Updating the OMERACT Filter: Core Areas as a Basis for Defining Core Outcome Sets

Abstract

Objective The OMERACT Filter provides guidelines for the development and validation of outcome measures for use in clinical research. The ‘Truth’ section of the OMERACT Filter pre-supposes an explicit framework for identifying the relevant core outcomes that are universal to all studies of the effects of intervention effects. There is no published outline for instrument choice or development that is aimed at measuring outcome, was derived from broad consensus over its underlying philosophy, or includes a structured and documented critique. Therefore, a new proposal for defining core areas of measurement (“Filter 2.0 Core Areas of Measurement”) was presented at OMERACT 11 to explore areas of consensus and consider whether already endorsed core outcome sets fit in to this newly proposed framework. Method Discussion groups critically reviewed the extent to which case studies of current OMERACT Working Groups complied with or negated the proposed framework, whether these observations had a more general application, and what issues remained to be resolved. Result Although there was a broad acceptance of the framework in general, several important areas of construction, presentation and clarity of the framework were questioned. The discussion groups and subsequent feedback highlighted 20 such issues. Conclusion These issues will require resolution in order to reach consensus on accepting the proposed Filter 2.0 framework of Core Areas as the basis for the selection of Core Outcome Domains and hence appropriate Core Outcome Sets for clinical trials.

The population impact of rheumatic and musculoskeletal diseases in relation to other non-communicable disorders: comparing two estimation approaches

“…We believe that the comparative impact of RMDs in relation to other NCDs with regard to a wide variety of adverse outcomes deserves to be specifically examined. The outcome measures in rheumatology (OMERACT) initiative has proposed a core set of measures to provide consistent and comparable estimates of disease burden and fully address the impact of RMDs [8,9]. PAF estimates computed for the core set of outcome measures can be immediately useful for enriching the public health policy debate and can help as a comprehensive starting point to provide in-depth population awareness about the importance of RMDs prevention and management.…”

Outcome Measures in Polymyalgia Rheumatica. A Systematic Review

“…Each outcome was characterized according to the OMERACT Filter 2.0 considering core areas (pathophysiological manifestations, life impact, death, resource use) and domains 8 .…”

“…According to the OMERACT Filter 2.0, such core sets should include at least 1 domain from each core area. Four core areas, broad aspects of a health condition, are defined: 3 encompass the "impact of health conditions" -life impact, resource use, and death; and a fourth core area encompasses pathophysiological manifestations 8,9 . This filter also considers domains, as subspecifications within 1 area 9,10 .…”

Fibromyalgia as a Contextual Factor Influencing Disease Activity Measurements in Spondyloarthritis and Psoriatic Arthritis

“…Comorbidities, differences in healthcare systems, and psychological status are all potential CF. The concept of CF is relatively new in the field of rheumatology and OMERACT, and which CF should be considered as "core" or "important" for the domain set of different disease entities has yet to be defined, let alone measured 8 . This may lead to confusion as to which factors should be labeled core domains versus CF.…”

“…Following the advocacy of the Outcome Measures in Rheumatology (OMERACT) to standardize a core domain set for a given rheumatic disease before considering instruments to select to measure outcomes 8 important move toward more objective measurement of disease activity as distinct from other domains, which serve different purposes in clinical trials and daily practice. Although the perfect instruments that represent joint or skin activity have yet to be validated or endorsed, there is potential that one of the composite indices, such as the Composite Psoriatic Disease Activity Index, or the Disease Activity Index for Psoriatic Arthritis, which combines active joint count and CRP, could fulfill the OMERACT filter of "truth" for the measurement of disease activity.…”