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      'Real-world' observational studies in arrhythmia research: data sources, methodology, and interpretation. A position document from European Heart Rhythm Association (EHRA), endorsed by Heart Rhythm Society (HRS), Asia-Pacific HRS (APHRS), and Latin America HRS (LAHRS).

      1 , 2 , 1 , 3 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22
      Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
      Oxford University Press (OUP)
      Arrhythmias, Atrial fibrillation, Database, EHRA position paper, Epidemiological study, European Heart Rhythm Association, Meta-analysis, Methodology, Nationwide cohort, Real-world observational study, Registry

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          Abstract

          The field of observational studies or "real world studies" is in rapid development with many new techniques introduced and increased understanding of traditional methods. For this reason the current paper provides an overview of current methods with focus on new techniques. Some highlights can be emphasized: We provide an overview of sources of data for observational studies. There is an overview of sources of bias and confounding. Next There is an overview of causal inference techniques that are increasingly used. The most commonly used techniques for statistical modelling are reviewed with focus on the important distinction of risk versus prediction. The final section provides examples of common problems with reporting observational data.

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          Author and article information

          Journal
          Europace
          Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology
          Oxford University Press (OUP)
          1532-2092
          1099-5129
          May 01 2020
          : 22
          : 5
          Affiliations
          [1 ] Aalborg University, Health Science and Technology, Aalborg, Denmark.
          [2 ] St. Vincenz-Krankenhaus Gmbh, Paderborn, Germany.
          [3 ] School of Medicine, Belgrade University, Belgrade, Serbia.
          [4 ] Cardiology Clinic, Clinical Center of Serbia, Belgrade, Serbia.
          [5 ] Service de Cardiologie, Centre Hospitalier Universitaire Trousseau et Université de Tours, Faculté de Médecine, Tours, France.
          [6 ] St. George's, University of London, Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UK.
          [7 ] Arrhythmia Section, Cardiology Department, Hospital Clínic, Universitat de Barcelona, Barcelona, Spain.
          [8 ] IDIBAPS, Institut d'Investigació August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
          [9 ] Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares (CIBERCV), Madrid, Spain.
          [10 ] Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy.
          [11 ] Aalborg University, Health Science and Technology, Aalborg, Denmark.
          [12 ] University of Colorado School of Medicine, Aurora, CO, USA.
          [13 ] Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
          [14 ] Cardiology, Chinese PLA General Hospital, Beijing, People's Republic of China.
          [15 ] Cardiology Department, Yonsei University College of Medicine, Seoul, Republic of Korea.
          [16 ] Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.
          [17 ] Cardiology Department, Korea University Medical Center, Seoul, Republic of Korea.
          [18 ] Brigham and Women's Hospital, Boston, MA, USA.
          [19 ] Duke Center for Atrial Fibrillation, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
          [20 ] Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil.
          [21 ] Liverpool Centre for Cardiovascular Science, University of Liverpool, Liverpool Heart & Chest Hospital, Liverpool, UK.
          [22 ] Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
          Article
          5625783
          10.1093/europace/euz210
          31725156
          811910ee-85b7-4ce3-a1cb-8d355fbf4003
          History

          Registry,Real-world observational study,Nationwide cohort,Methodology,Meta-analysis,European Heart Rhythm Association,Epidemiological study,EHRA position paper,Database,Atrial fibrillation,Arrhythmias

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