Total Enrollment Research Articles

Impact of state tuition guarantee policy on enrollment in public universities

PurposeThis study estimates the effect of the Truth-in-Tuition policy on the enrollment of first-year students, minority students and all students (total enrollment) in Illinois universities.Design/methodology/approachEconometric models yield robust estimates using state- and time-fixed effects. This research uses the nonparametric Difference-in-Difference (DID) method. Variation in the starting of the Truth-in-Tuition policy across the Midwestern states is used as a natural experiment.FindingsResults demonstrate that the Truth-in-Tuition policy helped increase freshman enrollment but did not significantly impact minority enrollment. This policy, however, shows a much larger drop in total enrollment in Illinois universities.Originality/valueA comparison between regionally competing institutions under different policy regimes was not analyzed earlier.

347 Quantifying phenotypic and genetic variation for cow fertility phenotypes in American Simmentals using total herd reporting data

Abstract Inefficiencies in reproduction are the largest drivers of loss in United States beef production. Nearly all reproductive traits are at least modestly heritable, making genetic selection and improvement possible over the long term. Cow-centric reproductive traits present unique challenges, as they are not expressed in male animals and will not be observed until later in the productive life of a female, if at all. This makes cow-centric fertility traits ideal candidates for selection with Expected Progeny Differences (EPDs). We used a commercially generated dataset from the American Simmental Association (ASA) to explore the phenotypic and genetic variation in these traits. The dataset comprised Total Herd Enrollment (THE) records, which required unbiased reporting of enrollment, calving, and disposal for 303,158 females (132,403 cows and 170,755 heifers). Using the THE data, we calculated three continuous and two discrete traits that are indicators of heifer and cow fertility and rebreeding ability. These traits were: 1) calving date (calving date of the cow relative to the start of the calving season), 2) calving interval (days between calves), 3) first calving interval (calving interval observation between the first and second calving record for a female), 4) heifer pregnancy (did the animal calve as 2-yr-old?), and 5) discrete early calving (did animal calve in the first 30 d of the calving season?). We observed a significant difference in calving date in mature cows that calved in the first 30 d of the calving season of their contemporary group as heifers compared with those that calved later (Table 1). Early calving heifers averaged a nearly 10 d sooner calving date throughout their productive lives compared with those that calved after 30 d as heifers (29.9 d vs. 40.2 d, P-value < 0.01). We used a combined pedigree and genomic approach, implemented in GIBBSF90+, to estimate genetic, environmental, and permanent environmental variance components. We estimated heritabilities of 0.24 (± 0.037215) for heifer pregnancy, 0.06 (± 0.009265) for calving date, 0.07 (± 0.015451) for discrete early calving, 0.04 (± 0.003954) for calving interval, and 0.04 (± 0.009604) for first calving interval. We observed positive phenotypic and genetic correlations between these traits, ranging from 0.01 to 0.96 (Table 2). This work provides an extensive population survey of phenotypic trends in reproductive performance and management in a large seedstock population. The heritable nature of the inspected traits motivates further work in understanding their genetic architectures and how they are affected by heterosis in crossbreeding programs.

P157 THE USE OF PARTICIPATORY ACTION RESEARCH TO PROMOTE INCREASED CONSUMPTION OF VEGETABLES AMONG AFRICAN WOMEN WITH/AT RISK OF HYPERTENSION IN GQEBERHA, SOUTH AFRICA

Background and objectives: Poor vegetable and fruit intake are reported in multiple studies of the South African population, especially among people with less income and lower educational status and it is a known risk factor for non-communicable diseases such as hypertension. “South Africa has one of the highest levels of hypertension globally, coupled with poor rates of diagnosis, treatment and control” Ware et al., (2019). It has been suggested that indigenous vegetables may aid in increasing vegetable intake, a recommendation of the South African Food Based Dietary Guidelines. As urbanisation and the nutrition transition increases in South Africa, the loss of indigenous knowledge and utilisation of indigenous vegetables is significant and is worse compared to countries such as Kenya and Tanzania. The aim of this study was to collaboratively promote the use of indigenous vegetables by African women in a peri-urban area with/at risk of hypertension with the goal of improving agency to increase vegetable intake. Methods: A qualitative participatory action research (PAR) methodology was utilised. African adult women with hypertension or at risk of hypertension were recruited from a local healthcare facility for a one year long project, with a total enrolment of 12-24 participants. Data collection included observations, focus groups, key informant interviews and the research journal of the researcher. Results: Participants worked collaboratively to co-construct relevant nutrition education materials, recipe development using local indigenous vegetables, clinic open day and a seminar for other community members. There was greater uptake of vegetable gardening at home and at the local community centre. Conclusions: using PAR methodologies to address inadequate vegetable intake and promote the use of indigenous vegetable crops may benefit personal agency which includes an individual's perceptions about how much control they have over themselves and their environment, in order to carry out a certain behaviour; self-confidence or efficacy; the ability to self-regulate and monitor behaviour and the ability to identify and use good coping skills.

