Validation of the Laryngeal Cognitive-Affective Tool.

BACKGROUND & AIMS: Cognitive-affective processes, including hypervigilance and symptom-specific anxiety, may contribute to chronic laryngeal symptoms and are potentially modifiable; however, a validated instrument to assess these constructs is lacking. The aims of this study were to develop and validate the Laryngeal Cognitive-Affective Tool (LCAT) instrument. METHODS: This 2-phase single-center prospective study enrolled participants from November 2021 to June 2023. In the initial phase 1:1 patient cognitive interviews and multidisciplinary team consensus were conducted to develop the LCAT. In the second phase asymptomatic and symptomatic participants completed a series of questionnaires to examine psychometric properties of the LCAT. RESULTS: A total of 268 participants were included: 8 in the initial phase and 260 in the validation phase (56 asymptomatic; 204 symptomatic). A 15-item LCAT was developed. In the validation phase, mean total LCAT and hypervigilance/anxiety subscores were significantly higher in symptomatic versus asymptomatic participants (P < .01). The LCAT had excellent internal consistency (α = 0.942) and split-half reliability (Guttman = 0.853). Using a median split, a score of 33 or greater was defined as elevated. CONCLUSIONS: The 15-item LCAT evaluates laryngeal hypervigilance and symptom-specific anxiety among patients with laryngeal symptoms. It has excellent reliability and construct validity. The LCAT highlights burdensome cognitive-affective processes that can accordingly help tailor treatments.

Behavioral Therapy for Functional Heartburn: Recommendation Statements.

BACKGROUND & AIMS: Brain-gut behavior therapies (BGBT) are increasingly recognized as effective therapeutic interventions for functional heartburn. However, recommendations regarding candidacy for treatment, initial treatment selection, and navigating treatment non-response have not been established for functional heartburn specifically. The aim of this study was to establish expert-based recommendations for behavioral treatment in patients with functional heartburn. METHODS: The validated RAND/University of California, Los Angeles Appropriateness Method was applied to develop recommendations. A 15-member panel composed of 10 gastrointestinal psychologists and 5 esophageal specialists ranked the appropriateness of a series of statements on a 9-point interval scale over 2 ranking periods. Statements were within the following domains: pre-therapy evaluation, candidacy criteria for BGBT, selection of initial BGBT, role of additional therapy for initial non-response to BGBT, and role of pharmacologic neuromodulation. The primary outcome was appropriateness of each intervention based on the recommendation statements. RESULTS: Recommendations for psychosocial assessment (eg, hypervigilance, symptom-specific anxiety, health-related quality of life), candidacy criteria (eg, motivated for BGBT, acknowledges the role of stress in symptoms), and treatment were established. Gut-directed hypnotherapy or cognitive behavioral therapy were considered appropriate BGBT for functional heartburn. Neuromodulation and/or additional BGBT were considered appropriate in the context of non-response. CONCLUSIONS: Gut-directed hypnotherapy and/or cognitive behavioral therapy are recommended as appropriate behavioral interventions for heartburn symptoms, depending on clinical indication, specific gut-brain targets, and preferred treatment modality (pharmacologic vs non-pharmacologic). Pre-therapy evaluation of psychosocial processes and candidacy for BGBT are important to determine eligibility for referral to psychogastroenterology services.

Laryngeal Recalibration Therapy Improves Laryngopharyngeal Symptoms in Patients With Suspected Laryngopharyngeal Reflux Disease.

