了解學士層級與學士後層級護理學系學生對臨床試驗與研究之認知程度

Abstract

背景 臨床試驗執行中心之設置漸趨普及，民眾接觸臨床試驗或受邀參加臨床試驗的機會持續增加，於第一線照護受試者並協助臨床試驗進行的臨床研究護理師之角色功能更顯重要。但在護理學生時期，相關的課程或學制內相關教育訓練仍未普遍。護理系學生應有機會接觸臨床研究護理師之角色功能，將其視為未來可行的執業途徑；護理學系學生也應具備臨床試驗研究相關知能，以有效的與臨床研究護理師溝通合作，共同照護參加試驗之病人，提升臨床試驗研究之成效與病人安全。現今體制內正規護理教育包含學士級與學士後層級，兩者均培訓基層護理人力，均有機會照護參加臨床試驗研究之病人受試者，因此評估不同層級護理系學生對臨床研究護理師、臨床試驗與研究之認知與理解程度的研究非常重要卻十分缺乏，加上2020年適逢全球受到COVID-19疫情影響，對於疫苗與藥物研發之臨床試驗有高度關注，也可能影響護理學生對臨床試驗與研究的認知有所改變，值得進一步探討。 方法 本研究為橫斷式研究，利用紙本及電子問卷兩種形式進行資料收集，以立意取樣方式分別於臺灣設有學士後護理系之學校進行收案，問卷內容包括：基本背景資料、臨床試驗執行實務知識、臨床試驗與臨床研究理解程度、臨床試驗術語認識程度、護理專業承諾、COVID-19對護生之影響、護生對COVID-19之防疫行為、身心健康狀態等。 結果 本研究共納入352位學士層級護生與156位學士後層級之護生。近55%護生知道臨床研究護理師已經是護理專業領域正式認可的進階護理師臨床專長領域之一；84.3%護生不曾照護過參加臨床試驗的病人。臨床試驗與臨床研究理解程度平均總分為70.4分（總分110分)。透過逐步多元線性迴歸分析，所有護生當中，能有較高的「臨床試驗認知程度」之因素包括：男性、學制為學士層級、知道臨床研究護理已是正式認可進階護理師臨床專長領域之一、臨床研究術語的認識程度較高、臨床試驗執行實務知識較高，以及護理專業承諾高者。 結論 研究結果發現我國護理學系學生不論學士層級或學士後層級，於在學階段接觸臨床研究或試驗的機會低，未來值得多增加接觸機會，且強化臨床試驗執行實務知識、增加臨床研究術語理解、提高機會認識臨床研究護理是進階護理執業的範疇，都能提高護生對臨床研究護理的認知，特別是學士後護理學系的課程及實習經驗未來可考慮增加有關臨床研究與臨床研究護理師專業範疇之介紹。

Background Clinical trial centers become popular nationwide and the chances of knowing or being invited to participate in clinical trials are increasing. Therefore, the role and function of clinical research nurses who are responsible for care the participants and assist clinical trials in the frontline is of essential importance. However, nurses usually receive limited training or education related to clinical trials during the school educational period. Nursing students should have access to understand the role and function of clinical research nurse and recognize as a viable way to practice in the future. Nursing students should also have the relevant knowledge of clinical trial, in order to effectively communicate and cooperate with clinical research nurses to jointly care for patients participating in the trial, and to improve the effectiveness of clinical trial research and patient safety. Formal nursing education in the current system includes bachelor's and post-bachelor's levels, both of which train primary care nursing staff and have the opportunity to care for patient subjects participating in clinical trial studies. It is therefore important to assess the differences of awareness toward clinical trials and clnical research nurse between bachelor and post-bachelor nursing students. In addition, under the global impact of the COVID-19 outbreak in 2020, the clinical trials of vaccine and new drug research and development are highly concerned, and may also affect nursing students' perception of clinical trials and research, which deserve further investigation. Method A cross-sectional study with purposive sampling was conducted in schools in Taiwan. The students were asked to complete either hard-copy or electronic questionnaire anonymously. This structured questionnaire comprised the clinical trial knowledge, understanding of clinical research and the effect of clinical trials on nursing practice, awareness of research-related terminology, professional commitment scale, the impact to nursing students for COVID-19 and related protective actions, Chinese health questionnaire and background information. Results A total of 352 bachelor nursing students and 104 second degree bachelor (post-bachelor) nursing students were recruited. Nearly 55% of the participants were aware that nurses specialize in care of clinical trial participants. 83% of the participants had no prior experience of caring for trial patients. The mean score of understanding of clinical trial and clinical research in nursing practice was 70.4 in a possible highest 110 scale. We further analyzed the associated factors related to understanding of clinical trial research by using stepwise multiple logistic regression. The results indicated better awareness toward the cinical trail research was associated with being male, at bachelor nursing program, recognizing that some nurses specialize in caring for clinical study participants, having higher level of clinical trial knowledge, having higher score on research-related terminology, and revealing higher professional commitment. Conclusion Overall, this research results showed the nursing students generally have limited opportunities to learn and to experience clinical research or trials at the school education. It is suggested to increase the opportunities to contact and to experiences clinical trial research, to have abundant practical to learn knowledge of clinical trial, and to understand clinical research terminology, especially for post-bachelor nursing studetns during their school educational stages.