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Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review
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: W...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571870/ https://www.ncbi.nlm.nih.gov/pubmed/34742250 http://dx.doi.org/10.1186/s12874-021-01440-5 |
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author | Bosco, Elliott Hsueh, Leon McConeghy, Kevin W. Gravenstein, Stefan Saade, Elie |
author_facet | Bosco, Elliott Hsueh, Leon McConeghy, Kevin W. Gravenstein, Stefan Saade, Elie |
author_sort | Bosco, Elliott |
collection | PubMed |
description | 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01440-5. |
format | Online Article Text |
id | pubmed-8571870 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-85718702021-11-08 Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review Bosco, Elliott Hsueh, Leon McConeghy, Kevin W. Gravenstein, Stefan Saade, Elie BMC Med Res Methodol Research 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. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12874-021-01440-5. BioMed Central 2021-11-06 /pmc/articles/PMC8571870/ /pubmed/34742250 http://dx.doi.org/10.1186/s12874-021-01440-5 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Bosco, Elliott Hsueh, Leon McConeghy, Kevin W. Gravenstein, Stefan Saade, Elie Major adverse cardiovascular event definitions used in observational analysis of administrative databases: a systematic review |
title | 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_short | 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 |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8571870/ https://www.ncbi.nlm.nih.gov/pubmed/34742250 http://dx.doi.org/10.1186/s12874-021-01440-5 |
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