Novel Digital Gastric Alimetry(R) Symptom Scales for Use in Gastroduodenal Disorders and Validation against Rome IV Criteria

BackgroundPatients with chronic gastroduodenal disorders present with overlapping symptoms. Guidelines emphasize symptom-based criteria, but clinical evaluations are inconsistent due to non-standardized assessments and recall bias. Gastric Alimetry(R) is a non-invasive test of gastric function enabling real-time symptom evaluation via a standardized app. MethodsParticipants meeting Rome IV criteria for functional dyspepsia (FD) and/or chronic nausea and vomiting syndrome (CNVS) underwent a Gastric Alimetry test, including a meal challenge, with symptoms recorded every 15 minutes in the app. Based on time-of-test symptoms, four novel scores were developed: nausea/vomiting, postprandial distress, epigastric pain, and burning/reflux. Group differences were analyzed using pairwise t-tests, and Rome IV classifications were predicted via logistic regression. Remote moderated usability testing assessed score acceptability. Key ResultsAmong 109 participants (79% female, 18-80 yrs), 54 met criteria for CNVS with/without FD, 41 for postprandial distress syndrome (PDS) only, and 14 for epigastric pain syndrome (EPS) with/without PDS. Symptom scores aligned with Rome IV classifications (p<.05 for CNVS and EPS). Logistic regression showed good discrimination for CNVS (AUC=0.85) and EPS (AUC=0.80), and moderate discrimination for PDS (AUC=0.68). Usability testing confirmed clinical utility and ease of use. Conclusions & InferencesGastric Alimetry symptom scores align with Rome IV classifications, with real-time patient-reported snapshots accurately reflecting chronic symptom burden. These scores provide a clinically applicable diagnostic tool alongside simultaneous physiological gastric function assessments. Key PointsO_LIFour novel Gastric Alimetry symptom scores summarize the relative severity of symptoms in subgroups aligned with Rome IV classifications. C_LIO_LIThe proposed time-of-test symptom scores showed moderate-to-good ability to predict diagnoses made using the Rome IV criteria. C_LIO_LIUsability testing with eight clinicians showed that the scores provided an easy-to-use and clinically useful tool to complement diagnosis of gastroduodenal disorders. C_LI