New insights into equivalence testing methodology and implications for BYOD

Date
Time 16:00 - 17:00
Location Webinar
Timezone Europe/London

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Overview

In this webinar, we review the accumulating evidence to support measurement equivalence of instruments when migrated to ePRO. We review meta analyses of published quantitative equivalence studies, and a newly published meta synthesis of unpublished cognitive interview studies on over 100 instruments performed by ICON.

These meta analyses provide strong evidence that the measurement properties of instrument migrations that follow ePRO design best practice are unaffected by migration from paper to electronic formats, and provide greater insights to the definition of migration best practice.

While this provides support for the use of bring your own device (BYOD) where instrument properties on mobile device models cannot be tested a priori, we also present new results from the industry’s first definitive BYOD quantitative equivalence study, where we assessed instrument measurement properties between paper, BYOD and provisioned devices. We will propose how the results of this study can be generalized to provide support for the use of BYOD in regulatory submission studies.

Because many PRO instruments were developed and validated on paper, care is needed when migrating them to electronic formats (ePRO) to ensure the measurement properties of the instrument are unchanged, and that the electronic version is easy to use in the target group of patients.

In 2009, the ISPOR ePRO Good Research Practices Task Force published recommendations on the evidence needed to support measurement equivalence when migrating from paper to electronic formats, which included cognitive interview and usability testing (minor modifications due to migration) and quantitative equivalence studies (moderate changes).

These recommendations have been largely adopted by the industry and regulators. However, over the 8 years since their publication, accumulating evidence has indicated that instrument measurement properties are generally well conserved when instruments are migrated to electronic forms where ePRO design best practice is followed. Does this mean that a qualitative or quantitative study may not always be needed when implementing ePRO?

Target audience

  • Professionals working in the field of Outcomes Research e.g. PRO, ePRO, eCOA, COA.
  • Pharmaceutical clinical development.
  • All instrument authors and license holders