2024-03-28T20:35:05Zhttp://repisalud.isciii.es/oai/requestoai:repisalud.isciii.es:20.500.12105/89022022-11-07T11:50:06Zcom_20.500.12105_2102com_20.500.12105_2052com_20.500.12105_2051col_20.500.12105_2103
00925njm 22002777a 4500
dc
Kodra, Yllka
author
Weinbach, Jérôme
author
Posada De la Paz, Manuel
author
Coi, Alessio
author
Lemonnier, S Lydie
author
van Enckevort, David
author
Roos, Marco
author
Jacobsen, Annika
author
Cornet, Ronald
author
Ahmed, S Faisal
author
Bros-Facer, Virginie
author
Popa, Veronica
author
Van Meel, Marieke
author
Renault, Daniel
author
von Gizycki, Rainald
author
Santoro, Michele
author
Landais, Paul
author
Torreri, Paola
author
Carta, Claudio
author
Mascalzoni, Deborah
author
Gainotti, Sabina
author
Lopez-Martin, Estrella
author
Ambrosini, Anna
author
Müller, Heimo
author
Reis, Robert
author
Bianchi, Fabrizio
author
Rubinstein, Yaffa
author
Lochmüller, Hanns
author
Taruscio, Domenica
author
2018
Rare diseases (RD) patient registries are powerful instruments that help develop clinical research, facilitate the planning of appropriate clinical trials, improve patient care, and support healthcare management. They constitute a key information system that supports the activities of European Reference Networks (ERNs) on rare diseases. A rapid proliferation of RD registries has occurred during the last years and there is a need to develop guidance for the minimum requirements, recommendations and standards necessary to maintain a high-quality registry. In response to these heterogeneities, in the framework of RD-Connect, a European platform connecting databases, registries, biobanks and clinical bioinformatics for rare disease research, we report on a list of recommendations, developed by a group of experts, including members of patient organizations, to be used as a framework for improving the quality of RD registries. This list includes aspects of governance, Findable, Accessible, Interoperable and Reusable (FAIR) data and information, infrastructure, documentation, training, and quality audit. The list is intended to be used by established as well as new RD registries. Further work includes the development of a toolkit to enable continuous assessment and improvement of their organizational and data quality.
Int J Environ Res Public Health. 2018 Aug 3;15(8). pii: E1644.
1660-4601
http://hdl.handle.net/20.500.12105/8902
30081484
10.3390/ijerph15081644
1660-4601
International journal of environmental research and public health
Patient registry
Quality
Rare diseases
Recommendations for Improving the Quality of Rare Disease Registries