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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project</title>
<author><name sortKey="Avillach, Paul" sort="Avillach, Paul" uniqKey="Avillach P" first="Paul" last="Avillach">Paul Avillach</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Coloma, Preciosa M" sort="Coloma, Preciosa M" uniqKey="Coloma P" first="Preciosa M" last="Coloma">Preciosa M. Coloma</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Gini, Rosa" sort="Gini, Rosa" uniqKey="Gini R" first="Rosa" last="Gini">Rosa Gini</name>
<affiliation><nlm:aff id="af4">Regional Health Agency of ARS, Florence, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Schuemie, Martijn" sort="Schuemie, Martijn" uniqKey="Schuemie M" first="Martijn" last="Schuemie">Martijn Schuemie</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Mougin, Fleur" sort="Mougin, Fleur" uniqKey="Mougin F" first="Fleur" last="Mougin">Fleur Mougin</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dufour, Jean Charles" sort="Dufour, Jean Charles" uniqKey="Dufour J" first="Jean-Charles" last="Dufour">Jean-Charles Dufour</name>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Mazzaglia, Giampiero" sort="Mazzaglia, Giampiero" uniqKey="Mazzaglia G" first="Giampiero" last="Mazzaglia">Giampiero Mazzaglia</name>
<affiliation><nlm:aff id="af5">Health Search—Italian College of General Practitioners, Florence, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Giaquinto, Carlo" sort="Giaquinto, Carlo" uniqKey="Giaquinto C" first="Carlo" last="Giaquinto">Carlo Giaquinto</name>
<affiliation><nlm:aff id="af6">Pedianet—Societa’ Servizi Telematici SRL, Padova, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fornari, Carla" sort="Fornari, Carla" uniqKey="Fornari C" first="Carla" last="Fornari">Carla Fornari</name>
<affiliation><nlm:aff id="af7">Centre on Public Health, University of Milano-Bicocca, Milano, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Herings, Ron" sort="Herings, Ron" uniqKey="Herings R" first="Ron" last="Herings">Ron Herings</name>
<affiliation><nlm:aff id="af8">PHARMO Coöperation UA, Utrecht, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Molokhia, Mariam" sort="Molokhia, Mariam" uniqKey="Molokhia M" first="Mariam" last="Molokhia">Mariam Molokhia</name>
<affiliation><nlm:aff id="af9">Department of Primary Care and Public Health Sciences, Kings College, London, UK</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<affiliation><nlm:aff id="af10">Aarhus University Hospital, Århus Sygehus, Denmark</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fourrier Reglat, Annie" sort="Fourrier Reglat, Annie" uniqKey="Fourrier Reglat A" first="Annie" last="Fourrier-Réglat">Annie Fourrier-Réglat</name>
<affiliation><nlm:aff id="af11">INSERM U 657, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fieschi, Marius" sort="Fieschi, Marius" uniqKey="Fieschi M" first="Marius" last="Fieschi">Marius Fieschi</name>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sturkenboom, Miriam" sort="Sturkenboom, Miriam" uniqKey="Sturkenboom M" first="Miriam" last="Sturkenboom">Miriam Sturkenboom</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af12">Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Van Der Lei, Johan" sort="Van Der Lei, Johan" uniqKey="Van Der Lei J" first="Johan" last="Van Der Lei">Johan Van Der Lei</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Trifir, Gianluca" sort="Trifir, Gianluca" uniqKey="Trifir G" first="Gianluca" last="Trifir">Gianluca Trifir</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af13">Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy</nlm:aff>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PMC</idno>
<idno type="pmid">22955495</idno>
<idno type="pmc">3555316</idno>
<idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3555316</idno>
<idno type="RBID">PMC:3555316</idno>
<idno type="doi">10.1136/amiajnl-2012-000933</idno>
<date when="2012">2012</date>
<idno type="wicri:Area/Pmc/Corpus">000375</idno>
<idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000375</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project</title>
<author><name sortKey="Avillach, Paul" sort="Avillach, Paul" uniqKey="Avillach P" first="Paul" last="Avillach">Paul Avillach</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Coloma, Preciosa M" sort="Coloma, Preciosa M" uniqKey="Coloma P" first="Preciosa M" last="Coloma">Preciosa M. Coloma</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Gini, Rosa" sort="Gini, Rosa" uniqKey="Gini R" first="Rosa" last="Gini">Rosa Gini</name>
