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Design for validation of acute myocardial infarction cases in Mini-Sentinel
ABSTRACT Purpose To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program. Methods The project consisted of four parts: (i) case identification—developing an algorithm...
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| Published in: | Pharmacoepidemiology and drug safety 2012-01, Vol.21 (S1), p.274-281 |
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| Main Authors: | , , , , , , , , |
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| container_title | Pharmacoepidemiology and drug safety |
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| creator | Cutrona, Sarah L. Toh, Sengwee Iyer, Aarthi Foy, Sarah Cavagnaro, Elizabeth Forrow, Susan Racoosin, Judith A. Goldberg, Robert Gurwitz, Jerry H. |
| description | ABSTRACT
Purpose
To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program.
Methods
The project consisted of four parts: (i) case identification—developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini‐Sentinel Distributed Database; (ii) chart retrieval—establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) ion and adjudication—trained nurse ors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm.
Results
Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed ion, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to International Classification of Diseases, Ninth Revision, codes 410.x0‐410.x1. Centralized data ion was performed because of the modest number of charts requested ( |
| doi_str_mv | 10.1002/pds.2314 |
| format | article |
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Purpose
To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program.
Methods
The project consisted of four parts: (i) case identification—developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini‐Sentinel Distributed Database; (ii) chart retrieval—establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) ion and adjudication—trained nurse ors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm.
Results
Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed ion, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to International Classification of Diseases, Ninth Revision, codes 410.x0‐410.x1. Centralized data ion was performed because of the modest number of charts requested (<155). The project's public health status accelerated chart retrieval in most instances.
Conclusions
We have established a process to validate AMI within Mini‐Sentinel, which may be used for other health outcomes. Challenges include the following: (i) ensuring that only minimum necessary data are transmitted by Data Partners for centralized chart review, (ii) establishing procedures to maintain data privacy while still allowing for timely access to medical charts, and (iii) securing access to charts for public health uses that do not require approval from an institutional review board while maintaining patient privacy. Copyright © 2012 John Wiley & Sons, Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.2314</identifier><identifier>PMID: 22262617</identifier><language>eng</language><publisher>Chichester, UK: John Wiley & Sons, Ltd</publisher><subject>administrative data ; Algorithms ; Confidentiality ; coronary artery disease ; Databases, Factual - statistics & numerical data ; Humans ; International Classification of Diseases ; myocardial infarction ; Myocardial Infarction - epidemiology ; Outcome Assessment, Health Care - methods ; Pilot Projects ; Predictive Value of Tests ; Time Factors ; United States - epidemiology ; United States Food and Drug Administration ; validation</subject><ispartof>Pharmacoepidemiology and drug safety, 2012-01, Vol.21 (S1), p.274-281</ispartof><rights>Copyright © 2012 John Wiley & Sons, Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5134-196024ecae04209456fd050c0a8b79671a5e835363d9e1239a438197acaa6ad3</citedby><cites>FETCH-LOGICAL-c5134-196024ecae04209456fd050c0a8b79671a5e835363d9e1239a438197acaa6ad3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,776,780,881,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22262617$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Cutrona, Sarah L.</creatorcontrib><creatorcontrib>Toh, Sengwee</creatorcontrib><creatorcontrib>Iyer, Aarthi</creatorcontrib><creatorcontrib>Foy, Sarah</creatorcontrib><creatorcontrib>Cavagnaro, Elizabeth</creatorcontrib><creatorcontrib>Forrow, Susan</creatorcontrib><creatorcontrib>Racoosin, Judith A.</creatorcontrib><creatorcontrib>Goldberg, Robert</creatorcontrib><creatorcontrib>Gurwitz, Jerry H.</creatorcontrib><title>Design for validation of acute myocardial infarction cases in Mini-Sentinel</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>ABSTRACT
Purpose
To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program.
Methods
The project consisted of four parts: (i) case identification—developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini‐Sentinel Distributed Database; (ii) chart retrieval—establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) ion and adjudication—trained nurse ors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm.
Results
Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed ion, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to International Classification of Diseases, Ninth Revision, codes 410.x0‐410.x1. Centralized data ion was performed because of the modest number of charts requested (<155). The project's public health status accelerated chart retrieval in most instances.
