Identifying the clinical domains of fibromyalgia: contributions from clinician and patient Delphi exercises.
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.


CONCLUSIONS
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.
Mease
Phillip J
PJ
Seattle Rheumatology Associates, Seattle, Washington 98104, USA. pmease@nwlink.com
Arnold
Lesley M
LM
Crofford
Leslie J
LJ
Williams
David A
DA
Russell
I Jon
IJ
Humphrey
Louise
L
Abetz
Linda
L
Martin
Susan A
SA
D000203:Activities of Daily Living; D000328:Adult; D003697:Delphi Technique; D005221:Fatigue / Q000150:complications / Q000175:diagnosis; D005260:Female; D005356:Fibromyalgia / Q000150:complications / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000150:complications / Q000175:diagnosis; D010820:Physicians; D011788:Quality of Life; D012219:Rheumatology; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000150:complications / Q000175:diagnosis