Table 2 Definitions of key concepts used in this study protocol (adapted from Boers et al. [9])
Key Concept | Definition |
|---|---|
Health condition | A situation of impaired health |
Health intervention | An activity performed by, for, with or on behalf of a client(s) whose purpose is to improve individual or population health, to alter or diagnose the course of a health condition or to improve functioning |
Core area | An aspect of health or a health condition that needs to be measured to assess appropriately the effects of a health intervention (core areas are broad concepts consisting of a number of more specific concepts called domains) |
Domain | Component of core area: a concept to be measured, a further specification of an aspect of health, categorised within a core area |
Outcome | Any identified result in a domain arising from exposure to a casual factor or a health intervention |
Measurement instrument | A tool to measure a quality or quantity of a variable; in this context, a domain or a contextual factor |
Core domain set | In the study of health interventions, the minimum set of domains and subdomains necessary to cover adequately all core areas (fully measure all relevant concepts of a specific health condition within a specified scope); it describes what to measure |
Core outcome measurement set | Definition introduced by the OMERACT Initiative |
The minimum set of outcome measurement instruments that must be administered in each intervention study of a certain health condition within a specified setting to cover adequately a corresponding core domain set; it describes how to measure | |
Core outcome set | Definition introduced by the COMET Initiative |
The agreed minimum set of outcomes that should be measured and reported in all clinical trials for a specific clinical area | |
Scope | The set of factors that describe the studies and circumstances to which the COS will apply; this is determined by the study questions and includes the health condition(s), target population, interventions and so forth |
Contextual factor | A variable that is not an outcome of the study, but needs to be recognised (and measured) to understand the study results; this includes potential confounders and effect modifiers |