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For Peer Review Only Journal: BMJ Open BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from Evidence-informed recommendations to reduce dissemination bias in clinical research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) project based on an international consensus meeting For peer review only Journal: BMJ Open Manuscript ID: bmjopen-2014-006666.R2 Article Type: Research Date Submitted by the Author: 15-Jan-2015 Complete List of Authors: Meerpohl, Joerg; Medical Center - University of Freiburg, German Cochrane Centre Schell, Lisa; Medical Center - University of Freiburg, German Cochrane Centre Bassler, Dirk; University Hospital Zurich, Department of Neonatology Gallus, Silvano; Istituto di Ricerche Farmacologiche Mario Negri, Department of Epidemiology Kleijnen, Jos; Kleijnen Systematic Reviews Ltd; Maastricht University, School for Public Health and Primary Care Kulig, Michael; Gemeinsamer Bundesausschuss, Medical Consultancy Department http://bmjopen.bmj.com/ La Vecchia, Carlo; University of Milan, Department of Clinical Sciences and Community Health Marusic, Ana; University of Split School of Medicine, Ravaud, Philippe; paris descartes University , Reis, Andreas; World Health Organization, Ethics, Equity, Trade & Human Rights Schmucker, Christine; Medical Center - University of Freiburg, German Cochrane Centre Strech, Daniel; Hannover Medical School Urrutia, Gerard; Iberoamerican Cochrane Centre, on September 23, 2021 by guest. Protected copyright. Wager, Elizabeth; Sideview, Antes, Gerd; Medical Center - University of Freiburg, German Cochrane Centre <b>Primary Subject Evidence based practice Heading</b>: Epidemiology, Ethics, Medical publishing and peer review, Research Secondary Subject Heading: methods EPIDEMIOLOGY, Protocols & guidelines < HEALTH SERVICES Keywords: ADMINISTRATION & MANAGEMENT, JOURNALISM (see Medical Journalism) For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 41 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 23, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 41 BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 Evidence-informed recommendations to reduce dissemination bias in clinical 4 research: conclusions from the OPEN (Overcome failure to Publish nEgative fiNdings) 5 6 project based on an international consensus meeting 7 8 9 Joerg J Meerpohl, deputy director1, Lisa K Schell, researcher1, Dirk Bassler, professor2,3, 10 Silvano Gallus, senior researcher4, Jos Kleijnen, professor5,6, Michael Kulig, researcher7, 11 12 Carlo La Vecchia, professor8, Ana Marušić, professor9, Philippe Ravaud, professor10, 13 11 1 14 Andreas Reis, technical officer , Christine Schmucker, researcher , Daniel Strech, 15 professor12, ForGerard Urrutia, peer researcher 13review, Elizabeth Wager, publicationsonly consultant14, Gerd 16 1 17 Antes, professor and the OPEN project consortium 18 19 20 Authors’ Affiliation: 21 1 German Cochrane Centre, Medical Center – University of Freiburg, Freiburg, Germany 22 2 23 Department of Neonatology, University Hospital Zurich, Zurich, Switzerland 24 3 Center for Pediatric Clinical Studies, University Children’s Hospital Tuebingen, Tuebingen, 25 26 Germany 27 4 Department of Epidemiology, IRCCS - Istituto di Ricerche Farmacologiche “Mario Negri”, 28 29 Milan, Italy 30 5 Kleijnen Systematic Reviews Ltd, York, United Kingdom 31 32 6 School for Public Health and Primary Care, Maastricht University, Maastricht, The 33 http://bmjopen.bmj.com/ Netherlands 34 35 7 Medical Consultancy Department, Gemeinsamer Bundesausschuss (G-BA), Berlin, 36 Germany 37 38 8 Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy 39 9 40 Department of Research in Biomedicine and Health, University of Split School of Medicine, 41 Split, Croatia on September 23, 2021 by guest. Protected copyright. 