Enhancing diversity, equity, inclusion, and accessibility in eosinophilic gastrointestinal disease research: the consortium for eosinophilic gastrointestinal disease researchers' journey.

In response to the social inequities that exist in health care, the NIH-funded Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) recently formed a diversity committee to examine systemic racism and implicit bias in the care and research of eosinophilic gastrointestinal diseases (EGIDs). Herein, we describe our process, highlighting milestones and issues addressed since the committee's inception, which we hope will inspire other researchers to enhance diversity, equity, inclusion, and accessibility (DEIA) in their fields. Our journey began by establishing mission and vision statements to define the purpose of the committee. Regular discussion of diversity-related topics was incorporated into existing meetings and web-based materials were shared. This was followed by educational initiatives, including establishing a library of relevant publications and a speaker series to address DEIA topics. We then established a research agenda focused on the following actionable items: (1) to define what is known about the demographics of EGIDs by systematic review of population-based studies; (2) to develop a practical tool for reporting participant demographics to reduce bias in EGID literature; (3) to examine health disparities in the care of individuals with eosinophilic esophagitis who present to the emergency department with an esophageal food impaction; (4) to examine how access to a gastroenterologist affects the conclusions of published research examining the prevalence of pediatric eosinophilic esophagitis; and (5) to develop a model for examining the dimensions of diversity, and provide a framework for CEGIR's ongoing projects and data capture. In addition to promoting consciousness of DEIA, this initiative has fostered inclusivity among CEGIR members and will continue to inspire positive changes in EGID care and research.

Diversity in Eosinophilic Gastrointestinal Disease Research To address systemic bias in patient care and research in eosinophilic gastrointestinal diseases, the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR) recently formed a diversity committee. The CEGIR diversity committee has defined its purpose through mission and vision statements and developed structured educational and research initiatives to enhance diversity, equity, inclusivity, and accessibility (DEIA) in all CEGIR activities. Here, we share the process of formation of our diversity committee, highlighting milestones achieved and summarizing future directions. We hope that this report will serve as a guide and an inspiration for other researchers to enhance DEIA in their fields.

Prospective Endoscopic Activity Assessment for Eosinophilic Gastritis in a Multisite Cohort.

INTRODUCTION: Eosinophilic gastritis (EG) is a chronic inflammatory disease of the stomach characterized by eosinophil-predominant gastric mucosal inflammation and gastrointestinal symptoms. The aim of this study was to prospectively evaluate endoscopic features in a large series of children and adults with EG to better understand the endoscopic manifestations and develop a standardized instrument for investigations. METHODS: Data were prospectively collected as part of the Consortium for Eosinophilic Gastrointestinal Disease Researchers, a national collaborative network. Endoscopic features were prospectively recorded using a system specifically developed for EG, the EG Endoscopic Reference System (EG-REFS). Correlations were made between EG-REFS and clinical and histologic features. RESULTS: Of 98 patients with EG, 65 underwent assessments using EG-REFS. The most common findings were erythema (72%), raised lesions (49%), erosions (46%), and granularity (35%); only 8% of patients with active histology (≥30 eosinophils/high-power field) exhibited no endoscopic findings. A strong correlation between EG-REFS scores and physician global assessment of endoscopy severity was demonstrated (Spearman r = 0.84, P < 0.0001). The overall score and specific components of EG-REFS were more common in the antrum than in the fundus or body. EG-REFS severity was significantly correlated with active histology, defined by a threshold of ≥30 eosinophils/high-power field (P = 0.0002). DISCUSSION: Prospective application of EG-REFS identified gastric features with a strong correlation with physician global assessment of endoscopic activity in EG. Endoscopic features demonstrated greater severity in patients with active histology and a predilection for the gastric antrum. Further development of EG-REFS should improve its utility in clinical studies.

High Patient Disease Burden in a Cross-sectional, Multicenter Contact Registry Study of Eosinophilic Gastrointestinal Diseases.

