JMIR Publications

ABSTRACT

Background:

Adverse drug reactions pose a serious threat to healthcare, leading to patient harm and substantial economic burden. Dashboards for drug safety surveillance are a valuable tool to tackle it.

Objective:

This qualitative study aims to develop a dashboard for drug safety tracking with active and iterative involvement of end-users. To support dashboard development, we formulate and iteratively refine design principles (DPs) for drug safety dashboards using the affordance theory

Methods:

Following a Design Science Research (DSR) approach, we conducted three cycles of iterative design and evaluation involving the end-users. Four proffesional end-users (with expertise in drug screening, drug discovery and data science) and six non-professional end-users (drug consumers) were engaged in the requirements gathering sessions through co-design workshops, usability testing through think-aloud sessions and heuristic evlauation. User experience was analysed using framework by Sauro and Lewis (2016). Heuristic evaluation was analysed using framework by Dowding and Merrill (2018).

Results:

The analysis resulted in a set of eight design principles refined using the prototype’s affordances (i.e, actionable properties of the dashboard that guide user interaction and interpretation of data). Following themes emerged in the DPs formulation and refinement: addressing the bootstrap problem through designing for immediate use (DP1a), allowing identification of patterns through visualising causality while signalising uncertainty (DP1b), tracking trends for relevant variables (DP1c), implementing user-controlled views (DP2a) and customisable levels of data granularity (DP2b), guiding user’s visual attention through spacial layouts (DP2c), designing for higher public value (DP3a) and providing features to support decision making for varied stakeholder’s groups (DP3b). A high-fidelity dashboard prototype for drug safety surveillance was proposed as a result of applying final set of DPs. Heuristic evaluation of the prototype revealed overall usability score of 84%.

Conclusions:

Applying design principles rooted in affordance theory led to a purposeful and user-relevant artefact that can improve understanding of drug safety data and potentially guide decision-making processes for professional users. Our theoretical contribution lies in providing refined design principles, while also demonstrating how affordances can aid dashboard development in pharmacovigilance. Our findings may be applicable to similar health information systems in related domains.