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Usability Testing: Steps Toward Ensuring Patient Inclusivity

Many Clinical Outcomes Assessments (COAs) are designed with the assumption that patients will complete the questionnaire in a printed paper format. To ensure patients are able to use a particular electronic application (app) to complete the same COA, and that the data collected is consistent with the paper version, we use additional types of testing. One of these testing varieties is Usability Testing (UT).

Usability Testing (UT) is a process which tests the device or application usability and functionality of electronic COA (eCOA) formats from the patient’s perspective. UT can be done to test a specific study device, or study application on a variety of devices. UT qualitatively demonstrates
that the content validity of a COA has been maintained during format migration, which can be requested or recommended in labeling claim applications with the FDA or the EMA.

In light of an increase in the use of eCOAs, it becomes increasingly important to ensure that the UT service offered by Language Service Providers (LSPs) is simple and effective and caters to the diverse patient population across the globe. Understanding issues in eCOA builds from a patient’s perspective helps strengthen the process of UT so that
potential issues can be avoided during the study, enabling the capture of well-calibrated quality data. The two articles in this e-book highlight two important aspects of the UT process- ensuring patient inclusivity and understanding common issues with eCOA designs directly from the patient experience.

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