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2.
Hepatology ; 2021 Mar 26.
Artigo em Inglês | MEDLINE | ID: mdl-33772833

RESUMO

BACKGROUND & AIMS: Chronic liver diseases (CLD) affect ~2% of the US population and are associated with substantial burden of hospitalization and costs. We estimated the national burden and consequences of financial hardship from medical bills in individuals with CLD. APPROACH & RESULTS: Using the National Health Interview Survey from 2014-18, we identified individuals with self-reported CLD. We used complex weighted survey analysis to obtain national estimates of financial hardship from medical bills and other financial toxicity measures (cost-related medication non-adherence, personal and/or healthcare related financial distress, food insecurity). We evaluated the association of financial hardship from medical bills with unplanned healthcare utilization and work productivity, accounting for differences in age, sex, race/ethnicity, insurance, income, education and comorbidities. Of 3,666 (representing 5.3 million) US adults with CLD, 1,377 (representing 2.0 million; [37%, 95% CI: 35-39%]) reported financial hardship from medical bills, including 549 (representing 740,000; [14%, 95% CI: 13-16%]) who were unable to pay medical bills at all. Adults who were unable to pay medical bills had 8.4 times higher odds of cost-related medication non-adherence (aOR, 8.39 [95% CI, 5.72-12.32]), 6.3-times higher odds of financial distress (aOR, 6.33 [4.44-9.03]) and 5.6-times higher odds of food insecurity (aOR, 5.59 [3.74-8.37]), as compared to patients without financial hardship from medical bills. Patients unable to pay medical bills had 1.9-times higher odds of emergency department visits (aOR, 1.85 [1.33-2.57]), and 1.8-times higher odds of missing work due to disease (aOR, 1.83 [1.26-2.67]). CONCLUSIONS: One in 3 adults with CLD experience financial hardship from medical bills, and frequently experience financial toxicity and unplanned healthcare utilization. These financial determinates of health have important implications in the context of value-based care.

3.
Gastroenterology ; 2021 Mar 17.
Artigo em Inglês | MEDLINE | ID: mdl-33744307

RESUMO

BACKGROUND AND AIMS: We conducted a retrospective cohort study to inform the safety of exposure to immunosuppressive and/or biologic agents around conception in expectant fathers with immune-mediated inflammatory diseases (IMIDs) on birth outcomes. METHODS: Using a de-identified administrative claims database (OptumLabs® Data Warehouse), we identified 7,453 expectant fathers with IMIDs (inflammatory bowel diseases, rheumatoid arthritis, psoriasis/psoriatic arthritis, ankylosing spondylitis) linked to newborns, with peri-conception medication exposure between 38-60 weeks prior to newborn delivery date (34-58 weeks prior for pre-term newborns), and neonatal follow-up for 3 months after delivery date. Through logistic regression, adjusting for paternal age and race (and in a subset for maternal age, race, presence of IMIDs and non-singleton births), we compared the risk of major congenital malformations (primary outcome) and preterm birth and low birthweight in fathers exposed to thiopurines (n=461), methotrexate (n=171), TNFα antagonists (n=1082) or non-TNF-targeting biologic agents (n=132) vs. fathers not exposed to any of these medications (n=5607). RESULTS: As compared to unexposed fathers (3.4% prevalence of major congenital malformations), exposure to thiopurines (RR, 1.12 [95% CI, 0.66-1.76]), methotrexate (RR, 0.67 [0.21-1.55]), TNFα antagonists (RR, 1.14 [0.81-1.57]), and non-TNF-targeting biologic agents (RR, 1.75 [0.80-3.24]) was not associated with increased risk of major congenital malformations. No association was observed between paternal medication exposure and risk of preterm birth or low birth weight. Results were stable on sub-analyses of linked father-mother-newborn triads. CONCLUSIONS: In a large cohort study of 7,453 expectant fathers with IMIDs, exposure to immunosuppressive or biologic agents around conception was not associated with increased risk of adverse birth outcomes.

