BACKGROUND & AIMS Standardized instruments are needed to assess the activity of eosinophilic esophagitis (EoE), to provide endpoints for clinical trials and observational studies. We aimed to develop and validate a patient-reported outcome (PRO) instrument and score, based on items that could account for variations in patients’ assessments of disease severity. We also evaluated relationships between patients’ assessment of disease severity and EoE-associated endoscopic, histologic, and laboratory findings. METHODS We collected information from 186 patients with EoE in Switzerland and the US (69.4% male; median age, 43 years) via surveys (n = 135), focus groups (n = 27), and semi-structured interviews (n = 24). Items were generated for the instruments to assess biologic activity based on physician input. Linear regression was used to quantify the extent to which variations in patient-reported disease characteristics could account for variations in patients’ assessment of EoE severity. The PRO instrument was prospectively used in 153 adult patients with EoE (72.5% male; median age, 38 years), and validated in an independent group of 120 patients with EoE (60.8% male; median age, 40.5 years). RESULTS Seven PRO factors that are used to assess characteristics of dysphagia, behavioral adaptations to living with dysphagia, and pain while swallowing accounted for 67% of the variation in patients’ assessment of disease severity. Based on statistical consideration and patient input, a 7-day recall period was selected. Highly active EoE, based on endoscopic and histologic findings, was associated with an increase in patient-assessed disease severity. In the validation study, the mean difference between patient assessment of EoE severity and PRO score was 0.13 (on a scale from 0 to 10). CONCLUSIONS We developed and validated an EoE scoring system based on 7 PRO items that assesses symptoms over a 7-day recall period. Clinicaltrials.gov number: NCT00939263.

SUMMARY BackgroundEosinophilic oesophagitis (EoO) is a chronic disease characterised by significant symptoms and challenging treatment regimens. Health-related quality of life (HRQOL) is a useful way to direct patient care. EoO symptoms and treatment may impact patient HRQOL. Currently, there is no reliable and valid measure of adult EoO patient HRQOL.

Background Perceived stigma has been linked to disease outcome in several chronic illnesses. Stigmatization of illness often leads to increased psychological distress and poorer quality of life. While body stigma has been identified as a specific inflammatory bowel disease (IBD) patient concern, no study to date has systematically investigated the presence of stigma in IBD or its effects on disease course and management. Methods Participants were recruited online and through the Illinois chapter of the Crohn’s & Colitis Foundation of America. A screening measure was used to identify an established IBD diagnosis. Patients completed the Perceived Stigma Scale in IBS, Inflammatory Bowel Disease Questionnaire, Rosenberg Self-Esteem Scale, General Self-Efficacy Scale, the Brief Symptom Inventory, and the Rating Form of IBD Patient Concerns. Results A total of 211 patients (156 CD, 55 UC) with a confirmed diagnosis for a minimum of 6 months completed the study. Eighty-four percent of participants reported perceived stigma. Hierarchical regression demonstrated that perceived stigma accounted for 10%–22% of the variance in health-related quality of life scores, 4%–16% for psychological distress, 5% for medication adherence, 19% for self-esteem, and 8% for self-efficacy. Effect sizes were small, but comparable with more traditionally evaluated patient variables. Conclusions The majority of IBD patients report some perceived stigmatization. These results suggest that perceived stigma is a significant predictor of poorer outcomes in patients with IBD when controlling for illness and demographic variables. Perceived stigma is a potentially important psychosocial factor in IBD patient care and warrants further investigation.

Summary Background Psychotherapy is not routinely recommended for in ulcerative colitis (UC). Gut-directed hypnotherapy (HYP) has been linked to improved function in the gastrointestinal tract and may operate through immune-mediated pathways in chronic diseases. Aims To determine the feasibility and acceptability of hypnotherapy and estimate the impact of hypnotherapy on clinical remission status over a 1 year period in patients with an historical flare rate of 1.3 times per year. Methods 54 patients were randomized at a single site to 7 sessions of gut-directed hypnotherapy (N = 26) or attention control (CON; N = 29) and followed for 1 year. The primary outcome was the proportion of participants in each condition that had remained clinically asymptomatic (clinical remission) through 52 weeks post-treatment. Results One-way ANOVA comparing hypnotherapy and control subjects on number of days to clinical relapse favored the hypnotherapy condition [F = 4.8 (1, 48), p = .03] by 78 days. Chi square analysis comparing the groups on proportion maintaining remission at 1 year was also significant [X2(1) = 3.9, p = .04], with 68% of hypnotherapy and 40% of control patients maintaining remission for 1 year. There were no significant differences between groups over time in quality of life, medication adherence, perceived stress or psychological factors. Conclusions This is the first prospective study that has demonstrated a significant effect of a psychological intervention on prolonging clinical remission in patients with quiescent UC. Clinical Trial # NCT00798642

