請用此 Handle URI 來引用此文件：
http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/65238完整後設資料紀錄
| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 張榮珍(Jung-Chen Chang) | |
| dc.contributor.author | Mei-Hui Wang | en |
| dc.contributor.author | 王美惠 | zh_TW |
| dc.date.accessioned | 2021-06-16T23:31:56Z | - |
| dc.date.available | 2025-03-13 | |
| dc.date.copyright | 2020-03-13 | |
| dc.date.issued | 2020 | |
| dc.date.submitted | 2020-02-21 | |
| dc.identifier.citation | 一、中文文獻
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| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/65238 | - |
| dc.description.abstract | 背景: 臨床試驗是人類醫學進步和發展的重要過程，受試者保護與試驗品質是試驗成功的重要因素。臨床試驗研究團隊中的臨床研究護理師(Clinical Research Nurse, CRN)已成為護理專業的進階新角色並具有關鍵重要性。了解CRN在面對臨床試驗工作時的情境判斷反應，可做為評估個人工作能力內涵之參考，以維護受試者安全並提升臨床試驗品質。情境判斷測驗(Situational Judgement Test, SJT)是近年醫學、牙醫與教育領域，用以評量個人在工作相關情境下的判斷，藉以理解受評量者之能力內涵，預估未來工作表現與專業期待之相符程度。本研究運用SJT理念，設計我國CRN於臨床試驗執行時可能遭遇的情境判斷，並評估CRN情境判斷高低分與個人背景與臨床試驗護理執行背景經驗之相關性。
方法: 經過焦點團體、專家會議與前驅測試，擬定具信度與效度之SJT問卷，適用於我國CRN於臨床試驗計畫執行之情境判斷，問卷共20題幹及40子題。運用滾雪球方式邀請具有臨床試驗執行經驗的CRN以不記名方式填寫問卷，並邀請其中30位完成再測評估，以建立再測信度，利用迴歸分析模型了解與SJT得分高低之相關因素。 結果: 本研究發展CRN適用的SJT問卷之專家內容效度為0.96，問卷內部一致性信度指標Cronbach’s Alpha為0.68，本研究共收集116位CRN之完整問卷，再測信度相關係數有30子題具顯著正相關(p<0.05)。將SJT得分高低分組後，運用羅吉斯逐步迴歸了解CRN於SJT評量可獲高分之可能相關因素，結果發現CRN的工作職稱為「臨床研究護理師」、最常執行收案科別為血液腫瘤科、曾執行多國多中心試驗計畫等三項因素具顯著相關性(p<0.05)。工作職稱若自述為「臨床研究護理師」則相較於自述為「研究助理」者，成為SJT高分者的勝算比為3.539(adjusted odds ratio, aOR= 3.539，95% CI: 1.264- 9.907)；若CRN最常執行試驗收案的科別為「血液腫瘤科者」，相較於非血液腫瘤科之CRN，其aOR為 6.057 (95% CI: 1.340- 27.383)；曾參與多國多中心試驗計畫的CRN，相較無此經驗者亦高出五倍以上機會成為SJT高分組(aOR= 6.812，95% CI:1.236- 37.534)。 結論: CRN的職稱與聘用均建議使用「臨床研究護理師」而非「研究助理」，正確的職稱與專業情境判斷高分具關連性；參與多國多中心臨床試驗計畫案之經驗有助於提升CRN之臨床情境判斷能力內涵，建議未來透過正式名稱聘任CRN,專業認同將有助於品質的提升；除了臨床研究護理以外，其他護理專業領域亦可發展具信效度之情境判斷測驗，用以了解護理師於特定情境下之判斷與行為抉擇意向，藉此可以發展合適的教育訓練計畫，提高專業的執業能力內涵共識，在傳統的知識傳遞外，能透過專家共識之情境判斷反應，逐步型塑新手往專家行為態度意向趨於專業認同的能力內涵。 | zh_TW |
| dc.description.abstract | Background: Clinical trials are an important process in the advancement and development of medicine. Subject protection and trial quality are two critical elements for success of clinical trials. The Clinical Research Nurse (CRN) is a vital role in the research team and has been a newly recognized advanced practice in nursing profession. CRN’s personal characteristics and nursing competency are crucial for safety of subjects and quality of clinical trials. Situational Judgement Test (SJT) has applied recently in medicine, dentisty, and education. Through SJT, we can predict the respondants’ future job performance and the similarity to professional expectation. This study aims to design SJT for CRN in the implementation of clinical trials in Taiwan. The personal background caracteristics and trial experiences are evaluated for the association with the SJT performance.
