You are here

  • Home
  • Archive
  • Volume 5, Issue 5
  • 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

Article Text

Article menu
XML
Evidence based practice
Research
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
  1. Joerg J Meerpohl1,
  2. Lisa K Schell1,
  3. Dirk Bassler2,3,
  4. Silvano Gallus4,
  5. Jos Kleijnen5,6,
  6. Michael Kulig7,
  7. Carlo La Vecchia8,
  8. Ana Marušić9,
  9. Philippe Ravaud10,
  10. Andreas Reis11,
  11. Christine Schmucker1,
  12. Daniel Strech12,
  13. Gerard Urrútia13,
  14. Elizabeth Wager14,
  15. Gerd Antes1
  16. the OPEN project consortium
  1. 1German Cochrane Centre, Medical Center—University of Freiburg, Freiburg, Germany
  2. 2Department of Neonatology, University Hospital Zurich, Zurich, Switzerland
  3. 3Center for Pediatric Clinical Studies, University Children's Hospital Tuebingen, Tuebingen, Germany
  4. 4Department of Epidemiology, IRCCS—Istituto di Ricerche Farmacologiche “Mario Negri”, Milan, Italy
  5. 5Kleijnen Systematic Reviews Ltd, York, UK
  6. 6School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands
  7. 7Medical Consultancy Department, Gemeinsamer Bundesausschuss (G-BA), Berlin, Germany
  8. 8Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
  9. 9Department of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia
  10. 10INSERM U738 Research Unit, Paris Descartes University, Paris, France
  11. 11Global Health Ethics, Department of Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland
  12. 12CELLS—Centre for Ethics and Law in the Life Sciences, Institute of History, Ethics and Philosophy of Medicine, Hannover Medical School, Hannover, Germany
  13. 13Centro Cochrane Iberoamericano-Servei d'Epidemiologia Clínica i Salut Pública, Institut d'Investigació Biomèdica Sant Pau, CIBERSP, Barcelona, Spain
  14. 14Sideview, Princes Risborough, UK
  1. Correspondence to Dr Joerg J Meerpohl; meerpohl{at}cochrane.de

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.

  • EPIDEMIOLOGY
  • JOURNALISM (see Medical Journalism)

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/

https://doi.org/10.1136/bmjopen-2014-006666

Statistics from Altmetric.com

    Request Permissions

    If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

    View Full Text

    Supplementary materials