FM-HI: The Fibromyalgia Health Index
FM-HI: The Fibromyalgia Health Index
- Type of Clinical Outcome Assessment (COA): Patient-reported outcome measure (PRO)
- Administration Mode: Self-administered
- Therapeutic Area: Fibromyalgia
- Approximate Completion Time: 7 minutes
- Required Supervision: None
- Recall Period: Immediate point in time
Instrument Variations
- The Fibromyalgia Health Index Short Form (FM-HI-SF)
- FM-HI Short From Completion Time: Under 1 minute
Symptom Subscales
- Number of Independently Validated Symptom Subscales: 12
Fatigue; Pain; Sleep & Daytime Sleepiness; Activity Participation; Shoulder & Arm Function; Cognition; Gastrointestinal Health; Social Performance; Headaches; Emotional Health; Mobility; Numbness
Instrument Attributes
- The FM-HI is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality-of-life from the perspective of patients with fibromyalgia.
- Designed and validated to fully satisfy published FDA guidance for use in drug-labeling claims and measuring changes in how a patient feels and functions.
- The FM-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with fibromyalgia.
- The instrument was developed using extensive patient input, including an analysis of 1,479 patient quotes and a large cross-sectional study involving 1,085 patients.
- The FM-HI is highly relevant to patients, has low patient burden, correlates with markers of disease severity, and demonstrates no floor or ceiling effects.
- The FM-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument).
- English
Additional translations available upon request.
- Weinstein, J., Rosero, S., Seabury, J., Varma, A., Engebrecht, C., Khosa, S., Heatwole, J., Dilek, N., Kaat, A., Matallana, L. K., & Heatwole, C. (2024). Patient-reported impact of symptoms in fibromyalgia (PRISM-FM). The Journal of Rheumatology. https://doi.org/10.3899/jrheum.2023-0698.
- “The FM Development and Validation of a Novel Fibromyalgia Outcome Measure to be Used in Clinical Studies”. S. Khosa, J. Weinstein, S. Rosero, J. Seabury, A. Varma, C. Engebrecht, J. Heatwole, N. Dilek, C. Heatwole. Poster session presented at The World Congress of Neurology; October 15-19, 2023; Montreal, Canada.
- “The FM-HI: Development and Validation of a Patient-Reported Outcome Measure in Fibromyalgia”. J. Weinstein, S. Rosero, J. Seabury, N. Dilek, J. Heatwole, A. Varma, C. Engebrecht, C. Heatwole. Poster session presented at The 5th International Congress on Controversies in Fibromyalgia; March 30-31, 2023; Vienna, Austria.
Instrument Scoring
All subscales are scored on a scale of 0 to 100 with 0 representing no disease burden and 100 representing the maximum level of disease burden. Symptom questions within each subscale are weighted based on participant-reported prevalence and average impact as identified through the cross-sectional study. Subscale scores are also weighted to generate a total FM-HI score (0-100) representing overall disease burden.