title: Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.
abstract: BACKGROUND
  The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications.
  
  
  METHODS
  We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision.
  
  
  RESULTS
  A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) and cluster (n = 10; n = 9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI -0.02 to 0.10).
  
  
  CONCLUSIONS
  This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].
authors.affiliation: Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. sally.hopewell@csm.ox.ac.uk.|Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. sally.hopewell@csm.ox.ac.uk.|Centre d'Epidémiologie Clinique, Paris Descartes University, Paris, France. sally.hopewell@csm.ox.ac.uk.
authors.forename: Sally
authors.initials: S
authors.lastname: Hopewell
authors.affiliation: Centre d'Epidémiologie Clinique, Paris Descartes University, Paris, France.|INSERM UMR 1153 equipe Methods, Paris Descartes University, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Queensland University of Technology (QUT), Queensland, Australia.
authors.forename: Ginny
authors.initials: G
authors.lastname: Barbour
authors.affiliation: Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Moher
authors.affiliation: Mayo Clinic, Minnesota, USA.
authors.forename: Victor
authors.initials: V
authors.lastname: Montori
authors.affiliation: University of California, Los Angeles, USA.
authors.forename: David
authors.initials: D
authors.lastname: Schriger
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Cook
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Gerry
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Omar
authors.initials: O
authors.lastname: Omar
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Dutton
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Corran
authors.initials: C
authors.lastname: Roberts
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Eleni
authors.initials: E
authors.lastname: Frangou
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Lei
authors.initials: L
authors.lastname: Clifton
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Virginia
authors.initials: V
authors.lastname: Chiocchia
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Ines
authors.initials: I
authors.lastname: Rombach
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Karolina
authors.initials: K
authors.lastname: Wartolowska
authors.affiliation: Centre d'Epidémiologie Clinique, Paris Descartes University, Paris, France.|INSERM UMR 1153 equipe Methods, Paris Descartes University, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D057189:Checklist / Q000592:standards*; D006801:Humans; D020407:Internet; D017063:Outcome Assessment, Health Care; D010506:Periodicals as Topic / Q000592:standards*
keywords: CONSORT; Randomised controlled trial; Reporting; Transparency