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Center for Health + Technology [CHeT]

URMC / Center for Health + Technology / Our Expertise / CHeT Outcomes / IBM-HI: The Inclusion Body Myositis Health Index

 

IBM-HI: The Inclusion Body Myositis Health Index

  • Type of Clinical Outcome Assessment (COA): Patient-reported outcome measure (PRO)
  • Administration Mode: Self-administered
  • Therapeutic Area: Inclusion body myositis
  • Approximate Completion Time: <11 minutes
  • Required Supervision: None
  • Recall Period: Immediate point in time

Instrument Variations

  • The Inclusion Body Myositis Health Index Short Form (IBM-HI-SF)
    • IBM-HI Short From Completion Time: Under 1 minute

Symptom Subscales

  • Number of Independently Validated Symptom Subscales: 13

Mobility; Core Strength; Hand & Finger Function; Shoulder & Arm Function; Emotional Health; Social Performance; Sleep & Daytime Sleepiness; Breathing; Activity Participation; Fatigue; Pain; Swallowing Function; Communication

Instrument Attributes

  • The IBM-HI is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality-of-life from the perspective of patients with inclusion body myositis.
  • Designed and validated to fully satisfy regulatory and published FDA guidance for use in drug-labeling claims and measuring changes in how a patient feels and functions.
  • The IBM-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with inclusion body myositis.
  • The instrument was developed using extensive patient input, including an analysis of 644 patient quotes and a large cross-sectional study involving 569 patients.
  • The IBM-HI is highly relevant to patients, has low patient burden, correlates with markers of disease severity, and demonstrates no floor or ceiling effects.
  • The IBM-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.95 for the full instrument).
  • English

Additional translations available upon request.

  • Gibson, C; Johnson, N; Eastwood, E; Heatwole, C.  Inclusion Body Myositis: What Most Impacts Patients’ Lives.  Journal of Clinical Neuromuscular Disease.  2016 Dec;18(2):67-71.
  • “Development of a Sensitive Disease-Specific Patient Reported Outcome Measure for IBM Clinical Trials.”  International Myositis Assessment and Clinical Studies Group (IMACS).  9/21/20.
  • Responsive Instrument for use in IBM Clinical Trials.” International Myositis Assessment and Clinical Studies Group (IMACS). 3/15/21.
  • “The Inclusion Body Myositis Health-Index (IBM-HI): Development of a Novel, Disease Specific Patient-Reported Outcome Measure for IBM in Clinical Trials.” J. Seabury, C. Gibson, N. Dilek, S. Rosero, A. Varma, J. Weinstein, C. Zizzi, P. Bhagchandani, C. Heatwole. Global Conference on Myositis. Prague, Czechoslovakia. 6/8/22.
  • “The Inclusion Body Myositis Health-Index (IBM-HI): Development of a Novel, Disease Specific Patient-Reported Outcome Measure for IBM in Clinical Trials.” S. Khosa, S. Rosero, J. Weinstein, A. Varma, J. Seabury, C. Engebrecht, P. Bhagchandani, C. Zizzi, J. Heatwole, N. Johnson, C. Gibson, N. Dilek, B. Martens, C. Heatwole. Oral & poster sessions presented at: 2023 Neuromuscular Study Group Annual Scientific Meeting; September 22-24, 2023; Orlando, FL.

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 IBM-HI score (0-100) representing overall disease burden.

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