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Discordance in investigator-reported and adjudicated sudden death in TIOSPIR
Accurate and consistent determination of cause of death is challenging in chronic obstructive pulmonary disease (COPD) patients. TIOSPIR (N=17 135) compared the safety and efficacy of tiotropium Respimat 5/2.5 µg with HandiHaler 18 µg in COPD patients. All-cause mortality was a primary end-point. A...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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European Respiratory Society
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5358526/ https://www.ncbi.nlm.nih.gov/pubmed/28344980 http://dx.doi.org/10.1183/23120541.00073-2016 |
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author | Wise, Robert A. Kowey, Peter R. Austen, George Mueller, Achim Metzdorf, Norbert Fowler, Andy McGarvey, Lorcan P. |
author_facet | Wise, Robert A. Kowey, Peter R. Austen, George Mueller, Achim Metzdorf, Norbert Fowler, Andy McGarvey, Lorcan P. |
author_sort | Wise, Robert A. |
collection | PubMed |
description | Accurate and consistent determination of cause of death is challenging in chronic obstructive pulmonary disease (COPD) patients. TIOSPIR (N=17 135) compared the safety and efficacy of tiotropium Respimat 5/2.5 µg with HandiHaler 18 µg in COPD patients. All-cause mortality was a primary end-point. A mortality adjudication committee (MAC) assessed all deaths. We aimed to investigate causes of discordance in investigator-reported and MAC-adjudicated causes of death and their impact on results, especially cardiac and sudden death. The MAC provided independent, blinded assessment of investigator-reported deaths (n=1302) and assigned underlying cause of death. Discordance between causes of death was assessed descriptively (shift tables). There was agreement between investigator-reported and MAC-adjudicated deaths in 69.4% of cases at the system organ class level. Differences were mainly observed for cardiac deaths (16.4% investigator, 5.1% MAC) and deaths assigned to general disorders including sudden death (17.4% investigator, 24.6% MAC). Reasons for discrepancies included investigator attribution to the immediate (e.g. myocardial infarction (MI)) over the underlying cause of death (e.g. COPD) and insufficient information for a definitive cause. Cause-specific mortality varies in COPD, depending on the method of assignment. Sudden death, witnessed and unwitnessed, is common in COPD and often attributed to MI without supporting evidence. |
format | Online Article Text |
id | pubmed-5358526 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | European Respiratory Society |
record_format | MEDLINE/PubMed |
spelling | pubmed-53585262017-03-24 Discordance in investigator-reported and adjudicated sudden death in TIOSPIR Wise, Robert A. Kowey, Peter R. Austen, George Mueller, Achim Metzdorf, Norbert Fowler, Andy McGarvey, Lorcan P. ERJ Open Res Original Articles Accurate and consistent determination of cause of death is challenging in chronic obstructive pulmonary disease (COPD) patients. TIOSPIR (N=17 135) compared the safety and efficacy of tiotropium Respimat 5/2.5 µg with HandiHaler 18 µg in COPD patients. All-cause mortality was a primary end-point. A mortality adjudication committee (MAC) assessed all deaths. We aimed to investigate causes of discordance in investigator-reported and MAC-adjudicated causes of death and their impact on results, especially cardiac and sudden death. The MAC provided independent, blinded assessment of investigator-reported deaths (n=1302) and assigned underlying cause of death. Discordance between causes of death was assessed descriptively (shift tables). There was agreement between investigator-reported and MAC-adjudicated deaths in 69.4% of cases at the system organ class level. Differences were mainly observed for cardiac deaths (16.4% investigator, 5.1% MAC) and deaths assigned to general disorders including sudden death (17.4% investigator, 24.6% MAC). Reasons for discrepancies included investigator attribution to the immediate (e.g. myocardial infarction (MI)) over the underlying cause of death (e.g. COPD) and insufficient information for a definitive cause. Cause-specific mortality varies in COPD, depending on the method of assignment. Sudden death, witnessed and unwitnessed, is common in COPD and often attributed to MI without supporting evidence. European Respiratory Society 2017-03-20 /pmc/articles/PMC5358526/ /pubmed/28344980 http://dx.doi.org/10.1183/23120541.00073-2016 Text en Copyright ©ERS 2017 http://creativecommons.org/licenses/by-nc/4.0/ This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. |
spellingShingle | Original Articles Wise, Robert A. Kowey, Peter R. Austen, George Mueller, Achim Metzdorf, Norbert Fowler, Andy McGarvey, Lorcan P. Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title | Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title_full | Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title_fullStr | Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title_full_unstemmed | Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title_short | Discordance in investigator-reported and adjudicated sudden death in TIOSPIR |
title_sort | discordance in investigator-reported and adjudicated sudden death in tiospir |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5358526/ https://www.ncbi.nlm.nih.gov/pubmed/28344980 http://dx.doi.org/10.1183/23120541.00073-2016 |
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