547 Application of public health theory to advance the diffusion of plain language summaries (PLS) in clinical research

Abstract

Objectives/Goals: Diffusion of innovations (DoI) posits that new health-related ideas spread through communities over time and across stages of adoption. We will apply DoI to understand a paradigm shift toward seeing participants as partners in clinical research, specifically through delivery of plain language summaries of results. Methods/Study Population: The return of results in lay language (plain language) to clinical trial participants represents a paradigm shift in the EU and now the USA. We will conduct a systematic review of the implementation of “lay summaries” or “plain language summaries” in different jurisdictions to understand current regulatory influence. We will then review PLS samples and published studies to determine the rate of adoption by industry and non-pharmaceutical company sponsors. Using the DoI framework, groups will be placed in an adopter category. Finally, we will employ an implementation science approach to understand the diffusion process and the translation to participants, laying the groundwork for a culture of change in medical product development. Results/Anticipated Results: Our search on PubMed using key terms “Diffusion of Innovation” and “Plain Language Summary” did not produce any relevant results in the context of clinical trials in the USA, which illustrates a gap in the literature and application of this theory in this context. In the future analyses, we will examine factors influencing the adoption stage and outcomes, such as regulatory action, what best practices have been defined/implemented (if any), culture shifts in the context of clinical research, health communications, and inclusion of patient voices in clinical research. Our analysis will include a network analysis to evaluate characteristics that influence adoption of PLS in clinical research. We hope to identify who is at the forefront of innovation and why. Discussion/Significance of Impact: Novel application of DoI theory will help lay the groundwork for a culture of change in patient-focused drug development, specifically for the dissemination of results to patients. In future studies, we plan to develop a tailored framework for the inclusion of PLS as part of a paradigm shift in the patient-focused drug development process.