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The purpose of this American Gastroenterological Association (AGA) Institute Clinical Practice Update (CPU) is to review the available evidence and provide expert advice regarding best practices for use of telemedicine in gastroenterology and hepatology. This CPU was commissioned and approved by the AGA Institute Clinical Practice Updates Committee (CPUC) and the AGA Governing Board to provide timely guidance on a topic of high clinical importance to the AGA membership and underwent internal peer review by the CPUC and external peer review through standard procedures of Gastroenterology. This expert commentary incorporates important, as well as recently published, studies in this field, and it reflects the experiences of the authors who are active gastroenterologists and hepatologists with extensive experience using telemedicine in clinical practice. [ABSTRACT FROM AUTHOR]

The liver plays a central role in the pharmacokinetics of drugs through drug metabolizing enzymes and transporters. Non-alcoholic steatohepatitis (NASH) causes disease-specific alterations to the absorption, distribution, metabolism, and excretion (ADME) processes, including a decrease in protein expression of basolateral uptake transporters, an increase in efflux transporters, and modifications to enzyme activity. This can result in increased drug exposure and adverse drug reactions (ADRs). Our goal was to predict drugs that pose increased risks for ADRs in NASH patients. Bibliographic research identified 71 drugs with reported ADRs in patients with liver disease, mainly non-alcoholic fatty liver disease (NAFLD), 54 of which are known substrates of transporters and/or metabolizing enzymes. Since NASH is the progressive form of NAFLD but is most frequently undiagnosed, we identified other drugs at risk based on NASH-specific alterations to ADME processes. Here, we present another list of 71 drugs at risk of pharmacokinetic disruption in NASH, based on their transport and/or metabolism processes. It encompasses drugs from various pharmacological classes for which ADRs may occur when used in NASH patients, especially when eliminated through multiple pathways altered by the disease. Therefore, these results may inform clinicians regarding the selection of drugs for use in NASH patients. Expression of several hepatic metabolizing enzymes and drug transporters are altered in NASH patients. Therefore, this review identifies drugs that may exhibit disrupted pharmacokinetics based on their ADME properties. [Display omitted] [ABSTRACT FROM AUTHOR]

Whether preoperative treatment of inflammatory bowel disease (IBD) with tumor necrosis factor inhibitors (TNFis) increases the risk of postoperative infectious complications remains controversial. The primary aim of this study was to determine whether preoperative exposure to TNFis is an independent risk factor for postoperative infectious complications within 30 days of surgery. We conducted a multicenter prospective observational study of patients with IBD undergoing intra-abdominal surgery across 17 sites from the Crohn's & Colitis Foundation Clinical Research Alliance. Infectious complications were categorized as surgical site infections (SSIs) or non-SSIs. Current TNFi exposure was defined as use within 12 weeks of surgery, and serum was collected for drug-level analyses. Multivariable models for occurrence of the primary outcome, any infection, or SSI were adjusted by predefined covariates (age, sex, preoperative steroid use, and disease type), baseline variables significantly associated (P <.05) with any infection or SSI separately, and TNFi exposure status. Exploratory models used TNFi exposure based on serum drug concentration. A total of 947 patients were enrolled from September 2014 through June 2017. Current TNFi exposure was reported by 382 patients. Any infection (18.1% vs 20.2%, P =.469) and SSI (12.0% vs 12.6%, P =.889) rates were similar in patients currently exposed to TNFis and those unexposed. In multivariable analysis, current TNFi exposure was not associated with any infection (odds ratio, 1.050; 95% confidence interval, 0.716–1.535) or SSI (odds ratio, 1.249; 95% confidence interval, 0.793–1.960). Detectable TNFi drug concentration was not associated with any infection or SSI. Preoperative TNFi exposure was not associated with postoperative infectious complications in a large prospective multicenter cohort. [Display omitted] In the largest multicenter prospective surgical cohort on the topic, P rospective Cohort of U lcerative C olitis and Crohn's Disease Patients Undergoing Surgery to Identify Risk Factors for Post-Operative IN fection I (PUCCINI) showed that preoperative tumor necrosis factor inhibitor use was not associated with any postoperative infections, including surgical site infections. [ABSTRACT FROM AUTHOR]

