基层医疗中整群随机对照试验患者招募的障碍与促进因素：对未来试验的启示
Barriers and facilitators to patient recruitment to a cluster randomized controlled trial in primary care: lessons for future trials.
作者信息
Foster Juliet M, Sawyer Susan M, Smith Lorraine, Reddel Helen K, Usherwood Tim
机构信息
Clinical Management Group, Woolcock Institute of Medical Research, University of Sydney, Sydney, Australia.
Centre for Adolescent Health, Royal Children's Hospital Melbourne, Melbourne, Australia.
出版信息
BMC Med Res Methodol. 2015 Mar 12;15:18. doi: 10.1186/s12874-015-0012-3.
BACKGROUND
Primary-care based randomized controlled trials (RCTs) build an important evidence base for general practice but little evidence exists about barriers to recruitment which often hamper such trials. We investigated the issues that impeded and facilitated recruitment to a clinical trial in general practice.
METHODS
GPs participating in a cluster RCT that tested interventions for improving medication adherence and asthma control completed a survey comprising quantitative and free text questions about their recruitment experiences. We used backward regression to analyze quantitative data and coded free text responses into themes.
RESULTS
40/55 of enrolled GPs recruited patients, but only one-third reached the planned recruitment target (5 patients/GP). In univariate analyses, poor patient recruitment by GPs was significantly associated with longer time to first patient enrolment, GP-perceived poor access to eligible patients and GP working in a practice training medical students. In regression analysis, only the first was significant (p = 0.001); the explained variance of the model was 48%. Themes from free text responses described recruitment barriers at the level of GP (e.g. GPs excluding patients for whom research appeared too challenging), practice (e.g. practice cultures disempowered GPs), patient (e.g. reluctance to change treatment for research) and study (e.g. protocol requirements complicating recruitment). Facilitators included GPs perceiving good support from the research team.
CONCLUSION
Targeted recruitment support early in the recruitment phase may enhance recruitment rates. Over time, interventions to enhance a general practice research culture are also likely to enhance skills to recruit patients, even for complex interventions. We recommend systematic evaluation of recruitment approaches and outcomes in future RCTs to optimize feasibility and success of these important trials.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12610000854033 (date registered 14/10/2010).
背景
基于初级保健的随机对照试验（RCT）为全科医疗建立了重要的证据基础，但关于招募过程中的障碍的证据很少，而这些障碍常常阻碍此类试验。我们调查了阻碍和促进全科医疗临床试验招募的问题。
方法
参与一项整群RCT的全科医生，该试验测试了改善药物依从性和哮喘控制的干预措施，他们完成了一项调查，其中包括关于他们招募经历的定量和自由文本问题。我们使用向后回归分析定量数据，并将自由文本回复编码为主题。
结果
55名登记的全科医生中有40名招募了患者，但只有三分之一达到了计划的招募目标（每位全科医生5名患者）。在单变量分析中，全科医生招募患者情况不佳与首次患者入组时间较长、全科医生认为难以接触到符合条件的患者以及在带教医学生的实习机构工作的全科医生显著相关。在回归分析中，只有第一个因素具有显著性（p = 0.001）；模型的解释方差为48%。自由文本回复中的主题描述了全科医生层面（例如，全科医生将研究似乎过于具有挑战性的患者排除在外）、诊所层面（例如，诊所文化使全科医生权力受限）、患者层面（例如，不愿为研究改变治疗）和研究层面（例如，方案要求使招募复杂化）的招募障碍。促进因素包括全科医生认为得到了研究团队的良好支持。
结论
在招募阶段早期提供有针对性的招募支持可能会提高招募率。随着时间的推移，增强全科医疗研究文化的干预措施也可能会提高招募患者的技能，即使是对于复杂的干预措施。我们建议在未来的随机对照试验中对招募方法和结果进行系统评估，以优化这些重要试验的可行性和成功率。
试验注册
澳大利亚和新西兰临床试验注册中心ACTRN12610000854033（注册日期2010年10月14日）。
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