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Fibromyalgia syndrome.

Philip Mease1, Lesley M Arnold, Robert Bennett

  • 1Seattle Rhumatology Associates, Seattle, WA 98104, USA. pmease@nwlink.com

The Journal of Rheumatology
|June 7, 2007
PubMed
Summary
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Consensus on fibromyalgia (FM) core assessment domains was reached, incorporating patient perspectives on symptoms like stiffness and cognitive issues. This advances standardized outcome measures for FM clinical trials.

Area of Science:

  • Rheumatology and clinical trial methodology.
  • Patient-reported outcomes and health status measurement.

Background:

  • The OMERACT 8 fibromyalgia (FM) workshop built upon prior work to establish consensus on core assessment domains.
  • Key objectives included evaluating outcome measures and defining the FM research agenda.

Framework:

  • The OMERACT (Outcome Measures in Rheumatology) process provides a structured approach for domain identification and outcome measure validation.
  • Patient input was integrated through focus groups and Delphi exercises to prioritize domains.

Implementation:

  • Patient and clinician-investigator domains largely overlapped, with patients highlighting stiffness, dyscognition, and motivation.
  • Core domains like pain, fatigue, sleep, and mood were validated using the OMERACT filter in recent FM trials.

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Implications:

  • The research agenda focuses on developing objective biomarkers, a responder index, and improved measures of function and quality of life in collaboration with global health initiatives.
  • Standardized outcome measures are crucial for advancing FM clinical trial design and interpretation.