Design, implementation, and management of an international medical device registry

Abstract Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and ap...

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Autores principales:	Herbert Mauch, Jasmin Kaur, Colin Irwin, Josie Wyss
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	International registry Medical device Cochlear implant Quality of life SSQ IROS Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/f202cfc85bab4137978a28e63e754d2a
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spelling	oai:doaj.org-article:f202cfc85bab4137978a28e63e754d2a2021-11-28T12:28:32ZDesign, implementation, and management of an international medical device registry10.1186/s13063-021-05821-51745-6215https://doaj.org/article/f202cfc85bab4137978a28e63e754d2a2021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05821-5https://doaj.org/toc/1745-6215Abstract Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. Methods We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. Results We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. Conclusions Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. Trial registration ClinicalTrials.gov NCT02004353. 9th December 2013.Herbert MauchJasmin KaurColin IrwinJosie WyssBMCarticleInternational registryMedical deviceCochlear implantQuality of lifeSSQIROSMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	International registry Medical device Cochlear implant Quality of life SSQ IROS Medicine (General) R5-920
spellingShingle	International registry Medical device Cochlear implant Quality of life SSQ IROS Medicine (General) R5-920 Herbert Mauch Jasmin Kaur Colin Irwin Josie Wyss Design, implementation, and management of an international medical device registry
description	Abstract Background Registries are powerful clinical investigational tools. Although in hospitals registries may be mandated, industry-sponsored, international registries are voluntary and therefore can require clearer objectives and more planning. The registry also needs sufficient resources and appropriate measurement tools to motivate long-term participation and ensure success. Methods We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants. Results We enlisted 77 participating clinics globally, who actively recruited a total of more than 1500 hearing implant users. We identified the stages in developing a registry specific to hearing loss. Furthermore, we report the challenges and successes in design and implementation and make recommendations for future registries. Conclusions Data collection infrastructure needs to be kept up to date throughout the defined registry lifetime, and it is essential to oversee data quality and completeness. Compliance at registry sites is important for data quality and needs to be weighed against the cost of site monitoring. To motivate sites to enter data accurately and expeditiously, we facilitated easy access to their own data which helped to support their clinical routine. Trial registration ClinicalTrials.gov NCT02004353. 9th December 2013.
format	article
author	Herbert Mauch Jasmin Kaur Colin Irwin Josie Wyss
author_facet	Herbert Mauch Jasmin Kaur Colin Irwin Josie Wyss
author_sort	Herbert Mauch
title	Design, implementation, and management of an international medical device registry
title_short	Design, implementation, and management of an international medical device registry
title_full	Design, implementation, and management of an international medical device registry
title_fullStr	Design, implementation, and management of an international medical device registry
title_full_unstemmed	Design, implementation, and management of an international medical device registry
title_sort	design, implementation, and management of an international medical device registry
publisher	BMC
publishDate	2021
url	https://doaj.org/article/f202cfc85bab4137978a28e63e754d2a
work_keys_str_mv	AT herbertmauch designimplementationandmanagementofaninternationalmedicaldeviceregistry AT jasminkaur designimplementationandmanagementofaninternationalmedicaldeviceregistry AT colinirwin designimplementationandmanagementofaninternationalmedicaldeviceregistry AT josiewyss designimplementationandmanagementofaninternationalmedicaldeviceregistry
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Design, implementation, and management of an international medical device registry

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