ESTABLISHING EQUIVALENCE OF ELECTRONIC CLINICIAN-REPORTED OUTCOME MEASURES
Author(s)
Feaster T1, Fuller R1, Mcnamara CW2, Lenderking WR3, Miller DS1, Sabatino D4, Butler A5
1Bracket, wayne, PA, USA, 2Cronos CCS, Lambertville, NJ, USA, 3Evidera, Lexington, MA, USA, 4Merck, Upper Gwynedd, PA, USA, 5Bracket, Wayne, PA, USA
OBJECTIVES: The purpose of this research is to propose recommendations to industry regarding a method to establish the evidence required to support measurement equivalence between electronic and paper-based Clinician-Reported Outcomes, based on the existing recommendations created for electronic Patient-Reported Outcomes. 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 proposed process for the documentation and the route for establishing equivalence between paper and electronic versions of ClinROs is based on the process for the documentation of ePROs. The first step is to determine the level of modification. The second step of the process for the documentation and the route for establishing equivalence between paper and eClinRO measures is to determine the level of evidence needed to support the validity of the changes. These include cognitive debriefing, usability testing, equivalence testing, and in the case of new scale development, full psychometric evaluation. CONCLUSIONS: This research has established recommendations for ClinROs in which rating scales are used based on direct observation of the patient or based on clinical judgment derived from an interview with the patient, or in some cases the caregiver. The majority of these eClinROs which are migrated will entail functionality and instruction adaptation or minor modifications. As a result, scale comparisons will typically require cognitive debriefing or usability testing to document the similarities between the 2 versions of the scale and thereby provide evidence to support the equivalence of the 2 versions.
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Value in Health, Vol. 19, No. 3 (May 2016)
Code
PRM22
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
Neurological Disorders