Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2015 May 5;5(5):e006666.
doi: 10.1136/bmjopen-2014-006666.

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

Joerg J Meerpohl  1 , Lisa K Schell  1 , Dirk Bassler  2 , Silvano Gallus  3 , Jos Kleijnen  4 , Michael Kulig  5 , Carlo La Vecchia  6 , Ana Marušić  7 , Philippe Ravaud  8 , Andreas Reis  9 , Christine Schmucker  1 , Daniel Strech  10 , Gerard Urrútia  11 , Elizabeth Wager  12 , Gerd Antes  1 ; OPEN project consortium
Collaborators, Affiliations

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

Joerg J Meerpohl et al. BMJ Open. .

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.

Keywords: EPIDEMIOLOGY; JOURNALISM (see Medical Journalism).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Example of framework worksheet used for discussion of recommendations.
See this image and copyright information in PMC

References

    1. Strech D. Normative arguments and new solutions for the unbiased registration and publication of clinical trials. J Clin Epidemiol 2012;65:276–81. 10.1016/j.jclinepi.2011.07.002 - DOI - PubMed
    1. Dwan K, Gamble C, Williamson PR et al. . Systematic review of the empirical evidence of study publication bias and outcome reporting bias—an updated review. PLoS ONE 2013;8:e66844 10.1371/journal.pone.0066844 - DOI - PMC - PubMed
    1. Antes G, Chalmers I. Under-reporting of clinical trials is unethical. Lancet 2003;361:978–9. 10.1016/S0140-6736(03)12838-3 - DOI - PubMed
    1. Dickersin K. The existence of publication bias and risk factors for its occurrence. JAMA 1990;263:1385–9. 10.1001/jama.1990.03440100097014 - DOI - PubMed
    1. Muller KF, Briel M, D'Amario A et al. . Defining publication bias: protocol for a systematic review of highly cited articles and proposal for a new framework. Syst Rev 2013;2:34 10.1186/2046-4053-2-34 - DOI - PMC - PubMed

Publication types