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Aim: To estimate the impact of universal anti-TNF therapy in patients with moderate-to-severe Crohn’s disease. Materials & methods: Developed a population-level Markov model to estimate the impact on health outcomes and medical expenditures of expanding anti-TNF therapy use versus current treatment practices. Results: Reductions in deaths (2600), hip fractures (980), major adverse cardiac events (2700) and patient out-of-pocket medical spending (2%) over 5 years. Total societal costs would be US$22,100 higher per patient per year, primarily due to the high cost of anti-TNF therapy. Conclusion: Expanding anti-TNF therapy use among US adult patients with moderate-to-severe Crohn’s disease would reduce morbidity and mortality, decrease disease-related medical costs and increase treatment costs compared with current practice. Despite the higher costs, this approach could substantially benefit patients.

Background: Anal cancer disproportionally impacts gay, bisexual, and other male sexual minorities (GBM). Human Papillomavirus (HPV) vaccination is a safe and effective method to prevent anal cancer; however, coverage of HPV vaccination among adult GBM is low. Key barriers to vaccination are lack of awareness and knowledge of anal cancer, low motivation to get vaccinated, and lack of access and availability. For many young GBM, regular interactions with the healthcare system center around HIV prevention. Thus, we propose that federally qualified health centers (FQHCs) can increase uptake and reach of HPV vaccination by integrating and promoting HPV vaccination in ongoing HIV preventive care (e.g., Pre-exposure Prophylaxis [PrEP]). The objectives of this project were to (1) assess the acceptability of integrating HPV vaccination with PrEP management and (2) determine needs for informed decision making. Methods: We conducted a web-based cross-sectional survey of unvaccinated GBM (18-45) who received PrEP care at a FQHC in Philadelphia. Data collection took place in 2021 and 2022. The main outcome was intent to initiate HPV vaccination within 12 months (5-point scale). Other measures included beliefs about HPV vaccination in PrEP care, perceived information needs, and preferred information delivery modes. Descriptive and bivariate statistics were used to analyze the data. Results: The sample (N=59) was ethnoracially diverse (50.0% non-White) and in the catchup (23.7%; 18-26 yrs.) or shared clinical decision making (76.3%; 27-45) age ranges. Most were gay identified (71.2%) cisgender men (74.6%). Just 23.7% were aware they were eligible for HPV vaccination and even fewer knew that vaccination could prevent anal cancer (11.9%). Overall vaccine intentions were high (M=3.7; SD=1.0). Intentions were 26.1% higher (M=4.4; SD=1.0) if HPV vaccination was offered during PrEP appointments. Most (88.7%) agreed that offering HPV vaccination during PrEP visits would increase the likelihood that they would get vaccinated; however, 64.4% strongly/somewhat agreed that they needed more information about HPV vaccination prior to making an informed decision. Perceived information need was inversely associated with vaccine intentions (r=-0.31, p=0.02). Most participants (>50%) indicated they wanted to know more about their risk for anal cancer and effectiveness of HPV vaccination. The majority (71.2%) preferred to get medically accurate information on anal cancer prevention from a website that they could go to on their own time. Other delivery modes were iPads at their doctor’s office (28.8%), printed information given to them by their doctor (28.8%), and text messages from a healthcare provider (25.4%). Conclusion: Offering and promoting HPV vaccination as part of PrEP management visits was highly acceptable among PrEP patients. Interventions should focus on raising awareness about anal cancer and promoting informed decision making for anal cancer prevention. Citation Format: Christopher W. Wheldon, Sarah Bass, Bradley Collins. Integrating HPV (human papillomavirus) vaccination into HIV prevention: Acceptability and information needs among PrEP (pre-exposure prophylaxis) patients at a federally qualified health center [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B052.

