Sharing Experiences in Selecting Clinical Outcome and Approving Validated Questionnaires : Insights from an Elderly Registry Study

Objectives: Underpinned by the context of a Korean traditional medicine cohort study on healthy aging, this research primarily aims to guide the selection of Clinical Outcome Assessments (COAs) for elderly healthy aging patient registry research, offering insights into the selection process; and secondly, to streamline the resource-intensive process of obtaining permissions for validated COAs, benefiting future traditional Korean medicine clinical researchers.Methods : In this study, we identified outcomes through a review of previous studies, followed by a process involving expert consultations to select the final outcomes. Subsequently, for the selected outcomes that were Clinical Outcome Assessments (COAs) developed tools, we searched in commercial databases to confirm the availability of Korean versions and the necessity of obtaining permissions. Finally, we obtained permissions for their utilization and, when needed, acquired the original instrument questionnaire through payment.Results: Through a literature review of existing observational studies, a total of 57 outcomes were selected, with 19 of them identified as COA instruments. Upon verifying usage permissions for these 19 instruments, it was found that 17 required author-specific permissions, and among these, 2 needed a purchase as they were commercially available.Conclusion: This study provides a detailed overview of outcome selection and permission acquisition for elderly patient registry research. It underscores the importance of Clinical Outcome Assessment (COA) tools and the rigorous approval process, aiming to enhance research reliability. Continuous verification of COA information is essential, and future research should explore Core Outcome Set (COS) development through consensus-building approaches like Delphi studies.