Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database

ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD‐9‐CM diagnoses in identifyi...

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Veröffentlicht in:Pharmacoepidemiology and drug safety 2013-08, Vol.22 (8), p.861-872
Hauptverfasser: Lo Re III, Vincent, Haynes, Kevin, Goldberg, David, Forde, Kimberly A., Carbonari, Dena M., Leidl, Kimberly B. F., Hennessy, Sean, Reddy, K. Rajender, Pawloski, Pamala A., Daniel, Gregory W., Cheetham, T. Craig, Iyer, Aarthi, Coughlin, Kara O., Toh, Sengwee, Boudreau, Denise M., Selvam, Nandini, Cooper, William O., Selvan, Mano S., VanWormer, Jeffrey J., Avigan, Mark I., Houstoun, Monika, Zornberg, Gwen L., Racoosin, Judith A., Shoaibi, Azadeh
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container_end_page 872
container_issue 8
container_start_page 861
container_title Pharmacoepidemiology and drug safety
container_volume 22
creator Lo Re III, Vincent
Haynes, Kevin
Goldberg, David
Forde, Kimberly A.
Carbonari, Dena M.
Leidl, Kimberly B. F.
Hennessy, Sean
Reddy, K. Rajender
Pawloski, Pamala A.
Daniel, Gregory W.
Cheetham, T. Craig
Iyer, Aarthi
Coughlin, Kara O.
Toh, Sengwee
Boudreau, Denise M.
Selvam, Nandini
Cooper, William O.
Selvan, Mano S.
VanWormer, Jeffrey J.
Avigan, Mark I.
Houstoun, Monika
Zornberg, Gwen L.
Racoosin, Judith A.
Shoaibi, Azadeh
description ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD‐9‐CM diagnoses in identifying SALI among health plan members in the Mini‐Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD). Methods We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD‐9‐CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009–2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status. Results Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9−34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0–100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0–56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6–97.9%) and identified 10/19 (52.6%) events. Conclusions Most individual hospital ICD‐9‐CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright © 2013 John Wiley & Sons, Ltd.
doi_str_mv 10.1002/pds.3470
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F. ; Hennessy, Sean ; Reddy, K. Rajender ; Pawloski, Pamala A. ; Daniel, Gregory W. ; Cheetham, T. Craig ; Iyer, Aarthi ; Coughlin, Kara O. ; Toh, Sengwee ; Boudreau, Denise M. ; Selvam, Nandini ; Cooper, William O. ; Selvan, Mano S. ; VanWormer, Jeffrey J. ; Avigan, Mark I. ; Houstoun, Monika ; Zornberg, Gwen L. ; Racoosin, Judith A. ; Shoaibi, Azadeh</creator><creatorcontrib>Lo Re III, Vincent ; Haynes, Kevin ; Goldberg, David ; Forde, Kimberly A. ; Carbonari, Dena M. ; Leidl, Kimberly B. F. ; Hennessy, Sean ; Reddy, K. Rajender ; Pawloski, Pamala A. ; Daniel, Gregory W. ; Cheetham, T. Craig ; Iyer, Aarthi ; Coughlin, Kara O. ; Toh, Sengwee ; Boudreau, Denise M. ; Selvam, Nandini ; Cooper, William O. ; Selvan, Mano S. ; VanWormer, Jeffrey J. ; Avigan, Mark I. ; Houstoun, Monika ; Zornberg, Gwen L. ; Racoosin, Judith A. ; Shoaibi, Azadeh</creatorcontrib><description>ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD‐9‐CM diagnoses in identifying SALI among health plan members in the Mini‐Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD). Methods We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD‐9‐CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009–2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status. Results Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9−34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0–100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0–56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6–97.9%) and identified 10/19 (52.6%) events. Conclusions Most individual hospital ICD‐9‐CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright © 2013 John Wiley &amp; Sons, Ltd.