ABSTRACT NUMBER: ESOC2026A2426 CONSENT FORM VARIABILITY IN THE ESCAPE NEXT TRIAL

Abstract Background and aims Obtaining informed consent can be challenging for acute stroke trials. Informed consent forms (ICFs) are highly variable across jurisdictions. We examined the ICFs used in the ESCAPE NEXT trial, an international acute stroke trial assessing the neuroprotectant nerinetide. Methods We analyzed ICFs from each of the 9 countries that participated in ESCAPE NEXT (Australia, Canada, Germany, Italy, the Netherlands, Norway, Singapore, Switzerland, the USA) for length, content, complexity, and use of substitute or deferred consent. A template consent form in English was drafted for each country as part of study start-up, which served as the basis for local versions. Results All countries allowed surrogates to provide consent for an incapacitated patient and all countries except the United States allowed some form of deferral of consent. There was a high degree of consistency regarding content. The mean length of the English ICFs was 14 pages, with the shortest being Singapore at 10 pages and the longest being Italy at 17 pages. The mean length of local language ICFs was 13 pages. Using the Flesh-Kincaid readability assessment, the highest grade level for English ICFs was Australia at 11.8, with the lowest being Norway and Canada, at 7.3. Conclusions Despite homogeneity in content, ICFs used in the ESCAPE NEXT trial varied meaningfully in length and complexity. These results suggest that the information essential to informed consent could likely be communicated in shorter and simpler ICFs than are used in many jurisdictions. Conflict of interest Nothing to disclose.