Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 May 1;120(5):1098-1107.
doi: 10.14309/ajg.0000000000003091. Epub 2024 Sep 23.

Results From a Psychometric Validation Study: Patients With Irritable Bowel Syndrome Report Higher Symptom Burden Using End-of-Day Vs Real-Time Assessment

Michelle Bosman  1 , Lisa Vork  1 , Daisy Jonkers  1 , Johanna Snijkers  1 , Rabia Topan  2 , Qasim Aziz  2 , Irina Midenfjord  3 , Magnus Simren  3 , Ad Masclee  1 , Daniel Keszthelyi  1 ; ESM study group
Collaborators, Affiliations
Multicenter Study

Results From a Psychometric Validation Study: Patients With Irritable Bowel Syndrome Report Higher Symptom Burden Using End-of-Day Vs Real-Time Assessment

Michelle Bosman et al. Am J Gastroenterol. .

Abstract

Introduction: Real-time assessment of gastrointestinal (GI) symptoms in irritable bowel syndrome (IBS) using the experience sampling method (ESM) is suggested as a more appropriate approach than currently used end-of-day or end-of-week reports. This psychometric evaluation study assesses the validity and reliability of a previously developed ESM-based patient-reported outcome measure (PROM) for real-time GI symptom assessment in IBS.

Methods: This multicenter validation study included 230 Rome IV patients with IBS (80% female; mean age 41.2 years) in 3 European countries. Patients completed the electronic ESM-PROM (up to 10 random moments daily, with a weekly minimum completion rate of 33%) and an end-of-day symptom diary for 7 consecutive days. End-of-week questionnaires (Gastrointestinal Symptom Rating Scale for IBS, IBS Severity Scoring System, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7) were completed at the end of the 7-day period.

Results: The ESM assessment had a mean completion rate of 71%. Strong and significant correlations (0.651-0.956) with moderate-to-good consistency (intra-class correlation coefficients 0.580-0.779) were observed between ESM and end-of-day scores. However, end-of-day scores were significantly higher (Δ0.790-1.758, P < 0.001) than mean daily ESM scores. Differences with end-of-week scores were more pronounced, with weaker correlations (Pearson's r 0.393-0.802). ESM-PROM exhibited moderate-to-good internal consistency (Cronbach's α 0.585-0.887) across 5 symptom domains. First and second half-week scores demonstrated good-to-excellent consistency (intraclass correlation coefficients 0.871-0.958).

Discussion: Psychometric evaluation demonstrated strong validity and reliability of the ESM-PROM for real-time GI symptom assessment in IBS. In addition, the ESM-PROM provides a precise and reliable ascertainment of individual symptom pattern and trigger interactions, without the bias of peak reporting when compared with retrospective methods. This highlights its potential as a valuable tool for personalized healthcare in monitoring disease course and treatment response in patients with IBS.

Keywords: experience sampling method; irritable bowel syndrome; patient-reported outcome; psychometric evaluation.

PubMed Disclaimer

Conflict of interest statement

Guarantor of the article: Daniel Keszthelyi, MD, PhD.

Specific author contributions: M.B. and L.V.: wrote the paper. M.B., L.V., J.S., R.L., and I.M.: collected data. L.V., D.J., Q.A., M.S., A.M., D.K., J.B., C.L., J.K., Z.M., S.K., H.B., E.Q., and D.K.: were involved in study design. M.B. and L.V.: analyzed data. D.J., Q.A., M.S., H.T., A.M., and D.K.: supervised the study. All authors contributed to revision of the manuscript and agreed to the submission of the article.

Financial support: The MEASuRE study was financially supported by a grant received from Grünenthal, GmbH (Aachen, Germany). The DISCOvERIE study was financially supported by the Horizon 2020 Framework Program (DISCOvERIE 848228). The ESM linaclotide study was financially supported by a grant received from AbbVie (North Chicago, IL).

