Daykin Anne, Clement Clare, Gamble Carrol, Kearney Anna, Blazeby Jane, Clarke Mike, Lane J Athene, Shaw Alison
Bristol Medical School, University of Bristol, Bristol, UK.
Bristol Randomised Trials Collaboration (BRTC), University of Bristol, Bristol, UK.
Trials. 2018 Jan 29;19(1):76. doi: 10.1186/s13063-018-2467-0.
Loss to follow-up (attrition) is a frequent problem in clinical trials and can introduce bias or reduce power. So, understanding retention issues and strategies to address these are important. As part of a multi-method project, this qualitative study aimed to explore retention strategies used by trial teams and factors which may influence strategy adoption.
A purposive sample of active trials was selected from the UK NIHR HTA portfolio of ongoing trials in 2014/2015. Semi-structured interviews with several trial team members from each trial and supplementary interviews with experienced trial managers explored strategies in collecting clinical outcome data and retaining participants. Interview data were analysed thematically using techniques of constant comparison.
Twenty-two semi-structured interviews with trial team members including chief investigators, trial managers, nurses and research administrators revealed strategies used to enhance retention. Some were recognised methods and planned from trial outset whilst others were implemented more responsively. Interviewees placed great value on fostering positive relationships with trial participants to enhance retention. However, these strategies took time which was not always appreciated by the wider trial team or funding bodies. The national focus on recruitment targets in networks posed a challenge to staff and was deemed detrimental to retention. The 'moral compass' of individual researchers relied on their own beliefs and values and research experience and the factors affected their confidence to pursue participant data during follow-up.
The role of trial staff and their underlying behaviours influence retention practices and, combined with emphasis on recruitment targets, can be detrimental to motivation and retention activities. There is a need to consider how to train and support trial staff involved in retention practices and recognition of retention from funding bodies and oversight organisations.
失访是临床试验中常见的问题，可能会引入偏差或降低检验效能。因此，了解留存问题及解决这些问题的策略非常重要。作为一个多方法项目的一部分，这项定性研究旨在探索试验团队使用的留存策略以及可能影响策略采用的因素。
从2014/2015年英国国家卫生研究院卫生技术评估（NIHR HTA）正在进行的试验项目中，选取了有代表性的一组正在进行的试验。对每个试验的多名试验团队成员进行了半结构化访谈，并对经验丰富的试验管理人员进行了补充访谈，探讨了收集临床结局数据和留住参与者的策略。采用持续比较技术对访谈数据进行了主题分析。
对包括首席研究员、试验管理人员、护士和研究管理人员在内的试验团队成员进行的22次半结构化访谈，揭示了用于提高留存率的策略。有些是公认的方法，在试验开始时就已规划好，而其他一些则是更灵活地实施。受访者高度重视与试验参与者建立积极的关系以提高留存率。然而，这些策略需要时间，而这并非总是得到更广泛的试验团队或资助机构的认可。全国范围内对网络招募目标的关注给工作人员带来了挑战，并被认为对留存率不利。个别研究人员的“道德准则”依赖于他们自己的信念、价值观和研究经验，这些因素影响了他们在随访期间获取参与者数据的信心。
试验工作人员的角色及其潜在行为会影响留存实践，再加上对招募目标的强调，可能会对积极性和留存活动产生不利影响。有必要考虑如何培训和支持参与留存实践的试验工作人员，以及资助机构和监督组织对留存的认可。