</description><identifier>ISSN: 1053-8569</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.3470</identifier><identifier>PMID: 23801638</identifier><identifier>CODEN: PDSAEA</identifier><language>eng</language><publisher>Chichester: Blackwell Publishing Ltd</publisher><subject>Acute Disease ; Aged ; Aged, 80 and over ; Biological and medical sciences ; Chemical and Drug Induced Liver Injury - diagnosis ; Chemical and Drug Induced Liver Injury - epidemiology ; Chemical and Drug Induced Liver Injury - physiopathology ; Chronic Disease ; Classification ; Clinical Coding ; Clinical trial. Drug monitoring ; Cross-Sectional Studies ; Databases, Factual - statistics &amp; numerical data ; Female ; General pharmacology ; hepatotoxicity ; Humans ; ICD-9 codes ; International Classification of Diseases ; Liver Diseases - diagnosis ; Liver Diseases - epidemiology ; Liver Diseases - physiopathology ; liver injury ; Male ; Medical Records - statistics &amp; numerical data ; Medical sciences ; Middle Aged ; Pharmacoepidemiology ; Pharmacology. Drug treatments ; Predictive Value of Tests ; Product Surveillance, Postmarketing ; Severity of Illness Index ; United States - epidemiology ; United States Food and Drug Administration ; validity</subject><ispartof>Pharmacoepidemiology and drug safety, 2013-08, Vol.22 (8), p.861-872</ispartof><rights>Copyright © 2013 John Wiley &amp; Sons, Ltd.</rights><rights>2014 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5390-a724600ea998ef7fd00506232f02a21fa0d5f9135f03b72bdbd10dc47ef63b8b3</citedby><cites>FETCH-LOGICAL-c5390-a724600ea998ef7fd00506232f02a21fa0d5f9135f03b72bdbd10dc47ef63b8b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fpds.3470$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fpds.3470$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,315,781,785,886,1418,27929,27930,45579,45580</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&amp;idt=27619530$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23801638$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Lo Re III, Vincent</creatorcontrib><creatorcontrib>Haynes, Kevin</creatorcontrib><creatorcontrib>Goldberg, David</creatorcontrib><creatorcontrib>Forde, Kimberly A.</creatorcontrib><creatorcontrib>Carbonari, Dena M.</creatorcontrib><creatorcontrib>Leidl, Kimberly B. F.</creatorcontrib><creatorcontrib>Hennessy, Sean</creatorcontrib><creatorcontrib>Reddy, K. Rajender</creatorcontrib><creatorcontrib>Pawloski, Pamala A.</creatorcontrib><creatorcontrib>Daniel, Gregory W.</creatorcontrib><creatorcontrib>Cheetham, T. Craig</creatorcontrib><creatorcontrib>Iyer, Aarthi</creatorcontrib><creatorcontrib>Coughlin, Kara O.</creatorcontrib><creatorcontrib>Toh, Sengwee</creatorcontrib><creatorcontrib>Boudreau, Denise M.</creatorcontrib><creatorcontrib>Selvam, Nandini</creatorcontrib><creatorcontrib>Cooper, William O.</creatorcontrib><creatorcontrib>Selvan, Mano S.</creatorcontrib><creatorcontrib>VanWormer, Jeffrey J.</creatorcontrib><creatorcontrib>Avigan, Mark I.</creatorcontrib><creatorcontrib>Houstoun, Monika</creatorcontrib><creatorcontrib>Zornberg, Gwen L.</creatorcontrib><creatorcontrib>Racoosin, Judith A.</creatorcontrib><creatorcontrib>Shoaibi, Azadeh</creatorcontrib><title>Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database</title><title>Pharmacoepidemiology and drug safety</title><addtitle>Pharmacoepidemiol Drug Saf</addtitle><description>ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD‐9‐CM diagnoses in identifying SALI among health plan members in the Mini‐Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD). Methods We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD‐9‐CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009–2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status. Results Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9−34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0–100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0–56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6–97.9%) and identified 10/19 (52.6%) events. Conclusions Most individual hospital ICD‐9‐CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright © 2013 John Wiley &amp; Sons, Ltd.