OBJECTIVES: Clinical features of eosinophilic esophagitis (EoE) have been well-described in the literature, however, characterization of features experienced by patients with other eosinophilic gastrointestinal diseases (EGIDs) is lacking. Using data collected from a patient contact registry, we sought to characterize and contrast patient-reported gastrointestinal and extragastrointestinal symptoms and comorbidities in non-EoE EGIDs, including eosinophilic gastritis, gastroenteritis and colitis, relative to EoE. METHODS: We conducted a cross-sectional study of contact registry data collected from 2015 to 2018. Statistical comparisons were made using chi-square (categorical measures) and the Mann-Whitney U test (continuous measures). Multivariable analyses were used to evaluate associations between treatment and feelings of isolation. RESULTS: Of the 715 reporting an EGID diagnosis (n = 525 EoE; n = 190 non-EoE EGID), a higher proportion of those with a non-EoE EGID reported more frequent specific and nonspecific gastrointestinal symptoms, including nausea, abdominal pain, diarrhea, constipation, and bloating (P < 0.01 for all). Participants with a non-EoE EGID were more likely to report higher frequency of fatigue, isolation, and deep muscle or joint pain (P < 0.01 for all). Specific food elimination and elemental formula treatments were associated with increased odds of more frequent (at least weekly) feelings of isolation for participants with EoE (adjusted odds rtaio [aOR]: 2.4; 95% confidence interval [CI]: 1.5--4.1 for specific food elimination and adjusted OR: 1.9; 95% CI: 1.2--3.3 for elemental formula). CONCLUSIONS: Significant differences exist in the symptoms and comorbidities experienced between those with EoE versus non-EoE EGIDs. Additional investigation is needed to elucidate the factors that may contribute to the high disease burden of these poorly understood conditions.

Variation in Endoscopic Activity Assessment and Endoscopy Score Validation in Adults With Eosinophilic Esophagitis.

BACKGROUND & AIMS: Eosinophilic esophagitis (EoE) is assessed endoscopically (endoscopic activity), based on grades of edema, rings, exudates, furrows, and strictures (EREFS). We examined variations in endoscopic assessments of severity, developed and validated 3 EREFS-based scoring systems, and assessed responsiveness of these systems using data from a randomized placebo-controlled trial of patients with EoE. METHODS: For the development set, 5 gastroenterologists reviewed EREFS findings from 266 adults with EoE and provided endoscopist global assessment scores (EndoGA, scale of 0 to 10); variation (ΔEndoGA) was assessed using linear regression. We evaluated simple scores (features given arbitrary values from 0 to 3) and developed 2 scoring systems (adjusted score range, 0-100). We then fitted our linear regression model with mean EndoGA to data from 146 adults recruited in centers in Switzerland and the United States between April 2011 and December 2012. For the validation set, we collected data from 120 separate adults (recruited in centers in Switzerland and the United States between May 2013 and July 2014), assessing regression coefficient-based scores using Bland-Altman method. We assessed the responsiveness of our scoring systems using data from a randomized trial of patients with EoE given fluticasone (n=16) or placebo (n=8). RESULTS: The distribution of EndoGA values differed among endoscopists (mean ΔEndoGA, 2.6±1.8; range 0-6.6). We developed 2 regression-based scoring systems to assess overall and proximal and distal esophageal findings; variation in endoscopic features accounted for more than 90% of the mean EndoGA variation. In the validation group, differences between mean EndoGA and regression-based scores were small (ranging from -4.70 to 2.03), indicating good agreement. In analyses of data from the randomized trial, the baseline to end of study change in patients given fluticasone was a reduction of 24.3 in simple score (reduction of 4.6 in patients given placebo, P=.052); a reduction of 23.5 in regression-based overall score (reduction of 6.56 in patients given placebo, P=.12), and a reduction of 23.8 (reduction of 8.44 in patients given placebo, P=.11). CONCLUSION: Assessments of endoscopic activity in patients with EoE vary among endoscopists. In an analysis of data from a randomized controlled trial, we found that newly developed scoring systems are no better than simple scoring system in detecting changes in endoscopic activity. These results support the use of a simple scoring system in evaluation of endoscopic activity in patients with EoE. clinicaltrials.gov no: NCT00939263 and NCT01386112.

Revisiting the NIH Taskforce on the Research needs of Eosinophil-Associated Diseases (RE-TREAD).

