{"id":"https://openalex.org/W4403859684","doi":"https://doi.org/10.1093/jamia/ocae273","title":"A machine learning framework to adjust for learning effects in medical device safety evaluation","display_name":"A machine learning framework to adjust for learning effects in medical device safety evaluation","publication_year":2024,"publication_date":"2024-10-29","ids":{"openalex":"https://openalex.org/W4403859684","doi":"https://doi.org/10.1093/jamia/ocae273","pmid":"https://pubmed.ncbi.nlm.nih.gov/39471493"},"language":"en","primary_location":{"id":"doi:10.1093/jamia/ocae273","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocae273","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11648715/pdf/ocae273.pdf","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5010573386","display_name":"Jejo Koola","orcid":"https://orcid.org/0000-0001-5171-8475"},"institutions":[{"id":"https://openalex.org/I36258959","display_name":"University of California San Diego","ror":"https://ror.org/0168r3w48","country_code":"US","type":"education","lineage":["https://openalex.org/I36258959"]}],"countries":["US"],"is_corresponding":true,"raw_author_name":"Jejo D Koola","raw_affiliation_strings":["Department of Medicine, University of California San Diego , San Diego, CA 92093,"],"raw_orcid":"https://orcid.org/0000-0001-5171-8475","affiliations":[{"raw_affiliation_string":"Department of Medicine, University of California San Diego , San Diego, CA 92093,","institution_ids":["https://openalex.org/I36258959"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5076829264","display_name":"Karthik Ramesh","orcid":"https://orcid.org/0000-0003-2938-7942"},"institutions":[{"id":"https://openalex.org/I36258959","display_name":"University of California San Diego","ror":"https://ror.org/0168r3w48","country_code":"US","type":"education","lineage":["https://openalex.org/I36258959"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Karthik Ramesh","raw_affiliation_strings":["School of Medicine, University of California San Diego , San Diego, CA 92093,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Medicine, University of California San Diego , San Diego, CA 92093,","institution_ids":["https://openalex.org/I36258959"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005925770","display_name":"Jialin Mao","orcid":"https://orcid.org/0000-0001-6671-3474"},"institutions":[{"id":"https://openalex.org/I205783295","display_name":"Cornell University","ror":"https://ror.org/05bnh6r87","country_code":"US","type":"education","lineage":["https://openalex.org/I205783295"]},{"id":"https://openalex.org/I4387153466","display_name":"Weill Cornell Medicine","ror":"https://ror.org/02r109517","country_code":"US","type":"education","lineage":["https://openalex.org/I205783295","https://openalex.org/I4387153466"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jialin Mao","raw_affiliation_strings":["Department of Population Health Sciences, Weill Cornell Medicine , New York, NY 10065,"],"raw_orcid":"https://orcid.org/0000-0001-6671-3474","affiliations":[{"raw_affiliation_string":"Department of Population Health Sciences, Weill Cornell Medicine , New York, NY 10065,","institution_ids":["https://openalex.org/I205783295","https://openalex.org/I4387153466"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5075206197","display_name":"Minsu Ahn","orcid":null},"institutions":[{"id":"https://openalex.org/I36258959","display_name":"University of California San Diego","ror":"https://ror.org/0168r3w48","country_code":"US","type":"education","lineage":["https://openalex.org/I36258959"]},{"id":"https://openalex.org/I4210150894","display_name":"Jacobs (United States)","ror":"https://ror.org/05pmj3x43","country_code":"US","type":"company","lineage":["https://openalex.org/I4210150894"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Minyoung Ahn","raw_affiliation_strings":["Jacobs School of Engineering, University of California San Diego , San Diego, CA 92093,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Jacobs School of Engineering, University of California San Diego , San Diego, CA 92093,","institution_ids":["https://openalex.org/I36258959","https://openalex.org/I4210150894"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5063516544","display_name":"Sharon E. Davis","orcid":"https://orcid.org/0000-0003-0792-8867"},"institutions":[{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Sharon E Davis","raw_affiliation_strings":["Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,"],"raw_orcid":"https://orcid.org/0000-0003-0792-8867","affiliations":[{"raw_affiliation_string":"Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,","institution_ids":["https://openalex.org/I901861585"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046611224","display_name":"Usha