- 學位論文
COVID-19疫情對臨床研究護理師工作內容及壓力感受之影響
The Impact of COVID-19 Pandemic on Clinical Research Nurses’ Practice and Work-Related Stress
摘要
背景與目的：COVID-19疫情可能對臨床試驗執行產生重大影響，疫情也會造成臨床研究護理師(clinical research nurse, CRN)工作改變，本研究目的在了解CRNs執行臨床試驗，如何受到COVID-19疫情影響，以及CRNs在疫情期間的工作壓力感受與身心健康。 方法： 採橫斷式研究設計，以文獻回顧收集各國在COVID-19疫情期間受到影響之臨床試驗事務，發展疫情對CRNs執行臨床試驗之影響量表，並同時收集基本資料、壓力感受、心理健康指標與個人防疫行為等資料，透過網路問卷收集資料，採取不記名單次填答，資料以SPSS軟體進行描述性及推論性統計分析。 結果與討論：共收案150位CRNs，多為女性及於北部工作。在台灣臨床試驗於疫情期間受到的衝擊包含收案減少、受試者回診頻率降低、CRNs遠距工作與廠商遠距稽核等因應。疫情下CRNs工作壓力有顯著正相關因素包含: 預計離開目前工作、自述憂鬱分數高及「試驗執行受疫情影響而改變」(例如:由CRNs或藥師寄送藥物給病人、開案會議改線上會議、稽核以遠距進行、花更多時間與病人、醫院或廠商溝通協調、需要回覆更多詢問等)；而與CRNs工作壓力呈顯著負相關的因素則有受僱身份是由臨床試驗機構管理組織(Site Management Organization, SMO)所聘任、具碩士學歷、以及「試驗執行受疫情影響而改變」(例如:受試者延長回診或延長領藥時間、疫情下採遠距工作模式、疫情下運動量減少等)，以上之多變量迴歸最終模型之整體解釋量為59.5%。此外，COVID-19疫情對臨床試驗活動的主要影響如下：受試者招募較困難、受試者的追蹤評估被迫取消或減少頻率、CRNs須遠距工作及贊助商或衛生主管機關需要遠距稽核等。 結論與建議：許多臨床試驗項目在疫情期間受到影響，疫情爆發初期，試驗計畫書當中尚未列出疫情期間的應對方法，導致試驗委託者、主持人與CRNs等工作上面臨挑戰與實務執行上的困難，因而可能增加工作壓力，建議未來可以在計畫書中列出發生重大公衛事件時的處理方法，例如藥物寄送、遠距看診、檢驗頻率調整與稽核方法改變等調整做法，讓試驗團隊，尤其是第一線的CRNs，即使在疫情期間，也能夠以最有效率的方式應對，避免計畫書程序違反或受試者權益受損。
並列摘要
Background and Objectives: The COVID-19 outbreak may have a significant impact on clinical trials and can also lead to changes in the work of clinical research nurses (CRNs). This study investigated the impact of the COVID-19 pandemic on clinical trial activities, clinical research nurses’ (CRN) practice, and their work-related stress. Method: A cross-sectional design was adopted, and a literature review was conducted to develop a questionnaire to evaluate the impact of COVID-19 pandemic on the conduct of clinical trials. An online survey was carried out to collect data on basic demographic information, the CRNs’ stress, depressive symptoms, the degree which clinical trial activities have been affected by the COVID-19 pandemic, and questions inquiring the personal pandemic prevention behaviors. CRNs responded once to the internet questionnaire anomalously. The SPSS statistical software was used to process and analyze the study data. Results: A total of 150 valid responses were collected. Most CRNs in this study were women working in northern Taiwan. A multivariate regression model was constructed to depict CRNs’ work-related stress during the pandemic. The adjusted R2 of the model was 59.5%. The following factors were associated with increased CRN work-related stress: planning to leave their current job, delivering investigational products to a participant’s home, conducting a remote site initiation visit, higher PHQ-2 score, being subject to a remote audit by sponsors or health authorities, needing to spend more time communicating with patients and other health care providers than before the pandemic, and having more queries to respond to than before the pandemic. By contrast, the following factors were associated with decreased CRNs’ work-related stress: being employed by a site management organization, having a master’s degree, patients’ less frequent visits to the hospital to collect investigational products, exercising less, and working remotely. Additionally, the study indicated that the major effects of the COVID-19 pandemic on clinical trial activities were the following: participant recruitment was more difficult, follow-up assessments were subject to cancellation or reduced frequency, CRNs shifted to remote work, and sponsors or health authorities shifted to remote audits. Conclusion: Many clinical trial activities have been affected by the pandemic, with no guidance provided in clinical trial protocols for how to adapt to the changed circumstances of the pandemic. This has caused difficulties for sponsors, principal investigators, and CRNs seeking to continue their work. The situation has also increased CRNs’ work-related stress. We suggest that clinical trial protocols incorporate guidance on the appropriate and best practices to be implemented in the event of a public health emergency such as COVID-19. Examples of topics to be addressed include how to deliver investigational products, when to commence remote follow-up visits, when to adjust the frequency of follow-up visits, and alternative methods of conducting audits. With such guidance, clinical research staff, especially CRNs, will be empowered to respond effectively when faced with the next public health emergency so they can avoid protocol deviations or impairments of the participants’ rights and interests.
參考文獻
延伸閱讀
- 黃鈺茹、李怡旻、黃婉翠、魏芳君（2022）。醫事人員於COVID-19疫情期間之壓力感受之探討。健康促進研究與實務，5(2)，33-43。https://doi.org/10.29442/HPRP.202207_5(2).0004
- 楊佩瑄、曾櫻花（2022）。COVID-19疫情期間護理師在基本特性、工作壓力、工作滿意度、組織承諾之差異及組織承諾之重要影響因素。護理雜誌，69(6)，33-44。https://doi.org/10.6224/JN.202212_69(6).06
- 黃莉雯（2022）。新冠疫情下之護理人員工作壓力之負面衝擊〔碩士論文，中山醫學大學〕。華藝線上圖書館。https://doi.org/10.6834/csmu202200180
- 黃靖文、張韶蘭、李潔梅（2021）。COVID-19疫情下大學行政人員工作不安全感、工作壓力與組織承諾之研究。學校行政，(136)，117-136。https://doi.org/10.6423/HHHC.202111_(136).0006
- 張惠君、陳書毓、許茵茵、王勇翔、游馥蓮、林慧姿、徐梨文、蘇淑女、吳純慧（2022）。The Difficulties and Responses of COVID-19 Pandemic to Hospital Nursing Supplies。彰化護理，29(2)，34-39。https://doi.org/10.6647/CN.202206_29(2).0007