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Table 2 OMERACT Filter 2.0 framework which specify all aspects of a health condition that should be considered in clinical trials (Adapted from Boers et al .[17])

From: A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

Core Area

Specification

Deatha

This core area 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 Impacta

This core area can include domains of the ICF [35] (such as activity and participation) and domains within the concept of health-related quality of life [28] (such as functional status, general health perceptions, and overall quality of life).

Resource Use/Economical Impacta

This core area describes the economic impact of health conditions both on society and on the individual. In fact, the presence of a health condition and its treatment incur resource use.

Pathophysiological Manifestationsb

This core area is to assess whether or not 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.

  1. aThese core areas belong to the concept ‘impact of health conditions’ which includes all aspects of health or a health condition that are important to the patient and society.
  2. bThis core area belong to the concept ‘pathophysiological manifestations of health conditions’.