Govindarajulu","orcid":"https://orcid.org/0000-0001-5864-7403"},"institutions":[{"id":"https://openalex.org/I98704320","display_name":"Icahn School of Medicine at Mount Sinai","ror":"https://ror.org/04a9tmd77","country_code":"US","type":"education","lineage":["https://openalex.org/I1320796813","https://openalex.org/I98704320"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Usha Govindarajulu","raw_affiliation_strings":["Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai , New York, NY 10029,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai , New York, NY 10029,","institution_ids":["https://openalex.org/I98704320"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056846095","display_name":"Amy M. Perkins","orcid":"https://orcid.org/0000-0001-9052-3558"},"institutions":[{"id":"https://openalex.org/I4210101790","display_name":"VA Tennessee Valley Healthcare System","ror":"https://ror.org/01c9rqr26","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1322918889","https://openalex.org/I2799886695","https://openalex.org/I4210101790","https://openalex.org/I4210112672"]},{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Amy M Perkins","raw_affiliation_strings":["Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","Geriatric Research Education and Clinical Care Center, Tennessee Valley Healthcare System VA , Nashville, TN 37212,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"Geriatric Research Education and Clinical Care Center, Tennessee Valley Healthcare System VA , Nashville, TN 37212,","institution_ids":["https://openalex.org/I4210101790"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057487553","display_name":"Dax Westerman","orcid":"https://orcid.org/0000-0002-9547-7789"},"institutions":[{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Dax Westerman","raw_affiliation_strings":["Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,","institution_ids":["https://openalex.org/I901861585"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074629603","display_name":"Henry Ssemaganda","orcid":"https://orcid.org/0009-0001-2877-3465"},"institutions":[{"id":"https://openalex.org/I4210106397","display_name":"Lahey Medical Center","ror":"https://ror.org/01m178w43","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210106397"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Henry Ssemaganda","raw_affiliation_strings":["Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center , Burlington, MA 01803,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center , Burlington, MA 01803,","institution_ids":["https://openalex.org/I4210106397"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5057054226","display_name":"Theodore Speroff","orcid":null},"institutions":[{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Theodore Speroff","raw_affiliation_strings":["Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","Department of Medicine, Vanderbilt University Medical Center , Nashville, TN 37232,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"Department of Medicine, Vanderbilt University Medical Center , Nashville, TN 37232,","institution_ids":["https://openalex.org/I901861585"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084415954","display_name":"Lucila Ohno\u2010Machado","orcid":"https://orcid.org/0000-0002-8005-7327"},"institutions":[{"id":"https://openalex.org/I32971472","display_name":"Yale University","ror":"https://ror.org/03v76x132","country_code":"US","type":"education","lineage":["https://openalex.org/I32971472"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Lucila Ohno-Machado","raw_affiliation_strings":["Department of Biomedical Informatics and Data Science, Yale School of Medicine , New Haven, CT 06510,"],"raw_orcid":"https://orcid.org/0000-0002-8005-7327","affiliations":[{"raw_affiliation_string":"Department of Biomedical Informatics and Data Science, Yale School of Medicine , New Haven, CT 06510,","institution_ids":["https://openalex.org/I32971472"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5060375617","display_name":"Craig Ramsay","orcid":"https://orcid.org/0000-0003-4043-7349"},"institutions":[{"id":"https://openalex.org/I195460627","display_name":"University of Aberdeen","ror":"https://ror.org/016476m91","country_code":"GB","type":"education","lineage":["https://openalex.org/I195460627"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Craig R Ramsay","raw_affiliation_strings":["Health Services Research Unit, University of Aberdeen , Aberdeen AB25 2ZD,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Health Services Research Unit, University of Aberdeen , Aberdeen AB25 2ZD,","institution_ids":["https://openalex.org/I195460627"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5015697849","display_name":"Art Sedrakyan","orcid":"https://orcid.org/0000-0003-3882-9765"},"institutions":[{"id":"https://openalex.org/I205783295","display_name":"Cornell