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

J.J. Meerpohl, L.K. Schell, D. Bassler, S. Gallus, J. Kleijnen, M. Kulig, C. la Vecchia, A. Marusic, P. Ravaud, A. Reis, C. Schmucker, D. Strech, G. Urrútia, E. Wager, G. Antes, the OPEN project consortium

Research output: Contribution to journalArticleAcademicpeer-review

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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.
Original languageEnglish
Article numbere006666
JournalBMJ Open
Volume5
Issue number5
DOIs
Publication statusPublished - 1 Jan 2015

Cite this

Meerpohl, J.J. ; Schell, L.K. ; Bassler, D. ; Gallus, S. ; Kleijnen, J. ; Kulig, M. ; la Vecchia, C. ; Marusic, A. ; Ravaud, P. ; Reis, A. ; Schmucker, C. ; Strech, D. ; Urrútia, G. ; Wager, E. ; Antes, G. ; OPEN project consortium, the. / 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. In: BMJ Open. 2015 ; Vol. 5, No. 5.
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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.",
author = "J.J. Meerpohl and L.K. Schell and D. Bassler and S. Gallus and J. Kleijnen and M. Kulig and {la Vecchia}, C. and A. Marusic and P. Ravaud and A. Reis and C. Schmucker and D. Strech and G. Urr{\'u}tia and E. Wager and G. Antes and {OPEN project consortium}, the",
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Meerpohl, JJ, Schell, LK, Bassler, D, Gallus, S, Kleijnen, J, Kulig, M, la Vecchia, C, Marusic, A, Ravaud, P, Reis, A, Schmucker, C, Strech, D, Urrútia, G, Wager, E, Antes, G & OPEN project consortium, T 2015, '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', BMJ Open, vol. 5, no. 5, e006666. https://doi.org/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. / Meerpohl, J.J.; Schell, L.K.; Bassler, D.; Gallus, S.; Kleijnen, J.; Kulig, M.; la Vecchia, C.; Marusic, A.; Ravaud, P.; Reis, A.; Schmucker, C.; Strech, D.; Urrútia, G.; Wager, E.; Antes, G.; OPEN project consortium, the.

In: BMJ Open, Vol. 5, No. 5, e006666, 01.01.2015.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - Meerpohl, J.J.

AU - Schell, L.K.

AU - Bassler, D.

AU - Gallus, S.

AU - Kleijnen, J.

AU - Kulig, M.

AU - la Vecchia, C.

AU - Marusic, A.

AU - Ravaud, P.

AU - Reis, A.

AU - Schmucker, C.

AU - Strech, D.

AU - Urrútia, G.

AU - Wager, E.

AU - Antes, G.

AU - OPEN project consortium, the

PY - 2015/1/1

Y1 - 2015/1/1

N2 - 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.

AB - 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.

U2 - 10.1136/bmjopen-2014-006666

DO - 10.1136/bmjopen-2014-006666

M3 - Article

VL - 5

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 5

M1 - e006666

ER -