#33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias

Drug Safety Matters

While structured data elements such as patient identifier, medicine name and reaction, are fundamental for adverse event reporting, they may not capture all relevant details. This is where the narrative fields come in, allowing reporters to disclose important contextual information, such as the patient’s full clinical course. But how do PV assessors interact with these narratives in spontaneous reports? What needs and challenges do they experience? These and other questions were addressed in an exploratory interview study by UMC researchers Joana Félix and Alem Zekarias.
Tune in to find out:

• What challenges are PV assessors faced with, when working with narratives?
• How could automation of certain tasks help streamline narrative analyses in the future?
• How can reporters craft narratives that effectively document adverse events?

Want to know more?

• Pharmacovigilance assessors’ experiences interacting with narrative fields in spontaneous reports: an exploratory interview study – poster presented at the 23rd ISoP Annual Meeting “Global Perspectives on Pharmacovigilance in the Digital Age and Advanced Therapeutics”, 1–5 October 2024 Montreal, Canada.
• Current Challenges in Pharmacovigilance: Pragmatic Approaches, by The Council for International Organisations of Medical Sciences (CIOMS). See page 133 on the role of narratives in good case management practices.

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Chapters

1. #33 Narrative fields and signal assessors, an exploratory study – Joana Félix and Alem Zekarias (00:00:00)

2. Intro (00:00:10)

3. What are "narrative fields"? (00:01:43)

4. Why this study? (00:03:53)

5. How was the study performed? (00:05:00)

6. Theme 1: Content and Value (00:08:22)

7. Theme 2: Processes (00:12:38)

8. Theme 3: Challenges (00:16:29)

9. Theme 4: Needs (00:26:33)

10. Takeaways (00:32:12)

11. Outro (00:37:38)