University","ror":"https://ror.org/05bnh6r87","country_code":"US","type":"education","lineage":["https://openalex.org/I205783295"]},{"id":"https://openalex.org/I4387153466","display_name":"Weill Cornell Medicine","ror":"https://ror.org/02r109517","country_code":"US","type":"education","lineage":["https://openalex.org/I205783295","https://openalex.org/I4387153466"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Art Sedrakyan","raw_affiliation_strings":["Department of Population Health Sciences, Weill Cornell Medicine , New York, NY 10065,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Population Health Sciences, Weill Cornell Medicine , New York, NY 10065,","institution_ids":["https://openalex.org/I205783295","https://openalex.org/I4387153466"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5080431459","display_name":"Frederic S. Resnic","orcid":"https://orcid.org/0000-0002-4105-4529"},"institutions":[{"id":"https://openalex.org/I1289019353","display_name":"Lahey Hospital and Medical Center","ror":"https://ror.org/03mbq3y29","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1289019353"]},{"id":"https://openalex.org/I4210106397","display_name":"Lahey Medical Center","ror":"https://ror.org/01m178w43","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210106397"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Frederic S Resnic","raw_affiliation_strings":["Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center , Burlington, MA 01803,","Division of Cardiovascular Medicine, Lahey Hospital and Medical Center , Burlington, MA 01805,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Comparative Effectiveness Research Institute, Lahey Hospital and Medical Center , Burlington, MA 01803,","institution_ids":["https://openalex.org/I4210106397"]},{"raw_affiliation_string":"Division of Cardiovascular Medicine, Lahey Hospital and Medical Center , Burlington, MA 01805,","institution_ids":["https://openalex.org/I4210106397","https://openalex.org/I1289019353"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5011689338","display_name":"Michael E. Matheny","orcid":"https://orcid.org/0000-0003-3217-4147"},"institutions":[{"id":"https://openalex.org/I4210101790","display_name":"VA Tennessee Valley Healthcare System","ror":"https://ror.org/01c9rqr26","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1322918889","https://openalex.org/I2799886695","https://openalex.org/I4210101790","https://openalex.org/I4210112672"]},{"id":"https://openalex.org/I901861585","display_name":"Vanderbilt University Medical Center","ror":"https://ror.org/05dq2gs74","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I4210162197","https://openalex.org/I901861585"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Michael E Matheny","raw_affiliation_strings":["Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,","Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","Department of Medicine, Vanderbilt University Medical Center , Nashville, TN 37232,","Geriatric Research Education and Clinical Care Center, Tennessee Valley Healthcare System VA , Nashville, TN 37212,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Biomedical Informatics, Vanderbilt University Medical Center , Nashville, TN 37203,","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"Department of Biostatistics, Vanderbilt University Medical Center , Nashville, TN 37232,","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"Department of Medicine, Vanderbilt University Medical Center , Nashville, TN 37232,","institution_ids":["https://openalex.org/I901861585"]},{"raw_affiliation_string":"Geriatric Research Education and Clinical Care Center, Tennessee Valley Healthcare System VA , Nashville, TN 37212,","institution_ids":["https://openalex.org/I4210101790"]}]}],"institutions":[],"countries_distinct_count":2,"institutions_distinct_count":15,"corresponding_author_ids":["https://openalex.org/A5010573386"],"corresponding_institution_ids":["https://openalex.org/I36258959"],"apc_list":{"value":3967,"currency":"USD","value_usd":3967},"apc_paid":null,"fwci":1.7105,"has_fulltext":true,"cited_by_count":2,"citation_normalized_percentile":{"value":0.89578903,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":91,"max":97},"biblio":{"volume":"32","issue":"1","first_page":"206","last_page":"217"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T13690","display_name":"Quality and Safety in Healthcare","score":0.22059999406337738,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"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/T13690","display_name":"Quality and Safety in Healthcare","score":0.22059999406337738,"subfield":{"id":"https://openalex.org/subfields/3607","display_name":"Medical Laboratory