Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats: A Review of Evidence and Recommendations for Clinical Trials and Bring Your Own Device

Therapeutic Innovation & Regulatory Science
Bill ByromWillie Muehlhausen

Abstract

A growing number of clinical trials employ electronic media, in particular smartphones and tablets, to collect patient-reported outcome data. This is driven by the ubiquity of the technology, and an increased awareness of associated improvements in data integrity, quality and timeliness. Despite this, there remains a lingering question relating to the measurement equivalence of an instrument when migrated from paper to a screen-based format. As a result, researchers often must provide evidence demonstrating the measurement equivalence of paper and electronic versions, such as that recommended by the ISPOR ePRO Good Research Practices Task Force. In the last decade, a considerable body of work has emerged that overwhelmingly supports the measurement equivalence of instruments using screen-based electronic formats. Our review of key works derives recommendations on evidence needed to support electronic implementation. We recommend application of best practice recommendations is sufficient to conclude measurement equivalence with paper PROMs. In addition, we recommend that previous usability evidence in a representative group is sufficient, as opposed to per-study testing. Further, we conclude that this also applies to studies usi...Continue Reading

References

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Apr 3, 2008·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Chad J GwaltneySaul Shiffman
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Feb 24, 2015·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Niloufar CampbellSam S Salek
Jan 7, 2018·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Willie MuehlhausenJeremy Sohn
May 14, 2018·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Bill ByromMarie McCarthy
Nov 1, 2015·Therapeutic Innovation & Regulatory Science·Chad GwaltneyJennifer Ross

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Citations

Jul 21, 2020·Circulation. Cardiovascular Quality and Outcomes·John J WarnerUNKNOWN American Heart Association Partnering with Regulators Learning Collaborative*
Jan 16, 2020·Journal of Medical Internet Research·Sarah M GooddayJohn Geddes
Nov 5, 2020·Pharmacoepidemiology and Drug Safety·Alison BourkeDorothee B Bartels
Jan 5, 2021·JMIR Perioperative Medicine·Jill MeirteUlrike Van Daele
Feb 26, 2021·Quality of Life Research : an International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation·Kevin P Weinfurt

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