Table 2.

Description of core area outlined in OMERACT Filter 2.0 [33–35]

Core Area	Description
Death	Includes possible specifications of death, such as generic or disease-specific (all-cause versus disease-specific mortality), and intervention-specific (for example, death due to surgery)
Life impact	Can include domains such as activity and participation and domains within the concept of health-related quality of life such as functional status, general health perceptions, and overall quality of life
Resource use/economic impact	Economic impact of health conditions on both society and the individual
Pathophysiological manifestations	This core area is meant to assess whether or not the effect of the intervention specifically targets the pathophysiology of the health condition and may include psychosocial manifestations. Example domains include: body function, reversible manifestations (including modifiable risk factors and actual manifestations of ill health), and irreversible manifestations (including non-modifiable risk factors and damage). This can also include biomarkers and surrogate outcomes