When the App Is the Barrier

Part of Decentralized Trials (DCT) Training: ePRO and Participant-Entered Data.

About 2 minutes. Free, in your language, no account needed.

Missing data is often a usability problem

Before concluding that a participant is non-adherent, find out whether the system is usable for them.

Notifications turned off, an app that logs out nightly, a phone that cannot run the version, a screen too small to read, a language they do not read well.

Ask about the mechanics

"Are the reminders coming through?" and "show me what you see when you open it" surface more than any compliance report.

Participants often assume the difficulty is their fault and do not mention it.

Digital access is unevenly distributed

Data allowances, shared devices, patchy connectivity, and low confidence with technology are real and unevenly spread.

A decentralized design that quietly excludes those participants produces a dataset that represents the people who found it easy. That is a bias, and it usually runs along the same lines as every other health inequity.

Escalate barriers as study issues

One participant struggling is support. Six participants with the same problem is a design fault that the sponsor needs to hear about while there is still time to fix it.

Report the pattern.

Know the alternatives that exist

Paper diaries, telephone entry, a provisioned device. Most studies have a route and not everybody knows it.

Offering it is not a favor. It is what keeps the participant in the study and their data in the dataset.

Record why data is missing

"Participant unable to access the app between 1 and 14 March; provisioned device issued 15 March" turns an unexplained gap into an explained one.

The analysis treats those differently, and it should.

Do not read burden as disinterest

Somebody completing three diaries a day, wearing a device and attending remote visits is carrying a lot. Falling behind is not a character judgment, and treating it as one loses participants.