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随机对照试验比较电话和邮件随访在招募结直肠癌筛查临床试验参与者方面的效果。

Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening.

机构信息

Department of Medicine, McMaster University, Hamilton, ON, Canada.

出版信息

Trials. 2013 Feb 11;14:40. doi: 10.1186/1745-6215-14-40.

Abstract

BACKGROUND

Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment.

METHODS

Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse.

RESULTS

After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01).

CONCLUSIONS

Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging.

TRIAL REGISTRATION

Clinicaltrials.gov NCT00865527.

摘要

背景

研究人员在招募参与者参加随机对照试验(RCT)时经常面临挑战。一些数据表明,电话提醒可能会导致更多的参与者注册。

方法

从家庭医生名单中招募年龄在 50 至 70 岁的患者,最初向他们邮寄参加结直肠癌筛查 RCT 的邀请。未回复的患者在最初邀请后四周随机分配通过电话或邮件进行后续邀请。主要结局是与研究护士一起参加资格筛选。

结果

在向 1348 名患者邮寄邀请后,有 104 名患者最初参加了结直肠癌筛查的 RCT。在未回复初始邮寄邀请的 952 名患者中,我们随机分配 480 名患者通过电话进行后续邀请,472 名患者通过邮件进行后续邀请。通过电话进行后续随访的非应答者(84/480,17.5%)比通过邮件进行后续随访的非应答者(43/472,9.1%)(相对风险(RR)1.92,95%置信区间(CI)1.36 至 2.71,P < 0.001)更频繁地参加资格筛选。通过电话进行后续随访的患者(59/480,12.3%)比通过邮件进行后续随访的患者(35/472,7.4%)(RR 1.66,95% CI 1.11 至 2.47,P=0.01)入组 RCT 的比例也更高。

结论

与基于邮件的方法相比,基于电话的随访可带来更多的入组。我们的研究结果可能会引起正在进行 RCT 研究的研究人员的兴趣,特别是涉及无症状参与者的筛查干预试验,对于这些参与者,自愿参与可能具有挑战性。

试验注册

Clinicaltrials.gov NCT00865527。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8d7e/3599938/a49481c28ace/1745-6215-14-40-1.jpg

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