1605552950","https://openalex.org/W1847771980","https://openalex.org/W1967862917","https://openalex.org/W1972113220","https://openalex.org/W1978108654","https://openalex.org/W1989484996","https://openalex.org/W1998653759","https://openalex.org/W2009428399","https://openalex.org/W2014799253","https://openalex.org/W2016919144","https://openalex.org/W2019307140","https://openalex.org/W2031668066","https://openalex.org/W2034309896","https://openalex.org/W2038951972","https://openalex.org/W2045908763","https://openalex.org/W2047221799","https://openalex.org/W2052038764","https://openalex.org/W2052513269","https://openalex.org/W2053975254","https://openalex.org/W2063022356","https://openalex.org/W2065800517","https://openalex.org/W2080706677","https://openalex.org/W2082081076","https://openalex.org/W2085983659","https://openalex.org/W2088824227","https://openalex.org/W2098571791","https://openalex.org/W2099817335","https://openalex.org/W2123833295","https://openalex.org/W2131924600","https://openalex.org/W2135690654","https://openalex.org/W2138290169","https://openalex.org/W2138499964","https://openalex.org/W2144409155","https://openalex.org/W2156517063","https://openalex.org/W2169711166","https://openalex.org/W2209559096","https://openalex.org/W2242307981","https://openalex.org/W2319648697","https://openalex.org/W2320756439","https://openalex.org/W2333702587","https://openalex.org/W2339224947","https://openalex.org/W2466391332","https://openalex.org/W2474073878","https://openalex.org/W2535857337","https://openalex.org/W2545458768","https://openalex.org/W2597269988","https://openalex.org/W2608809317","https://openalex.org/W2735301415","https://openalex.org/W2745473302","https://openalex.org/W2754973711","https://openalex.org/W2755504031","https://openalex.org/W2756079951","https://openalex.org/W2791281149","https://openalex.org/W2808135930","https://openalex.org/W2898891872","https://openalex.org/W2911154380","https://openalex.org/W2982183961","https://openalex.org/W3047310998","https://openalex.org/W3121385028","https://openalex.org/W3122958054","https://openalex.org/W3124062519","https://openalex.org/W4206724094","https://openalex.org/W4240373784","https://openalex.org/W4242936822","https://openalex.org/W4252553827","https://openalex.org/W4300822692","https://openalex.org/W4301055281"],"related_works":["https://openalex.org/W4382402052","https://openalex.org/W4376478569","https://openalex.org/W2914585126","https://openalex.org/W4308516671","https://openalex.org/W4408927973","https://openalex.org/W2189238412","https://openalex.org/W4405000514","https://openalex.org/W3198134153","https://openalex.org/W3013838175","https://openalex.org/W3104425677"],"abstract_inverted_index":{"PURPOSE:":[0],"We":[1,63],"review":[2],"statistical":[3,40,145],"methods":[4,177,207,226],"for":[5,25,43,47,68,73,171,233],"assessing":[6,69],"the":[7,28,85,101,110,116,160,173,184,191,248,263,273,278],"possible":[8],"impact":[9],"of":[10,186,251,268],"bias":[11,49],"due":[12,50],"to":[13,51,90,134,156,197,211,223,246,265],"unmeasured":[14,52,70,102,135,162,187,213],"confounding":[15,53],"in":[16,54,227,255],"real":[17],"world":[18],"data":[19,158],"analysis":[20,176,194],"and":[21,45,92,181,189,275,280],"provide":[22,198],"detailed":[23],"recommendations":[24],"choosing":[26,172,234],"among":[27],"methods.":[29],"METHODS:":[30],"By":[31],"updating":[32],"an":[33],"earlier":[34],"systematic":[35],"review,":[36],"we":[37,77,148,244],"summarize":[38],"modern":[39],"best":[41],"practices":[42],"evaluating":[44],"correcting":[46],"potential":[48,264],"estimating":[55],"causal":[56,201],"treatment":[57,202],"effect":[58],"from":[59],"non-interventional":[60,256],"studies.":[61,257],"RESULTS:":[62],"suggest":[64,128],"a":[65,81,199,220],"hierarchical":[66],"structure":[67],"confounding.":[71],"First,":[72],"initial":[74,126,236],"sensitivity":[75,175,193,242,253,269],"analyses,":[76,243],"strongly":[78],"recommend":[79],"applying":[80],"recently":[82],"developed":[83],"method,":[84],"E-value,":[86],"that":[87],"is":[88,108,195],"straightforward":[89],"apply":[91],"does":[93],"not":[94,131],"require":[95,154],"prior":[96],"knowledge":[97,107],"or":[98,118,166],"assumptions":[99],"about":[100],"confounder(s).":[103],"When":[104],"some":[105],"such":[106,252],"available,":[109],"E-value":[111],"could":[112,139],"be":[113,132,140],"supplemented":[114],"by":[115],"rule-out":[117],"array":[119],"method":[120],"at":[121],"this":[122],"step.":[123],"If":[124],"these":[125],"analyses":[127,138,254,270],"results":[129],"may":[130],"robust":[133],"confounding,":[136,214],"subsequent":[137,174,192,241],"conducted":[141],"using":[142],"more":[143,239],"specialized":[144,240],"methods,":[146],"which":[147],"categorize":[149],"based":[150],"on":[151,159],"whether":[152,190],"they":[153],"access":[155],"external":[157],"suspected":[161],"confounder(s),":[163],"internal":[164],"data,":[165],"no":[167],"data.":[168],"Other":[169],"factors":[170],"are":[178],"also":[179,261],"introduced":[180],"discussed,":[182],"including":[183],"types":[185],"confounders":[188],"intended":[196],"corrected":[200],"effect.":[203],"CONCLUSION:":[204],"Various":[205],"analytical":[206],"have":[208],"been":[209],"proposed":[210],"address":[212],"but":[215],"little":[216],"research":[217],"has":[218,262],"discussed":[219],"structured":[221],"approach":[222,260],"select":[224],"appropriate":[225,235],"practice.":[228],"In":[229],"providing":[230],"practical":[231],"suggestions":[232],"and,":[237],"potentially,":[238],"hope":[245],"facilitate":[247],"widespread":[249],"reporting":[250],"The":[258],"suggested":[259],"inform":[266],"pre-specification":[267],"before":[271],"executing":[272],"analysis,":[274],"therefore":[276],"increase":[277],"transparency":[279],"limit":[281],"selective":[282],"study":[283],"reporting.":[284]},"counts_by_year":[{"year":2026,"cited_by_count":16},{"year":2025,"cited_by_count":7},{"year":2024,"cited_by_count":11},{"year":2023,"cited_by_count":6},{"year":2022,"cited_by_count":9},{"year":2021,"cited_by_count":5}],"updated_date":"2026-11-12T12:28:57.059296","created_date":"2020-09-25T00:00:00"}