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KMID : 1161620240060010017
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Journal of KAIRB
2024 Volume.6 No. 1 p.17 ~ p.31
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Developing Measurement Items for the Service Quality of Clinical Trials based on the Brady & Cronin Model
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Lee Go-Eun
Kim Sang-Hee
Kim Sue
Chu Sang-Hui
Seok Jeong-Ho
Kim So-Yoon
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Abstract
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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.
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KEYWORD
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Clinical trials, Research subjects, Service quality, Validity
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