Janice L. Krieger|Jordan M. Neil|Yulia A. Strekalova|Melanie A. Sarge
Linguistic Strategies for Improving Informed Consent in Clinical Trials Among Low Health Literacy Patients
University of Florida|Texas Tech University|University of Florida|Texas Tech University|University of Florida|Texas Tech University|University of Florida|Texas Tech University
improving informed consent participate randomized clinical trials rcts key challenge cancer communication current study examines strategies enhancing randomization comprehension among patients diverse levels health literacy identifies cognitive affective predictors intentions participate cancer rctsusing posttestonly experimental design cancer patients n 500 randomly assigned receive one three message conditions explaining randomization ie plain language condition gambling metaphor benign metaphor control message statistical tests twosidedhealth literacy statistically significant moderator randomization comprehension p 03 among participants lowest levels health literacy benign metaphor resulted greater comprehension randomization compared plain language p 04 control p 004 messages among participants highest levels health literacy gambling metaphor resulted greater randomization comprehension compared benign metaphor p 04 serial mediation model showed statistically significant negative indirect effect comprehension behavioral intention personal relevance rcts anxiety associated participation rcts p 001the effectiveness metaphors explaining randomization depends health literacy benign metaphor particularly effective patients lower end health literacy spectrum theoretical model demonstrates cognitive affective predictors behavioral intention participate cancer rcts offers guidance future research employ communication strategies improve informed consent processes