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1.
Laryngo- Rhino- Otologie ; 101:S232, 2022.
Article in English | EMBASE | ID: covidwho-1967660

ABSTRACT

The COVID-19 pandemic continues to keep the world on tenterhooks with increasing numbers of infections and at the same time increasing cases of post-viral olfactory dysfunction. In 5 to 20 % of those affected, loss of smell persists after 1 to 2 months. In a multicentre study (n= 652, of which 404 were women), non-sinunasal, acquired olfactory disorders of different entities were considered: postviral 584 of which 490 after COVID-19 infection, idiopathic 28, traumatic 40. There was an overall olfactory improvement over 3.5 (± 1.2) months for threshold, discrimination and identification (t > 3.65;p < 0.001) for all olfactory disorders studied. When analyzed separately for COVID-19 infection, other postviral olfactory disorders showed initially poorer olfactiory function (M = 23.6 vs. 26.5;t = 2.9;p = 0.01), but showed comparable improvement over time (F = 0.05;p = 0.83). Patients with parosmia showed better olfaction (M = 23.2 vs. 25.1;t = 2.5;p = 0.02), but not in the subgroup analysis after COVID-19 infection. At the first visit after 4.1 ( ± 3.3) months after acute COVID 21% patients were normosmotic;at the second visit after a further 3.6 ( ± 1.5) months, 34% of patients had normosmia after COVID-19 infection. During the course, an improvement in the ability to smell was demonstrable. For many patients with COVID-19-associated olfactory loss, an improvement that is experienced as complete may only occur over the course of months and possibly years.

2.
Journal of Hepatology ; 77:S217-S218, 2022.
Article in English | EMBASE | ID: covidwho-1967497

ABSTRACT

Background and aims: To validate an innovative eradication model for HCV infection in undocumented migrants and low-income refugees living Southern Italy. Method: a prospective, multicenter, collaborative study was started in June 2018 with The studywas stopped in February 2020 due to the outbreak of SARS-CoV-2 infection in Italy and was resumed in February 2021. At the six 1st level centers participating to the study volunteer associations that deal with the first needs of disadvantaged people performed the enrolment and the screening for anti-HCV, HBsAg and anti-HIV;epidemiological data were collected in an electronic database. Anti-HCV-positive subjects were sent to two 3rd level centers for the clinical, virological and therapeutic evaluation. For the HCV-RNA-positive subjects HCV genotyping and a clinical, biochemical and ultrasound staging was performed. The HCV RNApositive subjects have been treated with sofosbuvir-velpatasvir for 12 weeks and followed for 12 months from the end of therapy. Results: Of the 3, 991 migrants observed in the study period, 3, 897 (97.6%) accepted to be screened. They were young (median age 26 years), predominantly male (85.9%) and came from North Africa (3.8%), from Sub-Saharan Africa (68.4%), from Eastern Europe (8.1%), from Indo-Pakistan (17%) and from other countries (2.7%). Of the 3, 897 enrolled subjects, 185 (4.7%) resulted anti-HCV positive. The Figure shows the HCV-cure cascade. All the 185 anti-HCV-positive subjects were linked to care at 3rdID and tested for HCV RNA and 53 (28.6%) resulted HCV-RNA positive. Of these, 46 (86.8%) started DAA regimen with sofosbuvir plus velpatasvir (15 with GT 1b, 10 with 1a, 16 with 3, 3 with 4 and 2 with 2). Forty-two completed the follow-up and 4 was still pending. Of these 42 subjects, 41 (97.6%) showed a SVR12 and SVR 24, and one dropped-out in follow-up after the stop of DAA treatment. No subject had adverse event. (Figure Presented) Conclusion: This model seems to be effective to eradicate HCV infection among a difficult-to-manage population, such as undocumented migrants and low-income refugees

3.
Journal of Hepatology ; 77:S142, 2022.
Article in English | EMBASE | ID: covidwho-1967495

ABSTRACT

Background and aims: In trials conducted in India, recombinant granulocyte colony stimulating factor (GCSF) improved survival in alcohol-associated hepatitis (AH). The aim of this trial was to determine the safety and efficacy of pegfilgrastim, a long-acting recombinant GCSF, in patients with AH in the United States. Method: This prospective, open label trial randomized patients with a clinical diagnosis of AH and a Maddrey discriminant function score ≥32 to standard of care (SOC) or SOC+pegfilgrastim (0.6 mg subcutaneously) on Day 1 and Day 8. SOC was 28 days of either pentoxifylline or prednisolone, as determined by the patient’s primary physician. The second injection of pegfilgrastim was not administered if the white blood cell count exceeded 30, 000/mm3 on Day 8. Primary outcomewas survival at Day 90. Secondary outcomes included the incidence of acute kidney injury (AKI), hepatorenal syndrome (HRS), hepatic encephalopathy, or infections. Results: The study was terminated early due to COVID19 pandemic. Eighteen patients were randomized to SOC and 16 to SOC+pegfilgrastim. All patients received prednisolone as SOC. Nine patients failed to receive a second dose of pegfilgrastin due to WBC>30, 000/ mm3 on Day 8. Survival at 90 days was similar in both groups (SOC: 0.83 [95% confidence interval {CI}: 0.57–0.94] vs. pegfilgrastim: 0.73 [95% CI: 0.44–0.89];p > 0.05). The incidences of AKI, HRS, hepatic encephalopathy, and infections were similar in both treatment arms and therewere no serious adverse events attributed to pegfilgrastim. Conclusion: This phase II trial found no survival benefit at 90 days among subjects with AH who received pegfilgrastim+prednisolone compared with subjects receiving prednisolone alone.

