What is a PRO?
Patient-reported outcomes (PROs) are any reports directly from patients on their health, condition, etc. without any input from their doctors, family, friends or other individuals. PRO is a blanket term relating to single or multidimensional aspects of patients’ symptoms, health, quality of life, treatment satisfaction, medication adherence, etc. PROs are often recorded in clinical trials, using validated instruments (PROMs) to measure the impact of the intervention as perceived by the patient.
When and why do you need to validate PROs?
PROs need to be validated early on during their development (e.g. through cognitive interviewing with a small patient sample) and later on during the final stages of their development with a larger sample. PROs need to be validated again if they are to be used with a different patient population to that which they were originally developed for and validated with. PROs also need to be validated if you are migrating them from a validated paper format to an electronic format, depending on the extent of the changes.
How can we help you?
YHEC’s outcomes research team can run cognitive interviews with patients to assist in early stage development of a PRO. The team can also perform cross cultural validation of a measure for multinational clinical trials using Rasch analysis. We can migrate paper PROs to electronic format and perform the subsequent validation work. Working with our colleagues within the University of York, we also offer a service for routinely administering PROs electronically (for example, within a trial or longitudinal study) and analysing the data collected.