Using short information leaflets as recruitment tools did not improve recruitment: a randomized controlled trial

Abstract

Objective: To assess if the type of patient information leaflet (PIL) received at an initial invitation to participate in a randomized trial influences the number of patients recruited.

Study design and setting: A randomized controlled trial was used to compare the effects of short or full PILs on recruitment in a primary care setting. Patients invited to take part in the Randomised Evaluation of the Effectiveness and Acceptability of Computerised Therapy study through a database mail out were randomly allocated to receive one of two types of PIL.

Results: The type of PIL received with the initial invitation did not influence recruitment. Of those receiving the short PIL, 5.4% were recruited compared with 5.1% in the full PIL group. The difference in proportions between the groups was not statistically significant (mean difference=0.3%; 95% confidence interval [CI]=-1.5%, 2.2%; P=0.75). Secondary analyses on the numbers of ineligible patients showed a statistically significant difference between the groups in favor of the full PIL group, which yielded fewer ineligible patients (P=0.04; mean difference=1.4%; CI=0.03%, 2.8%).

Conclusion: Providing patients with shorter PILs when inviting them to participate in research does not affect the numbers who are subsequently recruited and yields more ineligible patients. Therefore, it is recommended to use the full PIL as a recruitment tool.