How to collect patient-reported outcomes with ePRO

ePRO, electronic patient-reported outcomes, means patients answer study questionnaires on a phone, tablet or computer instead of a paper diary. You set it up by choosing validated instruments, moving them to an electronic format without changing what they measure, and scheduling each questionnaire from the protocol. Done well, you get dated answers, fewer missing entries and no transcription.

Why electronic beats paper diaries

A paper diary cannot tell you when the patient filled it in. Patients who catch up in the waiting room produce "parking lot" data that regulators distrust. An electronic questionnaire records the time of each answer and closes when its window ends.

How to set up ePRO in 7 steps

1. Pick the instruments. Take validated questionnaires where they exist, such as the EQ-5D or a disease-specific scale, and check the licence terms.
2. Migrate them with care. Keep the wording, answer options and recall period. Document that the electronic version measures the same thing as the paper original.
3. Write the schedule. For each questionnaire, set when it opens, how often it repeats, the time of day and how long the patient has to answer.
4. Choose the devices. Patients' own phones (BYOD) cost less and fit everyday life. Provisioned devices suit patients without a smartphone or instruments that need a fixed screen size.
5. Set the invitations and reminders. Invite by email, SMS or QR code, and remind patients who have not answered on the same channel.
6. Test with patients. Ask a few people from the target population to complete the questionnaires and fix what confuses them.
7. Monitor compliance. Follow completion by site and patient every week and call the sites whose patients fall behind.

Mistakes to avoid

• Rewording a validated instrument. A "clearer" question can break the validation. Ask the instrument owner before you change a word.
• Too many questionnaires. Patients drop out when the burden grows. Collect what the endpoints need.
• No plan for lost phones or new numbers. Decide how the site sends a fresh invitation without creating a new patient.

ePRO in Datacapt

Datacapt ePRO runs on mobile, tablet and desktop with nothing to install, in more than 85 languages. You build questionnaires with scales, dates, scores and conditional logic, reuse licensed instruments with their scoring in place, and set when each one opens and repeats per patient and visit. Datacapt reminds patients who have not answered by email or SMS, and a dashboard shows which questionnaires are open, late or done across every site. The answers sit in the same study, on the same patients, as your eCRF.

Keep reading

• What is ePRO and what is its role in clinical trials?
• eCOA vs ePRO
• Datacapt ePRO