Department of Surgery, University of Auckland, Auckland, New Zealand
Alimetry Ltd, Auckland, New Zealand.
BMJ Open. 2023 Nov 27;13(11):e074462. doi: 10.1136/bmjopen-2023-074462.
The Gastric Alimetry platform offers a multimodal assessment of gastric function through body surface gastric mapping (BSGM) and concurrent symptom-tracking via a validated App. We aim to perform a longitudinal cohort study to examine the impact of Gastric Alimetry, and changes in clinical management on patient symptoms, quality of life and psychological health.
This is a prospective multicentre longitudinal observational cohort study of participants with chronic gastroduodenal symptoms. Consecutive participants undergoing Gastric Alimetry will be invited to participate. Quality of life will be assessed via EuroQol-5D and the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life score. Gastrointestinal symptoms will be assessed via the Patient Assessment of Upper Gastrointestinal Symptom Severity index, and the Gastroparesis Cardinal Symptom Index. Psychometrics will be assessed, including anxiety via the General Anxiety Disorder-7, perceived stress using the Perceived Stress Scale 4, and depression via the Patient Health Questionnaire 9. Clinical parameters including diagnoses, investigations and treatments (medication and procedures) will also be captured. Assessments will be made the week after the BSGM test, at 30 days, 90 days, 180 days and 360 days thereafter. The primary outcome is feasibility of longitudinal follow-up of a cohort that have undergone Gastric Alimetry testing; from which patients' continuum of care can be characterised. Secondary outcomes include changes in patient-reported symptoms, quality of life and psychometrics (anxiety, stress and depression). Inferential causal analyses will be performed at the within patient level to explore causal associations between treatment changes and clinical outcomes. The impact of Gastric Alimetry on clinical management will also be captured.
The protocol has been approved in Aotearoa New Zealand by the Auckland Health Research Ethics Committee. Results will be submitted for conference presentation and peer-reviewed publication.
胃动力测定平台通过体表胃映射（BSGM）和通过经过验证的应用程序进行同时的症状跟踪，提供了对胃功能的多模式评估。我们旨在进行一项纵向队列研究，以检查胃动力测定和临床管理变化对患者症状、生活质量和心理健康的影响。
这是一项对慢性胃十二指肠症状患者进行的前瞻性多中心纵向观察队列研究。将邀请连续接受胃动力测定的参与者参加。生活质量将通过 EuroQol-5D 和患者对上消化道疾病生活质量评分进行评估。胃肠道症状将通过患者对上消化道症状严重程度指数和胃轻瘫关键症状指数进行评估。心理计量学将进行评估，包括使用一般焦虑障碍 7 项评估焦虑，使用感知压力量表 4 评估感知压力，以及使用患者健康问卷 9 评估抑郁。还将记录临床参数，包括诊断、检查和治疗（药物和程序）。在 BSGM 测试后的一周、30 天、90 天、180 天和 360 天后进行评估。主要结局是对接受胃动力测定测试的队列进行纵向随访的可行性；从中可以描述患者的连续护理情况。次要结局包括患者报告症状、生活质量和心理计量学（焦虑、压力和抑郁）的变化。将在患者个体内水平上进行推断因果分析，以探索治疗变化与临床结果之间的因果关系。胃动力测定对临床管理的影响也将被捕获。
该方案已在新西兰奥克兰获得奥克兰健康研究伦理委员会的批准。结果将提交会议报告和同行评审发表。
