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意大利临床护士的角色。

The role of the clinical trial nurse in Italy.

机构信息

Regional Palliative Care Network, Istituto Nazionale per la Ricerca sul Cancro, Largo Rosanna Benzi, Genoa, Italy.

出版信息

Eur J Oncol Nurs. 2012 Feb;16(1):87-93. doi: 10.1016/j.ejon.2011.04.001. Epub 2011 May 4.

Abstract

PURPOSE

To assess the role of the Clinical Trials Nurse (CTN) and to evaluate the quality of the job performed by Clinical Trials Nurses (CTNs) in Italy.

METHODS

The study design was descriptive. The sample included 30 CTNs in Italy who were involved in conducting clinical trials in the last years. Respondents completed the Italian Clinical Trials Nursing Questionnaire (CTNQ) developed to measure frequency and importance of clinical trials nursing activities. Data analyses included descriptive statistics, Student's t-test and Chi-Square test.

RESULTS

Thirty out of 34 CTNs consented to participate. Respondents were more involved in the experimental drug management, in the protocol implementation and, partially, in the informed consent process. CTNs have a marginal position with respect to the protocol assessment and planning, subject recruitment, data management. CTNs reported high rates for the importance evaluation. Number of years in the nursing role was significantly associated with data management related activities (p = 0.016). Items with minor response rate differences between frequency and importance were not statistically significant (p values ranging from 0.087 to 0.911). The CTNs reported to be autonomous and competent; however, they lack and/or do not perform some nursing-related responsibilities and/or activities.

CONCLUSIONS

Although CTNs are not involved in all of the activities listed on the CTNQ, most of them are fully aware to be a key member of research teams. Overall, the Italian CTN role is mostly practical task-oriented and focuses little on data management and organizational activities.

摘要

目的

评估临床研究护士(CTN)的角色,并评估意大利临床研究护士(CTNs)的工作质量。

方法

研究设计为描述性。样本包括意大利的 30 名参与过去几年进行临床试验的 CTNs。受访者完成了意大利临床研究护理问卷(CTNQ),旨在衡量临床试验护理活动的频率和重要性。数据分析包括描述性统计、学生 t 检验和卡方检验。

结果

34 名 CTNs 中有 30 名同意参与。受访者更多地参与实验药物管理、方案实施,以及部分知情同意过程。CTNs 在方案评估和规划、受试者招募、数据管理方面的地位边缘。CTNs 对重要性评估的评价率较高。护理角色的年限与数据管理相关活动显著相关(p=0.016)。频率和重要性之间响应率差异较小的项目无统计学意义(p 值范围为 0.087 至 0.911)。CTNs 报告称他们是自主和有能力的;然而,他们缺乏和/或没有履行一些与护理相关的责任和/或活动。

结论

尽管 CTNs 并未参与 CTNQ 列出的所有活动,但他们中的大多数人充分意识到自己是研究团队的关键成员。总体而言,意大利 CTN 的角色主要是注重实践任务,很少关注数据管理和组织活动。

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