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1.
European journal of ophthalmology ; : 11206721221124673, 2022.
Article in English | MEDLINE | ID: covidwho-2009295

ABSTRACT

AIM: To evaluate corneal morphology after use of 0.5% intracameral moxifloxacin (ICM) in cataract surgery in patients who presented late with hard cataracts. METHODS: Cross-sectional study conducted from June-2021 to December-2021 at a tertiary eye-care center. 90 patients over 60 years with high-risk characteristics for Covid-19, who presented late with higher grades of nuclear-sclerosis (NS), were included. They underwent phacoemulsification and 0.5%moxifloxacin (0.1 ml) was injected intracamerally at the end of surgery. Best-corrected visual acuity (BCVA), intraocular pressures (IOP), endothelial cell density (ECD), coefficient of variation in cell-area (CoV), hexagonality (Hex) and central corneal thickness (CCT) were measured preoperatively and postoperatively on day1, day7 and day30. Statistical analysis was done by Anova test. p-value<0.05 was considered significant. RESULTS: Mean age of presentation was 65.26±8.3 years. Mean preoperative BCVA (1/60-to-6/60), IOP (16.7±2.3 mm of Hg), CCT (523.93±39.6µ), ECD (2547±302.08cells/mm2), Hex (47.04±5.7%) and CoV (37.57±3.9) changed to BCVA (6/9-to-6/6), IOP (17.5±2.1 mm of Hg), CCT (538.42±36.9µ), ECD (2388.40±339.25cells/mm2), Hex (44.44±5.6%) and CoV (39.09±4.5) at day30 postoperative. Average rate of change at day30 was increase in CCT (2.89%), ECD loss (6.4%), decrease in Hex (4.9%) and increase in CoV (4.6%), though clinically insignificant. No case of endophthalmitis or toxic-anterior segment syndrome seen. CONCLUSION: 0.5% moxifloxacin (0.1 ml) is safe as intracameral antibiotic to prevent postoperative infection in high-risk patients. The reported changes in the corneal parameters were within the range of any routine surgeries of hard senile cataracts. No specific effect could be attributed to ICM.

2.
Gastroenterology ; 162(7):S-599, 2022.
Article in English | EMBASE | ID: covidwho-1967345

ABSTRACT

Background Coronavirus disease 2019 (COVID-19) can increase the risk of thrombosis, cardiovascular events, and kidney injury, but risks among patients with inflammatory bowel disease (IBD) remain unknown. We aimed to characterize risk for these complications among patients with IBD who developed COVID-19. Methods We analyzed complications of COVID-19 in patients reported to the Surveillance Epidemiology of Coronavirus Under Research Exclusion in Inflammatory Bowel Disease (SECURE-IBD) database prior to November 15, 2021. Our primary outcome was a composite of thrombotic complications (peripheral venous thrombosis, pulmonary embolism, thrombotic stroke, and peripheral arterial thrombosis), cardiovascular complications (new arrhythmia, heart failure, myocarditis/pericarditis, and vasculitis), and renal complications (acute kidney injury). Covariates included cardiovascular disease (including stroke), cardiovascular risk factors (diabetes mellitus, hypertension, or smoking), pulmonary disease (asthma, chronic obstructive pulmonary disease, or other chronic lung disease), thrombotic risk conditions (cancer), chronic kidney disease, chronic liver disease, “other” comorbidities, and COVID-19 vaccination with at least one dose. Multivariable analyses assessed the independent effect of variables significant in univariate analyses. Results Among 4,923 patients reported to SECURE-IBD, 79 (1.6%) had thrombotic, cardiovascular, and/or renal complications. There were 45 (0.9%) reports of acute kidney injury, 24 (0.5%) of arrythmias, 8 (0.2%) of peripheral venous thrombosis, 5 (0.1%) each of heart failure, myocarditis/pericarditis, and pulmonary embolism, and 1 (0.02%) each of vasculitis, peripheral atrial thrombosis, and thrombotic stroke. In univariate analyses, complications were more common in patients who were older (p < 0.01), black (p < 0.01), and on corticosteroids (p < 0.01) (Table 1). Patients with severe IBD were more likely to have complications than patients in remission (p < 0.01), as were those with more comorbidities (p < 0.01). Cardiovascular disease, cardiovascular risk factors, pulmonary disease, and chronic renal disease were associated with increased risk (p < 0.01 each). There was no association with vaccination status (p = 1). In multivariate analyses, age (aOR 1.04 [1.03, 1.06]), black race (aOR 4.02 [1.53, 10.55]), severe IBD (aOR 3.21 [1.31, 7.86]), corticosteroid use (aOR 3.63 [1.85, 7.12]), and one (aOR 2.33 [1.10, 4.91]), two (aOR 4.24 [1.42, 12.65]), and three or more (aOR 13.36 [3.48, 51.32]) comorbidities were significant predictors of complications (Table 2). Discussion Thrombotic, cardiovascular, and renal complications from COVID-19 were uncommon among patients with IBD. Patients with older age, black race, corticosteroid use, severe IBD, and greater number of comorbidities may require closer monitoring if they develop COVID-19. (Table Presented)