The Discover In-Hospital Cardiac Arrest (Discover IHCA) Study: An Investigation of Hospital Practices After In-Hospital Cardiac Arrest.

In-hospital cardiac arrest (IHCA) is a significant public health burden. Rates of return of spontaneous circulation (ROSC) have been improving, but the best way to care for patients after the initial resuscitation remains poorly understood, and improvements in survival to discharge are stagnant. Existing North American cardiac arrest databases lack comprehensive data on the post-resuscitation period, and we do not know current post-IHCA practice patterns. To address this gap, we developed the Discover In-Hospital Cardiac Arrest (Discover IHCA) study, which will thoroughly evaluate current post-IHCA care practices across a diverse cohort. Our study collects granular data on post-IHCA treatment practices, focusing on temperature control and prognostication, with the objective of describing variation in current post-IHCA practice. This is a multicenter, prospectively collected, observational cohort study of patients who have suffered IHCA and have been successfully resuscitated (achieved ROSC). There are 24 enrolling hospital systems (23 in the United States) with 69 individual enrolling hospitals (39 in the United States). We developed a standardized data dictionary, and data collection began in October 2023, with a projected 1000 total enrollments. Discover IHCA is endorsed by the Society of Critical Care Medicine. The study collects data on patient characteristics including pre-arrest frailty, arrest characteristics, and detailed information on post-arrest practices and outcomes. Data collection on post-IHCA practice was structured around current American Heart Association and European Resuscitation Council guidelines. Among other data elements, the study captures post-arrest temperature control interventions and post-arrest prognostication methods. Analysis will evaluate variations in practice and their association with mortality and neurologic function. We expect this study, Discover IHCA, to identify variability in practice and outcomes following IHCA, and be a vital resource for future investigations into best-practice for managing patients after IHCA.

A non-parametric approach to predict the recruitment for randomized clinical trials: an example in elderly inpatient settings

BackgroundAccurate prediction of subject recruitment, which is critical to the success of a study, remains an ongoing challenge. Previous prediction models often rely on parametric assumptions which are not always met or may be difficult to implement. We aim to develop a novel method that is less sensitive to model assumptions and relatively easy to implement.MethodsWe create a weighted resampling-based approach to predict enrollment in year two based on recruitment data from year one of the completed GRIPS and PACE clinical trials. Different weight functions accounted for a range of potential enrollment trajectory patterns. Prediction accuracy was measured by Euclidean distance for enrollment sequence in year two, total enrollment over time, and total weeks to enroll a fixed number of subjects, against the actual year two enrollment data. We compare the performance of the proposed method with an existing Bayesian method.ResultsWeighted resampling using GRIPS data resulted in closer prediction evidenced by better coverage of observed enrollment with the prediction intervals and smaller Euclidean distance from actual enrollment in year 2, especially when enrollment gaps were filled prior to the weighted resampling. These scenarios also produced more accurate predictions for total enrollment and number of weeks to enroll 50 participants. These same scenarios outperformed an existing Bayesian method for all 3 accuracy measures. In PACE data, using a reduced year 1 enrollment resulted in closer prediction evidenced by better coverage of observed enrollment with the prediction intervals and smaller Euclidean distance from actual enrollment in year 2, with the weighted resampling scenarios better reflecting the seasonal variation seen in year (1) The reduced enrollment scenarios resulted in closer prediction for total enrollment over 6 and 12 months into year (2) These same scenarios also outperformed an existing Bayesian method for relevant accuracy measures.ConclusionThe results demonstrate the feasibility and flexibility for a resampling-based, non-parametric approach for prediction of clinical trial recruitment with limited early enrollment data. Application to a wider setting and long-term prediction accuracy require further investigation.

