Table 1.

Research agenda for the Rheumatoid Arthritis Flare Working Group from OMERACT 11.

  1. Identify existing instruments and develop new measures to evaluate each patient-valued domain included in the core set and research agenda for RA flare including:

    1. Self-Management (and evaluation beyond RA)

    2. Stiffness

    3. Participation

  2. Examine other domains of importance to patients:

    1. Sleep

    2. Emotional distress

    3. Systemic Features

  3. Assess and validate flare domains by analyzing OMERACT preliminary flare questions in several longitudinal observation studies and two randomized control trials

  4. Employ methods, including item response therapy in the analysis and summation of multi-dimensional data for flare to evaluate thresholds of HCP and patient described domains associated with disease worsening

  5. Assess domain measures in the context of a (i) “Patient global question” with well characterized and validated anchors, (ii) Patient assessment using a flare questionnaire in the context of available PROs at the time of each self-report, (iii) Physician/HCP assessments of disease activity, and (iv) treatment change.

  6. Evaluate linguistic and cultural factors that pertain to domain identification and instrument selection and validation [Ref 32]

  7. Determine whether flare should be represented as a change or a state(or both)

  8. Determine duration/persistence criterion for defining flare