Technology"},"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/T11636","display_name":"Artificial Intelligence in Healthcare and Education","score":0.10999999940395355,"subfield":{"id":"https://openalex.org/subfields/2718","display_name":"Health Informatics"},"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/T13248","display_name":"Healthcare Technology and Patient Monitoring","score":0.06030000001192093,"subfield":{"id":"https://openalex.org/subfields/2746","display_name":"Surgery"},"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/machine-learning","display_name":"Machine learning","score":0.6721608638763428},{"id":"https://openalex.org/keywords/artificial-intelligence","display_name":"Artificial intelligence","score":0.6640579700469971},{"id":"https://openalex.org/keywords/computer-science","display_name":"Computer science","score":0.6328864097595215},{"id":"https://openalex.org/keywords/decision-tree","display_name":"Decision tree","score":0.551068902015686},{"id":"https://openalex.org/keywords/replicate","display_name":"Replicate","score":0.5071890354156494},{"id":"https://openalex.org/keywords/tree","display_name":"Tree (set theory)","score":0.46000033617019653},{"id":"https://openalex.org/keywords/patient-safety","display_name":"Patient safety","score":0.45514586567878723},{"id":"https://openalex.org/keywords/learning-curve","display_name":"Learning curve","score":0.4545052647590637},{"id":"https://openalex.org/keywords/health-care","display_name":"Health care","score":0.1635112762451172},{"id":"https://openalex.org/keywords/statistics","display_name":"Statistics","score":0.15701159834861755},{"id":"https://openalex.org/keywords/mathematics","display_name":"Mathematics","score":0.0971352756023407}],"concepts":[{"id":"https://openalex.org/C119857082","wikidata":"https://www.wikidata.org/wiki/Q2539","display_name":"Machine learning","level":1,"score":0.6721608638763428},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.6640579700469971},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.6328864097595215},{"id":"https://openalex.org/C84525736","wikidata":"https://www.wikidata.org/wiki/Q831366","display_name":"Decision tree","level":2,"score":0.551068902015686},{"id":"https://openalex.org/C2781162219","wikidata":"https://www.wikidata.org/wiki/Q26250693","display_name":"Replicate","level":2,"score":0.5071890354156494},{"id":"https://openalex.org/C113174947","wikidata":"https://www.wikidata.org/wiki/Q2859736","display_name":"Tree (set theory)","level":2,"score":0.46000033617019653},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.45514586567878723},{"id":"https://openalex.org/C34585555","wikidata":"https://www.wikidata.org/wiki/Q1368723","display_name":"Learning curve","level":2,"score":0.4545052647590637},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.1635112762451172},{"id":"https://openalex.org/C105795698","wikidata":"https://www.wikidata.org/wiki/Q12483","display_name":"Statistics","level":1,"score":0.15701159834861755},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.0971352756023407},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C134306372","wikidata":"https://www.wikidata.org/wiki/Q7754","display_name":"Mathematical analysis","level":1,"score":0.0},{"id":"https://openalex.org/C50522688","wikidata":"https://www.wikidata.org/wiki/Q189833","display_name":"Economic growth","level":1,"score":0.0},{"id":"https://openalex.org/C111919701","wikidata":"https://www.wikidata.org/wiki/Q9135","display_name":"Operating system","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D000069550","descriptor_name":"Machine Learning","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003663","descriptor_name":"Decision Trees","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004864","descriptor_name":"Equipment and Supplies","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true},{"descriptor_ui":"D004869","descriptor_name":"Equipment Safety","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":"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":"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":"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":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","is_major_topic":true},{"descriptor_ui":"D011358","descriptor_name":"Product Surveillance, Postmarketing","qualifier_ui":"Q000379","qualifier_name":"methods","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":"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":"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":"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}],"locations_count":4,"locations":[{"id":"doi:10.1093/jamia/ocae273","is_oa":false,"landing_page_url":"https://doi.org/10.1093/jamia/ocae273","pdf_url":null,"source":{"id":"https://openalex.org/S129839026","display_name":"Journal of the American