Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?

Bibliographic Details
Main Author: Santos, Catarina M.
Publication Date: 2021
Other Authors: Prada, Luísa, David, Cláudio, Costa, João, Ferreira, Joaquim J., Pinto, Fausto J., Caldeira, Daniel
Format: Article
Language: eng
Source: Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
Download full: http://hdl.handle.net/10451/47521
Summary: © 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/). Georg Thieme Verlag KG
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network_acronym_str RCAP
network_name_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
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spelling Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?Anticoagulant agentsAntiplatelet agentsCardiovascular systemFibrinolytic therapyHealth planning recommendations© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/). Georg Thieme Verlag KGIntroduction: Criticisms have been raised against the sole use of p-value in interpreting results from randomized controlled trials (RCTs). Additional tools have been suggested, like the fragility index (FI), a measure of a trial’s robustness/fragility, and derivative measures. The FI is the minimum number of patients who would have to be converted from nonevents to events, in the group with the least events, for a result to lose statistical significance. Objective: This study aimed to evaluate RCT supporting European Society of Cardiology (ESC) guidelines regarding antithrombotics, using the FI and FI-related measures. Methods FI, fragility quotient (FQ), and FI minus LTF lost to follow-up (FI LTF) were calculated for the RCT underpinning recommendations regarding antithrombotic therapy from the updated ESC guidelines. LTF was compared with FI. Results were calculated for the total group of studies, as per guideline and as per recommendation type. Results Overall, 61 studies were included. The median FI was 24.5 (interquartile range [IQR]: 9.0–60.0) and median FQ was 0.0035 (IQR: 0.0019–0.0056). Median FI LTF was 2.0 (IQR: 0.0–38.0). Twenty (32.8%) of the studies had one primary or main safety outcome with LTF exceeding FI. Peripheral arterial disease guideline and chronic coronary syndrome guideline had the lowest (2.5; IQR: 1.8–3.3) and the highest (48.5; IQR: 23.8–73.0) FI, respectively. Conclusion: The median FI suggests robustness of clinical trials evaluating antithrombotic drugs cited in the guidelines, but about one-third of them had LTF larger than FI. This emphasizes the need for assessing trials’ robustness when constructing guidelines.ThiemeRepositório da Universidade de LisboaSantos, Catarina M.Prada, LuísaDavid, CláudioCosta, JoãoFerreira, Joaquim J.Pinto, Fausto J.Caldeira, Daniel2021-04-22T15:17:58Z20212021-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/47521engTH Open. 2021 Apr 14;5(2):e125-e133.10.1055/s-0041-17250432512-9465info:eu-repo/semantics/openAccessreponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiainstacron:RCAAP2025-03-17T14:32:38Zoai:repositorio.ulisboa.pt:10451/47521Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireinfo@rcaap.ptopendoar:https://opendoar.ac.uk/repository/71602025-05-29T03:14:35.197506Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologiafalse
dc.title.none.fl_str_mv Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
title Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
spellingShingle Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
Santos, Catarina M.
Anticoagulant agents
Antiplatelet agents
Cardiovascular system
Fibrinolytic therapy
Health planning recommendations
title_short Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
title_full Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
title_fullStr Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
title_full_unstemmed Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
title_sort Antithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?
author Santos, Catarina M.
author_facet Santos, Catarina M.
Prada, Luísa
David, Cláudio
Costa, João
Ferreira, Joaquim J.
Pinto, Fausto J.
Caldeira, Daniel
author_role author
author2 Prada, Luísa
David, Cláudio
Costa, João
Ferreira, Joaquim J.
Pinto, Fausto J.
Caldeira, Daniel
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Santos, Catarina M.
Prada, Luísa
David, Cláudio
Costa, João
Ferreira, Joaquim J.
Pinto, Fausto J.
Caldeira, Daniel
dc.subject.por.fl_str_mv Anticoagulant agents
Antiplatelet agents
Cardiovascular system
Fibrinolytic therapy
Health planning recommendations
topic Anticoagulant agents
Antiplatelet agents
Cardiovascular system
Fibrinolytic therapy
Health planning recommendations
description © 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/). Georg Thieme Verlag KG
publishDate 2021
dc.date.none.fl_str_mv 2021-04-22T15:17:58Z
2021
2021-01-01T00:00:00Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/47521
url http://hdl.handle.net/10451/47521
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv TH Open. 2021 Apr 14;5(2):e125-e133.
10.1055/s-0041-1725043
2512-9465
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Thieme
publisher.none.fl_str_mv Thieme
dc.source.none.fl_str_mv reponame:Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
instname:FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron:RCAAP
instname_str FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
instacron_str RCAAP
institution RCAAP
reponame_str Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
collection Repositórios Científicos de Acesso Aberto de Portugal (RCAAP)
repository.name.fl_str_mv Repositórios Científicos de Acesso Aberto de Portugal (RCAAP) - FCCN, serviços digitais da FCT – Fundação para a Ciência e a Tecnologia
repository.mail.fl_str_mv info@rcaap.pt
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