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In response to the COVID-19 pandemic, the CDC issued guidance advising patients and providers to adopt social distancing practices such as home-based infusions (H-BI).We performed a mixed methods evaluation to summarize perceptions, concerns, and experiences with H-BI among all inflammatory bowel disease patients 18-90 years of age who transitioned to home-based infliximab or vedolizumab infusions between March to July 2020 at a tertiary care center. Semi-structured interviews were conducted and analyzed using an iterative, inductive thematic approach. Baseline characteristics and outcome on safety, COVID-19 transmission, delays in infusions, and H-BI persistence were collected.Of the 57 participants who transitioned to H-BI, 20 (33%) responded. Four major categories and six major themes related to expectations, experience, perceived safety, and logistical factors were identified. Initial perceptions were mixed, however these resolved. One patient developed COVID-19, one patient experienced an adverse event, 12 (21%) patients experienced an infusion delay, and 6 (11%) patients transitioned from H-BI.Despite mixed initial perceptions, respondents had a positive experience with most respondents planning to continue H-BI after the pandemic resolves. Several real-world actionable barriers were identified related to scheduling, communication between stakeholders, and nursing quality. No major safety concerns were identified.

Background Self-reported tobacco pack-year history plays a large role in decisions about low-dose CT screening for lung cancer, yet is challenging to measure accurately. Research Question To what extent does random measurement error in pack-year information impact screening decisions and screening effectiveness? Study Design and Methods Retrospective cohort study of 10,449 patients with pack-year history documented at least twice between October 2013 and July 2017 across 8 academic Veterans Affairs sites. Outcome measures included (1) observed reliability of pack-year information based on all repeat measures for the study population and (2) each person’s statistically “true” pack-year information based on best linear unbiased predictor from a multilevel linear random effects model. To examine how unreliability leads to misclassification of screening eligibility and inaccuracy in estimating lung cancer risk, we simulated pack-year observations for each person, first comparing simulated pack-year and lung cancer risk values with true values, then comparing outcomes when basing screening decisions on unreliable pack-year information vs true information. Results Reliability of assessing pack-year information in routine practice varied across sites. Thus, we examined the clinical impact of two different levels of reliability, based on the range of intraclass correlation coefficients observed. Using a ≥ 30-pack-year threshold led to a high rate of eligibility misclassifications (48.1% misclassified with higher reliability pack-year information and 60.7% misclassified with lower reliability information). However, using a lung cancer risk threshold leads to fewer misclassifications (47.3%-49.7% misclassified when using lower reliability pack-year information) and maintains screening effectiveness better when using unreliable pack-year information. Interpretation Random error in real-world pack-year assessments leads to a substantial rate of misclassifying who should be offered CT screening if a ≥ 30-pack-year criterion is used. However, using a lung cancer risk threshold mitigates the impact of unreliable pack-year information. Decision-makers concerned about the impact of unreliable pack-year information should consider using risk-based approaches to CT screening.

Although management of inflammatory bowel disease follows a similar approach for all adults, there are certain characteristics making its treatment more challenging in older patients. The advent of novel medical treatments has changed the paradigm of inflammatory bowel disease, with an increasing focus on preventing disease progression in addition to controlling symptoms. The safety of these therapies in the elderly needs to be considered. Management of inflammatory bowel disease in the elderly is confounded by comorbidities that can increase the risk of medication or surgical complications; polypharmacy and altered pharmacokinetics also increase the risk of drug-drug interactions and adverse events.

