從管理實務經驗發展臨床研究護理師績效指標

From the Prospective of Clinical Research Practical Experiences to Develop Clinical Research Nurses’ KPIs

陳慧娟(Hui-Chuan Chen)

指導教授 ： 胡文郁

國立臺灣大學/醫學院/護理學研究所/碩士(2017年)

https://doi.org/10.6342/NTU201703146

摘要

目的：旨在發展臨床研究護理師(Clinical Research Nursrs, CRN)之關鍵績效指標(Key Performance Indicators, KPIs)，及其重要性、易近性與認同度，並找出影響臨床研究護理師KPI的重要預測因子。

方法：採系統性文獻查證及橫斷式研究法，針對臺灣北中南地區之教學醫院級以上之臨床研究單位、受託研究機構或臨床試驗管理機構及臨床試驗贊助藥廠等，以滾雪球方式蒐集186位臨床試驗研究團隊成員，包括「臨床研究護理人員(N=78)、試驗計畫主持人(N=17)、臨床研究監測員(N=36)與其他臨床研究團隊成員(N=55)」，以專家會議建立問卷效度，並以SPSS17.0及R軟體進行交叉比對分析。

結果：1) 臨床研究團隊成員自覺KPI之重要性、易近性及認同度的總平均及排序和進行排序，並輔以Mann-Whitney U test分析組間差異，選出13項KPI「重要性、易近性及認同度」呈現沒有共識差異之變項；2) 組間差異分析顯示，CRN與試驗計畫主持人群組對KPI「重要性」「易近性」及「認同度」的共識性較高，其中僅5題(8.2%)「認同度」達統計顯著差異水準；CRN與臨床研究監測員群組對KPI「重要性」「易近性」及「認同度」之共識差異程度，分別為21題(34.4%)、21題(34.4%)與30題(49.2%)；CRN與其他研究團隊成員群組的KPI「重要性」「易近性」及「認同度」的共識差異程度為11題(18.0%)、25題(41.0%)與17題(27.9%)，顯示CRN與臨床研究監測員以及其他研究團隊成員對臨床研究護理師KPI之「重要性、易近性及認同度」之看法較無共識；3) 找出重要預測變項分別為「現任職稱為CRN」、「執行Phase IV臨床試驗最多」、「教育程度為碩博士」及「使用電子產品大於等於4項」。以線性多元迴歸方式進行臨床研究護理師KPI認同度之逐步迴歸，總解釋變異量分別為12.9%、14.6%、20.3%、20.8%。

結論：此研究結果可提出臨床研究護理人員績效計算之建議方案、臨床研究護理專業發展以及實務管理層面之參考。

關鍵字：臨床試驗/研究、臨床研究護理、臨床研究護理師、關鍵績效指標、績效評估

關鍵字

臨床試驗/研究 ； 臨床研究護理 ； 臨床研究護理師 ； 關鍵績效指標 ； 績效評估

並列摘要

Objective: There are 3 aims in this study. First, to identify and develop the Key Performance Indicators (KPIs) of clinical research nurses (CRN). Second, to converge consensus of CRN KPIs in the perpectives of clinical research professional teams in three characteristics of KPIs; importance, accessibility and agreement. Third, to identify important prodicting factors of CRN KPIs.

Method: Systemic literature review and cross sectional study are implemented. Experties in clinical research departments in medical centers around the north, middle and south areas of Taiwan, CROs (Clinical Research Organizations), SMOs (Site Management Organizations) and trial sponsor pharmaceutical companies in Taiwan are enrolled. A total of 186 clinical research team members are enrolled using snowball sampling, which includes CRN (N =78), principle investigators (N =17), Monitors (N =36) and other professionals (N =55). Expert consensus meetings are carried to identify the reliability and validity of the KPIs. The data set was analyzed by statistical software SPSS17.0 and R software for verification.

Results: 1) Thirteen KPI items (of all 61) in all 3 characteristics (importance, accessibility and agreement) showed no statistically difference between clinical research members (Mann-Whitney U test). 2) Inter-group analysis showed that CRN group shares the highest consensus with investigator group on KPI "importance", "accessibility" and "agreement", and only 5 (8.2%) KPI items in agreement are statistically different. The CRN group and the monitor group have different perspecitves in KPI "importance" 21 items (34.4%), "accessibility" 21 items (34.4%), and "agreement" 30 items (49.2%). The CRN group and the other group showed different perspecitves in KPI importance, accessibility, agreement in 11 items (18.0%), 25 items (41.0%) and 17 items (27.9%) respectively. Our data indicate that CRN group share less KPIs consensus with the monitor group and other professionals group. 3) Four regression analysis models are established to find the important predictors of KPI agreement; "job title as CRN" and "experience of more phase IV trials" are negative predictors for KPI agreement, "Education in master or PhD" and "Use of electronic products is greater than or equal to 4" are positive predictors. Stepwise linear regression and F test were performed and 12.9%, 14.6%, 20.3%, 20.8% of the variance of the four models could be explained.

Conclusion: This study proposes a CRN performance review proposal. This study can be applied to the development of clinical research nursing profesional and practical management system.

Key words: clinical trials/research, clinical research nursing, clinical research nurses, CRNs, key performance indicators, KPIs, performance evaluation

並列關鍵字

clinical trials/research ； clinical research nursing ； clinical research nurses ； CRNs ； key performance indicators ； KPIs ； performance evaluation

參考文獻

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