<affiliation><nlm:aff id="af4">Regional Health Agency of ARS, Florence, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Schuemie, Martijn" sort="Schuemie, Martijn" uniqKey="Schuemie M" first="Martijn" last="Schuemie">Martijn Schuemie</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Mougin, Fleur" sort="Mougin, Fleur" uniqKey="Mougin F" first="Fleur" last="Mougin">Fleur Mougin</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Dufour, Jean Charles" sort="Dufour, Jean Charles" uniqKey="Dufour J" first="Jean-Charles" last="Dufour">Jean-Charles Dufour</name>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Mazzaglia, Giampiero" sort="Mazzaglia, Giampiero" uniqKey="Mazzaglia G" first="Giampiero" last="Mazzaglia">Giampiero Mazzaglia</name>
<affiliation><nlm:aff id="af5">Health Search—Italian College of General Practitioners, Florence, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Giaquinto, Carlo" sort="Giaquinto, Carlo" uniqKey="Giaquinto C" first="Carlo" last="Giaquinto">Carlo Giaquinto</name>
<affiliation><nlm:aff id="af6">Pedianet—Societa’ Servizi Telematici SRL, Padova, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fornari, Carla" sort="Fornari, Carla" uniqKey="Fornari C" first="Carla" last="Fornari">Carla Fornari</name>
<affiliation><nlm:aff id="af7">Centre on Public Health, University of Milano-Bicocca, Milano, Italy</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Herings, Ron" sort="Herings, Ron" uniqKey="Herings R" first="Ron" last="Herings">Ron Herings</name>
<affiliation><nlm:aff id="af8">PHARMO Coöperation UA, Utrecht, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Molokhia, Mariam" sort="Molokhia, Mariam" uniqKey="Molokhia M" first="Mariam" last="Molokhia">Mariam Molokhia</name>
<affiliation><nlm:aff id="af9">Department of Primary Care and Public Health Sciences, Kings College, London, UK</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<affiliation><nlm:aff id="af10">Aarhus University Hospital, Århus Sygehus, Denmark</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fourrier Reglat, Annie" sort="Fourrier Reglat, Annie" uniqKey="Fourrier Reglat A" first="Annie" last="Fourrier-Réglat">Annie Fourrier-Réglat</name>
<affiliation><nlm:aff id="af11">INSERM U 657, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Fieschi, Marius" sort="Fieschi, Marius" uniqKey="Fieschi M" first="Marius" last="Fieschi">Marius Fieschi</name>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Sturkenboom, Miriam" sort="Sturkenboom, Miriam" uniqKey="Sturkenboom M" first="Miriam" last="Sturkenboom">Miriam Sturkenboom</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af12">Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Van Der Lei, Johan" sort="Van Der Lei, Johan" uniqKey="Van Der Lei J" first="Johan" last="Van Der Lei">Johan Van Der Lei</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Pariente, Antoine" sort="Pariente, Antoine" uniqKey="Pariente A" first="Antoine" last="Pariente">Antoine Pariente</name>
<affiliation><nlm:aff id="af1">LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af2">LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</nlm:aff>
</affiliation>
</author>
<author><name sortKey="Trifir, Gianluca" sort="Trifir, Gianluca" uniqKey="Trifir G" first="Gianluca" last="Trifir">Gianluca Trifir</name>
<affiliation><nlm:aff id="af3">Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</nlm:aff>
</affiliation>
<affiliation><nlm:aff id="af13">Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy</nlm:aff>
</affiliation>
</author>
</analytic>
<series><title level="j">Journal of the American Medical Informatics Association : JAMIA</title>
<idno type="ISSN">1067-5027</idno>
<idno type="eISSN">1527-974X</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass></textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><sec><title>Objective</title>
<p>Data from electronic healthcare records (EHR) can be used to monitor drug safety, but in order to compare and pool data from different EHR databases, the extraction of potential adverse events must be harmonized. In this paper, we describe the procedure used for harmonizing the extraction from eight European EHR databases of five events of interest deemed to be important in pharmacovigilance: acute myocardial infarction (AMI); acute renal failure (ARF); anaphylactic shock (AS); bullous eruption (BE); and rhabdomyolysis (RHABD).</p>
</sec>
<sec><title>Design</title>
<p>The participating databases comprise general practitioners’ medical records and claims for hospitalization and other healthcare services. Clinical information is collected using four different disease terminologies and free text in two different languages. The Unified Medical Language System was used to identify concepts and corresponding codes in each terminology. A common database model was used to share and pool data and verify the semantic basis of the event extraction queries. Feedback from the database holders was obtained at various stages to refine the extraction queries.</p>