4.
Semin Respir Crit Care Med ; 42(2): 199-211, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33548932

RESUMO

The right ventricle (RV), due to its morphologic and physiologic differences, is susceptible to sudden increase in RV afterload, as noted in patients with acute pulmonary embolism (PE). Functional impairment of RV function is a stronger presage of adverse outcomes in acute PE than the location or burden of emboli. While current iterations of most clinical prognostic scores do not incorporate RV dysfunction, advancements in imaging have enabled more granular and accurate assessment of RV dysfunction in acute PE. RV enlargement and dysfunction on imaging is noted only in a subset of patients with acute PE and is dependent on underlying cardiopulmonary reserve and clot burden. Specific signs like McConnell's and "60/60" sign are noted in less than 20% of patients with acute PE. About 2% of patients with acute PE develop chronic thromboembolic pulmonary hypertension, characterized by continued deterioration in RV function in a subset of patients with a continuum of RV function from preserved to overt right heart failure. Advances in molecular and other imaging will help better characterize RV dysfunction in this population and evaluate the response to therapies.

5.
Dig Dis Sci ; 2021 Feb 26.
Artigo em Inglês | MEDLINE | ID: mdl-33634430

RESUMO

BACKGROUND: Postoperative complication rates in patients with inflammatory bowel disease (IBD) receiving preoperative biologics have been analyzed without considering the surgical context. Emergency surgery may be associated with an increased risk of infectious complications, compared to elective operations. AIMS: To conduct a systematic review and meta-analysis investigating the relationship between preoperative biologic therapy and postoperative outcomes in Crohn's disease (CD) and ulcerative colitis (UC), focusing on elective surgery. METHODS: Electronic databases were searched up to February 12, 2020, for studies of patients with IBD undergoing elective abdominal surgery receiving biologic therapy within 3 months before surgery compared to no therapy, or another biologic therapy. Certainty of evidence was evaluated using GRADE. The primary outcomes were the rate of infections and total complications within 30 days. Pooled odds ratios (ORs) and 95% confidence intervals (CIs) were calculated. RESULTS: Thirty-three studies were included. Preoperative treatment with anti-tumor necrosis factor (TNF) therapy in patients with CD undergoing elective surgery was associated with increased odds of infection (OR 2.05; 95% CI 1.40-3.01), but not total complications (OR 1.03; 95% CI 0.71-1.51). In elective surgery for UC, preoperative anti-TNF therapy was not associated with infectious (OR 1.03; 95% CI 0.34-3.07) or total complications (OR 0.67; 95% CI 0.29-1.58). Limited data indicate that emergency surgery did not significantly affect the rate of complications. CONCLUSIONS: Anti-TNF therapy prior to elective surgery may increase the odds of postoperative infection in CD, although the certainty of evidence is very low. More evidence is needed, particularly for newer biologics.

6.
Artigo em Inglês | MEDLINE | ID: mdl-33556578

RESUMO

BACKGROUND AND AIMS: Despite increasing interest in histologic remission as a treatment target in ulcerative colitis (UC), the accuracy of histologic findings in left colon in detecting pancolonic histologic remission is unknown. METHODS: In a retrospective cohort study of patients with endoscopically active pancolitis undergoing treat-to-target interventions, we evaluated the diagnostic accuracy of left-sided (distal to splenic flexure) histologic and endoscopic findings on colonoscopy for detecting histologic and endoscopic healing elsewhere in the colon. RESULTS: Of 86 patients with moderate to severely active pancolitis who underwent 2 consecutive colonoscopies during treat-to-target interventions, 38% and 51% achieved histologic and endoscopic remission, respectively. Substantial agreement (kappa, 0.67; 95% confidence interval (CI), 0.51-0.83) was observed in histologic findings between left and right colon on follow-up colonoscopy. Histologic, and endoscopic, findings in left colon showed excellent accuracy in detecting pancolonic histologic remission (area under the curve (AUC), 0.96 [95% CI, 0.93-1.0]; misclassification rate, 5.9%), histologic normalization (AUC, 1.0, 0%), endoscopic improvement (AUC, 0.95 [0.96-1.0], 3.5%) and endoscopic remission (AUC, 0.98 [0.96-1.00], 5.8%), respectively. CONCLUSIONS: In patients with active pancolitis undergoing treat-to-target interventions, histologic and endoscopic findings in the left colon on colonoscopy have excellent accuracy for detecting pancolonic histologic remission, histologic normalization, endoscopic improvement, and endoscopic remission. Flexible sigmoidoscopy may suffice for monitoring histologic and endoscopic activity in patients with pancolitis.

