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1.
J Med Internet Res ; 23(10): e31400, 2021 10 11.
Article in English | MEDLINE | ID: covidwho-1463405

ABSTRACT

BACKGROUND: Many countries have experienced 2 predominant waves of COVID-19-related hospitalizations. Comparing the clinical trajectories of patients hospitalized in separate waves of the pandemic enables further understanding of the evolving epidemiology, pathophysiology, and health care dynamics of the COVID-19 pandemic. OBJECTIVE: In this retrospective cohort study, we analyzed electronic health record (EHR) data from patients with SARS-CoV-2 infections hospitalized in participating health care systems representing 315 hospitals across 6 countries. We compared hospitalization rates, severe COVID-19 risk, and mean laboratory values between patients hospitalized during the first and second waves of the pandemic. METHODS: Using a federated approach, each participating health care system extracted patient-level clinical data on their first and second wave cohorts and submitted aggregated data to the central site. Data quality control steps were adopted at the central site to correct for implausible values and harmonize units. Statistical analyses were performed by computing individual health care system effect sizes and synthesizing these using random effect meta-analyses to account for heterogeneity. We focused the laboratory analysis on C-reactive protein (CRP), ferritin, fibrinogen, procalcitonin, D-dimer, and creatinine based on their reported associations with severe COVID-19. RESULTS: Data were available for 79,613 patients, of which 32,467 were hospitalized in the first wave and 47,146 in the second wave. The prevalence of male patients and patients aged 50 to 69 years decreased significantly between the first and second waves. Patients hospitalized in the second wave had a 9.9% reduction in the risk of severe COVID-19 compared to patients hospitalized in the first wave (95% CI 8.5%-11.3%). Demographic subgroup analyses indicated that patients aged 26 to 49 years and 50 to 69 years; male and female patients; and black patients had significantly lower risk for severe disease in the second wave than in the first wave. At admission, the mean values of CRP were significantly lower in the second wave than in the first wave. On the seventh hospital day, the mean values of CRP, ferritin, fibrinogen, and procalcitonin were significantly lower in the second wave than in the first wave. In general, countries exhibited variable changes in laboratory testing rates from the first to the second wave. At admission, there was a significantly higher testing rate for D-dimer in France, Germany, and Spain. CONCLUSIONS: Patients hospitalized in the second wave were at significantly lower risk for severe COVID-19. This corresponded to mean laboratory values in the second wave that were more likely to be in typical physiological ranges on the seventh hospital day compared to the first wave. Our federated approach demonstrated the feasibility and power of harmonizing heterogeneous EHR data from multiple international health care systems to rapidly conduct large-scale studies to characterize how COVID-19 clinical trajectories evolve.


Subject(s)
COVID-19 , Pandemics , Adult , Aged , Female , Hospitalization , Hospitals , Humans , Male , Middle Aged , Retrospective Studies , SARS-CoV-2
2.
Brief Bioinform ; 22(2): 812-822, 2021 03 22.
Article in English | MEDLINE | ID: covidwho-1343653

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic has clearly shown that major challenges and threats for humankind need to be addressed with global answers and shared decisions. Data and their analytics are crucial components of such decision-making activities. Rather interestingly, one of the most difficult aspects is reusing and sharing of accurate and detailed clinical data collected by Electronic Health Records (EHR), even if these data have a paramount importance. EHR data, in fact, are not only essential for supporting day-by-day activities, but also they can leverage research and support critical decisions about effectiveness of drugs and therapeutic strategies. In this paper, we will concentrate our attention on collaborative data infrastructures to support COVID-19 research and on the open issues of data sharing and data governance that COVID-19 had made emerge. Data interoperability, healthcare processes modelling and representation, shared procedures to deal with different data privacy regulations, and data stewardship and governance are seen as the most important aspects to boost collaborative research. Lessons learned from COVID-19 pandemic can be a strong element to improve international research and our future capability of dealing with fast developing emergencies and needs, which are likely to be more frequent in the future in our connected and intertwined world.


