Establishing Equivalence of Electronic Clinician-Reported Outcome Measures. (January 2016)

• Record Type: Journal Article
• Authors: Fuller, Rebecca L. M.; McNamara, Cynthia W.; Lenderking, William R.; Edgar, Chris; Rylands, Angela; Feaster, Todd; Sabatino, Donald; Miller, David S.
• Is Part Of: Therapeutic innovation & regulatory science. Volume 50:Number 1(2016:Jan.)
• Page Start: 30
• Page End: 36
• Publication Date: 2016-01
• Subjects: clinical outcome assessments (COAs) -- clinician-reported outcomes (ClinROs) -- ePROs -- validity -- equivalence; Drugs -- Periodicals; Pharmacology -- Periodicals; Drugs -- Research -- Periodicals; Drugs -- Testing -- Periodicals; 615.1
• DOI: 10.1177/2168479015618693
• Languages: English
• ISSNs: 2168-4790

Abstract

Background: Electronic administration of clinician-reported outcomes (eClinROs) has advantages over paper-based methods, but the mode of administration change has the potential to affect the validity of the scale. The literature on migration of patient-reported outcomes (PROs) suggests that there are different levels of modification, which necessitate different approaches to demonstrating mode equivalence. However, little has been written on the migration of ClinROs to electronic administration. Methods: We propose a method of comparing paper and electronic versions of scales that includes a comparison based on content and a comparison based on format. The determination of whether the eClinRO has undergone minor, moderate, or substantial modification will drive the necessary studies required for validation. Results: The unique characteristics of ClinROs suggest 2 additional types of modifications, including functionality adaptation and adaptation of instructions. Conclusions: In many respects, the migration of a ClinRO to electronic administration is similar to that of a PRO. This article has explored the ways in which there might be special considerations for ClinROs that have not been elaborated for PROs.