7.
Artigo em Inglês | MEDLINE | ID: mdl-33640480

RESUMO

BACKGROUND AND AIMS: We conducted a retrospective cohort study comparing the risk of serious infections between patients treated with tumor necrosis factor-α (TNFα) antagonists vs. vedolizumab in patients with inflammatory bowel diseases (IBD). METHODS: Using an administrative claims database, we identified patients with IBD who were new-users of either TNFα antagonists or vedolizumab between 2014-2018 and had insurance coverage for at least 1y before and after treatment initiation. We compared the risk of serious infections (infections requiring hospitalization) between patients treated with vedolizumab or TNFα antagonists using marginal structural Cox proportional hazard models adjusted for baseline disease characteristics, healthcare utilization, comorbidities, and time-varying use of corticosteroids, immunomodulators and opiates. RESULTS: We included 4881 patients treated with TNFα antagonists (age, 41±15y, 60% with Crohn's disease [CD]) of whom 434 developed serious infections over 5786 person-year [PY] follow-up, and 1106 patients treated with vedolizumab (age, 44±16y, 39% with CD) of whom 86 developed serious infections over 1040-PY follow-up. Vedolizumab was associated with 46% lower risk of serious infections as compared with TNFα antagonists in patients with ulcerative colitis (HR,0.54 [95% CI,0.35-0.83), but no significant differences were observed in patients with CD (HR,1.30 [0.80-2.11]). Vedolizumab was associated with lower risk of extra-intestinal serious infections in patients with UC, but higher risk of gastrointestinal serious infections in patients with CD. CONCLUSIONS: In an observational study of patients with IBD, vedolizumab was associated with lower risk of serious infections as compared with TNFα antagonists, in patients with UC, but not in patients with CD.

9.
Ecotoxicol Environ Saf ; 208: 111757, 2021 Jan 15.
Artigo em Inglês | MEDLINE | ID: mdl-33396080

RESUMO

A pot study was performed to assess the phytoremedial potential of Cymbopogon citratus (D.C.) Staf. for reclamation of coal mine overburden dump wastes, emphasizing the outcome of amendment practices using cow dung manure (CM) and garden soil mixtures on the revegetation of over-burden wastes (OB). Wastes amendment with cow dung manure and garden soil resulted in a significant increase in soil health and nutrient status along with an increment in the phytoavailability of Zn and Cu which are usually considered as micronutrients, essential for plant growth. A significant increment in the total biomass of lemongrass by 38.6% under CM20 (OB: CM 80:20) was observed along with improved growth parameters under amended treatments as compared to OB (100% waste). Furthermore, the proportionate increases in the assimilative rate, water use efficiency, and chlorophyll fluorescence have been observed with the manure application rates. Lemongrass emerged out to be an efficient metal-tolerant herb species owing to its high metal-tolerance index (>100%). Additionally, lemongrass efficiently phytostablized Pb and Ni in the roots. Based on the strong plant performances, the present study highly encourages the cultivation of lemongrass in coal mining dumpsites for phytostabilization coupled with cow-dung manure application (20% w/w).