INTRODUCTION: Laryngopharyngeal symptoms such as cough, throat clearing, voice change, paradoxic vocal fold movement, or laryngospasm are hyper-responsive behaviors resulting from local irritation (e.g., refluxate) and heightened sympathetic tone. Laryngeal recalibration therapy (LRT) guided by a speech-language pathologist (SLP) provides mechanical desensitization and cognitive recalibration to suppress hyper-responsive laryngeal patterns. The aim of this study was to assess symptom response to LRT among patients with chronic laryngopharyngeal symptoms undergoing evaluation of gastroesophageal reflux disease (GERD). METHODS: Adults with chronic laryngopharyngeal symptoms referred for evaluation of GERD to a single center were prospectively followed. Inclusion criteria included ≥2 SLP-directed LRT sessions. Data from endoscopy, ambulatory reflux monitoring, and patient-reported outcomes were collected when available. The primary outcome was symptom response. RESULTS: Sixty-five participants completed LRT: mean age 55.4 years (SD 17.2), 46 (71%) female, mean body mass index 25.6 kg/m 2 (6.8), and mean of 3.7 (1.9) LRT sessions. Overall, 55 participants (85%) met criteria for symptom response. Specifically, symptom response was similar between those with isolated laryngopharyngeal symptoms (13/15, 87%) and concomitant laryngopharyngeal/esophageal symptoms (42/50, 84%). Among participants who underwent reflux monitoring, symptom response was similar between those with proven, inconclusive for, and no GERD (18/21 [86%], 8/9 [89%], 10/13 [77%]). DISCUSSION: Eighty-five percent of patients with chronic laryngopharyngeal symptoms referred for GERD evaluation who underwent LRT-experienced laryngeal symptom response. Rates of symptom response were maintained across patients with or without proven GERD and patients with or without concomitant esophageal reflux symptoms. SLP-directed LRT is an effective approach to incorporate into multidisciplinary management of chronic laryngopharyngeal symptoms/laryngopharyngeal reflux disease.

Food-related quality of life driven by hypervigilance and anxiety around eating in organic gastrointestinal conditions.

BACKGROUND: Food-related quality of life (FRQoL) measures the impact of diet, eating behaviours and food-related anxiety on quality of life. Patients often view food and eating as central to symptom management. This is the first study to examine FRQoL in patients with inflammatory bowel disease, celiac sprue, achalasia and eosinophilic oesophagitis. METHODS: A total of 289 adults aged ≥18 years completed self-report measures evaluating the use of dietary treatment, FRQoL and other psychosocial outcomes. Principal component factor analysis evaluated potential subscales within the Food-Related Quality of Life Scale (FRQoL-29), to date validated only with a total score. Univariate analyses investigated differences in FRQoL based on diagnosis, whereas correlations and hierarchical regression identified relationships between FRQoL and psychosocial outcomes. RESULTS: Factor analysis revealed four subscales within the FRQoL-29, with hypervigilance around eating being the primary driver in total score. Patients reported substantial impacts of FRQoL, with those not using diet therapy scoring significantly higher for FRQoL than those on a diet with and without the support of a registered dietitian (RD). Both social (r = 0.41, p < 0.001) and physical (r = 0.31, p < 0.001) domains of health-related quality of life were higher in patients with greater FRQoL. CONCLUSION: FRQoL is significantly degraded in patients with organic gastrointestinal illness diseases, and hypervigilance around food appears to contribute most to this. Use of dietary treatment and meeting with an RD were associated with lower FRQoL, though it is unclear if patients sought RD assistance before FRQoL declined. Future studies on the relationship between dietary treatment, RD support and FRQoL are warranted.

When Is Patient Behavior Indicative of Avoidant Restrictive Food Intake Disorder (ARFID) Vs Reasonable Response to Digestive Disease?