4.
Journal of Hepatology ; 77:S49-S50, 2022.
Article in English | EMBASE | ID: covidwho-1967493

ABSTRACT

Background and aims: A global study with equitable participation for cirrhosis and chronic liver disease (CLD) outcomes is needed. We initiated the Chronic Liver disease Evolution And Registry for Events and Decompensation (CLEARED) study to provide this global perspective. Aim to evaluate determinants of inpatient mortality and organ dysfunction in a multi-center worldwide study. Method: We prospectively enrolled pts with CLD/Cirrhosis >18 years without organ transplant or COVID-19 who were admitted non-electively. To maintain equity in outcome analysis, a maximum of 50 pts/site were allowed. Data for admission variables, hospital course, and inpatient outcomes (ICU, death, organ dysfunction [ODF]) were recorded. This was analyzed for death and ODs using significant variables on admission and including World Bank classification of low/middle-income countries (LMIC). A model for in-hospital mortality for all variables during the hospital course, including ODs) was analyzed. Results: 1383 pts (55 ± 13 yrs, 64% men, 39% White, 30% Asian, 10% Hispanic, 9% Black, 12% other) were enrolled from 49 centers (Fig A). 39% were from high-income while the rest were from LMICs. Admission MELDNa 23 (6–40) with history in past 6 months of hospitalizations 51%, infections 25%, HE 32%, AKI 23%, prior LVP 15%, hydrothorax 8% and HCC 4%. Leading etiologies were Alcohol 46% then NASH 23%, HCV 11% and HBV 13%. Most were on lactulose 52%, diuretics 53%, PPI 49% and statins 11%, SBP prophylaxis 16%, beta-blockers 35% and rifaximin 31%. 90% were admitted for liver-related reasons;GI bleed 30%, HE 34%, AKI 33%, electrolyte issues 30%, anasarca 24% and 25% admission infections. In-hospital course: Median LOS was 7 (1–140) days with 25% needing ICU. 15% died in hospital, 3% were transplanted, 46% developed AKI,15% grade 3–4 HE, 14% shock, 13% nosocomial infections and 13% needed ventilation. Logistic Regression: Fig B shows that liver-related/unrelated factors on admission which predicted in-hospital mortality and development of organ dysfunction with MELDNa and Infections being common among all models. Nosocomial infections and organ dysfunctions predicted mortality when all variables were considered. High-income countries had better mortality outcomes likely due to transplant and ICU availability. AUCs were >0.75 (Figure Presented) Conclusion: In this worldwide equitable experience, admission cirrhosis severity and infections are associated with inpatient outcomes, which are greater in low-income settings. Liver-related and unrelated factors and regional variations are important in defining critical care goals and outcome models in inpatients with cirrhosis.

5.
Radiotherapy and Oncology ; 170:S1638-S1639, 2022.
Article in English | EMBASE | ID: covidwho-1967485

ABSTRACT

Purpose or Objective The surface-guided radiotherapy (SGRT) VisionRT® system uses a combination of real-time optical and laserbased imaging to accurately position patients receiving radiotherapy. The aim of this study is to analyse the implementation efficiency of SGRT in four Genesis Care radiotherapy centers in Spain and to collect the RTT impressions regarding this system. Materials and Methods The system was implemented at GenesisCare facilities in Madrid, Barcelona, Alicante, and Málaga starting on August 15, 2020. Prior to this implementation, the centers were trained in a training program consisting of: A) An online course;B) A didactic weekend course;and C) Go live supervision during the first treatments for three days. The course was delivered by an expert VisionRT® trainer and a qualified radiotherapy technician. After two months of implementation, we collected the diagnostic and staging information of patients treated with the VisionRT system between the go live and October 16,2020. To evaluate the efficacy, we considered a goal of patients with SGRT in the practice: > 75% High, 75%- 50%: moderate, < 50%: low. Tattoo base method set up was allow for head and neck immobilization, skin cancer or clinician discretion. A questionnaire was carried out to the RTT working in these centers. The questionnaire contained a 1-5 satisfaction scale asking about the SGRT system: 1. very poor;2. poor;3. fair;4. good;or 5. very good regarding six points. These were safety (patient ID recognition), set up (precision increase, time reduction), management (no covid contact), confidence (technique), improvement (daily practice), and patient satisfaction (RTT point of view). Results 93.4 % of the patients in these four centers were positioned under SGRT conditions, and 6.6 % were positioned with a tattoo-based method. OF the total of 295 patients with SGRT, 212 of them were positioned without tattoos. The evaluated patients have breast cancer (43.0%), prostate cancer (18.6%), metastatic cancer (8.1 %) or lung cancer (5.4%). 21 RTT responded to the questionnaire. Results are as follows: 1. Safety: 61.9% very good and 38.1% good;2. Set-up: 61.9% very good, 28.6% good, and 9.5% moderate;3. Accuracy increase: 42.8% very good, 19% good, 28.6% fair, 4.8% poo,r and 4.8% very poor;4. Management (contactless COVID): 47.6% very good, 14.3% good, 23.8% fair, and 14.3% poor;5. Confidence (real time): 9.6% very good, 47.6% good, 33.2% fair, and 9.6% poor;5. Improvement: 52.4% very good, 23.8% good, 23.8% fair;6. Patient satisfaction with tattoo less from the technician point of view: 90.4% very good, 4.8% good, and 4.8% moderate. Conclusion The implementation of SGRT was carried out with high efficiency considering that 93,4% of care were delivered with this technique. RTT consider this technique very good for safety, accuracy, confidence, and improvement in the daily practice.

