Radiographic stool quantification: an equivalence study of 484 symptomatic and asymptomatic subjects

Abstract

Purpose

To determine if symptomatic patients referred for radiographic stool quantification have equivalent stool burden to asymptomatic patients.

Method

This was an IRB-approved HIPAA-compliant retrospective equivalence cohort study. An a priori equivalence power calculation was performed. Consecutive abdominal radiographs performed in adult outpatients with bloating, constipation, diarrhea, or abdominal pain to assess "fecal loading" [n = 242 (fecal cohort)] were compared to those performed in asymptomatic adult outpatients to assess "renal stones" [n = 242 (renal cohort)]. Radiographs were randomized and reviewed by two blinded independent abdominal radiologists. Exclusion criteria, designed to avoid unblinding, included urinary tract calculi ≥ 0.5 cm, multiple urinary tract calculi, and ureteral stent(s). Readers scored all radiographs (n = 484) for stool burden using validated Leech criteria [scale: 0 (none) to 15 (extreme diffuse)]. Mean Leech scores and 95% confidence intervals were calculated. Multivariable generalized linear modeling was performed to adjust for baseline medication use, age, and gender. The adjusted parameter estimate was used to test for equivalence in the mean difference between cohorts using Schuirmann's method of two one-sided t-tests. Inter-reader agreement was assessed with intraclass correlation coefficients.

Results

Overall mean Leech scores for fecal [6.9 (95% CI 6.7, 7.2)] and renal [7.3 (95% CI 7.1, 7.5)] cohorts were equivalent within a margin of 0.75 (adjusted mean difference: − 0.4 [90% CI − 0.7, − 0.04]; p value = 0.02). Inter-reader agreement was good [ICC: 0.62 (95% CI 0.56, 0.68)].

Conclusion

Radiographic stool quantification produces equivalent results in symptomatic and asymptomatic adults and is of uncertain value.

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