From Paper to Digital: Best Practices in Migrating Patient-Reported Outcomes
With the digital transformation wave, there’s a vital need to transition patient-reported outcome (PRO) instruments from traditional paper forms to electronic formats (ePRO). This research evaluates the equivalence in measurements between these two methods and suggests guidelines for the migration process.
Key Highlights:
Objective
Assess the equivalence of PRO instruments when moved from paper to electronic platforms through a synthesis of cognitive interview and usability studies.
Propose best practices and validation requirements for future ePRO designs.
Methodology:
The study amalgamated results from 53 cognitive interview and usability studies carried out by a contract research organization between 2012-2015.
The ensemble included 68 unique instruments, undergoing 101 evaluations in total.
The aim was to extract key insights and develop recommendations based on the accumulated data.
Results
Out of the 53 studies, only 5 (or 9%) indicated minor discrepancies during cognitive interviews that might influence the instrument’s measurement capabilities.
These discrepancies can be managed by adhering to ePRO best practices such as avoiding the need to scroll, using clear font sizes, maintaining visual analog scale line thickness, and offering comprehensive instructions.
On the usability front, 92% of the studies found the ePRO solution satisfactory in terms of display clarity, user navigation, functionality, and unassisted completion.
The usability issues that were identified can be rectified by ensuring good product design elements, like optimized button sizes, strategic placement, and responsive navigation features.
Conclusions
As evidence mounts, there seems to be less necessity to regularly conduct cognitive and usability interviews for minor adaptations during the instrument migration process.
By adhering to design best practices and selecting vendors that provide excellent user interface and user experience, many instrument migrations can move forward without the need for exhaustive validation studies. Instead, a methodical expert screen review might suffice.
In summary, the shift from traditional PRO instruments to ePRO can be smoothly facilitated by applying established best practices in design and relying on proven vendor solutions, reducing the need for rigorous validation in many cases.
