Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review

Abstract Background Major adverse cardiovascular events (MACE) are increasingly used as composite outcomes in randomized controlled trials (RCTs) and observational studies. However, it is unclear how observational studies most commonly define MACE in the literature when using administrative data. Me...

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Autores principales:	Elliott Bosco, Leon Hsueh, Kevin W. McConeghy, Stefan Gravenstein, Elie Saade
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Observational study Reproducibility Acute myocardial infarction Stroke Heart failure Acute coronary syndrome Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/3f1f28d291a34a6dbc1141ec19d94648
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spelling	oai:doaj.org-article:3f1f28d291a34a6dbc1141ec19d946482021-11-08T11:15:59ZMajor adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review10.1186/s12874-021-01440-51471-2288https://doaj.org/article/3f1f28d291a34a6dbc1141ec19d946482021-11-01T00:00:00Zhttps://doi.org/10.1186/s12874-021-01440-5https://doaj.org/toc/1471-2288Abstract Background Major adverse cardiovascular events (MACE) are increasingly used as composite outcomes in randomized controlled trials (RCTs) and observational studies. However, it is unclear how observational studies most commonly define MACE in the literature when using administrative data. Methods We identified peer-reviewed articles published in MEDLINE and EMBASE between January 1, 2010 to October 9, 2020. Studies utilizing administrative data to assess the MACE composite outcome using International Classification of Diseases 9th or 10th Revision diagnosis codes were included. Reviews, abstracts, and studies not providing outcome code definitions were excluded. Data extracted included data source, timeframe, MACE components, code definitions, code positions, and outcome validation. Results A total of 920 articles were screened, 412 were retained for full-text review, and 58 were included. Only 8.6% (n = 5/58) matched the traditional three-point MACE RCT definition of acute myocardial infarction (AMI), stroke, or cardiovascular death. None matched four-point (+unstable angina) or five-point MACE (+unstable angina and heart failure). The most common MACE components were: AMI and stroke, 15.5% (n = 9/58); AMI, stroke, and all-cause death, 13.8% (n = 8/58); and AMI, stroke and cardiovascular death 8.6% (n = 5/58). Further, 67% (n = 39/58) did not validate outcomes or cite validation studies. Additionally, 70.7% (n = 41/58) did not report code positions of endpoints, 20.7% (n = 12/58) used the primary position, and 8.6% (n = 5/58) used any position. Conclusions Components of MACE endpoints and diagnostic codes used varied widely across observational studies. Variability in the MACE definitions used and information reported across observational studies prohibit the comparison, replication, and aggregation of findings. Studies should transparently report the administrative codes used and code positions, as well as utilize validated outcome definitions when possible.Elliott BoscoLeon HsuehKevin W. McConeghyStefan GravensteinElie SaadeBMCarticleObservational studyReproducibilityAcute myocardial infarctionStrokeHeart failureAcute coronary syndromeMedicine (General)R5-920ENBMC Medical Research Methodology, Vol 21, Iss 1, Pp 1-18 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Observational study Reproducibility Acute myocardial infarction Stroke Heart failure Acute coronary syndrome Medicine (General) R5-920
spellingShingle	Observational study Reproducibility Acute myocardial infarction Stroke Heart failure Acute coronary syndrome Medicine (General) R5-920 Elliott Bosco Leon Hsueh Kevin W. McConeghy Stefan Gravenstein Elie Saade Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
description	Abstract Background Major adverse cardiovascular events (MACE) are increasingly used as composite outcomes in randomized controlled trials (RCTs) and observational studies. However, it is unclear how observational studies most commonly define MACE in the literature when using administrative data. Methods We identified peer-reviewed articles published in MEDLINE and EMBASE between January 1, 2010 to October 9, 2020. Studies utilizing administrative data to assess the MACE composite outcome using International Classification of Diseases 9th or 10th Revision diagnosis codes were included. Reviews, abstracts, and studies not providing outcome code definitions were excluded. Data extracted included data source, timeframe, MACE components, code definitions, code positions, and outcome validation. Results A total of 920 articles were screened, 412 were retained for full-text review, and 58 were included. Only 8.6% (n = 5/58) matched the traditional three-point MACE RCT definition of acute myocardial infarction (AMI), stroke, or cardiovascular death. None matched four-point (+unstable angina) or five-point MACE (+unstable angina and heart failure). The most common MACE components were: AMI and stroke, 15.5% (n = 9/58); AMI, stroke, and all-cause death, 13.8% (n = 8/58); and AMI, stroke and cardiovascular death 8.6% (n = 5/58). Further, 67% (n = 39/58) did not validate outcomes or cite validation studies. Additionally, 70.7% (n = 41/58) did not report code positions of endpoints, 20.7% (n = 12/58) used the primary position, and 8.6% (n = 5/58) used any position. Conclusions Components of MACE endpoints and diagnostic codes used varied widely across observational studies. Variability in the MACE definitions used and information reported across observational studies prohibit the comparison, replication, and aggregation of findings. Studies should transparently report the administrative codes used and code positions, as well as utilize validated outcome definitions when possible.
format	article
author	Elliott Bosco Leon Hsueh Kevin W. McConeghy Stefan Gravenstein Elie Saade
author_facet	Elliott Bosco Leon Hsueh Kevin W. McConeghy Stefan Gravenstein Elie Saade
author_sort	Elliott Bosco
title	Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
title_short	Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
title_full	Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
title_fullStr	Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
title_full_unstemmed	Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
title_sort	major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
publisher	BMC
publishDate	2021
url	https://doaj.org/article/3f1f28d291a34a6dbc1141ec19d94648
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Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review

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