OBJECTIVES: Childhood constipation is one of the most common reasons for pediatric outpatient visits and often difficult to manage. Expensive tests such as colonoscopy may be utilized with minimal diagnostic yield. The aim of this decision analytic model was to evaluate the cost savings associated with the use of a medical device technology to reduce unnecessary tests in pediatric patients with constipation.

METHODS: SITZMARKS capsule is a safe, non-invasive tool used to detect blockage or colonic inertia in pediatric or adult patients with constipation. SITZMARKS cost savings compared to current standard of care (SOC including barium enema, anorectal manometry, colonoscopy, thyroid function tests, and no treatment) was evaluated using TreeAge 2021 software in hypothetical pediatric patients who presented with inadequate colonic motility in an outpatient setting. Model parameters was elicited from answers to physician responses to a questionnaire and peer reviewed literature. Costs for procedures were derived from estimated private payer reimbursements and adjusted to 2021 dollars. Base case costs, sensitivity analysis and incremental cost effectiveness (ICE) were evaluated. The cost of 10 capsules of Sitzmarks is $849.

RESULTS: Assuming a diagnostic value of 80%, The use of SITZMARKS capsule as first-line resulted in an expected value of $4,307.20 per patient versus colonoscopy with an expected value of $11,596.57 and an incremental cost of $8,490.43. Barium Enema was also associated with cost savings with an expected value of $5,155 and an incremental cost of $847. Incremental cost-effectiveness analysis, showed that Sitzmarks dominated all standard of care. Results of sensitivity analysis showed that for SOC to be less expensive than Sitzmarks, the price of Sitzmarks would need to exceed $3000.

CONCLUSIONS:

The use of SITZMARKS as a first line diagnostic tool may improve diagnostic accuracy of constipation and results in significant cost savings associated with unnecessary tests with low diagnostic yield.