Background & Aims Guidelines suggest endoscopic screening of individuals who are at increased risk for Barrett's esophagus (BE) and esophageal adenocarcinoma. Tools based on clinical factors are available for identifying patients at risk, but only some have been validated. We aimed to compare and validate available tools. Methods We performed a prospective study of 1241 patients, ages 40 to 79 years, presenting either for their first esophagogastroduodenoscopy (EGD) or their first endoscopic therapy of early neoplastic BE, from April 2015 through June 2018. We calculated risk scores for 6 previously published tools (the Gerson, Locke, Thrift, Michigan BE pREdiction Tool [M-BERET], Nord-Trondelag Health Study [HUNT], and Kunzmann tools). We also investigated the accuracy of frequency and duration of gastroesophageal reflux disease (GERD), using data from a randomly selected 50% of patients undergoing their first EGD. We compared the ability of all these tools to discriminate patients with BE and early neoplasia from patients without BE, using findings from endoscopy as the reference standard. Results BE was detected in 81 of 1152 patients during their first EGD (7.0%). GERD symptoms alone identified patients with BE with an area under the receiver operating characteristic curve (AuROC) of 0.579. All of the tools were more accurate in identifying patients with BE than the frequency and duration of GERD (AuROC for GERD, 0.579 vs range for other tools, 0.660–0.695), and predicted risk correlated well with observed risk (calibration). The AUROCs of the HUNT tool (0.796), the M-BERET (0.773), and the Kunzmann tool (0.763) were comparable in discriminating between patients with early neoplasia (n = 94) vs no BE. Each tool was more accurate in discriminating BE with early neoplasia than GERD frequency and duration alone (AuROC, 0.667; P Conclusions The HUNT, M-BERET, and Kunzmann tools identify patients with BE with AuROC values ranging from 0.665 to 0.695, and discriminate patients with early neoplasia from patients without BE with AuROC values ranging from 0.763 to 0.796. These tools are more accurate than frequency and duration of GERD in identifying individuals at risk for neoplastic BE.

BACKGROUND: Safety of anti-tumour necrosis factor-α (TNFα) therapy in people with a history of cancer and with an immune-mediated disease is unknown. We aimed to assess the risk of recurrence of initial cancer or development of a new primary cancer after treatment with anti-TNFα therapy.METHODS: In this Danish, population-based cohort study we recruited adults (≥18 years) with inflammatory bowel disease (IBD), rheumatoid arthritis, or psoriasis and a primary cancer diagnosed between Jan 1, 1999 and Dec 31, 2016. Patients were recruited from the prospectively recorded Danish National Patient Registry and the Danish Cancer Registry. Participants were matched 1:10 between the treatment group who received anti-TNFα therapy and the control group (no anti-TNFα therapy) and we excluded individuals with a cancer diagnosed before their first anti-TNFα treatment (or before matching date for controls), individuals diagnosed with IBD, rheumatoid arthritis, or psoriasis after anti-TNFα initiation (or respective match date for controls), and individuals who received anti-TNFα with fewer than five matched controls. Using adjusted Cox proportional hazards regression, we estimated the primary outcome of development of recurrent or new primary cancer in patients who received anti-TNFα therapy compared with patients who did not receive this therapy, matched by sex, immune-mediated disease type, cancer type, and time from initial cancer diagnosis to first anti-TNFα registration.FINDINGS: Overall, 25 738 patients with immune-mediated disease and a history of cancer were identified. 434 patients who received anti-TNFα therapy after their initial cancer were matched to 4328 patients in the control group. During 18 752 person-years (median 5·6 years [IQR 2·8-7·9]) of follow up, 635 individuals developed recurrent or new primary cancer, 72 of whom had received anti-TNFα therapy and 563 of whom were in the control group. The median time between anti-TNFα treatment and recurrent or new primary cancer diagnosis was 2·8 years (IQR 1·7-5·4). The incidence of recurrent or new primary cancer development was 30·3 cases (95% CI 24·0-38·2) per 1000 person-years in the anti-TNFα treatment group and 34·4 cases (31·7-37·3) per 1000 person-years in the control group, yielding an adjusted hazard ratio of 0·82 (95% CI 0·61-1·11).INTERPRETATION: Use of anti-TNFα therapy was not associated with recurrent or new primary cancer development in patients with previous cancer. Timing of anti-TNFα therapy after an initial cancer diagnosis did not influence recurrent or new primary cancer development. This observation might guide clinical decision making among providers treating immune-mediated diseases with anti-TNFα medications.FUNDING: None.

