Crohn’s Disease Health Index Measures Burden of Disease

Noting a need for responsive outcome measures to monitor disease progression during clinical trials of therapies for Crohn’s disease (CD), researchers developed the Crohn's Disease-Health Index (CD-HI), “a disease-specific, patient-reported outcome measure that serially measures Crohn's disease (CD) symptomatic burden in adults with CD.”

In their report published in the Journal of Clinical Gastroenterology, the investigators wrote, “We conducted a national cross-sectional study of individuals with CD to identify the most prevalent and impactful symptoms of CD. The most relevant symptoms were included in the CD-HI. We used factor analysis, qualitative patient interviews, test-retest reliability evaluation, and known group validity testing to evaluate and optimize the CD-HI.”

In beta-testing, 15 adults with CD found the CD-HI easy to use and relevant. In addition, the authors wrote, “Twenty-three adults with CD participated in an assessment of test-retest reliability, which indicated high reliability of individual questions, subscales, and the full instrument (intraclass correlation coefficient = 0.84 for the full instrument). The CD-HI and its subscales demonstrated a high internal consistency (Cronbach α = 0.98 for the full instrument).”

The Health Index was able to distinguish between groups of patients with CD who were known to have differences in the severity of disease.

“This research supports the use of the CD-HI as a valid, sensitive, reliable, and relevant patient-reported outcome to determine the multifactorial disease burden of those with CD, assess the relevance and merit of future CD therapies, and support drug labeling claims,” the researchers concluded.

Varma A, Weinstein J, JSeabury J, et al. The Crohn's Disease-Health Index: development and evaluation of a novel outcome measure. J Clin Gastroenterol. 2024;58(10):1043-1051. doi: 10.1097/MCG.0000000000001976.