Standardized system and App for continuous patient symptom logging in gastroduodenal disorders: Design, implementation, and validation

Abstract

Background Functional gastroduodenal disorders include functional dyspepsia, chronic nausea and vomiting syndromes, and gastroparesis. These disorders are common, but their overlapping symptomatology poses challenges to diagnosis, research, and therapy. This study aimed to introduce and validate a standardized patient symptom‐logging system and App to aid in the accurate reporting of gastroduodenal symptoms for clinical and research applications. Methods The system was implemented in an iOS App including pictographic symptom illustrations, and two validation studies were conducted. To assess convergent and concurrent validity, a diverse cohort with chronic gastroduodenal symptoms undertook App‐based symptom logging for 4 h after a test meal. Individual and total post‐prandial symptom scores were averaged and correlated against two previously validated instruments: PAGI‐SYM (for convergent validity) and PAGI‐QOL (for concurrent validity). To assess face and content validity, semi‐structured qualitative interviews were conducted with patients. Key Results App‐based symptom reporting demonstrated robust convergent validity with PAGI‐SYM measures of nausea (rS =0.68), early satiation (rS =0.55), bloating (rS =0.48), heartburn (rS =0.47), upper gut pain (rS =0.40), and excessive fullness (rS =0.40); all p < 0.001 (n = 79). The total App‐reported Gastric Symptom Burden Score correlated positively with PAGI‐SYM (rS =0.56; convergent validity; p < 0.001), and negatively with PAGI‐QOL (rS = −0.34; concurrent validity; p = 0.002). Interviews demonstrated that the pictograms had adequate face and content validity. Conclusions and Inferences The continuous patient symptom‐logging App demonstrated robust convergent, concurrent, face, and content validity when used within a 4‐h post‐prandial test protocol. The App will enable standardized symptom reporting and is anticipated to provide utility in both research and clinical practice.

Gastric Alimetry®impacts the management pathway of chronic gastroduodenal disorders

“…The gastric mapping data is capable of identifying patient subgroups with neuromuscular dysfunction, while the symptom data can help determine symptom origins. (5,6) Gastric Alimetry is now being introduced into practice, challenging existing models of care.…”

Non-invasive thoracoabdominal mapping of post-oesophagectomy conduit function

“…Validated symptom profiling is also performed with the Gastric Alimetry test. While detailed symptom analysis was not a focus of this feasibility study, symptom profiling is proving useful elsewhere in distinguishing cases with hypersensitivity and pain syndromes, particularly when gastric function is normal, and is likely to be valuable in future post-operative studies (6, 11). Emerging spatial mapping techniques will also allow determination of electrical propagation patterns in future studies (9).…”

“…Gastric Alimetry was performed under a protocol adapted for oesophagectomy. This device comprises an HR stretchable electrode array (8x8 electrodes; 20 mm spacing; 196 cm 2 ), a wearable Reader, validated iOS app for symptom logging, and a cloud-based reporting platform (Figure 1) (9)(10)(11). Patients were fasted for >6 hours before array placement as guided by gastric position on CT (Figure 1A-E).…”

An automated artifact detection and rejection system for body surface gastric mapping

“…[5][6][7][8] A commercial BSGM system has recently become available, offering a standardized clinical test protocol with concurrent symptom capture, followed by spectral and spatial analytics. 3,4,9 Susceptibility to extrinsic noise and motion artifacts has been a longstanding challenge in the clinical implementation of noninvasive gastrointestinal myoelectrical recordings, posing a known pitfall to previous electrogastrography (EGG) interpretations. 4,7,10 We were, therefore, motivated to develop a robust and automated artifact detection and rejection algorithm for use in clinical BSGM systems in order to mitigate this problem.…”

“… 5 , 6 , 7 , 8 A commercial BSGM system has recently become available, offering a standardized clinical test protocol with concurrent symptom capture, followed by spectral and spatial analytics. 3 , 4 , 9 …”