Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart).
Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28; 9(2):161-168.EH

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.

Links

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Authors+Show Affiliations

Batra G

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, 751 85 Uppsala, Sweden.

Aktaa S

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.

Wallentin L

Department of Medical Sciences, Cardiology and Uppsala Clinical Research Center, Uppsala University, Uppsala Science Park, Hubben, Dag Hammarskjölds väg 38, 751 85 Uppsala, Sweden.

Maggioni AP

Italian Association of Hospital Cardiologists Research Center (ANMCO), Florence, Italy.

Wilkinson C

Population Health Sciences Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.

Casadei B

Division of Cardiovascular Medicine, NIHR Oxford Biomedical Research Centre, University of Oxford, Oxford, UK.

Gale CP

MeSH

HumansRegistriesCardiovascular DiseasesCardiologyResearch DesignRandomized Controlled Trials as Topic

Pub Type(s)

Review

Journal Article

Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

34351420

Citation

Batra, Gorav, et al. "Methodology for the Development of International Clinical Data Standards for Common Cardiovascular Conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart)." European Heart Journal. Quality of Care & Clinical Outcomes, vol. 9, no. 2, 2023, pp. 161-168.

Batra G, Aktaa S, Wallentin L, et al. Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). Eur Heart J Qual Care Clin Outcomes. 2023;9(2):161-168.

Batra, G., Aktaa, S., Wallentin, L., Maggioni, A. P., Wilkinson, C., Casadei, B., & Gale, C. P. (2023). Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). European Heart Journal. Quality of Care & Clinical Outcomes, 9(2), 161-168. https://doi.org/10.1093/ehjqcco/qcab052

Batra G, et al. Methodology for the Development of International Clinical Data Standards for Common Cardiovascular Conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28;9(2):161-168. PubMed PMID: 34351420.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Methodology for the development of international clinical data standards for common cardiovascular conditions: European Unified Registries for Heart Care Evaluation and Randomised Trials (EuroHeart). AU - Batra,Gorav, AU - Aktaa,Suleman, AU - Wallentin,Lars, AU - Maggioni,Aldo P, AU - Wilkinson,Chris, AU - Casadei,Barbara, AU - Gale,Chris P, PY - 2021/6/9/received PY - 2021/7/28/revised PY - 2021/8/2/accepted PY - 2021/8/6/pubmed PY - 2023/3/3/medline PY - 2021/8/5/entrez KW - Data definitions KW - Data standards KW - Data variables KW - EuroHeart KW - Methodology SP - 161 EP - 168 JF - European heart journal. Quality of care & clinical outcomes JO - Eur Heart J Qual Care Clin Outcomes VL - 9 IS - 2 N2 - 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. SN - 2058-1742 UR - https://www.unboundmedicine.com/medline/citation/34351420/Methodology_for_the_development_of_international_clinical_data_standards_for_common_cardiovascular_conditions:_European_Unified_Registries_for_Heart_Care_Evaluation_and_Randomised_Trials__EuroHeart__ DB - PRIME DP - Unbound Medicine ER -

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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).Eur Heart J Qual Care Clin Outcomes. 2023 Feb 28; 9(2):161-168.EH