3.
Gastroenterology ; 162(7):S-593, 2022.
Article in English | EMBASE | ID: covidwho-1967335

ABSTRACT

Background: Several SARS-CoV-2 vaccines are highly effective in preventing most infections, serious disease, hospitalization, and death from COVID-19 in the general population, but data regarding their use and efficacy in patients with inflammatory bowel disease (IBD) are limited. In this study we assessed the use patterns and efficacy of SARS-CoV-2 vaccines in patients with IBD. Methods: We established a multicenter matched case-control cohort of patients with IBD [Crohn's disease (CD), ulcerative colitis (UC)] and COVID-19 between February 2020 and December 2020 for the Surveillance of COVID-19 Impact on Long- Term Outcomes in IBD (SCOUT IBD) study. Cases were defined by the presence of COVID- 19-related symptoms and confirmatory SARS-CoV-2 PCR or IgG testing and non-COVID controls were defined as absence of symptoms and both a negative PCR and IgG in 2020. Cases were matched 1:1 to controls based on age, sex and IBD type. Data were collected on vaccine administration in 2021 and incidence of interval COVID-19 (defined as above) between January and September 2021. Results: The total cohort included 502 patients with IBD [UC (n=222, 44%), CD (n=278, 55%), IBD-undefined (n=2, 1%)] of whom 251 had a history of COVID-19 in 2020. The overall vaccination rate was 61% (n=306) with 189 (62%) patients receiving Pfizer-BioNTech, 101 (33%) Moderna, and 12 (4%) Johnson & Johnson. Vaccinated patients were more likely to be older (P=0.02), female (P=0.07), have a co-morbidity (cardiovascular, respiratory, renal) (P=0.04), or currently be on a biologic (P=0.01), and less likely to have had prior COVID-19 (P<0.001) than patients who did not get vaccinated (Table 1). The overall incidence of interval COVID-19 was 1.6% (N=8), with an infection rate of 0.3% (1/311) in vaccinated patients vs. 3.7% (7/184) in unvaccinated patients (P<0.01). Of infections occurring in unvaccinated patients, 1/7 (14.2%) was severe and required hospitalization requiring ICU admission, and the breakthrough infection in the vaccinated patient was mild and self-limited. COVID-19 reinfection occurred in one patient (0.4%) with prior COVID-19 who was unvaccinated. Under multivariable logistic regression, COVID-19 vaccination (aOR 0.05, 95% CI 0.01-0.41) and prior COVID-19 infection (OR 0.07, 95% CI 0.01-0.63) were highly protective against interval COVID-19. Conclusion: COVID-19 vaccines are effective in patients with IBD and markedly reduce the incidence of COVID-19. Prior COVID-19 is also protective against subsequent infection, although re-infections may occur at a very low rate. These results reaffirm the importance of COVID-19 vaccination in patients with IBD.(Table Presented)(Table Presented)

4.
Gastroenterology ; 162(7):S-592-S-593, 2022.
Article in English | EMBASE | ID: covidwho-1967334

ABSTRACT

Background: Inflammatory bowel disease (IBD) and IBD-related biologic therapies are not associated with worse outcomes of Coronavirus Disease 2019 (COVID-19), however, data are lacking regarding the long-term impact of COVID-19 and its inflammatory sequelae on the disease course of IBD. We aimed to investigate the long-term outcomes of patients with IBD and COVID-19. Methods: We performed a multicenter matched case-control study of patients with IBD [Crohn's disease (CD), ulcerative colitis (UC)] and COVID-19 between February 2020 and December 2020 at 5 large health systems. Cases were defined by the presence of COVID-19-related symptoms and confirmatory SARS-CoV-2 PCR or IgG testing. Non-COVID controls were defined as absence of symptoms and both a negative PCR and IgG during the study entry period. Cases were matched 1:1 to controls based on age, sex and IBD type. The primary composite outcome was IBD-related hospitalization or surgery, and outcomes were sub-stratified by COVID-19 severity. Results: We identified 251 cases with IBD [UC (n=111, 44%), CD (n=139, 55%)] and confirmed COVID-19, matched with 251 non-COVID-19 IBD controls, with a median follow-up of 394 days. COVID-19 patients had higher rates of prior IBD-related hospitalizations (36% vs. 27%;P=0.03), corticosteroid use (75% vs. 65%;P=0.06), and biologic exposure (73% vs. 64%;P=0.04) than controls. There were no differences in UC extent or CD phenotype between groups. In COVID-19 positive patients, the most common symptoms were fever (61%), cough (48%), fatigue (30%) and diarrhea (28%). Severe COVID-19 (defined as hospitalization, ICU requirement or mechanical ventilation) occurred in 16% (n=39) of cases. The primary composite outcome of IBD-related hospitalization or surgery occurred in 12% (n=38) of cases vs. 15% (n=29) of controls (P=0.24;Table 1). When further stratified by COVID-19 severity, the incidence of the primary composite outcome was highest in patients with severe COVID-19, followed by controls and non-severe COVID-19 (Figure 1). Under multivariate Cox regression, severe COVID-19 remained a predictor of worse IBD outcomes (aHR 2.09, 95% CI 0.91-4.86) whereas non-severe COVID-19 was associated with decreased risk (aHR 0.52, 95% CI 0.28- 0.99). Prior IBD-related hospitalization or surgery (aHR 3.10, 95% CI 1.70-6.57) and current steroid use (aHR 2.17, 95% CI 0.95-4.94) were also predictive of worse IBD outcomes. Conclusion: In this matched case-control study, a history of any COVID-19 infection did not appear to exacerbate the course of IBD, however, severe COVID-19 was associated with worse IBD outcomes. These data suggest that the inflammatory sequelae of COVID-19 may adversely impact the subsequent disease course of IBD. Further studies are required to confirm these associations, which underscore the importance of COVID-19 mitigation measures.(Table Presented) (Figure Presented)

