Safety of Biologic and Small Molecule Therapy for Inflammatory Bowel Disease Among Solid Organ Transplant Recipients: Systematic Review and Meta-Analysis.

BACKGROUND: Patients undergoing organ transplantation are often on immunosuppressing medications to prevent rejection of the transplant. The data on use of concomitant immunosuppression for inflammatory bowel disease (IBD) and organ transplant management are limited. This study sought to evaluate the safety of biologic and small molecule therapy for the treatment of IBD among solid organ transplant recipients. METHODS: Medline, Embase, and Web of Science databases were systematically searched for studies reporting on safety outcomes associated with the use of biologic and small molecule therapy (infliximab, adalimumab, certolizumab, golimumab, vedolizumab, ustekinumab, and tofacitinib) in patients with IBD postsolid organ transplant (eg, liver, kidney, heart, lung, pancreas). The primary outcome was infectious complications. Secondary outcomes included serious infections, colectomy, and discontinuation of biologic therapy. RESULTS: Seven hundred ninety-seven articles were identified for screening, yielding 16 articles for the meta-analyses with information on 163 patients. Antitumor necrosis factor α (Anti-TNFs; infliximab and adalimumab) were used in 8 studies, vedolizumab in 6 studies, and a combination of ustekinumab or vedolizumab and anti-TNFs in 2 studies. Two studies reported outcomes after kidney and cardiac transplant respectively, whereas the rest of the studies included patients with liver transplants. The rates of all infections and serious infections were 20.09 per 100 person-years (100-PY; 95% CI, 12.23-32.99 per 100-PY, I2 = 54%) and 17.39 per 100-PY (95% CI, 11.73-25.78 per 100-PY, I2 = 21%), respectively. The rates of colectomy and biologic medication discontinuation were 12.62 per 100-PY (95% CI, 6.34-25.11 per 100-PY, I2 = 34%) and 19.68 per 100-PY (95% CI, 9.97-38.84 per 100-PY, I2 = 74%), respectively. No cases of venous thromboembolism or death attributable to biologic use were reported. CONCLUSION: Biologic therapy is overall well tolerated in patients with solid organ transplant. Long-term studies are needed to better define the role of specific agents in this patient population.

Representation of Racial Minorities in the United States Colonoscopy Surveillance Interval Guidelines.

BACKGROUND/AIMS: Clinical guidelines should ideally be formulated from data representative of the population they are applicable to; however, historically, studies have disproportionally enrolled non-Hispanic White (NHW) patients, leading to potential inequities in care for minority groups. Our study aims to evaluate the extent to which racial minorities were represented in the United States Colorectal Cancer Surveillance Guidelines. METHODS: We reviewed US guidelines between 1997 and 2020 and all identified studies cited by recommendations for surveillance after a baseline colonoscopy with no polyps, adenomas, sessile serrated polyps, and hyperplastic polyps. We analyzed the proportion of studies reporting race, and among these studies, we calculated the racial distribution of patients and compared the proportion of Non-NHW patients between each subtype. RESULTS: For all guidelines, we reviewed 75 studies encompassing 9,309,955 patients. Race was reported in 24% of studies and 14% of total patients. Non-NHW comprised 43% of patients in studies for normal colonoscopies, compared with 9% for adenomas, 22% for sessile serrated polyps, and 15% for hyperplastic polyps. For the 2020 guidelines, we reviewed 33 studies encompassing 5,930,722 patients. Race was reported in 15% of studies and 21% of total patients. Non-NHW comprised 43% of patients in studies for normal colonoscopies, compared with 9% for tubular adenomas. Race was not cited for any other 2020 guideline. CONCLUSION: Racial minorities are significantly underrepresented in US Colorectal Cancer Surveillance Guidelines, which may contribute to disparities in care. Future studies should prioritize enrolling a diverse patient population to provide data that accurately reflects their population.

Disparities in Rates of Multitarget Stool DNA Test Completion for Colorectal Cancer Screening.

