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PP01-19: Applying User Experience Research to Understand Medical Evaluation of Adverse Events





Poster Presenter

      Niki Tetarenko

      • Sr Manager, PV Innovation
      • Bristol-Myers Squibb
        United States

Objectives

This research sought to identify the needs of medical safety reviewers and design user-driven data visualizations to enhance quality, efficiency, and confidence of decisions regarding the safety of pharmaceutical products (eg, product/event causality).

Method

In phase 1, medical safety reviewers were observed using contextual inquiry to understand their environment, processes and pain points. In phase 2, participatory design sessions led to the creation and refinement of data visualization prototypes to enhance pharmacovigilance decision making.

Results

In Phase 1 of this research, contextual inquiries surfaced the following key findings: 1) information is often fragmented, 2) processes are cumbersome and often manual and 3) knowledge often exists within silos. To address the challenge of fragmented information, Phase 2 of this research focused on a single high impact, high user value opportunity to consolidate, simplify and visualize key information to improve adverse event causality assessment within a patient’s individual journey. A patient’s individual journey can be defined as a representation of all relevant information regarding that patient within the safety database. Eight medical reviewers participated in iterative and participatory design sessions which identified the following: 1. Users want a quick summary of data, including: a. Patient demographics, and related risk factors b. Adverse event(s) c. Suspect product(s) d. Seriousness e. Case due date 2. Users want an expanded view of details, such as: a. AE outcome b. Rechallenge / Dechallenge c. Suspect products d. Therapy dates & dosage information e. Lab data with baseline values 3. Users wanted visualizations that: a. Were centered around the adverse event, relating all data and detail back to the adverse event b. Supported single case views as well as aggregated case views c. Enabled clear understanding of temporal relevance of each data element to the adverse event These specific data elements were then integrated into streamlined designs for a condensed and expanded view, aimed at easy and rapid understanding of the full context of the individual case safety report in support of these evaluations and decisions.

Conclusion

Our experience uncovered that bringing user experience research methodologies into the pharmacovigilance domain provides a means to develop relevant solutions with potential for great impact. This user-centered approach was welcomed by our colleagues, who were eager to share their experiences and be involved in improving the practice of pharmacovigilance. Leveraging contextual inquiries, we were able to uncover many distinct challenges inherent in completing the tasks associated with medical evaluation. Given the nature of the contextual inquiry being conducted within the users’ space, we were able to deeply understand the cognitive burden associated with these challenges and the potential to alleviate some of this burden by implementing data visualizations. To ensure that the needs of our medical safety reviewers were appropriately met, we continued to involve our colleagues throughout the process of designing these data visualizations. User feedback was used to create and iteratively refine the designs for data visualization. Though not specifically measured in this design phase, feedback from medical safety reviewers was overwhelmingly positive. Initial reactions suggested that implementing such data visualizations would significantly impact the efficiency and quality of decisions on event causality, even if these visualizations were to exist within an independent tool outside of the core safety database. While this research demonstrates how to improve the medical review of individual case safety reports, the basis of these visualizations – enabling a more holistic view of relevant information to evaluate safety data – is likely to be relevant to the practice of aggregate safety data review and signal evaluation. The next phase of this research will focus on conducting the proof of concept to test the functionality and user experience with these designs, in order to understand how well they address the users’ needs in practice.