</description><subject>Acute Disease</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biological and medical sciences</subject><subject>Chemical and Drug Induced Liver Injury - diagnosis</subject><subject>Chemical and Drug Induced Liver Injury - epidemiology</subject><subject>Chemical and Drug Induced Liver Injury - physiopathology</subject><subject>Chronic Disease</subject><subject>Classification</subject><subject>Clinical Coding</subject><subject>Clinical trial. Drug monitoring</subject><subject>Cross-Sectional Studies</subject><subject>Databases, Factual - statistics &amp; numerical data</subject><subject>Female</subject><subject>General pharmacology</subject><subject>hepatotoxicity</subject><subject>Humans</subject><subject>ICD-9 codes</subject><subject>International Classification of Diseases</subject><subject>Liver Diseases - diagnosis</subject><subject>Liver Diseases - epidemiology</subject><subject>Liver Diseases - physiopathology</subject><subject>liver injury</subject><subject>Male</subject><subject>Medical Records - statistics &amp; numerical data</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pharmacoepidemiology</subject><subject>Pharmacology. Drug treatments</subject><subject>Predictive Value of Tests</subject><subject>Product Surveillance, Postmarketing</subject><subject>Severity of Illness Index</subject><subject>United States - epidemiology</subject><subject>United States Food and Drug Administration</subject><subject>validity</subject><issn>1053-8569</issn><issn>1099-1557</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kd1u1DAQhSMEoqUg8QTIEkJwk8U_cZzcVKp220JVCtK25dJy_LP1krUXO2nJo_C2OGpYChJX4_F8Omfsk2UvEZwhCPH7rYozUjD4KNtHsK5zRCl7PJ4pySta1nvZsxjXEKZZXTzN9jCpICpJtZ_9vBatVbYbgDdAWbFyPnZWAumVjqDzwCrtOmsGIEVMN4mK-lYHDYTsOw1amxpg3boPQyqgu9HgaracgRPvFRBOgUXoV-BIbayzsQuis969jeBTavPlKO10CxbjyDZJMPGiE03yep49MaKN-sVUD7Krk-PL-Yf8_PPpx_nReS4pqWEuGC5KCLWo60obZhSEFJaYYAOxwMgIqKipEaEGkobhRjUKQSULpk1JmqohB9nhve62bzZaybRTEC3fBrsRYeBeWP73xNkbvvK3vCjSd1KUBN5NAsF_73Xs-MZGqdtWOO37yFFRVBgTRMuEvv4HXfs-uPS8RGFWMUzYA0EZfIxBm90yCPIxb57y5mPeCX31cPkd-DvgBLyZABGlaE0QTtr4h2MlqikZhfJ77s62evivIf-yWE7GE5-S0z92vAjfeMkIo_zrxSk_Qxdn88trxOfkF81R0i8</recordid><startdate>201308</startdate><enddate>201308</enddate><creator>Lo Re III, Vincent</creator><creator>Haynes, Kevin</creator><creator>Goldberg, David</creator><creator>Forde, Kimberly A.</creator><creator>Carbonari, Dena M.</creator><creator>Leidl, Kimberly B. 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F. ; Hennessy, Sean ; Reddy, K. Rajender ; Pawloski, Pamala A. ; Daniel, Gregory W. ; Cheetham, T. Craig ; Iyer, Aarthi ; Coughlin, Kara O. ; Toh, Sengwee ; Boudreau, Denise M. ; Selvam, Nandini ; Cooper, William O. ; Selvan, Mano S. ; VanWormer, Jeffrey J. ; Avigan, Mark I. ; Houstoun, Monika ; Zornberg, Gwen L. ; Racoosin, Judith A. ; Shoaibi, Azadeh</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5390-a724600ea998ef7fd00506232f02a21fa0d5f9135f03b72bdbd10dc47ef63b8b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Acute Disease</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biological and medical sciences</topic><topic>Chemical and Drug Induced Liver Injury - diagnosis</topic><topic>Chemical and Drug Induced Liver Injury - epidemiology</topic><topic>Chemical and Drug Induced Liver Injury - physiopathology</topic><topic>Chronic Disease</topic><topic>Classification</topic><topic>Clinical Coding</topic><topic>Clinical trial. Drug monitoring</topic><topic>Cross-Sectional Studies</topic><topic>Databases, Factual - statistics &amp; numerical data</topic><topic>Female</topic><topic>General pharmacology</topic><topic>hepatotoxicity</topic><topic>Humans</topic><topic>ICD-9 codes</topic><topic>International Classification of Diseases</topic><topic>Liver Diseases - diagnosis</topic><topic>Liver Diseases - epidemiology</topic><topic>Liver Diseases - physiopathology</topic><topic>liver injury</topic><topic>Male</topic><topic>Medical Records - statistics &amp; numerical data</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pharmacoepidemiology</topic><topic>Pharmacology. Drug treatments</topic><topic>Predictive Value of Tests</topic><topic>Product Surveillance, Postmarketing</topic><topic>Severity of Illness Index</topic><topic>United States - epidemiology</topic><topic>United States Food and Drug Administration</topic><topic>validity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lo Re III, Vincent</creatorcontrib><creatorcontrib>Haynes, Kevin</creatorcontrib><creatorcontrib>Goldberg, David</creatorcontrib><creatorcontrib>Forde, Kimberly A.</creatorcontrib><creatorcontrib>Carbonari, Dena M.