Assuntos
Biodegradação Ambiental , Cymbopogon/fisiologia , Esterco , Poluentes do Solo/metabolismo , Animais , Biomassa , Bovinos , Carvão Mineral , Minas de Carvão , Cymbopogon/crescimento & desenvolvimento , Metais , Desenvolvimento Vegetal , Raízes de Plantas/química , Plantas , Solo , Poluentes do Solo/análise
10.
Aliment Pharmacol Ther ; 53(7): 784-793, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33410551

RESUMO

BACKGROUND: Targeting histological remission or response in Crohn's disease (CD) is not recommended in clinical practice guidelines or as an outcome in clinical trials due to uncertainties regarding index validity and prognostic relevance. AIMS: To conduct a modified RAND/University of California Los Angeles appropriateness process with the goal of producing a framework to standardise histological assessment of CD activity in clinical trials. METHODS: A total of 115 statements generated from literature review and expert opinion were rated on a scale of 1-9 by a panel of 11 histopathologists and 6 gastroenterologists. Statements were classified as inappropriate, uncertain or appropriate based upon the median panel rating and degree of disagreement. RESULTS: The panellists considered it important to measure histological activity in clinical trials to determine efficacy and that absence of neutrophilic inflammation is an appropriate histological target. They were uncertain whether the Global Histological Activity Score was an appropriate instrument for measuring histological activity. The Geboes Score and Robarts Histopathology Index were considered appropriate. Two biopsies from five segments should be biopsied, and the colon and the ileum should be analysed separately for all indices. Endoscopic mucosal appearance should guide biopsy procurement site with biopsies taken from the ulcer edge, or the most macroscopically inflamed area in the absence of ulcers. CONCLUSION: We evaluated the appropriateness of items for assessing histological disease activity in CD clinical trials. These items will be used to develop a novel histological index.


Assuntos
Ensaios Clínicos como Assunto , Consenso , Doença de Crohn , Colo , Doença de Crohn/diagnóstico , Doença de Crohn/terapia , Humanos , Íleo , Los Angeles , Resultado do Tratamento
13.
Am J Gastroenterol ; 116(3): 584-592, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33443848

RESUMO

INTRODUCTION: Food insecurity is associated with negative nutritional outcomes and is experienced differently by women vs men. We evaluated the effects of gender on food insecurity and dietary intake in the United States. METHODS: Data from the National Health and Nutrition Examination Survey (2007-2016) were analyzed. Survey-weighted linear and logistic regression models were used to evaluate predictors of food security and the effect of food security on dietary consumption and body anthropometrics. Gender was modeled as a covariable and as an effect modifier. RESULTS: A total of 30,251 respondents were included. Approximately 15.1% (95% confidence interval [CI]: 14.1%-16.1%) of participants were food insecure. This increased over time from 11.7% in 2007-2008 to 18.2% in 2015-2016. A higher proportion of women experienced food insecurity compared with men (53.3% vs 46.7%, P = 0.02), although this was not significant after adjusting for poverty and other confounders (adjusted odds ratio 1.01; 95% CI: 0.93-1.09; P = 0.81). Among food insecure women, 32.4% (95% CI: 30.0%-34.9%) received emergency food assistance and 75.0% (95% CI: 71.5%-78.2%) received supplemental nutrition assistance benefits. Relative to men, food insecure women were less likely to meet the recommended dietary allowance of most macronutrients and micronutrients. They were also significantly more likely to be obese, have a wider waist circumference, and have higher total body fat percentage (P interaction all <0.001). DISCUSSION: Food insecurity represents a substantial public health challenge in the United States that differentially affects women compared with men. Alternative strategies may be required to meet the nutritional requirements for food insecure women.


Assuntos
Dieta , Disparidades nos Níveis de Saúde , Estado Nutricional , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Ingestão de Alimentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos Nutricionais , Pobreza , Fatores Sexuais , Fatores Socioeconômicos , Estados Unidos , Adulto Jovem
14.
Aliment Pharmacol Ther ; 53(3): 374-382, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33314269

