Gastroenterology. 2024 Feb 1:S0016-5085(24)00124-0.doi:10.1053/j.gastro.2023.11.307. Online ahead of print.

Jan Tack ¹, Florencia Carbone ², Lin Chang ³, Brian E Lacy ⁴

Author information

¹Translational Research in Gastrointestinal Disorders, University of Leuven, Leuven, Belgium; Department of Gastroenterology, Leuven University Hospitals, Leuven, Belgium. Electronic address: jan.tack@kuleuven.be.

²Department of Gastroenterology, Leuven University Hospitals, Leuven, Belgium.

³G. Oppenheimer Center for Neurobiology of Stress at University of California, Los Angeles, Los Angeles, California; Vatche and Tamar Manoukian Division of Digestive Diseases, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.

⁴Mayo Clinic Jacksonville, Jacksonville, Florida.

Abstract

Disorders of gut-brain interaction are characterized by chronic gastrointestinal symptoms in the absence of abnormal endoscopic or radiologic findings or objective biomarkers that can be identified during routine clinical evaluation. The assessment of the symptom pattern and severity, therefore, is the key modality to evaluate the presence, impact, and evolution of these conditions, for both clinical and regulatory purposes. Patient-reported outcomes are structured symptom assessment questionnaires designed to evaluate symptom patterns, quantify severity of symptoms, and evaluate response to treatment at follow-up. This review provides an overview of currently available patient-reported outcomes for evaluating the main disorders of gut-brain interaction, specifically, functional dyspepsia; irritable bowel syndrome; and chronic constipation. It summarizes their content, level of validation for clinical practice and for research, and the regulatory approach to these conditions. Expected future developments and need for further research on patient-reported outcomes for these and other disorders of gut-brain interaction are highlighted.