TY - JOUR
T1 - Digital Instruments for Reporting of Gastrointestinal Symptoms in Clinical Trials
T2 - Comparison of End-of-Day Diaries Versus the Experience Sampling Method
AU - Beckers, Abraham B
AU - Snijkers, Johanna T W
AU - Weerts, Zsa Zsa R M
AU - Vork, Lisa
AU - Klaassen, Tim
AU - Smeets, Fabienne G M
AU - Masclee, Ad A M
AU - Keszthelyi, Daniel
N1 - Funding Information:
AAMM and DK have received an unrestricted research grant from Will Pharma, which also supported ZZRMW and LV in attending a scientific meeting. AAMM and DK have received funding from Allergan, ZonMw, Grunenthal. DK has received funding from the Dutch Foundation for Gastroenterology-Hepatology (MLDS), United Europe Gastroenterology (UEG), Rome Foundation, and EU Horizon 2020, outside of submitted work. AAMM has received funding from the Dutch Foundation for Cancer Research (KWF), Pentax, outside of submitted work. TK received a salary from Will Pharma as part of the “Subsidie MKB Innovatiestimulering Topsectoren” (MIT), outside of submitted work. ABB, JTWS, and FGMS have nothing to declare.
Funding Information:
No specific funding was received for the current study. The irritable bowel syndrome (IBS) randomized controlled trial (RTC) was funded by ZonMw (The Netherlands Organization for Health Research and Development) with co-funding from Will Pharma. The IBS observational study was funded in part by Grunenthal. The functional dyspepsia (FD) RCT is funded by ZonMw. No specific funding was received for the FD observational trial.
Publisher Copyright:
© 2021 Eesti Rakenduslingvistika Uhingu Aastaraamat. All rights reserved.
PY - 2021/11/24
Y1 - 2021/11/24
N2 - BACKGROUND: Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials.OBJECTIVE: This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD).METHODS: Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods.RESULTS: In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively).CONCLUSIONS: This study demonstrates excellent adherence rates for smartphone app-based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials.
AB - BACKGROUND: Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials.OBJECTIVE: This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD).METHODS: Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods.RESULTS: In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively).CONCLUSIONS: This study demonstrates excellent adherence rates for smartphone app-based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials.
U2 - 10.2196/31678
DO - 10.2196/31678
M3 - Article
C2 - 34821561
SN - 2561-326X
VL - 5
JO - JMIR Formative Research
JF - JMIR Formative Research
IS - 11
M1 - e31678
ER -