TY - JOUR
T1 - The eurreca project as a model for data access and governance policies for rare disease registries that collect clinical outcomes
AU - Ali, Salma R.
AU - Bryce, Jillian
AU - Tan, Li En
AU - Hiort, Olaf
AU - Pereira, Alberto M.
AU - van den Akker, Erica L.T.
AU - Appelman-Dijkstra, Natasha M.
AU - Bertherat, Jerome
AU - Cools, Martine
AU - Dekkers, Olaf M.
AU - Kodra, Yllka
AU - Persani, Luca
AU - Smyth, Arelene
AU - Smythe, Christopher
AU - Taruscio, Domenica
AU - Faisal Ahmed, S.
N1 - Funding Information:
through active engagement and additional financial support.
Funding Information:
The EuRRECa project was launched in February 2018 through funding by the EU Health Programme with additional support from the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) and is open to all expert centres. The ultimate aim of the project is to maximise the opportunity for patients, health care professionals and researchers to participate and use high-quality, patient-centred registries for a wide range of rare conditions. EuRRECa consists of two centralised registries: a platform that allows electronic reporting of new clinical encounters (e-Reporting of Rare Conditions—e-REC) and another platform that acts as a Core Registry, collecting a common dataset for several rare conditions covered within Endo-ERN (https://endo-ern.eu/) and European Reference Network on Rare Bone Diseases (ERN-BOND; http://ernbond.eu/). These registries comply with EU GDPR [10] and are approved by the Information Governance authorities at the NHS Greater Glasgow and Clyde Health Board and the National Research Ethics Service in the UK. The project receives guidance from expert working groups that align with the condition-specific groups of Endo-ERN. This guidance flows through work packages that review the needs of patients and parents, comply with the highest ethical standards and maintain high levels of quality and interoperability [5]. As mentioned in the article by Kodra et al. [5], quality and interoperability are considered to be two of the most important elements in the establishment and maintenance of the registry. High-quality data are the basis for generating knowledge upon which decisions are made and interoperability should be based on FAIR principles (i.e., Findable, Accessible, Interoperable and Reusable) in order to make data available for wider use. It is also important to collect and implement patient reported outcome (PRO) tools into the registry, such as such as EQ5D and PROMIS, that have been extensively validated and have wide acceptability amongst clinical and patient groups. The use of validated PRO tools will improve production of high-quality data from the registry. By having clear policies on data governance and management that are acceptable to all its stakeholders including patients, health care professionals, researchers and industry, EuRRECa aims to sustain itself beyond the current lifetime of the project.
Funding Information:
Funding: S.F.A., J.B., M.C., O.M.D., O.H., L.P. are supported by the European Union’s Health Programme (2014–2020) on the EuRRECa project “777215/EuRRECa”. S.F.A. and N.A.-D. are supported by the European Union’s Health Programme (2014–2020) on the EuRR-Bone project “946831/EuRR-Bone”. A.M.P. is supported by the European Union’s Health Programme (2014–2020) on the Endo-ERN project (739527/Endo-ERN). (2017–2022).
Funding Information:
Acknowledgments: The EuRRECa and Endo-ERN projects are grateful to the European Society of Endocrinology and the European Society for Paediatric Endocrinology for funding support. We would also like to thank the support of the following reference centres that participate in the European Reference Network for Rare Endocrine Conditions (Endo-ERN): Assistance Publique-Consortium Cochin, Erasmus MC-University Medical Center Rotterdam, Ghent University Hospital, Leiden University Medical Center, NHS Greater Glasgow and Clyde Board and Universitätsklinikum Schleswig-Holstein.
Publisher Copyright:
© 2020 by the authors. Licensee MDPI, Basel, Switzerland.
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12/1
Y1 - 2020/12/1
N2 - Rare disease (RD) registries are important platforms that facilitate communication between health care professionals, patients and other members of the multidisciplinary team. RD registries enable data sharing and promotion of research and audits, often in an international setting, with the overall aim of improving patient care. RD registries also have a fundamental role in supporting the work of clinical networks such as the European Reference Networks (ERNs) for rare diseases. With the recent expansion of RD registries, it has become even more essential to outline standards of good practice in relation to governance, infrastructure, documentation, training, audits and adopting the Findable, Accessible, Interoperable and Reusable (FAIR) data principles to maintain registries of high quality. For the purpose of this paper, we highlight vital aspects of data access and data governance policies for RD registries, using the European Registries for Rare Endocrine Conditions (EuRRECa) as an example of a project that aims to promote good standards of practice for improving the quality of utilization of RD registries.
AB - Rare disease (RD) registries are important platforms that facilitate communication between health care professionals, patients and other members of the multidisciplinary team. RD registries enable data sharing and promotion of research and audits, often in an international setting, with the overall aim of improving patient care. RD registries also have a fundamental role in supporting the work of clinical networks such as the European Reference Networks (ERNs) for rare diseases. With the recent expansion of RD registries, it has become even more essential to outline standards of good practice in relation to governance, infrastructure, documentation, training, audits and adopting the Findable, Accessible, Interoperable and Reusable (FAIR) data principles to maintain registries of high quality. For the purpose of this paper, we highlight vital aspects of data access and data governance policies for RD registries, using the European Registries for Rare Endocrine Conditions (EuRRECa) as an example of a project that aims to promote good standards of practice for improving the quality of utilization of RD registries.
KW - Databases
KW - Endocrinology
KW - European reference networks
KW - Rare conditions
KW - Rare diseases
KW - Registries
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U2 - 10.3390/ijerph17238743
DO - 10.3390/ijerph17238743
M3 - Review article
C2 - 33255540
AN - SCOPUS:85096563907
VL - 17
SP - 1
EP - 12
JO - International Journal of Environmental Research and Public Health
JF - International Journal of Environmental Research and Public Health
SN - 1661-7827
IS - 23
M1 - 8743
ER -