bluuebunny/crossref_metadata_2025_split huggingface dataset:
A POPULATION-BASED APPROACH TO DIGITAL OUTREACH, TRIAGE, AND MONITORING OF IBD PATIENTS DURING THE COVID-19 PANDEMIC
Authors: Atreja Ashish , Fasihuddin Farah , Garge Shashank , Davidoff Liana , Rubin Jonathan , Kakkar Sarthak , Wedel Nicole , Madisetty Divya , Singhania Rohit , Jain Charu Madhwani , Kurra Sravya , Sands Bruce 
Published: January 2021

Abstract

Background
In March 2020, the Mount Sinai Health System Inflammatory Bowel Disease (IBD) center reported an increase in telephone call volume, with many IBD patients expressing anxiety about being on immunosuppressive agents during the COVID-19 pandemic. Consistent with GI society and CDC recommendations, we leveraged the Rx.Universe platform (Rx.Health, New York, NY) to rapidly design and deliver a population-based digital navigation program (DNP) to provide outreach, remote COVID-19 symptom monitoring, triage, and Telehealth to IBD patients.

Methods
After identifying all IBD patients seen in our IBD center from Electronic Health Records (Epic Systems), we “bulk prescribed” the DNP (Rx.Health, New York NY) to 6100 patients’ smartphones. Patients were asked to reply to the prompt if they had new or worsening COVID-19 symptoms and opted-in to regular digital monitoring through an electronic patient reported outcome (ePRO) instrument. Patient data was screened by our clinical coordinators, who directly contacted patients via phone calls and scheduled testing and Telehealth visits with IBD practitioners when appropriate.

Results
Of the 6100 patients who were sent the DNP, 1829 patients opted-in to be regularly monitored using text-based electronic patient reported outcome (ePRO) instruments. Of those who responded affirmatively, 145 patients were identified requiring additional medical attention and were triaged using Telehealth visits. Compared to patients who chose not to opt-in, patients who opted-in were more likely to be female, white, married, on biologics, and had high inflammatory markers (Table 1).

Conclusion
As demonstrated by the 30% of patients who opted-in to regular COVID-19 symptom monitoring, a digital navigation program population approach is an effective and efficient approach to provide continuity of care and to mitigate COVID-19 exposure in a high-risk, immunosuppressed IBD population. This scalable approach serves as a model for providing high quality, remote monitoring to patients during COVID-19 and beyond, as well as achieving “Treat to Target” goals.
EFFECTIVENESS OF ANTIBIOTICS AS A TREATMENT OPTION FOR PATIENTS WITH CROHN’S DISEASE: A META ANALYSIS
Authors: Patterson Joshua 
Published: January 2021

Abstract
Crohn’s Disease (CD) is an Inflammatory Bowel Disease (IBD) whose etiology has been suspected to include bacterial antigens. A treatment option, therefore, would be the usage of antibiotics. To that end, the purpose of this study was to perform a meta-analysis on the ability of antibiotics inducing remission or a favorable clinical response in Crohn’s disease (CD) patients. Thirty-two randomized, double-blind, placebo-controlled trials of antibiotics for treatment of CD in adults, totaling 3269 patients, were reviewed. Log-odds ratio and probability difference were performed to estimate risk difference. The Number Needed to Treat (NNT) was also calculated for each antibiotic reviewed (rifaximin, metronidazole, clarithromycin, and ciprofloxacin). The analysis revealed that antibiotics greatly improved patients’ Crohn’s disease activity, with a total response (defined as clinical response plus remission) odds ratio of 0.715 (95% CI: 0.6319–0.7971), a clinical response odds-ratio of 0.7478 (95% CI: 0.6214–0.8715), and a remission odds-ratio of 0.6877 (95% CI: 0.5768–0.7987). The Number Needed to Treat for each of the antibiotics used in the clinical trials were 5.018 (Ciprofloxacin), 6.480 (Clarithromycin), 7.556 (Metronidazole), and 6.824 (Rifaximin). This is an important outcome because it not only opens up a new treatment option for those suffering from Crohn’s Disease but it also leads credibility to the theory that Crohn’s is caused, at least in part, by bacteria, such as Mycobacterium avium subspecies paratuberculosis and adherent invasive E. coli.
CLINICAL SIGNIFICANCE OF PSOAS MUSCLE COMPOSITION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE
Authors: Lin Bixuan , Beniwal-Patel Poonam 
Published: January 2021

