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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:
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Self-Management (and evaluation beyond RA) -
Stiffness -
Participation
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Examine other domains of importance to patients:
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Sleep -
Emotional distress -
Systemic Features
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Assess and validate flare domains by analyzing OMERACT preliminary flare questions in several longitudinal observation studies and two randomized control trials -
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 -
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. -
Evaluate linguistic and cultural factors that pertain to domain identification and instrument selection and validation [Ref 32] -
Determine whether flare should be represented as a change or a state(or both) -
Determine duration/persistence criterion for defining flare
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