臨床試驗團隊成員對臨床研究護理師專業知識技能之認知差異探討

Differences in Professional Knowledge and Skills of Clinical Research Nurses among Trial Members

劉伊津(Yi-Chin Liu)

指導教授 ： 黃貴薰

國立臺灣大學/醫學院/護理學研究所/碩士(2016年)

https://doi.org/10.6342/NTU201603687

摘要

【背景】臨床試驗需仰賴一群訓練有素的團隊成員共同執行，常見的試驗團隊成員包含試驗主持人、臨床研究護理師、臨床研究專員等。臨床研究護理師常被試驗主持人授權執行大部分的事務，奠定其在臨床試驗中不可或缺的地位。然而，全世界卻少有臨床研究護理師的培訓機構。過去文獻多以臨床研究護理師之角度探討其應具備之專業知識與技能，較缺乏實務上與臨床研究護理師密切合作之試驗主持人與臨床研究專員的意見。
【目的】藉由建立中文版Australian cancer clinical trials nurse knowledge and skills questionnaire (Australian cancer CTN questionnaire)之信效度，了解並整合試驗團隊成員對臨床研究護理師專業知識與技能之認知與差異，以供未來設計臨床研究護理師培訓課程之參考。
【方法】以橫斷式研究設計採滾雪球取樣，收集323位個案之資料以SPSS 22.0套裝軟體進行分析；以內在一致性信度、專家效度、區辨效度建立量表之信效度，再以描述性與推論性統計探討研究變項間的差異與相關性。
【結果】本研究於2016年6至8月共收集試驗主持人63位、臨床研究護理師200位、臨床研究專員60位。中文版Australian cancer CTN questionnaire之Cronbach’s alpha為0.87~0.95，專家效度CVI值為0.99~1，區辨效度結果顯示本量表具良好之建構效度。研究發現，臨床研究護理師最重要及實用的知識為「知情同意過程」、「受試者篩選與招募」、「藥物安全與藥品安全性監視」；最重要及實用的技能為「溝通」與「時間管理」。
【結論】中文版Australian cancer CTN questionnaire具良好信效度，透過此量表得知「知情同意過程」、「受試者篩選與招募」、「藥物安全與藥品安全性監視」、「溝通」、「時間管理」為臨床研究護理師應具備之最重要及實用的專業知識與技能，故應納入臨床研究護理師之培訓課程。

關鍵字

臨床研究護理師 ； 專業知識 ； 專業技能 ； 護理教育

並列摘要

Background: All members of the multidisciplinary clinical research team must cooperate to accomplish clinical trials. Investigators, clinical research nurses (CRNs) and clinical research associates (CRAs) are the most common specialists in the clinical research team. As a crucial member of the clinical research team, CRNs are usually delegated by investigators to accomplish many study-related tasks, but a few training programs for them. It is rare to discuss the investigators’ and CRAs’ points of view of professional knowledge and skills for CRNs in the previous literatures.
Aims: 1) To adapt and validate the Australian cancer clinical trials nurse knowledge and skills questionnaire (Australian cancer CTN questionnaire) in Chinese. 2) To understand and integrate the differences in the professional knowledge and skills for CRNs among investigators, CRNs and CRAs. 3) To summarize the important training courses for CRNs.
Methodology: This is a cross-sectional study design and snowball sampling method was used to recruit participants. Three hundred and twenty-three participants were recruited and all data were analized by SPSS (version 22.0). Internal consistency reliability, content validity and discriminant validity were employed.
Result: Cronbach’s alpha for Chinese version of Australian cancer CTN questionnaire was excellent and ranged from 0.87-0.95 for subscales. Content validity ranged from 0.99-1. Criteria for discriminant validty were met. The most important and practical knowledge for CRNs are “Informed consent process”, “Participants screening and recruitment” and “Drug safety and pharmacovigilance”. “Communication” and “Time management” are the most important and practical skills for CRNs.
Conclusion: Chinese version of Australian cancer CTN questionnaire demonstrated good reliability and validity. “Informed consent process”, “Participants screening and recruitment”, “Drug safety and pharmacovigilance”, “Communication” and “Time management” are the most important and practical skills for CRNs and should be included in CRNs training program.

並列關鍵字

Clinical research nurse ； Professional knowledge ； Professional skill ； Nursing Education

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