A validated disease-specific symptom index for adults with celiac disease

Clin Gastroenterol Hepatol. 2009 Dec;7(12):1328-34, 1334.e1-3. doi: 10.1016/j.cgh.2009.07.031. Epub 2009 Aug 7.


Background & aims: Although the incidence of celiac disease (CD) is increasing, studies have been hampered by the lack of validated outcome measures. We sought to create a disease-specific Celiac Symptom Index (CSI) to reliably assess relevant symptoms.

Methods: A 36-item questionnaire was created after design by an expert committee and review/revision by patient focus groups. The survey, covering domains of CD-related symptoms and general health, was initially administered to 154 individuals with biopsy-proven CD; immunoglobulin (Ig)A tissue transglutaminase titers were determined, and gluten-free diet adherence was evaluated by a dietitian. The questionnaire was then revised to exclude questions with poor test characteristics and administered to a second, independent group of 52 individuals, to ensure validity.

Results: The subscales of "specific symptoms" and "general health" had excellent psychometric qualities that consisted of 11 and 5 items, respectively. The additive score based on these items was correlated with current general health, as measured by a visual analog scale and short form 36 general health subscale (P < or = .001 for both), as well as degree of adherence to the gluten-free diet (P = .008), lending external validity to the CSI. The resulting 16 questions make up the first CD-specific symptom index.

Conclusions: The CSI allows for disease-specific monitoring of symptoms as an independent outcome measure or as part of a surrogate for disease activity in individuals with CD. The CSI might be an important tool for future clinical CD research.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Celiac Disease / diagnosis*
  • Celiac Disease / pathology
  • Celiac Disease / physiopathology*
  • Diet, Gluten-Free
  • Female
  • Focus Groups
  • Humans
  • Immunoglobulin A / blood
  • Male
  • Middle Aged
  • Severity of Illness Index*
  • Surveys and Questionnaires


  • Immunoglobulin A