electronic Patient Reported Outcomes

ISPOR have recently published guidelines on the validation of ePRO systems.  They highlight and describe 8 essential components of the validation process.  These being:

1. System requirements
2. System design
3. Coding/tailoring/software development
4. Testing by system provider
5. Traceability
6. UAT
7. Installation/configuration management
8. Decommissioning plan

The guidelines do not, however, get into the tricky business of whether the e-version of PROMs get the same results as the paper version, how best to get patients to complete, respond, collect folow-up data etc., or whether there are any specific validation issues relating to ePROs.

HEDS are developing a programme of research that covers these topics.  Contact Professor John Brazier or Dr Georgina Jones for further details.