# Evaluating the Ability of Large Language Models to Identify Adherence to CONSORT Reporting Guidelines in Randomized Controlled Trials: A Methodological Evaluation Study

arXiv: https://arxiv.org/abs/2511.13107 · HTML: https://mlsanity.com/paper/2511.13107/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 10 of its 40 references that are in the map.
- First posted on arXiv 17 Nov 2025.

## Builds on (most cited first, 10 of 10)

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- [Large Language Models Encode Clinical Knowledge](https://mlsanity.com/paper/2212.13138/) (2022)
- [Don't Stop Pretraining: Adapt Language Models to Domains and Tasks](https://mlsanity.com/paper/2004.10964/) (2020)
- [Chain-of-Verification Reduces Hallucination in Large Language Models](https://mlsanity.com/paper/2309.11495/) (2023)
- [Human-Centered Artificial Intelligence: Reliable, Safe & Trustworthy](https://mlsanity.com/paper/2002.04087/) (2020)
- [Practical and Ethical Challenges of Large Language Models in Education: A Systematic Scoping Review](https://mlsanity.com/paper/2303.13379/) (2023)
- [Generative Artificial Intelligence-Supported Pentesting: A Comparison between Claude Opus, GPT-4, and Copilot](https://mlsanity.com/paper/2501.06963/) (2025)

## Abstract (arXiv)

The Consolidated Standards of Reporting Trials statement is the global benchmark for transparent and high-quality reporting of randomized controlled trials. Manual verification of CONSORT adherence is a laborious, time-intensive process that constitutes a significant bottleneck in peer review and evidence synthesis. This study aimed to systematically evaluate the accuracy and reliability of contemporary LLMs in identifying the adherence of published RCTs to the CONSORT 2010 statement under a zero-shot setting. We constructed a golden standard dataset of 150 published RCTs spanning diverse medical specialties. The primary outcome was the macro-averaged F1-score for the three-class classification task, supplemented by item-wise performance metrics and qualitative error analysis. Overall model performance was modest. The top-performing models, Gemini-2.5-Flash and DeepSeek-R1, achieved nearly identical macro F1 scores of 0.634 and Cohen's Kappa coefficients of 0.280 and 0.282, respectively, indicating only fair agreement with expert consensus. A striking performance disparity was observed across classes: while most models could identify compliant items with high accuracy (F1 score > 0.850), they struggled profoundly with identifying non-compliant and not applicable items, where F1 scores rarely exceeded 0.400. Notably, some high-profile models like GPT-4o underperformed, achieving a macro F1-score of only 0.521. LLMs show potential as preliminary screening assistants for CONSORT checks, capably identifying well-reported items. However, their current inability to reliably detect reporting omissions or methodological flaws makes them unsuitable for replacing human expertise in the critical appraisal of trial quality.