{"id":"https://openalex.org/W4410448615","doi":"https://doi.org/10.3233/shti250626","title":"Measuring Expressiveness of the Clincal Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) for the American Burn Association Burn Care Quality Program Registry Real-World Data (RWD)","display_name":"Measuring Expressiveness of the Clincal Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) for the American Burn Association Burn Care Quality Program Registry Real-World Data (RWD)","publication_year":2025,"publication_date":"2025-05-15","ids":{"openalex":"https://openalex.org/W4410448615","doi":"https://doi.org/10.3233/shti250626","pmid":"https://pubmed.ncbi.nlm.nih.gov/40380729"},"language":"en","primary_location":{"id":"doi:10.3233/shti250626","is_oa":true,"landing_page_url":"https://doi.org/10.3233/shti250626","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/SHTI250626","source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},"type":"book-chapter","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/SHTI250626","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5093130890","display_name":"Manju Bikkanuri","orcid":"https://orcid.org/0000-0002-6908-5597"},"institutions":[{"id":"https://openalex.org/I165951966","display_name":"The University of Texas at San Antonio Health Science Center","ror":"https://ror.org/02f6dcw23","country_code":"US","type":"education","lineage":["https://openalex.org/I165951966","https://openalex.org/I45438204"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Manju Bikkanuri","raw_affiliation_strings":["University of Texas Health Science Center at San Antonio TX USA"],"raw_orcid":"https://orcid.org/0000-0002-6908-5597","affiliations":[{"raw_affiliation_string":"University of Texas Health Science Center at San Antonio TX USA","institution_ids":["https://openalex.org/I165951966"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5087121662","display_name":"Muayad Hamidi","orcid":"https://orcid.org/0009-0005-9825-4993"},"institutions":[{"id":"https://openalex.org/I165951966","display_name":"The University of Texas at San Antonio Health Science Center","ror":"https://ror.org/02f6dcw23","country_code":"US","type":"education","lineage":["https://openalex.org/I165951966","https://openalex.org/I45438204"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Muayad Hamidi","raw_affiliation_strings":["University of Texas Health Science Center at San Antonio TX USA"],"raw_orcid":"https://orcid.org/0009-0005-9825-4993","affiliations":[{"raw_affiliation_string":"University of Texas Health Science Center at San Antonio TX USA","institution_ids":["https://openalex.org/I165951966"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046980164","display_name":"Meredith Zozus","orcid":"https://orcid.org/0000-0002-9332-1684"},"institutions":[{"id":"https://openalex.org/I165951966","display_name":"The University of Texas at San Antonio Health Science Center","ror":"https://ror.org/02f6dcw23","country_code":"US","type":"education","lineage":["https://openalex.org/I165951966","https://openalex.org/I45438204"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Meredith N. Zozus","raw_affiliation_strings":["University of Texas Health Science Center at San Antonio TX USA"],"raw_orcid":"https://orcid.org/0000-0002-9332-1684","affiliations":[{"raw_affiliation_string":"University of Texas Health Science Center at San Antonio TX USA","institution_ids":["https://openalex.org/I165951966"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5052127975","display_name":"Maryam Y. Garza","orcid":"https://orcid.org/0000-0002-2652-5935"},"institutions":[{"id":"https://openalex.org/I165951966","display_name":"The University of Texas at San Antonio Health Science Center","ror":"https://ror.org/02f6dcw23","country_code":"US","type":"education","lineage":["https://openalex.org/I165951966","https://openalex.org/I45438204"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Maryam Y. Garza","raw_affiliation_strings":["University of Texas Health Science Center at San Antonio TX USA"],"raw_orcid":"https://orcid.org/0000-0002-2652-5935","affiliations":[{"raw_affiliation_string":"University of Texas Health Science Center at San Antonio TX