42 10 43 INSERM U738 research unit, Paris Descartes University, Paris, France 44 11 Global Health Ethics, Department of Knowledge, Ethics and Research, World Health 45 46 Organization, Geneva, Switzerland 47 12 CELLS – Centre for Ethics and Law in the Life Sciences, Institute of History, Ethics and 48 49 Philosophy of Medicine, Hannover Medical School, Hannover, Germany 50 13 Centro Cochrane Iberoamericano-Servei d’Epidemiologia Clínica i Salut Pública, Institut 51 52 d’Investigació Biomèdica Sant Pau, Barcelona, Spain 53 14 Sideview, Princes Risborough, United Kingdom 54 55 56 Correspondence to: 57 58 Joerg J Meerpohl: [email protected] 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 41 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 4 Word count: 5 6 Abstract: 299 7 Text: 3321 8 9 10 11 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 23, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 41 BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 Structured abstract 4 5 6 Background 7 Dissemination bias in clinical research severely impedes informed decision-making not only 8 9 for healthcare professionals and patients, but also for funders, research ethics committees, 10 regulatory bodies and other stakeholder groups that make health-related decisions. 11 12 Decisions based on incomplete and biased evidence can not only harm people, but may also 13 14 have huge financial implications by wasting resources on ineffective or harmful diagnostic 15 and therapeuticFor measures peer and unnecessary review research. Due only to involvement of multiple 16 17 stakeholders it remains easy for any single group to assign responsibility for resolving the 18 problem to others. 19 20 21 Objective 22 23 To develop evidence-informed general and targeted recommendations addressing the 24 various stakeholders involved in knowledge generation and dissemination to help overcome 25 26 the problem of dissemination bias on the basis of previously collated evidence. 27 28 29 Methods 30 Based on findings from systematic reviews, document analyses and surveys, we developed 31 32 general and targeted draft recommendations. During a 2day workshop in summer 2013, 33 http://bmjopen.bmj.com/ these draft recommendations were discussed with external experts and key stakeholders 34 35 and refined following a rigorous and transparent methodological approach. 36 37 38 Results 39 40 Four general, over-arching recommendations applicable to all or most stakeholder groups 41 were formulated, addressing (1) awareness raising, (2) implementation of targeted on September 23, 2021 by guest. Protected copyright. 42 43 recommendations, (3) trial registration and results posting, and (4) systematic approaches to 44 evidence synthesis. These general recommendations are complemented and specified by 47 45 46 targeted recommendations tailored towards funding agencies, pharmaceutical and device 47 companies, research institutions, researchers (systematic reviewers and trialists), research 48 49 ethics committees, trial registries, journal editors and publishers, regulatory agencies, benefit 50 (health technology) assessment institutions and legislators. 51 52 53 Conclusions 54 55 Despite various recent examples of dissemination bias and several initiatives to reduce it, the 56 problem of dissemination bias has not been resolved. Tailored recommendations based on a 57 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 41 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 comprehensive approach will hopefully help increase transparency in biomedical research by 4 overcoming the failure to disseminate negative findings. 5 6 7 8 9 10 11 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 23, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 4 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 41 BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015. Downloaded from 1 2 3 Article Summary Section 4 5 6 7 Strengths and limitations of this study 8 9 Strengths: 10 11 • Comprehensive set of evidence-informed recommendations aimed at reducing 12 dissemination bias based on work conducted as part of European Union FP7 project 13 (OPEN project; www.open-project.eu) 14 • Both general and specific recommendations targeted at various key stakeholder 15 For peer review only 16 groups involved in the knowledge generation and translation process 17 • Use of a rigorous and transparent methodology to develop recommendations 18 including at consensus meeting including external experts and stakeholders 19 20 Limitation: 21 22 • Iteration of some recommendations which are not new but have so far not been 23 broadly implemented 24 25 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 on September 23, 2021 by guest. Protected copyright. 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 5 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 7 of 41 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2014-006666 on 5 May 2015.
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