Bias in dissemination of clinical research findings: Structured OPEN framework of what, who and why, based on literature review and expert consensus

Dirk Bassler, Katharina F. Mueller, Matthias Briel, Jos Kleijnen, Ana Marusic, Elizabeth Wager, Gerd Antes, Erik Von Elm, Douglas G. Altman, Joerg J. Meerpohl, Vittorio Bertelè, Xavier Bonfill, Marie Charlotte Bouesseau, Isabelle Boutron, Silvano Gallus, Silvio Garattini, Davina Ghersi, Ghassan Karam, Michael Kulig, Carlo La VecchiaJasper Littmann, Mario Malički, Bojana Murisic, Alexandra Nolting, Hector Pardo, Matthias Perleth, Philippe Ravaud, Andreas Reis, Lisa Schell, Christine Schmucker, Guido Schwarzer, Daniel Strech, Ludovic Trinquart, Gerard Urrutia, Robert Wolff

Research output: Contribution to journalArticlepeer-review


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. Setting: We performed a scoping review of definitions of the term 'publication bias' in highly cited publications. Participants: 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. Interventions: 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. Primary outcomes: We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research. Secondary outcomes: 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'.

Original languageEnglish
Article numbere010024
JournalBMJ Open
Issue number1
Publication statusPublished - 2016

ASJC Scopus subject areas

  • Medicine(all)


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