36499 The Clear Communication Index Pilot Study at the US Food and Drug Administration

Sharmi Das, MHS, Office of Analytics and Outreach, U.S. Food and Drug Administration - Center for Food Safety and Applied Nutrition, College Park, MD and Michael Herndon, Bachelor of Science, Journalism, Office of Analytics and Outreach, Division of Education, Outreach and Information, US Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD

Background:  A pilot study tested the CDC Clear Communication Index (Index) on a selection of public communication materials at the US Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN). The Index, designed by the Centers for Disease Control and Prevention, helps to develop and assess materials. This study aimed to understand if the Index could help to improve the clarity and quality of CFSAN materials for consumers, regulated industry, health professionals, and other stakeholders and serve as basic standard/criteria to assist the clearance process.

Program background: CFSAN materials intend to inform, educate, and/or encourage or require action. However, this is a challenge due to the technical and scientific nature of our information, and diverse audience. Much of CFSAN materials require stringent language in accordance with scientific evidence and the law to ensure regulatory compliance. The clearance process sometimes presents a challenge for professionals to agree on the content for an audience to know and understand about a given topic, within legal and scientific bounds. Thus, Index is a novel approach to address CFSAN's complex communications position.

Evaluation Methods and Results:  The study was theory-informed by the Social Cognitive Theory and Stage Theory. A planning committee of high-level champions helped with planning and implementation of the study. Forty-seven people were trained in the Index and offered continuous support. In each participating office, a participant was designated to coordinate groups of participants to review, score, and revise materials with the Index. Two online surveys evaluated the: 1) participant experience using the Index, and 2) office coordinator experience during the pilot period. Two focus groups sought to understand whether revised materials improved clarity. Preliminary results indicate mixed responses from participants about the Index and its application to FDA-CFSAN materials. Positive feedback from participants specified its relevance to Plain Language, 508 Compliance, and its potential to ensure quality and consistency of materials. Participants were challenged to respond to some Index questions or sections; in particular, the state of science, call to action, behavioral recommendations, and risk. Other concerns were about 'dumbing down' the science, and Index 'adding more work' to the clearance process. There were several barriers including participation/engagement and low morale for the Index and clearance process. Complete results will be presented at this conference.

Conclusions: The implementation of the Index at FDA-CFSAN would require three key components: (1) a demonstration to help clarify materials, (2) buy-in from communications professionals and subject matter experts, and (3) support from high-level champions to approve incorporation into the clearance process. Preliminary findings demonstrate that the organizational culture is relatively resistant to change. However, with some adaptation, the Index demonstrates potential to improve the clarity of FDA-CFSAN materials.

Implications for research and/or practice:  Feedback from pilot participants will determine how to move forward with the Index. With some revisions for FDA-CFSAN purposes and needs, the Index could be re-tested for its application and incorporation into materials development and the clearance process.