The patient sees their own data (ePRO)

What the study shows the patient of their own data, the site's approval for each patient, what the patient sees and what is never shown.

Patients who see their own path stay in a study longer, and loss to follow-up is what ruins a registry. With My data the patient opens the personal ePRO link and sees their own values over time: a chart and the values with their dates. What is shown, to whom and when is decided by the study and by the investigator of the patient's site.

What the study chooses

Open ePRO and press Patients’ own data. The project administrator or a data manager switches the function on and picks up to six variables: numbers of forms filled at two visits or more (HbA1c, weight, blood pressure) and the scores of the patient's own questionnaires. Forms for the unblinded team and the forms of randomisation, study drug and drug accountability are never offered and never shown: nothing on the page reveals the treatment arm. The function is off until the study switches it on.

The investigator's approval for each patient

On the patient card, Show the patient their data is the investigator's decision for this patient, for example after a talk at the visit. Stop showing hides the page again. Both go to the audit trail. When the patient moves to another site, the approval is cleared: the new site decides again.

What the patient sees, and what never

• Only the values that are checked: the form is complete, no query on the value is open and, when the study has the data manager's approval, the form is approved. The patient's own questionnaire answers show at once: they are what the patient sent.
• The date of a value is the date on its form (the sample date of a lab test), else the date of the visit.
• One neutral colour, the patient's own values only: no reference range, no red or green for high or low, no comparison with other patients and no interpretation. A fixed note asks to discuss the values with the doctor. Explaining a value would be a medical opinion, and the page would become a medical device.
• Below, “How your data helps”: how many patients and sites take part (counts only) and how many questionnaires the patient has sent.

In the demo

In the diabetes and hypertension demos the data manager switches My data on before the launch (HbA1c, weight and the thirst score; office and home blood pressure), and the investigators approve it for half of the patients a couple of weeks after giving the link. Open such a patient's personal link from the patient card to see the page.