Evidence map›Paper›PMID 38459719›Full record

ArticleClinical pharmacology and therapeutics2024

Algorithmic Identification of Treatment-Emergent Adverse Events From Clinical Notes Using Large Language Models: A Pilot Study in Inflammatory Bowel Disease.

Anna L Silverman, Madhumita Sushil, Balu Bhasuran, Dana Ludwig, James Buchanan, Rebecca Racz, Mahalakshmi Parakala, Samer El-Kamary, Ohenewaa Ahima, Artur Belov and 8 more

Open access · greenAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
8.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 23 citations in OpenAlex.

  1. Pooled it
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  16. How Artificial Intelligence Will Transform Clinical Care, Research, and Trials for Inflammatory Bowel Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 5 institutions in 2 countries.

Anna L Silverman *Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Phoenix, Arizona, USA.ORCID 0000-0002-1139-0900
Madhumita Sushil *Bakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0000-0001-7884-0526
Balu Bhasuran *Bakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0000-0002-9890-4627
Dana LudwigBakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0009-0008-1240-5685
James BuchananBakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0000-0001-8417-2288
Rebecca RaczUnited States Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-5487-5692
Mahalakshmi ParakalaDepartment of Public Health, University of California, Berkeley, Berkeley, California, USA.
Samer El-KamaryUnited States Food and Drug Administration, Silver Spring, Maryland, USA.
Ohenewaa AhimaUnited States Food and Drug Administration, Silver Spring, Maryland, USA.
Artur BelovUnited States Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0001-6848-1224
Lauren ChoiUnited States Food and Drug Administration, Silver Spring, Maryland, USA.
Monisha BillingsUnited States Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-2030-3207
Yan LiUnited States Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-6067-5574
Nadia HabalUnited States Food and Drug Administration, Silver Spring, Maryland, USA.
Qi LiuUnited States Food and Drug Administration, Silver Spring, Maryland, USA.ORCID 0000-0002-4053-4213
Jawahar TiwariUnited States Food and Drug Administration, Silver Spring, Maryland, USA.
Atul J ButteBakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0000-0002-7433-2740
Vivek A RudrapatnaBakar Computational Health Sciences Institute, San Francisco, California, USA.ORCID 0000-0003-1789-3004
United States Food and Drug Administration · USBerkeley Public Health Division · USUniversity of California, San Francisco · USUniversity of California System · USWinnMed · US

Funding

Clinical and Translational Science InstituteUL1TR001872 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI COLLARD, HAROLD R, JACOBY, VANESSA · 2016 to 2025
$112.1M
UCSF-Stanford Center of Excellence in Regulatory Science and InnovationU01FD005978 · FDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ALTMAN, RUSS BIAGIO, GIACOMINI, KATHLEEN M · 2016 to 2025
$34.5M
A data science framework for transforming electronic health records into real-world evidenceK99LM014099 · NLM · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI RUDRAPATNA, VIVEK ASHOK · 2023 to 2024
$178k
FDA HHS U01 FD005978NCATS NIH HHS UL1 TR001872NIH HHS K99LM014099NLM NIH HHS K99 LM014099
6 · The paper itself

Abstract

Outpatient clinical notes are a rich source of information regarding drug safety. However, data in these notes are currently underutilized for pharmacovigilance due to methodological limitations in text mining. Large language models (LLMs) like Bidirectional Encoder Representations from Transformers (BERT) have shown progress in a range of natural language processing tasks but have not yet been evaluated on adverse event (AE) detection. We adapted a new clinical LLM, University of California - San Francisco (UCSF)-BERT, to identify serious AEs (SAEs) occurring after treatment with a non-steroid immunosuppressant for inflammatory bowel disease (IBD). We compared this model to other language models that have previously been applied to AE detection. We annotated 928 outpatient IBD notes corresponding to 928 individual patients with IBD for all SAE-associated hospitalizations occurring after treatment with a non-steroid immunosuppressant. These notes contained 703 SAEs in total, the most common of which was failure of intended efficacy. Out of eight candidate models, UCSF-BERT achieved the highest numerical performance on identifying drug-SAE pairs from this corpus (accuracy 88-92%, macro F1 61-68%), with 5-10% greater accuracy than previously published models. UCSF-BERT was significantly superior at identifying hospitalization events emergent to medication use (P < 0.01). LLMs like UCSF-BERT achieve numerically superior accuracy on the challenging task of SAE detection from clinical notes compared with prior methods. Future work is needed to adapt this methodology to improve model performance and evaluation using multicenter data and newer architectures like Generative pre-trained transformer (GPT). Our findings support the potential value of using large language models to enhance pharmacovigilance.

Indexed as

AlgorithmsImmunosuppressive AgentsInflammatory Bowel DiseasesNatural Language ProcessingPharmacovigilanceAdverse Drug Reaction Reporting SystemsData MiningDrug-Related Side Effects and Adverse ReactionsElectronic Health RecordsFemaleHospitalizationHumansMalePilot ProjectsImmunosuppressive Agents

Identifiers

PMID38459719
PMCPMC11090709
OpenAlexW4392619666

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.