(A) Although clinical trials (CTs) aim to establish new strategies for reducing cancer morbidity and mortality, participation remains suboptimal, especially for racial and ethnic minorities, and few studies have evaluated tailored communication tools to address barriers/facilitators to CT participation across diverse groups.(B) mychoiceTM is a novel, culturally tailored online CT education tool designed to foster shared decision making between patients (pts) and their providers. The mychoiceTM tool was developed over 5 years utilizing community engagement, perceptual mapping, a clinically based RCT, and in-depth user-testing (UX) which we will discuss further here. UX was conducted to further guide the implementation of mychoiceTM in routine clinical settings and to understand when is the ideal time for patients to receive CT education as well as obtain feedback on the tool’s content and usability. A mixed methods approach was utilized and included a talk-aloud walk through of the mychoiceTM tool, an in-depth interview targeting specific sections, and a post-survey. In order to maintain a representative sample, pts were contacted from reviewing their EMR data that met the enrollment criteria (age≥18 yrs, able to speak and read English, in active or completed treatment ≤ last 6 months), and CT participation status (participated in a CT, offered a CT but did not participate, or were never offered), race, and gender at Fox Chase Cancer Center and Temple University Health System. In total, 27 pts completed UX. 16 participants (59%) were non-white (NW), and nearly 90% of NW participants were black. Participants were 52% female, and 48% male, and split fairly evenly amongst CT participation status (26% participated, 37% offered but never participated, 37% never offered and never participated).(C) Preliminary results showed that responses were generally consistent between NW and W participants. Nearly all patients said that they would use mychoiceTM if it was given to them by their provider, and the majority of both groups (81% of NW pts and 64% of W pts) said that they would like to receive mychoiceTM prior to making a treatment decision. While all pts found that the tool would have been helpful with making a treatment decision, NW pts found the tool generally more helpful than W pts did. 56% of NW pts gave it a 5 (extremely helpful), while only 36% of W pts rated it the same. 45% of W pts gave it a 3 (moderately helpful), while only 36% of NW pts did. Patients across both groups recommended potential content additions including: additional information on side effects, cancer specific resources, and ways to find support which will be included in the next iteration.(D) While mychoiceTM was well received overall, preliminary findings show that the tool is particularly helpful among NW pts. These findings are consistent with those from the previously conducted RCT and will guide the next steps in the tools growing research initiatives and upcoming implementation study. Citation Format: Linda Fleisher, Cassidy Kenny, Shayna Yeates Yeates, Zoe Landau, Patrick Kelly, Sarah Bass, Diane Ammerman, Canan Bilgin, Esprit Ma. mychoiceTM User-Testing – Insights from diverse cancer patients [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B007.

Aim: Estimate the impacts treating acute respiratory tract infections (ARTIs) in children aged 6 months through 12 years with narrow-spectrum antibiotics. Materials & methods: Decision-tree model to estimate children’s health, healthcare utilization and costs, and caregiver’s time and costs for using narrow-spectrum antibiotics in eligible children with an ARTI, compared with current use of narrow- and broad-spectrum antibiotics. Results: Reduced adverse drug reactions by 35,750 (14%) cases) and 4750 (12%) fewer emergency department visits, 300 (12%) fewer hospitalizations, and 50,500 (10%) avoided outpatient visits. Annual healthcare costs fell by US$120 million (22%). Total societal costs declined by US$131 million (20%). Conclusion: National implementation of narrow-spectrum antibiotics to treat ARTIs in children improves patient outcomes and reduces caregiver burden and annual healthcare costs.

