There have been a number of significant scientific and regulatory milestones driving the adoption of electronic patient-reported outcomes (ePRO) in clinical trials since the first screen-based ePRO solution, Minidoc, appeared in 1980. The work by Arthur Stone and colleagues in 2002 provided clear evidence of the so-called “parking lot effect”—patients completing missing entries in their paper diaries while waiting for their clinic appointment . Their study used a paper diary booklet containing a light sensor which enabled the times of entries written in the paper diary to be compared to those identified by the opening and closing of the booklet. The apparent completion compliance was 90%, but based on the sensor data the parking-lot effect brought this down to 11%—with 2 patients of the 40 studied completing entries in the 3-week diary prospectively.
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