6.
Radiotherapy and Oncology ; 170:S1069-S1070, 2022.
Article in English | EMBASE | ID: covidwho-1967474

ABSTRACT

Purpose or Objective Evaluation of the incidence of pulmonary toxicities, especially pneumonitis, for patients treated in a real setting with concurrent chemoradiation (CRT) followed by adjuvant durvalumab for unresectable stage III non-small-cell lung cancer (NSCLC). Materials and Methods This study included retrospectively 84 patients with unresectable stage III NSCLC treated by CRT followed by durvalumab in 5 french centers from May 2017 to May 2021. Pneumonitis incidence was analysed with a distinction between immune pneumonitis, lung infection and radiation pneumonitis. A multivariate analysis was realized for radiation pneumonitis to find predictive factors. Overall survival (OS) and Progression Free Survival (PFS) were also evaluated. Results With a median follow-up of 23 months, grade 3-4 pneumonitis were as follows: 3.4% of radiation pneumonitis, 5.9% of immune pneumonitis and 13.4% of lung infections. . In multivariate analysis, age ≥ 68 years-old, cardiovascular history and use of docetaxel came out as predictive factors for radiation pneumonitis.Considering the entire population, median PFS was 28.9 months and the 2-year OS was 70.8%. Besides, among our population study, 31% of patients presented at least one or more exclusion or non-inclusion criteria according to initial PACIFIC protocol. But there was no difference between the patients who meet the PACIFIC criteria and the others, whether for toxicity or survivals. The beginning of the durvalumab consolidation within 14 days after ending CRT seemed to improve the PFS according to PACIFIC’s findings. Conclusion In our real-word study, incidence of grade 3-4 radiation pneumonitis and immune pneumonitis are similar to those in the PACIFIC trial. Incidence of lung infections was higher, probably because of the context of SARS-CoV-2 pandemic. Age ≥ 68 years-old, cardiovascular history and use of docetaxel were found to be predictive factors for radiation pneumonitis. Moreover, PFS and OS were excellent

7.
Radiotherapy and Oncology ; 170:S866-S867, 2022.
Article in English | EMBASE | ID: covidwho-1967467

ABSTRACT

Purpose or Objective The Canadian Medical Association recently acknowledged that physician health remains a significant threat to the viability of Canada’s health care system. A 2014 survey reported a 44% prevalence of burnout among American oncologists. The purpose of this survey was to determine the national prevalence of burnout and document work engagement among Canadian radiation oncologists. Materials and Methods Between November 2019 and March 2020 (pre COVID pandemic), online questionnaire was distributed electronically to 333 Canadian radiation oncologists, across 49 centers, through the National Canadian Association of Radiation Oncology office mailing list. The survey included 62 questions determining job engagement, and validated burnout scale The Maslach Burnout Inventory (MBI) (22 questions). Results 241 of the 333 surveyed Canadian radiation oncologists (72%) completed the questionnaire and were included in this analysis. Responses to the MBI showed that 15% of radiation oncologist met the strict criteria for burnout (i.e. negative scores in all 3 domains: exhaustion, depersonalization, and low accomplishment). Another 60% scored negative in at least one of the three burnout domains. Using the more commonly reported definition of burnout (negative scores in either exhaustion and/or depersonalization), 44% of Canadian radiation oncologist were burnt out. Only 25% had positive scores in all 3 domains and were fully engaged in their work. The full burnout syndrome varies with the provinces and was the highest in British Columbia (22% ) and lowest in Quebec (3%). The responses to work engagement questions revealed a significant concerns regarding inefficiency in work flow (50%), heavy workloads (>50%), a poor work life balance (68%), lack of control over the work environment (47%) and lack of recognition from administrators (45%). 48% perceive the atmosphere at their primary work area as “chaotic and hectic”. Within the last 3 years, 41% had considered leaving their institution to work elsewhere and 51% were considering reducing their full-time equivalent (FTE). Reassuringly, 80% reported a sense of overall ability to provide high quality care and a 59% feel they have a supportive network of colleagues, 80% are willing to try something new. The top 4 strategies identified by respondants aimed to improve worklife quality were (1) more support staff at work, (2) more efficient care models, (3) more resources for patients, and (4) lighter workloads for physicians. Conclusion The survey shows that only 25% of the Canadian radiation oncologist is fully engaged in their work, 15 % meet the strict criteria for burnout and 44% meet the more commonly used burnout criteria. With the rising incidence of cancer and complexity of care, there is an urgent need for change, leverage the enthusiasm to “try something new”, and develop appropriate strategies to improve the wellbeing of the oncology work force.

8.
Radiotherapy and Oncology ; 170:S866, 2022.
Article in English | EMBASE | ID: covidwho-1967466

ABSTRACT

Purpose or Objective SABR has become standard of care for early stage lung cancer where surgery is contraindicated. As a result of the COVID- 19 pandemic access to surgery was limited and demand for SABR as primary treatment has increased. A national program to implement lung SABR in all radiotherapy centres was commissioned and an associated QA program was developed. One of its components was a planning benchmark case to ensure optimal planning of target volumes whilst sparing organs at risk following the SABR Consortium Guidelines. Results of the benefits of the QA process are presented here. Materials and Methods A dual-lesion planning benchmark DICOM dataset was circulated amongst 24 participating centres, including a planning CT and a structure set. Centres had to plan the lesions to 55Gy in 5# and meet dose constraints, coverage and conformity criteria outlined in the Guidelines. All plans were reviewed on Velocity v4.1 (Varian Medical Systems) and PTV coverage, dose distribution, plan conformity and OAR dose constraints were assessed. Prescription Dose Spillage (PDS) was used to define conformity in the high dose area as Body V100(cc)/PTV V100(cc) and Modified Gradient Index (MGI) was defined for conformity in low dose area as Body V50(cc)/PTV V100(cc). The Mann Whitney test was used to evaluate differences in conformity across plans, with statistical significance set at 5%. Results Mean V100% for first submissions for lesions 1 and 2 were 97.26% (S.D. 1.86) and 98.19 % (S.D.1.61), respectively. All mandatory OARs were well within tolerance. The largest variation across centres was plan conformity, which is summarised in Table 1. (Table Presented) Ten plans failed their first attempt and centres were asked to resubmit following detailed feedback. Mean PDS for these plans changed from 1.19 (S.D. 0.09) to 1.13 (S.D. 0.05), although this was not statistically significant (p=0.12). Mean MGI was significantly improved on resubmission, decreasing from 7.08 (S.D. 0.8) to 6.16 (S.D.0.84), (p=0.03). Figure 1 shows increase in consistency and improvement in conformity across centres after resubmission. On completion of the QA process, the final set of accepted plans had improved conformity indices from initial PDS and MGI, however these were not statistically significant (p=0.31 and p=0.13, respectively). (Figure Presented) Conclusion A national QA program for lung SABR is critical for the safe implementation of this technique and to ensure standards are consistently high across multiple centres. The planning benchmark has highlighted differences in plan conformity and technique, in particular for MGI, however feedback within the QA process has allowed for increased consistency across departments through improved quality.

