Background: Atrial fibrillation (AF) affects an estimated 33 million people worldwide, leading to increased mortality and an increased risk of heart failure and stroke. Many AF patient registries exist, but the ability to link and compare data across registries is hindered by differences in the outcome measures collected by each registry and a lack of harmonization.
Objectives: The purpose of this project was to develop a minimum set of standardized outcome measures that could be collected in AF patient registries and clinical practice.
Methods: AF patient registries were identified through multiple sources and invited to join the workgroup and submit outcome measures. Additional measures were identified through literature searches and reviews of consensus statements. Outcome measures were categorized using the Agency for Healthcare Research and Quality's supported Outcome Measures Framework (OMF). A minimum set of broadly relevant measures was identified. Measure definitions were harmonized through in-person and virtual meetings.
Results: One hundred twelve outcome measures, including those from thirteen registries, were curated according to the OMF and then harmonized into a minimum set of measures in the OMF categories of survival (3 measures), clinical response (3 measures), events of interest (9 measures), patient-reported outcomes (2 measures), and resource utilization (3 measures). The harmonized definitions build on existing consensus statements.
Conclusions: The harmonized measures represent a minimum set of outcomes that are relevant in AF research and clinical practice. Routine and consistent collection of these measures in registries and in other systems would support creation of a research infrastructure to efficiently address new questions and improve patient outcomes.
Keywords: Atrial fibrillation; Common data element; Data standard; Harmonization; Outcome measure; Patient outcome; Patient registry.
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