School of Nursing, Johns Hopkins University, Baltimore, MD, USA.
Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, MD, USA.
Clin Trials. 2021 Feb;18(1):92-103. doi: 10.1177/1740774520956969. Epub 2020 Sep 15.
BACKGROUND/AIMS: Electronic-based recruitment methods are increasingly utilized in clinical trials to recruit and enroll research participants. The cost-effectiveness of electronic-based methods and impact on sample generalizability is unknown. We compared recruitment yields, cost-effectiveness, and demographic characteristics across several electronic and traditional recruitment methods.
We analyzed data from the diet gout trial recruitment campaign. The diet gout trial was a randomized, controlled, cross-over trial that examined the effects of a dietary approaches to stop hypertension (DASH)-like diet on uric acid levels in adults with gout. We used four electronic medical record and four non-electronic medical record-based recruitment methods to identify and recruit potentially eligible participants. We calculated the response rate, screening visit completion rate, and randomization rate for each method. We also determined cost per response, the screening, and randomization for each method. Finally, we compared the demographic characteristics among individuals who completed the screening visit by recruitment method.
Of the 294 adults who responded to the recruitment campaign, 51% were identified from electronic medical record-based methods. Patient portal messaging, an electronic medical record-based method, resulted in the highest response rate (4%), screening visit completion rate (37%), and randomization rate (21%) among these eight methods. Electronic medical record-based methods ($60) were more cost-effective per response than non-electronic medical record-based methods ($107). Electronic-based methods, including patient portal messaging and Facebook, had the highest proportion of White individuals screened (52% and 60%). Direct mail to non-active patient portal increased enrollment of traditionally under-represented groups, including both women and African Americans.
An electronic medical record-based recruitment strategy that utilized the electronic medical record for participant identification and postal mailing for participant outreach was cost-effective and increased participation of under-represented groups. This hybrid strategy represents a promising approach to improve the timely execution and broad generalizability of future clinical trials.
背景/目的:电子招募方法在临床试验中越来越多地被用于招募和纳入研究参与者。电子招募方法的成本效益和对样本普遍性的影响尚不清楚。我们比较了几种电子和传统招募方法的招募效果、成本效益和人口统计学特征。
我们分析了饮食痛风试验招募活动的数据。饮食痛风试验是一项随机、对照、交叉试验,旨在研究一种类似于饮食方法来阻止高血压(DASH)的饮食对痛风成人尿酸水平的影响。我们使用四种电子病历和四种非电子病历的招募方法来确定和招募潜在合格的参与者。我们计算了每种方法的反应率、筛选就诊完成率和随机化率。我们还确定了每种方法的每个响应、筛选和随机化的成本。最后,我们比较了通过招募方法完成筛选就诊的个体的人口统计学特征。
在 294 名对招募活动做出回应的成年人中,有 51%是从电子病历基础方法中识别出来的。患者门户消息传递是一种电子病历基础方法,在这八种方法中,其反应率(4%)、筛选就诊完成率(37%)和随机化率(21%)最高。电子病历基础方法(60 美元)的每个响应成本比非电子病历基础方法(107 美元)更具成本效益。电子方法,包括患者门户消息传递和 Facebook,筛选出的白人比例最高(52%和 60%)。向非活跃患者门户发送直接邮件增加了代表性不足的群体的参与度,包括女性和非裔美国人。
一种基于电子病历的招募策略,该策略利用电子病历进行参与者识别,并利用邮寄邮件进行参与者外展,具有成本效益,并增加了代表性不足群体的参与度。这种混合策略代表了一种有前途的方法,可以提高未来临床试验的及时性和广泛的普遍性。