Subject(s)
COVID-19/epidemiology , Electronic Health Records , Medical Informatics , Pandemics , COVID-19/virology , Humans , SARS-CoV-2/isolation & purification
3.
Yearb Med Inform ; 30(1): 13-16, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1196870

ABSTRACT

BACKGROUND: On December 16, 2020 representatives of the International Medical Informatics Association (IMIA), a Non-Governmental Organization in official relations with the World Health Organization (WHO), along with its International Academy for Health Sciences Informatics (IAHSI), held an open dialogue with WHO Director General (WHO DG) Tedros Adhanom Ghebreyesus about the opportunities and challenges of digital health during the COVID-19 global pandemic. OBJECTIVES: The aim of this paper is to report the outcomes of the dialogue and discussions with more than 200 participants representing different civil society organizations (CSOs). METHODS: The dialogue was held in form of a webinar. After an initial address of the WHO DG, short presentations by the panelists, and live discussions between panelists, the WHO DG and WHO representatives took place. The audience was able to post questions in written. These written discussions were saved with participants' consent and summarized in this paper. RESULTS: The main themes that were brought up by the audience for discussion were: (a) opportunities and challenges in general; (b) ethics and artificial intelligence; (c) digital divide; (d) education. Proposed actions included the development of a roadmap based on the lessons learned from the COVID-19 pandemic. CONCLUSIONS: Decision making by policy makers needs to be evidence-based and health informatics research should be used to support decisions surrounding digital health, and we further propose next steps in the collaboration between IMIA and WHO such as future engagement in the World Health Assembly.


Subject(s)
Biomedical Technology , COVID-19 , Health Information Exchange , Medical Informatics , Telemedicine , World Health Organization , Artificial Intelligence , Global Health , Humans , Interinstitutional Relations , Medical Informatics/education , Medical Informatics/organization & administration , Societies, Medical , World Health Organization/organization & administration
4.
J Med Internet Res ; 23(3): e22219, 2021 03 02.
Article in English | MEDLINE | ID: covidwho-1088863

ABSTRACT

Coincident with the tsunami of COVID-19-related publications, there has been a surge of studies using real-world data, including those obtained from the electronic health record (EHR). Unfortunately, several of these high-profile publications were retracted because of concerns regarding the soundness and quality of the studies and the EHR data they purported to analyze. These retractions highlight that although a small community of EHR informatics experts can readily identify strengths and flaws in EHR-derived studies, many medical editorial teams and otherwise sophisticated medical readers lack the framework to fully critically appraise these studies. In addition, conventional statistical analyses cannot overcome the need for an understanding of the opportunities and limitations of EHR-derived studies. We distill here from the broader informatics literature six key considerations that are crucial for appraising studies utilizing EHR data: data completeness, data collection and handling (eg, transformation), data type (ie, codified, textual), robustness of methods against EHR variability (within and across institutions, countries, and time), transparency of data and analytic code, and the multidisciplinary approach. These considerations will inform researchers, clinicians, and other stakeholders as to the recommended best practices in reviewing manuscripts, grants, and other outputs from EHR-data derived studies, and thereby promote and foster rigor, quality, and reliability of this rapidly growing field.


Subject(s)
COVID-19/epidemiology , Data Collection/methods , Electronic Health Records , Data Collection/standards , Humans , Peer Review, Research/standards , Publishing/standards , Reproducibility of Results , SARS-CoV-2/isolation & purification
5.
J Am Med Inform Assoc ; 28(7): 1411-1420, 2021 07 14.
Article in English | MEDLINE | ID: covidwho-1075534

