Supporting Evidence for Electronic and Paper Diary Equivalence

Supporting Evidence for Electronic and Paper Diary Equivalence

When electronic Patient Reported Outcomes (ePRO) or electronic patient diaries became an option for clinical data collection over a decade ago, they introduced a few challenges as any novel method in a highly regulated environment such as clinical investigations. One of the most important is the equivalence in data collected on paper and electronically.

Among efforts to study equivalence, the most notable is a study done by the ISPOR Taskforce published in 2009. A recent meta analysis by Muehlhausen et al. (2015) provides additional support for ISPOR Taskforce’s conclusion that quantitative equivalence studies are not necessary for migrating questionnaires with changes classified as minor in their paper. Minor changes include placing a paper and pencil questionnaire into electronic patient diary format without significantly altering content, the response options or recall period, changing the number of questions that display on a screen, and minor wording changes such as going from “mark an option” to “select an option”. The majority of changes when switching from paper format to electronic patient diaries fall into this category.

This data is reassuring for sponsors and researchers that are utilizing ISPOR Taskforce’s best practices for questionnaire migration to electronic devices such as smartphones, tablets, computers, etc.