Pericardiocentesis, Chest Tube Insertion, and Needle Thoracostomy During Resuscitation of Nontraumatic Adult In-Hospital Cardiac Arrest: A Retrospective Cohort Study.

In-hospital cardiac arrest (IHCA) is a significant public health burden. Rates of return of spontaneous circulation (ROSC) have been improving, but the best way to care for patients after the initial resuscitation remains poorly understood, and improvements in survival to discharge are stagnant. Existing North American cardiac arrest databases lack comprehensive data on the postresuscitation period, and we do not know current post-IHCA practice patterns. To address this gap, we developed the Discover IHCA study, which will thoroughly evaluate current post-IHCA care practices across a diverse cohort. Our study collects granular data on post-IHCA treatment practices, focusing on temperature control and prognostication, with the objective of describing variation in current post-IHCA practices. This is a multicenter, prospectively collected, observational cohort study of patients who have suffered IHCA and have been successfully resuscitated (achieved ROSC). There are 24 enrolling hospital systems (23 in the United States) with 69 individuals enrolling in hospitals (39 in the United States). We developed a standardized data dictionary, and data collection began in October 2023, with a projected 1000 total enrollments. Discover IHCA is endorsed by the Society of Critical Care Medicine. The study collects data on patient characteristics, including prearrest frailty, arrest characteristics, and detailed information on postarrest practices and outcomes. Data collection on post-IHCA practice was structured around current American Heart Association and European Resuscitation Council guidelines. Among other data elements, the study captures postarrest temperature control interventions and postarrest prognostication methods. The majority of participating hospital systems are large, academic, tertiary care centers serving urban populations. The analysis will evaluate variations in practice and their association with mortality and neurologic function. We expect this study, Discover IHCA, to identify variability in practice and outcomes following IHCA and be a vital resource for future investigations into best practices for managing patients after IHCA.

Aggressive hydration with lactated Ringer’s solution versus plasma solution for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (ALPS study): protocol for a multicentre, double-blind, randomised controlled trial

IntroductionEndoscopic retrograde cholangiopancreatography (ERCP) plays an indispensable role in treating pancreato-biliary diseases but carries a risk of post-ERCP pancreatitis (PEP). Despite advances in the prevention strategies, prevention of PEP remains...

Web Site Accessibility Among Doctor of Physical Therapy Programs in the United States.

Given the impetus to improve accessibility for diverse learners seeking physical therapist education, it is critical that all entry points to access information have minimal barriers. This study identified Web site accessibility barriers among Doctor of Physical Therapy (DPT) programs in the United States. Web site accessibility has been evaluated among many institutions of higher education, but none focused on DPT education. Individuals with disabilities may be adversely affected by Web site accessibility barriers. This cross-sectional study included 262 DPT programs in the United States. Doctor of Physical Therapy program characteristics collected were geographic region, institutional control type (public/private), medical school affiliation, accreditation status, total institutional enrollment, and DPT class size. The Web Accessibility Evaluation (WAVE) Tool assessed data related to accessibility barriers among DPT program homepage Uniform Resource Locators. Three primary outcomes from the WAVE Tool included WAVE Total Errors, Error Density, and Total Alerts. Web site homepage accessibility barriers varied among programs for WAVE Total Errors (range 0-150), Error Density (range 0-14.6%), and Total Alerts (range 1-331). Median Total Errors were greater among private (9.0) versus public (5.0) institution Web sites (P < .001). Median Total Errors were greater among those institutions not affiliated with a medical school (9.0) compared with those that had an affiliated medical school (7.0) (P = .04). No differences in accessibility barriers were identified according to geographic region or accreditation status (P > .05). Median Total Errors were significantly different between institutional enrollment quartiles (H[3] = 17.9, P < .001), with no differences noted between DPT class size quartiles for any outcome (P > .05). Generally, weak-fair inverse correlations were observed between student enrollment for the institution and Web site accessibility barrier outcomes. Homepage accessibility barriers varied greatly among DPT programs in the United States. Factors, including being a private institution, no medical school affiliation, and lower institutional enrollment, were related to increased accessibility barriers.

Effects of cinnamon supplementation on metabolic biomarkers in individuals with type 2 diabetes: a systematic review and meta-analysis.

