Cochlear AG, Basel, Switzerland.
Cochlear France SAS, Toulouse, France.
Trials. 2021 Nov 25;22(1):845. doi: 10.1186/s13063-021-05821-5.
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.
We summarize our learnings from 10 years of running a medical device registry that surveys patient-reported benefits of hearing implants.
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.
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.
ClinicalTrials.gov NCT02004353. 9 December 2013.
注册是强大的临床研究工具。虽然在医院中注册可能是强制性的，但由行业赞助的国际注册是自愿的，因此可能需要更明确的目标和更多的规划。该注册还需要足够的资源和适当的测量工具来激励长期参与并确保成功。
我们总结了我们在运行一个医疗器械注册中心方面的 10 年经验，该注册中心调查了患者对听力植入物的受益报告。
我们在全球范围内招募了 77 家参与诊所，他们共招募了 1500 多名听力植入用户。我们确定了开发针对听力损失的特定注册的阶段。此外，我们报告了在设计和实施方面的挑战和成功，并为未来的注册提出了建议。
在整个定义的注册生命周期内，需要不断更新数据收集基础设施，监督数据质量和完整性至关重要。在注册站点的合规性对于数据质量很重要，需要权衡站点监测的成本。为了激励站点准确快速地输入数据，我们为他们提供了方便访问自己数据的机会，这有助于支持他们的临床常规。
ClinicalTrials.gov NCT02004353. 2013 年 12 月 9 日。
