Contextualising adverse events of special interest to characterise the baseline incidence rates in 24 million patients with COVID-19 across 26 databases: a multinational retrospective cohort study.

Background: Adverse events of special interest (AESIs) were pre-specified to be monitored for the COVID-19 vaccines. Some AESIs are not only associated with the vaccines, but with COVID-19. Our aim was to characterise the incidence rates of AESIs following SARS-CoV-2 infection in patients and compare these to historical rates in the general population. Methods: A multi-national cohort study with data from primary care, electronic health records, and insurance claims mapped to a common data model. This study's evidence was collected between Jan 1, 2017 and the conclusion of each database (which ranged from Jul 2020 to May 2022). The 16 pre-specified prevalent AESIs were: acute myocardial infarction, anaphylaxis, appendicitis, Bell's palsy, deep vein thrombosis, disseminated intravascular coagulation, encephalomyelitis, Guillain- Barré syndrome, haemorrhagic stroke, non-haemorrhagic stroke, immune thrombocytopenia, myocarditis/pericarditis, narcolepsy, pulmonary embolism, transverse myelitis, and thrombosis with thrombocytopenia. Age-sex standardised incidence rate ratios (SIR) were estimated to compare post-COVID-19 to pre-pandemic rates in each of the databases. Findings: Substantial heterogeneity by age was seen for AESI rates, with some clearly increasing with age but others following the opposite trend. Similarly, differences were also observed across databases for same health outcome and age-sex strata. All studied AESIs appeared consistently more common in the post-COVID-19 compared to the historical cohorts, with related meta-analytic SIRs ranging from 1.32 (1.05 to 1.66) for narcolepsy to 11.70 (10.10 to 13.70) for pulmonary embolism. Interpretation: Our findings suggest all AESIs are more common after COVID-19 than in the general population. Thromboembolic events were particularly common, and over 10-fold more so. More research is needed to contextualise post-COVID-19 complications in the longer term. Funding: None.

An Edge Based Framework for Risk Assessment of Communicable Disease

Along with the development of edge computing and Artificial Intelligence (AI), there has been an explosion of health-care system. As COVID-19 spread globally, the pandemic created significant challenges for the global health system. Therefore, we proposed an edge-based framework for risk assessment of communicable disease called CDM-FL. The CDM-FL consists of two modules, the common data model (CDM) and federated learning (FL). The CDM can process and store multi-source heterogeneous data with standardized semantics and schema. This provides more data for model training using medical data globally. The model is deployed on edge nodes that can measure patients' status locally and with low latency. It also keeps patient privacy from being disclosed that patient are more likely to share their medical data. The results based on real-world data show that CDM-FL can help physicians to evaluate the risk of communicable disease as well as save lives during severe epidemic situations. © 2022 IEEE.

Unraveling COVID-19: A Large-Scale Characterization of 4.5 Million COVID-19 Cases Using CHARYBDIS.

Purpose: Routinely collected real world data (RWD) have great utility in aiding the novel coronavirus disease (COVID-19) pandemic response. Here we present the international Observational Health Data Sciences and Informatics (OHDSI) Characterizing Health Associated Risks and Your Baseline Disease In SARS-COV-2 (CHARYBDIS) framework for standardisation and analysis of COVID-19 RWD. Patients and Methods: We conducted a descriptive retrospective database study using a federated network of data partners in the United States, Europe (the Netherlands, Spain, the UK, Germany, France and Italy) and Asia (South Korea and China). The study protocol and analytical package were released on 11th June 2020 and are iteratively updated via GitHub. We identified three non-mutually exclusive cohorts of 4,537,153 individuals with a clinical COVID-19 diagnosis or positive test, 886,193 hospitalized with COVID-19, and 113,627 hospitalized with COVID-19 requiring intensive services. Results: We aggregated over 22,000 unique characteristics describing patients with COVID-19. All comorbidities, symptoms, medications, and outcomes are described by cohort in aggregate counts and are readily available online. Globally, we observed similarities in the USA and Europe: more women diagnosed than men but more men hospitalized than women, most diagnosed cases between 25 and 60 years of age versus most hospitalized cases between 60 and 80 years of age. South Korea differed with more women than men hospitalized. Common comorbidities included type 2 diabetes, hypertension, chronic kidney disease and heart disease. Common presenting symptoms were dyspnea, cough and fever. Symptom data availability was more common in hospitalized cohorts than diagnosed. Conclusion: We constructed a global, multi-centre view to describe trends in COVID-19 progression, management and evolution over time. By characterising baseline variability in patients and geography, our work provides critical context that may otherwise be misconstrued as data quality issues. This is important as we perform studies on adverse events of special interest in COVID-19 vaccine surveillance.

A two-stage workflow to extract and harmonize drug mentions from clinical notes into observational databases.

BACKGROUND: The content of the clinical notes that have been continuously collected along patients' health history has the potential to provide relevant information about treatments and diseases, and to increase the value of structured data available in Electronic Health Records (EHR) databases. EHR databases are currently being used in observational studies which lead to important findings in medical and biomedical sciences. However, the information present in clinical notes is not being used in those studies, since the computational analysis of this unstructured data is much complex in comparison to structured data. METHODS: We propose a two-stage workflow for solving an existing gap in Extraction, Transformation and Loading (ETL) procedures regarding observational databases. The first stage of the workflow extracts prescriptions present in patient's clinical notes, while the second stage harmonises the extracted information into their standard definition and stores the resulting information in a common database schema used in observational studies. RESULTS: We validated this methodology using two distinct data sets, in which the goal was to extract and store drug related information in a new Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) database. We analysed the performance of the used annotator as well as its limitations. Finally, we described some practical examples of how users can explore these datasets once migrated to OMOP CDM databases. CONCLUSION: With this methodology, we were able to show a strategy for using the information extracted from the clinical notes in business intelligence tools, or for other applications such as data exploration through the use of SQL queries. Besides, the extracted information complements the data present in OMOP CDM databases which was not directly available in the EHR database.