Medical Informatics Association","issn_l":"1067-5027","issn":["1067-5027","1527-974X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"host_organization":"https://openalex.org/P4310311648","host_organization_name":"Oxford University Press","host_organization_lineage":["https://openalex.org/P4310311648","https://openalex.org/P4310311647"],"host_organization_lineage_names":["Oxford University Press","University of Oxford"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of the American Medical Informatics Association","raw_type":"journal-article"},{"id":"pmid:39471493","is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/39471493","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":"Journal of the American Medical Informatics Association : JAMIA","raw_type":null},{"id":"pmh:oai:pubmedcentral.nih.gov:11648715","is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11648715/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11648715/pdf/ocae273.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Am Med Inform Assoc","raw_type":"Text"},{"id":"pmh:oai:europepmc.org:11367902","is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/11648715","pdf_url":null,"source":{"id":"https://openalex.org/S4306400806","display_name":"Europe PMC (PubMed Central)","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"host_organization":"https://openalex.org/I1303153112","host_organization_name":"European Bioinformatics Institute","host_organization_lineage":["https://openalex.org/I1303153112"],"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":"Text"}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:11648715","is_oa":true,"landing_page_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11648715/","pdf_url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11648715/pdf/ocae273.pdf","source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"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":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"J Am Med Inform Assoc","raw_type":"Text"},"sustainable_development_goals":[],"awards":[{"id":"https://openalex.org/G6399140587","display_name":null,"funder_award_id":"P50 HD103537","funder_id":"https://openalex.org/F4320337611","funder_display_name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development"},{"id":"https://openalex.org/G6442848003","display_name":null,"funder_award_id":"K01HL159315","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"},{"id":"https://openalex.org/G6966074968","display_name":null,"funder_award_id":"R01 HL149948","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"},{"id":"https://openalex.org/G8999583355","display_name":null,"funder_award_id":"K01 HL159315","funder_id":"https://openalex.org/F4320337338","funder_display_name":"National Heart, Lung, and Blood Institute"}],"funders":[{"id":"https://openalex.org/F4320337338","display_name":"National Heart, Lung, and Blood Institute","ror":"https://ror.org/012pb6c26"},{"id":"https://openalex.org/F4320337611","display_name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development","ror":"https://ror.org/04byxyr05"}],"has_content":{"pdf":true,"grobid_xml":false},"content_urls":{"pdf":"https://content.openalex.org/works/W4403859684.pdf"},"referenced_works_count":44,"referenced_works":["https://openalex.org/W105856836","https://openalex.org/W566101460","https://openalex.org/W1516659296","https://openalex.org/W1590763174","https://openalex.org/W1759025684","https://openalex.org/W1894479445","https://openalex.org/W1964672088","https://openalex.org/W1967587789","https://openalex.org/W2003336670","https://openalex.org/W2003790307","https://openalex.org/W2013529414","https://openalex.org/W2034530625","https://openalex.org/W2067728401","https://openalex.org/W2079320572","https://openalex.org/W2095960325","https://openalex.org/W2125794271","https://openalex.org/W2126331248","https://openalex.org/W2133429879","https://openalex.org/W2154609285","https://openalex.org/W2161619512","https://openalex.org/W2164005910","https://openalex.org/W2295598076","https://openalex.org/W2327353653","https://openalex.org/W2331795354","https://openalex.org/W2337090803","https://openalex.org/W2468431774","https://openalex.org/W2555245543","https://openalex.org/W2611163880","https://openalex.org/W2612690371","https://openalex.org/W2718690139","https://openalex.org/W2745401084","https://openalex.org/W2803552707","https://openalex.org/W2893963456","https://openalex.org/W2933621115","https://openalex.org/W2947751279","https://openalex.org/W3115244792","https://openalex.org/W3118255311","https://openalex.org/W3163109953","https://openalex.org/W3173486119","https://openalex.org/W4364377242","https://openalex.org/W4407815411","https://openalex.org/W6792016901","https://openalex.org/W6929950662","https://openalex.org/W6967503984"],"related_works