Division of Rehabilitation & Ageing, University of Nottingham, Queens Medical Centre, B98, B Floor, Nottingham NG7 2UH, UK.
Trials. 2014 Mar 29;15:98. doi: 10.1186/1745-6215-15-98.
Recruiting to randomized controlled trials is fraught with challenges; with less than one third recruiting to their original target. In preparation for a trial evaluating the effectiveness of a blood test to screen for lung cancer (the ECLS trial), we conducted a qualitative study to explore the potential barriers and facilitators that would impact recruitment.
Thirty two people recruited from community settings took part in four focus groups in Glasgow and Dundee (UK). Thematic analysis was used to code the data and develop themes.
Three sub-themes were developed under the larger theme of recruitment strategies. The first of these themes, recruitment options, considered that participants largely felt that the invitation to participate letter should come from GPs, with postal reminders and face-to-face reminders during primary care contacts. The second theme dealt with understanding randomization and issues related to the control group (where bloods were taken but not tested). Some participants struggled with the concept or need for randomization, or for the need for a control group. Some reported that they would not consider taking part if allocated to the control group, but others were motivated to take part even if allocated to the control group by altruism. The final theme considered perceived barriers to participation and included practical barriers (such as flexible appointments and reimbursement of travel expenses) and psychosocial barriers (such as feeling stigmatized because of their smoking status and worries about being coerced into stopping smoking).
Focus groups provided useful information which resulted in numerous changes to proposed trial documentation and processes. This was in order to address participants information needs, improve comprehension of the trial documentation, enhance facilitators and remove barriers to participation. The modifications made in light of these findings may enhance trial recruitment and future trials may wish to consider use of pretrial focus groups.
随机对照试验的招募充满挑战；只有不到三分之一的试验能够招募到最初的目标人数。在为一项评估血液检测筛查肺癌有效性的试验（ECLS 试验）做准备时，我们进行了一项定性研究，以探索可能影响招募的潜在障碍和促进因素。
从社区环境中招募了 32 人，在格拉斯哥和邓迪（英国）参加了 4 个焦点小组。使用主题分析对数据进行编码并开发主题。
在“招募策略”这一大主题下，形成了三个子主题。第一个主题是“招募选项”，参与者普遍认为，邀请参加试验的信应该来自全科医生，同时通过邮政提醒和在初级保健接触时进行面对面提醒。第二个主题涉及对随机化和对照组（采血但不检测）相关问题的理解。一些参与者对随机化的概念或必要性，或对对照组的必要性感到困惑。一些人表示，如果被分配到对照组，他们将不会考虑参加，但也有人出于利他主义动机，即使被分配到对照组也愿意参加。最后一个主题考虑了参与的感知障碍，包括实际障碍（如灵活的预约和报销旅行费用）和心理社会障碍（如因吸烟状况而感到受辱和担心被迫戒烟）。
焦点小组提供了有用的信息，导致对拟议试验文件和流程进行了多项更改。这是为了满足参与者的信息需求，提高对试验文件的理解，增强促进因素，消除参与障碍。根据这些发现进行的修改可能会提高试验的招募率，未来的试验可能希望考虑使用试验前焦点小组。