</sec>
<sec><title>Measurements</title>
<p>Standardized and age specific incidence rates (IRs) were calculated to facilitate benchmarking and harmonization of event data extraction across the databases. This was an iterative process.</p>
</sec>
<sec><title>Results</title>
<p>The study population comprised overall 19 647 445 individuals with a follow-up of 59 929 690 person-years (PYs). Age adjusted IRs for the five events of interest across the databases were as follows: (1) AMI: 60–148/100 000 PYs; (2) ARF: 3–49/100 000 PYs; (3) AS: 2–12/100 000 PYs; (4) BE: 2–17/100 000 PYs; and (5) RHABD: 0.1–8/100 000 PYs.</p>
</sec>
<sec><title>Conclusions</title>
<p>The iterative harmonization process enabled a more homogeneous identification of events across differently structured databases using different coding based algorithms. This workflow can facilitate transparent and reproducible event extractions and understanding of differences between databases.</p>
</sec>
</div>
</front>
</TEI>
<pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Am Med Inform Assoc</journal-id>
<journal-id journal-id-type="iso-abbrev">J Am Med Inform Assoc</journal-id>
<journal-id journal-id-type="publisher-id">jamia</journal-id>
<journal-id journal-id-type="hwp">amiajnl</journal-id>
<journal-title-group><journal-title>Journal of the American Medical Informatics Association : JAMIA</journal-title>
</journal-title-group>
<issn pub-type="ppub">1067-5027</issn>
<issn pub-type="epub">1527-974X</issn>
<publisher><publisher-name>BMJ Group</publisher-name>
<publisher-loc>BMA House, Tavistock Square, London, WC1H 9JR</publisher-loc>
</publisher>
</journal-meta>
<article-meta><article-id pub-id-type="pmid">22955495</article-id>
<article-id pub-id-type="pmc">3555316</article-id>
<article-id pub-id-type="publisher-id">amiajnl-2012-000933</article-id>
<article-id pub-id-type="doi">10.1136/amiajnl-2012-000933</article-id>
<article-categories><subj-group subj-group-type="heading"><subject>Focus on Data Sharing</subject>
</subj-group>
</article-categories>
<title-group><article-title>Harmonization process for the identification of medical events in eight European healthcare databases: the experience from the EU-ADR project</article-title>
</title-group>
<contrib-group><contrib contrib-type="author"><name><surname>Avillach</surname>
<given-names>Paul</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Coloma</surname>
<given-names>Preciosa M</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Gini</surname>
<given-names>Rosa</given-names>
</name>
<xref ref-type="aff" rid="af4">4</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Schuemie</surname>
<given-names>Martijn</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mougin</surname>
<given-names>Fleur</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Dufour</surname>
<given-names>Jean-Charles</given-names>
</name>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Mazzaglia</surname>
<given-names>Giampiero</given-names>
</name>
<xref ref-type="aff" rid="af5">5</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Giaquinto</surname>
<given-names>Carlo</given-names>
</name>
<xref ref-type="aff" rid="af6">6</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fornari</surname>
<given-names>Carla</given-names>
</name>
<xref ref-type="aff" rid="af7">7</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Herings</surname>
<given-names>Ron</given-names>
</name>
<xref ref-type="aff" rid="af8">8</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Molokhia</surname>
<given-names>Mariam</given-names>
</name>
<xref ref-type="aff" rid="af9">9</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pedersen</surname>
<given-names>Lars</given-names>
</name>
<xref ref-type="aff" rid="af10">10</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fourrier-Réglat</surname>
<given-names>Annie</given-names>
</name>
<xref ref-type="aff" rid="af11">11</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Fieschi</surname>
<given-names>Marius</given-names>
</name>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Sturkenboom</surname>
<given-names>Miriam</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
<xref ref-type="aff" rid="af12">12</xref>
</contrib>
<contrib contrib-type="author"><name><surname>van der Lei</surname>
<given-names>Johan</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Pariente</surname>
<given-names>Antoine</given-names>
</name>
<xref ref-type="aff" rid="af1">1</xref>
<xref ref-type="aff" rid="af2">2</xref>
</contrib>
<contrib contrib-type="author"><name><surname>Trifirò</surname>
<given-names>Gianluca</given-names>
</name>
<xref ref-type="aff" rid="af3">3</xref>