BACKGROUND & AIMS: Dietary modification is common in patients with digestive diseases to improve symptoms; however, food avoidance can become problematic. Avoidant Restrictive Food Intake Disorder (ARFID) is characterized as failure to meet one's nutritional needs owing to sensory hypersensitivity, lack of interest in eating, or fear of aversive consequences from eating, and is associated with negative medical and psychosocial outcomes. This study characterizes ARFID behaviors in adults with achalasia, celiac sprue, eosinophilic esophagitis, and inflammatory bowel disease. METHODS: In this cross-sectional study, 289 adults aged 18 and older completed self-report measures evaluating use of dietary treatment, ARFID symptoms, and psychosocial outcomes. Primary analyses investigated the occurrence of ARFID in patients with achalasia, celiac, eosinophilic esophagitis, and inflammatory bowel disease. Secondary analyses explored the associations between ARFID symptoms and clinical and psychosocial outcomes. RESULTS: More than half (53.7%) of the total sample met the diagnostic criteria for ARFID based on the Nine-Item ARFID Screen (NIAS), with 78.4% of patients with achalasia meeting criteria. Patients on a physician-directed diet showed greater fear of gastrointestinal symptoms (P = .025), less interest in food (P = .046), and a higher total NIAS score (P = .045). For patients using dietary therapy, those who had met with a dietitian reported higher NIAS scores (P = .039). Food avoidance/restriction was associated with increased anxiety and depression, and diminished health-related quality of life. CONCLUSIONS: It is likely that ARFID rates, as measured by the NIAS, are inflated in these 4 patient groups. These findings highlight the need for updated assessments of ARFID in patients with complex digestive diseases.

Esophageal Hypervigilance and Symptom-Specific Anxiety in Patients with Eosinophilic Esophagitis.

BACKGROUND & AIMS: Patient symptom reporting often does not correlate with the pathophysiological markers of esophageal disease, including eosinophilic esophagitis (EoE). Esophageal hypervigilance and symptom-specific anxiety are emerging as important considerations in understanding symptom reporting. As such, we aimed to conduct the first study of these constructs in EoE. METHODS: A retrospective review of an EoE patient registry was conducted and included eosinophils per high power field (from esophagogastroduodenoscopy biopsy: proximal, distal), endoscopic reference score, distal distensibility plateau (functional luminal imaging probe), Brief Esophageal Dysphagia Questionnaire, Visual Dysphagia Question of EoE Activity Index, Northwestern Esophageal Quality of Life scale, and the Esophageal Hypervigilance and Anxiety Scale. Correlational and regression analyses evaluated relationships of hypervigilance and anxiety with Brief Esophageal Dysphagia Questionnaire, Visual Dysphagia Question of EoE Activity Index, and Northwestern Esophageal Quality of Life scale when controlling for histology and endoscopic severity. RESULTS: One hundred and three patients had complete data, 69.9% were male, and the mean (SD) age was 40.66 (13.85) years. Forty-one percent had elevated dysphagia and 46% had elevated hypervigilance and anxiety. Esophageal symptom-specific anxiety emerged as the most important predictor of Brief Esophageal Dysphagia Questionnaire severity (44.8% of the variance), Visual Dysphagia Question of EoE Activity Index severity (26%), and poor health-related quality of life (HRQoL) (55.3%). Hypervigilance was also important, but to a lesser extent. Pathophysiological variables did not significantly predict symptoms or HRQoL. Recent food impaction can predict symptom-specific anxiety and proton pump inhibitor use can reduce hypervigilance. CONCLUSIONS: Hypervigilance and symptom-specific anxiety are important for our understanding of self-reported patient outcomes in EoE. These processes outweigh endoscopic and histologic markers of EoE disease activity across dysphagia, difficulty eating, and HRQoL. Clinicians should assess hypervigilance and anxiety, especially in patients with refractory symptoms and poor HRQoL.

Validation of the Short-Form Esophageal Hypervigilance and Anxiety Scale.