ABSTRACT

OBJECTIVE: The Consortium for Clinical Characterization of COVID-19 by EHR (4CE) is an international collaboration addressing coronavirus disease 2019 (COVID-19) with federated analyses of electronic health record (EHR) data. We sought to develop and validate a computable phenotype for COVID-19 severity. MATERIALS AND METHODS: Twelve 4CE sites participated. First, we developed an EHR-based severity phenotype consisting of 6 code classes, and we validated it on patient hospitalization data from the 12 4CE clinical sites against the outcomes of intensive care unit (ICU) admission and/or death. We also piloted an alternative machine learning approach and compared selected predictors of severity with the 4CE phenotype at 1 site. RESULTS: The full 4CE severity phenotype had pooled sensitivity of 0.73 and specificity 0.83 for the combined outcome of ICU admission and/or death. The sensitivity of individual code categories for acuity had high variability-up to 0.65 across sites. At one pilot site, the expert-derived phenotype had mean area under the curve of 0.903 (95% confidence interval, 0.886-0.921), compared with an area under the curve of 0.956 (95% confidence interval, 0.952-0.959) for the machine learning approach. Billing codes were poor proxies of ICU admission, with as low as 49% precision and recall compared with chart review. DISCUSSION: We developed a severity phenotype using 6 code classes that proved resilient to coding variability across international institutions. In contrast, machine learning approaches may overfit hospital-specific orders. Manual chart review revealed discrepancies even in the gold-standard outcomes, possibly owing to heterogeneous pandemic conditions. CONCLUSIONS: We developed an EHR-based severity phenotype for COVID-19 in hospitalized patients and validated it at 12 international sites.


Subject(s)
COVID-19 , Electronic Health Records , Severity of Illness Index , COVID-19/classification , Hospitalization , Humans , Machine Learning , Prognosis , ROC Curve , Sensitivity and Specificity
6.
J Am Med Inform Assoc ; 27(11): 1721-1726, 2020 11 01.
Article in English | MEDLINE | ID: covidwho-1024117

ABSTRACT

Global pandemics call for large and diverse healthcare data to study various risk factors, treatment options, and disease progression patterns. Despite the enormous efforts of many large data consortium initiatives, scientific community still lacks a secure and privacy-preserving infrastructure to support auditable data sharing and facilitate automated and legally compliant federated analysis on an international scale. Existing health informatics systems do not incorporate the latest progress in modern security and federated machine learning algorithms, which are poised to offer solutions. An international group of passionate researchers came together with a joint mission to solve the problem with our finest models and tools. The SCOR Consortium has developed a ready-to-deploy secure infrastructure using world-class privacy and security technologies to reconcile the privacy/utility conflicts. We hope our effort will make a change and accelerate research in future pandemics with broad and diverse samples on an international scale.


Subject(s)
Biomedical Research , Computer Security , Coronavirus Infections , Information Dissemination , Pandemics , Pneumonia, Viral , Privacy , COVID-19 , Humans , Information Dissemination/ethics , Internationality , Machine Learning
7.
NPJ Digit Med ; 3(1): 109, 2020 Aug 19.
Article in English | MEDLINE | ID: covidwho-728999

ABSTRACT

We leveraged the largely untapped resource of electronic health record data to address critical clinical and epidemiological questions about Coronavirus Disease 2019 (COVID-19). To do this, we formed an international consortium (4CE) of 96 hospitals across five countries ( www.covidclinical.net ). Contributors utilized the Informatics for Integrating Biology and the Bedside (i2b2) or Observational Medical Outcomes Partnership (OMOP) platforms to map to a common data model. The group focused on temporal changes in key laboratory test values. Harmonized data were analyzed locally and converted to a shared aggregate form for rapid analysis and visualization of regional differences and global commonalities. Data covered 27,584 COVID-19 cases with 187,802 laboratory tests. Case counts and laboratory trajectories were concordant with existing literature. Laboratory tests at the time of diagnosis showed hospital-level differences equivalent to country-level variation across the consortium partners. Despite the limitations of decentralized data generation, we established a framework to capture the trajectory of COVID-19 disease in patients and their response to interventions.

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