Clinical registries data quality attributes to support registry-based randomised controlled trials: A scoping review.
Contemp Clin Trials
; 119: 106843, 2022 08.
Article
em En
| MEDLINE
| ID: mdl-35792338
ABSTRACT
BACKGROUND:
Clinical registries have become an important platform for performance measurement, quality improvement, and clinical research including registry-based randomised controlled trials (RRCTs). However, the success of RRCTs is highly dependent on the quality of the registry. The aim of this study was to undertake a scoping review to identify the key characteristics that a registry must possess to be considered of high quality to successfully support the conduct of a RRCT.METHODS:
A comprehensive search of four databases and grey literature was conducted. A narrative synthesis was conducted with a focus on summarising the characteristics that a high-quality registry must possess to support the conduct of RRCTs, and the mechanisms underpinning the collection of high-quality data.RESULTS:
A total of 50 articles were included. Data accuracy, completeness, population capture, data standardisation, and timeliness were identified as essential data attributes of a high-quality clinical registry. The legal and ethical environment in which a registry operates, the available infrastructure support, and ongoing participation by healthcare providers were identified as impacting the collection of high-quality data.CONCLUSIONS:
This review summarises the considerable work undertaken to determine the criteria with which to judge the suitability of a clinical registry to support a RRCT. Moving forward, the certification of individual clinical registries may be one way of identifying registries that can support a RRCT. In the interim, we propose the Registry Attributes Framework which can be used to ascertain the suitability of a registry to support a RRCT. Ultimately, the ideal goal should be to define minimum acceptable standards for a registry's key performance indicators (as depicted in the Framework) that would determine its certification status. New registries planned to support a RRCT should be designed and constructed against agreed standards once these are established.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Melhoria de Qualidade
/
Confiabilidade dos Dados
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article