BACKGROUND & AIMS: Esophageal hypervigilance and anxiety are emerging as important drivers of dysphagia symptoms and reduced quality of life across esophageal diagnoses. The esophageal hypervigilance and anxiety scale (EHAS) is a validated measure of these cognitive-affective processes. However, its length may preclude it from use in clinical practice. We aimed to create a short form version of the EHAS using established psychometric practices. METHODS: A retrospective review of a registry of patients who visited a university-based esophageal motility clinic for diagnostic testing was conducted. Patients were included if they completed the 15-item EHAS and questionnaires assessing dysphagia severity and health-related quality of life (HRQOL) at the time of motility testing. Principle components factor analysis identified items for possible removal. Tests for reliability and concurrent validity were performed on the full EHAS and short-form version (EHAS-7). RESULTS: 3,976 adult patients with confirmed esophageal disease were included: 30% with achalasia or EGJOO, 13% with EoE, 13% with GERD, 39% normal motility. Eight items were removed from the scale based on a factor loading of > 0.70, resulting in a single scale 7-item EHAS-7 scored from 0 to 28. The EHAS-7 demonstrated excellent internal consistency (α = 0.91) and split-half reliability (0.88) as was found in the full EHAS in the current study and prior validation. Concurrent validity existed between the EHAS-7 and measures of dysphagia (r = 0.33) and HRQOL (r = -0.73, both P < .001). CONCLUSIONS: The EHAS-7 is a 7-item scale to assess esophageal hypervigilance and symptom-specific anxiety that performs as well as the original 15-item version. Shorter questionnaires allow for implementation in clinical practice. The EHAS-7 is a useful tool for clinicians to quickly assess how hypervigilance and anxiety may be contributing to their patients' clinical presentations.

Validation in French of the Brief Esophageal Dysphagia Questionnaire in Patients Referred For Esophageal Manometry.

A brief esophageal dysphagia questionnaire (BEDQ) was recently developed in English to evaluate frequency and intensity of dysphagia. Our aim was to validate this questionnaire in French in a cohort of patients referred for esophageal manometry. Patients referred for esophageal high resolution manometry were offered to fill out different questionnaires including Eckart score, GERDQ score and BEDQ. BEDQ was translated in French by two French native speakers and experts in esophageal motility. Patients were grouped according to the indications of esophageal high resolution manometry (dysphagia, GERD, others). The total BEDQ score was calculated and compared between groups. The validation method used the assessment of internal consistency with Cronbach's alpha and reliability with Guttman split-half reliability. BEDQ questionnaire was completed by 608 patients (44% males, mean age 54 years). The total score had an excellent internal consistency (Cronbach's alpha = 0.90) and reliability (Guttman statistic = 0.92). The correlation was good with Eckardt score (r = 0.65, p < 0.001) but poor with the GERDQ score (r = 0.21, p < 0.01). Patients referred for dysphagia (n = 197) had an Eckardt score and a BEDQ score significantly higher than those referred for GERD or other indications (5.48 vs 3.65 and 3.53 respectively for Eckardt score and 15.85 vs 4.64 and 5.78 for BEDQ, p < 0.001). BEDQ is a valid questionnaire in French to assess dysphagia in clinical practice. It remains to be determined if this score is sensitive to symptom variation and thus useful for the follow up of patients with dysphagia.

Patient Perspectives on Medical Trauma Related to Inflammatory Bowel Disease.

Post-traumatic stress symptoms (PTSS) in response to medical trauma are understudied in inflammatory bowel disease (IBD). Two studies identify surgery, hospitalizations, and disease severity as risk factors. We aimed to document IBD-related patient experiences and how these relate to PTSS via a qualitative study. Adult patients with confirmed IBD recruited from two gastroenterology clinics underwent a semi-structured interview with a psychologist and completed the Post Traumatic Stress Disorder Symptom Scale for DSM5 (PSSI-5). Interviews were analyzed using an interpretive phenomenological approach. Themes and subthemes with representative quotations were documented based on thematic saturation. 16 participants, five met PSSI-5 criteria for PTSD. Five themes emerged: disease uncertainty, information exchange/quality, medical procedures, surgery, and coping. Patients with IBD may experience medical PTSS from several sources. Information, communication, and trust in clinicians is vital but may be sub-optimal. Both adaptive and maladaptive coping strategies are used to mitigate PTSS.

Social media in inflammatory bowel disease: the patient and physician perspective.

PURPOSE OF REVIEW: Social media use by patients with inflammatory bowel disease (IBD) and their respective providers continues to increase, promoting disease awareness and scholarship. In this review article, we summarize the current literature regarding social media use and IBD, discuss both the patient and physician perspective, and provide guidance to avoid commonly encountered pitfalls. RECENT FINDINGS: Patients and providers commonly rely on social media to share medical information, advocate for improved IBD care, and to network and collaborate on common research interests. This shift from more traditional formats of education and networking continues to grow exponentially, and even more rapidly so during the COVID-19 pandemic. SUMMARY: Social media use in the IBD community will continue to grow and lead to further innovation. Providers should be aware of social media as a valuable tool for their patients and themselves.

