Objectives: Cochlear implantation can restore access to sound and speech understanding in subjects with substantial hearing loss where acoustic hearing aids do not. The Health Utilities Index Mark III (HUI3) is commonly used to measure health utility across all types of intervention and is sensitive to changes in hearing. In the current study we analysed for factors predicting clinically important gains in HUI3 scores in adult Nucleus cochlear implant recipients, implanted in a single centre. Design: Retrospective analysis of data collected in an observational study. Demographic and other baseline parameters were analysed for their association with gains in HUI3 scores. Participants: One-hundred and thirty-seven adult recipients of Nucleus cochlear implants who had at least one-year follow-up. Main Outcome Measures: HUI3 scores and speech, spatial, quality (SSQ) scale scores were collected at baseline before device activation and one-year after. Difference scores were computed. Clinically important gain was defined as 0.1 point on the HUI3 scale. Results: Baseline telephone use and baseline HUI3 hearing, speech and emotion attribute levels were significantly associated with clinically important gains in HUI3 scores. However, SSQ scores increased significantly with or without clinically important gains in HUI3 scores. Conclusion: Those subjects who were unable to use the telephone prior to cochlear implantation were one-and-a-half times more likely to obtain a clinically important gain in health utility. Those subjects who were unhappy, or experienced difficulties communicating with strangers were twice or more likely to obtain a clinically important gain in HUI3 scores compared to those who did not.
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
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