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Ann Oncol. 2015 Jan;26(1):231-7. doi: 10.1093/annonc/mdu489. Epub 2014 Oct 29.

Poor patient-reported outcomes reporting according to CONSORT guidelines in randomized clinical trials evaluating systemic cancer therapy.

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Department of Pneumology, Desgenettes Hospital Department of Medical Oncology, Centre Léon BERARD, University of Lyon, Lyon, France.
Joint Austin-Ludwig Oncology Unit, Austin Hospital, Melbourne, Victoria, Australia.
INSERM, U1086, Caen Clinical Research Unit, François Baclesse Center, Caen Department of Medicine, CHU de Caen, Caen.
Department of Medical Oncology, Lyon-Sud Hospital Center, Hospices Civils de Lyon, Pierre-Bénite.
Department 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.
Department 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



The 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.


patients-reported outcomes; quality of life; randomized clinical trials; reporting quality

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