ESM for IBS
Research type
Research Study
Full title
The Experience Sampling Method (ESM): Validation of a newly developed real-time Patient-Reported Outcome Measure (PROM) and its Evaluation of triggers for Chronic Abdominal Pain’
IRAS ID
242248
Contact name
Qasim Aziz
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Summary of Research: Irritable Bowel Syndrome (IBS) is one of the most common causes of chronic abdominal pain. Symptoms of IBS differ from person to person and even within one person complaints can differ from day to day. The most common symptoms are chronic or intermittent abdominal pain, often associated with an urge to empty the bowels. At this moment, there is no conclusive explanation for the symptoms in IBS, but research indicates that multiple factors play a role in inducing and maintaining IBS symptoms. As a result from this, there are no tests (i.e. blood testing or abdominal ultrasound) to diagnose IBS. Disease severity and treatment efficacy are measured using symptom questionnaires or symptom diaries, completed by the patient. Unfortunately, currently available questionnaires and diaries are not able to present a fully accurate overview of individual symptom patterns.
The aim of the current study is to evaluate a newly developed method for symptom registration in IBS, the Experience Sampling Method (ESM). ESM is a digital questionnaire method that assesses the severity of abdominal complaints as well as daily life factors, that possibly influence the severity of the gastrointestinal symptoms. This questionnaire can be completed using a smartphone application (“app”). The app sends out auditory signals (“beeps”) multiple times a day, at random moments, and a questionnaire can be completed following every beep. The repeated assessments will provide a detailed overview of the abdominal symptoms during the day and possible associations between the symptoms and important daily life aspects.
In this study, ESM assessments will be compared to end-of-day symptom reports and it is expected that ESM provides a more accurate overview of individual symptom patterns in IBS patients than the end-of-day method.Summary of results: Objectives: Sleep quality may impact symptom experience in Irritable Bowel Syndrome (IBS). Our aim was to investigate the relationship between sleep quality and gastrointestinal (GI) symptoms using actigraphy and the Experience Sampling Method (ESM).
Methods: IBS patients were recruited from a tertiary Neurogastroenterology clinic and the community. GI symptoms and mood were recorded on a smartphone application, ten times per day, over seven consecutive days. Subjective sleep quality was recorded every morning to reflect the night before. Objective measures of sleep quality were estimated from wrist-worn actigraphy. Cross-lagged structural equation models were built to assess the directionality of sleep-symptom relationships over time.
Results: Eighty IBS patients completed the study (mean age: 37 (range 20 - 68), 89% female, 78% community). Sixty-six % patients had a Pittsburgh Sleep Quality Index (PSQI) score ≥ 8 indicating a clinically significant sleep disturbance. Eighty-two % (95% CI: 72-90) screened positive for a sleep disorder, most commonly insomnia. In cross-lagged analysis, poor subjective sleep quality predicted next day abdominal pain and lower GI symptoms, but not vice versa. No significant relationship with GI symptoms was found for any objective sleep measure using actigraphy.
Conclusions: Poor subjective sleep quality was associated with higher next day lower GI symptom levels, but not vice versa. Objective sleep measures did not predict next day abdominal symptoms, potentially supporting the conclusion that it is the perception of sleep quality which is most influential. This study may be used to guide future research into the effect of sleep interventions on GI symptoms.REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0236
Date of REC Opinion
28 Jun 2019
REC opinion
Further Information Favourable Opinion