COVID-19 vaccination prevents severe disease in most patients with inflammatory bowel disease (IBD), but immunosuppressive medications can blunt serologic response. We followed adults with IBD for >1 year post–COVID-19 vaccination to describe factors associated with SARS-CoV-2 infection after vaccination, evaluate for a protective SARS-CoV-2 antibody level, characterize SARS-CoV-2 antibody persistence, and identify factors associated with humoral immune response durability. Using a prospective cohort of COVID-19 immunized adults with IBD, we analyzed factors associated with SARS-CoV-2 infection after vaccination. We evaluated for an association between SARS-CoV-2 antibody level 12 weeks postvaccination and subsequent SARS-CoV-2 infection and assessed for a threshold of protection using receiver-operating characteristic curve analysis. We then conducted a separate analysis evaluating factors associated with persistence of SARS-CoV-2 antibodies 52 weeks postimmunization. Almost half (43%) of 1869 participants developed COVID-19 after vaccination, but most infections were mild, and <1% required hospitalization. Older age and corticosteroid use were associated with a decreased risk of SARS-CoV-2 infection postvaccination (50–59 years of age vs 18–29 years of age: adjusted hazard ratio, 0.57; 95% confidence interval, 0.44–0.74; steroid users vs nonusers: adjusted hazard ratio, 0.58; 95% confidence interval, 0.39–0.87). Most (98%) participants had detectable antibody levels at 52 weeks postvaccination. Antibody levels at 12 weeks and number of vaccine doses were positively associated with higher antibody levels at 52 weeks, while anti-tumor necrosis factor α therapy was negatively associated. COVID-19 vaccination generates an effective and durable protective response for the vast majority of adults with IBD, including vulnerable populations such as corticosteroid users and older individuals. Patients with IBD benefit from COVID-19 booster vaccination. [Display omitted] [ABSTRACT FROM AUTHOR]

Evaluating cardiovascular safety of sphingosine 1-phosphate (S1P) receptor modulators is warranted due to S1P receptor expression on cardiomyocytes and vascular endothelial cells. This analysis reports the cardiovascular safety of ozanimod, an S1P receptor modulator, in patients with moderately to severely active ulcerative colitis from the phase 3 True North (TN) and open-label extension (OLE). All patients who received ozanimod in TN (n = 796) and all eligible TN patients who entered the OLE (n = 823) were included. Cardiovascular-related adverse events were evaluated in patients with up to 146 weeks of ozanimod exposure (2219 patient-years), which included 52 weeks during TN. On TN day 1, first-dose ozanimod resulted in a 0.2 beats per minute mean decrease in heart rate from pretreatment to hour 6; 2 patients experienced bradycardia, which resolved without treatment modification. Mean systolic and diastolic blood pressure increases of 5.1 and 2.2 mm Hg, respectively, were observed at TN week 52. No second-degree Mobitz type II atrioventricular block events were reported; 1 third-degree atrioventricular block unrelated to ozanimod occurred in the OLE. Cardiac and vascular treatment-emergent adverse events were infrequent (3.8% [31 of 823] and 8.5% [70 of 823]); no ozanimod-related cardiovascular deaths occurred. The incidences of deep-vein thrombosis (0.2%; 2 of 823), pulmonary embolism (0.2%; 2 of 823), and ischemic stroke (0.4%; 3 of 823) in the OLE were low. No new cardiovascular safety signals were identified, consistent with findings from previous ozanimod studies. There were few major adverse cardiovascular events or thromboembolic events, which were unrelated or unlikely related to ozanimod. Ozanimod has a well-tolerated cardiovascular safety profile when prescribed in accordance with the label. Clinical trial registry website and trial numbers: ClinicalTrials.gov numbers: NCT02435992 and NCT02531126. [Display omitted] [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to determine the clinical safety and feasibility of a novel single-port flexible robot for Transoral Robotic Surgery (TORS).Materials and Methods: This was a prospective phase II / IDEAL stage 2 clinical trial of both benign and malignant lesions of the head and neck. The primary endpoint included conversion rates and perioperative complications within 30 days following surgery. The study was registered on www.ClinicalTrials.gov (NCT03010813). The Fisher's exact test and Mann-Whitney U test were used to compare categorical, and non-parametric data for the trial. A p value <0.05 was considered to be statistically significant. Statistical analysis was performed with SPSS 20.0 (IBM Corp., Armonk, New York) RESULTS: Twenty-one patients safely underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA) demonstrating the feasibility of access to the nasopharynx, oropharynx, larynx and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all patients.Conclusions: In a prospective Phase II clinical trial, a novel single-port flexible robotic system appears safe and feasible to use for transoral endoscopic head and neck surgery to access the nasopharynx, oropharynx, larynx and hypopharynx. [ABSTRACT FROM AUTHOR]