Summary Background Although rectal indometacin 100 mg is effective in reducing the frequency and severity of pancreatitis after endoscopic retrograde cholangiopancreatography (ERCP) in high-risk patients, the optimal dose is unknown, and pancreatitis incidence remains high. The aim of this study was to compare the efficacy of two dose regimens of rectal indometacin on the frequency and severity of pancreatitis after ERCP in high-risk patients. Methods In this randomised, double-blind, comparative effectiveness trial, we enrolled patients from six tertiary medical centres in the USA. Eligible patients were those at high risk for the development of pancreatitis after ERCP. We randomly assigned eligible patients (1:1) immediately after ERCP to receive either two 50 mg indometacin suppositories and a placebo suppository (standard-dose group) or three 50 mg indometacin suppositories (high-dose group). 4 h after the procedure, patients assigned to the high-dose group received an additional 50 mg indometacin suppository, whereas patients in the standard-dose group received an additional placebo suppository. The randomisation schedule, stratified according to study centre and with no other restrictions, was computer generated by an investigator who was uninvolved in the clinical care of any participants, distributed to the sites, and kept by personnel not directly involved with the study. These same personnel were responsible for packaging the drug and placebo in opaque envelopes. Patients, study personnel, and treating physicians were masked to study group assignment. The primary outcome of the study was the development of pancreatitis after ERCP. Analyses were done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov , number NCT01912716 , and enrolment is complete. Findings Between July 9, 2013, and March 22, 2018, 1037 eligible patients were enrolled and randomly assigned to receive either standard-dose (n=515) or high-dose indometacin (n=522). Pancreatitis after ERCP occurred in 141 (14%) of 1037 patients—76 (15%) of 515 patients in the standard-dose indometacin group and 65 (12%) of 522 patients in the high-dose indometacin group (risk ratio [RR] 1·19, 95% CI 0·87–1·61; p=0·32). We observed 19 adverse events that were potentially attributable to study drug. Clinically significant bleeding occurred in 14 (1%) of 1037 patients—six (1%) of 515 patients in the standard-dose indometacin group and eight (2%) of 522 patients in the high-dose indometacin group (p=0·79). Three (1%) of 522 patients in the high-dose indometacin group developed acute kidney injury versus none in the standard-dose group (p=0·25). A non-ST elevation myocardial infarction occurred in the standard-dose indometacin group 2 days after ERCP. A transient ischaemic attack occurred in the high-dose indometacin group 5 days after ERCP. All 19 adverse events, in addition to the 141 patients who developed pancreatitis after ERCP, were considered serious as all required admission to hospital. We observed no allergic reactions or deaths at 30 day follow-up. Interpretation Dose escalation to rectal indometacin 200 mg did not confer any advantage compared with the standard 100 mg regimen, with pancreatitis incidence remaining high in high-risk patients. Current practice should continue unchanged. Further research should consider the pharmacokinetics of non-steroidal anti-inflammatory drugs to determine the optimal timing of their administration to prevent pancreatitis after ERCP. Funding American College of Gastroenterology.