5.
National Journal of Physiology, Pharmacy and Pharmacology ; 12(7):907-915, 2022.
Article in English | EMBASE | ID: covidwho-1928809

ABSTRACT

In 2019, a new variant of coronavirus emerged that put the whole world on a standstill due to its unprecedented spread and morbidity. Since then, scientists have been working on several theories to explain the origin and pathogenesis of the virus. Over this period of time, it has been observed clinically that individual variation exists in the way this virus infects people, its symptomatology and sequelae. The pathophysiology is still unclear. This review was taken up to consolidate all the available information until date about current theories of etiopathogenesis with an understanding of potential therapeutic targets on the mechanisms. This review also highlights the gray areas that need to be addressed in the future. Research papers published up to December 7, 2020 were included based on a search on PubMed, Google Scholar, etc., to get the latest relevant literature on this topic. Coronavirus expresses differently in different individuals, affecting different organ systems, and having variable severity. However, the underlying pathogenic mechanisms are not completely understood. Due to the lack of definite curative therapy, it is essential to explore the basic pathophysiology so as to develop more effective and target-based therapies in the future.

6.
60th IEEE Conference on Decision and Control (CDC) ; : 3531-3531, 2021.
Article in English | Web of Science | ID: covidwho-1868523
7.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-334610

ABSTRACT

IMPORTANCE: Risk calculators can facilitate shared medical decision-making 1 . Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for COVID-19-related complications among patients with IBD 2,3 . OBJECTIVES: Develop an individualized prognostic risk prediction tool for predicting the probability of adverse COVID-19 outcomes in patients with IBD. DESIGN SETTING AND PARTICIPANTS: This study developed and validated prognostic penalized logistic regression models 4 using reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) from March-October 2020. Model development was done using a training data set (85% of cases reported March 13 - September 15, 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported September 16-October 20, 2020). MAIN OUTCOMES AND MEASURES: COVID-19 related:Hospitalization+: composite outcome of hospitalization, ICU admission, mechanical ventilation, or deathICU+: composite outcome of ICU admission, mechanical ventilation, or deathDeathWe assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and reported the corresponding 95% confidence intervals (CIs). RESULTS: We included 2709 cases from 59 countries (mean age 41.2 years [s.d. 18], 50.2% male). A total of 633 (24%) were hospitalized, 137 (5%) were admitted to the ICU or intubated, and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set AUC (95% CI) of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.94 (0.89, 0.99) for Death. Age, comorbidities, corticosteroid use, and male gender were associated with higher risk of death, while use of biologic therapies was associated with a lower risk. CONCLUSIONS AND RELEVANCE: Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of IBD patients. A free online risk calculator ( https://covidibd.org/covid-19-risk-calculator/ ) is available for healthcare providers to facilitate discussion of risks due to COVID-19 with IBD patients. The tool numerically and visually summarizes the patient's probabilities of adverse outcomes and associated CIs. Helping physicians identify their highest-risk patients will be important in the coming months as cases rise in the US and worldwide. This tool can also serve as a model for risk stratification in other chronic diseases. KEY POINTS: Question: How well can a multivariable risk model predict the risk of hospitalization, intensive care unit (ICU) stay, or death due to COVID-19 in patients with inflammatory bowel disease (IBD)?Findings: Multivariable prediction models developed using data from an international voluntary registry of IBD patients and available for use online ( https://covidibd.org/ ) have very good discrimination for predicting hospitalization (Test set AUC 0.79) and excellent discrimination for ICU admission (Test set AUC 0.88) and death (Test set AUC 0.94). The models were developed with a training sample of 2009 cases and validated in an independent test sample of 700 cases comprised of a random sub-sample of cases and all cases entered in the registry during a one-month period after model development. Meaning: This risk prediction model may serve as an effective tool for healthcare providers to facilitate conversations about COVID-19-related risks with IBD patients.