Methods: Through focus groups and expert meetings, a reliable and valid SJT questionnaire is developed which is applicable to the situational judgment in the implementation of clinical trial by CRNs in Taiwan. The questionnaire contains 20 clinical situations and 40 questions. A snowball method is used to invite CRNs to respond to the SJT anonymously. Among all participants, 30 CRNs are invited for test-retest reliability. The statistical methods contain univariate analyses (t-test) and logistic regression. Results: The content validity index (CVI) of the SJT is 0.96 and the internal consistency reliability is 0.68. The SJT has also acceptable retest reliability (p<0.05). A total of 130 questionnaires sent out, 116 CRNs respond to the questionnaire. After grouping CRN into high- and low-SJT scores, we used stepwise logistic regression to understand the possible factors related to SJT performance. Using CRN as job title, working in Hematology, and implementing global multi-center clinical trial are essential factors related to high scored in SJT (p <0.05). If the job title is 'Clinical Research Nurse', the odds ratio for high-scored SJT is 3.539 (adjusted odds ratio, aOR = 3.539, 95% CI: 1.264-9.907) compared with the job title being 'Research Assistant.' Working in the field of hematology, CRNs can scored high in SJT (aOR: 6.057, 95% CI: 1.340-27.383). If the CRNs have experiences in global trials with multi-centers, their scores were five times higher than those who did not have this experience (aOR = 6.812, 95% CI: 1.236- 37.534). Conclusion: It is recommended to use 'Clinical Research Nurse' instead of 'Research Assistant' as the job-title for CRN. The professional title and experiences in clinical trials are associated with the scores of SJT. Professional recognition will help improve the competency for CRNs. Reliable and effective clinical situation judgment tests can be developed in the nursing profession. In the process of professionalism, SJT can be used to improve the competency of CRN in the process of novice to expert. | en |
| dc.description.provenance | Made available in DSpace on 2021-06-16T23:31:56Z (GMT). No. of bitstreams: 1 ntu-109-R05426016-1.pdf: 4568139 bytes, checksum: 8f9a16b7706db013a179a6ff108519f4 (MD5) Previous issue date: 2020 | en |
| dc.description.tableofcontents | 口試委員會審定書 i