Objective To summarize and investigate the comparative efficacy and safety of targeted disease-modifying antirheumatic drugs (DMARDs) for active psoriatic arthritis (PsA). Methods Randomized clinical trials (RCTs) evaluating efficacy and safety of targeted synthetic DMARDs (tofacitinib, apremilast) as well as biological DMARDs (guselkumab, ustekinumab, secukinumab, ixekizumab, brodalumab, clazakizumab, abatacept, adalimumab, etanercept, infliximab, certolizumab, and golimumab) were identified by systemic literature review. Traditional meta-analysis and network meta-analysis using a random effects model were performed to estimate pooled odds ratios (OR) and 95% CI to compare and rank these treatments according to ACR20 response, 75% improvement in psoriasis area and severity index (PASI75), numbers of adverse events (AE) and serious adverse events (SAE). Similar analyses were conducted among biologic-naive population and biologic-experienced/failed population. Results We deemed 29 RCTs eligible, including 10,204 participants and 17 treatments. During induction therapy (first 12–16 weeks), all treatments except clazakizumab were more efficacious than placebo in achieving ACR20 and PASI75. Although tofacitinib, apremilast, and ixekinumab 80 mg every 2 weeks had a higher rate of AE, no significant difference was revealed for SAE among all treatments. Network meta-analysis demonstrated that infliximab, golimumab, etanercept, adalimumab, guselkumab, and secukinumab 300 mg outperformed other drugs in achieving both ACR20 and PASI75. Infliximab, guselkumab, adalimumab, golimumab, secukinumab (300 mg and 150 mg), and ustekinumab (45 mg and 90 mg) are characterized by both high efficacy and safety. Similar rankings were observed in the analysis among biologic-naive patients. Moreover, ustekinumab, secukinumab (300 mg and 150 mg), ixekizumab, abatacept, certolizumab pegol, tofacitinib, and apremilast were still associated with higher ACR20 compared to placebo while ustekinumab, secukinumab (300 mg), ixekizumab and tofacitinib with higher PASI75 among biologic-experienced/failed patients. Conclusion Regarding the overall risk-benefit profile, infliximab, guselkumab, adalimumab, golimumab, secukinumab, and ustekinumab may be safer and more efficacious treatments than the other targeted DMARDs for active PsA during induction therapy.

Surveillance colonoscopy is recommended to reduce colorectal cancer (CRC)-related morbidity and mortality in patients with inflammatory bowel disease (IBD). The comparative effectiveness of varying colonoscopy intervals on CRC outcomes among patients with IBD is unknown.We performed a retrospective cohort study of patients with confirmed CRC within a cohort of 77,824 patients with IBD during 2000 to 2015 in the National Veterans Health Administration. We examined the association between colonoscopy surveillance intervals on CRC stage, treatment, or all-cause and cancer-specific mortality. The interval of colonoscopy prior to CRC diagnosis was categorized as those performed within1 year, 1 to 3 years, 3 to 5 years, or none within 5 years.Among 566 patients with CRC-IBD, most (69.4%) did not have colonoscopy within 5 years prior to CRC diagnosis, whereas 9.7% had colonoscopy within 1 year prior to diagnosis, 17.7% within 1 to 3 years, and 3.1% between 3 and 5 years. Compared with no surveillance, colonoscopy within 1 year (adjusted odds ratio, 0.40; 95% confidence interval [CI], 0.20-0.82), and 1 to 3 years (adjusted odds ratio, 0.56; 95% CI, 0.32-0.98) were less likely to be diagnosed at late stage. Regardless of IBD type and duration, colonoscopy within 1 year was associated with a lower all-cause mortality (adjusted hazard ratio, 0.56; 95% CI, 0.36-0.88).In a national cohort of patients with CRC-IBD, colonoscopy within 3 years prior to CRC diagnosis was associated with early tumor stage at diagnosis, and colonoscopy within 1 year was associated with a reduced all-cause mortality compared with no colonoscopy. Our findings support colonoscopy intervals of 1 to 3 years in patients with IBD to reduce late-stage CRC and all-cause mortality.

BACKGROUND & AIMS: Helicobacter pylori induces immune tolerance and is associated with a lower risk for immune-mediated disorders, such as autoimmune and inflammatory bowel diseases (IBD). We aimed to determine the effects of treatment for H pylori infection on the incidence of autoimmune disease and IBD. METHODS: We collected data from the National Health Insurance Research Database in Taiwan on patients younger than 18 years old without a prior diagnosis of autoimmune disease or IBD. Patients with peptic ulcer disease (PUD) with treatment of H pylori infection (PUD+HPRx), PUD without H pylori treatment (PUD–HPRx), a urinary tract infection (UTI) treated with cephalosporin, or without PUD (controls) were matched for age, sex, insurance, and Charlson’s comorbidity index score. RESULTS: Of the 1 million patients we collected data from in 2005, we included 79,181 patients in the study. We compared the effects of treatment for H pylori infection on the risk of autoimmunity or IBD and found that PUD+HPRx has the highest adjusted hazard risk (aHR) for autoimmunity or IBD (aHR, 2.36), compared to PUD–HPRx (aHR, 1.91) or UTI (aHRs, 1.71) (P

