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.
“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]
The Abstract defines publication bias, and the discussion of ROB-ME mentions funnel plots and tests for asymmetry, but neither passage states a ten-study prerequisite. A search for that threshold and for Cochrane guidance found no supporting passage in our copy. The paper also cannot establish how many studies were included in the citing authors’ outcomes. (LLM, conf=0.73)
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Therapeutic Vaccines for Follicular Lymphoma: A Systematic Review
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Retinal thinning in epilepsy: A meta-analysis
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Metformin for asthma exacerbations
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High- versus low-dose phototherapy for neonatal jaundice
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Preterm Delivery and Long-Term Risk of Maternal Stroke: Systematic Review and Meta-Analysis
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Effectiveness of SARS-CoV-2 testing strategies
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Editors’ Choice: December 2023
Tricco, A. C., McGowan, J., & Tovey, D. I. (2023) · Journal of Clinical Epidemiology · doi:10.1016/j.jclinepi.2023.111233
GPT's Performance in Identifying Outcome Changes on ClinicalTrials.govPreprint
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Immunotherapy for advanced and recurrent malignant pleural mesothelioma
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Risk of bias across study designs
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Time-lag reporting bias in interrupted time series studies: a methodological study
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Self-citation
- 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
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › 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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