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ROB-ME: a tool for assessing risk of bias due to missing evidence in systematic reviews with meta-analysis
Open accessAbstract
Various methods are available to help users assess whether selective non-publication of studies or selective non-reporting of study results has occurred, but not its impact on a meta-analysis. This limitation of existing methods leaves users to decide their own approach for judging the risk of bias in a meta-analysis result. In this paper, Page and colleagues describe the ROB-ME (risk of bias due to missing evidence) tool, a structured approach for assessing the risk of bias that arises when entire studies, or particular results within studies, are missing from a meta-analysis because of the P value, magnitude, or direction of the study results. The tool is anticipated to help authors and users of systematic reviews identify meta-analyses at high risk of bias and interpret results appropriately.
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“We were not able to assess publication bias as none of the outcomes studied included more than 10 studies, which is a pre-requisite according to Cochrane's recommendations.83”
From Interventions to improve adherence to lipid-lowering drugs: a systematic review and meta-analysis (2025) · cites this paper as [83]
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Self-citationThe Cochrane Collaboration's tool for assessing risk of bias in randomised trials
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“32 33 We also plan to develop an interactive online version of the tool to facilitate use and prepare a bank of worked examples for educational purposes.”
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Metadata
- Authors
- Page, M. J., Sterne, J. A. C., Boutron, I., Hróbjartsson, A., Kirkham, J. J., Li, T., Lundh, A., Mayo-Wilson, E., McKenzie, J. E., Stewart, L. A., Sutton, A. J., Bero, L., Dunn, A. G., Dwan, K., Elbers, R. G., Kanukula, R., Meerpohl, J. J., Turner, E. H., & Higgins, J. P. T.
- Affiliations
- Monash University (AU)
- National Institute for Health and Care Research (GB)
- Inserm (FR)
- University of Southern Denmark (DK)
- Manchester Academic Health Science Centre (GB)
- University of Colorado Anschutz (US)
- Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA
- University of York (GB)
- University of Leicester (GB)
- Center for Bioethics and Humanities, University of Colorado, Aurora, CO, USA
- The University of Sydney (AU)
- Liverpool School of Tropical Medicine (GB)
- Erasmus MC (NL)
- University of Freiburg (DE)
- Oregon Health & Science University (US)
- Corresponding author
- Page, Matthew J
- ORCID
- Venue
- BMJ
- Publisher
- BMJ
- Published
- 2023-11-20
- Volume
- 383
- Pages
- e076754
- ISSN
- 1756-1833 (ISSN-L)
- OpenAlex
- W4388824619
- Cited by
- 134
- References
- 28
- Citations by year
- 2026: 63 · 2025: 50 · 2024: 17 · 2023: 4
- FWCI
- 9.50
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- www.bmj.com/company/legal-information/terms-conditions/legal-information/tdm-licencepolicy (tdm)
- Locations
- BMJ (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion, cc-by-nc-nd)
- Bristol Research (University of Bristol) (publishedVersion, cc-by)
- University of Southern Denmark Research Portal (University of Southern Denmark) (publishedVersion)
- LSTM Online Archive (Liverpool School of Tropical Medicine) (acceptedVersion)
- Research Explorer (The University of Manchester) (submittedVersion, other-oa)
- HAL (submittedVersion)
- Adelaide Research & Scholarship (AR&S) (University of Adelaide) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- HighWire Press Open Archive (submittedVersion)
- Explore Bristol Research (submittedVersion, cc-by)
- Funders
- University Hospitals Bristol NHS Foundation Trust
- NIHR Bristol Biomedical Research Centre
- Australian Research Council
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Keywords
- risk of bias, absence of evidence, publication bias, meta-analysis, systematic reviews, bias assessment tools
- MeSH terms
- Systematic Reviews as Topic, Humans, Research Design, Bias
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