<xref ref-type="aff" rid="af13">13</xref>
<on-behalf-of>on behalf of the EU-ADR consortium</on-behalf-of>
</contrib>
</contrib-group>
<aff id="af1"><label>1</label>
LESIM, ISPED, University Bordeaux Segalen, Bordeaux, France</aff>
<aff id="af2"><label>2</label>
LERTIM, EA 3283, Faculté de Médecine, Université Aix Marseille 2, Marseille, France</aff>
<aff id="af3"><label>3</label>
Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, The Netherlands</aff>
<aff id="af4"><label>4</label>
Regional Health Agency of ARS, Florence, Italy</aff>
<aff id="af5"><label>5</label>
Health Search—Italian College of General Practitioners, Florence, Italy</aff>
<aff id="af6"><label>6</label>
Pedianet—Societa’ Servizi Telematici SRL, Padova, Italy</aff>
<aff id="af7"><label>7</label>
Centre on Public Health, University of Milano-Bicocca, Milano, Italy</aff>
<aff id="af8"><label>8</label>
PHARMO Coöperation UA, Utrecht, The Netherlands</aff>
<aff id="af9"><label>9</label>
Department of Primary Care and Public Health Sciences, Kings College, London, UK</aff>
<aff id="af10"><label>10</label>
Aarhus University Hospital, Århus Sygehus, Denmark</aff>
<aff id="af11"><label>11</label>
INSERM U 657, University Bordeaux Segalen, Bordeaux, France</aff>
<aff id="af12"><label>12</label>
Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands</aff>
<aff id="af13"><label>13</label>
Department of Clinical and Experimental Medicine and Pharmacology, Section of Pharmacology, University of Messina, Messina, Italy</aff>
<author-notes><corresp><label>Correspondence to</label>
Dr P Avillach, LESIM ISPED, University Bordeaux, 146 rue Leo Saignat 33076, Bordeaux, France; <email>avillach@mac.com</email>
</corresp>
<fn><p>PA and PMC contributed equally to this work.</p>
</fn>
</author-notes>
<pub-date pub-type="ppub"><season>Jan-Feb</season>
<year>2013</year>
</pub-date>
<pub-date pub-type="epub"><day>6</day>
<month>9</month>
<year>2012</year>
</pub-date>
<volume>20</volume>
<issue>1</issue>
<fpage>184</fpage>
<lpage>192</lpage>
<history><date date-type="received"><day>4</day>
<month>3</month>
<year>2012</year>
</date>
<date date-type="accepted"><day>10</day>
<month>8</month>
<year>2012</year>
</date>
</history>
<permissions><copyright-statement>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</copyright-statement>
<copyright-year>2012</copyright-year>
</permissions>
<self-uri xlink:title="pdf" xlink:type="simple" xlink:href="amiajnl-2012-000933.pdf"></self-uri>
<abstract><sec><title>Objective</title>
<p>Data from electronic healthcare records (EHR) can be used to monitor drug safety, but in order to compare and pool data from different EHR databases, the extraction of potential adverse events must be harmonized. In this paper, we describe the procedure used for harmonizing the extraction from eight European EHR databases of five events of interest deemed to be important in pharmacovigilance: acute myocardial infarction (AMI); acute renal failure (ARF); anaphylactic shock (AS); bullous eruption (BE); and rhabdomyolysis (RHABD).</p>
</sec>
<sec><title>Design</title>
<p>The participating databases comprise general practitioners’ medical records and claims for hospitalization and other healthcare services. Clinical information is collected using four different disease terminologies and free text in two different languages. The Unified Medical Language System was used to identify concepts and corresponding codes in each terminology. A common database model was used to share and pool data and verify the semantic basis of the event extraction queries. Feedback from the database holders was obtained at various stages to refine the extraction queries.</p>
</sec>
<sec><title>Measurements</title>
<p>Standardized and age specific incidence rates (IRs) were calculated to facilitate benchmarking and harmonization of event data extraction across the databases. This was an iterative process.</p>
</sec>
<sec><title>Results</title>
<p>The study population comprised overall 19 647 445 individuals with a follow-up of 59 929 690 person-years (PYs). Age adjusted IRs for the five events of interest across the databases were as follows: (1) AMI: 60–148/100 000 PYs; (2) ARF: 3–49/100 000 PYs; (3) AS: 2–12/100 000 PYs; (4) BE: 2–17/100 000 PYs; and (5) RHABD: 0.1–8/100 000 PYs.</p>
</sec>
<sec><title>Conclusions</title>
<p>The iterative harmonization process enabled a more homogeneous identification of events across differently structured databases using different coding based algorithms. This workflow can facilitate transparent and reproducible event extractions and understanding of differences between databases.</p>
</sec>
</abstract>
</article-meta>
</front>
</pmc>
</record>
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