9.
Gastroenterology ; 162(7):S-1251, 2022.
Article in English | EMBASE | ID: covidwho-1967439

ABSTRACT

stress. We studied admissions, readmission (RAD) rates, and demographics of ALD patients before and after the onset of the COVID-19 pandemic. Methods: We reviewed the number of hospitalizations before and after the onset of the COVID-19 pandemic for ALD at four teaching hospitals in the Northwell Health System, two bordering New York City to the east (region A) and two in NYC (region B). Coding data of hospital discharges for ALD (alcoholic hepatitis, alcohol-associated cirrhosis, nonspecific alcohol liver disease) during the 14 months between January 2019 and February 2020 (period 1) were compared to those between June 2020 and July 2021 (period 2) for admissions, RAD, and demographics. Data from March to May 2020 were excluded due to New York City lockdown, limited and delayed access to health care due to COVID-19 pandemic. The Fisher's exact test and Mann- Whitney test are used for statistic comparisons. Results: The number of hospitalizations for ALD increased by 32% during the COVID-19 pandemic. However, the increase was only observed in region A, but not in region B (55% vs -1%). With the onset of the pandemic, the median age for ALD admissions decreased by 4.5 years overall, significantly in region B (7.5 years), but not in region A (2 years). In both regions, the percentage of the white race admissions also decreased. No significant difference was observed in the gender distribution, Medicaid insurance status and overall rate of RAD (Table 1). However, the white population had decreased RAD rates from 32% to 17% in region B, the non-white population RAD rates increased from 17% to 31% in region A, and in regions A and B combined (Table 2). Conclusion: Our study shows that admission for ALD increased during the COVID-19 pandemic in areas bordering NYC but not in NYC. These rates differed by race, accompanied with a slight shift to younger age. Our results suggest that observations based on certain communities or regions may not be universally applicable. Future research for the impact of COVID-19 on ALD and other social-economic adaptation should take demographic and geographic variations into consideration. (Table Presented)

10.
Gastroenterology ; 162(7):S-1249, 2022.
Article in English | EMBASE | ID: covidwho-1967435

ABSTRACT

Background: The presence of comorbidities has been associated with worse outcomes in patients with SARS-CoV2 virus infection. It has been reported that patients with cirrhosis and COVID-19 showed higher mortality rates than patients without cirrhosis. This study aims to analyze the case fatality rate (CFR) in patients with cirrhosis and COVID-19, as well as the implications that this infection has on the incidence of acute decompensations. Methods: A multicenter prospective cohort study was conducted in 13 COVID-19 centers in Mexico. Patients with cirrhosis and COVID-19 were compared with randomly selected age- and sex-matched controls with COVID-19 without cirrhosis. The characteristics and development of decompensation in patients with cirrhosis were analyzed. Results: A total of 96 patients with cirrhosis and COVID-19 and 193 controls with COVID-19 were studied. Age (56.80 vs. 56.45 years, respectively;P=0.80) and male sex proportion (65.6% vs. 65.6%, respectively;P=0.98) was comparable between the two groups. Patients with cirrhosis and COVID-19 had a higher CFR than patients without cirrhosis (29.2% versus 19.2%, respectively, P=0.05) (Figure 1). There were no differences in the use of invasive mechanical ventilation, vasopressors, or the hospitalization length. The most common decompensations were worsening ascites (43%), encephalopathy (42%), and variceal bleeding (13%). Acute kidney injury occurred in 60% of patients with cirrhosis and 30% fulfill criteria of hepatorenal syndrome. Conclusion: Cirrhosis may impose a significant death risk factor in moderateto- severe COVID-19. Moreover, COVID-19 might be an important trigger of acute decompensation of cirrhosis, which could influence short-term CFR. (Figure Presented)

11.
Gastroenterology ; 162(7):S-1247, 2022.
Article in English | EMBASE | ID: covidwho-1967429

ABSTRACT

Introduction In a study involving > 10,000 patients hospitalized with COVID-19, we found that liver injury, which was present in ~70% of patients upon hospital admission, correlates with in-hospital mortality (Satapathy et al., Eur J Gastroenterol Hepatol 2021). Curiously, severe liver chemistry abnormalities (LCA) were seen less often in patients with diabetes or hypertension, although these diseases confer increased risk of severe disease. This raises the question whether home medications protect from COVID-19 associated liver injury. We now analyzed associations between LCA and twenty-six groups of antidiabetic, antihypertensive, and other common mediations. Results 9898 patients hospitalized with COVID-19 in 13 hospitals in New York between March 1 to August 31, 2020, who had an complete records on admission were retrospectively analyzed. LCA measured were alanine and aspartate aminotransferases, alkaline phosphatase, and bilirubin, and were defined as absent, mildmoderate (up to four times elevated), or severe. Diseases and socioeconomic factors were similar to the initial study. 67.2% had hypertension, and 40.8% had diabetes. The most common medications included insulin (12.2%), metformin (18.3%), sulfonylureas (6.8%), DDP4 inhibitors (6.3%), ACE inhibitors (14.8%), ARBs (18.6%), beta-blockers (33.2%), calcium-channel blockers (26.5%), diuretics (21.6%), statins (41.5%), PPIs (22.1%), H2- blockers (6.8%), antiplatelets (31.0%), anticoagulants (20.5%). Comparisons between groups were analyzed using Kruskal-Wallis test, chi-squared test, and Fisher's exact test. Univariate and multivariate regression analysis were performed. Univariate analysis showed a higher risk for severe LCA in men, Asian and Black race, non-Hispanic ethnicity. As in our prior analysis, hypertension and diabetes were associated with less frequent severe LCA. In addition, hyperlipidemia, CAD, CHF, atrial fibrillation, CKD, ESRD, GERD, asthma, COPD, cancer, and liver disease were inversely associated with severe LCA. Medications that were associated with less frequent severe LCA included statins, ACE, ARBs, calcium-channel blockers, betablockers, diuretics, antiplatelet medications, insulin, biguanide, sulfonylureas, PPIs, H2- blockers, and anticoagulants, but not oral steroids. In multivariate analysis, male gender, Asian and Black race were associated with increased risk of severe LCA. Hypertension, ESRD and asthma were associated with less frequent severe LCA, but not diabetes. Among medications, only metformin showed a statistically significant correlation with severe LCA on admission, with a hazard ratio 0.57 (p 0.0002). Conclusions Metformin use was inversely associated with severe liver chemistry abnormalities upon hospital admission with COVID- 19 in a large cohort of patients during the initial pandemic in New York.

