Table 1 OMERACT Filter 2.0 framework: core areas to be considered for outcome measurement in health intervention studies (adapted from Boers et al. [9])

Death

This core area includes possible specifications of death, such as generic or disease-specific (all causes versus disease-specific mortality), and intervention-specific (for example, death due to surgery).

Life impact

This core area can include domains of the International Classification of Functioning, Disability and Health (ICF) (such as activity and participation) and domains for health-related quality of life (such as functional status, general health perceptions and overall quality of life).

Resource use and economic impact

This core area describes the economic impact of health conditions both on society and on the individual. A health condition and its treatment incur resource use.

Pathophysiological manifestations

This core area assesses whether the effect of the intervention specifically targets the pathophysiology of the health condition. Pathophysiology can include psychosocial manifestations. Example domains are ICF body function, reversible manifestations (including modifiable risk factors and actual manifestations of ill health) and irreversible manifestations (including unmodifiable risk factors and damage). This area can also encompass all biomarkers and surrogate outcomes.