ePRO

PRO (patient reported outcomes) or COA (clinical outcomes assessment) are data that are documented directly by the subjects and that describe their personal well-being. They are recorded using so-called quality of life questionnaires or diaries. If the data is collected electronically this is referred to as ePRO or eCOA.

The well-being of the subjects is coming more and more into the focus of sponsors and thus frequently serves as a primary or secondary endpoint of clinical trials. Using ePRO solutions has many advantages over capturing PRO data on paper. On the one hand, the labor-intensive and error-prone process of transferring paper to a database is eliminated. On the other hand, the subjects’ compliance is higher for a number of reasons: by the help of targeted reminders they are supported to enter data regularly and on time. In addition, answering the questions on a device is perceived as a more private situation compared to answering questionnaires on paper as the completed questionnaires are not handed out to the attending staff, but sent to the database directly. So all in all, the use of ePRO solutions increases data quality enormously.

With our products, we simultaneously serve customers who want to capture ePROs on the private devices of the subjects (BYOD, bring your own device) or those who want to equip subjects with devices on which the data collection is to be carried out (provisioned mode). Both modes have several advantages and disadvantages that should be taken into consideration.

The app LinkPRO is a native app that is installed on a mobile device (smartphone or tablet). It is available to the subjects through the Android and iOS app stores and can be downloaded directly to their personal devices. After a successful installation, subject registers by entering the study data and his personal user credentials. Now the configuration for the study is loaded and the subject can personalize the app by i. e. setting the language. Now the app is configured and the subject can start documentation. If specified, the subject is reminded of data entry by in-app alerts. The subject can document online or offline, the data is stored encrypted on the device. Once internet access has been established, the stored data is automatically sent to the eCRF. If it becomes necessary to change a questionnaire or a diary due to an amendment, this is possible without any action required from the subject. The configuration is checked regularly and updated if necessary as soon as internet access is available.

Our ePRO browser application enables patients to directly access the eCRF via browser with a straight forward graphical user interface. The extension introduces full flexibility with the possibility to assign groups of patients to different questionnaire sequences and to show sets of questions only for specific reporting time points. The data manager is enabled to overview patient’s progress and to manage patient’s access to the questionnaires.