Development of a Otologic Surgery Registry Using Hearing Threshold Data Linked to Medical Record Database in Japan: A Preliminary Study.

BACKGROUND: Routinely collected medical data, such as electronic medical records (EMRs) and medical claims, are necessary for developing disease registries. This study aimed to develop an otologic surgery registry by integrating data from EMRs, medical claims, and otorhinolaryngology department information systems (ORL-DIS) and to assess the agreement of hearing tests between registry-determined evaluations (RDE) and surgeon-determined evaluations (SDE). METHODS: A stapes surgery registry was developed by linking data from ORL-DIS, EMRs, and medical claims from two hospitals in Japan. SDE were recorded by the surgeons, whereas RDE were automatically assigned by the registry system. This study focused on pre- and postoperative hearing evaluations. Pure-tone averages (PTA) for air conduction (AC) and bone conduction (BC) were calculated. Agreement between SDE and RDE was assessed using Bland-Altman plots, and mean differences and 95% limits of agreement (95% LoA) were calculated. In SDE, cases with incomplete data were excluded. RESULTS: A total of 164 patients (187 cases) were included. The Bland-Altman analysis revealed a high agreement between preoperative AC-PTA (mean difference: -1.61 dB; 95% LoA: -12.5 to 9.29 dB) and BC-PTA (mean difference: -1.05 dB; 95% LoA: -13.9 to 11.8 dB) measurements by SDE and RDE. Additionally, postoperative improvements showed a moderate agreement. The integration of audiometric data into the registry significantly reduced manual errors. CONCLUSION: This study successfully established the first otologic surgery registry in Japan that integrates audiometric data from EMRs. This registry provides a valuable resource for analyzing surgical outcomes and a framework for future otologic research.