Introduction:
Patient-Reported Outcome (PRO) data collection has taken a digital leap forward, becoming a pivotal part of contemporary clinical trials and patient care. As technology advances, more clinical studies are leaning towards electronic platforms like smartphones and tablets for data collection in both field-based and in-clinic scenarios.
Trend Drivers:
- Ubiquity of Modern Devices: The widespread availability, affordability, and reliability of contemporary mobile devices have facilitated this shift.
- Quality Assurance: The need to ensure data’s integrity, timeliness, and quality is paramount.
- Patient-Centric Approach: The growing desire to enhance trial participation convenience has led to the exploration of BYOD (Bring Your Own Device) approaches. This not only improves patient-reported outcome measure (PROM) completion rates but might also curtail implementation costs.
The Transition Challenge:
A significant portion of PROMs was originally conceptualized and authenticated in paper format. As they transition to digital, it’s crucial to maintain the instrument’s measurement properties. Some of the routine modifications while transitioning include:
- Formatting Changes: For instance, featuring only one question per screen.
- Terminology Updates: Modifying instructions from “tick” or “circle” (for paper) to “select” for digital platforms.
- Display Alterations: Adjusting the orientation of response choices, like shifting from a horizontal list on paper to a vertical one on a device screen.
Conclusion:
As the healthcare landscape continues to evolve, ensuring that these electronic adaptations of PROMs remain equivalent to their original paper versions is crucial. The goal is to maintain the accuracy and reliability of data, making healthcare more adaptable, efficient, and patient-friendly.
