Reducing drug self-injection errors: A randomized trial comparing a “standard” versus “plain language” version of Patient Instructions for Use.

Background: Many American adults struggle to use and interpret medical-related instructions. Plain language materials have been shown to improve patient understanding and adherence. Objective: The study objective was to compare the effectiveness of a “standard” Patient Instructions for Use (PIFU-standard) with a “plain language” Patient Instructions for Use (PIFU-PL) by testing user comprehension and ability to administer a biologic agent with an auto-injector (“pen”). Methods: A trained research assistant administered sociodemographic items and the Rapid Estimate of Adult Literacy in Medicine to study participants (n = 50). Next, using a priori random assignment, participants received either PIFU-PL or PIFU-standard. Participants' knowledge of preparation (6 steps) and pre-injection (3 steps) procedures, and demonstrated correctness of self-administration (15 steps) were then evaluated. Results: Participants receiving the PIFU-PL were more likely to correctly describe a greater number of both preparation (4.5 ± 1.3 versus 3.1 ± 1.5, P = 0.01) and pre-injection steps (2.4 ± 0.8 versus 1.6 ± 0.6, P = 0.01), and demonstrated more correct self-injection steps (13.1 ± 2.1 versus 10.8 ± 4.4, P = 0.05) as compared to participants receiving the PIFU-standard. Conclusion: Participants given “plain language” instructions had a significantly better understanding of how to prepare for and self-administer medication with a pen and were consistently more accurate in demonstrating how to self-inject. [ABSTRACT FROM AUTHOR]