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 Vecchia & 15 others Jasper 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 journalArticle

7 Citations (Scopus)

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'.

Original languageEnglish
Article numbere010024
JournalBMJ Open
Volume6
Issue number1
DOIs
Publication statusPublished - 2016

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Publication Bias
Research
Publications
Clinical Trials
Policy Making
Guidelines

ASJC Scopus subject areas

  • Medicine(all)

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

In: BMJ Open, Vol. 6, No. 1, e010024, 2016.

Research output: Contribution to journalArticle

Bassler, D, Mueller, KF, Briel, M, Kleijnen, J, Marusic, A, Wager, E, Antes, G, Von Elm, E, Altman, DG, Meerpohl, JJ, Bertelè, V, Bonfill, X, Bouesseau, MC, Boutron, I, Gallus, S, Garattini, S, Ghersi, D, Karam, G, Kulig, M, La Vecchia, C, Littmann, J, Malički, M, Murisic, B, Nolting, A, Pardo, H, Perleth, M, Ravaud, P, Reis, A, Schell, L, Schmucker, C, Schwarzer, G, Strech, D, Trinquart, L, Urrutia, G & Wolff, R 2016, 'Bias in dissemination of clinical research findings: Structured OPEN framework of what, who and why, based on literature review and expert consensus', BMJ Open, vol. 6, no. 1, e010024. https://doi.org/10.1136/bmjopen-2015-010024
Bassler, Dirk ; Mueller, Katharina F. ; Briel, Matthias ; Kleijnen, Jos ; Marusic, Ana ; Wager, Elizabeth ; Antes, Gerd ; Von Elm, Erik ; Altman, Douglas G. ; Meerpohl, Joerg J. ; Bertelè, Vittorio ; Bonfill, Xavier ; Bouesseau, Marie Charlotte ; Boutron, Isabelle ; Gallus, Silvano ; Garattini, Silvio ; Ghersi, Davina ; Karam, Ghassan ; Kulig, Michael ; La Vecchia, Carlo ; Littmann, Jasper ; Malički, Mario ; Murisic, Bojana ; Nolting, Alexandra ; Pardo, Hector ; Perleth, Matthias ; Ravaud, Philippe ; Reis, Andreas ; Schell, Lisa ; Schmucker, Christine ; Schwarzer, Guido ; Strech, Daniel ; Trinquart, Ludovic ; Urrutia, Gerard ; Wolff, Robert. / Bias in dissemination of clinical research findings : Structured OPEN framework of what, who and why, based on literature review and expert consensus. In: BMJ Open. 2016 ; Vol. 6, No. 1.
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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'.",
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T2 - Structured OPEN framework of what, who and why, based on literature review and expert consensus

AU - Bassler, Dirk

AU - Mueller, Katharina F.

AU - Briel, Matthias

AU - Kleijnen, Jos

AU - Marusic, Ana

AU - Wager, Elizabeth

AU - Antes, Gerd

AU - Von Elm, Erik

AU - Altman, Douglas G.

AU - Meerpohl, Joerg J.

AU - Bertelè, Vittorio

AU - Bonfill, Xavier

AU - Bouesseau, Marie Charlotte

AU - Boutron, Isabelle

AU - Gallus, Silvano

AU - Garattini, Silvio

AU - Ghersi, Davina

AU - Karam, Ghassan

AU - Kulig, Michael

AU - La Vecchia, Carlo

AU - Littmann, Jasper

AU - Malički, Mario

AU - Murisic, Bojana

AU - Nolting, Alexandra

AU - Pardo, Hector

AU - Perleth, Matthias

AU - Ravaud, Philippe

AU - Reis, Andreas

AU - Schell, Lisa

AU - Schmucker, Christine

AU - Schwarzer, Guido

AU - Strech, Daniel

AU - Trinquart, Ludovic

AU - Urrutia, Gerard

AU - Wolff, Robert

PY - 2016

Y1 - 2016

N2 - 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'.

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