Abstract

Background
Total psoas muscle cross sectional area, as identified with computed tomography (CT), has been associated with clinical outcomes in various disease states. Unfortunately, total psoas CSA does not differentiate muscle density nor fat, both of which may be abnormal in obesity. Using a novel CT method to partition psoas muscle into low and high density muscle, recent studies have demonstrated low and high attenuating psoas muscle may be superior to total psoas CSA in identifying sarcopenic obesity. The impact of varying muscle composition in patients with inflammatory bowel disease is unknown.

Methods
We conducted a retrospective cohort study of IBD patients from a tertiary care center. Psoas muscle composition was determined using a novel and validated CT method. High and low attenuating bilateral psoas muscle was measured at the level of the 3rd lumbar vertebra. Clinical remission, surgery, hospitalization, and corticosteroid use were stratified by low and high density muscle and evaluated 6 weeks from the index CT.

Results
We identified 115 consecutive patients with a routine CT scan. Majority of patients had a greater quantity of low-density muscle (LDM), 95% had CD and 71% were not in clinical remission at the time of baseline CT. Of those with a greater quantity of LDM, 68% had history of IBD surgery and 60% were current/former smokers.
The mean pre-CT body mass index (BMI) for the greater quantity LDM was significantly higher (p=0.002) than the mean pre-CTE BMI for those with low LDMC. Seventy percent with greater quantity of low-density muscle were either overweight or obese and 20% had a normal range BMI. Six months after the baseline CT, 53% in the lower quantity LDM had clinical remission, whereas 33.3% had remission in the high LDMC (p=0.05). Patients with greater quantity LDM were more likely to require corticosteroids in the 6 months after index CT, as compared to those with lower quantity LDM (p=0.02).

Conclusion
This observational study showed an association between greater quantity of LDM and obesity and worse IBD-related outcomes. This is the first study to evaluate the impact of muscle composition on IBD outcomes and our results offer a novel tool to risk stratify patients with IBD. Our study is limited by the retrospective nature, limited sample size, and narrow longitudinal follow-up. Larger prospective studies with greater longitudinal follow-up are needed to confirm our retrospective findings.
SMALL-BOWEL CAPSULE ENDOSCOPY IN INFLAMMATORY BOWEL DISEASE TYPE UNCLASSIFIED
Authors: Singeap Ana-Maria , Girleanu Irina , Chiriac Stefan , Cuciureanu Tudor , Stanciu Carol , Trifan Anca 
Published: January 2021

Abstract

Background and aim
Ulcerative colitis (UC) and Crohn’s disease (CD) are idiopathic inflammatory bowel diseases (IBD) with no unique, gold standard diagnostic test. UC and Crohn’s colitis are in approximately 10% of cases impossible to be distinguished. The term IBD type unclassified (IBD-U) is officially proposed for the cases of chronic colitis showing overlapping endoscopic, radiological, and biopsy histological features between UC and CD, while indetermined colitis is reserved for colectomy specimen. Our aim was to evaluate the role of small-bowel capsule endoscopy (SBCE) in the diagnostic work-up of IBD-U.

Material and methods
We prospectively studied all cases of IBD-U explored by SBCE in our tertiary referral gastroenterology center. Patients were investigated by SBCE after contraindications were excluded. Diagnostic criteria for small bowel CD consisted in more than 3 ulcerations, irregular ulcers or stenosis; if fulfilled, Crohn’s colitis was sustained. The absence of CD features in the small bowel (SB) strengthened the assumption of UC. Follow-up data were recorded.

Results
Fifteen patients with IBD-U were explored by SBCE. Seven patients had SB lesions meeting the diagnostic criteria for CD. The remaining eight examinations showed no SB significant findings; therefore, they were classified as UC. No complications occurred. The patients were treated accordingly. Follow-up data recorded a case of colectomy for refractory UC.

