TY - JOUR T1 - Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). AU - Batra,Gorav, AU - Aktaa,Suleman, AU - Camm,A John, AU - Costa,Francisco, AU - Di Biase,Luigi, AU - Duncker,David, AU - Fauchier,Laurent, AU - Fragakis,Nikolaos, AU - Frost,Lars, AU - Hijazi,Ziad, AU - Juhlin,Tord, AU - Merino,José L, AU - Mont,Lluis, AU - Nielsen,Jens C, AU - Oldgren,Jonas, AU - Polewczyk,Anna, AU - Potpara,Tatjana, AU - Sacher,Frederic, AU - Sommer,Philipp, AU - Tilz,Roland, AU - Maggioni,Aldo P, AU - Wallentin,Lars, AU - Casadei,Barbara, AU - Gale,Chris P, PY - 2022/09/06/received PY - 2022/10/12/accepted PY - 2022/10/02/revised PY - 2023/9/13/medline PY - 2022/10/17/pubmed PY - 2022/10/16/entrez KW - Atrial fibrillation KW - Atrial flutter KW - Catheter ablation KW - Data standards KW - Data variables KW - EuroHeart SP - 609 EP - 620 JF - European heart journal. Quality of care & clinical outcomes JO - Eur Heart J Qual Care Clin Outcomes VL - 9 IS - 6 N2 - AIMS: Standardized data definitions are essential for monitoring and assessment of care and outcomes in observational studies and randomized controlled trials (RCTs). The European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart) project of the European Society of Cardiology aimed to develop contemporary data standards for atrial fibrillation/flutter (AF/AFL) and catheter ablation. METHODS AND RESULTS: We used the EuroHeart methodology for the development of data standards and formed a Working Group comprising 23 experts in AF/AFL and catheter ablation registries, as well as representatives from the European Heart Rhythm Association and EuroHeart. We conducted a systematic literature review of AF/AFL and catheter ablation registries and data standard documents to generate candidate variables. We used a modified Delphi method to reach a consensus on a final variable set. For each variable, the Working Group developed permissible values and definitions, and agreed as to whether the variable was mandatory (Level 1) or additional (Level 2). In total, 70 Level 1 and 92 Level 2 variables were selected and reviewed by a wider Reference Group of 42 experts from 24 countries. The Level 1 variables were implemented into the EuroHeart IT platform as the basis for continuous registration of individual patient data. CONCLUSION: By means of a structured process and working with international stakeholders, harmonized data standards for AF/AFL and catheter ablation for AF/AFL were developed. In the context of the EuroHeart project, this will facilitate country-level quality of care improvement, international observational research, registry-based RCTs, and post-marketing surveillance of devices and pharmacotherapies. SN - 2058-1742 UR - https://www.unboundmedicine.com/medline/citation/36243903/Data_standards_for_atrial_fibrillation/flutter_and_catheter_ablation:_The_European_Unified_Registries_for_Heart_Care_Evaluation_and_Randomized_Trials__EuroHeart__ DB - PRIME DP - Unbound Medicine ER -