Frequency of abnormal fecal biomarkers in irritable bowel syndrome.

PRIMARY STUDY OBJECTIVE: Determine the frequency of abnormal fecal biomarker test results in patients with 13 irritable bowel syndrome (IBS)-related ICD-9 (International Statistical Classification of Diseases and Related Health Problems) codes. STUDY DESIGN: Quantitative review of de-identified records from patients in whom IBS was a possible diagnosis. METHODS: Records were selected for analysis if they included any of 13 IBS-related diagnostic codes and laboratory test results of fecal testing for all biomarkers of interest. Data collection was restricted to one 12-month period. Frequency distributions were calculated to identify rates of abnormal results for each biomarker within the total number of tests conducted in the eligible population. RESULTS: Two thousand, two hundred fifty-six records were included in the study, of which 1867 (82.8%) included at least one abnormal value. Quantitative stool culture for beneficial bacteria (Lactobacillus and Bifidobacterium) indicated low growth suggestive of intestinal dysbiosis in 73.1% of records, followed by abnormally elevated eosinophil protein X (suggestive of food allergy) in 14.3%, elevated calprotectin (suggestive of inflammation) in 12.1%, detection of parasites in 7.5%, and low pancreatic elastase (suggestive of exocrine pancreatic insufficiency) in 7.1%. CONCLUSIONS: Abnormal fecal biomarkers are prevalent in patients with diagnoses suggestive of IBS. Abnormal fecal biomarker testing, if confirmed in additional independent clinical trials, could substantially reduce the economic costs associated with diagnosis and management of IBS.

Novel Testing Enhances Irritable Bowel Syndrome Medical Management: The IMMINENT Study.

PRIMARY STUDY OBJECTIVE: To evaluate the economic utility of a fecal biomarker panel structured to suggest alternative, treatable diagnoses in patients with symptoms of irritable bowel syndrome (IBS) by quantifying, comparing, and contrasting health service costs between tested and non-tested patients. STUDY DESIGN: Retrospective, matched cohort study comparing direct medical costs for IBS patients undergoing fecal biomarker testing with those of matched control subjects. METHODS: We examined de-identified medical and pharmacy claims of a large American pharmacy benefit manager to identify plan members who underwent panel testing, were eligible for covered benefits for at least 180 days prior to the test date, and had data available for 30, 90, and 365 days after that date. We used propensity score matching to develop population-based control cohorts for each tested cohort, comprised of records with IBS-related diagnoses but for which panel testing was not performed. Primary outcome measures were diagnostic and medical services costs as determined from claims data. RESULTS: Two hundred nine records from tested subjects met inclusion criteria. The only significant baseline differences between groups were laboratory costs, which were significantly higher in each tested cohort. At each follow-up time point, total medical and gastrointestinal procedural costs were significantly higher in non-tested cohorts. Within tested cohorts, costs declined significantly from baseline, while costs rose significantly in non-tested control cohorts; these differences were also significant between groups at each time point. CONCLUSIONS: Structured fecal biomarker panel testing was associated with significantly lower medical and gastrointestinal procedural costs in this study of patients with IBS symptoms.