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
; 9(2): 161-168, 2023 02 28.
Article
em En
| MEDLINE
| ID: mdl-34351420
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 ANDRESULTS:
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Cardiologia
/
Doenças Cardiovasculares
Tipo de estudo:
Clinical_trials
/
Guideline
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
Eur Heart J Qual Care Clin Outcomes
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Suécia