12.
Gastroenterology ; 162(7):S-1246, 2022.
Article in English | EMBASE | ID: covidwho-1967426

ABSTRACT

Background Frailty is defined as a clinical state of increased vulnerability to health and age associated stressors. The liver frailty index (LFI), composed of grip strength, chair stand and balance testing, is an accepted predictor of morbidity and mortality in cirrhosis. With the need for COVID-19 related social distancing, many appointments are being carried out virtually. The chair stand subcomponent of the LFI has the potential to be evaluated virtually, with a high reliability as compared to in-person testing noted in other disease populations. Objective To determine if the chair stand test is an independent predictor of morbidity and mortality in patients with cirrhosis. Methods 822 adult patients with cirrhosis were prospectively enrolled from five centers (3 in Canada, 1 in the United States, and 1 in India). Inclusion criteria included adult patients with cirrhosis. 787 of these patients completed a chair stand test at baseline, measured as the time (seconds) a patient takes to rise from sitting with their arms folded across their chest five times (measured in-person). The times were divided into 3 categories: >15 seconds, between 10 and 15 seconds, and <10 seconds. Patients who could not complete 5 chair stands were classified in the >15 seconds category. Primary outcome was all-cause mortality. Secondary outcome was unplanned all-cause hospital admission. Fine-Gray proportional hazard regression models were used to evaluate the association between the chair stand time and the outcomes. We adjusted for baseline age, sex, and MELD score and accounted for liver transplantation as a competing risk. Cumulative incidence functions were used to create a graphical representation of the survival analysis. Results Patients were divided into three groups: group 1, <10 seconds (n = 276);group 2, 10-15 seconds (n = 290);and group 3, >15 seconds (n = 221). Mortality was increased in group 3 in comparison to group 1 (HR 3.21, 95% CI: 2.16-4.78, p<0.001). Similarly, the hazard of non-elective hospitalizations was higher in group 3 in comparison to group 1 (HR 2.24, 95% CI: 1.73-2.91, p<0.001). Overall, patients with chair stand times greater than 15 seconds had increased all-cause mortality (HR 2.78, 95% CI 2.01-3.83, p<0.001) and non-elective hospitalizations (HR 1.84, 95% CI 1.48-2.29, p<0.001) when compared to patients with times less than 15 seconds. Conclusion A time to complete 5 chair stands of >15 seconds predicts morbidity and mortality in patients with cirrhosis. This test shows promise as a frailty measure that could be evaluated over a virtual platform. (Figure Presented)

13.
Gastroenterology ; 162(7):S-1137, 2022.
Article in English | EMBASE | ID: covidwho-1967411

ABSTRACT

INTRODUCTION Patients with liver disease, notably cirrhosis, are at a higher risk for hospitalizations and mortality after COVID-19. However, previous studies did not report long-term outcomes;furthermore, the effect of COVID-19 on underlying liver disease and long-term prognosis and risk for decompensation is hitherto unknown. We aimed to compare the short and long-term outcomes of patients with compensated cirrhosis with and without COVID-19. METHODS A retrospective cohort study was performed using TriNetX (a multiinstitutional research network). Patients with compensated cirrhosis who were tested for COVID-19 were identified between January 2020 and December 2020. These patients were then stratified into two groups based on results of COVID-19 testing;compensated cirrhosis who tested positive (COVID-19 group) and compensated cirrhosis who tested negative and were never diagnosed with COVID-19 (non-COVID-19 group). The primary outcomes were risk for decompensation of cirrhosis, need for inpatient/ ICU services and mortality. Clinical outcomes were compared at 3 months in the two groups (short term outcomes). Patients who survived at 3 months were then followed up to 1 year (long term outcomes). Outcomes were compared after 1:1 propensity score matching (PSM) to account for the confounding variables (age, gender, race, diabetes, ischemic heart disease, hypertension, chronic kidney disease, chronic lower respiratory disease and nicotine dependence). RESULTS We identified a total of 18228 patients with compensated cirrhosis who were tested for COVID-19 during the study period. Of these, 1217 patients tested positive for COVID-19 and were included in the COVID-19 group, and the remaining 17011 were included in the non-COVID-19 group. There were significant differences in characteristics, however, after PSM, both groups were well matched (Table 1). Patients in the COVID-19 group had a significantly higher risk of mortality at 3 months and the risk remained high even after PSM (Table 2). COVID- 19 group had a higher risk for decompensation, inpatient or ICU care. However, follow up of survivors at 1 year did not show an increased risk of mortality, decompensation, inpatient or ICU care in both unmatched and matched analysis (Table 2). . CONCLUSION Our study showed that patients with compensated cirrhosis who tested positive for COVID-19 are at higher risk of decompensation and poor outcomes in the short-term secondary to acute insult from COVID-19 disease. However, for patients who survive the acute COVID-19 insult, long-term outcomes including the risk of decompensation, mortality or need for hospitalization are similar when compared to cirrhosis patients who never acquired COVID- 19 disease. This study demonstrates that patients with cirrhosis who survive COVID-19 may not have worsening of their underlying liver disease or long-term prognosis. (Table Presented)Baseline characteristics of the two study cohorts before and after propensity score matching (Table Presented) Clinical outcomes of the two study cohorts before and after propensity score matching

