title: 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.
abstract: BACKGROUND
  Dissemination bias in clinical research severely impedes informed decision-making not only for healthcare professionals and patients, but also for funders, research ethics committees, regulatory bodies and other stakeholder groups that make health-related decisions. Decisions based on incomplete and biased evidence cannot only harm people, but may also have huge financial implications by wasting resources on ineffective or harmful diagnostic and therapeutic measures, and unnecessary research. Owing to involvement of multiple stakeholders, it remains easy for any single group to assign responsibility for resolving the problem to others.
  
  
  OBJECTIVE
  To develop evidence-informed general and targeted recommendations addressing the various stakeholders involved in knowledge generation and dissemination to help overcome the problem of dissemination bias on the basis of previously collated evidence.
  
  
  METHODS
  Based on findings from systematic reviews, document analyses and surveys, we developed general and targeted draft recommendations. During a 2-day workshop in summer 2013, these draft recommendations were discussed with external experts and key stakeholders, and refined following a rigorous and transparent methodological approach.
  
  
  RESULTS
  Four general, overarching recommendations applicable to all or most stakeholder groups were formulated, addressing (1) awareness raising, (2) implementation of targeted recommendations, (3) trial registration and results posting, and (4) systematic approaches to evidence synthesis. These general recommendations are complemented and specified by 47 targeted recommendations tailored towards funding agencies, pharmaceutical and device companies, research institutions, researchers (systematic reviewers and trialists), research ethics committees, trial registries, journal editors and publishers, regulatory agencies, benefit (health technology) assessment institutions and legislators.
  
  
  CONCLUSIONS
  Despite various recent examples of dissemination bias and several initiatives to reduce it, the problem of dissemination bias has not been resolved. Tailored recommendations based on a comprehensive approach will hopefully help increase transparency in biomedical research by overcoming the failure to disseminate negative findings.
authors.affiliation: German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
authors.forename: Joerg J
authors.initials: JJ
authors.lastname: Meerpohl
authors.affiliation: German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
authors.forename: Lisa K
authors.initials: LK
authors.lastname: Schell
authors.affiliation: Department of Neonatology, University Hospital Zurich, Zurich, Switzerland Center for Pediatric Clinical Studies, University Children's Hospital Tuebingen, Tuebingen, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Bassler
authors.affiliation: Department of Epidemiology, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
authors.forename: Silvano
authors.initials: S
authors.lastname: Gallus
authors.affiliation: Kleijnen Systematic Reviews Ltd, York, UK School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.
authors.forename: Jos
authors.initials: J
authors.lastname: Kleijnen
authors.affiliation: Medical Consultancy Department, Gemeinsamer Bundesausschuss (G-BA), Berlin, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Kulig
authors.affiliation: Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
authors.forename: Carlo
authors.initials: C
authors.lastname: La Vecchia
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: Marušić
authors.affiliation: INSERM U738 Research Unit, Paris Descartes University, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: Global Health Ethics, Department of Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Reis
authors.affiliation: German Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Schmucker
authors.affiliation: CELLS-Centre for Ethics and Law in the Life Sciences, Institute of History, Ethics and Philosophy of Medicine, Hannover Medical School, Hannover, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Strech
authors.affiliation: Centro Cochrane Iberoamericano-Servei d'Epidemiologia Clínica i Salut Pública, Institut d'Investigació Biomèdica Sant Pau, CIBERSP, Barcelona, Spain.
authors.forename: Gerard
authors.initials: G
authors.lastname: Urrútia
authors.affiliation: Sideview, Princes Risborough, 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
mesh_terms: D015982:Bias; D035843:Biomedical Research / Q000458:organization & administration; D003657:Decision Making; D019317:Evidence-Based Medicine; D006801:Humans; D011643:Publishing; D013673:Technology Assessment, Biomedical
keywords: EPIDEMIOLOGY; JOURNALISM (see Medical Journalism)