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The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing.

ABSTRACT: Introduction: The Food and Drug Administration Center for Biologics Evaluation and Research conducts post-market surveillance of biologic products to ensure their safety and effectiveness. Studies have found that common vaccine exposures may be missing from structured data elements of electronic health records (EHRs), instead being captured in clinical notes. This impacts monitoring of adverse events following immunizations (AEFIs). For example, COVID-19 vaccines have been regularly administered outside of traditional medical settings. We developed a natural language processing (NLP) algorithm to mine unstructured clinical notes for vaccinations not captured in structured EHR data. Methods: A random sample of 1,000 influenza vaccine administrations, representing 995 unique patients, was extracted from a large U.S. EHR database. NLP techniques were used to detect administrations from the clinical notes in the training dataset [80% (N = 797) of patients]. The algorithm was applied to the validation dataset [20% (N = 198) of patients] to assess performance. Full medical charts for 28 randomly selected administration events in the validation dataset were reviewed by clinicians. The NLP algorithm was then applied across the entire dataset (N = 995) to quantify the number of additional events identified. Results: A total of 3,199 administrations were identified in the structured data and clinical notes combined. Of these, 2,740 (85.7%) were identified in the structured data, while the NLP algorithm identified 1,183 (37.0%) administrations in clinical notes; 459 were not also captured in the structured data. This represents a 16.8% increase in the identification of vaccine administrations compared to using structured data alone. The validation of 28 vaccine administrations confirmed 27 (96.4%) as "definite" vaccine administrations; 18 (64.3%) had evidence of a vaccination event in the structured data, while 10 (35.7%) were found solely in the unstructured notes. Discussion: We demonstrated the utility of an NLP algorithm to identify vaccine administrations not captured in structured EHR data. NLP techniques have the potential to improve detection of vaccine administrations not otherwise reported without increasing the analysis burden on physicians or practitioners. Future applications could include refining estimates of vaccine coverage and detecting other exposures, population characteristics, and outcomes not reliably captured in structured EHR data.

SUBMITTER: Deady M

PROVIDER: S-EPMC8727347 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundMerging disparate and heterogeneous datasets from clinical routine in a standardized and semantically enriched format to enable a multiple use of data also means incorporating unstructured data such as medical free texts. Although the extraction of structured data from texts, known as natural language processing (NLP), has been researched at least for the English language extensively, it is not enough to get a structured output in any format. NLP techniques need to be used together with clinical information standards such as openEHR to be able to reuse and exchange still unstructured data sensibly.ObjectivesThe aim of the study is to automatically extract crucial information from medical free texts and to transform this unstructured clinical data into a standardized and structured representation by designing and implementing an exemplary pipeline for the processing of pediatric medical histories.MethodsWe constructed a pipeline that allows reusing medical free texts such as pediatric medical histories in a structured and standardized way by (1) selecting and modeling appropriate openEHR archetypes as standard clinical information models, (2) defining a German dictionary with crucial text markers serving as expert knowledge base for a NLP pipeline, and (3) creating mapping rules between the NLP output and the archetypes. The approach was evaluated in a first pilot study by using 50 manually annotated medical histories from the pediatric intensive care unit of the Hannover Medical School.ResultsWe successfully reused 24 existing international archetypes to represent the most crucial elements of unstructured pediatric medical histories in a standardized form. The self-developed NLP pipeline was constructed by defining 3.055 text marker entries, 132 text events, 66 regular expressions, and a text corpus consisting of 776 entries for automatic correction of spelling mistakes. A total of 123 mapping rules were implemented to transform the extracted snippets to an openEHR-based representation to be able to store them together with other structured data in an existing openEHR-based data repository. In the first evaluation, the NLP pipeline yielded 97% precision and 94% recall.ConclusionThe use of NLP and openEHR archetypes was demonstrated as a viable approach for extracting and representing important information from pediatric medical histories in a structured and semantically enriched format. We designed a promising approach with potential to be generalized, and implemented a prototype that is extensible and reusable for other use cases concerning German medical free texts. In a long term, this will harness unstructured clinical data for further research purposes such as the design of clinical decision support systems. Together with structured data already integrated in openEHR-based representations, we aim at developing an interoperable openEHR-based application that is capable of automatically assessing a patient's risk status based on the patient's medical history at time of admission.

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The Food and Drug Administration Biologics Effectiveness and Safety Initiative Facilitates Detection of Vaccine Administrations From Unstructured Data in Medical Records Through Natural Language Processing.

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