B0267 - The Gas and Bloating Diary APP: A Prospective Comparison With Daily Paper Diary

Monday, October 24, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

VJ

Veeraen Jonnalagadda, MD

Augusta University
Augusta, Georgia

Veeraen Jonnalagadda, MD¹, Yun Yan, PhD¹, Tennakoon Karunaratne, MD¹, Amalesh Sanku, MBA², Amanda Laufer, PA-C¹, Satish Rao, MD¹
¹Augusta University, Augusta, GA; ²Sagertech, Communications, Naperville, IL

Introduction: Physicians rely on subject's recall of gas-related symptoms to facilitate diagnosis and treatment, but patient's recall may be unreliable or biased. Aim: To develop and prospectively test the reliability of a novel Gas and Bloating digital Diary APP and compare with a validated paper diary in healthy subjects.

Methods: In a randomized, prospective, cross over study, healthy subjects recorded daily symptoms on either a paper diary or digital phone APP for 2 weeks each. Symptoms include bloating, gas, nausea, belching, abdominal distension, abdominal pain, constipation, indigestion, vomiting, and diarrhea. Symptoms frequency (0=none, 1=1/day, 2=2-3/day and 3=more than 3/day), duration (0=none,1=1-10 minutes, 2=10-30 mins, and 3= ≥ 30 mins), and severity (VAS (0 (none) to 10 (several)) were assessed. An overall index score was calculated for each symptoms, range from 9 (none) to 60 (severe). Correlational analysis were performed to determine the test-retest reliability, subject's preference, and validity of APP.

Results: Thirty subjects (F/M=16/14; 18-75 yrs) participated. The APP symptom scores significantly correlated (ICC > 0.915, p< 0.001) between week 1 and 2, except diarrhea (ICC+0.099, p=0.390) (Table 1). There were significant correlations for 14-day APP diary and paper diary for bloating, gas, belching, abdominal pain, constipation, and indigestion (ICC >0.585, p< 0.010). However, mean indices for nausea, distension, diarrrhea, and vomiting were low in both diaries suggesting infrequent occurrence of these symptoms in health, and lack of significant association (icc< 0.102, P >0.602). Significantly more subjects preferred the APP to paper diary (63.3% vs 33.3%, p=0.018).

Discussion: Gas and Bloating Diary APP is a reliable and reproducible digital tool for assessing gas-related symptoms and highly correlates with paper diary. APP was significantly preferred over paper diary. The detailed daily log and summary report together with normative data allows for improved understanding and management of patients with gas and bloating but requires validation in patients. The research module provides accurate analysis of symptoms and saves time for research use.

	APP Test-retest/Reliability (n=30)				Validity (n=30), APP vs Paper
	First week	Second week	ICC	P	APP	Paper	ICC	P
Bloating index	0.91 ± 0.40	0.67 ± 0.30	0.926	< 0.001	0.75 ± 0.34	0.32 ± 0.13	0.585	0.010
Gas index	2.37 ± 0.58	1.92 ± 0.50	0.915	< 0.001	2.04 ± 0.53	1.90 ± 0.72	0.889	< 0.001
Nausea index	0.29 ± 0.27	0.23 ± 0.21	0.984	< 0.001	0.26 ± 0.25	0.05 ± 0.02	0.210	0.265
Belching index	0.62 ± 0.32	0.82 ± 0.43	0.936	< 0.001	0.67 ± 0.36	0.92 ± 0.45	0.873	< 0.001
Distention index	0.27 ± 0.19	0.31 ± 0.21	0.969	< 0.001	0.27 ± 0.20	0.09 ± 0.45	0.226	0.248
Abdominal pain index	0.19 ± 0.12	0.17 ± 0.14	0.964	< 0.001	0.16 ± 0.13	0.09 ± 0.04	0.680	0.002
Constipation index	2.87 ± 0.71	2.94 ± 0.68	0.962	< 0.001	2.84 ± 0.68	0.93 ± 0.72	0.925	< 0.001
Indigestion index	0.25 ± 0.21	0.31 ± 0.25	0.988	< 0.001	0.28 ± 0.23	0.33 ± 0.21	0.969	< 0.001
Vomiting index	0.00 ± 0.00	0.00 ± 0.00			0.00 ± 0.00	0.00 ± 0.00	0.000	0.500
Diarrhea index	0.03 ± 0.01	0.03 ± 0.01	0.099	0.390	0.02 ± 0.01	0.04 ± 0.03	-0.065	0.566

Table: Table 1. Test-retest/Reliability, and Validity of Gas and Bloating APP versus Paper Form Diary in Healthy Subjects

Disclosures:

Veeraen Jonnalagadda indicated no relevant financial relationships.

Yun Yan indicated no relevant financial relationships.

Tennakoon Karunaratne indicated no relevant financial relationships.

Amalesh Sanku indicated no relevant financial relationships.

Amanda Laufer indicated no relevant financial relationships.

Satish Rao: Salix Pharmaceuticals – Grant/Research Support. Vibrant – Advisor or Review Panel Member. Vibrant – Clinical Advisory Board.

Veeraen Jonnalagadda, MD¹, Yun Yan, PhD¹, Tennakoon Karunaratne, MD¹, Amalesh Sanku, MBA², Amanda Laufer, PA-C¹, Satish Rao, MD¹. B0267 - The Gas and Bloating Diary APP: A Prospective Comparison With Daily Paper Diary, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.