9.
Open Forum Infectious Diseases ; 8(SUPPL 1):S320, 2021.
Article in English | EMBASE | ID: covidwho-1746559

ABSTRACT

Background. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causes coronavirus disease 2019 (COVID-19), an infection with widely varying clinical severity. Severe COVID-19 was initially proposed to be secondary to cytokine storm syndrome (CSS). However, studies since showed that patients with severe COVID-19 rarely display CSS cytokine phenotypes, and may have more limited inflammatory responses instead. Methods. Prospective cohorts, aged 0-90 years of age who tested positive by polymerase chain reaction (PCR) for SARS-CoV-2 were enrolled from inpatient hospitals and outpatient testing centers in Memphis, TN from May 2020-January 2021. Longitudinal blood samples were obtained including acute, sub-acute and convalescent timepoints. Severity scores of asymptomatic, mild, moderate, and severe COVID-19 were assigned at time of convalescent assessment. Plasma was analyzed with a quantitative human magnetic 38-plex cytokine assay. Results. : 169 participants were enrolled, including 8 asymptomatic, 117 mild, 22 moderate and 17 severe cases, and 5 children with post-COVID-19 multisystem inflammatory syndrome in children (MIS-C). All moderate and severe patients were hospitalized and received treatment (39%). Clear distinctions were seen between asymptomatic-mild cases and moderate-severe cases at acute timepoints and during disease progression for GCSF, IL-8, IL-10, IL-15, IL-1Ra, IP-10, MIP-1a, MIP-1β, and TGFα. There was a significant difference between participants who did and did not require hospitalization for acute timepoint levels of IL-10, IL-15, MIP-1 β and TGFα (p< 0.01). Only 4 participants with active COVID-19 were found to meet criteria for CSS (2%), only 3 of which were severe. MIS-C participants showed nearly universally elevated cytokine levels compared to those with active COVID-19. Conclusion. Moderate and severe acute COVID-19 has a distinct cytokine profile from asymptomatic and mild cases, as detected from acute, subacute and convalescent plasma.

10.
60th IEEE Conference on Decision and Control, CDC 2021 ; 2021-December:3531, 2021.
Article in English | Scopus | ID: covidwho-1746111

ABSTRACT

The COVID-19 pandemic that has swept the world has shown a wide variety of behavior across countries, ranging from a gentle rise and gentle fall in India, to multiple waves with each peak higher than its predecessor in the USA, UK, and other countries. It is therefore a challenge to present a unified model that can manifest this wide range of behavior. In this paper, we present a new mathematical model called SUTRA for pandemics that have undetected (asymptomatic) patients, and demonstrate that it does indeed accurately predict the variety of behavior observed during the COVID-19 pandemic. The acronym SUTRA stands for Susceptible, Undetected, Tested (positive), and Removed Approach. There are several novel features of our proposed model. First, whereas previous papers have divided the patient population into Asymptomatic and Infected, we divide patients instead into Tested (T) and Undetected (U). This explicitly accounts for the fact that, due to contact tracing and other such protocols, some fraction of asymptomatic patients do get detected. Second, we introduce a parameter called "reach,"to take into account the spatial spread of apandemic over time. Third, we present numerically stable methods for estimating the parameters in our model.We have applied our model to predict the progression of the COVID-19 pandemic in several countries, displaying a variety of behaviors. In all cases, the predictions closely match the actually observed outcomes. In the interests of brevity, we present only the predictions for India. © 2021 IEEE.

12.
Journal of Crohn's and Colitis ; 16:i572-i573, 2022.
Article in English | EMBASE | ID: covidwho-1722357

ABSTRACT

Background: Coronavirus disease 2019 (COVID-19) tends to cause mild disease in children, although severe disease occurs rarely. Children with inflammatory bowel disease (IBD) often receive immunosuppressive medications that may increase risk of infectious complications. Little is known about the severity of breakthrough infection after COVID-19 vaccination in children with IBD. We describe COVID-19 outcomes among children with IBD, including those with breakthrough infection. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is a database created to evaluate COVID-19 outcomes in IBD patients. We included children (age ≤18) from the SECURE-IBD database through November 17th, 2021. We used descriptive statistics to summarize demographic/disease characteristics of the study population, both overall and stratified by hospitalization status, and performed bivariate comparisons. We reported demographic and clinical details of patients requiring an intensive care unit stay and those with breakthrough infection (defined as ≥1 COVID-19 vaccination prior to infection), respectively. Results: We analyzed 606 pediatric IBD COVID-19 cases from 37 countries. The most common IBD medications were tumor necrosis factor (TNF) antagonist monotherapy (48%) and sulfasalazine/ mesalamine (20%). Most patients (85%) had no non-IBD comorbidities. No patients died, and 28 children (5%) were hospitalized. Factors associated with hospitalization included non-IBD comorbid conditions (43% hospitalized vs 13% not;p <0.01), moderate/severe IBD disease activity (61% vs 15%;p <0.01 overall), gastrointestinal symptoms (68% vs 16%, p <0.01), and steroid use (29% vs 6%, p <0.01). TNF antagonist monotherapy was associated with a decreased likelihood of hospitalization (29% vs 49%;p value 0.03) (Table 1). Seven patients needed intensive care, and three (0.5%) required mechanical ventilation (Table 2). There were nine fully vaccinated and five partially vaccinated patients who developed breakthrough infection, of whom only one required hospitalization but did not need a ventilator (Table 3). The majority of patients with breakthrough infection (13/14) were on systemic immunosuppressants at the time of COVID-19 infection (10/14 on TNF antagonists). Conclusion: We found that children with IBD have a relatively low risk of severe COVID-19 outcomes. Among children with IBD who developed COVID-19 after vaccination, the majority were on immunosuppressants and had mild disease that did not require hospitalization. These data may reassure families and providers of children with IBD during the COVID-19 pandemic and support public health recommendations for COVID-19 vaccination among eligible children with IBD.

