School of Social and Community Medicine, University of Bristol, 39 Canynge Hall, Whatley Road, Bristol BS8 2PS, UK.
Trials. 2011 Mar 15;12:78. doi: 10.1186/1745-6215-12-78.
Recruitment to randomised controlled trials (RCTs) with very different treatment arms is often difficult. The ProtecT (Prostate testing for cancer and Treatment) study successfully used qualitative research methods to improve recruitment and these methods were replicated in five other RCTs facing recruitment difficulties. A similar qualitative recruitment investigation was undertaken in the SPARE (Selective bladder Preservation Against Radical Excision) feasibility study to explore reasons for low recruitment and attempt to improve recruitment rates by implementing changes suggested by qualitative findings.
In Phase I of the investigation, reasons for low levels of recruitment were explored through content analysis of RCT documents, thematic analysis of interviews with trial staff and recruiters, and conversation analysis of audio-recordings of recruitment appointments. Findings were presented to the trial management group and a plan of action was agreed. In Phase II, changes to design and conduct were implemented, with training and feedback provided for recruitment staff.
Five key challenges to trial recruitment were identified in Phase I: (a) Investigators and recruiters had considerable difficulty articulating the trial design in simple terms; (b) The recruitment pathway was complicated, involving staff across different specialties/centres and communication often broke down; (c) Recruiters inadvertently used 'loaded' terminology such as 'gold standard' in study information, leading to unbalanced presentation; (d) Fewer eligible patients were identified than had been anticipated; (e) Strong treatment preferences were expressed by potential participants and trial staff in some centres. In Phase II, study information (patient information sheet and flowchart) was simplified, the recruitment pathway was focused around lead recruiters, and training sessions and 'tips' were provided for recruiters. Issues of patient eligibility were insurmountable, however, and the independent Trial Steering Committee advised closure of the SPARE trial in February 2010.
The qualitative investigation identified the key aspects of trial design and conduct that were hindering recruitment, and a plan of action that was acceptable to trial investigators and recruiters was implemented. Qualitative investigations can thus be used to elucidate challenges to recruitment in trials with very different treatment arms, but require sufficient time to be undertaken successfully.
CRUK/07/011; ISRCTN61126465.
具有非常不同治疗方案的随机对照试验（RCT）的招募工作通常很困难。Prostate testing for cancer and Treatment（ProTect）研究成功地使用定性研究方法来改善招募工作，并且这些方法在其他 5 项面临招募困难的 RCT 中得到了复制。在 SPARE（选择性膀胱保留与根治性切除）可行性研究中进行了类似的定性招募调查，以探讨招募率低的原因，并尝试通过实施定性研究结果建议的更改来提高招募率。
在调查的第一阶段，通过对 RCT 文件进行内容分析、对试验工作人员和招募人员进行主题分析以及对招募预约的音频记录进行会话分析，探讨了低招募水平的原因。研究结果提交给试验管理小组，并达成行动计划。在第二阶段，对设计和进行进行了更改，并为招募人员提供了培训和反馈。
在第一阶段确定了试验招募的五个关键挑战：（a）研究人员和招募人员难以用简单的术语阐明试验设计；（b）招募途径复杂，涉及不同专业/中心的工作人员，沟通经常中断；（c）招募人员在研究信息中无意中使用了“加载”术语，如“金标准”，导致不平衡的表述；（d）实际鉴定出的合格患者人数少于预期；（e）在一些中心，潜在参与者和试验工作人员表达了强烈的治疗偏好。在第二阶段，简化了研究信息（患者知情同意书和流程图），围绕主要招募人员进行了招募途径，并为招募人员提供了培训课程和“技巧”。但是，患者资格问题无法解决，独立的试验指导委员会建议于 2010 年 2 月关闭 SPARE 试验。
定性调查确定了阻碍招募的试验设计和实施的关键方面，并实施了试验研究人员和招募人员可接受的行动计划。因此，定性调查可用于阐明具有非常不同治疗方案的试验中的招募挑战，但需要足够的时间才能成功进行。
CRUK/07/011；ISRCTN61126465。
