Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.
Identifieur interne : 002E17 ( Ncbi/Merge ); précédent : 002E16; suivant : 002E18Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.
Auteurs : Denis Maillet [France] ; Hui K. Gan [Australie] ; Jean-Yves Blay [Belgique] ; Benoit You [France] ; Julien Péron [France]Source :
- European journal of cancer (Oxford, England : 1990) [ 1879-0852 ] ; 2016.
Descripteurs français
- KwdFr :
- Analyse multivariée, Antinéoplasiques (effets indésirables), Effets secondaires indésirables des médicaments (diagnostic), Effets secondaires indésirables des médicaments (étiologie), Essais contrôlés randomisés comme sujet (), Essais contrôlés randomisés comme sujet (normes), Humains, Oncologie médicale (), Oncologie médicale (normes), Plan de recherche (normes), Résultat thérapeutique, Systèmes de signalement des effets indésirables des médicaments (normes), Tumeurs (traitement médicamenteux).
- MESH :
- diagnostic : Effets secondaires indésirables des médicaments.
- effets indésirables : Antinéoplasiques.
- normes : Essais contrôlés randomisés comme sujet, Oncologie médicale, Plan de recherche, Systèmes de signalement des effets indésirables des médicaments.
- traitement médicamenteux : Tumeurs.
- étiologie : Effets secondaires indésirables des médicaments.
- Analyse multivariée, Essais contrôlés randomisés comme sujet, Humains, Oncologie médicale, Résultat thérapeutique.
English descriptors
- KwdEn :
- Adverse Drug Reaction Reporting Systems (standards), Antineoplastic Agents (adverse effects), Drug-Related Side Effects and Adverse Reactions (diagnosis), Drug-Related Side Effects and Adverse Reactions (etiology), Humans, Medical Oncology (methods), Medical Oncology (standards), Multivariate Analysis, Neoplasms (drug therapy), Randomized Controlled Trials as Topic (methods), Randomized Controlled Trials as Topic (standards), Research Design (standards), Treatment Outcome.
- MESH :
- chemical , adverse effects : Antineoplastic Agents.
- diagnosis : Drug-Related Side Effects and Adverse Reactions.
- drug therapy : Neoplasms.
- etiology : Drug-Related Side Effects and Adverse Reactions.
- methods : Medical Oncology, Randomized Controlled Trials as Topic.
- standards : Adverse Drug Reaction Reporting Systems, Medical Oncology, Randomized Controlled Trials as Topic, Research Design.
- Humans, Multivariate Analysis, Treatment Outcome.
Abstract
Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership.
DOI: 10.1016/j.ejca.2015.08.025
PubMed: 26630531
Links toward previous steps (curation, corpus...)
- to stream PubMed, to step Corpus: 002519
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- to stream PubMed, to step Checkpoint: 002451
Links to Exploration step
pubmed:26630531Le document en format XML
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<term>Humans</term>
<term>Medical Oncology (methods)</term>
<term>Medical Oncology (standards)</term>
<term>Multivariate Analysis</term>
<term>Neoplasms (drug therapy)</term>
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<term>Randomized Controlled Trials as Topic (standards)</term>
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<term>Effets secondaires indésirables des médicaments (diagnostic)</term>
<term>Effets secondaires indésirables des médicaments (étiologie)</term>
<term>Essais contrôlés randomisés comme sujet ()</term>
<term>Essais contrôlés randomisés comme sujet (normes)</term>
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<keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term>
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<term>Randomized Controlled Trials as Topic</term>
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<term>Plan de recherche</term>
<term>Systèmes de signalement des effets indésirables des médicaments</term>
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<term>Multivariate Analysis</term>
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<front><div type="abstract" xml:lang="en">Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership.</div>
</front>
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<DateCreated><Year>2016</Year>
<Month>01</Month>
<Day>03</Day>
</DateCreated>
<DateCompleted><Year>2016</Year>
<Month>05</Month>
<Day>02</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>01</Month>
<Day>03</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1879-0852</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>52</Volume>
<PubDate><Year>2016</Year>
<Month>Jan</Month>
</PubDate>
</JournalIssue>
<Title>European journal of cancer (Oxford, England : 1990)</Title>
<ISOAbbreviation>Eur. J. Cancer</ISOAbbreviation>
</Journal>
<ArticleTitle>Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.</ArticleTitle>
<Pagination><MedlinePgn>26-32</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/j.ejca.2015.08.025</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S0959-8049(15)00824-2</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Randomised controlled trials (RCTs) represent a major source of information on treatment-related adverse events (AEs). In this study, we reviewed the use and the reporting methods of aggregated-AEs (A-AEs) outcomes in RCTs reports published in oncology and compared that to the expectations of European Organisation for Research and Treatment of Cancer (EORTC) membership.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">RCTs reports published between 2007 and 2011 were reviewed regarding the reporting of A-AEs-outcomes. A-AEs were defined as summary outcome combining several related AEs, usually grouped by organ system e.g. cardiac-AEs, dermatologic-AEs. Trial characteristics associated with the use of A-AEs outcomes were investigated. The expectation of EORTC members concerning A-AEs utilisation was queried through a survey.