This research project is designed to assist the U.S. Food and Drug Administration Center for Drug Evaluation and Research's (FDA/CDER's) Office of Communications in meeting the challenges of communicating scientific information to the public, especially about prescription drugs and over-the-counter medications. FDA has already undertaken several activities to enhance its communication strategies to the public about the risks and benefits of the products it regulates. Our research will focus on understanding how adults in the United States may differ with respect to health literacy skills and examine how health literacy and other consumer characteristics may impact the effectiveness of FDA communications. In addition, we will explore and then evaluate how messages and products can be modified to meet the needs of various audience segments. We address the following research questions: (1) What factors influence people's comprehension of medication risk and benefit information and drug-related decisions? (2) What role does the media play in communicating scientific data about medications to the public? (3) Does targeting messages and materials to certain audience segments improve the transmission of scientific information and promote informed decision making? Aim 1 includes conducting a web-based panel survey of 1,300 U.S. noninstitutionalized adults aged 18 to 74 years and then developing audience segments relevant to CDER.
Aim 2 contains three simultaneous activities: (a) performing content analysis and media monitoring, (b) conducting formative research with new audience segments, and (c) assessing current FDA outreach and dissemination strategies relative to the CDER Strategic Plan and FDA Strategic Plan for Risk Communication.
In Aim 3, we will share findings from Aims 1 and 2 with the FDA/CDER/Office of Communications and then collaborate to develop, implement, and evaluate a pilot study. The pilot study will provide these newly identified audience segments with information about FDA products to help promote more informed decisions about drug safety, medication choices, and adherence. Our expected outcomes from this project are (1) the development of a more nuanced understanding and approach to developing scientific communication about medications, (2) enhanced capacity within CDER for developing communication tools and services that meet the information needs of most U.S. adults, and (3) understanding of how this knowledge can be used to create campaigns through traditional and new media channels.
In this research project, we focus on understanding how health literacy and other characteristics may influence the effectiveness of FDA communications in achieving public health objectives. In addition, we explore and evaluate how messages about prescription and over-the-counter medications can be modified to meet the needs of various audience segments and promote informed decision making.
|McCormack, Lauren; Craig Lefebvre, R; Bann, Carla et al. (2016) Consumer Understanding, Preferences, and Responses to Different Versions of Drug Safety Messages in the United States: A Randomized Controlled Trial. Drug Saf 39:171-84|