Table 2.

Issues emerging from breakout groups requiring clarification and resolution before the Core Area model could be fully accepted.

DeathDeath may not be an outcome of interest
Should states worse than death be mentioned?
Life impactShould life impact be subdivided further?
Resource useWhat 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 manifestationsCan clinical signs (and sometimes symptoms) also indicate pathophysiological status?
Need to be flexible about how this is defined
Contextual factorsCan 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 issuesCan 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 issuesDifference 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