背景:临床试验和大规模研究的招募具有挑战性,特别是对于慢性疼痛等复杂疾病的患者。电子邮件招聘有可能提高效率,为了降低成本,并改善代表性不足的患者人群的获取。这项研究的目的是检查有效性,效率,以及“学习将正念应用于疼痛”(LAMP)研究的电子邮件与邮政邮件招募的公平性,一项基于正念的慢性疼痛干预措施的三中心临床试验。
方法:使用VA电子健康记录(EHR)从美国退伍军人事务部(VA)的三个机构招募诊断为慢性疼痛的患者。招聘材料使用邮政邮件(n=7986)或电子邮件(n=19,333)发送。电子邮件招募组的患者在收到任何电子邮件之前也会邮寄介绍性明信片。邮寄地址和电子邮件地址从EHR获得。通过登录安全LAMP研究网站的患者的反应率来衡量有效性。效率是通过从发送招募材料到患者登录LAMP门户的天数以及每种招募方法的估计成本来衡量的。要评估公平性,我们研究了电子邮件招聘对代表性不足的人群是否效果较差,基于EHR的人口统计信息。
结果:电子邮件与邮政邮件招聘相比,有效性-未调整的回复率更高(18.9%对6.3%),根据控制年龄的多变量分析,电子邮件招募的调整后反应率高出三倍以上(RR=3.5,95%CI3.1-3.8),性别,种族,种族,rurality,和网站。效率电子邮件招聘的平均响应时间(1天比8天)明显更低,成本也更低。公平电子邮件招募导致所有亚群的响应率更高,包括年纪较大的,非白色,西班牙裔,农村,女退伍军人
结论:电子邮件招聘是一种有效的,高效,以及大规模招募VA患者的公平方式,慢性疼痛临床试验。
背景:临床试验登记号:NCT04526158。患者登记于2020年12月4日开始。
BACKGROUND: Recruitment for clinical trials and large-scale studies is challenging, especially for patients with complex conditions like chronic pain. Email recruitment has the potential to increase efficiency, to reduce costs, and to improve access for underrepresented patient populations. The objective of this study was to examine the effectiveness, efficiency, and equitability of email versus postal mail recruitment for the Learning to Apply Mindfulness to Pain (LAMP) study, a three-site clinical trial of mindfulness-based interventions for chronic pain.
METHODS: Patients with chronic pain diagnoses were recruited from three United States Department of Veterans Affairs (VA) facilities using the VA electronic health record (EHR). Recruitment materials were sent using either postal mail (n = 7986) or email (n = 19,333). Patients in the email recruitment group were also mailed introductory postcards before any emails. Mailing addresses and email addresses were obtained from the EHR. Effectiveness was measured by the response rate of patients who logged into the secure LAMP study website. Efficiency was measured by the number of days from when the recruitment materials were sent to when patients logged into the LAMP portal as well as the estimated costs of each recruitment approach. To assess equitability, we examined whether email recruitment was less effective for underrepresented populations, based on demographic information from the EHR.
RESULTS: Effectiveness-unadjusted response rates were greater for email versus postal-mail recruitment (18.9% versus 6.3%), and adjusted response rates were over three times greater for email recruitment (RR = 3.5, 95% CI 3.1-3.8) based on a multivariable analysis controlling for age, gender, race, ethnicity, rurality, and site. Efficiency-email recruitment had a significantly lower mean response time (1 day versus 8 days) and a lower cost. Equity-email recruitment led to higher response rates for all subpopulations, including older, non-White, Hispanic, rural, and female Veterans.
CONCLUSIONS: Email recruitment is an effective, efficient, and equitable way to recruit VA patients to large-scale, chronic pain clinical trials.
BACKGROUND: Clinical Trial Registration Number: NCT04526158. Patient enrollment began on December 4, 2020.