Structure and establishment of the German Cochlear Implant Registry (DCIR).

Abstract

Hearing rehabilitation of patients with severe hearing loss or deafness using cochlear implants (CI) is avery successful but also complex and lifelong process that requires high quality standards for structure, process, and results. Medical registries represent an ideal tool for conducting quality control relevant to care while at the same time collecting scientific data. Therefore, at the initiative of the Executive Committee of the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), aGermany-wide CI registry (the German Cochlear Implant Register, DCIR) was to be established. The following goals were to be achieved: 1)legal and contractual basis for the register; 2)definition of the register contents; 3)development of evaluation standards (hospital-specific and national annual reports); 4)development of alogo; 5)practical operation of the registry. After defining acatalog of services that defines the content, structure, and operation of the DCIR, aregistry operator with audiological expertise was sought. After considering various offers, the registry was technically implemented in cooperation with the provider INNOFORCE (Ruggell, Liechtenstein) as registry operator. This also included the realization of an interface for data transfer from previously existing databases and development of adata protection concept for productive operation of the DCIR under the scientific leadership of the DGHNO-KHC Executive Committee. Since January 2022, it has been possible for participating hospitals to enter pseudonymized data into the DCIR. To date, 75hospitals in Germany have contractually agreed to participate in the registry. During the first 15months, data from over 2500implants in over 2000patients were registered in the DCIR. The work presented here describes the structuring, development, and successful establishment of the DCIR. Introduction of the DCIR represents an important milestone of future scientifically based quality control in CI care. The registry presented here can therefore be considered as an example for other areas of medical care and thus also sets an international standard.