Kaiser Permanente Center for Health Research, Portland, OR 97227, USA.
Clin Trials. 2012 Apr;9(2):226-31. doi: 10.1177/1740774511432727. Epub 2012 Jan 24.
Traditional recruitment methods for clinical trials, such as telephone, mail, and print media, are often inefficient, costly, and use large amounts of staff time and resources.
This analysis was conducted to determine whether retention, demographics, and outcomes differed between enrolled participants who responded to recruitment outreach using an Internet-based information and registration system and enrollees whose first contact was with study staff via telephone.
We identified potentially eligible participants from Kaiser Permanente Northwest (KPNW) databases and mailed brochures inviting them to participate in the Life weight loss maintenance study. We also used employee newsletters, a member-directed website, and messages to employee email distribution lists to publicize the study. All outreach methods contained both a website address and a telephone number through which respondents could register for an information session. The website contained the same information as was provided by staff over the telephone.
Out of 2122 potential participants who expressed interest in the study, 70% did so through the website. There was no difference in retention rates between enrollees who initiated contact through the website (WEB = 308) and enrollees who contacted the study by telephone (staff = 161). The WEB group was younger (p = 0.01), had higher income (p = 0.01) and education (p < 0.01) levels, and lower body mass index (BMI; p < 0.01). There was a trend toward greater weight loss in the WEB group (p = 0.06).
We did not conduct a formal cost analysis of the two methods. Also, the population for this analysis was mostly Caucasian and middle income; thus, we cannot draw conclusions about the generalizability of our findings to more racially and economically diverse populations.
Enrolled participants who used a website to register for an initial study information session had similar study retention and outcome performance as enrollees who used a more traditional telephone method. For larger clinical trials, a website may help researchers more efficiently and cost-effectively achieve recruitment, eligibility, and randomization goals. More research is needed to determine whether similar recruitment and retention patterns are observed among racially and economically diverse populations when these and similar methods are compared.
传统的临床试验招募方法，如电话、邮件和印刷媒体，往往效率低下、成本高昂，并且需要大量的员工时间和资源。
本分析旨在确定通过基于互联网的信息和注册系统进行招募宣传的参与者与首先通过电话与研究人员联系的参与者在保留率、人口统计学特征和结局方面是否存在差异。
我们从 Kaiser Permanente Northwest (KPNW) 数据库中确定了潜在的合格参与者，并邮寄了宣传册邀请他们参加 Life weight loss maintenance 研究。我们还利用员工通讯、会员导向的网站以及向员工电子邮件分发列表发布消息来宣传该研究。所有的招募方法都包含了一个网站地址和一个电话号码，通过该电话号码，受访者可以注册参加信息会议。该网站包含了与员工通过电话提供的相同信息。
在对该研究表示有兴趣的 2122 名潜在参与者中，有 70% 通过网站表达了兴趣。通过网站和电话联系的参与者的保留率没有差异（通过网站[WEB]登记的参与者为 308 名，通过电话联系的参与者为 161 名）。WEB 组更年轻（p = 0.01），收入（p = 0.01）和教育程度（p < 0.01）更高，体重指数（BMI；p < 0.01）更低。WEB 组的体重减轻趋势更大（p = 0.06）。
我们没有对这两种方法进行正式的成本分析。此外，本分析的人群主要是白人和中等收入者；因此，我们不能得出关于我们的研究结果在更具种族和经济多样性的人群中具有普遍性的结论。
通过网站注册参加初始研究信息会议的参与者与使用更传统电话方法的参与者相比，具有相似的研究保留率和结局表现。对于更大的临床试验，网站可能有助于研究人员更有效地、更具成本效益地实现招募、资格筛选和随机分组的目标。需要进行更多的研究，以确定在比较这些方法和类似方法时，在种族和经济多样化的人群中是否观察到类似的招募和保留模式。
