Development of the Diary for Irritable Bowel Syndrome Symptoms to Assess Treatment Benefit in Clinical Trials: Foundational Qualitative Research

Abstract

Results support the content validity of the IBS patient-reported outcome measures. A pilot study was recently initiated to inform item reduction, develop scoring algorithms, and provide preliminary psychometric information. Comprehensive psychometric evaluation and responder definition development will follow.

Cognitive and Behavioral Differences Between Subtypes in Refractory Irritable Bowel Syndrome

“…The possibility of measurement bias nevertheless highlights the importance of developing measures that account for the experience of each bowel subtype in IBS. This is increasingly recognized amongst researchers and collaborative working groups in IBS with regards to outcome measures (Fehnel et al, 2017). Our findings suggest that this is important also for psychological and process measures developed for IBS.…”

“…The importance of cognitions and behaviors in maintaining symptoms is recognized across CBT protocols, but little research has been conducted into the differential role these may have across the IBS subtypes. Each subtype has a unique set of symptoms (Fehnel et al, 2017;Marquis et al, 2014) associated with specific perceptual experiences (Rønnevig, Vandvik, & Bergbom, 2009). For example, diarrhea is associated with urgency and unpredictability (Drossman et al, 2009;Drossman et al, 2011;Håkanson, 2014;Rønnevig et al, 2009), while constipation may be associated with straining (Håkanson, 2014;Rønnevig et al, 2009).…”

“…developments in IBS subtype specific outcome measures demonstrates the importance and utility of tailoring such measures (Fehnel et al, 2017). Furthermore, a qualitative study could explore specific motivations for behavioral responses to particular symptoms.…”

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

“…Recently, the ‘Diary for irritable bowel syndrome symptoms’ was developed by the patient‐reported outcome consortium ibs working group (PRO Consortium IBS‐WG) . The conceptual framework for this 24‐hour diary is based on two core symptoms: abdominal symptoms and bowel movement‐related symptoms.…”

“…Focus groups revealed that problems with swallowing are not very frequently encountered in the context of IBS. Bowel incontinence might occur, but was not reported by the majority of IBS patients and was therefore thought not generalizable to the target population of the ESM-PROM.Recently, the 'Diary for irritable bowel syndrome symptoms' was developed by the patient-reported outcome consortium ibs working group (PRO Consortium IBS-WG) 40. The conceptual framework for this 24-hour diary is based on two core symptoms: abdominal symptoms and bowel movement-related symptoms.…”