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dc.contributor.authorBylicki, Oen
dc.contributor.authorGan, Hui Ken
dc.contributor.authorJoly, Fen
dc.contributor.authorMaillet, Den
dc.contributor.authorYou, Ben
dc.contributor.authorPéron, Jen
dc.identifier.citationAnnals of Oncology : Official Journal of the European Society For Medical Oncology / Esmo 2014; 26(1): 231-7en
dc.description.abstractThe Consolidated Standards of Reporting Trials (CONSORT) guidance was extended in 2013 to provide a set of specific recommendations regarding patient-reported outcomes (PROs) reporting in randomized clinical trials (RCTs). There is limited data regarding how well current publications of oncology RCTs report PROs if assessed using these guidelines.All phase III medical oncology RCTs published between 2007 and 2011 were reviewed according to the 2013 PROs CONSORT recommendations and an 11-point PROs reporting quality score (PRORQS) was defined based on the criteria.The majority of trials did not report on PROs at all (201 of 325; 62%). Of the remaining 124 trials, the mean PRORQS score was 5.0 on an 11-point scale. The items related to methods of PROs collection and analysis were poorly reported (Description of the prespecified PRO hypothesis: 26% of RCTs; methods for PRO data collection (paper, telephone, electronic, other): 16%; statistical approaches for managing missing data: 37%). The only factor significantly associated with improved PROs reporting was where PROs reporting was the subject of a dedicated secondary manuscript, as was the case in 36 of the 124 (29%) of RCTs.Despite their clinical relevance, our findings show that some aspects of PROs reporting may greatly be improved, especially critical methodological aspects of PROs collection and analysis. The exceptions were where PROs were described in PROs-specific secondary publication. Use of the 2013 PROs CONSORT extensions should be encouraged and their effects on PROs reporting subsequently reassessed.en
dc.subject.otherpatients-reported outcomesen
dc.subject.otherquality of lifeen
dc.subject.otherrandomized clinical trialsen
dc.subject.otherreporting qualityen
dc.titlePoor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.en
dc.typeJournal Articleen
dc.identifier.journaltitleAnnals of oncology : official journal of the European Society for Medical Oncology / ESMOen
dc.identifier.affiliationJoint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australiaen
dc.identifier.affiliationDepartment of Pneumology, Desgenettes Hospital Department of Medical Oncology, Centre Léon BERARD, University of Lyon, Lyon, France.en
dc.identifier.affiliationINSERM, U1086, Caen Clinical Research Unit, François Baclesse Center, Caen Department of Medicine, CHU de Caen, Caen.en
dc.identifier.affiliationDepartment of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite.en
dc.identifier.affiliationDepartment of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite EMR UCBL/HCL 3738, Faculté de Médecine Lyon-Sud, Oullins Department of Medical Oncology, University of Lyon, Lyon.en
dc.identifier.affiliationDepartment of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite Biostatistics Unit, Hospices Civils de Lyon, Lyon Biometry and Evolutionary Biology Laboratory, Health and Biostatistics Team, CNRS UMR 5558, Villeurbanne, France
dc.type.austinJournal Articleen
item.fulltextNo Fulltext-
item.openairetypeJournal Article-
item.openairecristype Oncology- Newton-John Cancer Wellness and Research Centre-
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