14.
Gastroenterology ; 162(7):S-1083-S-1084, 2022.
Article in English | EMBASE | ID: covidwho-1967408

ABSTRACT

Background: Inflammatory bowel disease (IBD) is a disease with repeated relapses and remissions, and it is considered that IBD patients had more than a little conflict between the threat of COVID-19 infection by visiting the doctor and the anxiety about their own disease by postponing the visit. We investigated the impact of the COVID-19 pandemic on the anxiety and behavioral changes of Japanese IBD patients. Methods: We collected questionnaires from 3032 IBD patients aged 16 years or older attending 31 facilities in Japan between March 2020 and June 2021. The primary endpoint was anxiety felt by IBD patients during the COVID-19 pandemic. Results: The median age was 44 years;43.3% of the participants were female. 60.6% of the participants was diagnosed with ulcerative colitis and 39.4% with Crohn’s disease (CD), and the median disease duration was 10 years. Regarding IBD medications, about 80% of the patients were taking 5-ASA, followed by thiopurine (31.4%), biological agents (47.4%), and less than 10% of the patients were taking steroids or budesonide. 37.7% of participants reported that they were in clinical remission, whereas 35.6% were in mild and 19.3% were in moderate activity. The questionnaires were collected throughout the middle of the second wave to the end of four waves of COVID19 in Japan. The mean VAS score is 5.1±2.5 during this pandemic, which indicated moderate anxiety. The most frequent causes of anxiety were the risk of SARS-CoV-2 infection by visiting hospital, the risk of infection by IBD itself, and the risk of infection by IBD medication. Factors associated with anxiety are women, housewives, time to visit hospital, transportation by train, use of immunosuppressive drugs, and nutritional therapy. The results of the questionnaire survey on medical visits showed that about 90% of the patients went to the hospital and received treatment as scheduled. During this pandemic, 97.5% of the patients continued oral medication and injections as physicians indicated. Most of participants felt the need for a family doctor and primarily sought guidance, and information regarding SARS-COV-2 from television or internet news. 35.6% of the patients were given information about prevention of SARS-COV-2 by their physicians. 42.6% of the patients received an explanation about the continuation of medication from their physicians. Conclusion: Japanese IBD patients had moderate disease-related anxiety. The percentage of patients with a behavioral change was small. Based on the content of anxiety obtained in this study, we should continue to proactively inform patients about infectious diseases such as SARS-COV2 and the accompanying accurate information related to IBD management, thereby relieving their anxiety. (Figure Presented)

15.
Gastroenterology ; 162(7):S-1081, 2022.
Article in English | EMBASE | ID: covidwho-1967405

ABSTRACT

Background: The spread of COVID-19 has had a major impact on the health of people worldwide. The clinical background and clinical course of Japanese inflammatory bowel disease (IBD) patients with COVID-19 remains unclear. Patients with IBD are often on immunosuppressive therapy, and there has been concern about the severity of COVID-19. We conducted the multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19. Methods: This study is an observational cohort of Japanese IBD patients diagnosed with COVID-19, and was registered in the UMIN Clinical Trials Registry (ID UMIN000040656). Data on age, gender, IBD (classification, treatment, and activity), COVID-19 symptoms and severity, and treatment of COVID-19 were analyzed. Results: From 72 facilities in Japan, one hundred eighty-seven patients were registered from June 2020 to October 2021 (Table1). The estimated incidence ratio of COVID19 in Japanese IBD patients was 0.61%. The median age (±SD) was 42.0±15.6, 4.8% of patients were obese with BMI >30, 7.0% were current smokers, and 31.0% had some complications. Of the patients enrolled, 104 had ulcerative colitis, 74 had Crohn's disease, 3 had IBD-Unclassified, and 6 had intestinal Behcet's disease. The majority of IBD patients with COVID-19 (73%) were in clinical remission. COVID-19 cases were most common in the 20-50 age group, but the COVID-19 severity rate according to WHO classification tended to be higher in the elderly than in middle-aged persons (Figure1). In Japan, the second SARS-CoV-2 vaccination rate jumped from 0% to 90% in just four months from May to September 2021 because the elderly received vaccination preferentially. Therefore, during the fifth wave of the epidemic (July-September 2021), infections among elderly IBD patients were particularly low compared with the younger. According to WHO classification regarding COVID-19 severity, 172 patients (92%) had non-severe, 12 (6%) were severe including serious conditions. Most IBD patients (UC and CD) with COVID-19 had no change in disease activity. A logistic regression analysis stepwise method revealed that older age, higher BMI, and steroid use were risk factors for COVID-19 severity. Six of eight patients who had COVID-19 after vaccination were receiving anti-TNF-alpha antibodies. Conclusion: The estimated incidence ratio of COVID19 in Japanese IBD patients was 0.61%. Age, BMI, and steroid use were associated with COVID-19 severity in Japanese IBD patients. (Table Presented) Table1. Case profile of the registered patients (Figure Presented) Figure1. The Age distribution of patients with COVID-19 and the COVID-19 severity rate

16.
Gastroenterology ; 162(7):S-1031, 2022.
Article in English | EMBASE | ID: covidwho-1967398

ABSTRACT

Background/Aim: It is easy to predict that the actual COVID-19 pandemic would have had a negative impact on cancer screening activities and the outcomes of screenings, but to date, real-time population-based evidence to substantiate this concern is very scarce. In this study, to understand the changes in the behavior and performance of CRC screening following the COVID-19 pandemic, the indicators of CRC screening processes and outcome measures were compared with both monthly data in 2019 and monthly changes focusing on the peaks that appeared in 2020. Method: This population-based nationwide study used fecal immunochemical test (FIT) and colonoscopy claims data from the Korean National Health Insurance System (NHIS) from 2019 to 2020. Data were analyzed from 15,867,759 subjects in 2019 and 16,155,930 subjects in 2020. We compared the data of CRC screening (FIT/ colonoscopy) of the COVID-19 pandemic period (2020) with those of the same period of 2019. Result: In the COVID-19 period, 3,445,660 (21.3%) subjects underwent FIT, whereas in 2019, 6,490,707 (40.9%) subjects performed FIT (almost 2-fold). Participation rate in colonoscopy after FIT positive fell in 2020 by 36.0% compared with the average rate recorded in 2019 (44.5%). In particular, it was confirmed that the participation rate of the CRC screening further decreased immediately after the COVID-19 peak periods (first and second wave: March 2020 and August 2020). Conclusion: The overall adherences to CRC screening tests decreased substantially during COVID-19 pandemic. Therefore, urgent modulation for not only easier access but also planning a restart for CRC screening is needed to address the growing burden of under-detected CRC in Korea.

