The use of electronic devices to collect clinician-reported outcome (ClinRO) measures is rapidly increasing worldwide. With industry moving toward electronic data collection, creating clear guidelines on the recommended approach for establishing equivalence between the electronic version of a clinician-administered measure and the paper version is of utmost importance. Current proposals regarding a standardized approach are based on the existing recommendations created for electronic PROs. Establishing a standardized electronic clinician-reported outcome (eClinRO) measure provides many benefits including: eliminating duplication of data, reducing the likelihood of transcription errors, enabling real-time access for data review, and ensuring accurate and complete data collection.
As part of a large industry-sponsored study, Bracket set out to establish a method for establishing the equivalence of a ClinRO and its electronic version. As adoption of electronic Clinical Outcomes Assessments (eCOA) increases, the process of establishing equivalence is critical. Bracket collaborated with the sponsor to define such a process. In this article, those methods are detailed.
One important finding when migrating a ClinRO to an electronic version is the need for measurement equivalence testing:
“…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.”
The full article is available on the Therapeutic Innovation & Regulatory Science website.
FULL CITATION: Establishing Equivalence of Electronic Clinician-Reported Outcome Measures. Therapeutic Innovation & Regulatory Science. 2015 December. doi: 10.1177/2168479015618693. Epub 2015 Dec 10.
JOURNAL: Therapeutic Innovation & Regulatory Science
AUTHORS: Fuller, RM, McNamara, CW, Lenderking, WR, Edgar, C, Rylands, A, Feaster, T, Sabatino, D, Miller, DS.