WHEN DO WE HAVE ENOUGH EVIDENCE TO ACCEPT MIGRATION OF PATIENT-REPORTED OUTCOME MEASURES (PROMS) FROM PAPER TO SCREEN-BASED FORMATS WITHOUT ADDITIONAL TESTING?
Author(s)
Bill Byrom, B.Sc., Ph.D., Vice President of Product Strategy and Innovation, CRF Health, London, United Kingdom
Presentation Documents
PURPOSE: To review key publications exploring measurement equivalence between PROMs on paper and electronic formats and to identify whether there are cases where this body of work may be sufficient to support migration without the need for additional study-specific testing. If these cases exist, we will explore how to present appropriate evidence of faithful migration.
DESCRIPTION: A growing number of clinical trials employ electronic modes, in particular smartphones and tablets, to collect PROM data. Care is required when migrating from paper to electronic modes in order to preserve the instrument’s measurement properties. Ensuring measurement equivalence when migrating PROMs is an essential step in the use of electronic data collection. As a result, for use in regulatory submissions, researchers often must provide evidence demonstrating the measurement equivalence between paper and electronic formats. Qualitative and/or quantitative studies are routinely performed to demonstrate evidence of measurement equivalence, in line with recommendations from the ISPOR Electronic Patient-Reported Outcome (ePRO) Good Research Practices Task Force (Coons et al. 2009). Since the publication of those recommendations, there has been a growing body of published work supporting the preservation of measurement properties when migrating a PROM to an electronic screen-based format when following ePRO design best practices such as the ePRO Consortium recommendations. Through presentation and audience discussion the workshop will review the key works concerning ePRO measurement equivalence and, where appropriate, identify case examples where existing evidence is sufficient and case examples where additional testing is recommended. The workshop will further explore pragmatic approaches to demonstrating faithful migration which may help to drive quality and reduce timelines for ePRO implementation.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Code
W20
Topic
Patient-Centered Research, Study Approaches