Evidence map›Paper›PMID 25943371›Full record

ArticleBMJ open2015

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, Lisa K Schell, Dirk Bassler, Silvano Gallus, Jos Kleijnen, Michael Kulig, Carlo La Vecchia, Ana Marušić, Philippe Ravaud, Andreas Reis and 6 more

Abstract readConsensus Statement
In one paragraph

Article in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
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  11. Fraud in publications-retractions and deterrents.Indian journal of anaesthesia · 2019
    Article
  12. Editors Should Declare Conflicts of Interest.Journal of bioethical inquiry · 2019
    Article
  13. Review
  14. Article
  15. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Joerg J MeerpohlGerman Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
Lisa K SchellGerman Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
Dirk BasslerDepartment of Neonatology, University Hospital Zurich, Zurich, Switzerland Center for Pediatric Clinical Studies, University Children's Hospital Tuebingen, Tuebingen, Germany.
Silvano GallusDepartment of Epidemiology, IRCCS-Istituto di Ricerche Farmacologiche "Mario Negri", Milan, Italy.
Jos KleijnenKleijnen Systematic Reviews Ltd, York, UK School for Public Health and Primary Care, Maastricht University, Maastricht, The Netherlands.
Michael KuligMedical Consultancy Department, Gemeinsamer Bundesausschuss (G-BA), Berlin, Germany.
Carlo La VecchiaDepartment of Clinical Sciences and Community Health, University of Milan, Milan, Italy.
Ana MarušićDepartment of Research in Biomedicine and Health, University of Split School of Medicine, Split, Croatia.
Philippe RavaudINSERM U738 Research Unit, Paris Descartes University, Paris, France.
Andreas ReisGlobal Health Ethics, Department of Knowledge, Ethics and Research, World Health Organization, Geneva, Switzerland.
Christine SchmuckerGerman Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
Daniel StrechCELLS-Centre for Ethics and Law in the Life Sciences, Institute of History, Ethics and Philosophy of Medicine, Hannover Medical School, Hannover, Germany.
Gerard UrrútiaCentro Cochrane Iberoamericano-Servei d'Epidemiologia Clínica i Salut Pública, Institut d'Investigació Biomèdica Sant Pau, CIBERSP, Barcelona, Spain.
Elizabeth WagerSideview, Princes Risborough, UK.ORCID http://orcid.org/0000-0002-4202-7813
Gerd AntesGerman Cochrane Centre, Medical Center-University of Freiburg, Freiburg, Germany.
OPEN project consortium

Funding

World Health Organization 001
6 · The paper itself

Abstract

backgroundDissemination 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.

objectiveTo 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.

methodsBased 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.

resultsFour 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.

conclusionsDespite 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.

Indexed as

Biomedical ResearchBiasDecision MakingEvidence-Based MedicineHumansPublishingTechnology Assessment, BiomedicalEPIDEMIOLOGYJOURNALISM (see Medical Journalism)

Identifiers

PMID25943371
PMCPMC4431130

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.