Refining Patient Reported Outcomes
Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures, November, 2008
Summary: The article presents recommendations from ISPOR’s ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or equivalence, of ePROs to the paper-based PRO measures from which they were adapted. It provides a general framework for decisions regarding the level of evidence needed to support modifications that are made to PRO measures when they are migrated from paper to ePRO devices in accordance with the current U.S FDA’s Draft Guidance on PROs in Clinical Research.