Conclusions
SBCE is a useful safe tool in the management of IBD unclassified. Due to its diagnostic valences, SBCE plays a particular role in the process of proper clinical decision-making.
COLLABORATIVE DEVELOPMENT OF CROHN’S DISEASE CLINICAL DATA STANDARDS BY STANDARDS DEVELOPMENT AND CROHN’S DISEASE EXPERTS TO FOSTER DATA REVIEW, SHARING, AND REUSE
Authors: Owen, Rebecca Baker John 
Published: January 2021

Abstract

Background
The ability to access expansive collections of well-curated biological, clinical, and behavioral data will propel scientific progress and enable the discoveries needed to improve treatments for human disease. Development and adoption of standards transform incompatible and disparate data into universal and illuminating information, facilitating discoveries that could have invaluable impact on Crohn’s disease clinical research. When standards are applied, data is collected, organized, and analyzed in a clear and consistent manner, allowing all researchers to leverage information from studies around the world.
Required by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and adopted by the world’s leading research organizations, CDISC standards enable the accessibility, interoperability, and reusability of data. CDISC standards addresses each step of the clinical research process to drive operational efficiencies within the organizations that use them, expedite the regulatory review process and reduce time to market.

Methods
With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC formed a team of standards development and Crohn’s disease experts to follow our consensus-based, clinical data standards process, which consists of six stages:
Scoping – Identification of development topics
Concept Modeling – Deep dive understanding of topics
Standards Development – Development of standards content
Internal Review – Targeted review
Public Review – User community review
Publication – Freely available on the CDISC website

Results
The project Standards Development and Internal Review stages completed in September 2020, resulting in the following topics available for the Public Review stage.
- Questionnaires, Ratings and Scales (including standard symptom measures, patient/investigator reported outcomes, and socio-economic measures)
- Prior and Baseline, and On-Study Treatments (including response to prior treatment)
- Disease Staging (location and phenotypic descriptions of the disease)
- Endoscopy Assessments
- Cross-section Imaging Assessments (including CT, MRI and Ultrasound)
- Histopathology of Biopsy Samples
- Biomarkers of Interest for Crohn’s Disease

Conclusion
To make the greatest impact on Crohn’s disease research, widespread promotion of the availability of the standards for researchers to adopt and implement to their data is of highest importance. CDISC provides complementary education courses and implementation information to assist in this adoption. Widespread adoption of the standards will bring clarity to Crohn’s disease data and will enable the accessibility, interoperability, and reusability of data, driving operational efficiencies, expediting regulatory review, and reducing time to market.
CIGARETTE SMOKE INCREASES RISK FOR COLORECTAL NEOPLASIA IN INFLAMMATORY BOWEL DISEASE
Authors: Van Der Sloot Kimberley , Tiems Johan , Visschedijk Marijn , Festen Eleonora , van Dullemen Hendrik , Weersma Rinse , Kats-Ugurlu Gursah , Dijkstra Gerard 
Published: January 2021

Abstract

Objective
Patients with inflammatory bowel disease are at increased risk of colorectal neoplasia (CRN) due to mucosal inflammation. As current surveillance guidelines form a burden on patients and healthcare costs, stratification of high-risk patients is crucial. Cigarette smoke reduces inflammation in ulcerative colitis (UC) but not Crohn’s disease (CD) and forms a known risk factor for CRN in the general population. Due to this divergent association, the effect of smoking on CRN in IBD is unclear and subject of this study.

Design
In this retrospective cohort study, 1,386 IBD patients with previous biopsies analyzed and reported in the PALGA register, were screened for development of CRN. Clinical factors and cigarette smoke were evaluated. Patients were stratified for guideline-based risk of CRN. Cox-regression modeling was used to estimate the effect of cigarette smoke and its additive effect within the current risk stratification for prediction of CRN.