RESUMO

BACKGROUND: Immune checkpoint inhibitors may variably impact patients with pre-existing autoimmune diseases. AIMS: To evaluate the risks and outcomes of adverse events in patients with pre-existing inflammatory bowel diseases treated with immune checkpoint inhibitors. METHODS: Through a systematic literature review up until July 31, 2020, we identified 12 studies reporting the impact of immune checkpoint inhibitors in 193 patients with inflammatory bowel disease. Outcomes of interest were relapse of inflammatory bowel disease, need for corticosteroids and/or biologics to manage inflammatory bowel disease relapse, and discontinuation of immune checkpoint inhibitors. We calculated pooled rates (with 95% confidence intervals [CI]) using random effects meta-analysis, and examined risk factors associated with adverse outcomes through qualitative synthesis of individual studies. RESULTS: On meta-analysis, 40% patients (95% CI, 26%-55%) experienced relapse of inflammatory bowel disease with immune checkpoint inhibitors. Among patients who experienced relapse, 76% (95% CI, 65%-85%) required corticosteroids, and 37% (95% CI, 22%-53%) required biologic therapy. Overall, 35% patients (95% CI, 17%-57%) with inflammatory bowel disease discontinued immune checkpoint inhibitors. Gastrointestinal perforation and abdominal surgery due to immune checkpoint inhibitor complications occurred in <5% patients. In a large study, inhibitors of cytotoxic T-lymphocyte antigen-4 (CTLA-4) were associated with a higher risk of relapse than programmed cell death 1 (PD-1) and programmed death ligand 1 (PD-L1) inhibitors. CONCLUSIONS: Approximately 40% of patients with pre-existing inflammatory bowel diseases experience relapse with immune checkpoint inhibitors, with most relapsing patients requiring corticosteroids and one-third requiring biologics. CTLA-4 inhibitors may be associated with higher risk of relapse.


Assuntos
Colite , Doenças Inflamatórias Intestinais , Antígeno CTLA-4 , Humanos , Doenças Inflamatórias Intestinais/tratamento farmacológico
15.
Eur Heart J Cardiovasc Imaging ; 22(2): 179-185, 2021 Jan 22.
Artigo em Inglês | MEDLINE | ID: mdl-33324979

RESUMO

AIMS : Recovery of left ventricular ejection fraction (LVEF) after aortic valve replacement has prognostic importance in patients with aortic stenosis (AS). The mechanism by which myocardial fibrosis impacts LVEF recovery in AS is not well characterized. We sought to evaluate the predictive value of extracellular volume fraction (ECV) quantified by cardiac CT angiography (CTA) for LVEF recovery in patients with AS after transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS : In 109 pre-TAVR patients with LVEF <50% at baseline echocardiography, CTA-derived ECV was calculated as the ratio of change in CT attenuation of the myocardium and the left ventricular (LV) blood pool before and after contrast administration. Early LVEF recovery was defined as an absolute increase of ≥10% in LVEF measured by post-TAVR follow-up echocardiography within 6 months of the procedure. Early LVEF recovery was observed in 39 (36%) patients. The absolute increase in LVEF was 17.6 ± 8.8% in the LVEF recovery group and 0.9 ± 5.9% in the no LVEF recovery group (P < 0.001). ECV was significantly lower in patients with LVEF recovery compared with those without LVEF recovery (29.4 ± 6.1% vs. 33.2 ± 7.7%, respectively, P = 0.009). In multivariable analysis, mean pressure gradient across the aortic valve [odds ratio (OR): 1.07, 95% confidence interval (CI): 1.03-1.11, P: 0.001], LV end-diastolic volume (OR: 0.99, 95% CI: 0.98-0.99, P: 0.035), and ECV (OR: 0.92, 95% CI: 0.86-0.99, P: 0.018) were independent predictors of early LVEF recovery. CONCLUSION : Increased myocardial ECV on CTA is associated with impaired LVEF recovery post-TAVR in severe AS patients with impaired LV systolic function.

