Adams Mary, Caffrey Louise, McKevitt Christopher
King's College London, Division of Health and Social Care Research, and National Institute for Health Research (NIHR) Biomedical Research Centre at Guy's & St Thomas' NHS Foundation Trust and King's College London, Faculty of Life Sciences and Medicine, Capital House, 42 Weston Street, London, SE1 3QD, UK.
Health Res Policy Syst. 2015 Mar 12;13:8. doi: 10.1186/1478-4505-13-8.
In the UK, the recruitment of patients into clinical research is a national health research and development policy priority. There has been limited investigation of how national level factors operate as barriers or facilitators to recruitment work, particularly from the perspective of staff undertaking patient recruitment work. The aim of this study is to identify and examine staff views of the key organisational barriers and facilitators to patient recruitment work in one clinical research group located in an NHS Academic Health Science Centre.
A qualitative study utilizing in-depth, one-to-one semi-structured interviews with 11 purposively selected staff with particular responsibilities to recruit and retain patients as clinical research subjects. Thematic analysis classified interview data by recurring themes, concepts, and emergent categories for the purposes of establishing explanatory accounts.
The findings highlight four key factors that staff perceived to be most significant for the successful recruitment and retention of patients in research and identify how staff located these factors within patients, studies, the research centre, the trust, and beyond the trust. Firstly, competition for research participants at an organisational and national level was perceived to undermine recruitment success. Secondly, the tension between clinical and clinical research workloads was seen to interrupt patient recruitment into studies, despite national funding arrangements to manage excess treatment costs. Thirdly, staff perceived an imbalance between personal patient burden and benefit. Ethical committee regulation, designed to protect patients, was perceived by some staff to detract from clarification and systematisation of incentivisation strategies. Finally, the structure and relationships within clinical research teams, in particular the low tacit status of recruitment skills, was seen as influential.
The results of this case-study, conducted in an exemplary NHS academic research centre, highlight current systematic challenges to patient recruitment and retention in clinical studies more generally as seen from the perspective of staff at the 'sharp end' of recruiting. Staff experience is that, beyond individual clinical research design and protocol factors, wider organisational and extra-organisational norms, structures, and processes operate as significant facilitators or hindrances in the recruitment of patients as research subjects.
在英国,将患者纳入临床研究是国家卫生研究与发展政策的重点。对于国家层面的因素如何成为招募工作的障碍或促进因素,尤其是从从事患者招募工作的人员角度进行的调查有限。本研究的目的是确定并考察一个位于国民保健服务体系(NHS)学术健康科学中心的临床研究团队中工作人员对患者招募工作的关键组织障碍和促进因素的看法。
采用定性研究方法,对11名经过有目的挑选、负责招募和留住患者作为临床研究对象的工作人员进行深入的一对一半结构化访谈。主题分析根据反复出现的主题、概念和新出现的类别对访谈数据进行分类,以建立解释性说明。
研究结果突出了工作人员认为对成功招募和留住研究患者最为重要的四个关键因素,并确定了工作人员如何在患者、研究、研究中心、信托机构以及信托机构之外定位这些因素。首先,在组织和国家层面上对研究参与者的竞争被认为会破坏招募的成功。其次,尽管有国家资金安排来管理过高的治疗费用,但临床工作量和临床研究工作量之间的紧张关系被认为会干扰患者进入研究。第三,工作人员认为个人患者负担与收益之间存在不平衡。一些工作人员认为,旨在保护患者的伦理委员会规定会妨碍激励策略的澄清和系统化。最后,临床研究团队内部的结构和关系,特别是招募技能的隐性地位较低,被认为具有影响力。
在一个堪称典范的NHS学术研究中心进行的本案例研究结果,更广泛地突出了从招募一线工作人员角度看临床研究中患者招募和留住方面当前存在的系统性挑战。工作人员的经验是,除了个别临床研究设计和方案因素外,更广泛的组织和组织外规范、结构及流程在招募患者作为研究对象方面起着重要的促进或阻碍作用。