Urinary incontinence is prevalent among women, and it has a substantial economic impact. Mixed urinary incontinence, with both stress and urgency urinary incontinence symptoms, has a greater adverse impact on quality of life and is more complex to treat than either stress or urgency urinary incontinence alone. Studies evaluating the cost-effectiveness of treating both the stress and urgency urinary incontinence components simultaneously are lacking.Cost-effectiveness was assessed between perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery and midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. The impact of baseline severe urgency urinary incontinence symptoms on cost-effectiveness was assessed.This prospective economic evaluation was performed concurrently with the Effects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence randomized trial that was conducted from October 2013 to April 2016. Participants included 480 women with moderate-to-severe stress and urgency urinary incontinence symptoms and at least 1 stress urinary incontinence episode and 1 urgency urinary incontinence episode on a 3-day bladder diary. The primary within-trial analysis was from the healthcare sector and societal perspectives, with a 1-year time horizon. Costs were in 2019 US dollars. Effectiveness was measured in quality-adjusted life-years and reductions in urinary incontinence episodes per day. Incremental cost-effectiveness ratios of combined treatment vs midurethral sling surgery alone were calculated, and cost-effectiveness acceptability curves were generated. Analysis was performed for the overall study population and subgroup of women with Urogenital Distress Inventory irritative scores of ≥50th percentile.The costs for combined treatment were higher than the cost for midurethral sling surgery alone from both the healthcare sector perspective ($5100 [95% confidence interval, $5000-$5190] vs $4470 [95% confidence interval, $4330-$4620]; P.01) and the societal perspective ($9260 [95% confidence interval, $8590-$9940] vs $8090 [95% confidence interval, $7630-$8560]; P.01). There was no difference between combined treatment and midurethral sling surgery alone in quality-adjusted life-years (0.87 [95% confidence interval, 0.86-0.89] vs 0.87 [95% confidence interval, 0.86-0.89]; P=.90) or mean reduction in urinary incontinence episodes per day (-4.76 [95% confidence interval, -4.51 to 5.00] vs -4.50 [95% confidence interval, -4.25 to 4.75]; P=.13). When evaluating the overall study population, from both the healthcare sector and societal perspectives, midurethral sling surgery alone was superior to combined treatment. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone is ≤28% from the healthcare sector and ≤19% from the societal perspectives for a willingness-to-pay value of ≤$150,000 per quality-adjusted life-years. For women with baseline Urogenital Distress Inventory irritative scores of ≥50th percentile, combined treatment was cost-effective compared with midurethral sling surgery alone from both the healthcare sector and societal perspectives. The probability that combined treatment is cost-effective compared with midurethral sling surgery alone for this subgroup is ≥90% from both the healthcare sector and societal perspectives, at a willingness-to-pay value of ≥$150,000 per quality-adjusted life-years.Overall, perioperative behavioral and pelvic floor muscle therapies combined with midurethral sling surgery was not cost-effective compared with midurethral sling surgery alone for the treatment of women with mixed urinary incontinence. However, combined treatment was of good value compared with midurethral sling surgery alone for women with baseline severe urgency urinary incontinence symptoms.

Introduction Demonstrating the validity of a public health simulation model helps to establish confidence in the accuracy and usefulness of a model’s results. In this study we evaluated the validity of the Prevention Impacts Simulation Model (PRISM), a system dynamics model that simulates health, mortality, and economic outcomes for the US population. PRISM primarily simulates outcomes related to cardiovascular disease but also includes outcomes related to other chronic diseases that share risk factors. PRISM is openly available through a web application. Methods We applied the model validation framework developed independently by the International Society of Pharmacoeconomics and Outcomes Research and the Society for Medical Decision Making modeling task force to validate PRISM. This framework included model review by external experts and quantitative data comparison by the study team. Results External expert review determined that PRISM is based on up-to-date science. One-way sensitivity analysis showed that no parameter affected results by more than 5%. Comparison with other published models, such as ModelHealth, showed that PRISM produces lower estimates of effects and cost savings. Comparison with surveillance data showed that projected model trends in risk factors and outcomes align closely with secular trends. Four measures did not align with surveillance data, and those were recalibrated. Conclusion PRISM is a useful tool to simulate the potential effects and costs of public health interventions. Results of this validation should help assure health policy leaders that PRISM can help support community health program planning and evaluation efforts.

