P221: Patient and Prescriber Engagement in Recombinant ADAMTS13 Additional Risk Minimization Measures (aRMM)
Poster Presenter
Marie Liles-Burden
Director, Pharmacovigilance Risk Management
Takeda United States
Objectives
To highlight the importance of patient engagement and patient input in the development of the recombinant ADAMTS13 additional risk minimization measure (aRMM) via usability and comprehension study.
Method
The study was performed in July 2024 to test key message comprehension by aRMM target audiences: a survey to assess key safety messages in the HCP guide and patient alert card and an interview to gain insight on preferences and design elements. Target audiences were UK cTTP patients and prescribers.
Results
26 participants (13 HCPs and 13 patients) were recruited. Referring to the HCP guide test, 100% of participants were able to find and understand all safety messages. Among patient alert card testing, 92% of participants were able to find and understand all safety messages. Approximately 54% of healthcare professionals were likely to use both mediums (paper and digital) to access the HCP guide and approximately 83% of patients were likely to use both mediums (8 out of 13) or the digital version of the patient alert card only (2 out of 13). The design and layout were preferred by the study participants appreciating the clarity of text and visual markers for key points. Suggestions included laminating patient alert cards for durability, greater visual cues for severe allergic reactions, bolding or color changes for specific safety information. Following the usability and comprehension study, the aRMMs were updated prior to the submission to the health reflecting the patients and HCPs feedback.
Conclusion
Incorporation of the patient and prescriber voice ensures material understanding by prescribers and patients alike. Sponsor should be encouraged to test the aRMMs with the target audience to ensure the comprehension and usability by patients and HCPs.
