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

노인등록연구 사례를 통한 임상평가지표 선정 과정 및 검증된 설문도구 승인 경험의 공유

  • Nahyun Cho (Department of Diagnostics, College of Korean Medicine, Wonkwang University) ;
  • Hyungsun Jun (Department of Diagnostics, College of Korean Medicine, Wonkwang University) ;
  • Won-Bae Ha (Department of Korean Medicine Rehabilitation, College of Korean Medicine, Won-Kwang University) ;
  • Junghan Lee (Department of Korean Medicine Rehabilitation, College of Korean Medicine, Won-Kwang University) ;
  • Mi Mi Ko (Korea Medicine Science Research Division, Korea Institute of Oriental Medicine) ;
  • Young-Eun Kim (Korea Medicine Data Research Division, Korea Institute of Oriental Medicine) ;
  • Jeeyoun Jung (Korea Medicine Science Research Division, Korea Institute of Oriental Medicine) ;
  • Jungtae Leem (Department of Diagnostics, College of Korean Medicine, Wonkwang University)
  • 조나현 (원광대학교 한의과대학 진단학교실) ;
  • 전형선 (원광대학교 한의과대학 진단학교실) ;
  • 하원배 (원광대학교 한의과대학 한방재활의학과) ;
  • 이정한 (원광대학교 한의과대학 한방재활의학과) ;
  • 고미미 (한국한의학연구원 한의과학연구부) ;
  • 김영은 (한국한의학연구원 한의약데이터부) ;
  • 정지연 (한국한의학연구원 한의과학연구부) ;
  • 임정태 (원광대학교 한의과대학 진단학교실)
  • Received : 2023.09.27
  • Accepted : 2024.02.16
  • Published : 2024.03.01

Abstract

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.

Keywords

Acknowledgement

본 논문은 한국한의학연구원의 연구비 지원을 받아서 수행되었습니다. (과제번호 KSN2312021). 본 논문은 또한 2024년도 정부(과기정통부)의 재원으로 한국연구재단 세종펠로우쉽사업의 지원을 받아 (NRF-2022R1C1C2008738) 수행된 연구입니다.

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