Background
Celiac disease (CD) is common but under-diagnosed in the United States (US). A proposed quality guideline recommends that ≥4 specimens be submitted during duodenal biopsy. Adherence to this recommendation in clinical practice is unknown.
Objectives
To measure the number of specimens submitted during duodenal biopsy among patients throughout the U.S., and to determine the incremental diagnostic yield of adherence to the recommended number of specimens.
Design
Retrospective cohort study.
Methods
132,352 patients without known CD underwent duodenal biopsy submitted to a pathology laboratory operating in 43 states in the U.S. We used multivariate logistic regression to identify factors associated with submitting ≥4 specimens. We also compared prevalence of newly diagnosed CD in biopsies with ≥4 specimens to <4 specimens.
Results
Of the 132,352 patients who underwent biopsy (67% female, mean age 52.9), ≥4 specimens were submitted in 45,995 (35%). A modest increase in the proportion of biopsies with ≥4 specimens occurred after this guideline was proposed in 2006 (OR for 2009 vs. 2006 1.51 95%CI 1.22–1.88), but the rate of adherence in 2009 remained low at 37%. Among patients in whom the indication was malabsorption/suspected CD (n=3,261), adherence to this standard was only 39.5%. The probability of a new diagnosis of CD was increased when ≥4 specimens were submitted (1.8% vs. 0.7%, p<0.0001).
Limitations
Retrospective analysis lacking clinical follow-up. Guideline publication occurred during the study period, possibly influencing clinical practice and confounding results.
Conclusions
Although this proposed standard remains a subject of debate, adherence to submitting ≥4 specimens is low in the U.S. Adherence yields a diagnosis rate of 1.8%, a small absolute increase, but a doubling of the diagnosis rate of CD. Efforts to increase adherence are warranted.