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      GENERATOR HEART FAILURE DataMart: An integrated framework for heart failure research

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          Abstract

          Background

          Heart failure (HF) is a multifaceted clinical syndrome characterized by different etiologies, risk factors, comorbidities, and a heterogeneous clinical course. The current model, based on data from clinical trials, is limited by the biases related to a highly-selected sample in a protected environment, constraining the applicability of evidence in the real-world scenario. If properly leveraged, the enormous amount of data from real-world may have a groundbreaking impact on clinical care pathways. We present, here, the development of an HF DataMart framework for the management of clinical and research processes.

          Methods

          Within our institution, Fondazione Policlinico Universitario A. Gemelli in Rome (Italy), a digital platform dedicated to HF patients has been envisioned (GENERATOR HF DataMart), based on two building blocks: 1. All retrospective information has been integrated into a multimodal, longitudinal data repository, providing in one single place the description of individual patients with drill-down functionalities in multiple dimensions. This functionality might allow investigators to dynamically filter subsets of patient populations characterized by demographic characteristics, biomarkers, comorbidities, and clinical events (e.g., re-hospitalization), enabling agile analyses of the outcomes by subsets of patients. 2. With respect to expected long-term health status and response to treatments, the use of the disease trajectory toolset and predictive models for the evolution of HF has been implemented. The methodological scaffolding has been constructed in respect of a set of the preferred standards recommended by the CODE-EHR framework.

          Results

          Several examples of GENERATOR HF DataMart utilization are presented as follows: to select a specific retrospective cohort of HF patients within a particular period, along with their clinical and laboratory data, to explore multiple associations between clinical and laboratory data, as well as to identify a potential cohort for enrollment in future studies; to create a multi-parametric predictive models of early re-hospitalization after discharge; to cluster patients according to their ejection fraction (EF) variation, investigating its potential impact on hospital admissions.

          Conclusion

          The GENERATOR HF DataMart has been developed to exploit a large amount of data from patients with HF from our institution and generate evidence from real-world data. The two components of the HF platform might provide the infrastructural basis for a combined patient support program dedicated to continuous monitoring and remote care, assisting patients, caregivers, and healthcare professionals.

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          Most cited references36

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          The FAIR Guiding Principles for scientific data management and stewardship

          There is an urgent need to improve the infrastructure supporting the reuse of scholarly data. A diverse set of stakeholders—representing academia, industry, funding agencies, and scholarly publishers—have come together to design and jointly endorse a concise and measureable set of principles that we refer to as the FAIR Data Principles. The intent is that these may act as a guideline for those wishing to enhance the reusability of their data holdings. Distinct from peer initiatives that focus on the human scholar, the FAIR Principles put specific emphasis on enhancing the ability of machines to automatically find and use the data, in addition to supporting its reuse by individuals. This Comment is the first formal publication of the FAIR Principles, and includes the rationale behind them, and some exemplar implementations in the community.
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            2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

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              High-performance medicine: the convergence of human and artificial intelligence

              Eric Topol (2019)
              The use of artificial intelligence, and the deep-learning subtype in particular, has been enabled by the use of labeled big data, along with markedly enhanced computing power and cloud storage, across all sectors. In medicine, this is beginning to have an impact at three levels: for clinicians, predominantly via rapid, accurate image interpretation; for health systems, by improving workflow and the potential for reducing medical errors; and for patients, by enabling them to process their own data to promote health. The current limitations, including bias, privacy and security, and lack of transparency, along with the future directions of these applications will be discussed in this article. Over time, marked improvements in accuracy, productivity, and workflow will likely be actualized, but whether that will be used to improve the patient-doctor relationship or facilitate its erosion remains to be seen.
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                Author and article information

                Contributors
                Journal
                Front Cardiovasc Med
                Front Cardiovasc Med
                Front. Cardiovasc. Med.
                Frontiers in Cardiovascular Medicine
                Frontiers Media S.A.
                2297-055X
                22 March 2023
                2023
                : 10
                : 1104699
                Affiliations
                [ 1 ]Department of Cardiovascular and Pulmonary Sciences, Catholic University of the Sacred Heart , Rome, Italy
                [ 2 ]Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                [ 3 ]Università del Piemonte Orientale , Dipartimento Medicina Translazionale, Azienda Ospedaliero-Universitaria Maggiore della Carità , Dipartimento Toraco-Cardio-Vascolare, Unità Operativa Complessa di Cardiologia 1, Novara, Italy
                [ 4 ]Gemelli Generator, Fondazione Policlinico Universitario A. Gemelli IRCCS , Rome, Italy
                [ 5 ]Department of Bioimaging, Radiation Oncology and Hematology, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Università Cattolica S. Cuore , Rome, Italy
                Author notes

                Edited by: Zhenjie Yao, Chinese Academy of Sciences (CAS), China

                Reviewed by: Yang Chen, University College London, United Kingdom Benoît Tyl, Bayer HealthCare, Germany

                Specialty Section: This article was submitted to General Cardiovascular Medicine, a section of the journal Frontiers in Cardiovascular Medicine

                Article
                10.3389/fcvm.2023.1104699
                10073733
                62d6f9ab-b140-4714-bfb6-f7a9c999d73b
                © 2023 D'Amario, Laborante, Delvinoti, Lenkowicz, Iacomini, Masciocchi, Luraschi, Damiani, Rodolico, Restivo, Ciliberti, Paglianiti, Canonico, Paternello, Cesario, Valentini, Scambia and Crea.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 21 November 2022
                : 07 March 2023
                Page count
                Figures: 8, Tables: 2, Equations: 0, References: 36, Pages: 0, Words: 0
                Funding
                This study received partial funding from the Italian Ministry for University and Research (MUR) under the Program PON “Research and Innovation” supporting the development of the artificial intelligence platform “Gemelli Generator” at Policlinico Universitario A. Gemelli IRCCS in Rome (Italy).
                Categories
                Cardiovascular Medicine
                Original Research

                heart failure,big data,artificial intelligence,machine learning,datamart

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