Evaluating the Ability of Large Language Models to Identify Adherence to CONSORT Reporting Guidelines in Randomized Controlled Trials: A Methodological Evaluation Study
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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