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Comparative assessment of Cochrane's ROB and ROB2 in dentistry trials: a meta-research study
João Viana1, Vanessa Machado2, Luís Proença2
1Egas Moniz School of Health and Science, Egas Moniz Center for Interdisciplinary Research, 2829-511, Almada, Portugal. jviana@egasmoniz.edu.pt.
Systematic Reviews
|July 29, 2025
Summary
Cochrane
Area of Science:
- Dental Research
- Evidence Synthesis
- Meta-Research
Background:
- Assessing risk of bias is crucial for evaluating the quality of clinical trials.
- Cochrane's Risk of Bias (RoB) tool and its updated version, RoB2, are widely used.
- Understanding the differences in their application in dentistry is important for consistent evidence appraisal.
Purpose of the Study:
- To compare the performance of Cochrane's Risk of Bias (RoB) and RoB2 tools.
- To evaluate the agreement between RoB and RoB2 in assessing bias in dental randomized clinical trials.
- To identify discrepancies in bias assessment between the two tools in dental research.
Main Methods:
- A meta-research study analyzing 150 in vivo randomized clinical trials in dentistry.
- Trials published between 2020-2022 were selected from major databases (PubMed/Medline, Scopus, EMBASE).
- Data on impact factor, journal quartile, CONSORT adherence, and study model were recorded.
Main Results:
- Only 33.3% of studies showed low risk of bias by both RoB and RoB2.
- RoB2 downgraded the risk assessment for a significant proportion of studies initially classified as low risk by RoB (29.6% to some concerns, 37% to high risk).
- The overall agreement between RoB and RoB2 in dental studies was found to be low.
Conclusions:
- There are notable differences in bias assessment between Cochrane's RoB and RoB2 tools in dentistry.
- These discrepancies can impact the synthesis of evidence and clinical decision-making in dental research.
- Further investigation into the application and implications of RoB2 in dental trials is warranted.
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