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  • 學位論文

臨床研究護理師專業核心能力之建構

Constructing Professional Core Competence of Clinical Research Nursing

指導教授 : 胡文郁

摘要


研究目的: 確立之臨床研究護理師專業核心能力之定義、內容與執業範疇,進而建置臨床研究護理師之專業分級制度。 方 法: 本研究應用系統性文獻回顧及修正型德爾菲法分三階段進行,首先搜尋1950至2016期間正式出版的資料庫文獻,國內外研究護理及相關的學會或協會所發表文章或正式之公告,經同儕評讀納入之文章或專書共16篇內容進行評析,建構臨床研究護理師專業核心能力清單與檢核表內容之初稿。第二階段進行研究護理師焦點團體討論、確認第一回合德爾菲法前驅問卷「臨床研究護理師專業核心能力之評核表」內容;第三階段進行修正式德爾菲研究法,採立意取樣以滾雪球方式,進行二回合之專家共識會議(含問卷調查)。本研究共回收46份有效專家問卷,使用SPSS 22.0版windows套裝軟體進行資料分析,進行各題項之修正,各細項能力之刪除標準為:平均數 (Mean) < 4.0分與標準差(SD) >1的題目。 結 果: (1)確認臨床研究護理師八大專業核心能力(core competence),分別為「臨床研究實務執行」、「照護」、「研究」、「溝通與團隊合作」、「管理與領導」、「倫理思辨與共享決策」、「教育與專業發展」、「國際視野與文化」八大專業核心能力及其96項能力(competency)之描述。(2)建構臨床研究護理師專業能力分級制度,從CRN I (Novice)生手、CRN II (Advanced Beginner)進階學習階段、CRN III (Cometent)勝任階段、CRN IV (Proficient) 精通階段,CRN V( Expert) 專家階段共分成五個層級(3)依上述能力分級建置臨床研究護理師基礎及進階教育課程之建議。 結論與應用:已確立之臨床研究護理師專業核心能力及其專業能力分級制度,可作為臨床研究護理師職能基準、聘僱條件及臨床研究護理師工作考核之績效指標與獎勵之參考。可從臨床研究實務執行,管理與領導、教學與研究等構面,循序漸進培訓人才,優化台灣臨床試驗品質。

並列摘要


Objective:The purpose of this study is to construct the competence and draft ladder system of the Clinica Research Nurse in Taiwan. Method:The process of this study can be divided into "the process of systematic literature review, focus group discussion, the implementation of modified Delphi research method" three stages and two-round experts meeting to carry out. First, I used the way of two-round systematic review to find papers, which discussed about the professional core competence/competency of CRNs, to appraisal it. Enrolled criteria of papers were 1) To discuss about the professional competence or competency of CRNs, or CRC or Clinical professionism 2) The research population were CRNs ,CRCs, CRA, and Investigators 3) Papers which published by Chinese or English with full text and I could get the full text. Second, I used PubMed (1950s-2016), MEDLINE via Ovid online (1951-2016), CINAHL (2004-2016), Cochrane Library (2004-2016), NDLTD (2007-2016), and Airiti Library (2007-2016), ACRP (2013-2016), and Google Scholar (1979-2016) as my database. By using key words to search these databases, there were 12 related articles for me to appraisal it and I selected 16 articles for questionnaire. After extracting the role, scope, and job description for CRN`s competence, I invited three experts to make face validity for my questionnaire. The data were collected by utilizing structural questionnaires, including fundamental attributes, competencies and ladder system , among 46 clinical research professionism from the teaching hospitals distributed in the Northern, Middle, and Southern district of Taiwan, Clinical Research Organization, Site Management Organzation and Pharmacy Industry Company. Quantitative and qualitative data were analysed using SPSS 22.0. According to the results of 46 expert questionnaires, replies and recommendations of the replies in the second round, the amendments are as follows: Mean< (4.0) and standard deviation (SD)> 1. Results:The key results are:(1) Eight professional core competence (Clinical Research Pracitice, Care, Research, Communication and Team Work Collaboration , Management amd Leadership, Ethics Thinking and Shared Decision Making, Education and Professional Development, and International Vision and cultural competence) were identified and ninety-six competencies were constructed;(2) CRN`s ladder system and five levels (CRN I Novice, CRN II Advanced Beginner, CRN III Cometent, CRN IV Proficient, and CRN V Expert) were constructed by their competence;(3) Foundation and advanced education curriculum were recommended according to the competence and ladder system of CRN`s` level. Conclusions:The identified professional core competence and professional competencies classification system of the CRNs could be used as a reference for the performance indicators and rewards of clinical research nurses 'functional benchmarks, employment conditions and clinical research nurses' work assessment. Clinical site and Stakeholders will use them to develop the training program and performance evaluation standard (clinical research practice implementation, management and leadership, education and research facets) for CRNs and optimize the quality of clinical trials in Taiwan.

參考文獻


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