title: Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study.
abstract: OBJECTIVE
  To investigate the effectiveness of open peer review as a mechanism to improve the reporting of randomised trials published in biomedical journals.
  
  
  METHODS
  Retrospective before and after study.
  
  
  METHODS
  BioMed Central series medical journals.
  
  
  METHODS
  93 primary reports of randomised trials published in BMC-series medical journals in 2012.
  
  
  METHODS
  Changes to the reporting of methodological aspects of randomised trials in manuscripts after peer review, based on the CONSORT checklist, corresponding peer reviewer reports, the type of changes requested, and the extent to which authors adhered to these requests.
  
  
  RESULTS
  Of the 93 trial reports, 38% (n=35) did not describe the method of random sequence generation, 54% (n=50) concealment of allocation sequence, 50% (n=46) whether the study was blinded, 34% (n=32) the sample size calculation, 35% (n=33) specification of primary and secondary outcomes, 55% (n=51) results for the primary outcome, and 90% (n=84) details of the trial protocol. The number of changes between manuscript versions was relatively small; most involved adding new information or altering existing information. Most changes requested by peer reviewers had a positive impact on the reporting of the final manuscript--for example, adding or clarifying randomisation and blinding (n=27), sample size (n=15), primary and secondary outcomes (n=16), results for primary or secondary outcomes (n=14), and toning down conclusions to reflect the results (n=27). Some changes requested by peer reviewers, however, had a negative impact, such as adding additional unplanned analyses (n=15).
  
  
  CONCLUSIONS
  Peer reviewers fail to detect important deficiencies in reporting of the methods and results of randomised trials. The number of these changes requested by peer reviewers was relatively small. Although most had a positive impact, some were inappropriate and could have a negative impact on reporting in the final publication.
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK Centre d'Epidémiologie Clinique, Université Paris Descartes, INSERM U1153, France sally.hopewell@csm.ox.ac.uk.
authors.forename: Sally
authors.initials: S
authors.lastname: Hopewell
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK.
authors.forename: Gary S
authors.initials: GS
authors.lastname: Collins
authors.affiliation: Centre d'Epidémiologie Clinique, Université Paris Descartes, INSERM U1153, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK.
authors.forename: Ly-Mee
authors.initials: LM
authors.lastname: Yu
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Cook
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK.
authors.forename: Milensu
authors.initials: M
authors.lastname: Shanyinde
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK.
authors.forename: Rose
authors.initials: R
authors.lastname: Wharton
authors.affiliation: Ottawa Hospital Research Institute, Canada.
authors.forename: Larissa
authors.initials: L
authors.lastname: Shamseer
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
mesh_terms: D010380:Peer Review; D010506:Periodicals as Topic; D011643:Publishing / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic; D058028:Research Report; D012189:Retrospective Studies