Fibromyalgia syndrome module at OMERACT 9: domain construct

Area of Science:

• Rheumatology and Clinical Trial Methodology
• Fibromyalgia (FM) Research
• Outcome Measurement in Clinical Trials

Background:

• Establishing a core domain set for fibromyalgia (FM) assessment in clinical trials and practice.
• Reviewing the performance characteristics of outcome measures for FM.
• Discussing the development of a responder index for FM assessment.

Framework:

• Consensus reached on essential FM domains: pain, tenderness, fatigue, patient global, multidimensional function, and sleep disturbance for all trials.
• Dyscognition and depression recommended for some FM trials; stiffness, anxiety, functional imaging, and biomarkers identified for research interest.
• FM outcome measures generally demonstrate reliability, discriminative ability, and feasibility.

Implementation:

• Analysis of 10 FM clinical trials involving 4 drugs to map key domains.
• Updates on the status of outcome measures and development of objective markers for FM.
• Review of cognitive dysfunction (dyscognition) in FM and development of assessment measures.

Implications:

• A multidimensional symptom core set is proposed for evaluating FM in clinical trials.
• Ongoing research focuses on improved measures for single domains and composite outcomes in FM.
• Development of more sophisticated measures, including a responder index and objective markers, is advancing FM assessment.