13.
Gastroenterology ; 160(6):S-332-S-333, 2021.
Article in English | EMBASE | ID: covidwho-1598866

ABSTRACT

Background: Coronavirus disease 2019 (COVID-19) can cause gastrointestinal (GI) symp-toms, which may be associated with improved outcomes. There are limited data on COVID-19 and GI symptoms among inflammatory bowel disease (IBD) patients. We aimed to describe new GI symptoms and their association with clinical outcomes in IBD patients with COVID-19.Methods: We utilized data from the Surveillance of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD), an international, collaborative registry of IBD patients with confirmed COVID-19. Any new GI symptoms during the time of COVID-19 infection were recorded. We performed descriptive statistics and bivariate analyses to characterize patients with and without new GI symptoms. We also performed a sensitivity analysis of new GI symptoms comparing patients in remission versus those not in remission by physician global assessment. Multivariable logistic regression assessed independent associ-ation of any new GI symptoms with the odds of death due to COVID-19 adjusting for age, sex, race, number of comorbidities, baseline corticosteroid use, and tumor necrosis factor (TNF) antagonist use.Results: Of 2,917 IBD patients with COVID-19, 764 (26.2%) experienced new GI symptoms. The most commonly reported new GI symptom was diarrhea (Table 1). IBD was noted to be in remission in 382 (50%) patients at time of COVID-19 infection. New GI symptoms were common (23.3%) among IBD patients in remission though were more frequently observed in patients with active disease (29.4%). Patients with new GI symptoms were more likely to be older, female, have active disease, of Asian race, and have at least one co-morbidity (Table 2). Patients on any medication, in particular TNF antagonist monotherapy, were less likely to report new GI symptoms. On bivariate analyses, IBD patients with new GI symptoms were more likely to be hospitalized (31.4% vs. 19.2%, p<0.001) but were not more likely to require intensive care/ventilator (5.8% vs. 4.6%, p=0.18) or die due to COVID-19 (2.0% vs 2.5%, p=0.39). On multivariable analysis, new GI symptoms were not significanlty associated with risk of death due to COVID-19 (adjusted OR 0.72, 95% CI 0.38-1.36).Conclusion: New GI symptoms are common among IBD patients with COVID-19. Diarrhea was the most predominant symptom. Patients in remission and those with active disease both frequently reported new GI symptoms. While IBD patients with new GI symptoms were more likely to be hospitalized, they were not more likely to die due to COVID-19.(Table Presented)Table 1. Description of Gastrointestinal (GI) Symptoms Among IBD Patients with COVID-19. New GI symptoms reported among all patients and stratified by disease activity at time of COVID-19 infection.(Table Presented)

14.
Gastroenterology ; 160(6):S-329-S-330, 2021.
Article in English | EMBASE | ID: covidwho-1598320

ABSTRACT

Background: Risk calculators can be an important tool for enabling shared decision making between patients and their health care providers. Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for complications from COVID-patients with inflammatory bowel disease (IBD). We developed a prognostic risk prediction tool for estimating the probability of hospitalization, intensive care unit (ICU) admission, and death due to COVID-19 in patients with IBD. Methods: Based on reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) from March to October 2020, we modeled the probability of Hospitalization+ (a composite outcome of hospitalization, ICU and/or death), ICU+ (a composite outcome of ICU admission, intubation, and/or death) and Death separately using the Least Absolute Shrinkage and Selection set consisting of a random sample of cases reported between March 2020 and a pre-set cutoff date. Model validation was conducted using a test data set consisting of the remaining cases not in the training data plus all additional cases from one month past the cutoff date. We assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and corresponding 95% confidence intervals. Results: Overall, 2709 cases from 59 countries were included (mean age 41.3 years (s.d. 633 (24%) were hospitalized, 137 (5%) were admitted to ICU or intubated, and 69 (3%) died. The models have excellent discrimination, with an AUC and associated 95% confidence interval estimated on the test data set of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.95 (0.91, 0.99) for Death. Age, comorbidities, corticosteroid use, and male sex were associated with higher risk of death while use of biologic therapies was associated with a lower risk of death (Figure 1). The online risk calculator is free and publicly available at https://covidibd.org/covid-19-riskcalculator/ for health care providers to facilitate discussion of the risk from COVID-19 with their IBD patients (Figure 2). After the physician inputs patient information, the prediction tool numerically and visually summarizes the patient’s probabilities of adverse outcomes intervals. Conclusion: Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of IBD patients. The risk calculator could provide a basis for distinguishing between high and low-risk patients to aid in personalizing clinical guidance.