16.
Artigo em Inglês | MEDLINE | ID: mdl-33279779

RESUMO

BACKGROUND AND AIMS: Endoscopic improvement is an important treatment target for mild-to-moderate ulcerative colitis (UC). However, early endoscopic evaluation is not always feasible. We aimed to develop a clinical decision support tool to discriminate patients who have achieved endoscopic improvement from those with more severe inflammation following mesalamine induction therapy. METHODS: We performed a post-hoc analysis of data from a phase 3 non-inferiority trial of 726 adults with mild-to-moderate UC treated with mesalamine. Multivariable logistic regression modeling determined associations between candidate variables and endoscopic improvement (Mayo endoscopic subscore=0-1 according to blinded central reading) at Week 8. Internal model validation was performed using bootstrap resampling. A clinical decision support tool was developed to stratify patients into low, intermediate, and high probability groups for endoscopic improvement. RESULTS: Variables associated with endoscopic improvement at Week 8 included 50% reduction in fecal calprotectin from baseline (odds ratio [OR] 2.64, 95% CI: 1.81, 3.85), reduction in rectal bleeding (OR 1.79 per point reduction, 95% CI: 1.35, 2.89), and improvement in physician global assessment (OR 2.32 per point improvement, 95% CI: 1.88, 2.85). The baseline Geboes score (OR 0.74 per grade, 95% CI: 0.65, 0.85) and prolonged disease duration (OR 0.95 per year, 95% CI: 0.92, 0.98) were negatively associated with endoscopic improvement. This model strongly discriminated endoscopic improvement in the development dataset (area under the curve [AUC] 0.84, 95% CI: 0.81, 0.87) and during validation (AUC 0.83). CONCLUSIONS: We developed and validated a clinical decision support tool that has good discriminative performance for induction of endoscopic improvement in patients with mild-to-moderate UC treated with mesalamine.

17.
Artigo em Inglês | MEDLINE | ID: mdl-33279781
18.
Artigo em Inglês | MEDLINE | ID: mdl-33346141

RESUMO

Crohn's disease (CD) can lead to bowel damage, stricturing, and obstruction thereby resulting in surgery and hospitalization. The Randomized Evaluation of an Algorithm for Crohn's Treatment (REACT) trial showed that early combined immunosuppression (ECI) with symptom-based treatment escalation for 24 months resulted in a lower risk of surgery, hospitalization, or CD-related complications compared with conventional management (CM).1 Treatment earlier in the disease course may be associated with reduced risk of complications compared with later initiation, although data are sparse.2 We performed a post hoc analysis of REACT to evaluate the impact of baseline disease duration on surgery, hospitalization, or CD-related complications in patients treated with ECI compared with CM.

19.
Inflamm Bowel Dis ; 2020 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-33325507

RESUMO

BACKGROUND: Identifying biologic-treated patients with inflammatory bowel diseases (IBDs) at higher risk of serious infections is a priority. We conducted a retrospective cohort study evaluating frailty and risk of serious infections in biologic-treated patients with IBD. METHODS: Using an administrative claims database, we identified biologic-treated patients with IBD between 2014 and 2018 with follow-up 1 year before and after treatment initiation. Using a validated claims-based hospital frailty risk scoring system, patients were classified as frail and nonfrail. We compared the risk of serious infections (infections requiring hospitalization) between frail and nonfrail patients using Cox proportional hazard analysis adjusting for age, comorbidities, disease characteristics, health care utilization, use of corticosteroids, immunomodulators, and opiates. RESULTS: We included 5987 biologic-treated patients with IBD (4881 on TNFα antagonists, 1106 on vedolizumab), of whom 2350 (39.3%) were classified as frail; over 7115 person-years of follow-up was included, and 520 patients developed serious infection. Frailty was not associated with increased risk of serious infection (adjusted hazard ratio [aHR], 1.12; 95% CI, 0.93-1.36), whereas advanced age (older than 60 years), high comorbidity burden, corticosteroid use, opiate use, and prior serious infection were associated with increased risk of serious infection. On stratified analysis, frailty was associated with increased risk of serious infections in vedolizumab-treated patients (aHR, 1.69; 95% CI, 1.03-2.79) but not in TNFα antagonist-treated patients (aHR, 1.03; 95% CI, 0.83-1.27). CONCLUSIONS: In biologic-treated patients with IBD, frailty assessed using a claims-based frailty index was not independently associated with increased risk of serious infections. Future studies evaluating objective and biological measures of frailty are warranted to risk-stratify older patients with IBD.

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