GOALS: The aim was to assess patient adherence to multitarget stool DNA testing as well as factors associated with adherence. BACKGROUND: In the United States, disparities in colorectal cancer screening exist along racial and socioeconomic lines. While some studies suggest that stool-based screening tests may help reduce the screening gap, the data for multitarget stool DNA testing is unclear. STUDY: We conducted a single-center retrospective cohort study on multitarget stool DNA testing ordered between April 2020 and July 2021. We calculated the proportion of patients who completed testing and used multivariate logistic regression to identify covariates associated with test adherence. RESULTS: Among 797 patients ordered for multitarget stool DNA testing, 481 patients (60.4%) completed testing. Adherence rates by patient subgroups ranged from 35.8% to 78.1%. Higher test adherence was found in Asian patients (odds ratio 2.65, 95% CI 1.36-5.18) and those who previously completed colorectal cancer screening (OR 1.45, 95% CI 1.01-2.09), while Black patients (OR 0.58, 95% CI 0.39-0.87), patients with resident primary care physicians (OR 0.34, 95% CI 0.21-0.56), and patients contacted through an outreach program (OR 0.47, 95% CI 0.25-0.87) had lower adherence. CONCLUSIONS: A significant proportion of patients ordered for multitarget stool DNA testing did not complete testing. Differences in adherence rates among patient subgroups may be reflective of underlying disparities in health care access.

Medicare Patients Face High Out-of-Pocket Costs for Specialty Inflammatory Bowel Disease Medications.

INTRODUCTION: Medicare patients in the United States may face high out-of-pocket (OOP) costs for specialty inflammatory bowel disease (IBD) medications. METHODS: We conducted a study of Medicare OOP costs for specialty IBD medications between 2020 and 2022 and compared them to incomes of typical Medicare beneficiaries. RESULTS: In 2022, median OOP costs ranged from 6.4% to 59.2% of annual income for a Medicare patient with approximately median income. Inflation-adjusted OOP costs for most medications increased between 2020 and 2022 though decreased for infliximab and its biosimilars. DISCUSSION: OOP costs may limit many Medicare beneficiaries' access to specialty IBD medications.

Real-world compliance with the 2020 U.S. Multi-Society Task Force on Colorectal Cancer polypectomy surveillance guidelines: an observational study.

BACKGROUND AND AIMS: Overuse of screening colonoscopy increases cost and procedural adverse events, but inadequate surveillance can miss the development of colorectal cancer. We measured compliance with the 2020 U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) polypectomy surveillance guidelines in clinical records and a survey. METHODS: We performed a retrospective study comparing surveillance intervals for first-time average-risk colonoscopies with the 2020 USMSTF guidelines. Cases were analyzed from 3 intervals (March 2021 to May 2021, November 2021 to January 2022, and April 2022 to May 2022), collectively termed the postguideline period, and a baseline period from November 2019 to January 2020. Real-world compliance rates were compared with results of a survey conducted between November 2020 and February 2021. RESULTS: Overall compliance was 48.9% among 532 colonoscopies, ranging from 8.3% for low-risk adenomas (LRAs), 88.3% for high-risk adenomas, 63.1% for sessile serrated polyps (SSPs), and 88.6% for hyperplastic polyps. Compliance for LRA increased from the baseline period (.8% vs 8.3%, P = .003), and 95.3% of nonadherent LRA cases followed the 2012 USMSTF guidelines. Compliance for LRAs was 18.6% among respondents who provided a compliant surveillance interval for LRAs in the survey. Noncompliance was associated with finishing training >10 years ago (odds ratio, 1.9; 95% confidence interval, 1.4-2.7) and performing over 800 colonoscopies annually (odds ratio, 2.0; 95% confidence interval, 1.5-2.6). CONCLUSIONS: Adoption of the 2020 USMSTF surveillance guidelines remains low at 2 years. Further research into outcomes for patients with LRAs and SSPs may increase guideline adoption.

Turnover among new Medicare Advantage enrollees may be greater than perceived.

