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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)

Christian Torp-Pedersen, Andreas Goette, Peter Bronnum Nielsen, Tatjana Potpara, Laurent Fauchier, Alan John Camm, Elena Arbelo, Giuseppe Boriani, Flemming Skjoeth, John Rumsfeld, Frederick Masoudi, Yutao Guo, Boyoung Joung, Marwan M Refaat, Young-Hoon Kim, Christine M Albert, Jonathan Piccini, Alvaro Avezum, Gregory Y H Lip, Bulent Gorenek, Nikolaos Dagres, Francesco Violi, Xin Du, Masaharu Akao, Eue-Keun Choi, Renato D Lopes, Evren Emin Ozcan, Deirdre Lane, Francisco Marin, Christopher Peter Gale, Kevin Vernooy, Gulmira Kudaiberdieva, Valentina Kutyifa, Vassil B Traykov, Carolina Guevara, Tze-Fan Chao, Sana M Al-Khatib,

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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.