Electronic Patient-Reported Outcome (ePRO) Measure

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An Electronic Patient-Reported Outcome (ePRO) Measure is a PRO instrument that is an electronic survey.



References

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  • (Coonsoel et al., 2009) ⇒ Stephen J. Coonsoel, Chad J. Gwaltney, Ron D. Hays, J. Jason Lundy, Jeff A. Sloan, Dennis A. Revicki, William R. Lenderking, David Cella, and Ethan Basch. (2009). “Recommendations on Evidence Needed to Support Measurement Equivalence Between Electronic and Paper‐based Patient‐reported Outcome (PRO) Measures: ISPOR EPRO Good Research Practices Task Force Report.” Value in Health 12, no. 4
    • QUOTE:
      • Background: Patient-reported outcomes (PROs) are the consequences of disease and/or its treatment as reported by the patient. The importance of PRO measures in clinical trials for new drugs, biological agents, and devices was underscored by the release of the US Food and Drug Administration's draft guidance for industry titled “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.” The intent of the guidance was to describe how the FDA will evaluate the appropriateness and adequacy of PRO measures used as effectiveness end points in clinical trials. In response to the expressed need of ISPOR members for further clarification of several aspects of the draft guidance, ISPOR's Health Science Policy Council created three task forces, one of which was charged with addressing the implications of the draft guidance for the collection of PRO data using electronic data capture modes of administration (ePRO). The objective of this report is to present recommendations from ISPOR's ePRO Good Research Practices Task Force regarding the evidence necessary to support the comparability, or measurement equivalence, of ePROs to the paper-based PRO measures from which they were adapted.
      • Conclusions: The electronic administration of PRO measures offers many advantages over paper administration. We provide 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. The key issues include: 1) the determination of the extent of modification required to administer the PRO on the ePRO device and 2) the selection and implementation of an effective strategy for testing the measurement equivalence of the two modes of administration. We hope that these good research practice recommendations provide a path forward for researchers interested in migrating PRO measures to electronic data collection platforms.