Veal Gareth J, Malik Salma, Lupo Mariangela, MacFarlane Susan, Lepola Pirkko, Costello Mary, Ceci Adriana, Boué Carine, Lecour Charlotte, Otto Annette, Rastegari Maryam, Berry Philip
Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK.
Service de Pharmacologie Clinique, Hospices Civils de Lyon, Lyon, France.
BMJ Paediatr Open. 2017 Sep 5;1(1):e000170. doi: 10.1136/bmjpo-2017-000170. eCollection 2017.
The key role played by research nurses in coordinating clinical trials in a paediatric setting has developed in line with increasing complexities of trial design. A questionnaire-based survey was conducted to investigate the training of research nurses involved in paediatric trials across Europe, to identify potential training needs and compare roles across specialties and countries.
A structured, cross-sectional questionnaire survey was used, with the aim of describing and quantifying research nurse experiences. The questionnaire was designed to cover four main areas of interest: demographics, training, clinical trial experience and research nurse roles/activities.
The questionnaire was completed by 341 respondents across 45 different specialties in 20 European countries. A higher percentage of research nurses within 3 years of taking up post were dissatisfied with the level of training received (16%), as compared with those in post for 3-6 years (8%) and >6 years (6%). There was a trend towards a higher percentage of respondents receiving self-funded training in mainland Europe, with reported values of 15%-20%, as compared with <5% in the UK and Ireland. Only 3% of research nurses prescribed investigational medicinal products in a clinical trial setting, with contrasting roles observed between countries.
While high levels of training satisfaction were observed, 67% of respondents felt they would benefit from additional training in line with frequently changing practices. Currently, low levels of nurse prescribing are observed in a paediatric clinical trial setting across Europe. Appropriate research nurse training programmes should be promoted through national networks across Europe.
随着试验设计的复杂性不断增加，研究护士在儿科环境中协调临床试验所发挥的关键作用也得到了发展。开展了一项基于问卷调查的研究，以调查欧洲参与儿科试验的研究护士的培训情况，确定潜在的培训需求，并比较不同专业和国家的角色。
采用结构化横断面问卷调查，旨在描述和量化研究护士的经历。问卷设计涵盖四个主要感兴趣领域：人口统计学、培训、临床试验经验以及研究护士的角色/活动。
来自20个欧洲国家45个不同专业的341名受访者完成了问卷。与任职3 - 6年（8%）和超过6年（6%）的研究护士相比，任职3年内的研究护士对所接受培训水平的不满比例更高（16%）。在欧洲大陆，接受自费培训的受访者比例有上升趋势，报告值为15% - 20%，而在英国和爱尔兰这一比例低于5%。只有3%的研究护士在临床试验环境中开具研究用药品处方，不同国家的情况存在差异。
虽然培训满意度较高，但67%的受访者认为，鉴于实践不断变化，他们将从额外培训中受益。目前，在欧洲儿科临床试验环境中，护士开具处方的比例较低。应通过欧洲各国的网络推广合适的研究护士培训项目。
