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Title: Adherence to CONSORT adverse event reporting guidelines in randomized clinical trials evaluating systemic cancer therapy: a systematic review.
Austin Authors: Péron, Julien;Maillet, Denis;Gan, Hui K ;Chen, Eric X;You, Benoit
Affiliation: Julien Péron, Denis Maillet, and Benoit You, Centre Hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite; Julien Péron, Hospices Civils de Lyon; Julien Péron and Benoit You, Université de Lyon, Lyon; Julien Péron, Centre National de la Recherche Scientifique Unité Mixte de Recherche 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne; Benoit You, EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, Oullins, France
Hui K. Gan, Joint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australia
Eric X. Chen, Princess Margaret Hospital, University Health Network; and Eric X. Chen, University of Toronto, Toronto, Ontario, Canada
Issue Date: 23-Sep-2013
Publication information: Journal of Clinical Oncology 2013; 31(31): 3957-63
Abstract: 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.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.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.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.
Gov't Doc #: 24062406
DOI: 10.1200/JCO.2013.49.3981
Type: Journal Article
Subjects: Antineoplastic Agents.adverse effects
Clinical Trials, Phase III as Topic
Drug-Related Side Effects and Adverse Reactions
Guideline Adherence.standards.statistics & numerical data
Guidelines as Topic
Neoplasms.drug therapy
Randomized Controlled Trials as Topic.standards
Appears in Collections:Journal articles

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