Eosinophil-associated diseases (EADs) are rare, heterogeneous disorders characterized by the presence of eosinophils in tissues and/or peripheral blood resulting in immunopathology. The heterogeneity of tissue involvement, lack of sufficient animal models, technical challenges in working with eosinophils, and lack of standardized histopathologic approaches have hampered progress in basic research. Additionally, clinical trials and drug development for rare EADs are limited by the lack of primary and surrogate endpoints, biomarkers, and validated patient-reported outcomes. Researchers with expertise in eosinophil biology and eosinophil-related diseases reviewed the state of current eosinophil research, resources, progress, and unmet needs in the field since the 2012 meeting of the NIH Taskforce on the Research of Eosinophil-Associated Diseases (TREAD). RE-TREAD focused on gaps in basic science, translational, and clinical research on eosinophils and eosinophil-related pathogenesis. Improved recapitulation of human eosinophil biology and pathogenesis in murine models was felt to be of importance. Characterization of eosinophil phenotypes, the role of eosinophil subsets in tissues, identification of biomarkers of eosinophil activation and tissue load, and a better understanding of the role of eosinophils in human disease were prioritized. Finally, an unmet need for tools for use in clinical trials was emphasized. Histopathologic scoring, patient- and clinician-reported outcomes, and appropriate coding were deemed of paramount importance for research collaborations, drug development, and approval by regulatory agencies. Further exploration of the eosinophil genome, epigenome, and proteome was also encouraged. Although progress has been made since 2012, unmet needs in eosinophil research remain a priority.

Quality of Care Delivered to Veterans with COPD Exacerbation and the Association with 30-Day Readmission and Death.

Quality of chronic obstructive pulmonary disease (COPD) care is thought to be an important intermediate process to improve the well-being of patients admitted to hospital for exacerbation. We sought to examine the quality of inpatient COPD care and the associations with readmission and mortality. We performed a cohort study of 2,364 veterans aged over 40 and hospitalized for COPD between 2005 and 2011 at five Department of Veterans Affairs hospitals. We examined whether patients received six guideline recommended care items including short-acting bronchodilators, corticosteroids, antibiotics, positive-pressure ventilation (in cases of acute hypercarbic respiratory failure), chest imaging, and arterial blood gas measurement. Our primary outcome was all-cause hospital readmission or death within 30 days. Overall quality of care was not significantly associated with readmission or death (acute care aOR 0.98; 95% CI 0.87-1.11; ICU aOR 0.89; 95% CI 0.71-1.13). Delivery of corticosteroids and antibiotics was associated with reduced odds of readmission and death (aOR 0.77; 95% CI 0.61-0.92). Few patients received all of the recommended care items (18% of acute care, 38% of ICU patients). Quality of care did not vary by race or sex but did vary significantly across sites and did not improve over time. Our composite measure of COPD care quality was not associated with readmission or death. Further efforts are needed to improve care delivery to patients hospitalized with COPD.

Immunization Practices of U.S. Obstetrician/Gynecologists for Pregnant Patients.

INTRODUCTION: U.S. obstetrician/gynecologists play a critical role as vaccinators of pregnant women. However, little is known about their current immunization practices. Thus, study objectives were to determine (1) practices related to assessment of vaccination status and vaccine delivery for pregnant patients; (2) barriers to stocking and administering vaccines; and (3) factors associated with administering both influenza and tetanus, diphtheria, and acellular pertussis (Tdap) vaccines. METHODS: An e-mail and mail survey among a national sample of obstetrician/gynecologists conducted July-October 2015 (analysis August 2016-August 2017). RESULTS: The response rate was 73.2% (353/482). Among obstetrician/gynecologists caring for pregnant women (n=324), vaccination status was most commonly assessed for influenza (97%), Tdap (92%), and measles, mumps, and rubella vaccines (88%). Vaccines most commonly administered included influenza (85%) and Tdap (76%). Few respondents reported administering other vaccines to pregnant patients. More physicians reported using standing orders for influenza (66%) than Tdap (39%). Other evidence-based strategies for increasing vaccine uptake were less frequently used (electronic decision support, 42%; immunization information system to record [13%] or assess vaccination status [11%]; reminder/recall, 7%). Barriers most commonly reported were provider financial barriers, yet provider attitudinal barriers were rare. Providers who administered both influenza and Tdap vaccines were more likely to be female, perceive fewer financial and practice barriers, less likely to be in private practice, and perceive more patient barriers. CONCLUSIONS: Although most obstetrician/gynecologists administer some vaccines to pregnant women, the focus remains on influenza and Tdap. Financial barriers and infrequent use of evidence-based strategies for increasing vaccination uptake may be hindering delivery of a broader complement of adult vaccines in obstetrician/gynecologist offices.

