[P3–015]: THE IMPACT OF ELECTRONIC CLINICAL OUTCOME ASSESSMENTS (ECOA) ON ALZHEIMER's DISEASE CLINICAL TRIAL DATA QUALITY

Recommendations for the Electronic Migration and Implementation of Clinician-Reported Outcome Assessments in Clinical Trials

“…2,4,5 Advantages specific to electronic ClinRO (eClinRO) assessments include improved standardization among raters (ie, all raters are exposed to the same validation checks and administration reminders on the electronic device) and reduced calculation errors (eg, complex total scores can be automatically calculated). [6][7][8] Importantly, the full benefits of eClinRO assessments are realized when there is faithful migration from one mode of data collection to another (eg, from paper to an electronic format). Faithful migration was first defined in reference to migration of PRO measures to electronic platforms (electronic PRO [ePRO]), 9 and for ClinRO assessments, it means preserving the content and the psychometric properties of the original scale (ie, validated reference) such that the clinician completing the ClinRO assessment interprets and responds to the items the same way regardless of mode of data collection (eg, pen and paper vs tablet computer).…”

“…4,5,9,[10][11][12] These guidelines should include best practices for migrating ClinRO assessments (ie, the process by which ClinRO assessments are migrated to an electronic data collection mode) to an electronic platform and recommendations for additional evidence (including psychometric testing) when necessary (ie, whether evidence is required to support the adequacy of the electronic data collection mode). Although there remains a significant need for additional research, the limited literature and regulatory guidance on eClinRO assessments indicate that when migration best practices are followed, 10 the psychometric properties of eClinRO scales are preserved, 6 rater error rates decrease, 7,8 and there are fewer risks to data integrity. 2 It is likely that the literature establishing equivalence between paper and ePRO measures [13][14][15] is also applicable to ClinRO assessments, as long as the concept of "faithful migration," first defined for ePRO measures, 9 is adapted to ClinRO assessments.…”