Electronic patient-reported outcome measures (ePROs) provide a novel method of measure administration. ePROs are designed to capture a greater volume of patient data with savings in costs and time associated with traditional data collection techniques. However, many assumptions are made about the validity of such an approach and whether it produces results that are comparable with the traditional method of administering questionnaires.
Galen has witnessed the growing interest in ePROs due to the steady increase in demand for electronic versions of our existing measures. The team at Galen has over 20 years expertise in developing and validating PROs and has established a considerable anthology of internationally recognised PROs covering over 30 diseases. Galen are employing this expertise, and the same dedication that has made them world renowned, in developing new ePROs and adapting existing pen and paper measures to electronic format.
Our team at Galen can advise and share their expertise in the design and development of new ePROs. Our services also include adapting existing PROs to ePROs. Such work requires evaluation of the equivalence of different methods of administration using Rasch analysis and assessing the psychometric properties of the new electronic format.
One of our newest measures, the PRIMUS, has recently been successfully validated for electronic administration. The RGHQoL (for patients with recurrent genital herpes) has also been successfully administered by internet. We are also in the process of converting and assessing a number of our existing measures for electronic administration.
In order to retain the high quality of our measures certain procedures are required for electronic administration that is likely to provide equivalent data to the original pen and paper format. Where electronic versions of GR PROs are developed these should be formatted as closely as possible to the original:
- Scaling and psychometric properties (including reliability, construct validity and responsiveness) of the electronic version must be established before the measure can be used in a clinical study.
- For new measures where it is intended to administer the PRO electronically, it is essential to validate a paper and pen version parallel to the electronic version.
Sponsors must also assign the copyright of the electronic versions of our measures to GR. We welcome enquiries to work collaboratively in developing new ePROs and validating existing PROs for electronic administration. Please contact us to find out which of our measures are available in ePRO format.