A user-centred approach to developing a digital laboratory information system for high-volume clinical data: lessons learned from a malaria study in Kenya

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ABSTRACT Introduction Digital health interventions can potentially improve research-related procedures and outcomes. However, many fall short of the expected benefits. Implementing user-centred design (UCD) in their development increases their relevance and adoption. Here we describe a UCD approach in building a data collection platform for use in a research trial requiring timely management of malaria microscopy results. Methodology UCD was used to transform a paper-based laboratory information system used to manage malaria microscopy to an end-to-end digital equivalent. The approach was based on the three cycles of the information systems research framework i.e. relevance, prototype design and rigour. In the relevance cycle, the paper-based workflow was evaluated and a needs assessment conducted. In the prototype design cycle, a set of electronic case report forms, a revised laboratory request form and an online data dashboard were developed. In the rigour cycle, interviews were held with the relevant users to gain insight on design of each prototype iteration. All staff were trained and the deployment of the finalised digital platform was launched at a single point in time. Three months after implementation of the finalised system, users’ experiences were assessed. Results Turnaround time on reporting microscopy results reduced from a median of 15 days to 3 days(p value < 0.0001). The amount of paper used was reduced to eight times less than before. Redundant data entry activities were removed, and labour-intensive clerical activities were replaced with automated digital processes. Users reported improved work productivity and efficiency in managing microscopy results. Conclusion The UCD data platform enabled the design of a contextually relevant, successfully adopted and clinically impactful laboratory information system. The manner in which digital health data collections systems are developed, and introduced to users is as critical as their features and functions What is already known on this topic Successful deployments of digital health interventions are hard won. Better approaches are needed to develop and deploy them. What this study adds User centred design approaches can be successfully applied even in the context where the implementation of clinical trials may benefit from a digital health intervention. How this study might affect research, practice or policy We demonstrate how user centred design was applied. This could serve as a reference for applying it in similar contexts.

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