539 Identifying best practices: Content analysis of Plain Language Summary (PLS) resources for disseminating study results to participants

Abstract

OBJECTIVES/GOALS: Investigators have an ethical obligation to return study results back to participants in a timely and layperson-friendly manner, but most do not. This lack of communication can erode trust in the research enterprise. One solution to this issue is Plain Language Summaries (PLS). METHODS/STUDY POPULATION: We investigated and collected best practices for PLS and results dissemination as part of formative research for a pilot PLS project. This pilot was used to inform the development of our own PLS resources, which we will share broadly with other CTSAs. We employed a two-part system for analysis. First, we examined extant PLS resources from five major, publicly accessible sources spanning academia, government, publishing, and nonprofits for themes and best practices. Then, we examined actual PLS from each source and collected more specific feedback. We examined PLS structure, length, inclusion of graphics, multiple language availability, readability, and potential for improvement. RESULTS/ANTICIPATED RESULTS: Guidance sources recommended that PLS have logical and organized structures, and included essential trial information (e.g., study drug, adverse events). Suggestions for length varied widely, from 250 words to 15 pages. Guidance also recommended the use of media, including infographics, audio, and video. Only pharma guidance recommended multilingual PLS. Actual PLS included many common trial elements, including study purpose, treatment description, results, and adverse events. PLS in our analyses were 10-12 pages, and contained many infographics, including flow charts of study phases, visual explanations of treatment and participant demographics, and adverse event tables. None were multilingual, and most were readable at the 7th grade level, although one used undergraduate-level language. DISCUSSION/SIGNIFICANCE: General guidance was similar across sources. In our analyses of PLS, we found novel recommendations, such as including auditory pronunciation guides, and personalized thank you letters to participants. In future research, we recommend focusing on novel dissemination methods such as short interactive videos and patient-actor testimonials.