a broad aspect of health or a health condition that must be measured to properly assess the effects of a health intervention. Each Core Area consists of more specific outcome domains and plays a distinct role in capturing the full impact of an intervention. Collectively, the Core Areas represent the entire “universe” of concepts that could be measured to understand the effects of an intervention.
There are four universally recognized Core Areas that every Core Outcome Domain Set (CODS) — and ultimately every Core Outcome Set (COS) — should address:
1. Death/Lifespan
2. Life Impact
3. Pathophysiological Manifestations (Manifestations/Abnormalities)
4. Resource Use/Economic Impact (Societal/Resource Use)
Example
When developing a Core Outcome Set for rheumatoid arthritis, the working group ensures that all four Core Areas are represented:
Death/Lifespan: Mortality during long-term follow-up.
Life Impact: Patient-reported pain, fatigue, and quality of life.
Pathophysiological Manifestations: Joint swelling and inflammatory biomarkers.
Resource Use/Economic Impact: Costs related to medications, hospitalizations, and lost productivity.
This guarantees that the Core Outcome Set captures not just clinical signs but also the full impact of the disease and its treatment on patients and society.