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Center for Health + Technology [CHeT]

URMC / Center for Health + Technology / Our Expertise / CHeT Outcomes / CCM-HI: The Cerebral Cavernous Malformations Health Index

 

CCM-HI: The Cerebral Cavernous Malformations Health Index

  • Type of Clinical Outcome Assessment (COA): Patient-reported outcome measure (PRO)
  • Administration Mode: Self-administered
  • Therapeutic Area: Cerebral cavernous malformations
  • Approximate Completion Time: <10 minutes
  • Required Supervision: None
  • Recall Period: Immediate point in time

Instrument Variations

  • The Cerebral Cavernous Malformations Health Index Short Form (CCM-HI-SF)
    • CCM Short From Completion Time: Under 1 minute

Symptom Subscales

  • Number of Independently Validated Symptom Subscales: 20

Headaches; Mobility; Shoulder & Arm Function; Cognition; Hand & Finger Function; Lower Extremity Strength; Activity Participation; Communication; Sleep & Daytime Sleepiness; Fatigue; Hearing & Inner Ear Function; Pain; Sensation; Emotional Health; Social Satisfaction; Social Performance; Gastrointestinal Health; Swallowing Function; Vision; Seizures

Instrument Attributes

  • The CCM-HI is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality-of-life from the perspective of patients with cerebral cavernous malformations.
  • 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 CCM-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with cerebral cavernous malformations.
  • The instrument was developed using extensive patient input, including an analysis of 770 patient quotes and a large cross-sectional study involving 311 patients.
  • The CCM-HI is highly relevant to patients, has low patient burden, correlates with markers of disease severity, and demonstrates low floor and no ceiling effects.
  • Utilized in industry studies.
  • The CCM-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.92 for the full instrument).
  • English

Additional translations available upon request.

Pending
  • “The Cerebral Cavernous Malformations Health Index (CCM-HI): Development and Validation of a Novel, Disease-Specific Patient Reported Outcome Measure for Clinical Trials. Angioma Alliance CCM Scientific Meeting. Virtual. 11/12/21.
  • “The Cerebral Cavernous Malformations Health Index (CCM-HI): Development and Validation of a Novel Disease-Specific Patient Reported Outcome Measure for Clinical Trials. J. Weinstein, S. Rosero, J. Seabury, A. Varma, C. Zizzi, J. Heatwole, N. Dilek, C. Lee, C. Heatwole. International CCM Scientific Meeting. Durham, NC. 11/17/22.
  • “A 12-Month Longitudinal Study of Disease Progression in Cerebral Cavernous Malformations”. J. Seabury, J. Weinstein, A. Varma, S. Rosero, C. Engebrecht, S. Khosa, J. Heatwole, C. Zizzi, M. Coffey, D. Alexandrou, N. Dilek, H. Blei, C. Lee, C. Heatwole. Oral session presented at: CCM Scientific Meeting 2023; July 6-7, 2023; Miami, FL.
  • “CCM-Health Index Longitudinal Study Results”. J. Seabury, J. Weinstein, A. Varma, S. Rosero, C. Engebrecht, S. Khosa, J. Heatwole, C. Zizzi, M. Coffey, D. Alexandrou, N. Dilek, H. Blei, C. Lee, C. Heatwole Oral session presented at: CCM Family Meeting 2023; July 6-7, 2023; Miami, FL.
  • “Results from a 12-Month Natural History Study of Patients With Cerebral Cavernous Malformations”. C. Heatwole, J. Seabury, A. Varma, S. Rosero, C. Engebrecht, S. Khosa, C. Shupe, C. Irwin, J. Heatwole, C. Zizzi, D. Alexandrou, N. Dilek, R. Watson, H. Blei, C. Lee, J. Weinstein. The American Academy of Neurology 76th Annual Meeting; April 13-18, 2024; Denver, CO.

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

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