Death | Death may not be an outcome of interest |
Should states worse than death be mentioned? |
Life impact | Should life impact be subdivided further? |
Resource use | What does “resource use” mean? |
Are there any surrogates? |
What point of view is considered (patient, health system, society)? |
Will measurement of resource use be impractical in many trials? |
Pathophysiological manifestations | Can clinical signs (and sometimes symptoms) also indicate pathophysiological status? |
Need to be flexible about how this is defined |
Contextual factors | Can we better define what these contextual factors are? |
Can we provide a list? |
Can we better distinguish between factors? |
Who decides what is required? |
Some general issues | Can we provide more concrete examples? |
Are adverse effects a core area in themselves? |
Difference between domains and instruments unclear |
Will instruments crossing domains be a problem? |
Process issues | Difference between core areas and primary and secondary outcomes |
Does core set development come to a stop if one or more core domains does not have a validated instrument? |
There should be provision for updating or revision of core outcome sets as further data accumulate |