":["https://openalex.org/W4254851101","https://openalex.org/W3171007296","https://openalex.org/W22115721","https://openalex.org/W2321234655","https://openalex.org/W2065444835","https://openalex.org/W4394550905","https://openalex.org/W2952773340","https://openalex.org/W2470062578","https://openalex.org/W2981861370","https://openalex.org/W4229503580"],"abstract_inverted_index":{"OBJECTIVES:":[0],"Traditional":[1],"methods":[2,25,352],"for":[3,13,56,112,220,293,312,367],"medical":[4,84,374],"device":[5,22,119,209,243,252,282,317,375],"post-market":[6,316,355],"surveillance":[7,356],"often":[8],"fail":[9],"to":[10,18,45,52,71,90,107,324,339,363],"accurately":[11,227,259],"account":[12],"operator":[14,57,108,176,275,329],"learning":[15,30,49,58,92,177,199,234,276,309,330,368],"effects,":[16,369],"leading":[17],"biased":[19],"assessments":[20],"of":[21,79,150,168,207,233,238,248,267,315,337,349],"safety.":[23],"These":[24],"struggle":[26],"with":[27,162,261,302],"non-linearity,":[28],"complex":[29,341],"curves,":[31],"and":[32,54,110,131,139,155,172,174,188,201,203,240,284,365],"time-varying":[33],"covariates,":[34],"such":[35],"as":[36],"physician":[37],"experience.":[38],"To":[39,122],"address":[40],"these":[41,113],"limitations,":[42],"we":[43,125],"sought":[44],"develop":[46],"a":[47,95,182,189,271,360],"machine":[48,308],"(ML)":[50],"framework":[51,226,289,345],"detect":[53,91,364],"adjust":[55,111,366],"effects.":[59],"MATERIALS":[60],"AND":[61],"METHODS:":[62],"A":[63,307],"gradient-boosted":[64],"decision":[65],"tree":[66],"ML":[67,338],"method":[68],"was":[69],"used":[70,136],"analyze":[72],"synthetic":[73,160],"datasets":[74,161,239],"that":[75],"replicate":[76],"the":[77,101,148,175,205,208,229,262,303,313,335,347],"complexity":[78],"clinical":[80,145],"scenarios":[81],"involving":[82],"high-risk":[83],"devices.":[85],"We":[86,157,194],"designed":[87],"this":[88],"process":[89],"effects":[93,200,235,277],"using":[94],"risk-adjusted":[96],"cumulative":[97],"sum":[98],"method,":[99],"quantify":[100],"excess":[102],"adverse":[103],"event":[104],"rate":[105],"attributable":[106],"inexperience,":[109],"alongside":[114],"patient":[115,140,169],"factors":[116],"in":[117,197,236,246,265,280,285,353],"evaluating":[118],"safety":[120,210,221,244,296,376],"signals.":[121],"maintain":[123],"integrity,":[124],"employed":[126],"blinding":[127],"between":[128,153],"data":[129,135,146],"generation":[130],"analysis":[132],"teams.":[133],"Synthetic":[134],"underlying":[137],"distributions":[138],"feature":[141],"correlations":[142],"based":[143],"on":[144],"from":[147],"Department":[149],"Veterans":[151],"Affairs":[152],"2005":[154],"2012.":[156],"generated":[158],"2494":[159],"widely":[163],"varying":[164],"characteristics":[165],"including":[166],"number":[167],"features,":[170],"operators":[171],"institutions,":[173],"form.":[178],"Each":[179],"dataset":[180],"contained":[181],"hypothetical":[183],"study":[184],"device,":[185,191],"Device":[186,192],"B,":[187],"reference":[190],"A.":[193],"evaluated":[195,215],"accuracy":[196],"identifying":[198,202],"estimating":[204],"strength":[206],"signal.":[211],"Our":[212,225],"approach":[213],"also":[214],"different":[216],"clinically":[217,294],"relevant":[218,295],"thresholds":[219],"signal":[222,297],"detection.":[223],"RESULTS:":[224],"identified":[228],"presence":[230],"or":[231],"absence":[232],"93.6%":[237],"correctly":[241],"determined":[242],"signals":[245,283],"93.4%":[247],"cases.":[249],"The":[250],"estimated":[251],"odds":[253],"ratios'":[254],"95%":[255],"confidence":[256],"intervals":[257],"were":[258],"aligned":[260],"specified":[263],"ratios":[264],"94.7%":[266],"datasets.":[268],"In":[269],"contrast,":[270],"comparative":[272],"model":[273],"excluding":[274],"significantly":[278,372],"underperformed":[279],"detecting":[281],"accuracy.":[286],"Notably,":[287],"our":[288,344],"achieved":[290],"100%":[291],"specificity":[292],"thresholds,":[298],"although":[299],"sensitivity":[300],"varied":[301],"threshold":[304],"applied.":[305],"DISCUSSION:":[306],"framework,":[310],"tailored":[311],"complexities":[314],"evaluation,":[318],"may":[319,371],"provide":[320],"superior":[321],"performance":[322],"compared":[323],"standard":[325],"parametric":[326],"techniques":[327],"when":[328],"is":[331],"present.":[332],"CONCLUSION:":[333],"Demonstrating":[334],"capacity":[336],"overcome":[340],"evaluative":[342],"challenges,":[343],"addresses":[346],"limitations":[348],"traditional":[350],"statistical":[351],"current":[354],"processes.":[357],"By":[358],"offering":[359],"reliable":[361],"means":[362],"it":[370],"improve":[373],"evaluation.":[377]},"counts_by_year":[{"year":2026,"cited_by_count":1},{"year":2025,"cited_by_count":1}],"updated_date":"2026-06-23T06:36:01.041984","created_date":"2025-10-10T00:00:00"}