Esophageal Hypervigilance and Visceral Anxiety Are Contributors to Symptom Severity Among Patients Evaluated With High-Resolution Esophageal Manometry.

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 (Radj = 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: Radj = 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.

Food-related quality of life in patients with inflammatory bowel disease and irritable bowel syndrome.

BACKGROUND: Food-related quality of life (FRQoL) evaluates the impact of diet, eating behaviors, and food-related anxiety on a person's quality of life. This is the first study to evaluate FRQoL in inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS), two illnesses where food and diet are of importance. METHODS: One hundred seventy-five participants (80 IBS, 95 IBD) participated in the study by completing measures evaluating FRQoL, psychological distress, and health-related quality of life. Primary analyses evaluated differences in FRQoL between IBD and IBS patients. Secondary analyses compared differences based on remission status, dietary use, and dietary consultation, as well as evaluated potential predictors of FRQoL. RESULTS: IBD patients in remission report the highest FRQoL (IBD-remission: 91.2 (26.5) vs. IBD-active: 67.7 (19.6) and IBS-active: 67.6 (18.3), p < .001). Using more dietary treatments is associated with decreased FRQoL for IBS (r = - 0.23, p < .05) and IBD patients (r = - 0.31, p < .01). IBS patients are more likely to use dietary treatments than IBD (IBS = 81% vs. IBD = 64%, p < .01), with self-directed diets being the most commonly used approach. Symptom severity is the strongest predictor of FRQoL in both groups (IBD: R2 = .27, p < .01; IBS: R2 = .23, p < .001). CONCLUSION: FRQoL is a unique construct for IBD and IBS patients that can be influenced by several clinical and dietary factors, including number of diets and type of diet used, depending on the diagnosis. Thus, FRQoL should be considered when working with both IBD and IBS patients.

Inflammatory Bowel Disease Patient Experiences with Psychotherapy in the Community.

This study aimed to characterize patient expectations for integrating mental health into IBD treatment, describe experiences with psychotherapy, and evaluate therapy access and quality. Adults with IBD were recruited online and via a gastroenterology practice. Participants, 162 adults with IBD, completed online questionnaires. The sample was primarily middle-aged, White, and female. Sixty percent had Crohn's Disease. Disease severity was mild to moderate; 38% reported utilizing therapy for IBD-specific issues. The greatest endorsed barrier to psychotherapy was its cost. Psychotherapy was perceived as leading to modest gains in quality of life, emotional well-being, and stress reduction. Participants reported a disparity between their desire for mental health discussions and their actual interactions with providers. The majority of participants (81%) stated there are insufficient knowledgeable therapists. A significant number of patients with IBD endorsed the desire for mental health integration into care. Disparities exist in reported provider-patient communication on these topics. There appears to be a dearth of IBD-knowledgeable therapists in the community.

Impact on Health-Related Quality of Life in Adults with Eosinophilic Gastritis and Gastroenteritis: A Qualitative Assessment.

BACKGROUND: Eosinophilic gastritis (EG) and eosinophilic gastroenteritis (EGE) are chronic immune-mediated conditions of the digestive tract, which affect the stomach only, or the stomach and small intestines, respectively. Though these disorders are uncommon, they are being increasingly recognized and diagnosed. While health-related quality of life (HRQOL) has been evaluated in other eosinophilic gastrointestinal diseases, this study is the first to describe HRQOL impacts unique to EG/EGE. AIMS: This study aims to qualitatively describe experiences of adults diagnosed with EG and EGE. We aim to identify impacts on HRQOL in this population in order to inform clinical care and assessment. METHODS: Seven patients diagnosed with EG or EGE participated in semi-structured interviews assessing common domains of HRQOL. RESULTS: Four distinct themes emerged from qualitative analyses, which represent impacts to HRQOL: the psychological impact of the diagnosis, impact on social relationships, financial impact, and impact on the body. These generally improved over time and with effective treatment. CONCLUSIONS: This study demonstrated that patients with EG/EGE experience impacts to HRQOL, some of which differ from HRQOL of other eosinophilic gastrointestinal diseases. These results support the development of a disease-specific measure, or adaptation of an existing measure, to assess HRQOL in EG/EGE.