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Among 325 RCTs published between 2007 and 2011, 94 (29%) included one or more A-AE outcomes. A clear description of the nature of AEs included in such aggregations was provided in 19 articles (20%). No description of A-AEs was conversely provided in the other 75 articles (80%). The most commonly used A-AEs-outcomes were dermatologic-AEs (45%) and cardiac-AEs (33%). In multivariate analysis, the use of A-AEs outcomes was more frequent when trials were conducted in Europe (p = 0.038) and in trials performed on colon/rectal cancers (p = 0.016). Finally, there is no consensus of EORTC members regarding the utilisation of A-AEs but a majority of them (88%) felt that a clear description of A-AEs should systematically be reported.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The use of A-AEs is infrequent in oncology RCT manuscripts although their use is accepted by most clinicians. However, a clear definition of A-AEs is strongly recommended if they are to be used in order to avoid a loss of important details about drug toxicities that is useful to clinicians.</AbstractText>
<CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
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<ForeName>Denis</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Gan</LastName>
<ForeName>Hui K</ForeName>
<Initials>HK</Initials>
<AffiliationInfo><Affiliation>Medical Oncology Unit, Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne, Victoria, Australia; School of Cancer Medicine, La Trobe University, Melbourne, Australia.</Affiliation>
</AffiliationInfo>
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<ForeName>Jean-Yves</ForeName>
<Initials>JY</Initials>
<AffiliationInfo><Affiliation>Medical Oncology Department, Centre Léon Bérard, Lyon, France; EORTC, 83 Avenue Mounier, Bruxelles, Belgium.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>You</LastName>
<ForeName>Benoit</ForeName>
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<AffiliationInfo><Affiliation>Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France; EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, F-69600, Oullins, France; Université de Lyon, F-69622, Lyon, France.</Affiliation>
</AffiliationInfo>
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<ForeName>Julien</ForeName>
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<AffiliationInfo><Affiliation>Medical Oncology Department, Centre Hospitalier Lyon-Sud, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, F-69310, Pierre-Bénite, France; Hospices Civils de Lyon, Biostatistics Unit, F-69003, Lyon, France; CNRS UMR 5558, Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, Villeurbanne, France. Electronic address: julien.peron@chu-lyon.fr.</Affiliation>
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<Month>11</Month>
<Day>27</Day>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="Y">Adverse Drug Reaction Reporting Systems</DescriptorName>
<QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName>
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<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
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<MeshHeading><DescriptorName UI="D015999" MajorTopicYN="N">Multivariate Analysis</DescriptorName>
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<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Aggregated adverse events outcomes</Keyword>
<Keyword MajorTopicYN="N">EORTC</Keyword>
<Keyword MajorTopicYN="N">Methods</Keyword>
<Keyword MajorTopicYN="N">Neoplasms</Keyword>
<Keyword MajorTopicYN="N">Publishing standards</Keyword>
<Keyword MajorTopicYN="N">Randomised controlled trials as topic</Keyword>
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<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2015</Year>
<Month>06</Month>
<Day>09</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="revised"><Year>2015</Year>
<Month>08</Month>
<Day>26</Day>
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<PubMedPubDate PubStatus="accepted"><Year>2015</Year>
<Month>08</Month>
<Day>26</Day>
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<PubMedPubDate PubStatus="entrez"><Year>2015</Year>
<Month>12</Month>
<Day>3</Day>
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<PubMedPubDate PubStatus="pubmed"><Year>2015</Year>
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<PubMedPubDate PubStatus="medline"><Year>2016</Year>
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<ArticleIdList><ArticleId IdType="pubmed">26630531</ArticleId>
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<ArticleId IdType="doi">10.1016/j.ejca.2015.08.025</ArticleId>
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<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>France</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Rhône-Alpes</li>
<li>Région de Bruxelles-Capitale</li>
<li>Victoria (État)</li>
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<settlement><li>Bruxelles</li>
<li>Lyon</li>
<li>Melbourne</li>
<li>Pierre-Bénite</li>
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<tree><country name="France"><region name="Auvergne-Rhône-Alpes"><name sortKey="Maillet, Denis" sort="Maillet, Denis" uniqKey="Maillet D" first="Denis" last="Maillet">Denis Maillet</name>
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<name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Péron">Julien Péron</name>
<name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name>
</country>
<country name="Australie"><region name="Victoria (État)"><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K" last="Gan">Hui K. Gan</name>
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<country name="Belgique"><region name="Région de Bruxelles-Capitale"><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name>
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