Background
Registries are powerful clinical investigational tools. More challenging, however, is an international registry conducted by industry. That requires considerable planning, clear objectives and endpoints, resources and appropriate measurement tools.
Methods
This paper aims to summarize our learning from ten years of running a medical device registry monitoring patient-reported benefits from hearing implants.
Results
We enlisted 113 participating clinics globally, resulting in a total enrolment of more than 1500 hearing-implant users. We identify the stages in developing a registry specific to a sensory handicap such as hearing loss, its challenges and successes in design and implementation, and recommendations for future registries.
Conclusions
Data collection infrastructure needs to be maintained up to date throughout the defined registry lifetime and provide adequate oversight of 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 provide accurate and timely data entry we facilitated easy access to their own data which helped to support their clinical routine.
Trial registration:
ClinicalTrials.gov NCT02004353