A review of the availability and cost effectiveness of chronic obstructive pulmonary disease (COPD) management interventions in rural Australia and New Zealand.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a chronic, progressive disease, which consumes a significant proportion of the Australian and New Zealand healthcare budget. Studies have shown that people living with COPD outside of urban areas have higher rates of hospitalisations. Two international reviews have demonstrated reduced hospital admissions and length of stay in people with COPD who participate in an integrated disease management program. However, most studies included in these reviews are in urban settings. The purpose of this review is to explore the type and cost-effectiveness of COPD management interventions located in rural or remote settings of Australia and New Zealand in order to inform planning and ongoing service development in the authors' local health district. METHOD: Six databases and Google scholar were searched to find literature relating to the availability and cost-effectiveness of non-pharmaceutical interventions for the management of COPD in rural and remote areas of Australia and New Zealand. RESULTS: Two studies were found that met the inclusion criteria. Both studies had small sample sizes, were single intervention studies and showed a positive influence on variables such as number of hospital admissions and length of stay at 12 months post-intervention. However, because of the limited number of studies and the lack of homogeneity of interventions, no conclusions regarding availability and cost-effectiveness of COPD interventions in rural and remote areas of Australia and New Zealand could be drawn. CONCLUSIONS: Limited literature exists to inform planning and development of services for people with COPD living in rural and remote areas of Australia and New Zealand. Approximately 50% of pulmonary rehabilitation programs are situated in rural and remote locations in Australia and New Zealand. Outcomes from existing programs need to be reported in a consistent and coordinated manner to allow evaluation of health resource utilisation.

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

OBJECTIVE: Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory condition with a paucity of information on health-related quality of life (HRQOL). The objective of the study was to report on the measurement properties of the PedsQL EoE Module. METHODS: The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE. RESULTS: The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% missing), excellent group comparison reliability across total scale scores (patient α 0.93; parent proxy α 0.94), good reliability for the 7 individual scales (patient α 0.75-0.87; parent proxy α 0.81-0.92), excellent test-retest reliability (patient intraclass correlation coefficient 0.88; parent intraclass correlation coefficient 0.82), demonstrated no floor effects and low ceiling effects, and demonstrated a high percentage of scaling success for most scales. Intercorrelations with the PedsQL Generic Core Scales were in the medium (0.30) to large (0.50) range. PedsQL EoE Module scores were worse among patients with active histologic disease (≥ 5 eos/hpf) compared with those in remission (patient self-report: 63.3 vs 69.9 [P < 0.05]; parent proxy report: 65.1 vs 72.3 [P < 0.01]), and those treated with dietary restrictions compared with those with no restrictions (patient self-report: 61.6 vs 74.3 [P < 0.01]; parent proxy report: 65.5 vs 74.7 [P < 0.01]). CONCLUSIONS: The results demonstrate excellent measurement properties of the PedsQL EoE Module. Patients with active histologic disease and those treated with dietary restrictions demonstrated worse PedsQL scores. The PedsQL EoE Module may be used in the evaluation of pediatric EoE disease-specific HRQOL in clinical research and practice.

Long-term cost-effectiveness of screening strategies for hearing loss.

Routine hearing screening can identify patients who are motivated to seek out and adhere to treatment, but little information exists on the cost-effectiveness of hearing screening in a general population of older veterans. We compared the cost-effectiveness of three screening strategies (tone-emitting otoscope, hearing handicap questionnaire, and both together) against no screening (control group) in 2,251 older veterans. The effectiveness measure for each group was the proportion of hearing aid use 1 year after screening. The audiology cost measure included costs of hearing loss screening and audiology care for 1 year after screening. Incremental cost-effectiveness was the audiology cost of additional hearing aid use for each screening group compared with the control group. The mean total audiology cost per patient was $77.04, $122.70, $121.37, and $157.08 for the control, otoscope, questionnaire, and dual screening groups, respectively. The tone-emitting otoscope appears to be the most cost-effective approach for hearing loss screening, with a significant increase in hearing aid use 1 year after screening (2.8%) and an insignificant incremental cost-effectiveness of $1,439.00 per additional hearing aid user compared with the control group. For this population of older veterans, screening for hearing loss with the tone-emitting otoscope is cost-effective.

