Lauren McCormack|R. Craig Lefebvre|Carla Bann|Olivia Taylor|Paula Rausch
Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial
RTI International|RTI International|RTI International|RTI International|Center for Drug Evaluation and Research|United States Food and Drug Administration
part mission us food drug administration fda communicates public regularly benefits risks prescription overthecounter otc drugs effectively communicating risk however significant public health challenge better understand different populations understand information communicated fda drug safety conducted randomized experiment examine comprehension measures effectiveness drug safety messages occurred postmarket surveillance phase used internet panel survey 1244 consumers 58 used prescription drugs past year half sample panel randomized read previous fda drug safety communication dsc drug name changed half randomized read revised version dsc examined making certain modifications way drug risk information communicated impact comprehension behavioral intentions including users likelihood discontinuing drug also studied comprehension varied respondent characteristics health literacy skills risk perceptions trust message based fiveitem comprehension index revised version message associated significantly greater comprehension information relative standard version 63 vs 52 correct p 0001 significantly respondents found revised version clear 82 vs 73 p 0000 fewer group reported learning something new 78 vs 84 p 0015 significant differences emerged two groups terms message informative convincing helpful found significant differences two groups terms behavioral intentions risk perception trust found making plain language changes dsc significantly increased consumers level comprehension content providing support ongoing use exploration strategies pharmacovigilance communication research study findings important implications future drug safety communication messages related prescription drugs