P228: Patient-Centered Design for Device Risk Communication in Informed Consents: A User Testing Validation Study
Poster Presenter
Andrea Mariana Zuleta
Manager, Office of Health Literacy
Abbvie United States
Objectives
Our objective was to create standard device risk language and frequency tables for consents of device and combination product studies (autoinjector, on-body injector, prefilled syringe, infusion pump, intraocular applicator, and IVD tests) to ensure patient satisfaction and comprehension.
Method
Using ISO 14971 and health literacy principles, we created standardized device risk communication for 6 medical devices. It was user tested with a diverse representative sample of adult patients, who participated in semi-structured interviews and provided feedback to validate the new material.
Results
We conducted virtual interviews with adult patients across the United States (N=26). Reviewers were screened, consented, and assigned 1 of 6 device risk materials to review based on their existing health conditions and previous experience with medical devices. Feedback on the material was collected through semi-structured, qualitative interviews. Patients were asked basic demographic and health literacy questions. They ranged in age from 19 to 67 years. 54% identified as White, 30% African American or Black, 8% Hispanic or Latino, and 8% Asian or Pacific Islander. 65% had marginal health literacy, 27% had adequate health literacy, and 8% had limited health literacy. After interviews were completed, thematic analysis was used to determine primary themes from interview transcripts. These showed reviewers expressed high satisfaction with the material due to the effective application of health literacy design principles, which aided in their understanding of the content. Feedback positively highlighted the simplicity of the language, especially in defining the study device and its operation, with patients appreciating the clear explanation of associated risks and harms. Most participants successfully interpreted and summarized the frequency bands and percentages in the risk tables. However, a few found it challenging to conceptualize smaller percentages (e.g., less than 0.001%). Some reviewers also noted difficulty in differentiating between certain verbal risk descriptors (e.g., occasional, remote, and improbable) because they felt the terms were too similar. Reviewers emphasized the need for images, specifically images of the corresponding device as well as risk visualizations to aid in numeracy issues with interpreting frequency bands and percentages. Interview feedback was used to further optimize the risk language and tables by identifying text reviewers found unclear, while ensuring the risk material met regulatory standards.
Conclusion
This study developed, evaluated, and optimized standard device risk language and risk tables aimed at enhancing clinical trial participants’ comprehension and satisfaction in device and combination product consents. The materials received positive feedback during interviews for their use of clear and straightforward language, which effectively defined study devices, how they worked, and explained associated risks. The implementation of health literacy design principles proved instrumental in patient understanding of device risk information. This is particularly important because, unlike drug risk communication, there is less guidance on device risk communication best practices, and patients are less familiar with medical devices and their risk terminology. Providing patients with clear, simplified device risk communication materials is critical to their ability to make an informed decision at the time of consent. Despite the overall effectiveness of the risk language, some participants encountered difficulties with the risk frequency tables, particularly with interpreting small percentages and distinguishing between verbal risk descriptors they perceived as having the same or similar definitions. The findings underscore the importance of user-centered design in creating consent materials that not only meet regulatory requirements but also prioritize patient comprehension and satisfaction, ultimately contributing to more informed decision-making in clinical studies. This study builds on existing research on the development of patient-facing materials in healthcare, encouraging further integration of user feedback to enhance the clarity and effectiveness of risk communication.
Disclosure Statement:
All authors are employees of AbbVie. The design, study conduct, and financial support for this research were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval of the publication.
