S561 The Gas and Bloating Diary APP: A Prospective Comparison With Daily Paper Diary

Abstract

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