Ms. Sabrina Kurtz-Rossi, Senior Research Specialist, Center for Health Literacy Research + Practice attended the Global Health Literacy Summit 2024 in The Netherlands to present a paper on the Readability, Understandability and Actionability of Key Information (RUAKI) on Informed Consent Forms Prospective Pilot Study-Within-a-Study.
The paper's co-author, Andreas Klein, MD, Interim Chief, Division of Hematology Oncology, Tufts Medical Center and Associate Professor of Medicine, Tufts University School of Medicine: "A prospective study in the context of an actual clinical trial was needed to demonstrate the real-world impact of easy-to-read, plain language writing on informed consent forms on study participants."
The pilot study demonstrated feasibility of conducting such a study-within-a-study, randomizing study participants into intervention and control groups and collecting and managing data via online survey. Based on experience with the pilot and feedback from an advisory group, the study team will expand the intervention to include training study staff to use plain language oral and written communication in their informed consent conversations to improve study participant understanding and confidence in their informed consent decision.
The International Health Literacy Association (IHLA) is a membership-based organization dedicated to the professional develop of its members and the field of health literacy research and practice. The organization holds a Global Health Literacy Summit every 3 years.
