Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

doi:10.1093/ehjqcco/qcab052

Review

. 2023 Feb 28;9(2):161-168.

doi: 10.1093/ehjqcco/qcab052.

Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Gorav Batra¹, Suleman Aktaa², Lars Wallentin¹, Aldo P Maggioni³, Chris Wilkinson⁴, Barbara Casadei⁵, Chris P Gale²

Affiliations

¹ Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, 751 85 Uppsala, Sweden.
² Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds Institute for Data Analytics, University of Leeds, and Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³ Italian Association of Hospital Cardiologists Research Center (ANMCO), Florence, Italy.
⁴ Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
⁵ Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.

PMID: 34351420
PMCID: PMC9972518
DOI: 10.1093/ehjqcco/qcab052

Review

Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Gorav Batra et al. Eur Heart J Qual Care Clin Outcomes. 2023.

. 2023 Feb 28;9(2):161-168.

doi: 10.1093/ehjqcco/qcab052.

Authors

Gorav Batra¹, Suleman Aktaa², Lars Wallentin¹, Aldo P Maggioni³, Chris Wilkinson⁴, Barbara Casadei⁵, Chris P Gale²

Affiliations

¹ Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, 751 85 Uppsala, Sweden.
² Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds Institute for Data Analytics, University of Leeds, and Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.
³ Italian Association of Hospital Cardiologists Research Center (ANMCO), Florence, Italy.
⁴ Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.
⁵ Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.

PMID: 34351420
PMCID: PMC9972518
DOI: 10.1093/ehjqcco/qcab052

Abstract

Aims: Data standards are consensual specifications for the representation of data arising from different sources. If provided with internationally harmonized variables, permissible values, and clinical definitions, they have the potential to enable reliable between- and within-country analysis of care and outcomes. The European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart) is a European Society of Cardiology project that allows participating countries to collect patient data to undertake quality improvement, observational studies, drug and device surveillance, and registry-based randomized controlled trials for cardiovascular conditions. This paper describes the methodology for development of harmonized data standards for EuroHeart.

Methods and results: We adopted a five-step process for the development of harmonized data standards. The process includes (i) identification of clinical domains for data standard development by evaluating specific cardiovascular conditions with high prevalence and opportunities for quality improvement; (ii) construction of data standard specifications by systematic review of the literature; (iii) selection of variables by a domain-specific Working Group using a modified Delphi method; (iv) validation of data standards by a domain-specific Reference Group; and (v) implementation of the developed data standards into an IT platform.

Conclusion: This paper describes the approach adopted by EuroHeart for the development of clinical data standards for cardiovascular disease. The methodology has been developed and is used by EuroHeart to create a suite of international data standards for cardiovascular diseases. The EuroHeart data standards may be used to systematically capture individual patient data about clinical care and for research.

Keywords: Data definitions; Data standards; Data variables; EuroHeart; Methodology.

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Figures

**Graphical Abstract**
The EuroHeart methodology for the development of international clinical data standards for cardiovascular conditions.

**Figure 1**
Operational framework during the development of the EuroHeart data standards.

**Figure 2**
Process for development of the EuroHeart data standards.

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Aktaa S, Batra G, Cleland JGF, Coats A, Lund LH, McDonagh T, Rosano G, Seferovic P, Vasko P, Wallentin L, Maggioni AP, Casadei B, Gale CP; Heart Failure Association of the European Society of Cardiology. Aktaa S, et al. Eur Heart J. 2022 Jun 14;43(23):2185-2195. doi: 10.1093/eurheartj/ehac151. Eur Heart J. 2022. PMID: 35443059 Free PMC article.
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.
Hoogervorst LA, Geurkink TH, Lübbeke A, Buccheri S, Schoones JW, Torre M, Laricchiuta P, Piscoi P, Pedersen AB, Gale CP, Smith JA, Maggioni AP, James S, Fraser AG, Nelissen RGHH, Marang-van de Mheen PJ. Hoogervorst LA, et al. Int J Health Policy Manag. 2023;12:7648. doi: 10.34172/ijhpm.2023.7648. Epub 2023 Jul 18. Int J Health Policy Manag. 2023. PMID: 37579359 Free PMC article.
Do we need to reconsider how we design and conduct randomized controlled trials?
Batra G, Wallentin L. Batra G, et al. Eur Heart J Qual Care Clin Outcomes. 2022 Jun 6;8(4):374-376. doi: 10.1093/ehjqcco/qcac010. Eur Heart J Qual Care Clin Outcomes. 2022. PMID: 35175349 Free PMC article. No abstract available.
Data standards for atrial fibrillation/flutter and catheter ablation: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart).
Batra G, Aktaa S, Camm AJ, Costa F, Di Biase L, Duncker D, Fauchier L, Fragakis N, Frost L, Hijazi Z, Juhlin T, Merino JL, Mont L, Nielsen JC, Oldgren J, Polewczyk A, Potpara T, Sacher F, Sommer P, Tilz R, Maggioni AP, Wallentin L, Casadei B, Gale CP. Batra G, et al. Eur Heart J Qual Care Clin Outcomes. 2023 Sep 12;9(6):609-620. doi: 10.1093/ehjqcco/qcac068. Eur Heart J Qual Care Clin Outcomes. 2023. PMID: 36243903 Free PMC article.
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References

1. Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo Ret al. . Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017;135:e146–e603. - PMC - PubMed
1. Chung S-C, Gedeborg R, Nicholas O, James S, Jeppsson A, Wolfe Cet al. . Acute myocardial infarction: a comparison of short-term survival in national outcome registries in Sweden and the UK. Lancet 2014;383:1305–1312. - PMC - PubMed
1. Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. Eur Heart J 2017;38:3056–3065. - PMC - PubMed
1. Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Relations between implementation of new treatments and improved outcomes in patients with non-ST-elevation myocardial infarction during the last 20 years: experiences from SWEDEHEART registry 1995 to 2014. Eur Heart J 2018;39:3766–3776. - PubMed
1. Bebb O, Hall M, Fox KAA, Dondo TB, Timmis A, Bueno Het al. . Performance of hospitals according to the ESC ACCA quality indicators and 30-day mortality for acute myocardial infarction: national cohort study using the United Kingdom Myocardial Ischaemia National Audit Project (MINAP) register. Eur Heart J 2017;38:974–982. - PMC - PubMed

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[1] Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo Ret al. . Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017;135:e146–e603. - PMC - PubMed

[2] Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo Ret al. . Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017;135:e146–e603. - PMC - PubMed

[3] Chung S-C, Gedeborg R, Nicholas O, James S, Jeppsson A, Wolfe Cet al. . Acute myocardial infarction: a comparison of short-term survival in national outcome registries in Sweden and the UK. Lancet 2014;383:1305–1312. - PMC - PubMed

[4] Chung S-C, Gedeborg R, Nicholas O, James S, Jeppsson A, Wolfe Cet al. . Acute myocardial infarction: a comparison of short-term survival in national outcome registries in Sweden and the UK. Lancet 2014;383:1305–1312. - PMC - PubMed

[5] Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. Eur Heart J 2017;38:3056–3065. - PMC - PubMed

[6] Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. Eur Heart J 2017;38:3056–3065. - PMC - PubMed

[7] Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Relations between implementation of new treatments and improved outcomes in patients with non-ST-elevation myocardial infarction during the last 20 years: experiences from SWEDEHEART registry 1995 to 2014. Eur Heart J 2018;39:3766–3776. - PubMed

[8] Szummer K, Wallentin L, Lindhagen L, Alfredsson J, Erlinge D, Held Cet al. . Relations between implementation of new treatments and improved outcomes in patients with non-ST-elevation myocardial infarction during the last 20 years: experiences from SWEDEHEART registry 1995 to 2014. Eur Heart J 2018;39:3766–3776. - PubMed

[9] Bebb O, Hall M, Fox KAA, Dondo TB, Timmis A, Bueno Het al. . Performance of hospitals according to the ESC ACCA quality indicators and 30-day mortality for acute myocardial infarction: national cohort study using the United Kingdom Myocardial Ischaemia National Audit Project (MINAP) register. Eur Heart J 2017;38:974–982. - PMC - PubMed

[10] Bebb O, Hall M, Fox KAA, Dondo TB, Timmis A, Bueno Het al. . Performance of hospitals according to the ESC ACCA quality indicators and 30-day mortality for acute myocardial infarction: national cohort study using the United Kingdom Myocardial Ischaemia National Audit Project (MINAP) register. Eur Heart J 2017;38:974–982. - PMC - PubMed

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Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

Affiliations

Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)

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