The electrocardiogram (ECG) is the main source of heartbeat analysis. However, analyzing the ECG alone can be problematic because ECG data can be noisy. This research analyzes the associations between ECG and a variety of biomedical signals, and uses these associations to detect heartbeat locations with a higher accuracy than just analyzing ECG alone.

9527 Background: Activation of the WNT/β-catenin pathway is associated with low/absent tumor-infiltrating lymphocytes (TILs) and resistance to anti-PD-L1/anti-CTLA-4 agents in mouse melanoma models. We aimed to investigate if APC/CTNNB1 mutations in melanoma pts are associated with TIL status, prediction of response to immunotherapy (IT), and overall survival (OS). Methods: Pts with CM and APC or CTNNB1 mutations identified in melanoma tumors using the TruSight Tumor 26 Illumina assay were enrolled. Demographics, clinical (stage, treatment response, follow-up), pathologic (TIL status), and molecular (BRAF/NRAS, C→T (i.e. UV signature) nucleotide transition, functional significance by IMPACT, mutant allele frequency (MAF) corrected from the % tumor) characteristics were investigated. Results: We identified a total of 25 pts (13 males; age at original diagnosis (median 61 yrs, range 22-78 yrs). CTNNB1 and APC mutations were mutually exclusive. 48% (12/25) had APC mutations and 52% (13/25) had CTNNB1 mutations; of which (i.e. CTNNB1 mutations) 69% (9/13) had absent TILs. 88% (22/25) of APC/CTNNB1 mutations had moderate functional significance, 64% (16/25) of the mutations had a C→T nucleotide change, 36% (9/25) had BRAFV600, and 20% (5/25) NRASQ61 mutations. 64% (14/22) of pts with stage II-III progressed to stage IV; of these 14 pts, 8 (57%) developed parenchymal BrM. 13 of the stage II-III 22 pts who progressed to stage IV received IT; of these 13 pts, 7 (53%) had absent TILs. APC/CTNNB1 mutations did not influence response to IT, irrespective of the MAF of the mutations. Of the 12 pts with MCM and measurable disease who received IT 9/12 had absent TILs and 7/12 responded. The median OS from the time of diagnosis of distant MCM (N = 17; 14 pts who progressed from initial stage II-III and 3 pts who were originally diagnosed with stage IV) was 18.8 months (range, 2.4-48.0 months). Conclusions: APC & CTNNB1 mutations are mutually exclusive. CTNNB1 mutations are more frequently associated with absent TILs. Pts with MCM had relatively shorter OS (18.8 months) in part due to development of BrM. In this small cohort APC/CTNNB1 mutations did not seem to impair response to immunotherapy.

RNA-binding proteins act at various stages of gene expression to regulate and fine-tune patterns of mRNA accumulation. One protein in this class is Drosophila Su(s), a nuclear protein that has been previously shown to inhibit the accumulation of mutant transcripts by an unknown mechanism. Here, we have identified several additional RNAs that are downregulated by Su(s). These Su(s) targets include cryptic wild-type transcripts from the developmentally regulated Sgs4 and ng1 genes, noncoding RNAs derived from tandemly repeated alphabeta/alphagamma elements within an Hsp70 locus, and aberrant transcripts induced by Hsp70 promoter transgenes inserted at ectopic sites. We used the alphabeta RNAs to investigate the mechanism of Su(s) function and obtained evidence that these transcripts are degraded by the nuclear exosome and that Su(s) promotes this process. Furthermore, we showed that the RNA binding domains of Su(s) are important for this effect and mapped the sequences involved to a 267-nucleotide region of an alphabeta element. Taken together, these results suggest that Su(s) binds to certain nascent transcripts and stimulates their degradation by the nuclear exosome.

