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Background: Self-rating scales are frequently used to screen for anxiety and depression in patients with irritable bowel syndrome (IBS). Different cutoff values are recommended in literature, and guidelines have suggested the use of other screening instruments over time. The aim of this study was to assess the correlation between the most commonly used psychological screening instruments for anxiety and depression in IBS and to compare custom cutoff scores for these instruments. Methods: Irritable bowel syndrome patients (n = 192) completed several questionnaires including the Hospital Anxiety and Depression Scale (HADS, HADS-A and HADS-D subscale), Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7). Agreement at different cutoff points, for depressive and anxiety disorder, was assessed by use of the Gwet AC1 coefficient.Key Results: Hospital Anxiety and Depression Scale (HADS)-D and PHQ-9 scores, and HADS-A and GAD-7 scores showed high correlations (r s = 0.735 and r s = 0.805, respectively). For depressive disorder, a Gwet AC1 value of 0.829 was found when recommended cutoff points from literature were compared (PHQ-9 cutoff ≥10, HADS-D cutoff ≥8). For anxiety disorder, a Gwet AC1 value of 0.806 was found when recommended cutoff points from literature were compared (GAD-7 cutoff ≥10, HADS-A cutoff ≥8). Even higher agreements were found when higher HADS cutoff values were chosen, with impact on sensitivity and specificity. Conclusions & Inferences:Custom cutoff values deem the HADS subscales (HADS-D and HADS-A) concordant to PHQ-9 and GAD-7 scores. The choice of a cutoff value has substantial impact on sensitivity/specificity and is dependent on patient population, setting, and the purpose of use.

Purpose The Irritable Bowel Syndrome Quality of Life (IBS-QoL) questionnaire is a commonly used and validated IBS-specific QoL instrument. However, this questionnaire is in contrast to the EQ-5D-5L, not preference-based and as such does not allow calculation of QALYs. The objective of this study was to describe the convergent- and known-group validity of both questionnaires and to develop a mapping algorithm from EQ-5D-5L which enable IBS-QoL scores to be transformed into utility scores for use in economic evaluations. Methods We used data from two multicenter randomized clinical trials, which represented the estimation and external validation dataset. The convergent validity was investigated by examining correlations between the EQ-5D-5L and IBS-QoL and the known-group validity by calculating effect sizes. Ordinary least squares (OLS), censored least absolute deviations (CLAD), and mixture models were used in this mapping approach. Results 283 IBS patients were included (n = 189 vs. n = 84). Mean IBS-QoL score was 71.13 (SD 15.66) and mean EQ-5D-5L utility score was 0.73 (SD 0.19). The overall sensitivity of the IBS-QoL and EQ-5D-5L to discriminate between patient and disease characteristics was similar. CLAD model 4, containing the total IBS-QoL score and squared IBS-SSS (IBS severity scoring system), was chosen as the most appropriate model to transform IBS-QoL scores into EQ-5D-5L utility scores. Conclusion This study reports the development of an algorithm where the condition-specific questionnaire IBS-QoL can be used to calculate utility values for use in economic evaluations. Including a clinical measure, IBS-SSS, in the model improved the performance of the algorithm.

Background Irritable bowel syndrome (IBS) is a highly prevalent disorder with significant negative impact on quality of life of patients that results in high healthcare use and costs. Improving healthcare outcomes for IBS patients is warranted, however the exact needs of IBS patients with regard to therapy and control of symptoms are unknown. Methods Focus group interviews, using a two-stage model, were performed with twenty-three IBS patients meeting Rome III criteria and one mother of a patient, from four different regions from the Netherlands. Results Twenty-four participants were included of whom majority were female (n = 21), mean age was 43 years, and mean duration of IBS was 18 years. Five categories of patients’ perspectives were identified: clear communication, a multidisciplinary treatment team, centers of expertise, focus on scientific research and information about IBS that is widely available for patients. Conclusions Based on these findings we highlight the need for IBS care givers to take these key items into account in IBS care. These elements aid clinicians, but mostly patients, in coping and management of symptoms and subsequent healthcare outcomes, reducing overall healthcare use and costs.

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Background Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent adherence to a smartphone app used as symptom diary in a randomized clinical trial on irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time and provide useful information regarding possible symptom triggers, and they are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. Objective This study aimed to compare the adherence rates of a smartphone-based end-of-day diary and ESM for symptom assessment in IBS and functional dyspepsia (FD). Methods Data from 4 separate studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+8-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary for a 2+12-week (pretreatment + treatment) period, and an observational study in which patients completed ESM assessments using a smartphone app for 1 week. Adherence rates were compared between these 2 symptom sampling methods. Results In total, 25 patients with IBS and 15 patients with FD were included. Overall adherence rates for the end-of-day diaries were significantly higher than those for ESM (IBS: 92.7% vs 69.8%, FD: 90.1% vs 61.4%, respectively). Conclusions This study demonstrates excellent adherence rates for smartphone app–based end-of-day diaries as used in 2 separate clinical trials. Overall adherence rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuous sampling during longer clinical trials.

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.