Identifying core domains to assess flare in rheumatoid arthritis: an OMERACT international patient and provider combined Delphi consensus

Abstract

As part of the process to develop a measure for RA flare, patients and HCPs agreed on eight core domains. Next steps include identifying items to assess domains and conducting studies to validate and refine a new measure.

Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study

“…This analysis was only performed for the primary working definition of flare, based on patient-reported worsening. The sequence for addition of variables was guided by the results from the final Delphi exercise held by the OMERACT RA Flare Group (variable for domain with highest agreement added first),7 and in cases in which more than one variable per domain was available, the variable yielding the highest SMD between patients with and without flare was selected. The analyses were first performed in all patients (with the stiffness variable added last due to missing data) and then in patients with available stiffness data.…”

“…Through a process involving dedicated patient focus groups in five countries and three rounds of Delphi exercises with both healthcare professionals (HCPs) and patients with RA participating, a set of 14 candidate domains for flare were identified—pain, tender joints, swollen joints, physical function, patient global assessment, physician global assessment, laboratory measures, fatigue, stiffness, participation, self-management, systemic features, sleep and emotional distress 5 7. The latter six domains are not part of the core set for assessment of RA,8 9 while fatigue was identified by OMERACT patients as important to assess and has been included in the most recent recommendations on reporting of disease activity in clinical trials 10 11.…”

“…The latter six domains are not part of the core set for assessment of RA,8 9 while fatigue was identified by OMERACT patients as important to assess and has been included in the most recent recommendations on reporting of disease activity in clinical trials 10 11. In the final Delphi exercise, with both HCPs and patients participating, more than 70% overall agreement was reached on essential or important areas to define a flare for the domains pain, physical function, swollen and tender joints, participation, stiffness, patient global assessment and self-management 7. The key components of the OMERACT filter are the demonstration of truth, discrimination and feasibility through a data-driven approach 12.…”

Identifying key domains of health-related quality of life for patients with chronic obstructive pulmonary disease: interviews with healthcare professionals

“…When comparing these outcomes to the ones in this study, there is a high degree of overlap. This is a somewhat surprising result, since other researchers that included both patient and HCP perspective in their research pertaining to chronic diseases have reported marked discrepancies in the two perspectives [28][29][30]. There was one clear exception to this high agreement between patients and HCPs: depression.…”

We Still Don’t Know How to Taper Glucocorticoids in Rheumatoid Arthritis, and We Can Do Better

“…While not yet validated, such a definition is being developed using Outcome Measures in Rheumatology Clinical Trials RA flare criteria 19 . Fifth, studies should be designed to have enough power to create statistical models to detect important predictors of successful withdrawal, such as age, sex, and type of background RA therapy.…”