Identifying the clinical domains of fibromyalgia: Contributions from clinician and patient delphi exercises

Authors

  • Phillip J. Mease,

    Corresponding author
    1. Seattle Rheumatology Associates, Seattle, Washington
    • Seattle Rheumatology Associates, 1101 Madison Street, Suite 1000, Seattle, WA 98104
    Search for more papers by this author
    • Dr. Mease has received consultant fees and grant/research support (less than $10,000 each) from Pfizer, Cypress Biosciences, Forest, Eli Lilly, Allergan, Fralex, Boehringer-Ingelheim, Jazz, Wyeth, and Pierre Fabre, and has received speaking fees (less than $10,000) from Pfizer.

  • Lesley M. Arnold,

    1. University of Cincinnati, Cincinnati, Ohio
    Search for more papers by this author
    • Dr. Arnold has received consultant fees, speaking fees, and/or grant/research support (less than $10,000 each) from Cypress Bio sciences, Boehringer-Ingelheim, Forest, Allergan, Organon, Sanofi-Aventis, Sepracor, and Vivus, and (more than $10,000 each) from Eli Lilly, Pfizer, and Wyeth.

  • Leslie J. Crofford,

    1. University of Kentucky, Lexington
    Search for more papers by this author
    • Dr. Crofford has received consultant fees and/or grant/research support (less than $10,000 each) from Pfizer, Eli Lilly, Allergan, and Wyeth.

  • David A. Williams,

    1. University of Michigan, Ann Arbor
    Search for more papers by this author
    • Dr. Williams has received consultant fees (less than $10,000 each) from Eli Lilly, Cypress Biosciences, Forest, and Pierre Fabre.

  • I. Jon Russell,

    1. University of Texas, San Antonio
    Search for more papers by this author
    • Dr. Russell has received consultant fees, speaking fees, and/or honoraria (less than $10,000) from Lilly and (more than $10,000 each) from Pfizer and Jazz.

  • Louise Humphrey,

    1. Mapi Values, Bollington, UK
    Search for more papers by this author
    • Ms Humphrey and Ms Abetz received research/grant support from Pfizer and were contracted by Pfizer to assist in the present study.

  • Linda Abetz,

    1. Mapi Values, Bollington, UK
    Search for more papers by this author
    • Ms Humphrey and Ms Abetz received research/grant support from Pfizer and were contracted by Pfizer to assist in the present study.

  • Susan A. Martin

    1. Pfizer, Ann Arbor, Michigan
    Search for more papers by this author
    • Ms Martin owns stock in Pfizer.


Abstract

Objective

In evaluating the effectiveness of fibromyalgia (FM) therapies, it is important to assess the impact of those therapies on the full array of domains considered important by both clinicians and patients. The objective of this research was to identify and prioritize the key clinically relevant and important domains impacted by FM that should be evaluated by outcome assessment instruments used in FM clinical trials, and to approach consensus among clinicians and patients on the priority of those domains to be assessed in clinical care and research.

Methods

Group consensus was achieved using the Delphi method, a structured process of consensus building via questionnaires together with systematic and controlled opinion feedback. The Delphi exercises involved 23 clinicians with expertise in FM and 100 patients with FM as defined by American College of Rheumatology criteria.

Results

The Delphi exercise revealed that the domains ranked most highly by patients were similar to the domain rankings by clinicians. Pain was consistently ranked highest by both panels. Fatigue, impact on sleep, health-related quality of life, comorbid depression, and cognitive difficulty were also ranked highly. Stiffness was ranked highly by patients but not clinicians. In contrast, side effects was important to clinicians but was not identified as important in the patient Delphi exercise.

Conclusion

The clinician and patient Delphi exercises identified and ranked key domains that need to be assessed in FM research. Based on these results, a conceptual framework for measuring patient-reported outcomes is proposed.

Ancillary