Potential competing interests: M.B., L.V., J.S., R.T., Q.A., I.M., C.L., J.K., E.Q., S.K., and A.M. declare no conflicts of interests. D.J. has received research funding from public-private partnership grants of Top Knowledge Institute (TKI) Agri&Food and Health Holland, by the Carbokinetics program as part of the NWO-CCC Partnership Program, by Organic A2BV/Mothersfinest BV and by H2020 DISCOvERIE/848228 (outside the submitted paper). M.S. has received unrestricted research grants from Genetic Analysis AS and BioGaia, has participated as a Consultant/Advisory Board member of Danone Nutricia Research, Ironwood, Biocodex, Genetic Analysis AS, Tillotts, Takeda, Kyowa Kirin, AbbVie, BioGaia, and Cinclus Pharma, and received speaker's fee from Tillotts, Kyowa Kirin, Takeda, Biocodex, Sanofi, AbbVie, Janssen Immunology, Pfizer, Ferrer, BioGaia, Renapharma, Mayoly, and Bromatech. J.B. was an employee of Grunenthal GmbH until March 2022 and thereafter worked as an independent consultant in pharma under the umbrella of JBPharmaConsult. Z.M. has received research funding from ZonMw, MLDS, Niels Stensen Fellowship, TKI (private-public partnership), and Galapagos, participated in advisory boards of Johnson & Johnson, Lilly, Pfizer, and AbbVie, and received speaker's fee from Galapagos, Takeda, and Lilly (paid to host institute). H.T. has participated as a Consultant/Advisory Board member for Cinclus Pharma, Dr Falk Gmbh, PRO.MED.CS, and VIPUN and received speaker's fee from Tillotts, Takeda, and Shire. D.K. has received research funding from ZonMw, MLDS, UEG, Rome Foundation, Horizon Europe, Horizon 2020, Grunenthal, and Allergan and speaker's fee from Dr Falk (paid to host institute).

Data transparency statement: Individual participant data will not be available for sharing. Other document—i.e., study protocol, statistical analysis plan, and analytic code—will be available immediately after publication with no end date for researchers who provide a methodologically sound proposal with the purpose of achieving aims in the approved proposal. Proposals and requests should be directed to m.bosman@maastrichtuniversity.nl to gain access; data requestors will need to sign a data access agreement.

Clinical trial registry: Studies were registered in the US National Library of Medicine: NCT02880722 and NCT03336034.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Data collection during a period with ESM assessments, end-of-day diaries, and end-of-week questionnaires. ESM, experience sampling method.
Figure 2.
Figure 2.
Two examples of questions as asked in the ESM-PROM application (a: assessment of abdominal pain and b: assessment of feeling stressed). ESM, experience sampling method; PROM, patient-reported outcome measure.
Figure 3.
Figure 3.
Daily end-of-day diary scores and mean and maximum ESM scores for abdominal pain (on an 11-point NRS). Differences tested using linear mixed-effects models are shown in Table 3 (N = 162). ESM, experience sampling method; NRS, numeric rating scale.
See this image and copyright information in PMC

References

    1. Lacy BE, Mearin F, Chang L, et al. . Bowel disorders. Gastroenterology 2016;150(6):1393–407.e5. - PubMed
    1. Mearin F, Lacy BE. Diagnostic criteria in IBS: Useful or not? Neurogastroenterol Motil 2012;24(9):791–801. - PubMed
    1. Tack J, Carbone F, Chang L, et al. . Patient reported outcomes in disorders of gut-brain interaction. Gastroenterology 2024;166(4):572–87.e1. - PubMed
    1. U.S. Department of Health and Human Services FDA. Guidance for industry irritable bowel syndrome–clinical evaluation of drugs for treatment. U.S. Food and Drug Administration: Silver Spring, MD, 2012.
    1. European Medicines Agency (EMA). Guideline on the Evaluation of Medicinal Products for the Treatment of Irritable Bowel Syndrome. EMA: London, UK, 2013.

LinkOut - more resources