15.
Gastroenterology ; 160(6):S-332, 2021.
Article in English | EMBASE | ID: covidwho-1596783

ABSTRACT

Background: Comorbidities Increase The Risk Covid-19 Morbidity And Mortality. As Comorbidities Are Common In Patients With Inflammatory Bowel Diseases (Ibd), We Sought To Evaluate The Effect Of Comorbidities On Covid-19 Outcomes Among Ibd Patients. Methods: Data Were Obtained From Surveillance Epidemiology Of Coronavirus Under Research Exclusion For Inflammatory Bowel Disease (Secure-Ibd), An International Registry To Determine Characteristics And Outcomes Of Covid-19 In Ibd Patients. We Used Multivariable Regression To Analyze Associations Between Eleven Non-Ibd Comorbidities And Covid-19-Related Hospitalization Or Death. We First Modeled Each Comorbidity Individually, Adjusting Potential Confounders Such As Age, Gender, Race, Ethnicity And Medication Use. Then, To Determine The Independent Effects Of Each Comorbidity, We Fit A Model Including All Comorbidities As Covariates. Results: 2,035 Patients From 58 Countries Were Included (Mean Age Was 42.7 Years, 50.6% Male). A Total Of 538 Patients (26.4%) Experienced Covid-19-Related Hospitalization Or Death. Of Eleven Comorbidities Analyzed, All But A History Of Stroke And Obesity Were Associated With Hospitalization Or Death In Our Initial Analysis, With Adjusted Odds Ratio (Aor) Ranging From 1.9 (Asthma And Cardiovascular Disease) To 3.7 (Chronic Kidney Disease). After Adjusting For Age, Sex, Medications, And Comorbidites Found To Significantly Influence Severe Covid-19 In The Initial Analysis, The Independent Associations For Most Comorbidities Remained Significant And Were Strongest For Chronic Kidney Disease (Aor 3.02, 95% Ci 1.45-6.31) And Chronic Obstructive Pulmonary Disease (Copd) (Aor 2.92, 95% Ci 1.32-6.48) (Table 1). Conclusion: Comorbidities Are Associated With Covid-19 Hospitalization And Death Among Ibd Patients. These Data Can Be Used To Risk-Stratify Ibd Patients And Guide Treatment And Lifestyle Decisions During The Ongoing Pandemic. (Table Presented) Independent Effects Of Individual Comorbidities On The Risk Of Hospitalization Or Death From Covid-19 In Patients With Inflammatory Bowel Diseases

16.
Gastroenterology ; 160(6):S-525, 2021.
Article in English | EMBASE | ID: covidwho-1594630

ABSTRACT

Background: Cases of Coronavirus disease 2019 (COVID-19) have emerged in discrete waves across different regions in the world. We explored temporal trends in the reporting of COVID-19 in patients with inflammatory bowel disease (IBD), in a large global database. Methods: The Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) is an international registry to study the character-istics and outcomes of patients with IBD diagnosed with COVID-19. Joinpoint regression models calculated the average percent change (APC) with 95% confidence intervals (CI) in weekly reported cases of COVID-19 in patients in the registry stratified by geographic regions (Asia, Europe, Latin America, and North America) during two time periods: March 22 to September 12 and September 13 to November 14, 2020. We also determined the APC in US regions (Midwest, Northeast, South and West) during the two time periods. Results: Across 63 countries and dependencies, 3,195 cases of COVID-19 in people with IBD were reported over an 8-month period. Overall, COVID-19 reporting steadily decreased throughout the world by 4.5% per week (95% CI: −5.7, −3.2) from March 22 to September 12, 2020 but then steadily climbed by 12.4% per week (95% CI: 6.8, 18.3) from September 13 to November 14, 2020. After stratification by geographic region, weekly reporting declined before September 13 in North America (APC = −2.0%;95% CI: −3.7, −0.4), Asia (APC =− 4.4%;95% CI: −7.8, −0.9), and Europe (APC = −8.6%;95% CI: −10.6, −6.6), but escalated in Latin America (APC = 3.4%;95% CI: 0.7, 6.1) (Figure 1). After September 12, the rate of weekly cases decreased in Latin America (APC = −19.0%;95% CI: −33.3, −1.7) and Asia (APC = −19.3%;95% CI: −34.6, −0.5), while increased in North America (APC = 10.7%;95% CI: 4.3, 17.4) and Europe (APC = 28.0%;95% CI: 17.3, 39.6) (Figure 1). Within the US, temporal trends differed by region: Midwest (stable APC: −0.8%;95% CI: −3.5, 1.9 then increase APC: 27.3%;95%: 16.1, 39.6), Northeast (decrease APC: −9.1%;95% CI:− 11.8, −6.2 then stable APC: 2.4%;95% CI: −9.9, 16.5), South (increase APC: 5.3%;95%CI: 2.5, 8.3 then decrease APC: −12.0;95% CI: −18.4, −5.0), and West (stable APC: 0.2%;95% CI: −3.0, 3.5 then stable APC: 9.0%;95% CI: −13.8, 37.9) (Figure 2). Conclusion: COVID-19 reporting to SECURE-IBD declined steadily during the first wave of the pandemic throughout the world except Latin America. Starting in September, reports to SECURE-IBD rose in both Europe and North America, consistent with the second wave of the pandemic in these countries.(Figure presented)Figure 1. Global regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Asia, B. Europe, C. Latin America, and D. North America: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020(Figure presented)Figure 2. United States regional temporal trends in reporting of COVID-19 in patients with IBD from the SECURE-IBD registry: A. Midwest, B. Northeast, C. South, and D. West: March 22–28 to September 6-12 and September 13-19 to November 8–14, 2020

