‘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)

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.

Cardiovascular Research Using the Korean National Health Information Database

“…‘Real-world’ observation studies use several types of data sources, including regulatory sponsored studies, registries sponsored by learned societies, nationwide cohorts, claims data, investigator-initiated and industry-sponsored studies, and hospital cohorts. 1) Electronic medical records have now become the standard method to collect patient data and for administrative work regarding reimbursement and payment. This exponential growth of data is gaining tremendous interest as a novel research tool.…”

Atrial Cardiomyopathy: Pathophysiology and Clinical Consequences

“…Thus, in many patients with AF the atrial cardiomyopathy appears as the driving factor for the development of AF in the future. Therefore, the first experimental studies about electrical remodeling do not resemble the full spectrum of electrophysiological and structural changes seen in patients with different types of AF [3][4][5][6][7][8].…”

Ambulatory ECG monitoring for syncope and collapse in United States, Europe, and Japan: The patients’ viewpoint

“…First, our findings are observational and therefore cannot be deemed to be as strong as those provided by randomized controlled trials. Nonetheless, the utility of ‘real world’ observations (ie, outside externally required constraints of clinical research trials) such as are presented here is receiving increased attention as has recently been highlighted by a multi‐society consensus report 11 . Second, due to privacy constraints and the complexity of the survey, the patient sample in each geography was relatively small.…”

“…The survey reported here was designed to use ‘real world’ data, 10,11 with three overall objectives. First was to assess, among syncope/collapse patients residing in three differing geographies (USA, United Kingdom and Germany [UK/D], and Japan) who have undergone AECG monitoring, their understanding of the range of AECG technologies and the relative utility of various wearable and insertable diagnostic AECG monitoring systems.…”