대한기관윤리심의기구협의회지 (The Journal of KAIRB)

  • 제6권1호
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  • Pages.17-31
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  • 2024
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  • 2734-0724(pISSN)
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  • 2671-4388(eISSN)
대한기관윤리심의기구협의회 (Korean Association of Institutional Review Boartds)
권호 표지

Brady & Cronin의 모델에 기반한 임상시험 서비스 질 측정 문항 개발

Developing Measurement Items for the Service Quality of Clinical Trials based on the Brady & Cronin Model

  • 이고은 (연세대학교 간호대학) ;
  • 김상희 (연세대학교 간호대학 & 김모임 연구소) ;
  • 김수 (연세대학교 간호대학 & 김모임 연구소) ;
  • 추상희 (연세대학교 간호대학 & 김모임 연구소) ;
  • 석정호 (연세대학교 의과대학 강남세브란스병원 정신과학교실, 의학행동과학연구소) ;
  • 김소윤 (연세대학교 의과대학 인문사회의학교실 의료법 윤리학과)
  • Go-Eun Lee (College of Nursing, Yonsei University) ;
  • Sanghee Kim (College of Nursing, Mo-Im Kim Nursing Research Institute, Yonsei University) ;
  • Sue Kim (College of Nursing, Mo-Im Kim Nursing Research Institute, Yonsei University) ;
  • Sang Hui Chu (College of Nursing, Mo-Im Kim Nursing Research Institute, Yonsei University) ;
  • Jeong-Ho Seok (Department of Psychiatry, Gangnam Severance Hospital, Institute of Behavioral Sciences in Medicine, Yonsei University College of Medicine) ;
  • So Yoon Kim (Division of Medical Law and Bioethics, Department of Medical Humanities and Social Sciences, Yonsei University College of Medicine)
  • 투고 : 2024.01.26
  • 심사 : 2024.02.21
  • 발행 : 2024.02.29
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초록

Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

키워드

과제정보

이 논문은 제 1저자의 2023 연세대학교 일반대학원 박사학위 논문으로 수행된 연구를 기반으로 작성되었습니다. 이 연구는 대한기관윤리심의기구협의회의 2022 KAIRB 학술연구과제지원사업(과제번호: KAIRB-과 2022-02)과 연세대학교 간호대학 대학원생 연구지원사업의 지원을 받아 수행되었습니다. 제 1저자는 연세대학교 간호대학과 한국연구재단(NRF)이 지원하는 4단계 Brain Korea 21 프로젝트에서 장학금을 받았습니다.

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