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Open Access Research

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

Arthur D Wong1, John Kirby2, Gordon H Guyatt13, Paul Moayyedi1, Parag Vora2 and John J You13*

Author Affiliations

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

2 Department of Radiology, McMaster University, Hamilton, ON, Canada

3 Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada

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Trials 2013, 14:40  doi:10.1186/1745-6215-14-40

Published: 11 February 2013

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

Keywords:
Randomized controlled trial; Recruitment; Telephone; Mail; Colorectal cancer screening