癌症臨床試驗研究護士工作量初探－以TCOG為例

A Pilot Study on Workload of Cancer Clinical Trial Nurses in TCOG

封威蓮(Wei-Lien Feng) ； 劉滄梧(Tsang-Wu Liu) ； 彭汪嘉康(Jacqueline Whang-Peng)

《中華民國癌症醫學會雜誌》 21卷3期 (2005/09) Pp. 7-13

https://doi.org/10.6588/JCOS.2005.21.3.2

摘要

成功的臨床試驗需要足夠的資源及合理的預算分配，特別在執行多中心(multi-center)的臨床試驗計劃，精準評估工作量乃成為必要手段。研究護士(clinical trial nurses, CTNs)是臨床試驗中實際工作執行者，為能確保良好試驗品質及有效資源分配，瞭解研究護士工作量確有其必要。
本研究目的旨在探討台灣癌症臨床研究合作組織(Taiwan Cooperative Oncology Group, TCOG)研究護士的工作量，以美國癌症放射治療研究組織(Radiation Therapy Oncology Group, RTOG)改良美國國家癌症研究院的癌症臨床研究審查委員會(Cancer Clinical Investigations Review Committee, CCIRC)所訂定算式作為評估工具，並以工作日誌分析每日工作內容及其影響因素。資料為收集15位研究護士過去一年工作量，包括個人負責收案醫院、執行研究計劃、計劃型態、參與或協同參與的研究醫師、新收案病例、追蹤個案及個案報告表等數量。其中七位全職研究護士以自評方式連續記錄10個工作天的日誌（2003年11底至12月初），記錄的項目包括工作起迄時間、工作場所、執行的計劃、工作內容及其他共五項。以SPSS10.0版套裝統計軟體進行描述性統計分析。結果顯示，(1)15位研究護士平均每年工作量積分為38.5±20.5分，中位值36（範圍19.5~93）分，其中有26.7% 研究護士工作量超過CCIRC全職同工(full-time equivalence, FTE)預期積分40分；(2)七位研究護士平均每位負責收案醫院為2.1（範圍1~3）所，每日工作場所平均6（範圍3~14）處，每日執行4（範圍1~7）個不同的計劃，其中以phase III計劃最多。工作內容以研究相關護理最多（佔54.3%），資料處理及行政文書各佔20.9%、20.8%，交通部份則為3.9%。工作時間分佈最多用在填寫資料表格，平均每天67.3（範圍0~290）分鐘，其次為篩檢病患平均34.5（範圍0~210）分鐘，接受病患及家屬衛教平均為31(範圍0~100）分鐘。研究結果顯示TCOG研究護士年平均收案量未達到CCIRC標準全職同工積分40分。但是發現研究護士工作流程繁複、工作場所多、研究計劃多樣且資料表格複雜，僅以RTOG改良過算式計算新收案及追蹤案例數量方式無法反應實際的工作量。因此，建議應考慮加入個案篩檢量、資料表格量、執行計劃量、副作用的評估、疾病特性及病患指導等相關項目，以趨向工作量合理的評估。
本研究代表TCOG研究護士某段時間工作量初評的結果，提供目前台灣研究護士工作現況的資料，希望可以作為未來發展臨床試驗研究護士工作量評估工具之參考依據，期盼以合理研究護士人力提升試驗品質。

關鍵字

臨床試驗 ； 研究護士 ； 工作量

並列摘要

The purpose of this study is to understand workload of clinical trial nurses (CTNs) in Taiwan Cooperative Oncology Group (TCOG) measured by modified CCIRC algorithm. Data are collected from 15 full-time CTNs on the number of hospitals (sites) and investigators per site, the number, and phase of study they are responsible for, number of patients newly enrolled and under follow up and the quantity of data collected by each of them in the one year period. Seven full-time CTNs also recorded their detailed work content, divided into 5 categories and total 28 items, for 10 continuous working days. All data are analyzed in descriptive statistics by SPSS 10.0. The results are as follows:
(1) The mean (±SD) workload credits by modified CCIRC algorithm were 38.5 ± 20.5, median 36 (range 19.5~93); 26.7% of CTNs have workload exceeded the fulltime equivalence (FET) target of 40 credits per year;
(2) The mean number of hospital each CTN responsible for was 2.1(range 1~3). The average number of the workplace CTN visits everyday was 6 (range 3~14). The average number of conducted protocols was 4 (range 1~7). Most of onducted protocols were phase III trials. The average percentage of time spent in daily activity was: research related nursing work (54.3%), data management (20.9%), administrative activities (20.8%) and transportation (3.9%), respectively. Most of the time is spent on filling in the case report forms, screening for eligibility, and providing consultations for patients and caregivers. Each item costs 67.3 (range 0~290), 34.5 (range 0~210), 31 (range 0~100) minutes per day, respectively.
Although the average working credits is less than the expected working credit of 40 points by CCIRC FET, CTNs' work contains complicated working procedures, large amount of data forms and variety of research plans which are not reflected by the assessment of CCIRC algorithm. We suggest that the assessment should also include the measurement of related factors such as numbers of subject screened, data quantity, protocol complexity, disease characteristics and the time required for counseling.
Findings from this pilot study on workload of CTNs in TCOG has provided useful information to understand working environment of CTNs in Taiwan and can serve as reference for developing a more comprehensive workload measurement tools for CTNs in the future.

並列關鍵字

clinical trial ； clinical trial nurse CTN ； workload