Results
151 (11.0%) patients developed CRN. Previously described risk factors, i.e. first-degree family member with CRN in CD (p-value=0.001), presence of post-inflammatory polyps in UC (p-value=0.004), were replicated. Former smoking increased risk of CRN in UC (HR1.72;1.04–2.84), whereas passive smoke exposure yielded no effect. For CD, active smoking (2.52; 1.14–5.58) and passive smoke exposure (1.88;1.10–3.21) significantly increased CRN risk. Addition of cigarette smoking to the current risk-stratification model significantly improved model fit for CD.

Conclusion
This study is the first to describe the important role of cigarette smoke in CRN development in IBD patients. Adding this risk factor improves the current risk stratification for CRN surveillance strategies.
MINIMAL INVASIVE MANAGEMENT OF PEDIATRIC CROHN’S ANORECTAL STRICTURE, LESS IS MORE
Authors: Rocourt Dorothy , Hoover Travis 
Published: January 2021

Abstract

Background
Anorectal stricture (ARS) is an uncommon but potentially disabling manifestation of perianal Crohn disease (CD) in pediatric patients. Various treatment options are available but there is little data regarding their efficacy, particularly in the pediatric population. We present three case reports of patients with symptomatic ARS treated with serial dilation and biologic therapy.

Methods
An institutional review board-approved retrospective review was performed using electronic health records. Three patients with ileocolonic CD and perianal involvement with symptomatic ARS were identified. All patients were treated with serial rectal dilations under general anesthesia using Hegar dilators.

Results
All patients are currently asymptomatic at follow-ups ranging from 1 to 3.5 years since the last dilation. Patient demographics and details of ARS management are presented in Table 1. All patients tolerated the procedures well and did not experience complications such as perforation, sepsis, or fecal incontinence. Rectal biopsy in each patient showed active inflammation, suggesting type 1 stricture according to the Hughes-Cardiff Classification (vs. type 2 fibrotic stricture). Patient 1 experienced 6 recurrences, each managed with an average of 2 dilations until disease control was established with ustekinumab (USK) and eventually vedolizumab (VDZ). She underwent ileocecal resection three years after the final dilation. Patient 2 underwent ileocecal resection immediately following the first series of dilations. He later experienced one stricture recurrence at 2 years, which was managed with one dilation and increased USK dosing frequency. Patient 3 received steroid suppositories prior to dilation and has been self-dilating at home. He has had no recurrences requiring operative dilation. Self-dilation was not feasible in patients 1 and 2.

Conclusion
Inflammatory anorectal stricture associated with perianal Crohn disease in pediatric patients can be managed successfully with dilation until disease control with biologic therapy. Recurrences of stricture can also be managed with dilation and modification of biologic therapy. If tolerated, self-dilation may reduce recurrence.

Background
Anorectal stricture (ARS) is an uncommon but potentially disabling manifestation of perianal Crohn disease (CD) in pediatric patients. Various treatment options are available but there is little data regarding their efficacy, particularly in the pediatric population. We present three case reports of patients with symptomatic ARS treated with serial dilation and biologic therapy.

Crohn’s rectal stricture pre and post dilation
SHAPE MEMORY POLYMER HYDROGEL FOAMS FOR FISTULA CLOSURE
Authors: Monroe Mary , Beaman Henry , Vakil Anand , Du Changling 
Published: January 2021

Abstract

Introduction
Crohn’s disease can lead to fistula formation between portions of the urinary, reproductive, and digestive systems. The abnormal connections caused by these tunneling sores cause severe pain, infections, and abscess formation. Currently, 83% of Crohn’s patients with fistula formation undergo surgical intervention to either drain or bypass the fistula openings, and ~23% of these patients ultimately require bowel resections.
To address this clinical need, we propose to synthesize a shape memory polymer (SMP) hydrogel foam system for fistula closure and healing. SMP foams are porous materials that can be heated and compressed into a low-profile geometry that is retained after cooling. This shape enables minimally invasive delivery (i.e. via catheter) to a fistula site. Once the foams are heated to body temperature, they expand back to their original shape to conform to the implantation site geometry. Here, we present a degradable SMP hydrogel foam with antimicrobial and antioxidant phenolic acids for potential use as a fistula closure scaffold.

