• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Automated Analysis of MAUDE Database Based on Chain-of-Thought Reasoning

Corresponding author: HUA Lei, leihua@xztu.edu.cn
DOI: 10.12201/bmr.202506.00070
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Purpose/Significance: To address the challenges of high technical complexity and low efficiency in MAUDE database analysis, this study designed and implemented the AutoQUEST automated analysis framework. By integrating large language model and chain-of-thought reasoning techniques, the framework reduces the complexity of database analysis and accelerates research output. Methods/Process: The AutoQUEST framework employs a dual-chain structure combining think and do chains, equipped with capabilities for automatic generation of research questions, structured SQL query formulation, and data analysis. Five distinct cases were used to evaluate the framework in terms of query success rates, execution duration, and report quality. Results/Conclusions: In the best case, the framework achieved a 100% query success rate, an execution time of 158 seconds, and an overall quality score of 4.74 out of 5. By effectively automating high-quality analysis of the MAUDE database, the framework provides convenient and reliable data analysis support to healthcare institutions, manufacturers, and regulatory authorities.

    Key words: medical device adverse event, MAUDE database; large language model; chain-of-thought reasoning

    Submit time: 24 June 2025

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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  • ID Submit time Number Download
    1 2025-03-21

    10.12201/bmr.202506.00070V1

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HUA Lei, GONG Yang, WU Lili, HU Guohua, He Guoping, Liu Jinyuan. Automated Analysis of MAUDE Database Based on Chain-of-Thought Reasoning. 2025. biomedRxiv.202506.00070

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