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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 黃貴薰 | |
| dc.contributor.author | Yi-Chin Liu | en |
| dc.contributor.author | 劉伊津 | zh_TW |
| dc.date.accessioned | 2021-06-15T11:09:36Z | - |
| dc.date.available | 2019-03-01 | |
| dc.date.copyright | 2017-03-01 | |
| dc.date.issued | 2016 | |
| dc.date.submitted | 2016-10-19 | |
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| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/48805 | - |
| dc.description.abstract | 【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。 | zh_TW |
| dc.description.abstract | 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. | en |
| dc.description.provenance | Made available in DSpace on 2021-06-15T11:09:36Z (GMT). No. of bitstreams: 1 ntu-105-R03426004-1.pdf: 1485224 bytes, checksum: e9d5960e5c0b665a7fb573f332f4490e (MD5) Previous issue date: 2016 | en |
| dc.description.tableofcontents | 口試委員會審定書 i
誌謝 ii 中文摘要 iii 英文摘要 iv 目錄 v 表目錄 vii 圖目錄 ix 第一章 緒論 1 第一節 研究動機與重要性 1 第二節 研究目的 5 第三節 名詞界定 6 第二章 文獻查證 7 第一節 臨床試驗團隊成員在臨床試驗中所扮演的角色 7 第二節 臨床研究護理師培訓課程 14 第三節 專業能力認知的相關影響因素 26 第四節 臨床研究護理師能力評估問卷之簡介與比較 29 第三章 研究方法 33 第一節 研究設計與架構 33 第二節 研究場所 34 第三節 研究對象 34 第四節 研究工具 36 第五節 資料收集過程 37 第六節 資料分析 39 第七節 研究倫理考量 42 第四章 研究結果 43 第一節 基本屬性分析 43 第二節 中文版Australian cancer CTN questionnaire信效度檢測 49 第三節 基本屬性與研究變項之差異性分析 66 第四節 基本屬性與研究變項之相關性分析 83 第五節 研究變項之重要性與實用性的差異性分析 87 第五章 討論 100 第一節 中文版Australian cancer CTN questionnaire信效度 100 第二節 不同臨床試驗團隊成員在基本屬性之差異 103 第三節 基本屬性與研究變項間之差異性與相關性 106 第四節 研究變項之重要性與實用性的差異性 115 第五節 臨床研究護理師培訓課程之建置 119 第六章 結論與建議 127 第一節 結論 127 第二節 研究限制與建議 130 第三節 研究結果之應用 132 參考資料 135 中文部分 135 英文部分 137 附錄 142 附錄一 中文版Australian cancer CTN questionnaire 142 附錄二 Australian cancer CTN questionnaire使用授權同意書 145 附錄三 倫理委員會研究案許可書 146 附錄四 倫理委員會變更案許可書 147 | |
| dc.language.iso | zh-TW | |
| dc.subject | 護理教育 | zh_TW |
| dc.subject | 臨床研究護理師 | zh_TW |
| dc.subject | 專業知識 | zh_TW |
| dc.subject | 專業技能 | zh_TW |
| dc.subject | Professional skill | en |
| dc.subject | Clinical research nurse | en |
| dc.subject | Professional knowledge | en |
| dc.subject | Nursing Education | en |
| dc.title | 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 | zh_TW |
| dc.title | Differences in Professional Knowledge and Skills of Clinical Research Nurses among Trial Members | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 105-1 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 胡文郁,陳建煒 | |
| dc.subject.keyword | 臨床研究護理師,專業知識,專業技能,護理教育, | zh_TW |
| dc.subject.keyword | Clinical research nurse,Professional knowledge,Professional skill,Nursing Education, | en |
| dc.relation.page | 147 | |
| dc.identifier.doi | 10.6342/NTU201603687 | |
| dc.rights.note | 有償授權 | |
| dc.date.accepted | 2016-10-19 | |
| dc.contributor.author-college | 醫學院 | zh_TW |
| dc.contributor.author-dept | 護理學研究所 | zh_TW |
| 顯示於系所單位： | 護理學系所 | |
文件中的檔案：
| 檔案 | 大小 | 格式 | |
|---|---|---|---|
| ntu-105-1.pdf 未授權公開取用 | 1.45 MB | Adobe PDF |
系統中的文件，除了特別指名其著作權條款之外，均受到著作權保護，並且保留所有的權利。