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Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus
  1. Dirk Bassler1,
  2. Katharina F Mueller2,
  3. Matthias Briel3,
  4. Jos Kleijnen4,
  5. Ana Marusic5,
  6. Elizabeth Wager6,
  7. Gerd Antes7,
  8. Erik von Elm8,
  9. Douglas G Altman9,
  10. Joerg J Meerpohl7
  11. on behalf of the OPEN Consortium
  1. 1Department of Neonatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
  2. 2Center for Pediatric Clinical Studies, University Children's Hospital Tuebingen, Tuebingen, Germany
  3. 3Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland
  4. 4School for Public Health and Primary Care (CAPHRI), Maastricht University, Maastricht, The Netherlands
  5. 5Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia
  6. 6Sideview, Princes Risborough, Bucks, UK
  7. 7German Cochrane Centre, Medical Center—University of Freiburg, Freiburg, Germany
  8. 8Cochrane Switzerland, IUMSP, University Hospital Lausanne, Lausanne, Switzerland
  9. 9Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  1. Correspondence to Dr Dirk Bassler; dirk.bassler{at}usz.ch

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.

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’.

  • MEDICAL ETHICS
  • QUALITATIVE RESEARCH
  • Publication Bias
  • OPEN Project
  • Dissemination bias

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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