</creatorcontrib><creatorcontrib>Leidl, Kimberly B. F.</creatorcontrib><creatorcontrib>Hennessy, Sean</creatorcontrib><creatorcontrib>Reddy, K. Rajender</creatorcontrib><creatorcontrib>Pawloski, Pamala A.</creatorcontrib><creatorcontrib>Daniel, Gregory W.</creatorcontrib><creatorcontrib>Cheetham, T. 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F.</au><au>Hennessy, Sean</au><au>Reddy, K. Rajender</au><au>Pawloski, Pamala A.</au><au>Daniel, Gregory W.</au><au>Cheetham, T. Craig</au><au>Iyer, Aarthi</au><au>Coughlin, Kara O.</au><au>Toh, Sengwee</au><au>Boudreau, Denise M.</au><au>Selvam, Nandini</au><au>Cooper, William O.</au><au>Selvan, Mano S.</au><au>VanWormer, Jeffrey J.</au><au>Avigan, Mark I.</au><au>Houstoun, Monika</au><au>Zornberg, Gwen L.</au><au>Racoosin, Judith A.</au><au>Shoaibi, Azadeh</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database</atitle><jtitle>Pharmacoepidemiology and drug safety</jtitle><addtitle>Pharmacoepidemiol Drug Saf</addtitle><date>2013-08</date><risdate>2013</risdate><volume>22</volume><issue>8</issue><spage>861</spage><epage>872</epage><pages>861-872</pages><issn>1053-8569</issn><eissn>1099-1557</eissn><coden>PDSAEA</coden><abstract>ABSTRACT Purpose The validity of International Classification of Diseases, Ninth Revision, Clinical Modification (ICD‐9‐CM) codes to identify diagnoses of severe acute liver injury (SALI) is not well known. We examined the positive predictive values (PPVs) of hospital ICD‐9‐CM diagnoses in identifying SALI among health plan members in the Mini‐Sentinel Distributed Database (MSDD) for patients without liver/biliary disease and for those with chronic liver disease (CLD). Methods We selected random samples of members (149 without liver/biliary disease; 75 with CLD) with a principal hospital diagnosis suggestive of SALI (ICD‐9‐CM 570, 572.2, 572.4, 572.8, 573.3, 573.8, or V42.7) in the MSDD (2009–2010). Medical records were reviewed by hepatologists to confirm SALI events. PPVs of codes and code combinations for confirmed SALI were determined by CLD status. Results Among 105 members with available records and no liver/biliary disease, SALI was confirmed in 26 (PPV, 24.7%; 95%CI, 16.9−34.1%). Combined hospital diagnoses of acute hepatic necrosis (570) and liver disease sequelae (572.8) had high PPV (100%; 95%CI, 59.0–100%) and identified 7/26 (26.9%) events. Among 46 CLD members with available records, SALI was confirmed in 19 (PPV, 41.3%; 95%CI, 27.0–56.8%). Acute hepatic necrosis (570) or hepatorenal syndrome (572.4) plus any other SALI code had a PPV of 83.3% (95%CI, 51.6–97.9%) and identified 10/19 (52.6%) events. Conclusions Most individual hospital ICD‐9‐CM diagnoses had low PPV for confirmed SALI events. Select code combinations had high PPV but did not capture all events. Copyright © 2013 John Wiley &amp; Sons, Ltd.</abstract><cop>Chichester</cop><pub>Blackwell Publishing Ltd</pub><pmid>23801638</pmid><doi>10.1002/pds.3470</doi><tpages>12</tpages><oa>free_for_read</oa></addata></record>
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source Wiley Online Library - AutoHoldings Journals; MEDLINE
subjects Acute Disease
Aged
Aged, 80 and over
Biological and medical sciences
Chemical and Drug Induced Liver Injury - diagnosis
Chemical and Drug Induced Liver Injury - epidemiology
Chemical and Drug Induced Liver Injury - physiopathology
Chronic Disease
Classification
Clinical Coding
Clinical trial. Drug monitoring
Cross-Sectional Studies
Databases, Factual - statistics & numerical data
Female
General pharmacology
hepatotoxicity
Humans
ICD-9 codes
International Classification of Diseases
Liver Diseases - diagnosis
Liver Diseases - epidemiology
Liver Diseases - physiopathology
liver injury
Male
Medical Records - statistics & numerical data
Medical sciences
Middle Aged
Pharmacoepidemiology
Pharmacology. Drug treatments
Predictive Value of Tests
Product Surveillance, Postmarketing
Severity of Illness Index
United States - epidemiology
United States Food and Drug Administration
validity
title Validity of diagnostic codes to identify cases of severe acute liver injury in the U.S. Food and Drug Administration's Mini-Sentinel Distributed Database
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