Aggregated adverse-events outcomes in oncology phase III reports: A systematic review.
Identifieur interne : 002451 ( PubMed/Curation ); précédent : 002450; suivant : 002452Aggregated 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
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Gan</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><country xml:lang="fr">Australie</country><wicri:regionArea>Medical Oncology Unit, Olivia Newton-John Cancer and Wellness Centre, Austin Hospital, Melbourne, Victoria, Australia; School of Cancer Medicine, La Trobe University, Melbourne</wicri:regionArea></affiliation></author><author><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name><affiliation wicri:level="1"><nlm:affiliation>Medical Oncology Department, Centre Léon Bérard, Lyon, France; EORTC, 83 Avenue Mounier, Bruxelles, Belgium.</nlm:affiliation><country xml:lang="fr">Belgique</country><wicri:regionArea>Medical Oncology Department, Centre Léon Bérard, Lyon, France; EORTC, 83 Avenue Mounier, Bruxelles</wicri:regionArea></affiliation></author><author><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea></affiliation></author><author><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Péron">Julien Péron</name><affiliation wicri:level="1"><nlm: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.</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>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</wicri:regionArea></affiliation></author></analytic><series><title level="j">European journal of cancer (Oxford, England : 1990)</title><idno type="eISSN">1879-0852</idno><imprint><date when="2016" type="published">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems (standards)</term><term>Antineoplastic Agents (adverse effects)</term><term>Drug-Related Side Effects and Adverse Reactions (diagnosis)</term><term>Drug-Related Side Effects and Adverse Reactions (etiology)</term><term>Humans</term><term>Medical Oncology (methods)</term><term>Medical Oncology (standards)</term><term>Multivariate Analysis</term><term>Neoplasms (drug therapy)</term><term>Randomized Controlled Trials as Topic (methods)</term><term>Randomized Controlled Trials as Topic (standards)</term><term>Research Design (standards)</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Analyse multivariée</term><term>Antinéoplasiques (effets indésirables)</term><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><term>Humains</term><term>Oncologie médicale ()</term><term>Oncologie médicale (normes)</term><term>Plan de recherche (normes)</term><term>Résultat thérapeutique</term><term>Systèmes de signalement des effets indésirables des médicaments (normes)</term><term>Tumeurs (traitement médicamenteux)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antineoplastic Agents</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Neoplasms</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antinéoplasiques</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Drug-Related Side Effects and Adverse Reactions</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Medical Oncology</term><term>Randomized Controlled Trials as Topic</term></keywords><keywords scheme="MESH" qualifier="normes" xml:lang="fr"><term>Essais contrôlés randomisés comme sujet</term><term>Oncologie médicale</term><term>Plan de recherche</term><term>Systèmes de signalement des effets indésirables des médicaments</term></keywords><keywords scheme="MESH" qualifier="standards" xml:lang="en"><term>Adverse Drug Reaction Reporting Systems</term><term>Medical Oncology</term><term>Randomized Controlled Trials as Topic</term><term>Research Design</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Tumeurs</term></keywords><keywords scheme="MESH" qualifier="étiologie" xml:lang="fr"><term>Effets secondaires indésirables des médicaments</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Humans</term><term>Multivariate Analysis</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Analyse multivariée</term><term>Essais contrôlés randomisés comme sujet</term><term>Humains</term><term>Oncologie médicale</term><term>Résultat thérapeutique</term></keywords></textClass></profileDesc></teiHeader><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></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26630531</PMID><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><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Maillet</LastName><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></Author><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></Author><Author ValidYN="Y"><LastName>Blay</LastName><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></Author><Author ValidYN="Y"><LastName>You</LastName><ForeName>Benoit</ForeName><Initials>B</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; EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, F-69600, Oullins, France; Université de Lyon, F-69622, Lyon, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Péron</LastName><ForeName>Julien</ForeName><Initials>J</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; 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></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType><PublicationType UI="D016454">Review</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2015</Year><Month>11</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Eur J Cancer</MedlineTA><NlmUniqueID>9005373</NlmUniqueID><ISSNLinking>0959-8049</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000970">Antineoplastic Agents</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D016907" MajorTopicYN="Y">Adverse Drug Reaction Reporting Systems</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000970" MajorTopicYN="N">Antineoplastic Agents</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D064420" MajorTopicYN="N">Drug-Related Side Effects and Adverse Reactions</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000209" MajorTopicYN="Y">etiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008495" MajorTopicYN="N">Medical Oncology</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D015999" MajorTopicYN="N">Multivariate Analysis</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D009369" MajorTopicYN="N">Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012107" MajorTopicYN="Y">Research Design</DescriptorName><QualifierName UI="Q000592" MajorTopicYN="N">standards</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><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><Keyword MajorTopicYN="N">Research designs</Keyword><Keyword MajorTopicYN="N">Research standards</Keyword></KeywordList></MedlineCitation><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></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2015</Year><Month>08</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2015</Year><Month>12</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2015</Year><Month>12</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2016</Year><Month>5</Month><Day>3</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">26630531</ArticleId><ArticleId IdType="pii">S0959-8049(15)00824-2</ArticleId><ArticleId IdType="doi">10.1016/j.ejca.2015.08.025</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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