Assessing Adherence and Barriers to Long-Term Elimination Diet Therapy in Adults with Eosinophilic Esophagitis.

BACKGROUND: The six-food elimination diet (SFED) is an effective treatment approach for eosinophilic esophagitis (EoE), but it can be challenging and affect patients' quality of life. AIM: Assess patients' long-term adherence to SFED and potential factors influencing adherence. METHODS: EoE patients were recruited online via multiple platforms. Patients were classified as reaching the maintenance stage if they responded to SFED and identified specific trigger foods by reintroduction. Maintenance stage patients were categorized into those actively following the elimination diet (ACTIVE) and those no longer on their prescribed diet (FORMER). Participants completed a study-specific questionnaire assessing patient experiences related to SFED use. RESULTS: Forty-two participants were identified as having reached the SFED's maintenance stage. 57% (24/42) of the maintenance stage patients were ACTIVE users. FORMER users rated the SFED's effectiveness at treating symptoms (5.45 ± 3.96, 10 max.) lower than ACTIVE users (8.29 ± 2.76, p = .02). A greater percentage of FORMER users (100%) agreed social situations create challenges in following the diet compared to ACTIVE users (67%, p < .05). Anxiety related to SFED was also higher among FORMER users (64%) compared to ACTIVE users (21%, p < .01). Both ACTIVE (95.8%) and FORMER (81.8%, NSS) users would recommend the elimination diet to other EoE patients. CONCLUSIONS: Understanding SFED adherence is multifactorial and complex. Factors influencing SFED adherence during long-term maintenance with diet therapy include diet effectiveness, social situations, and diet-related anxiety. Despite a lower than expected long-term adherence to maintenance of an elimination diet, the majority would recommend diet therapy as a treatment to other EoE patients.

Validation of a Self-efficacy Scale for Adolescents and Young Adults With Inflammatory Bowel Disease.

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.

Development of the Northwestern Esophageal Quality of Life Scale: A Hybrid Measure for Use Across Esophageal Conditions.

OBJECTIVES: Measures of health-related quality of life (HRQOL) in chronic esophageal conditions such as gastroesophageal reflux disease, eosinophilic esophagitis, and achalasia are widely used to measure this important patient-reported outcome. We seek to leverage these existing measures to create a hybrid measure of esophageal illness HRQOL (the Northwestern Esophageal Quality of Life-NEQOL), allowing for broad use across diseases while maintaining sensitivity to nuances of a specific condition. METHODS: A three-step, mixed-methods process per FDA guidelines for patient-reported outcome (PRO) development was followed: review and consolidation of existing HRQOL measure items into a single questionnaire, reliability and validity analyses (principle components factor analysis, Cronbach alpha, Guttman split-half, inter-item correlation, test-retest correlation, and Pearson's correlation with related constructs) based on responses from a representative sample of esophageal illness patients, and individual structured cognitive interviews with patients for item refinement and reduction. RESULTS: An initial 30-item measure was created. Two-hundred twelve patients completed the reliability and validity portion of the study, and 15 completed cognitive interviews. Factor analysis and item-reduction resulted in 11 items being removed from the NEQOL prior to patient interviews. Construct validity was supported by moderate and significant correlations with psychological distress and general HRQOL. Test-retest reliability was excellent. Following patient interviews, an additional 5 items were removed because of floor effects or participant feedback yielding a 14-item, single scale measure of HRQOL. CONCLUSIONS: Although more research is warranted, the NEQOL is a reliable and a valid hybrid measure of disease-specific HRQOL across several chronic esophageal conditions.