OBJECTIVES: To characterize the proportion of Medicare Advantage (MA) enrollees who switched insurers or disenrolled to traditional Medicare (TM) in the years immediately after first choosing to join an MA health plan. STUDY DESIGN: Retrospective analysis using 2012-2017 Medicare enrollment data. METHODS: We studied enrollees who joined MA between 2012 and 2016 and identified all enrollees who changed insurers (switched insurance or disenrolled to TM) at least once between the start of enrollment and the end of the study period. We categorized each change as switching insurers or disenrollment to TM, and by whether the previous insurer had exited the market. RESULTS: Among 6,520,169 new MA enrollees, 15.6% had changed insurance within 1 year after enrollment in MA and 49.2% had changed insurance by 5 years. More enrollees switched insurers rather than disenrolled, and most enrollees who changed insurers did not do so as a result of insurer exits. CONCLUSIONS: New MA enrollees change insurers at a substantial rate when followed across multiple years. These changes may disincentivize insurers from investing in preventive care and chronic disease management and, as shown in several non-MA populations, may lead to discontinuities in care, increased expenditures, and inferior health outcomes.

What eye tracking can tell us about how radiologists use automated breast ultrasound.

Purpose: Automated breast ultrasound (ABUS) presents three-dimensional (3D) representations of the breast in the form of stacks of coronal and transverse plane images. ABUS is especially useful for the assessment of dense breasts. Here, we present the first eye tracking data showing how radiologists search and evaluate ABUS cases. Approach: Twelve readers evaluated single-breast cases in 20-min sessions. Positive findings were present in 56% of the evaluated cases. Eye position and the currently visible coronal and transverse slice were tracked, allowing for reconstruction of 3D "scanpaths." Results: Individual readers had consistent search strategies. Most readers had strategies that involved examination of all available images. Overall accuracy was 0.74 (sensitivity = 0.66 and specificity = 0.84). The 20 false negative errors across all readers can be classified using Kundel's (1978) taxonomy: 17 are "decision" errors (readers found the target but misclassified it as normal or benign). There was one recognition error and two "search" errors. This is an unusually high proportion of decision errors. Readers spent essentially the same proportion of time viewing coronal and transverse images, regardless of whether the case was positive or negative, correct or incorrect. Readers tended to use a "scanner" strategy when viewing coronal images and a "driller" strategy when viewing transverse images. Conclusions: These results suggest that ABUS errors are more likely to be errors of interpretation than of search. Further research could determine if readers' exploration of all images is useful or if, in some negative cases, search of transverse images is redundant following a search of coronal images.

Patient Preference and Adherence to Aminosalicylates for the Treatment of Ulcerative Colitis.

Ulcerative colitis (UC) is a chronic inflammatory disorder that requires sustained treatment for optimal outcomes. The 5-aminosalicylate (5-ASA) class of medications are first-line for the treatment of mild-to-moderate UC but suffer from suboptimal adherence rates in real-world settings. This review summarizes the literature on adherence and patient preference to 5-ASA in patients with UC. We begin by highlighting key studies that measure real-world adherence rates, as well as some of the pitfalls associated with certain techniques. We examine the data on the consequences of non-adherence, which range from decreased quality of life and higher risk of colorectal cancer at the individual level to increased costs to the overall healthcare system. We then turn to the reasons and risk factors for non-adherence and summarize the current understanding of the barriers towards adherence. Afterwards, we describe the research on patient preferences between 5-ASA formulations and dosing regimen. Finally, we summarize the evidence regarding interventions to improve 5-ASA adherence. While adherence remains a challenge in practice, understanding the current state of the field can better inform future efforts towards increasing adherence, and thus clinical outcomes, in UC.

Natural Language Generation Model for Mammography Reports Simulation.

Extending the size of labeled corpora of medical reports is a major step towards a successful training of machine learning algorithms. Simulating new text reports is a key solution for reports augmentation, which extends the cohort size. However, text generation in the medical domain is challenging because it needs to preserve both content and style that are typical for real reports, without risking the patients' privacy. In this paper, we present a conditioned LSTM-RNN architecture for simulating realistic mammography reports. We evaluated the performance by analyzing the characteristics of the simulated reports and classifying them into benign and malignant classes. An average classification AUC was calculated over two distinct test sets. A qualitative analysis was also performed in which a masked radiologist classified 0.75 of the simulated reports as real reports, showing that both the style and content of the simulated reports were similar to real reports. Finally, we compared our RNN-LSTM generative model with Markov Random Fields. The RNN-LSTM provided significantly better and more stable performance than MRFs ( , Wilcoxon).