誌謝 ii 中文摘要 iii Abstract v 目錄 vii 圖目錄 xi 表目錄 xii 第一章 緒論 1 第一節 背景分析 1 第二節 研究動機 3 第三節 研究目的 5 第二章 文獻探討 6 第一節 臨床試驗與臨床研究護理師 6 一、全球與台灣之臨床試驗 6 二、臨床研究護理師角色功能 7 三、臨床研究護理師工作範疇 10 四、臨床研究護理師培育訓練 11 第二節 能力概念分析 13 一、能力的定義與概念 13 二、護理核心能力素養 15 三、護理師能力特質 16 四、臨床研究護理師能力內涵 20 五、小結 23 第三節 情境判斷測驗之介紹 24 一、情境判斷發展歷程 24 二、情境判斷測驗應用分析 25 三、情境判斷測驗於醫學教育 26 四、SJT計分方式 29 五、小結 31 第三章 研究方法 49 第一節 研究設計 49 一、焦點團體會議 49 二、效度檢測 50 三、信度檢測 51 四、研究對象與選樣 52 第二節 研究架構 54 一、研究概念架構 54 第三節 研究工具 56 第四節 研究步驟 56 一、焦點團體 56 二、前驅研究 56 三、專家共識會議 57 四、資料統計分析 57 五、研究倫理考量 59 第四章 研究結果 60 第一節 臨床研究護理師「情境判斷測驗」問卷發展歷程 60 一、第一次焦點團體 (2019.5.18) 60 二、第二次焦點團體 (2019.6.20) 61 三、前驅測試 (2019.7.15~2019.8.3) 61 四、專家共識會議 (2019.9.12) 61 第二節 臨床研究護理師「情境判斷測驗」問卷效度與信度 65 一、建構效度 65 二、內部一致性(internal consistency) 65 三、再測信度(test-retest reliability) 67 第三節 臨床研究護理師背景資料 70 第四節 情境判斷測驗(SJT)與CRN的背景變項相關性 73 一、臨床研究護理師背景經歷與SJT表現之相關性 73 二、運用逐步多變項羅吉斯迴歸檢視SJT高分與否的相關因素 75 三、運用逐步多變項羅吉斯迴歸檢視與血液腫瘤科CRN相關的因素 77 第五章 討論 80 第一節 情境判斷測驗問卷之發展 80 第二節 臨床研究護理師情境判斷測驗之表現 82 第三節 情境判斷測驗(SJT)與CRN的背景變項相關性 84 第六章 結論與建議 87 第一節 研究結論 87 第二節 未來臨床應用建議 87 第三節 研究限制 88 第四節 未來研究建議 89 參考文獻 90 一、中文文獻 90 二、英文文獻 93 附錄 101 附件一、國立臺灣大學醫學院附設醫院研究倫理委員會核准函 101 附件二、問卷研究受訪者說明書 104 附件三、研究問卷 105 附件四、CRN情境判斷測驗(SJT)初稿題目之前驅測試結果 (SJT初稿) 117 附件五、臨床研究護理師之情境判斷選項分佈(SJT 定稿) 123 附件六、情境判斷測驗(SJT)作答與專家共識標準答案一致之人數百分比 130 附件七、遺漏值取代說明 132 附件八、專家成員名單 135 圖 2-1 能力之冰山模式 (iceberg model)14 圖 2-2 能力之成長樹模式(growing tree model)15 圖 3-1 研究概念架構圖54 圖 3-2 研究流程圖55 圖 4-1 CRN於情境判斷測驗表現高分之相關因素預測模型下之曲線77 表 2-1 好護理師特質實證研究 32 表 2-2 情境判斷測驗應用於醫學之實證研究 39 表 4-1 臨床研究護理師「情境判斷測驗」(SJT)專家內容效度(CVI) 63 表 4-2 再次專家內容效度各題得分之次數分佈與平均值 64 表 4-3 SJT測驗之內部一致性 66 表 4-4 情境判斷測驗(SJT)測驗之再測信度 68 表 4-5 臨床研究護理師基本背景資料 71 表 4-6 臨床研究護理師基本背景及試驗經歷與SJT表現之關聯性 74 表 4-7 臨床研究護理師於情境判斷測驗表現高分之相關因素 76 表 4-8 血液腫瘤科CRN與背景特性、試驗經歷及SJT表現之關聯性 78 | |
| dc.language.iso | zh-TW | |
| dc.subject | 臨床研究護理師 | zh_TW |
| dc.subject | 情境判斷測驗 | zh_TW |
| dc.subject | 臨床試驗 | zh_TW |
| dc.subject | 能力內涵 | zh_TW |
| dc.subject | 護理能力內涵 | zh_TW |
| dc.subject | clinical trial | en |
| dc.subject | clinical research nurse | en |
| dc.subject | competency | en |
| dc.subject | nursing competency | en |
| dc.subject | situational judgment test | en |
| dc.title | 應用情境判斷測驗了解臨床研究護理師對工作情境之能力內涵 | zh_TW |
| dc.title | Applying Situational Judgement Test to Understand the Competency toward Job-related Situations among Clinical Research Nurses | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 108-1 | |
| dc.description.degree | 碩士 | |
| dc.contributor.coadvisor | 宋曜廷(Yao-Ting Sung),胡文郁(Wen-Yu Hu) | |
| dc.subject.keyword | 臨床研究護理師,情境判斷測驗,臨床試驗,能力內涵,護理能力內涵, | zh_TW |
| dc.subject.keyword | clinical research nurse,situational judgment test,clinical trial,competency,nursing competency, | en |
| dc.relation.page | 135 | |
| dc.identifier.doi | 10.6342/NTU202000334 | |
| dc.rights.note | 有償授權 | |
| dc.date.accepted | 2020-02-21 | |
| 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 | |
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