Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review
Identifieur interne : 005117 ( Main/Exploration ); précédent : 005116; suivant : 005118Adherence to CONSORT Adverse Event Reporting Guidelines in Randomized Clinical Trials Evaluating Systemic Cancer Therapy: A Systematic Review
Auteurs : Julien Peron [France] ; Denis Maillet [France] ; Hui K. Gan [Australie] ; Eric X. Chen [Canada] ; Benoit You [France]Source :
- Journal of clinical oncology [ 0732-183X ] ; 2013.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Cancer, Recommandation.
English descriptors
- KwdEn :
Abstract
Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.
Affiliations:
- Australie, Canada, France
- Auvergne-Rhône-Alpes, Ontario, Rhône-Alpes
- Lyon, Toronto, Villeurbanne
- Université de Toronto
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Lyon</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="03"><s1>Université de Lyon</s1><s2>Lyon</s2><s3>FRA</s3><sZ>1 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region">Auvergne-Rhône-Alpes</region><region type="old region">Rhône-Alpes</region><settlement type="city">Lyon</settlement></placeName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Centre National de la Recherche Scientifique Unite Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé</s1><s2>Villeurbanne</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region><region type="old region" nuts="2">Rhône-Alpes</region><settlement type="city">Villeurbanne</settlement><settlement type="city" wicri:auto="agglo">Lyon</settlement></placeName></affiliation></author><author><name sortKey="Maillet, Denis" sort="Maillet, Denis" uniqKey="Maillet D" first="Denis" last="Maillet">Denis Maillet</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon</s1><s2>Pierre-Bénite</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Pierre-Bénite</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion><wicri:noRegion>Pierre-Bénite</wicri:noRegion></affiliation></author><author><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K." last="Gan">Hui K. Gan</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Joint Austin-Ludwig Oncology Unit, Austin Hospital</s1><s2>Melbourne, Victoria</s2><s3>AUS</s3><sZ>3 aut.</sZ></inist:fA14><country>Australie</country><wicri:noRegion>Melbourne, Victoria</wicri:noRegion></affiliation></author><author><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>Princess Margaret Hospital, University Health Network</s1><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Princess Margaret Hospital, University Health Network</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="08"><s1>University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3><sZ>4 aut.</sZ></inist:fA14><country>Canada</country><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université de Toronto</orgName></affiliation></author><author><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon</s1><s2>Pierre-Bénite</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>2 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Pierre-Bénite</wicri:noRegion><wicri:noRegion>Hospices Civils de Lyon</wicri:noRegion><wicri:noRegion>Pierre-Bénite</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Centre National de la Recherche Scientifique Unite Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé</s1><s2>Villeurbanne</s2><s3>FRA</s3><sZ>1 aut.</sZ><sZ>5 aut.</sZ></inist:fA14><country>France</country><placeName><region type="region" nuts="2">Auvergne-Rhône-Alpes</region><region type="old region" nuts="2">Rhône-Alpes</region><settlement type="city">Villeurbanne</settlement><settlement type="city" wicri:auto="agglo">Lyon</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>EMR UCBL/ HCL 3738, Faculté de Médecine Lyon-Sud</s1><s2>Oullins</s2><s3>FRA</s3><sZ>5 aut.</sZ></inist:fA14><country>France</country><wicri:noRegion>Oullins</wicri:noRegion><wicri:noRegion>Faculté de Médecine Lyon-Sud</wicri:noRegion><wicri:noRegion>Oullins</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2013">2013</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adhesion</term><term>Cancer</term><term>Cancerology</term><term>Clinical trial</term><term>Evidence-based medicine</term><term>Malignant tumor</term><term>Randomization</term><term>Recommendation</term><term>Secondary effect</term><term>Systematic review</term><term>Toxicity</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Cancer</term><term>Adhérence</term><term>Effet secondaire</term><term>Tumeur maligne</term><term>Toxicité</term><term>Recommandation</term><term>Essai clinique</term><term>Randomisation</term><term>Traitement</term><term>Revue systématique</term><term>Médecine factuelle</term><term>Cancérologie</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Cancer</term><term>Recommandation</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose The Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2004 to provide a set of 10 specific and comprehensive guidelines regarding adverse event (AE) reporting in randomized clinical trials (RCTs). Limited data exist regarding adherence to these guidelines in publications of oncology RCTs. Methods All phase III RCTs published between 2007 and 2011 were reviewed using a 16-point AE reporting quality score (AERQS) based on the 2004 CONSORT extension. Multivariable linear regression was used to identify features associated with improved reporting quality. Results A total of 325 RCTs were reviewed. The mean AERQS was 10.1 on a 16-point scale. The most common items that were poorly reported were the methodology of AE collection (adequately reported in only 10% of studies), the description of AE characteristics leading to withdrawals (15%), and whether AEs are attributed to trial interventions (38%). Even when reported, the methods of AE collection and analysis were highly heterogeneous. The multivariable regression model revealed that industry funding, intercontinental trials, and trials in the metastatic setting were predictors of higher AERQS. The quality of AE reporting did not improve significantly over time and was not better among articles published in journals with a high impact factor. Conclusion Our findings show that some methodologic aspects of AE collection and analysis were poorly reported. Given the importance of AEs in evaluating new treatments, authors should be encouraged to adhere to the 2004 CONSORT guidelines regarding AE reporting.</div></front></TEI><affiliations><list><country><li>Australie</li><li>Canada</li><li>France</li></country><region><li>Auvergne-Rhône-Alpes</li><li>Ontario</li><li>Rhône-Alpes</li></region><settlement><li>Lyon</li><li>Toronto</li><li>Villeurbanne</li></settlement><orgName><li>Université de Toronto</li></orgName></list><tree><country name="France"><noRegion><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Peron">Julien Peron</name></noRegion><name sortKey="Maillet, Denis" sort="Maillet, Denis" uniqKey="Maillet D" first="Denis" last="Maillet">Denis Maillet</name><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Peron">Julien Peron</name><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Peron">Julien Peron</name><name sortKey="Peron, Julien" sort="Peron, Julien" uniqKey="Peron J" first="Julien" last="Peron">Julien Peron</name><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name><name sortKey="You, Benoit" sort="You, Benoit" uniqKey="You B" first="Benoit" last="You">Benoit You</name></country><country name="Australie"><noRegion><name sortKey="Gan, Hui K" sort="Gan, Hui K" uniqKey="Gan H" first="Hui K." last="Gan">Hui K. Gan</name></noRegion></country><country name="Canada"><noRegion><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name></noRegion><name sortKey="Chen, Eric X" sort="Chen, Eric X" uniqKey="Chen E" first="Eric X." last="Chen">Eric X. Chen</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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