Background. Diabetes and left ventricular hypertrophy (LVH) can cause coronary flow reserve abnormalities in the absence of coronary artery disease (CAD). We sought to evaluate the impact of LVH and diabetes on the relationship between ischemia, severe CAD, and transient ischemic dilation (TID) on adenosine myocardial perfusion imaging (MPI). Methods and Results. We prospectively recruited 157 patients referred for routine single-day adenosine technetium 99m MPI. LVH was assessed by use of transthoracic echocardiography. A ratio of 1.19 or greater on MPI defined TID in men and 1.31 or greater in women. Summed difference scores were determined by use of a 17-segment 5-point scoring system. TID was present in 22 of 157 patients (14%), diabetes in 54 of 157 (34%), and LVH in 42 of 157 (27%). By multivariate logistic regression, LVH, ischemia (summed difference score >2), and diabetes were independently predictive of TID. The incidence of TID was stratified by the presence or absence of diabetes and/or LVH in those with ischemia on MPI (8/8 [100%] vs 0/11 [0%], P

What Is an IVC Filter? What Is Its Purpose? Patients who have a blood clot in their leg, referred to as deep vein thrombosis (DVT), are at risk of the clot breaking off and traveling toward the lung. It gets to the lung via the big vein in the abdomen (Figure 1), called the inferior vena cava (IVC). The traveling clot is called an embolus. Once it reaches the lung (after having passed through the right chambers of the heart) and becomes lodged in the lung, it is called a pulmonary embolism (PE). A filter can be inserted into the IVC (Figure 1) to catch and trap a traveling clot, preventing it from reaching the lung. Such filters used to be called Greenfield filters, but a variety of differently shaped filters now exist, so a more generic and better term is IVC filter. Filters can be nonremovable and thus are permanent, or they can be removable and thus can be left in for only a few weeks or months. Figure 1. The main image shows a filter in the big vein in the abdomen, preventing a clot that breaks off a deep vein thrombosis from reaching the lung. The traveling clot gets caught in the filter, thus protecting the lung. Some filters have a hook at their top (oval inset), allowing them to be removed with a catheter once they are not needed any more; these are called removable or transient inferior vena cava filters. ### How Is an IVC Filter Placed? Filters are typically placed by a radiologist or vascular surgeon or cardiologist through a vein in either the neck or the groin and then deployed via a catheter into the correct position in the IVC (Figure 1). The placement itself is relatively straightforward and takes only 10 to 15 minutes. Together with preparations, the procedure may take 30 to 45 minutes; it can be done as …

The use of fetal tissue for scientific research is a good example of the ways that cultural definitions have enveloped and galvanized the link between culture, science, and politics. Since the Roe vs. Wade decision in 1973, use of fetal tissue has been connected to arguably one of the hottest political firestorms of the century…abortion. While the abortion issue, as well as the use of fetal tissue for research, has been debated and discussed in almost every major field of thought, the debate consistently fails to address some of the key cultural interpretations we give to issues such as gender, science, and the role of women, who have largely been forgotten, and how these interpretations influence the national debate. To gain understanding of how these issues affect the fetal tissue dialogue, one must explore the role these cultural interpretations have in the discussion on the use of fetal tissue for research by looking at the cultural meanings we give to the terms “mother” and “fetus” and how these scientific metaphors affect the way we think about women who donate fetal tissue. These concepts must then be applied to fetal tissue use by exploring both political and ethical arguments surrounding the issue.

This NCI funded study examined the relationship between the use of Internet health information by people newly diagnosed with cancer (N=500), with patient task behavior and perceived self efficacy. Study variables were compared among Direct users of Internet health information (people using the Internet themselves), Indirect users of Internet health information (people receiving Internet health information from friends or family members), and Non-users of Internet health information (people not using the Internet or receiving health information from the Internet). The subjects were recruited from persons who called the Atlantic Region of the NCI's Cancer Information Service (CIS), located at Fox Chase Cancer Center in Philadelphia, PA. Follow up phone interviews were done with participants six weeks after initial contact to assess impact of the use of the Internet on perceived patient task behavior and self efficacy. Results show significant relationships between Internet use and all study variables.