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    Area of Science:

    • Computational biology
    • Data science
    • Pharmacovigilance

    Background:

    • Identifying similar clinical cases from large datasets is crucial for pharmacovigilance.
    • Existing methods may not effectively capture complex relationships within adverse event reports.

    Purpose of the Study:

    • To explore document network creation using varying information thresholds and clustering algorithms.
    • To identify document clusters representing similar clinical cases from vaccine adverse event data.

    Main Methods:

    • Constructed networks from vaccine adverse event reports using structured data (Medical Dictionary for Regulatory Activities Preferred Terms) and text mining output.
    • Linked reports based on shared terms (PTs) and their combinations (dyads to sextuplets), and applied information-theoretic weighting.
    • Applied three clustering algorithms: Visualization of Similarities (VOS), Louvain, and k-means, evaluating performance on simulated and real-world datasets.

    Main Results:

    • The VOS algorithm generally outperformed Louvain and k-means in identifying known clusters.
    • The optimal weighting scheme depended on the complexity of the clinical case cluster.
    • Singleton weighting was effective for clusters driven by a single term, such as intussusception.
    • Clustering based on text mining output showed marginal differences compared to structured data.

    Conclusions:

    • The developed approach effectively supports the identification of similar nodes (documents) within a document network.
    • Network construction and clustering offer a viable strategy for discovering similar clinical cases in pharmacovigilance.
    • Algorithm and weighting scheme selection should consider the nature of the clinical cases being investigated.