ePROs have increasingly been adopted mainly by industry researchers seeking to benefit from the significant advantages associated with their use. As ePROs continue to gain momentum, HPR will help users by providing clear instructions for the migration of our questionnaires from traditional paper and pen to online or handheld devices.
ePRO users are required by Health Authorities to provide evidence supporting comparability or measurement equivalence between electronic and traditional measures, and this can entail additional work on the part of sponsors to ensure that this is achieved successfully. A substantial amount of research has been undertaken in order to establish the equivalence of properly adapted questionnaires.
Evidence for measurement equivalence between paper-based and electronic questionnaires can be generated through a combination of different methodologies, including
- review of screenshots,
- usability testing
- equivalence testing.
Failure to follow these critical steps may lead to:
- less than accurate translation of the user interface or instructions,
- errors in layout ranging from repeating items,
- missing an item altogether
- mixing up response options,
- ergonomic problems (translated text being too long or large and not fitting completely in the designated space).
Though using ePRO will initially cost more than using paper questionnaires, significant savings will be made without the need for physical distribution, missing data handling etc., and there are many other advantages of ePRO over paper e.g.
- accuracy and integrity of the data collected,
- real-time availability of data,
- time saving through electronic data capture
- higher compliance and engagement of patients.
ePRO licensing with HPR:
- It is unlikely that individuals who request a licence will have the resources to pay for ePRO adaptation and probably won't have the need anyway, as his or her study will be localised and small-scale. Therefore student/individual licensees are offered only paper questionnaires.
- Non-commercial licensees must contract with our preferred coordinator for ePRO adaptation services. You may be able to use your own IT resources to do the actual programming, or you may wish to use a specialist IT company. In either case, the ePRO coordinator will be responsible for the overall process, including screenshots-checking (mandatory step), usability and equivalence testing (if needed) and distribution.
- Commercial licensees may use our preferred coordinator for ePRO adaptation services or they may have their own arrangements. We will discuss your specific ePRO requirements as part of the licensing process.
For more specific information please contact firstname.lastname@example.org