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5. Patient Reported Outcomes (PROs, ePROs)
The term PRO (patient reported outcome) is used for all data that is directly provided by patients. This includes all types of questionnaires and diaries either in paper or electronic form. If an electronic hand-held system such as a tablet or text messaging (SMS) are used, it is called ePRO. Typically this electronic data is either in a daily diary form in the patient’s hands, or questionnaires administered during site visits.
In our rapidly developing electronic world the technical tools that can be utilised to receive this data in an efficient, patient-friendly manner are constantly evolving.
Advantages of ePRO
- Higher quality of data:
- Automated edit checks ensure PRO data is often 100% clean – no need for extensive data cleaning.
- Alarms and context-sensitive eDiary design achieves higher adherence to protocol.
- Immediate intervention possible when problems or deviations occur.
- Allows clinicians to concentrate on treating their patients - and spend less time on data entry.
Disadvantages of ePRO
- Greater technical effort and therefore more expensive than paper.
- Not all patients are familiar with modern technology.
- Like every electronic instrument there can be failures and break-downs.
- More time required for the site staff to explain the use of the system to the patient.
- Access to the internet needs to be available.