ESTABLISHING EQUIVALENCE OF ELECTRONIC CLINICIAN-REPORTED OUTCOME MEASURES

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Electronic administration of clinician-reported outcomes (eClinROs) has advantages over paper-based methods such as reduced missing data, reduced rates of transcription errors, and increased compliance. However, changing the modality of administration from paper to electronic has the potential to affect the validity of the scale. Clear FDA and EMA guidelines have been established for electronic data in clinical research and have minimized the debate regarding validation procedures. The ISPOR ePRO Task Force developed recommendations regarding establishing the measurement equivalence of electronic administration of patient reported outcomes (ePROs) to their paper versions. While ePROS are increasingly utilized in clinical research, dementia clinical research relies heavily on eClinROs. However, limited guidance and research is available demonstrating equivalence between an eClinRO and its paper equivalent. We propose a process for documentation and a route for establishing equivalence between paper and eClinROs based on processes for ePROs. The first step is to determine level of modification. The first 2 levels, functionality and instruction adaptation, are specific to eClinROs. The next three levels—minor, moderate, and substantial—are derived from the ISPOR Task Force recommendations for ePROs. The second step is to determine the 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/substantial changes, full psychometric evaluation. An important goal with eClinROs is to collect data that have equal or higher reliability than produced by the original paper scale. As there are no existing guidelines on establishing measurement equivalence, we have set forth guidance for documentation and a route for establishing equivalence of paper and eClinROs, based on FDA regulations for creation of PROs and ISPOR recommendations for equivalence evaluation for paper and ePROs. We have set forth initial best practice recommendations for documentation and a route for evaluating equivalence of paper and eClinROs. Further discussions with key stake holders are needed to fully define and reinforce best practice for all types of COAs (eClinRO, ePerfO, eObsRO), to identify areas of commonality and difference in equivalency evaluation.