Development, content validity, and cross‐cultural adaptation of a patient‐reported outcome measure for real‐time symptom assessment in irritable bowel syndrome

Abstract

An ESM-based PROM, suitable for momentary assessment of IBS symptom patterns was developed, taking into account content validity and cross-cultural adaptation. This PROM will be implemented in a specifically designed smartphone application and further validation in a multicenter setting will follow.

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

“…Selection and inclusion of psychological items was extensively discussed as these ESM psychological items have not been validated before in patients with gastrointestinal disorders. Item selection was therefore performed based on a recent publication evaluating psychometric validation properties of the ESM in patients with mental disorders, the previously developed ESM‐IBS questionnaire, together with patients’ opinion in focus group interviews …”

“…For development of this framework, an extensive systematic literature search was performed to obtain available retrospective questionnaires for selection of FD‐specific items . Moreover, ESM‐specific constructs (ie, psychological status, social, and contextual factors) were derived from previously used ESM questionnaires at the departments of Gastroenterology and Hepatology, and Psychiatry and Psychology of Maastricht University Medical Center (MUMC+) …”

The development of a patient‐reported outcome measure for real‐time symptom assessment in a population with functional urologic complaints—A focus group study

“…The development of the questions to be used in “Uromate”, started with an initial draft based on a theoretical framework from the literature . Items concerning social factors, contextual, and environmental factors and psychological status following the ESM specific construct, were derived from questions used in previous ESM validation studies . A specific list of questions that incorporated urological complaints like urgency and frequency were compiled by our research team.…”

“…ESM has already proven its clinical value to assess affective states and the influence of contextual factors at the level of individual subjects in psychiatric patients with affective disorders . Moreover, ESM has been successfully piloted in IBS patients, where ESM has been proven to provide more accurate information about IBS symptoms than current assessment with retrospective questionnaires . The purpose of the urological ESM is to investigate the multifactorial character of OAB, as well to assess symptom triggers to better select adequate treatment options.…”

The Experience Sampling Method—Evaluation of treatment effect of escitalopram in IBS with comorbid panic disorder

“…The ESM is an electronic assessment method, which collects data repeatedly at random moments over the day, during several consecutive days. The assessments focus on the in‐the‐moment physical and mental state of the subject, in the natural environment . Considerable differences between real‐time and end‐of‐day abdominal pain scores were demonstrated in a cross‐sectional study, raising the question of whether real‐time symptom assessment may be superior to retrospective methods in the detection of treatment response in IBS patients .…”