An electronic patient-reported outcome (ePRO), as the name implies are patient reported outcomes that are collected by electronically. ePRO methods are most commonly used in clinical trials, but are also used in other study designs such a cohort studies and patient registries. Patient self-reported data are playing an increasing role in the collection of clinical data and are particularly useful for collection of quality of life assessment questions, health scales and medical compliance monitoring. With new technologies, patients can easily self-complete forms and questionnaires though easy to use web interfaces that allow for efficient and accurate data collection.
ePRO offers a number of benefits compared to paper based data collection, including higher patient compliance compared to paper, better data quality and accuracy of study results, reduces missing data, data errors, and since the data can be entered in real-time at the time of an event, memory recall is reduced or eliminated. ePRO software also provides accurate data and time stamped information and allows investigator to review and monitor the self-completed data in real-times.
Dacima’s ePRO functionalities allow for the creation of a study database that can include both self-reported and traditional data collection forms so that some forms can be designed for collection by patient interviewer at the time of a patient follow-up visit. Forms that will be self-completed are simply flagged by the designer of the database and the system then automatically manages the forms that need to be self-completed, and displays them in a simplified interface that allows the patient to easily complete the questionnaires without the need for any training. The interface displays the questionnaires as a web survey type interface that allows the patient to easily navigate from page to page. If the questionnaires are divide into multiple forms the software automatically joins the forms sequentially giving the user a seamless experience without any complex navigation. In study designs that involve an interviewer collecting some of the data during the interviewing process, while other forms are meant for self completion, the study interviewer can, with the click of the mouse, activate the self-completion forms and then allow the patient to complete the ePRO forms on a tablet or computer. Dacima’s ePRO software also allows forms to be completed later, by sending an email with a web link which allows the patient to complete the forms at home. Integration with the web visit-scheduling feature even allows the ePRO forms to be scheduled for self-compeletion before the patients’ next follow-up visit. The system will automatically send patients email reminders to complete their questionnaire before their follow-up interview.
Dacima’s ePRO module is built on Dacima’s clinical EDC software engine so includes all the features of the Dacima Clinical Suite, including the complete audit trail and requirements of FDA 21 CRF Part 11. For studies that involve all collection of all data directly from patients, Dacima’s Survey software allows the all the questionnaires to be self completed.Like this article? Share it!