Longitudinal outcomes after Gastric Alimetry™ testing

All consecutive adults undergoing Gastric Alimetry(TM) testing. For participants the study involves undergoing the Gastric Alimetry(TM) test (4.5 hour recording using the Gastric Alimetry Array and Reader with a Ensure drink and Oatmeal bar meal stimulus at 30 minutes, followed by 4 hours of postprandial recording). Participants will complete baseline questionnaires during the test. Participants will then receive email/text reminders to complete the questionnaires on their mobile phone (MyCap App) if they provide informed consent for the longitudinal study. Observations include Gastric Alimetry(TM) test report (electrophysiology, spatial and spectral metrics, symptoms) and patient reports outcomes including symptom severity scales, quality of life, and health psychology questionnaires. Quality of life will be assessed via EuroQol-5D (EQ-5D) and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QOL) score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity (PAGI-SYM) index, and the Gastroparesis Cardinal Symptom Index (GCSI). Anxiety will be assessed through the General Anxiety Disorder-7 (GAD-7), perceived stress using the Perceived Stress Scale 4 (PSS-4), and depression via the Patient Health Questionnaire 9 (PHQ-9). Clinical parameters including, diagnoses (Gastric Alimetry™ phenotype, Rome-IV diagnosis), investigations (gastric emptying, transit studies, manometry, endoscopy), and treatments (medications, and procedures), as well as changes in the above measures, and date of change will also be captured. At each of the post-test time points (index test, 30-days, 90-days, 180-days and 365-days), participants will be asked to complete a daily symptom diary for seven days. Each evening, they will rate the severity of seven gastrointestinal symptoms over the past 24 hours. Each symptom is rated using a 0–10 Likert scale, with anchors at 0 “none,” indicating no symptom experience, and 10 indicating the “most severe imaginable” extent of a symptom experience. The rating is determined by the worst symptom experience in the past 24 hours for each symptom. The symptoms are stomach burn, stomach pain, nausea, bloating, postprandial fullness, early satiation, belching, and number of vomiting events. An additional rating distress arising from excessive belching is included, using a 0-10 Likert scale, with anchors at 0 “none,” and 10 “worst imaginable bother.” Enrolled participants will be followed up for a total of 1 year. Planned comparisons include between patients with chronic gastroduodenal disorders (e.g., chronic nausea vomiting syndromes and functional dyspepsia as defined by Rome-IV, healthy volunteers, and those with and without gastroparesis). MyCap is a readily available resource (add-on to REDCap: https://projectmycap.org/). It is anticipated that 15-30 minutes will be needed to finish the baseline questionnaires and 5-10 minutes for subsequent follow-up questionnaires.