17.
Gastroenterology ; 160(6):S-331, 2021.
Article in English | EMBASE | ID: covidwho-1590915

ABSTRACT

Background The impact of immune-modifying therapies on outcomes of the Coronavirus disease 2019 (COVID-19) may vary depending on their mechanism of action. The purpose of this study was to determine the impact of vedolizumab (VDZ), a gut-selective anti-integrin, on COVID-19 outcomes in inflammatory bowel disease (IBD) patients. Methods Utilizing data from the Surveillance of Coronavirus Under Research Exclusion for IBD (SECUREIBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we studied the impact of VDZ use compared to non-use, and VDZ monotherapy compared to anti-tumor necrosis factor (TNF) monotherapy, on hospitalization and severe COVID-19 (intensive care unit stay, mechanical ventilation and/or death) in adult IBD patients using multivariable logistic regression analyses. Backward selection of covariates was performed to obtain parsimonious models. P values #0.05 were considered significant for all analyses. Results Of 2,631 adult patients with confirmed COVID-19 on any IBD medication in the registry as of November 11, 2020, 312 (11.9%) patients were on VDZ of whom 236 (9.0%) were on VDZ monotherapy. A total of 731 (27.8%) patients were on an anti-TNF monotherapy. COVID-19 outcomes were similar for VDZ users versus non-users [adjusted odds ratio (aOR) 0.91, 95% confidence interval (CI) 0.74 to 1.09 for hospitalization and 1.12, 95% CI 0.60 to 2.10 for severe COVID-19, Table]. However, compared to anti-TNF monotherapy, VDZ monotherapy was positively associated with hospitalization and severe COVID-19 (aOR 1.66, 95% CI 1.17 to 2.35 and 4.71, 95% CI 1.65 to 13.45, respectively). Discussion VDZ use, compared to non-use, was not associated with adverse COVID-19 outcomes. However, when compared to anti-TNF monotherapy, VDZ monotherapy was associated with increased risk of hospitalization and ICU requirement/death. These findings suggest the comparable safety of VDZ relative to most other IBD therapies. The observed effect of anti-TNF may be related to improved safety and/or a possible protective effect against more aggressive COVID-19.(Table presented) Table: Multivariable regression analyses with backward selection of covariates for COVID-19 outcomes by medication class from adult cases in the SECURE-IBD registry

18.
Gastroenterology ; 160(6):S-338, 2021.
Article in English | EMBASE | ID: covidwho-1590914

ABSTRACT

Introduction In the United States (US), race and ethnicity impact outcomes of chronic diseases including inflammatory bowel disease (IBD). The aim of this study was to evaluate racial and ethnic disparities in the coronavirus disease 2019 (COVID-19) outcomes among IBD patients and to assess the degree to which observed disparities may be attributed to non-IBD comorbidities. Methods Using data from the Surveillance of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD), an international, collaborative registry of IBD patients with confirmed COVID-19, we used multivariable logistic regression to evaluate associations between race and ethnicity and COVID-19 outcomes. These included hospitalization and severe COVID-19 defined as a composite of intensive care unit stay, mechanical ventilation and/or death. Results We analyzed 988 US cases (96 [9.7%] Hispanic;141 [14.3%] non-Hispanic Black;680 [68.8%] non-Hispanic White). Bivariate analyses of outcomes are reported in the Table. Compared to non-Hispanic White patients, Hispanic patients had higher odds of hospitalization [adjusted odds ratio (aOR) 2.01, 95% CI 1.07 to 3.79] but not severe COVID-19 (2.75, 95% CI 0.93 to 8.10). Compared to non-Hispanic White patients, non-Hispanic Black patients had higher odds of hospitalizations (aOR 2.47, 95% CI 1.48 to 4.11) and severe COVID-19 (2.50, 95% CI 1.01 to 6.20) after adjusting for age, sex, and IBD activity (Figure). Upon adjusting for comorbidities, the odds of hospitalization and severe COVID-19 remained unchanged in Hispanic individuals compared to non-White Hispanic individuals (aOR 2.14, 95% CI 1.09 to 4.18 for hospitalizations and 2.69, 95% CI 0.77 to 9.38 for severe COVID-19), but decreased in Black individuals compared to non-White Hispanic individuals (aOR 2.21, 95% CI 1.30 to 3.76 for hospitalization and 2.13, 95% CI 0.81 to 5.59 for severe COVID-19). Conclusions The odds of adverse COVID-19 outcomes are higher in Hispanic and non-Hispanic Black, compared with non-Hispanic White individuals with IBD, accounted for partially by underlying comorbidities. (Table presented) COVID-19 Outcomes for United States cases reported to SECURE-IBD, overall and stratified by race/ethnicity (Figure presented) Odds ratios of A) hospitalization due to COVID-19 and B) severe COVID-19 outcomes (ICU stay, mechanical ventilation or death) among Hispanic vs. non-Hispanic White individuals and among non-Hispanic Black vs. non-Hispanic White individuals

