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PresentationT-CAIREM 2025 · Nov 2025

Medevi-RoB: Benchmarking Large Language Models for Automated Risk-of-Bias (RoB 2) Assessment

David Nguyen, Medevi Team

At T-CAIREM 2025 we presented preliminary results from Medevi-RoB, our benchmark for automated Risk of Bias 2 (RoB 2) assessment of randomized controlled trials.

Why automate risk-of-bias assessment?

RoB 2 assesses how study design and reporting affect the trustworthiness of trial results, but it is slow and variable: risk-of-bias analysis takes 6–12 weeks in a typical review, and inter-rater reliability for the overall judgement is only 0.16 even among expert reviewers.

What we did

We evaluated outcome-level RoB 2 judgements from Cochrane reviews in dermatology, neurology and anesthesia, comparing gpt-oss-120b under algorithmic (per-domain) and single-shot chain-of-thought prompting with minimal- and extensive-prompt GPT-4 baselines.

Key findings

  • Modern open-source reasoning models with structured prompting substantially outperformed earlier GPT-4 baselines across all RoB 2 domains.
  • LLM-derived predictions reached human-level agreement on every domain, with Cohen’s κ from 0.190 (deviations from intended interventions) to 0.573 (randomization process).
  • Algorithmic prompting tends to overestimate risk when information is missing; single-shot prompting tends to underestimate it. Overall accuracy is similar (about 72%).
  • Cost per paper was $0.0034 for single-shot and $0.0188 for algorithmic prompting.

What’s next

We are completing the evaluation on about 1,000 randomized trials, comparing fine-tuned open models, and extending the framework to ROBINS-I, QUADAS-C and AMSTAR.

Cite this work

Nguyen D, Medevi Team. Medevi-RoB: Benchmarking Large Language Models for Automated Risk-of-Bias (RoB 2) Assessment. Presented at: T-CAIREM 2025; November 2025.