Background Inflammatory bowel disease (IBD) is associated with substantial symptom burden, variability in clinical outcomes, and high direct costs. We sought to determine if a care coordination–based strategy was effective at improving patient symptom burden and reducing healthcare costs for patients with IBD in the top quintile of predicted healthcare utilization and costs. Methods We performed a randomized controlled trial to evaluate the efficacy of a patient-tailored multicomponent care coordination intervention composed of proactive symptom monitoring and care coordinator–triggered algorithms. Enrolled patients with IBD were randomized to usual care or to our care coordination intervention over a 9-month period (April 2019 to January 2020). Primary outcomes included change in patient symptom scores throughout the intervention and IBD-related charges at 12 months. Results Eligible IBD patients in the top quintile for predicted healthcare utilization and expenditures were identified. A total of 205 patients were enrolled and randomized to our intervention (n = 100) or to usual care (n = 105). Patients in the care coordinator arm demonstrated an improvement in symptoms scores compared with usual care (coefficient, –0.68, 95% confidence interval, –1.18 to –0.18; P = .008) without a significant difference in median annual IBD-related healthcare charges ($10,094 vs $9080; P = .322). Conclusions In this first randomized controlled trial of a patient-tailored care coordination intervention, composed of proactive symptom monitoring and care coordinator–triggered algorithms, we observed an improvement in patient symptom scores but not in healthcare charges. Care coordination programs may represent an effective value-based approach to improving symptoms scores without added direct costs in a subgroup of high-risk patients with IBD. ( ClinicalTrials.gov , Number: NCT04796571 ).

Recent data have shown increasing incidence of colorectal cancer (CRC) among those younger than 50 years of age.1,2 In response, the American Cancer Society (ACS) introduced new guidelines in May 2018 that recommend initiation of CRC screening in average-risk adults at age 45, which is 5 years earlier than existing recommendations from the US Preventive Services Task Force and US Multi-Society Task Force on Colorectal Cancer.3-5 Most screening colonoscopies are ordered directly by primary care providers (PCPs) via "direct" or "open.

High-quality bowel preparation (prep) before colonoscopy is essential for the success of the procedure.1 Bowel preps should be safe, tolerable, efficacious, and allow for visualization of polyps 5 mm or larger.2 Full-volume (4 L) polyethylene glycol-3350 with electrolyte solution (PEG-ELS) has been considered a standard bowel prep regimen, with good safety and efficacy profiles, and is available as a generic.2.

Background and Aims Endoscopy is essential for disease assessment in ulcerative colitis (UC), but subjectivity threatens accuracy and precision. We aimed to pilot a fully automated video analysis system for grading endoscopic disease in UC. Methods A developmental set of high-resolution UC endoscopic videos were assigned Mayo endoscopic scores (MESs) provided by 2 experienced reviewers. Video still-image stacks were annotated for image quality (informativeness) and MES. Models to predict still-image informativeness and disease severity were trained using convolutional neural networks. A template-matching grid search was used to estimate whole-video MESs provided by human reviewers using predicted still-image MES proportions. The automated whole-video MES workflow was tested using unaltered endoscopic videos from a multicenter UC clinical trial. Results The developmental high-resolution and testing multicenter clinical trial sets contained 51 and 264 videos, respectively. The still-image informative classifier had excellent performance with a sensitivity of 0.902 and specificity of 0.870. In high-resolution videos, fully automated methods correctly predicted MESs in 78% (41 of 50, κ = 0.84) of videos. In external clinical trial videos, reviewers agreed on MESs in 82.8% (140 of 169) of videos (κ = 0.78). Automated and central reviewer scoring agreement occurred in 57.1% of videos (κ = 0.59), but improved to 69.5% (107 of 169) when accounting for reviewer disagreement. Automated MES grading of clinical trial videos (often low resolution) correctly distinguished remission (MES 0,1) versus active disease (MES 2,3) in 83.7% (221 of 264) of videos. Conclusions These early results support the potential for artificial intelligence to provide endoscopic disease grading in UC that approximates the scoring of experienced reviewers.