USA","institution_ids":["https://openalex.org/I165951966"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I165951966"],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.29660643,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"327","issue":null,"first_page":"1368","last_page":"1372"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10350","display_name":"Electronic Health Records Systems","score":0.6528000235557556,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10350","display_name":"Electronic Health Records Systems","score":0.6528000235557556,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11614","display_name":"Cloud Data Security Solutions","score":0.6335999965667725,"subfield":{"id":"https://openalex.org/subfields/1710","display_name":"Information Systems"},"field":{"id":"https://openalex.org/fields/17","display_name":"Computer Science"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T11719","display_name":"Data Quality and Management","score":0.5649999976158142,"subfield":{"id":"https://openalex.org/subfields/1803","display_name":"Management Science and Operations Research"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/food-and-drug-administration","display_name":"Food and drug administration","score":0.51558917760849},{"id":"https://openalex.org/keywords/medicine","display_name":"Medicine","score":0.45534902811050415},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.4457811713218689},{"id":"https://openalex.org/keywords/clinical-trial","display_name":"Clinical trial","score":0.43925637006759644},{"id":"https://openalex.org/keywords/medline","display_name":"MEDLINE","score":0.4389484226703644},{"id":"https://openalex.org/keywords/quality","display_name":"Quality (philosophy)","score":0.4125562906265259},{"id":"https://openalex.org/keywords/data-mining","display_name":"Data mining","score":0.40396058559417725},{"id":"https://openalex.org/keywords/medical-emergency","display_name":"Medical emergency","score":0.3036310076713562},{"id":"https://openalex.org/keywords/pathology","display_name":"Pathology","score":0.11100080609321594}],"concepts":[{"id":"https://openalex.org/C3018890749","wikidata":"https://www.wikidata.org/wiki/Q204711","display_name":"Food and drug administration","level":2,"score":0.51558917760849},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.45534902811050415},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.4457811713218689},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.43925637006759644},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.4389484226703644},{"id":"https://openalex.org/C2779530757","wikidata":"https://www.wikidata.org/wiki/Q1207505","display_name":"Quality (philosophy)","level":2,"score":0.4125562906265259},{"id":"https://openalex.org/C124101348","wikidata":"https://www.wikidata.org/wiki/Q172491","display_name":"Data mining","level":1,"score":0.40396058559417725},{"id":"https://openalex.org/C545542383","wikidata":"https://www.wikidata.org/wiki/Q2751242","display_name":"Medical emergency","level":1,"score":0.3036310076713562},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.11100080609321594},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C138885662","wikidata":"https://www.wikidata.org/wiki/Q5891","display_name":"Philosophy","level":0,"score":0.0},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.0},{"id":"https://openalex.org/C111472728","wikidata":"https://www.wikidata.org/wiki/Q9471","display_name":"Epistemology","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D002056","descriptor_name":"Burns","qualifier_ui":"Q000628","qualifier_name":"therapy","is_major_topic":true},{"descriptor_ui":"D002056","descriptor_name":"Burns","qualifier_ui":"Q000628","qualifier_name":"therapy","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","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":"D012042","descriptor_name":"Registries","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D012042","descriptor_name":"Registries","qualifier_ui":"Q000592","qualifier_name":"standards","is_major_topic":true},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014481","descriptor_name":"United States","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014486","descriptor_name":"United States Food and Drug