Scenario* | Population | Intervention | Example title of COS | Example title of guidance document | Regulator |
A | COS is narrower | COS is narrower | How to evaluate the clinical outcome of joint-preserving treatment for osteonecrosis of the femoral head: development of a core outcome set | Guideline on clinical investigation of medicinal products used in the treatment of osteoarthritis | EMA |
B | COS is narrower | Exact match | None | None | N/A |
C | COS is narrower | COS is broader | Selecting Core Outcomes for Randomised Effectiveness trials In Type 2 diabetes (SCORE-IT): a patient and healthcare professional consensus on a core outcome set for type two diabetes | Guideline on clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus | EMA |
E | Exact match | COS is narrower | None | None | N/A |
F | Exact match | Exact match | Achieving consensus on minimum data items (including core outcome domains) for a longitudinal observational cohort study in rheumatoid arthritis | Clinical development programmes for drugs, devices, and biological products for the treatment of rheumatoid arthritis | FDA |
G | Exact match | COS is broader | Toward establishing core outcome domains for trials in kidney transplantation: report of the standardised outcomes in nephrology-kidney transplantation consensus workshops | Delayed graft function in kidney transplantation: developing drugs for prevention | FDA |
I | COS is broader | COS is narrower | None | None | N/A |
J | COS is broader | Exact match | None | None | N/A |
K | COS is broader | COS is broader | Chronic rhinosinusitis outcome Measures (CHROME) – developing a core outcome set for trials of interventions in chronic rhinosinusitis | Non-allergic rhinitis: developing drug products for treatment | FDA |
COS=core outcome set; EMA=European Medicines Agency; FDA=US Food and Drug Administration; N/A=not applicable.
*Letters relate to those in figure 1, top panel.