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URMC / Center for Health + Technology / Our Expertise / CHeT Outcomes / CD-HI: The Crohn’s Disease Health Index

 

CD-HI: The Crohn’s Disease Health Index

  • Type of Clinical Outcome Assessment (COA): Patient-reported outcome measure (PRO)
  • Administration Mode: Self-administered
  • Therapeutic Area: Crohn’s disease
  • Approximate Completion Time: <15 minutes
  • Required Supervision: None
  • Recall Period: Immediate point in time

Instrument Variations

  • The Crohn’s Disease Health Index Short Form (CD-HI-SF)
    • CD Short From Completion Time: Under 1 minute

Symptom Subscales

  • Number of Independently Validated Symptom Subscales: 12

Fatigue; Dietary Restrictions; Gastrointestinal Health; Sleep & Daytime Sleepiness; Bowel Control; Emotional Health; Joint Health; Pain; Neck & Back Health; Activity Participation; Social Health; Skin Health

Instrument Attributes

  • The CD-HI is a patient-reported outcome (PRO) measure designed to assess symptoms and health-related quality-of-life from the perspective of patients with Crohn’s disease.
  • 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 CD-HI is a fully valid, reliable, responsive, and disease-specific instrument capable of measuring changes in patient-reported health in patients with Crohn’s disease.
  • The instrument was developed using extensive patient input, including an analysis of 792 patient quotes and a large cross-sectional study involving 403 patients.
  • The CD-HI is highly relevant to patients, has low patient burden, correlates with markers of disease severity, and demonstrates low floor and no ceiling effects.
  • The CD-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument).
  • English

Additional translations available upon request.

  • Varma, Anika BS1; Weinstein, Jennifer MS1; Seabury, Jamison BS1; Rosero, Spencer BS1; Wagner, Ellen MS1; Zizzi, Christine MPA1; Luebbe, Elizabeth MS2; Dilek, Nuran MS2; McDermott, Michael PhD2; Heatwole, John3; Saubermann, Lawrence MD4; Temple, Larissa MD5; Rogoff, Scott JD6; Heatwole, Chad MD, MS-CI1,2. Patient-Reported Impact of Symptoms in Crohn's Disease. The American Journal of Gastroenterology 117(12):p 2033-2045, December 2022. | DOI: 10.14309/ajg.0000000000001954.
  • Varma A, Weinstein J, Seabury J, Rosero S, Wagner E, Zizzi C, Kaat A, Luebbe E, Dilek N, Heatwole J, Saubermann L, Temple L, Rogoff S, Heatwole C. The Crohn's Disease-Health Index: Development and Evaluation of a Novel Outcome Measure. J Clin Gastroenterol. 2024 Jan 26. doi: 10.1097/MCG.0000000000001976. Epub ahead of print. PMID: 38277500.
  • “Results from a National Cross-Sectional Study of Disease Burden in Crohn’s Disease.” J. Seabury, J. Weinstein, C. Zizzi, E. Wagner, S. Rosero, E. Luebbe, N. Dilek, M. McDermott, L. Saubermann, L. Temple, S. Rogoff, C. Heatwole. Crohn’s and Colitis Congress. Virtual. 1/23/21.  
  • “The Crohn’s Disease-Health Index (CD-HI): Development and Validation of a Novel, Disease-Specific Patient Reported Outcome Measure for Clinical Trials.” J. Seabury, J. Weinstein, S. Rosero, A. Varma, E. Wagner, C. Zizzi, N. Dilek, M. McDermott, A. Kaat, L. Saubermann, L. Temple, S. Rogoff, C. Heatwole. Advances in Inflammatory Bowel Disease Conference. Orlando, FL. 12/9/21.
  • “Development and Validation of the Crohn’s Disease-Health Index (CD-HI), a Clinically-Relevant, Disease-Specific Patient-Reported Outcome Measure.” A. Varma, J. Seabury, J. Weinstein, S. Rosero, E. Wagner, C. Zizzi, N. Dilek, M. McDermott, A. Kaat, L. Saubermann, L. Temple, S. Rogoff, C. Heatwole. Crohn’s and Colitis Congress. Las Vegas, NV. 1/22/22.
  • “The Crohn’s Disease-Health Index (CD-HI): A Disease-Specific Patient Reported Outcome Measure for Therapeutic Trials and Clinical Monitoring.” A. Varma, J. Seabury, J. Weinstein, S. Rosero, E. Wagner, C. Zizzi, N. Dilek, A. Kaat, L. Saubermann, L. Temple, S. Rogoff, C. Heatwole. Inflammatory Bowel Disease (IBD) Innovate: Product Development for Crohn’s & Colitis. Virtual. 11/18/22.
  • “Development and Validation of a Patient-Reported Outcome Measure for Crohn’s Disease: The Crohn’s Disease-Health Index (CD-HI), A Fully Validated Tool to Bolster Clinical Trial and Research Infrastructure”. S. Rosero, A. Varma, J. Seabury, J. Weinstein, E. Wagner, C. Zizzi, C. Engebrecht, A. Kaat, E. Luebbe, N. Dilek, J. Heatwole, L. Saubermann, L. Temple, S. Rogoff, C. Heatwole. Poster session presented at: 2023 Crohn’s & Colitis Congress; January 19-21, 2023; 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 CD-HI score (0-100) representing overall disease burden.

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