Dataset Information

Medical device surveillance with electronic health records.

ABSTRACT: Post-market medical device surveillance is a challenge facing manufacturers, regulatory agencies, and health care providers. Electronic health records are valuable sources of real-world evidence for assessing device safety and tracking device-related patient outcomes over time. However, distilling this evidence remains challenging, as information is fractured across clinical notes and structured records. Modern machine learning methods for machine reading promise to unlock increasingly complex information from text, but face barriers due to their reliance on large and expensive hand-labeled training sets. To address these challenges, we developed and validated state-of-the-art deep learning methods that identify patient outcomes from clinical notes without requiring hand-labeled training data. Using hip replacements-one of the most common implantable devices-as a test case, our methods accurately extracted implant details and reports of complications and pain from electronic health records with up to 96.3% precision, 98.5% recall, and 97.4% F1, improved classification performance by 12.8-53.9% over rule-based methods, and detected over six times as many complication events compared to using structured data alone. Using these additional events to assess complication-free survivorship of different implant systems, we found significant variation between implants, including for risk of revision surgery, which could not be detected using coded data alone. Patients with revision surgeries had more hip pain mentions in the post-hip replacement, pre-revision period compared to patients with no evidence of revision surgery (mean hip pain mentions 4.97 vs. 3.23; t?=?5.14; p?

SUBMITTER: Callahan A

PROVIDER: S-EPMC6761113 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Medical device surveillance with electronic health records.

Callahan Alison A Fries Jason A JA Ré Christopher C Huddleston James I JI Giori Nicholas J NJ Delp Scott S Shah Nigam H NH

NPJ digital medicine 20190925

Post-market medical device surveillance is a challenge facing manufacturers, regulatory agencies, and health care providers. Electronic health records are valuable sources of real-world evidence for assessing device safety and tracking device-related patient outcomes over time. However, distilling this evidence remains challenging, as information is fractured across clinical notes and structured records. Modern machine learning methods for machine reading promise to unlock increasingly complex i ...[more]

PMID: 31583282

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Project description:BACKGROUND:Administrative health records (AHRs) and electronic medical records (EMRs) are two key sources of population-based data for disease surveillance, but misclassification errors in the data can bias disease estimates. Methods that combine information from error-prone data sources can build on the strengths of AHRs and EMRs. We compared bias and error for four data-combining methods and applied them to estimate hypertension prevalence. METHODS:Our study included rule-based OR and AND methods that identify disease cases from either or both data sources, respectively, rule-based sensitivity-specificity adjusted (RSSA) method that corrects for inaccuracies using a deterministic rule, and probabilistic-based sensitivity-specificity adjusted (PSSA) method that corrects for error using a statistical model. Computer simulation was used to estimate relative bias (RB) and mean square error (MSE) under varying conditions of population disease prevalence, correlation amongst data sources, and amount of misclassification error. AHRs and EMRs for Manitoba, Canada were used to estimate hypertension prevalence using validated case definitions and multiple disease markers. RESULTS:The OR method had the lowest RB and MSE when population disease prevalence was 10%, and the RSSA method had the lowest RB and MSE when population prevalence increased to 20%. As the correlation between data sources increased, the OR method resulted in the lowest RB and MSE. Estimates of hypertension prevalence for AHRs and EMRs alone were 30.9% (95% CI: 30.6-31.2) and 24.9% (95% CI: 24.6-25.2), respectively. The estimates were 21.4% (95% CI: 21.1-21.7), for the AND method, 34.4% (95% CI: 34.1-34.8) for the OR method, 32.2% (95% CI: 31.8-32.6) for the RSSA method, and ranged from 34.3% (95% CI: 34.1-34.5) to 35.9% (95% CI, 35.7-36.1) for the PSSA method, depending on the statistical model. CONCLUSIONS:The OR and AND methods are influenced by correlation amongst the data sources, while the RSSA method is dependent on the accuracy of prior sensitivity and specificity estimates. The PSSA method performed well when population prevalence was high and average correlations amongst disease markers was low. This study will guide researchers to select a data-combining method that best suits their data characteristics.

Project description:There is an urgent need to monitor the mental health of large populations, especially during crises such as the COVID-19 pandemic, to timely identify the most at-risk subgroups and to design targeted prevention campaigns. We therefore developed and validated surveillance indicators related to suicidality: the monthly number of hospitalisations caused by suicide attempts and the prevalence among them of five known risks factors. They were automatically computed analysing the electronic health records of fifteen university hospitals of the Paris area, France, using natural language processing algorithms based on artificial intelligence. We evaluated the relevance of these indicators conducting a retrospective cohort study. Considering 2,911,920 records contained in a common data warehouse, we tested for changes after the pandemic outbreak in the slope of the monthly number of suicide attempts by conducting an interrupted time-series analysis. We segmented the assessment time in two sub-periods: before (August 1, 2017, to February 29, 2020) and during (March 1, 2020, to June 31, 2022) the COVID-19 pandemic. We detected 14,023 hospitalisations caused by suicide attempts. Their monthly number accelerated after the COVID-19 outbreak with an estimated trend variation reaching 3.7 (95%CI 2.1-5.3), mainly driven by an increase among girls aged 8-17 (trend variation 1.8, 95%CI 1.2-2.5). After the pandemic outbreak, acts of domestic, physical and sexual violence were more often reported (prevalence ratios: 1.3, 95%CI 1.16-1.48; 1.3, 95%CI 1.10-1.64 and 1.7, 95%CI 1.48-1.98), fewer patients died (p = 0.007) and stays were shorter (p < 0.001). Our study demonstrates that textual clinical data collected in multiple hospitals can be jointly analysed to compute timely indicators describing mental health conditions of populations. Our findings also highlight the need to better take into account the violence imposed on women, especially at early ages and in the aftermath of the COVID-19 pandemic.

Dataset Information

Medical device surveillance with electronic health records.

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Medical device surveillance with electronic health records.

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