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

2021Artigo científico Acesso aberto
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dc.contributor.authorSantos, Catarina M.
dc.contributor.authorPrada, Luísa
dc.contributor.authorDavid, Cláudio
dc.contributor.authorCosta, João
dc.contributor.authorFerreira, Joaquim J.
dc.contributor.authorPinto, Fausto J.
dc.contributor.authorCaldeira, Daniel
dc.date.accessioned2021-04-22T15:17:58Z
dc.date.available2021-04-22T15:17:58Z
dc.date.issued2021
dc.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 KGpt_PT
dc.description.abstractIntroduction: 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.pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationTH Open. 2021 Apr 14;5(2):e125-e133.pt_PT
dc.identifier.doi10.1055/s-0041-1725043pt_PT
dc.identifier.eissn2512-9465
dc.identifier.urihttp://hdl.handle.net/10451/47521
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherThiemept_PT
dc.relation.publisherversionhttps://www.thieme.com/books-main/internal-medicine/product/4175-th-openpt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectAnticoagulant agentspt_PT
dc.subjectAntiplatelet agentspt_PT
dc.subjectCardiovascular systempt_PT
dc.subjectFibrinolytic therapypt_PT
dc.subjectHealth planning recommendationspt_PT
dc.titleAntithrombotic therapy recommendations in the European Society of Cardiology Guidelines : how robust are the randomized controlled trials underpinning them?pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.endPagee133pt_PT
oaire.citation.issue02pt_PT
oaire.citation.startPagee125pt_PT
oaire.citation.titleTH Openpt_PT
oaire.citation.volume05pt_PT
person.familyNameSantos
person.familyNamePrada
person.familyNameAntunes David
person.familyNameCosta
person.familyNameFerreira
person.familyNamePinto
person.familyNameCaldeira
person.givenNameCatarina
person.givenNameLuísa
person.givenNameCláudio Virgílio
person.givenNameJoão
person.givenNameJoaquim J
person.givenNameFausto J.
person.givenNameDaniel
person.identifier480560
person.identifier1624753
person.identifier1308889
person.identifier.ciencia-id2610-0EC0-FE33
person.identifier.ciencia-id0C16-4DE0-15E7
person.identifier.ciencia-id7D15-5CD6-6159
person.identifier.ciencia-idC311-AEDD-6DBB
person.identifier.ciencia-idAA19-EC35-8D01
person.identifier.orcid0000-0001-6520-6665
person.identifier.orcid0000-0002-7082-7594
person.identifier.orcid0000-0002-8749-8598
person.identifier.orcid0000-0002-5831-4921
person.identifier.orcid0000-0003-3950-5113
person.identifier.orcid0000-0002-8034-4529
person.identifier.orcid0000-0002-2520-5673
person.identifier.ridG-9363-2015
person.identifier.scopus-author-id55499748300
person.identifier.scopus-author-id7403252466
person.identifier.scopus-author-id7102740158
person.identifier.scopus-author-id36623384200
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
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