In this article, the authors review the evolving state of diversity in the field of radiology. The authors discuss several early and recent historical legislative milestones that increased the equitable delivery of health care in the United States, such as Title VI of the Civil Rights Act of 1964, which ensured that funds for Medicare reimbursement would be available only to desegregated hospitals. Furthermore, the authors examine the current state of diversity and representation in radiology, in which underrepresented minorities represent 8.3% of training and practicing radiologists, and women represent 27.8% of radiologists. Finally, the authors present arguments for diversity in the current medical education system, analyze hurdles to increasing representation in radiology, and consider the future of diversity and inclusiveness in the field. [ABSTRACT FROM AUTHOR]

Background/objective: The Active Healthy Kids 2018 Hong Kong Report Card provides evidence-based assessment across 12 indicators of physical activity behaviors, sleep, and related community and government initiatives for children and youth. Methods: The systematic development process provided by the Active Healthy Kids Global Alliance was used. The best available data from the past 10 years were reviewed by a panel of experts. According to predefined benchmarks, letter grades were assigned to 12 indicators (Overall Physical Activity, Organized Sport Participation, Active Play, Active Transportation, Sedentary Behaviors, Physical Fitness, Sleep, Family, School, Community and Environment, Government, and Obesity). Results: Three of the five activity behaviors received C- or C grades: Overall Physical Activity (C-), Sedentary Behaviors (C-), and Organized Sport Participation (C). Active Transportation was graded B þ. Same to the 2016 Hong Kong Report Card, Active Play could not be graded. School and Government were graded C. Family and Community and Environment was graded D- and B, respectively. Three new indicators were added after the 2016 Report Card and they were graded from C- (Sleep) to D (Physical Fitness) or D- (Obesity). Conclusions: Children and youth in Hong Kong have low physical activity and physical fitness levels and high sedentary behaviors despite a generally favorable community environment. A high prevalence of obesity and low levels of family support warrant more public health action. Researchers should address the surveillance gap in active play and peer support. [ABSTRACT FROM AUTHOR]

Background Attention-deficit/hyperactivity disorder (ADHD) shows substantial heritability and is two to seven times more common in male individuals than in female individuals. We examined two putative genetic mechanisms underlying this sex bias: sex-specific heterogeneity and higher burden of risk in female cases. Methods We analyzed genome-wide autosomal common variants from the Psychiatric Genomics Consortium and iPSYCH Project ( n = 20,183 cases, n = 35,191 controls) and Swedish population register data ( n = 77,905 cases, n = 1,874,637 population controls). Results Genetic correlation analyses using two methods suggested near complete sharing of common variant effects across sexes, with r g estimates close to 1. Analyses of population data, however, indicated that female individuals with ADHD may be at especially high risk for certain comorbid developmental conditions (i.e., autism spectrum disorder and congenital malformations), potentially indicating some clinical and etiological heterogeneity. Polygenic risk score analysis did not support a higher burden of ADHD common risk variants in female cases (odds ratio [confidence interval] = 1.02 [0.98–1.06], p = .28). In contrast, epidemiological sibling analyses revealed that the siblings of female individuals with ADHD are at higher familial risk for ADHD than the siblings of affected male individuals (odds ratio [confidence interval] = 1.14 [1.11–1.18], p = 1.5E-15). Conclusions Overall, this study supports a greater familial burden of risk in female individuals with ADHD and some clinical and etiological heterogeneity, based on epidemiological analyses. However, molecular genetic analyses suggest that autosomal common variants largely do not explain the sex bias in ADHD prevalence. [ABSTRACT FROM AUTHOR]

