Abstract
Abstract Background Fecal calprotectin (FC) is a key non-invasive biomarker used to monitor inflammatory bowel disease (IBD). Despite its clear clinical value, patient adherence to the test remains suboptimal, mainly due to reluctance related to stool collection. The objective of the ACCALMI study was to compare the acceptability of a new stool collection device, similar to the one used for fecal immunochemical tests (FIT), with a standard stool container, and to evaluate its impact on patient compliance. Methods In this prospective, single-center study, 156 patients with an established diagnosis of IBD and who had been prescribed a FC test as part of their routine care, were randomly assigned to either the standard container group or the alternative device group (Procise Stool Collection Device™), which includes a collection tube with a thin spiral-shaped probe facilitating stool collection. Acceptability was assessed using a 4-category ordinal scale (from “poor” to “very good”) and a visual analog scale (VAS, from 0 to 10). Analyses were conducted in both per-protocol and intention-to-treat (ITT) populations, with missing data handled using the maximum bias method. Factors associated with improved FC acceptability, and compliance with FC testing, were analyzed. Results The alternative stool collection device significantly improved acceptability compared to the standard method, both on the ordinal scale (OR 2.69, p < 0.001) and the visual analogue scale, although for the latter it did not reach the predefined threshold of a 30-point difference (95% CI: 19.7 to 44.7). ITT analysis showed similar results. Embarrassment and discomfort associated with the standard container were alleviated by the alternative device. Long home-hospital distances (>50 km) and use of the alternative device were the only factors significantly associated with better acceptability in multivariate analysis. Compliance was similar between the two groups and remarkably high (92%). Conclusion The ACCALMI study demonstrated that the alternative stool collection device, similar to the one used in FIT, is more accepted by IBD patients than the standard container, thus improving the acceptability of FC testing. These findings support the integration of patient-centered innovations in diagnostic and follow-up testing to improve the monitoring of IBD. Funding This study was partially funded by Takeda® Acknowledgments Collaboration with Biosynex®.
Published Version
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