Summary Background Knowledge about determinants of quality of life (QoL) in eosinophilic oesophagitis (EoO) patients helps to identify patients at risk of experiencing poor QoL and to tailor therapeutic interventions accordingly. Aim To evaluate the impact of symptom severity, endoscopic and histological activity on EoE‐specific QoL in adult EoE patients. Methods Ninety‐eight adult EoE patients were prospectively included (64% male, median age 39 years). Patients completed two validated instruments to assess EoE‐specific QoL (EoO‐QoL‐A) and symptom severity (adult EoE activity index patient‐reported outcome) and then underwent esophagogastroduodenoscopy with biopsy sampling. Physicians reported standardised information on EoE‐associated endoscopic and histological alterations. The Spearman's rank correlation coefficient was calculated to determine the relationship between QoL and symptom severity. Linear regression and analysis of variance was used to quantify the extent to which variations in severity of EoE symptoms, endoscopic and histological findings explain variations in QoL. Results Quality of life strongly correlated with symptom severity (r = 0.610, P < 0.001). While the variation in severity of symptoms, endoscopic and histological findings alone explained 38%, 35% and 22% of the variability in EoE‐related QoL, respectively, these together explained 60% of variation. Symptom severity explained 18–35% of the variation in each of the five QoL subscale scores. Conclusions Eosinophilic oesophagitis symptom severity and biological disease activity determine QoL in adult patients with eosinophilic oesophagitis. Therefore, reduction in both eosinophilic oesophagitis symptoms as well as biological disease activity is essential for improvement of QoL in adult patients. http://Clinicaltrials.gov number, NCT00939263.

Background Esophageal dysphagia is common in gastroenterology practice and has multiple etiologies. A complication for some patients with dysphagia is food impaction. A valid and reliable questionnaire to rapidly evaluate esophageal dysphagia and impaction symptoms can aid the gastroenterologist in gathering information to inform treatment approach and further evaluation, including endoscopy. Methods 1,638 patients participated over two study phases. 744 participants completed the Brief Esophageal Dysphagia Questionnaire (BEDQ) for phase 1; 869 completed the BEDQ, Visceral Sensitivity Index, Gastroesophageal Reflux Disease Questionnaire, and Hospital Anxiety and Depression Scale for phase 2. Demographic and clinical data were obtained via the electronic medical record. The BEDQ was evaluated for internal consistency, split-half reliability, ceiling and floor effects, and construct validity. Key Results The BEDQ demonstrated excellent internal consistency, reliability, and construct validity. The symptom frequency and severity scales scored above the standard acceptable cutoffs for reliability while the impaction subscale yielded poor internal consistency and split-half reliability; thus the impaction items were deemed qualifiers only and removed from the total score. No significant ceiling or floor effects were found with the exception of 1 item, and inter-item correlations fell within accepted ranges. Construct validity was supported by moderate yet significant correlations with other measures. The predictive ability of the BEDQ was small but significant. Conclusions & Inferences The BEDQ represents a rapid, reliable and valid assessment tool for esophageal dysphagia with food impaction for clinical practice that differentiates between patients with major motor dysfunction and mechanical obstruction.

Self-efficacy (SE) is a strong predictor of health outcomes in chronic diseases. The aim of the study was to develop a valid and reliable SE scale for adolescents and young adults with inflammatory bowel disease (IBD). Participants with IBD, 12 to 25 years' old, were recruited via outpatient gastroenterology clinics and online to provide demographic and clinical information and to complete psychosocial questionnaires. Reliability statistics, principle components factor analysis, and Pearson correlations with psychosocial variables assessed the psychometric properties of the IBD Self-efficacy Scale for Adolescents and Young Adults (IBDSES-A). A total of 95 participants completed the study. Internal consistency and split-half reliability of the IBDSES-A fell above the acceptable standard cutoff. Principle components factor analysis yielded 3 potential subscales. Test-retest reliability was excellent. Construct validity is supported by significant positive correlations with self-esteem and health-related quality of life, and negative correlations with depression and anxiety. IBDSES-A, a 13-item disease-specific scale to assess SE toward disease management, demonstrates good reliability and construct validity and could be a useful tool in understanding the role of SE in pediatric IBD self-management and outcomes.

OBJECTIVES: Symptoms are inconsistently associated with esophageal motor findings on high-resolution manometry (HRM). We aimed to evaluate predictors of dysphagia severity, including esophageal hypervigilance and visceral anxiety, among patients evaluated with HRM. METHODS: Adult patients undergoing HRM at 4 academic medical centers (United States and France) were prospectively evaluated. HRM was completed and analyzed per the Chicago Classification v3.0. Validated symptom scores, including the Brief Esophageal Dysphagia Questionnaire and Esophageal Hypervigilance and Anxiety Scale, were completed at the time of HRM. RESULTS: Two hundred thirty-six patients, aged 18–85 (mean 53) years, 65% female, were included. Approximately 59 (25%) patients had a major motor disorder on HRM: 19 achalasia, 24 esophagogastric junction outflow obstruction, 12 absent contractility, and 4 jackhammer. Approximately 177 (75%) patients did not have a major motor disorder: 71 ineffective esophageal motility and 106 normal motility. Having a major motor disorder was a significant predictor of dysphagia severity (R2adj = 0.049, P < 0.001), but the Esophageal Hypervigilance and Anxiety Scale score carried a predictive relationship of Brief Esophageal Dysphagia Questionnaire that was 2-fold higher than having a major motor disorder: R2adj = 0.118 (P < 0.001). This finding remained when evaluated by the major motor disorder group. HRM metrics were nonsignificant. DISCUSSION: In a prospective, international multicenter study, we found that esophageal hypervigilance and visceral anxiety were the strongest predictors of dysphagia severity among patients evaluated with HRM. Thus, an assessment of esophageal hypervigilance and visceral anxiety is important to incorporate when evaluating symptom severity in clinical practice and research studies.