Background/Objective: The purpose of this study is to examine the reliability and validity of "Perceived Physical Literacy Instrument" (PPLI) questionnaire in adolescents. Methods: Based on physical literacy literature, a 9-item instrument was developed for initial tests. The self-report measure was administered to 1945 adolescents in Hong Kong. Confirmatory factor analysis (CFA) was used to examine a three-factor structure of physical literacy. A chi-square difference test analysed several competing models and compared the results between the proposed models (i.e., a three-factor solution) and other alternative models (i.e., a one-factor or two-factor solution). Furthermore, the measurement invariance across gender groups was examined by using multiple-group confirmatory factor analysis. Mean scores for physical literacy factors were also examined by demographic characteristics. Results: Confirmatory factor analysis (CFA) showed that the construct demonstrated a good fit to the model. For convergent validity, our results, evaluating the factor loading of each items, the values of composite reliability (CR) and the average variance extracted (AVE) of the three factors, revealed that the three-factor validity of physical literacy was satisfactory. The chi-square difference test between models was significant indicating that all the latent variables had satisfactory discriminant validity. Moreover, the findings of measurement invariance showed that the PPLI is invariant across gender. Conclusions: The PPLI thus appeared to be reliable and valid as a measure of the perceived physical literacy of adolescents. Thus, along with other validated instruments, protocols and research designs, the PPLI could be widely used to test adolescents' self-perception of physical literacy and their own physical and mental health conditions and thereby health. Physical education professionals may thus recommend appropriate intervention programmes for younger generations. [ABSTRACT FROM AUTHOR]

The fisheries sector in Ghana is a significant source of livelihood for many communities along the coast. However, the sector faces several challenges, including the power dynamics between the industrial bottom trawl industry and small-scale fishers. The concept of resource scarcity has frequently been used to characterise conflicts between industrial vessels and small-scale canoes in Ghana. This paper seeks to build on this dominant narrative that resource scarcity is the key driver of conflicts, arguing that exclusion, and resistance to exclusion can also explain contemporary conflicts in marine fisheries, and that indeed apparent resource scarcity can be caused by exclusion. A political ecology lens reveals that fisheries conflict in Ghana is entwined with established and emerging socio-political domains of exclusion, namely, regulation, legitimisation, force, and the market. We explain how contradictory regulations and ambiguous boundary delimitations, combined with a long period of weak enforcement, have helped industrial trawlers exploit fisheries in ways that exclude small-scale fishers. Additionally, with foreign-aid diplomacy legitimising the expansion of foreign-owned industrial trawlers, the infiltration of illegal catch into the small-scale value chain harms local businesses. We conclude that conflict serves as both a tool and a symptom of exclusion through its connection to regulatory, jurisdictional, and political contexts, as well as market dynamics. • Coastal small-scale fisheries face significant challenges in ocean economy governance • Fisheries conflict in Ghana seems to have arisen not only from resource depletion, but also been driven by active patterns of exclusion • Industrial fishers exclude small-scale fishers through a range of power domains • Foreign-aid dependency seems to be legitimising the expansion of foreign industrial trawlers • Conflict serves as both a tool and a symptom of exclusion [ABSTRACT FROM AUTHOR]

Patients with chronic medically complex disorders like inflammatory bowel diseases (BD) often have mental health and psychosocial comorbid conditions. There is growing recognition that factors other than disease pathophysiology impact patients' health and wellbeing. Provision of care that encompasses medical care plus psychosocial, environmental and behavioral interventions to improve health has been termed “whole person care” and may result in achieving highest health value. There now are multiple methods to survey patients and stratify their psychosocial, mental health and environmental risk. Such survey methods are applicable to all types of IBD programs including those at academic medical centers, independent health systems and those based within independent community practice. Once a practice determines that a patient has psychosocial needs, a variety of resources are available for referral or co-management as outlined in this paper. Included in this white paper are examples of psychosocial care that is integrated into IBD practices plus innovative methods that provide remote patient management. [ABSTRACT FROM AUTHOR]