The health outcome definition by clinicaltrials.gov has been adopted by the two University of Waterloo Research Ethics Boards (REBs) with a slight modification to the wording to more clearly explain the effects of an intervention on health outcome. The definition the REBs will use to define health outcomes is: “A planned measurement described in the study protocol that is used to determine a change in health status as a result of interventions on participants in a clinical trial.”
Health outcomes measured in a clinical trial need to involve these three key elements:
- A change in health status (or no change in health status if that is a study objective).
- The outcome is the result of a health intervention such that there is a before and after assessment (i.e., a pre- and post-)
- The health outcome is an actual measured component of the study (i.e., outcome measures are described in the methods section of the protocol) and not something that is listed as a futuristic benefit.