Long-term effectiveness of screening for hearing loss: the screening for auditory impairment--which hearing assessment test (SAI-WHAT) randomized trial.

OBJECTIVES: To evaluate the effect of hearing screening on long-term hearing outcomes in a general population of older veterans. DESIGN: Hearing loss in the elderly is underdetected and undertreated. Routine hearing screening has been proposed, but it is not clear whether screening identifies patients who are sufficiently motivated to adhere to treatment. A four-arm randomized clinical trial was conducted to compare three screening strategies with no screening in 2,305 older veterans seeking general medical care. SETTING: Veterans Affairs Puget Sound Health Care System. INTERVENTIONS: The screening strategies were a tone-emitting otoscope, a widely used questionnaire about hearing handicap, and a combination of both tools. MEASUREMENTS: Hearing aid use 1 year after screening. RESULTS: Of participants who underwent screening with the tone-emitting otoscope, questionnaire, and combined testing, 18.6%, 59.2%, and 63.6%, respectively, screened positive for hearing loss (P<.01 for test of equality across three arms). Patients proceeded to formal audiology evaluation 14.7%, 23.0%, and 26.6% of the time in the same screening arms, compared with 10.8% in the control arm (P<.01 for test of equality across four arms). Hearing aid use 1 year after screening was 6.3%, 4.1%, and 7.4% in the same arms, compared with 3.3% in the control arm (P<.01). Hearing aid users experienced significant improvements in hearing-related function and communication ability. CONCLUSION: In older veterans, screening for hearing loss led to significantly more hearing aid use. Screening with the tone-emitting otoscope was more efficient. The results are most applicable to older populations with few cost barriers to hearing aids.

Effectiveness of group versus individual hearing aid visits.

Demand for hearing aid services in the Veterans Health Administration increased over 300% from 1996 to 2005, challenging the delivery of timely, high-quality care. Using group visits may help meet these needs, but whether this approach would still provide high-quality rehabilitation is unclear. This study determined whether group visits worsen hearing aid outcomes. It included a retrospective observational cohort in veterans seeking hearing aids at the Department of Veterans Affairs Puget Sound Health Care System from September 2004 to March 2005, when the clinic was using both individual and group visits. Medical records were reviewed for all new hearing aid patients seen during this period. Hearing-related outcome questionnaires were compared between patients seen for individual versus group fitting and/or follow-up visits. Results revealed that hearing thresholds were similar between patients seen individually and in groups. Of 74 patients who returned self-administered questionnaires after the follow-up, those who received both fitting and follow-up in a group format reported similar hearing handicap and better hearing-related function, satisfaction, and adherence than patients who received individual visits. Group visits did not appear to yield worse outcomes in this nonrandomized retrospective chart review. Definitive statements must await randomized comparisons.

Screening for Auditory Impairment-Which Hearing Assessment Test (SAI-WHAT): RCT design and baseline characteristics.

BACKGROUND: Effective screening programs should not merely detect presence of disease, but also lead to long-term benefit. We describe the rationale and design of the first randomized clinical trial to study the long-term effects of routine screening for hearing loss. We also describe the baseline characteristics of the randomized cohort. METHODS: We randomized 2305 veterans age 50 years or older to a control arm without screening, or to screening with: physiologic testing (AudioScope), a self-administered questionnaire (Hearing Handicap Inventory for the Elderly-Screening version [HHIE-S]), or both tests. The primary outcome measure will be hearing aid use one year after screening. We will also study a number of secondary outcomes, including appointments made with and visits to an audiologist, cases of aidable hearing loss, hearing aids dispensed, self-rated communication ability, and hearing-related quality of life. RESULTS: Baseline demographic and health status measures were evenly distributed across the screening arms. The percentage of patients who screened positive for hearing loss was 18.6%, 59.2%, and 63.6% for the AudioScope, HHIE-S, and combined screening arms, respectively. IMPLICATIONS: Long-term results are needed to gain insight into whether the AudioScope is associated with high rates of false negative screening, the HHIE-S is associated with high rates of false positive screening, or a combination of both. Identifying the best screening program will depend on determining which strategy leads to successful hearing aid use.