Electronic patient-reported outcome

An electronic patient-reported outcome (ePRO) is a patient-reported outcome that is collected by electronic methods. ePRO methods are most commonly used in clinical trials, but they are also used elsewhere in health care. As a function of the regulatory process, a majority of ePRO questionnaires undergo the linguistic validation process.

The two main methods currently used for ePRO are computers/Smartphones and telephone systems

Computers are most often touch-screen devices, ranging from small hand-helds such as the Palm Pilot, through tablet PCs. The smaller devices are often used as electronic diaries, designed to be used for symptom reporting on a daily basis. Larger devices are generally used in a clinic setting. Computers generally run dedicated ePRO applications - the use of the web for ePRO is not yet widespread. Typically a single question at a time is presented on the screen, with a set of possible response options. The user taps on the appropriate response with finger or stylus, then moves on to the next questions.

Telephones normally use an interactive voice response system (IVR). The user calls into a dedicated phone line, and hears a spoken script which details the question, and the possible responses. Each response option is given a number, and the user presses the corresponding number key on the phone keypad to record the choice. IVR systems are more often used for diaries, with the patient phoning in e.g. from home, but they can be used in a clinic setting.

There are also a number of custom devices designed specifically for use as ePRO data collection devices.

Diaries are used when it is desirable to obtain frequent assessments over a period of time, for example when a condition fluctuates in severity. In such cases recall of severity over a period of time is unlikely to be accurate. Research has shown substantial bias in such summary recall, with ratings unduly influenced by how the patient is feeling at the time of making the rating, and by maximum severity rather than average severity during the assessment interval. Diaries can overcome this problem by recording severity either on a momentary basis ("How bad is your pain right now?") or by recall over short periods ("How bad has your pain been today?"). However, when diary data is collected on paper, it is not known when the ratings are actually made, and there is evidence that compliance may be quite poor. In one study, patients were given an instrumented paper diary that recorded covertly when it was opened. The study showed frequent cases of "back-filling", filling in a batch of entries some time, often days, after they were due, and even in some cases of "forward filling", completing entries before they were due.

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