Development of a real-time patient-reported outcome measure for symptom assessment in patients with functional dyspepsia using the experience sampling method.

Fabiënne G M Smeets, Daniel Keszthelyi, Lisa Vork, Jan Tack, Nicholas J Talley, Magnus Simren, Qasim Aziz, Alexander C Ford, José M Conchillo, Joanna W Kruimel, Jim Van Os, Ad A M Masclee

Journal: Neurogastroenterology and motility 2020;31(2):e13496

PMID: 30393939

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Abstract

BACKGROUND

Patient-reported outcome measures (PROMs) are used to assess symptoms in patients with functional dyspepsia (FD). Current end-of-day questionnaires have several limitations including sensitivity to recall and ecological bias. The experience sampling method (ESM) is characterized by random and repeated assessments across momentary states in daily life and therefore less sensitive to these limitations. This study describes the development of a novel PROM based on ESM technology.

METHODS

An initial draft of the PROM was developed based on literature. Focus group interviews with FD patients according to Rome IV criteria, and an expert meeting with international opinion leaders in the field of functional gastrointestinal disorders were conducted in order to select items for the PROM. Cognitive interviews were performed to evaluate patients' understanding of the selected items and to create the definitive PROM.

KEY RESULTS

A systematic literature search revealed 59 items across four domains (ie, physical status; mood and psychological factors; context and environment; and nutrition, medication, and substance use). After patient focus group interviews and an international expert meeting, the number of items was reduced to 33. Cognitive interviews resulted in some minor linguistic changes in order to improve patients' understanding.

CONCLUSIONS AND INFERENCES

A novel digital ESM-based PROM for real-time symptom assessment in patients with functional dyspepsia was developed. This novel PROM has the potential to identify individual symptom patterns and specific triggers for dyspeptic symptoms, and optimize treatment strategies.

Address: Division of Gastroenterology and Hepatology, Department of Internal Medicine, Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands.; NUTRIM, School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands.; Department of Clinical and Experimental Medicine, Translational Research Center for Gastrointestinal Disorders (TARGID), University of Leuven, Leuven, Belgium.; Faculty of Health and Medicine, University of Newcastle, Callaghan, Australia.; Department of Internal Medicine and Clinical Nutrition, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.; Centre for Neuroscience and Trauma, Wingate Institute of Neurogastroenterology, Blizard Institute, Barts and the London School of Medicine & Dentistry, Queen Mary University of London, London, UK.; Leeds Gastroenterology Institute, Leeds Teaching Hospitals NHS Trust, Leeds, UK.; Leeds Institute of Biomedical and Clinical Sciences, University of Leeds, Leeds, UK.; Department of Psychiatry and Medical Psychology, Maastricht University Medical Center (MUMC+), Maastricht, The Netherlands.; Department of Psychiatry, Utrecht University Medical Centre, Utrecht, The Netherlands.; King's Health Partners Department of Psychosis Studies, King's College London, Institute of Psychiatry, London, UK.

DOI: 10.1111/nmo.13496

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https://doi.org/10.1111/nmo.13496

MeSH Terms: Dyspepsia, Humans, Patient Reported Outcome Measures, Symptom Assessment