Sponsor companies are increasingly required to employ methods for patient-reported outcomes (PROs) that ensure timely, accurate and attributable data collection, as well as to improve patient compliance. In many drug trials, electronic patient-reported outcome (ePRO) systems, particularly electronic diaries (eDiaries), have been shown to be an effective and superior method of driving patient compliance when compared to paper-based methods. ePRO systems can be set up for real-time completion, eliminating errors or bias due to patient recall. The quick availability of data allows sponsors to track compliance closely and intervene with remediation measures when required. ePRO can also be used whether data is being reported by patients themselves or by their care-givers, such as in the cases of pediatric studies, and when studying diseases with severe motor symptoms or cognitive impairment.
A common misconception is that eDiaries would be too complex or time-consuming for some patients (for example elderly) or their care-givers to use for PRO data collection, resulting in poor patient and protocol compliance.
Metrics-based ePRO vendors that measure patient compliance-to-protocol tell a different story; the elderly are actually one of the most compliant groups, with an average of 92% compliance, whereas the presumably most ‘tech-savvy’ groups of teenagers and adults have the lowest compliance rates, implying little correlation between technical expertise and ePRO compliance.