Methods
Foams were synthesized with 3-arm and linear poly(ethylene glycol) (PEG), amylopectin/pullulan, and phenolic acids in combination with hexamethylene diisocyanate in the presence of surfactants, catalysts, and foam blowing agents to form a hydrophilic, chemically crosslinked foam. Resulting foams were characterized in terms of swelling ratios, pore sizes, glass transition temperatures, and shape recovery. Degradation profiles were characterized in glucoamylase. Antimicrobial efficacy against E. coli was measured by quantifying colony forming units of bacteria following exposure to SMP hydrogels. Antioxidant properties were assessed in the presence of hydrogen peroxide.

Results
SMP hydrogel swelling ratio, stiffness, shape memory properties are tuned by altering monomer ratios and lengths and foaming conditions. In preliminary degradation studies in glucoamylase, degradation rates are dependent upon starch content; increased degradation is observe with increase pullalan content, Figure 1. Phenolic acid-containing SMP foams exhibit antimicrobial efficacy against E. coli and antioxidant properties in hydrogen peroxide.

Conclusions
Current studies include full material characterization of the library of synthesized hydrogels and longer-term degradation analysis. This system can be further built upon in future studies to include a drug-delivery component. Overall, SMP hydrogel foams present a highly tunable platform material that can be modified with required functionalities to promote fistula closure.
DIFFERENTIAL MANIFESTATIONS OF INLAMMATORY BOWEL DISEASE (IBD) BASED ON RAGE AND IMMIGRATION STATUS
Authors: Crowe Brooks , Khalessi Ali , Xia Yuhe , Rubinfeld Gregory , Baylor Jessica , Radin Arielle , Liang Peter , Chen Lea Ann 
Published: January 2021

Abstract

Background
The increasing incidence of IBD globally presents an important opportunity to study intrinsic and environmental determinants of disease development. We examined how race and immigration status influence IBD manifestations, treatments, and outcomes in a diverse, tertiary-care public hospital that serves predominantly the uninsured and underinsured.

Methods
We conducted a single-center retrospective review of all IBD patients treated from 1997–2017. Using logistic regression modeling, we compared disease onset, treatment, and outcomes by race (White, Black, Hispanic, Asian) and immigration status (US-born vs. foreign-born). To assess for the potential confounder of race in analyses of US versus foreign-born subjects, we further evaluated differences in IBD characteristics among foreign-born patients in each of the four racial groups.

Results
A total of 577 patients were identified, of which 29.8% were White, 27.4% Hispanic, 21.7% Black, and 13.0% Asian. Of these patients, 260 had a confirmed country of birth, with 69.6% being foreign-born. The time between IBD diagnosis and last documented follow up was not statistically different between races, nor by foreign versus US-born status. Asian IBD patients were less likely than White IBD patients to be female (OR 0.38, 95% CI: 0.20, 0.69). Among ulcerative colitis (UC) patients, Asians were more likely than White patients to have isolated proctitis (OR 10.34, 95% CI: 1.58, 203.08). Black patients were less likely to be diagnosed with UC (OR 0.57, 95% CI: 0.36, 0.91) and more likely to undergo IBD-related intestinal resection (OR 2.49, 95% CI: 1.40, 4.50), though the opposite was true in foreign-born Black patients. Overall, foreign-born patients were more likely to be diagnosed with UC (OR 1.77, 95% CI: 1.04, 3.02). They were also less likely to be diagnosed before 16 years of age (OR 0.19, 95% CI: 0.08, 0.41), have undergone intestinal resections (OR 0.39, 95% CI: 0.19, 0.83), or have received biologics (OR 0.43, 95% CI: 0.25, 0.76). No single race accounted for the decreased use of biologics or intestinal resections among foreign-born patients.

Conclusions
IBD phenotype varies by race, although foreign-born patients of all races show evidence of later onset and milder disease. As our study was performed in a large single-center safety-net hospital, our study design minimized socioeconomic confounders. These findings may aid in disease prognostication and clinical management and furthermore may provide insight into intrinsic and environmental influences on IBD pathogenesis.