Background & Aims Improving care coordination for patients with high-intensity specialty care needs, such as cirrhosis, can increase quality of healthcare and reduce utilization. We examined the relationship between care concentration and risk of hospitalization for patients with cirrhosis. Methods We performed a retrospective cohort study of 26,006 Medicare enrollees with cirrhosis with more than 4 outpatient visits over 180 days. We collected data on 2 validated measures of care concentration: the usual provider of care (UPC) index, a measure of the proportion of a patient’s total visits that is with their most regularly seen provider, and the continuity of care (COC) index, a measure of care density and dispersion. Both use a scale of 0 to 1. Time to death or liver transplantation was evaluated using a multivariable Cox proportional hazards model. Hospital days and 30-day readmissions per person-year were evaluated in negative binomial models. Results The median COC score was 0.40 (interquartile range, 0.26–0.60) and the median UPC was 0.60 (interquartile range, 0.50–0.80). Increasing care concentration (based on COC and UPC index scores) were associated with increased mortality and hospitalization. The highest 25th percentile of COC and UPC scores were associated with adjusted hazard ratios for mortality of 1.20 (95% CI, 1.10–1.31) and 1.14 (95% CI, 1.06–1.24), adjusted incidence rate ratios for hospital days of 1.12 (95% CI, 1.02–1.23) and 1.10 (95% CI, 1.01–1.20), and adjusted incidence rate ratios for readmissions of 1.19 (95% CI, 1.06–1.34) and 1.12 (95% CI, 1.00–1.25), respectively. Conclusions Based on a study of Medicare enrollees, care concentration is low among patients with cirrhosis. However, increased concentration is associated with increased mortality and increased healthcare utilization. These data indicate that, to optimize outcomes for persons with cirrhosis, team-based care might be necessary.

Background Existing guidelines aim to stratify the likelihood of choledocholithiasis to guide the use of ERCP versus a lower-risk diagnostic study such as EUS, MRCP, or intraoperative cholangiography. Objective To assess the performance of existing guidelines in predicting choledocholithiasis and to determine whether trends in laboratory parameters improve diagnostic accuracy. Design Retrospective cohort study. Setting Tertiary-care hospital. Patients Hospitalized patients presenting with suspected choledocholithiasis over a 6-year period. Interventions Assessment of the American Society for Gastrointestinal Endoscopy (ASGE) guidelines, its component variables, and laboratory trends in predicting choledocholithiasis. Main Outcome Measurements The presence of choledocholithiasis confirmed by EUS, MRCP, or ERCP. Results A total of 179 (35.9%) of the 498 eligible patients met ASGE high-probability criteria for choledocholithiasis on initial presentation. Of those, 99 patients (56.3%) had a stone/sludge on subsequent confirmatory test. Of patients not meeting high-probability criteria on presentation, 111 (34.8%) had a stone/sludge. The overall accuracy of the guidelines in detecting choledocholithiasis was 62.1% (47.4% sensitivity, 73% specificity) based on data available at presentation. The accuracy was unchanged when incorporating the second set of liver chemistries obtained after admission (63.2%), suggesting that laboratory trends do not improve performance. Limitations Retrospective study, inconsistent timing of the second set of biochemical markers. Conclusion In our cohort of patients, existing choledocholithiasis guidelines lacked diagnostic accuracy, likely resulting in overuse of ERCP. Incorporation of laboratory trends did not improve performance. Additional research focused on risk stratification is necessary to meet the goal of eliminating unnecessary diagnostic ERCP.

Quality measurement is the “new normal” in gastroenterology. As we have argued, quality measurement presents a unique and valuable educational opportunity for our trainees. But to capitalize on this opportunity, and to train gastroenterologists who will thrive in our increasingly integrated, quality-oriented healthcare system, we need to engage trainees in formal educational programs on this topic. We also need to be thoughtful about not only the potential benefits, but also the potential harms of quality measurement. And as a profession, we need to be sure that we have a voice in defining and improving not only quality of care, but also the quality measures by which we are judged.