I18. Obtaining Patient and Professional Consensus on Flare, and Testing its Accuracy in Drug Trials

Abstract

Flare is commonly used by patients with RA and healthcare professionals (HCPs) to describe episodes of disease worsening. Since the standard of care in RA is remission, or low disease activity, assessment the impact of flare becomes important to determine whether prevention and/or rapid intervention is needed. As there is no globally agreed definition for disease flare, the Outcome Measure in Rheumatology (OMERACT) RA Flare Group conducted patient focus groups to identify potential important domains in measuring flare. Three rounds of Delphi exercise were then conducted to examine consensus and disagreement between patients and HCPs on the importance of these domains. The working group decided a priori that domains would be considered potentially core if >70% of all participants rated them as essential to measuring flare. Several domains reached this combined 70% threshold (Pain, Function, Tender Joints, Swollen Joints, Stiffness, Patient Global Assessment, Participation, and Self-management. Others achieved 70% threshold in either patient or HCPs but not both. These including RA Core Set measures, laboratory tests such as ESR and CRP, assessor global assessment, which were rated highly by HCPs but not patients, and fatigue, which reached the 70% threshold for patients but not by HCPs. The validity of these domains in discriminating flare and nonflare was assessed using Norwegian DMARD (NOR-DMARD), an inception cohort study of patients starting a new DMARD. Patients were classified as being in flare, provided that they had responded to DMARD treatment initially, using 3 different surrogate definitions: (a) patient-reported worsening; (b) increase in DMARD/systemic corticosteroid treatment; or (c) combined treatment change and patientreported worsening. Result showed that current instruments used to measure most of the proposed domains performed well in differentiating patients in flare from those not in flare. These results led to the attendees at OMERACT 11 endorsing a Core Domain set to measure RA flares that added four new domains (fatigue, stiffness, participation and self-management) to the existing RA core set. The OMERACT RA Flare Group has developed Preliminary Flare Questions which are being assessed in randomized controlled trials and longitudinal observation studies to establish a definition for disease flare in RA. (Table Presented).