Conclusions
We have established a process to validate AMI within Mini‐Sentinel, which may be used for other health outcomes. Challenges include the following: (i) ensuring that only minimum necessary data are transmitted by Data Partners for centralized chart review, (ii) establishing procedures to maintain data privacy while still allowing for timely access to medical charts, and (iii) securing access to charts for public health uses that do not require approval from an institutional review board while maintaining patient privacy. Copyright © 2012 John Wiley & Sons, Ltd.</description><subject>administrative data</subject><subject>Algorithms</subject><subject>Confidentiality</subject><subject>coronary artery disease</subject><subject>Databases, Factual - statistics & numerical data</subject><subject>Humans</subject><subject>International Classification of Diseases</subject><subject>myocardial infarction</subject><subject>Myocardial Infarction - epidemiology</subject><subject>Outcome Assessment, Health Care - methods</subject><subject>Pilot Projects</subject><subject>Predictive Value of Tests</subject><subject>Time Factors</subject><subject>United States - epidemiology</subject><subject>United States Food and Drug Administration</subject><subject>validation</subject><issn>1053-8569</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><recordid>eNp1kEtvEzEURi1URB8g9Reg2ZXNtH6M7fEGqU2fUB4iFZXYWLeeO8XtZBzsSSH_vg4JEV10Zcvf0bnXHyG7jO4zSvnBtEn7XLDqBdli1JiSSak3Fncpyloqs0m2U7qjNGemekU2OeeKK6a3yMdjTP62L9oQiwfofAODD30R2gLcbMBiMg8OYuOhK3zfQnR_YwcJU34oPvnel2PsB99j95q8bKFL-GZ17pCr05Or0Xl5-eXsYnR4WTrJRFUyoyiv0AHSilNTSdU2VFJHob7RRmkGEmshhRKNQcaFgUrUzGhwAAoasUPeL7XT2c0EG5enR-jsNPoJxLkN4O3TpPc_7W14sEJlvdJZsLcSxPBrhmmwE58cdh30GGbJGqZrqetKZvLdknQxpBSxXU9h1C6at7l5u2g-o2__32oN_qs6A-US-O07nD8rsl-PxyvhivdpwD9rHuK9zX_Q0l5_PrPsu_4wPvp2an-IR25EnI4</recordid><startdate>201201</startdate><enddate>201201</enddate><creator>Cutrona, Sarah L.</creator><creator>Toh, Sengwee</creator><creator>Iyer, Aarthi</creator><creator>Foy, Sarah</creator><creator>Cavagnaro, Elizabeth</creator><creator>Forrow, Susan</creator><creator>Racoosin, Judith A.</creator><creator>Goldberg, Robert</creator><creator>Gurwitz, Jerry H.</creator><general>John Wiley & Sons, Ltd</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>201201</creationdate><title>Design for validation of acute myocardial infarction cases in Mini-Sentinel</title><author>Cutrona, Sarah L. ; Toh, Sengwee ; Iyer, Aarthi ; Foy, Sarah ; Cavagnaro, Elizabeth ; Forrow, Susan ; Racoosin, Judith A. ; Goldberg, Robert ; Gurwitz, Jerry H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5134-196024ecae04209456fd050c0a8b79671a5e835363d9e1239a438197acaa6ad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>administrative data</topic><topic>Algorithms</topic><topic>Confidentiality</topic><topic>coronary artery disease</topic><topic>Databases, Factual - statistics & numerical data</topic><topic>Humans</topic><topic>International Classification of Diseases</topic><topic>myocardial infarction</topic><topic>Myocardial Infarction - epidemiology</topic><topic>Outcome Assessment, Health Care - methods</topic><topic>Pilot Projects</topic><topic>Predictive Value of Tests</topic><topic>Time Factors</topic><topic>United States - epidemiology</topic><topic>United States Food and Drug Administration</topic><topic>validation</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Cutrona, Sarah L.</creatorcontrib><creatorcontrib>Toh, Sengwee</creatorcontrib><creatorcontrib>Iyer, Aarthi</creatorcontrib><creatorcontrib>Foy, Sarah</creatorcontrib><creatorcontrib>Cavagnaro, Elizabeth</creatorcontrib><creatorcontrib>Forrow, Susan</creatorcontrib><creatorcontrib>Racoosin, Judith A.</creatorcontrib><creatorcontrib>Goldberg, Robert</creatorcontrib><creatorcontrib>Gurwitz, Jerry H.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Pharmacoepidemiology and drug safety</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Cutrona, Sarah L.</au><au>Toh, Sengwee</au><au>Iyer, Aarthi</au><au>Foy, Sarah</au><au>Cavagnaro, Elizabeth</au><au>Forrow, Susan</au><au>Racoosin, Judith A.</au><au>Goldberg, Robert</au><au>Gurwitz, Jerry H.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Design for validation of acute myocardial infarction cases in Mini-Sentinel</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2012-01</date><risdate>2012</risdate><volume>21</volume><issue>S1</issue><spage>274</spage><epage>281</epage><pages>274-281</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><abstract>ABSTRACT
Purpose
To describe the acute myocardial infarction (AMI) validation project, a test case for health outcome validation within the US Food and Drug Administration–funded Mini‐Sentinel pilot program.
Methods
The project consisted of four parts: (i) case identification—developing an algorithm based on the International Classification of Diseases, Ninth Revision, to identify hospitalized AMI patients within the Mini‐Sentinel Distributed Database; (ii) chart retrieval—establishing procedures that ensured patient privacy (collection and transfer of minimum necessary amount of information, and redaction of direct identifiers to validate potential cases of AMI); (iii) ion and adjudication—trained nurse ors gathered key data using a standardized form with cardiologist adjudication; and (iv) calculation of the positive predictive value of the constructed algorithm.
Results
Key decision points included (i) breadth of the AMI algorithm, (ii) centralized versus distributed ion, and (iii) approaches to maintaining patient privacy and to obtaining charts for public health purposes. We used an algorithm limited to International Classification of Diseases, Ninth Revision, codes 410.x0‐410.x1. Centralized data ion was performed because of the modest number of charts requested (<155). The project's public health status accelerated chart retrieval in most instances.
Conclusions
We have established a process to validate AMI within Mini‐Sentinel, which may be used for other health outcomes. Challenges include the following: (i) ensuring that only minimum necessary data are transmitted by Data Partners for centralized chart review, (ii) establishing procedures to maintain data privacy while still allowing for timely access to medical charts, and (iii) securing access to charts for public health uses that do not require approval from an institutional review board while maintaining patient privacy. Copyright © 2012 John Wiley & Sons, Ltd.</abstract><cop>Chichester, UK</cop><pub>John Wiley & Sons, Ltd</pub><pmid>22262617</pmid><doi>10.1002/pds.2314</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
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| source | Wiley |
| subjects | administrative data Algorithms Confidentiality coronary artery disease Databases, Factual - statistics & numerical data Humans International Classification of Diseases myocardial infarction Myocardial Infarction - epidemiology Outcome Assessment, Health Care - methods Pilot Projects Predictive Value of Tests Time Factors United States - epidemiology United States Food and Drug Administration validation |
| title | Design for validation of acute myocardial infarction cases in Mini-Sentinel |
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