Design, implementation, and management of an international medical device registry.
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.
['Mauch|Herbert|H|http://orcid.org/0000-0002-0186-7859', 'Kaur|Jasmin|J|', 'Irwin|Colin|C|', 'Wyss|Josie|J|']
D000068598:Data Accuracy D034381:Hearing Loss D006801:Humans D019736:Prostheses and Implants D012042:Registries D011795:Surveys and Questionnaires
Medical device International registry Cochlear implant IROS Quality of life SSQ