17.
Gastroenterology ; 162(7):S-1007, 2022.
Article in English | EMBASE | ID: covidwho-1967395

ABSTRACT

Background: Patients with inflammatory bowel diseases (IBD) are commonly treated with immunosuppressive agents. Following the novel corona virus (SARS-CoV-2) pandemic, these patients received early the currently EMA approved vaccines. Data on efficacy and safety of SARS-CoV-2 vaccination on this population are lacking. Methods: Greek IBD patients, from 10 tertiary referral centres, who had completed the initial vaccination protocol with the available anti-COVID-19 vaccines (BNT162b2, mRNA-1273, Ad26.CoV2.S, ChAdOx1) at least two weeks before enrolment, were prospectively studied. Demographic and safety data were collected and blood samples were drawn for serum Anti-S1 IgG measurement [Euroimmun Anti-SARS-CoV-2 QuantiVac ELISA (IgG)]. Results: In total 403 IBD patients (59% Crohn's disease, median age 45 years, 53% male) and 124 healthy controls (HC) were included (Table 1). Antibody testing was conducted after a median of 31 (IQR, 23-46) days post-vaccination. Following a full vaccination regimen, 98% of IBD patients seroconverted (anti-S1 IgG³11 RU/ml). In total, IBD patients had lower anti-S1 levels than HC (RU/ ml 108 vs 133 RU/ml, P=0.00009) Administration of mRNA vaccines resulted in higher seroconversion rates and higher antibody titers than viral vector ones (98.6% vs 93.6%, P= 0.02 and 111.2 RU/ml vs 76 RU/ml, P<0.0001, respectively). Treatment with vedolizumab monotherapy was associated with higher antibody levels than anti-TNFα or ustekinumab monotherapy (P=0.02 and P=0.03). Longer timing between vaccination and antibody measurement was independently associated with impaired vaccine response. In multivariable analysis, specifically in mRNA-vaccinated cohort, older age, anti-TNFα treatment and treatment with biologics plus IMMs were significantly associated with lower antibody response (P=0.01, P=0.008, and P=0.02 respectively). Patients with prior COVID-19 infection showed numerically higher levels of antibodies. All vaccines were safe in IBD patients. Conclusions: Patients with IBD have high seroconversion rates to anti-SARS-CoV-2 vaccines. However, they demonstrate impaired antibody responses compared to HC. Patients receiving viral vector vaccines, and those on anti-TNFα or combination treatment may have further response impairment and it is important to consider booster vaccination in those low-response groups. (Table Presented)

18.
Gastroenterology ; 162(7):S-1006, 2022.
Article in English | EMBASE | ID: covidwho-1967392

ABSTRACT

BACKGROUND Little is known about the impact of immunosuppressants on COVID-19 vaccination in patients with immune-mediated inflammatory diseases (IMID). Although humoral response may be attenuated in patients using immunomodulators (IMM) and TNFinhibitors (anti-TNF), data regarding cellular response are scarce and conflicting. This study was aimed to identify immune response to COVID-19 vaccination in IMID patients. METHODS A prospective observational multicentre cohort study was conducted to examine the immunogenicity of mRNA vaccines to SARS-CoV-2 in adult IMID patients using immunosuppressive therapy (anti-TNF, IMM, anti-TNF+IMM, anti-IL12/23, anti-IL-17, anti-IL-23) or no therapy as compared to healthy controls (HC). Patient details and vaccination history were recorded. Blood samples were drawn at 3 time points: before, 3-4 weeks after first and 2 weeks after second vaccination. Humoral immune response to S and RBD proteins were assessed by ELISA. Neutralization was tested against 4 variants of SARS-CoV-2 by surrogate neutralization ELISA. Cellular immune responses were determined based on analysis of 9 secreted cytokines and cytotoxic molecules after stimulation of PBMC with S peptide pools. Response to N protein was used to assess SARS-CoV-2 exposure. RESULTS A total of 159 subjects (133 IMID patients and 26 HC) were included in this study (median age 42 years [IQR 30-53], 52% male). Of 133 IMID patients, 87 had inflammatory bowel disease, 23 psoriatic arthritis, 18 psoriasis, 11 ankylosing spondylarthritis and 4 rheumatoid arthritis. Of these, 44 used anti-TNF, 9 IMM, 18 anti-TNF+IMM, 33 anti-IL-12/23, 9 anti-IL-17, 10 anti-IL-23 therapy and 10 no therapy. All subjects received 2 doses of mRNA vaccines (2x Pfizer, 2x Moderna or mixed) between December 2020 and September 2021. The vast majority of subjects had minimal binding antibody and T cell responses to N, indicating they were COVID-19 naïve. After dose 1, anti-TNF group had lower IL-2 vs untreated IMID (p<0.01), and the anti-IL-23 group had lower IFN-g vs HC (p<0.01), though there was wide variation in responses within groups. Following dose 2, median responses between groups were mostly similar, but antibody responses were significantly lower in patients on anti-TNF as compared to HC in subjects that received two doses of Pfizer (p=0.01). Pooled data for all subjects combined show a higher response to Moderna over Pfizer in ELISA, neutralization and T cell readouts, and a lower response for those over 60 years of age after dose 2. Longer follow-up is in process to monitor the durability of these responses over time and after third dose. CONCLUSION Immune responses after 2 doses of mRNA vaccines in immunocompromised IMID patients largely reach the level of that of HC albeit antibody responses in the anti-TNF group are weaker and with wide variability between subjects within some groups