Administration","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false}],"locations_count":2,"locations":[{"id":"doi:10.3233/shti250626","is_oa":true,"landing_page_url":"https://doi.org/10.3233/shti250626","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/SHTI250626","source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},{"id":"pmid:40380729","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/40380729","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,"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":"Studies in health technology and informatics","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.3233/shti250626","is_oa":true,"landing_page_url":"https://doi.org/10.3233/shti250626","pdf_url":"https://ebooks.iospress.nl/pdf/doi/10.3233/SHTI250626","source":{"id":"https://openalex.org/S4210179765","display_name":"Studies in health technology and informatics","issn_l":"0926-9630","issn":["0926-9630","1879-8365"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310318577","host_organization_name":"IOS Press","host_organization_lineage":["https://openalex.org/P4310318577"],"host_organization_lineage_names":["IOS Press"],"type":"book series"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Studies in Health Technology and Informatics","raw_type":"book-chapter"},"sustainable_development_goals":[{"display_name":"Partnerships for the goals","id":"https://metadata.un.org/sdg/17","score":0.4099999964237213}],"awards":[{"id":"https://openalex.org/G2126012127","display_name":null,"funder_award_id":"UM1 TR004538","funder_id":"https://openalex.org/F4320337472","funder_display_name":"National Center for Advancing Translational Sciences"}],"funders":[{"id":"https://openalex.org/F4320332161","display_name":"National Institutes of Health","ror":"https://ror.org/01cwqze88"},{"id":"https://openalex.org/F4320337472","display_name":"National Center for Advancing Translational Sciences","ror":"https://ror.org/04pw6fb54"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W4410448615.pdf","grobid_xml":"https://content.openalex.org/works/W4410448615.grobid-xml"},"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W2026337388","https://openalex.org/W1591825783","https://openalex.org/W2597209334","https://openalex.org/W2076628636","https://openalex.org/W1968470787","https://openalex.org/W2920600216","https://openalex.org/W4290794148","https://openalex.org/W4300705810","https://openalex.org/W1966157979","https://openalex.org/W2406195353"],"abstract_inverted_index":{"The":[0,18],"United":[1],"States":[2],"(US)":[3],"21st":[4],"Century":[5],"Cures":[6],"Act":[7],"of":[8,15,20,49,86,102],"2016":[9],"was":[10,121],"developed":[11],"to":[12,54,61,88,124,143,152],"accelerate":[13],"development":[14,29],"new":[16],"therapeutics.":[17],"use":[19,65],"real-world":[21],"data":[22,92,133],"(RWD)":[23],"in":[24,30,137],"regulatory":[25,52],"submissions":[26,53,60],"for":[27,51,81,104],"therapeutic":[28],"the":[31,55,62,66,84,100,107,125,138,148],"US":[32,37],"is":[33],"increasingly":[34],"supported":[35],"by":[36],"Food":[38],"and":[39,58,147],"Drug":[40,57],"Administration":[41],"(FDA)":[42],"guidance.":[43],"Registries":[44],"are":[45],"a":[46],"recognized":[47],"source":[48],"RWD":[50],"FDA.":[56],"Biologics":[59],"FDA":[63],"must":[64],"Clinical":[67],"Data":[68,74],"Interchange":[69],"Standards":[70],"Consortium":[71],"(CDISC)":[72],"Study":[73],"Tabulation":[75],"Model":[76],"(SDTM)":[77],"format.":[78],"However,":[79],"designed":[80],"clinical":[82],"trials,":[83],"ability":[85],"SDTM":[87,103,127,139,145,153],"represent":[89],"RWD,":[90],"including":[91],"from":[93],"registries":[94],"has":[95],"been":[96],"questioned.":[97],"To":[98],"evaluate":[99],"expressiveness":[101],"registry":[105],"data,":[106],"American":[108],"Burn":[109,111],"Association,":[110],"Care":[112],"Quality":[113],"Program":[114],"(BCQP)":[115],"Registry":[116,132],"v4.1":[117],"as":[118],"an":[119],"exemplar":[120],"systematically":[122],"mapped":[123,151],"CDISC":[126],"v3.3":[128],"standard.":[129],"All":[130],"BCQP":[131],"elements":[134],"were":[135],"representable":[136],"with":[140],"93%":[141],"mapping":[142],"standard":[144],"domains,":[146],"remaining":[149],"7%":[150],"Supplemental":[154],"Qualifiers.":[155]},"counts_by_year":[],"updated_date":"2026-08-25T07:29:55.448023","created_date":"2025-10-10T00:00:00"}
