title: Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus.
abstract: OBJECTIVE
  The aim of this study is to review highly cited articles that focus on non-publication of studies, and to develop a consistent and comprehensive approach to defining (non-) dissemination of research findings.
  
  
  METHODS
  We performed a scoping review of definitions of the term 'publication bias' in highly cited publications.
  
  
  METHODS
  Ideas and experiences of a core group of authors were collected in a draft document, which was complemented by the findings from our literature search.
  
  
  METHODS
  The draft document including findings from the literature search was circulated to an international group of experts and revised until no additional ideas emerged and consensus was reached.
  
  
  METHODS
  We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research.
  
  
  RESULTS
  Our 'What, Who and Why?' approach includes issues that need to be considered when disseminating research findings (What?), the different players who should assume responsibility during the various stages of conducting a clinical trial and disseminating clinical trial documents (Who?), and motivations that might lead the various players to disseminate findings selectively, thereby introducing bias in the dissemination process (Why?).
  
  
  CONCLUSIONS
  Our comprehensive framework of (non-) dissemination of research findings, based on the results of a scoping literature search and expert consensus will facilitate the development of future policies and guidelines regarding the multifaceted issue of selective publication, historically referred to as 'publication bias'.
authors.affiliation: Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
authors.forename: Dirk
authors.initials: D
authors.lastname: Bassler
authors.affiliation: Center for Pediatric Clinical Studies, University Children's Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Katharina F
authors.initials: KF
authors.lastname: Mueller
authors.affiliation: Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland.
authors.forename: Matthias
authors.initials: M
authors.lastname: Briel
authors.affiliation: School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands.
authors.forename: Jos
authors.initials: J
authors.lastname: Kleijnen
authors.affiliation: Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
authors.forename: Ana
authors.initials: A
authors.lastname: Marusic
authors.affiliation: Sideview, Princes Risborough, Bucks, UK.
authors.forename: Elizabeth
authors.identifier: http://orcid.org/0000-0002-4202-7813
authors.initials: E
authors.lastname: Wager
authors.affiliation: German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
authors.forename: Gerd
authors.initials: G
authors.lastname: Antes
authors.affiliation: Cochrane Switzerland, IUMSP, University Hospital Lausanne, Lausanne, Switzerland.
authors.forename: Erik
authors.initials: E
authors.lastname: von Elm
authors.affiliation: Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
authors.forename: Joerg J
authors.initials: JJ
authors.lastname: Meerpohl
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D032921:Consensus; D006801:Humans; D033181:Information Dissemination; D017594:Publication Bias
keywords: Dissemination bias; MEDICAL ETHICS; OPEN Project; Publication Bias; QUALITATIVE RESEARCH