19.
Gastroenterology ; 162(7):S-1005, 2022.
Article in English | EMBASE | ID: covidwho-1967390

ABSTRACT

Background: Immune responses to the SARS-CoV-2 vaccination may be influenced by immunomodulatory drugs (IMDs). We investigated the immune responses and safety in fully vaccinated Japanese patients with IBD. Subjects and Methods: IBD patients and control subjects at 39 institutes were invited to participate in the study from March to October 2021. Blood sample collections to measure anti-SARS-CoV-2 spike IgG antibody titers were planned pre-1st vaccination, pre-2nd vaccination, and at 4 weeks, 3 months and 6 months post-2nd vaccination. Immune responses were compared between groups, considering baseline characteristics and IMD treatments. (UMIN000043545) The interim analyses presented here include mainly data from the 4-weeks post-2nd vaccination time-point. Results: In total, 679 IBD patients and 203 controls were enrolled (Table 1). The IBD group received the BNT162b2 vaccine (86.2%) and the mRNA-1273 vaccine (12.5%), and the control group received the BNT162b2 vaccine (86.9%) and the mRNA-1273 vaccine (12.1%). Only 4 cases (0.7%) in the IBD group and 2 (1.0%) in the control group were infected with COVID-19. Adverse events of 2nd vaccination occurred in 48.4% of the IBD group and 35.1% of the control group. Comparison between administrated and non-administrated IBD patients for each IMD revealed an attenuated genomic mean titer (GMT [U/mL]) in those taking systemic steroids (18.85 vs 31.24), anti-TNF monotherapy (28.31 vs 42.99), anti- TNF therapy+ immunomodulator (IM) (12.86 vs 35.26), vedolizumab+IM (19.49 vs 30.39), ustekinumab+IM (20.44 vs 30.79), and tofacitinib (9.54 vs 32.08), but not in those taking oral 5-ASA (29.50 vs 32.40), or vedolizumab (41.85 vs 40.20) and ustekinumab (55.56 vs 39.26) monotherapies. Estimated least square means of the GMT by a multiple linear regression model are shown in Table 2. GMTs were significantly influenced by increasing age and allergy (51.2, 95%CI 42.1-62.3;p=0.0293), and tended to be influenced by COVID- 19 infection (139.1, 41.0-472.2;p=0.0572). Sex, smoking, drinking, IBD, and adverse events of 2nd vaccination did not affect the GMT. The GMT was significantly higher for mRNA- 1273 (90.3 [60.8-134.1]) than for BNT162b2 (39.6 [35.2-44.6], p= 0.0001). Systemic steroids (22.9 [13.9-37.7], p=0.0119), IM (24.2 [18.7-31.4], p<0.0001), anti-TNF agents (20.8 [15.3-28.3], p<0.0001), vedolizumab (25.2 [15.0-42.2], p=0.0409), ustekinumab (28.9 [18.5-45.0], p=0.0754), and tofacitinib (5.5 [2.8-10.9], p<0.0001), but not oral 5- ASA (39.1 [31.9-47.9], p=0.3225), attenuated GMTs at 4 weeks post-2nd vaccination (Table 2). Conclusion: Aging and most IMD options attenuated immunogenicity in fully vaccinated IBD patients. Prioritization of a booster vaccination should be considered for IBD patients treated with IMDs. (Table Presented) (Table Presented)

20.
Gastroenterology ; 162(7):S-982, 2022.
Article in English | EMBASE | ID: covidwho-1967387

ABSTRACT

Background Dysbiosis of the gut microbiota may be responsible for the pathogenesis of ulcerative colitis (UC). Restoration of gut microbiota diversity by means of faecal microbiota transplantation (FMT) is of increasing interest as a therapeutic option in the management of UC. The aims of this phase II feasibility study are to estimate the magnitude of treatment response to FMT in treatment-naïve patients with newly diagnosed UC, evaluate donor and patient recruitment rates and determine optimal study conditions for phase III study (ISRCTN 58082603). Methods Treatment-naïve patients with histologically confirmed UC below the sigmoid were recruited. Subjects were randomised to single FMT enema, five daily enemas and control group. All groups received antibiotic for 10 days and bowel preparation 48 hours before the interventions. They were followed up for 12 weeks with quality of life (QOL) scores (IBDex, CUCQ-32) and 16S RNA study on faecal samples. Endoscopic (Mayo score) and histological assessments were performed at the baseline and week 12. The primary endpoints were endoscopic remission of UC and rate of persistent microbial engraftment at 12 weeks. Secondary endpoints included QoL and mucosal cytokine profiling with IL-10. Clinical remission was defined as Mayo score ≤ 2 with an endoscopic Mayo score of 0. Results Eighteen UC patients were recruited between July 2016 and February 2020 until the COVID-19 pandemic, of those five achieved clinical remission. One subject from the control group withdrew at week 4 due to worsening symptoms. 72% improved Mayo and QOL scores, and 44% avoided medical treatment. Clinical remission was more observed among subjects with lower baseline QoL and mild-moderate disease, although this did not reach statistical significance (P=0.173). No correlation between FMT dose, frequency and clinical remission were observed. The 16S evaluation of the faecal samples demonstrated successful engraftment of FMT and showed a similar faecal microbiota profile amongst the intervention groups, which was markedly different from the control group. Coprococcus was found to be much more abundant amongst subjects who responded to the FMT intervention. This study also suggested an inverse correlation between IL-10 and the severity of UC. Conclusions FMT intervention protocols were well adhered and 94% completion rate, though the recruitment period was much longer than the original plan due to some unforeseen interruptions. Yet, this feasibility study demonstrated potential for employing this method for a larger multicentre RCT to further evaluate FMT dose and frequency effects. The correlation between IL-10 and IL-10 producing microorganisms should be sought in the future study.

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