19.
PUBMED; 2021.
Preprint in English | PUBMED | ID: ppcovidwho-293123

ABSTRACT

Importance: Risk calculators can facilitate shared medical decision-making 1 . Demographics, comorbidities, medication use, geographic region, and other factors may increase the risk for COVID-19-related complications among patients with IBD 2,3 . Objectives: Develop an individualized prognostic risk prediction tool for predicting the probability of adverse COVID-19 outcomes in patients with IBD. Design Setting and Participants: This study developed and validated prognostic penalized logistic regression models 4 using reports to Surveillance Epidemiology of Coronavirus Under Research Exclusion for Inflammatory Bowel Disease (SECURE-IBD) from March-October 2020. Model development was done using a training data set (85% of cases reported March 13 - September 15, 2020), and model validation was conducted using a test data set (the remaining 15% of cases plus all cases reported September 16-October 20, 2020). Main Outcomes and Measures: COVID-19 related:Hospitalization+: composite outcome of hospitalization, ICU admission, mechanical ventilation, or deathICU+: composite outcome of ICU admission, mechanical ventilation, or deathDeathWe assessed the resulting models' discrimination using the area under the curve (AUC) of the receiver-operator characteristic (ROC) curves and reported the corresponding 95% confidence intervals (CIs). Results: We included 2709 cases from 59 countries (mean age 41.2 years [s.d. 18], 50.2% male). A total of 633 (24%) were hospitalized, 137 (5%) were admitted to the ICU or intubated, and 69 (3%) died. 2009 patients comprised the training set and 700 the test set. The models demonstrated excellent discrimination, with a test set AUC (95% CI) of 0.79 (0.75, 0.83) for Hospitalization+, 0.88 (0.82, 0.95) for ICU+, and 0.94 (0.89, 0.99) for Death. Age, comorbidities, corticosteroid use, and male gender were associated with higher risk of death, while use of biologic therapies was associated with a lower risk. Conclusions and Relevance: Prognostic models can effectively predict who is at higher risk for COVID-19-related adverse outcomes in a population of IBD patients. A free online risk calculator ( https://covidibd.org/covid-19-risk-calculator/ ) is available for healthcare providers to facilitate discussion of risks due to COVID-19 with IBD patients. The tool numerically and visually summarizes the patient's probabilities of adverse outcomes and associated CIs. Helping physicians identify their highest-risk patients will be important in the coming months as cases rise in the US and worldwide. This tool can also serve as a model for risk stratification in other chronic diseases. Key Points: Question: How well can a multivariable risk model predict the risk of hospitalization, intensive care unit (ICU) stay, or death due to COVID-19 in patients with inflammatory bowel disease (IBD)?Findings: Multivariable prediction models developed using data from an international voluntary registry of IBD patients and available for use online ( https://covidibd.org/ ) have very good discrimination for predicting hospitalization (Test set AUC 0.79) and excellent discrimination for ICU admission (Test set AUC 0.88) and death (Test set AUC 0.94). The models were developed with a training sample of 2009 cases and validated in an independent test sample of 700 cases comprised of a random sub-sample of cases and all cases entered in the registry during a one-month period after model development. Meaning: This risk prediction model may serve as an effective tool for healthcare providers to facilitate conversations about COVID-19-related risks with IBD patients.

20.
American Journal of Gastroenterology ; 116(SUPPL):S1356-S1357, 2021.
Article in English | EMBASE | ID: covidwho-1534870

ABSTRACT

Introduction: Prior data indicate that within procedural specialties, women may be less likely to be first and senior authors of manuscripts during the COVID-19 pandemic, especially for studies pertaining to the pandemic. Women are more likely faced with challenges of balancing work and other duties such as household responsibilities and childcare, especially for those who are mothers. The purpose of this study was to determine the gender distribution of authorship of manuscripts in high-impact gastroenterology and hepatology journals during the early part of the COVID-19 pandemic. Methods: Manuscripts published between March 1, 2019 to January 1, 2020 and March 1, 2020 to January 1, 2021 in 16 high-impact gastroenterology and hepatology journals were identified using bibliometric data. Genders of first authors and senior authors were determined by matching first names with a predicted gender using a validated multinational database (Genderize.io). Number of women and men first and senior authors, and whether the manuscript was related to COVID-19 were recorded. Comparisons between female first and senior authorship of manuscripts from 2019 and 2020 were analyzed using Fisher exact testing. Results: In 2019, women were first authors of 777 (27.4%) manuscripts and senior authors of 546 (18.4%) manuscripts. In 2020, women were first authors of 999 (28.5%) manuscripts and senior authors of 646 (17.7%) manuscripts. There were no statistically significant differences of women first or senior authorship from 2019 to 2020. During the pandemic, women were first authors of 902 (28.9%) non-COVID-19 related manuscripts and 97 (25.7%) COVID-19 related manuscripts. Women were senior authors of 586 (18.0%) non-COVID-19 related manuscripts and 60 (15.6%) COVID-19 related manuscripts. There were no statistically significant differences of women authorship between non-COVID and COVID related manuscripts. Conclusion: The frequency and proportion of women first and senior authorship in 2020 was comparable to that in 2019. Women maintained scientific productivity in gastroenterology regarding publications in high-impact gastroenterology journals, despite facing increased challenges during the early part of the COVID-19 pandemic..

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