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.

Patient-Related Benefits for Adults with Cochlear Implantation: A Multicultural Longitudinal Observational Study.

OBJECTIVES: To assess subjectively perceived, real-world benefits longitudinally for unilateral cochlear implant (CI) recipients in a multinational population treated routinely. To identify possible predictors of self-reported benefits. DESIGN: This was a prospective, multicenter, repeated-measures study. Self-assessment of performance at preimplantation and postimplantation at 1, 2, and 3 years using standardized, validated, local language versions of the Speech, Spatial, and Qualities of Hearing Scale (SSQ), and the Health Utilities Index Mark 3 (HUI3) was performed. Outcomes were analyzed using a longitudinal mixed-effects model incorporating country effect. Patient demographics were explored for associations with change over time. SUBJECTS: Two hundred ninety-one routinely treated, unilateral CI recipients, aged 13-81 years, from 9 clinics across 4 countries. RESULTS: Highly significant improvements were observed for all outcome measures (p < 0.0001). Postimplantation, mean outcome scores remained stable beyond 1 year, with notable individual variability. A significant association for one or more outcomes with preimplantation contralateral hearing aid use, telephone use, age at implantation, implantation side, preimplantation comorbidities, dizziness, and tinnitus was observed (p < 0.004). CONCLUSIONS: Longitudinal benefits of CI treatment can be measured using clinically standardized self-assessment tools to provide a holistic view of patient-related benefits in routine clinical practice for aggregated data from multinational populations. Self-reported outcomes can provide medical-based evidence regarding CI treatment to support decision-making by health service providers.

Evaluation of new technology for intraoperative evoked compound action potential threshold measurements.

OBJECTIVE: To determine whether new technology for intraoperative evoked compound action potential (ECAP) threshold measurements-the CR120 Intraoperative Remote Assistant device-is comparable to the existing Custom Sound(®) clinical system, as well as assess test-retest accuracy of the systems. DESIGN: Within subject, repeated measures comparative design. STUDY SAMPLE: ECAP data were collected from 81 pediatric subjects (41 females and 40 males). RESULTS: The average ECAP threshold measurement time for the Custom Sound system was 6.2 minutes (SD = 1.0) versus 4.8 minutes (SD = 0.7) for the CR120 device. ECAP thresholds measured with Custom Sound and the CR120 device had an average Pearson product-moment correlation coefficient for all electrodes (N = 1724) of 0.92, p < 0.01; an average mean absolute difference of 6 CLs (SD = 6); and a 95% confidence interval of - 1 to 1 CLs. The test-retest results for Custom Sound and the CR120 device are also included. CONCLUSION: A significant reduction in the measurement time for ECAP thresholds was noted with the CR120 device. Furthermore, ECAP thresholds measured with the CR120 device are equivalent to Custom Sound within a clinically acceptable range.

A collaboratively-derived science-policy research agenda.

The need for policy makers to understand science and for scientists to understand policy processes is widely recognised. However, the science-policy relationship is sometimes difficult and occasionally dysfunctional; it is also increasingly visible, because it must deal with contentious issues, or itself becomes a matter of public controversy, or both. We suggest that identifying key unanswered questions on the relationship between science and policy will catalyse and focus research in this field. To identify these questions, a collaborative procedure was employed with 52 participants selected to cover a wide range of experience in both science and policy, including people from government, non-governmental organisations, academia and industry. These participants consulted with colleagues and submitted 239 questions. An initial round of voting was followed by a workshop in which 40 of the most important questions were identified by further discussion and voting. The resulting list includes questions about the effectiveness of science-based decision-making structures; the nature and legitimacy of expertise; the consequences of changes such as increasing transparency; choices among different sources of evidence; the implications of new means of characterising and representing uncertainties; and ways in which policy and political processes affect what counts as authoritative evidence. We expect this exercise to identify important theoretical questions and to help improve the mutual understanding and effectiveness of those working at the interface of science and policy.