Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments

This article provides guidance on the circumstances under which allowing a subject to opt out of responding to ePRO items may be appropriate. Three main scenarios are discussed: (1) requiring subjects to complete all items in all the instruments in the study, (2) allowing subjects to opt out of at least some selective items that do not support key primary or secondary endpoints, and (3) allowing subjects to opt out of responding to any or all items in the study. For either of the 2 scenarios allowing the subject to opt out of responding to an item, the use of programmed edit checks is highly recommended to confirm that the subject intended to "skip" or "opt out of" the item. This ensures that, at the end of the study, the database contains an explicit data point indicating when a subject has actively decided to skip an item. While this article is focused on patient-reported outcomes, the issues raised could also apply to other clinical outcome assessments, such as clinician- and observer-reported outcomes.

Source: Therapeutic Innovation and Regulatory Science - October 21, 2015 Category: Drugs & Pharmacology Authors: O'Donohoe, P., Lundy, J. J., Gnanasakthy, A., Greene, A., on behalf of the Patient-Reported Outcome (PRO) Consortium and the ePRO Consortium at the Critical Path Institute Tags: Special Section on Clinical Outcome Assessments Source Type: research