By Melissa Mooney, Director, Ecoa Solutions Engineering, Ecoa Technologies, and Stephanie Philpott, Scientific Manager, Patient Centered Solutions, Real World Solutions
When clinical studies began collecting patient-reported outcomes, most of the instruments used for documentation were designed and validated in a paper format. As technology has progressed, however, the use of electronic modes for gathering PRO data has both improved the quality, reduced the loss of data, and minimized inconveniences for study participants.1
Due to these process improvements, there has been an uptick of interest in the utilization of electronic solutions for PRO data (ePRO) collection in clinical trials. The adoption of ePRO has been further encouraged by regulators and other health organizations as well.2-4
Oftentimes PRO instruments originally designed in a paper format will require some redesign for administration in an electronic solution, and it cannot necessarily be assumed that the PRO instrument will retain the same level of content validity and/or psychometric measurement properties in its new format. This white paper addresses how equivalency can be achieved when migrating PROs from paper to electronic format.