The global prevalence of type 2 diabetes mellitus (DM2) has been rising significantly over the years. Recent studies have shown beneficial effects of cinnamon on metabolic biomarkers. The objective of this review was to assess the effect of cinnamon supplementation on metabolic biomarkers in patients with DM2. The Pubmed/MEDLINE, Cochrane CENTRAL, and Embase databases were searched up to November 10, 2022. A systematic search was performed for randomized controlled trials (RCTs) evaluating the effect of cinnamon supplementation on metabolic biomarkers, in adults and the elderly with DM2, and comparing the data for a cinnamon intervention group with that for a placebo group or a control group. The main exclusion criteria were studies (1) with other types of diabetes (ie, gestational diabetes or type 1 diabetes), (2) without cinnamon consumption, (3) that did not evaluate metabolic biomarkers, or (4) in vitro and animal studies. Two researchers independently screened 924 records, evaluated full-text studies, extracted data, and appraised their quality. A third researcher was consulted to resolve any discrepancies. The data were pooled using random-effects models and expressed as the weighted mean difference (WMD) with 95% CI. Heterogeneity was assessed using Cochran's Q test and quantified using I2 statistics. Risk of bias was assessed using the Joanna Briggs Institute (JBI) instrument. Sensitivity analysis and the GRADE system were used to assess the robustness and certainty of the findings. In total, 28 RCTs with a duration ranging from 30 to 120 days and a total enrollment of 3054 patients with DM2 were included. Participants consuming cinnamon showed a significant reduction in fasting blood glucose (FBG) (WMD: -15.26 mg/dL; 95% CI: -22.23 to -8.30; I2 = 88%), postprandial glucose (WMD: -39.22 mg/dL; 95% CI: -63.90 to -14.55; I2 = 100%), HbA1c (WMD: -0.56 mg/dL; 95% CI: -0.99 to -0.13; I2 = 94%), and HOMA-IR (WMD = -0.76, 95% CI: -1.13 to -0.39; I2 = 22%) compared with the control group. An intervention of cinnamon in capsule form reduced FBG (WMD:-18.43 mg/dL, 95% CI: -26.32 to -10.53; I2 = 89%), postprandial glucose (WMD: -44.83 mg/dL, 95% CI: -70.67 to -18.99; I2 = 100%), HbA1c (WMD: -0.56 mg/dL, 95% CI: -1.02 to -0.09; I2 = 94%), total cholesterol (WMD: -13.39 mg/dL; 95% CI: -24.71 to -2.07; I2 = 96%), LDL-C (WMD: -6.49 mg/dL, 95% CI: -12.69 to -0.29; I2 = 92%), and triglycerides (WND: -19.75 mg/dL; 95% CI, -33.71 to -5.80; I2 = 88%). Both doses (≤2 g/day and >2 g/day) reduced FBG and postprandial glucose. Only cinnamon doses of ≤2 g/day reduced HbA1c (WMD: -0.68 mg/dL, 95% CI: -1.16 to -0.1; I2 = 92%), HOMA-IR (WMD: -0.94 mg/dL; 95% CI: -1.21 to -0.67; I2 = 0%), and BMI (WMD: -1.18 kg/m2; 95% CI: -1.97 to -0.39; I2 = 0%). The data suggest that cinnamon improves the glycemic and lipid profile and reduces the BMI, particularly in DM2 patients who receive cinnamon supplementation in capsule form and at a dose of ≤2 g/day. PROSPERO registration no. CRD42022370332.

OTHR-18. IMPACT OF COVID-19 ON CLINICAL TRIAL ENROLLMENT IN THE DEPARTMENT OF PEDIATRIC HEMATOLOGY ONCOLOGY AT WASHINGTON UNIVERSITY SCHOOL OF MEDICINE/ST. LOUIS CHILDREN’S HOSPITAL FROM 2017 TO 2023

Abstract BACKGROUND COVID-19 had a significant impact on clinical research within the healthcare system worldwide. However, there are only limited reports on its effects on clinical trials in pediatric cancer, specifically in brain tumors. We reviewed the impact of COVID-19 in the Department of Hematology and Oncology in St. Louis Children’s Hospital (SLCH). We analyzed the number of clinical trials open at our center from 2017 to 2023. We hypothesized that in 2020 there would be a significant drop in study participant enrollments at our site overall. METHODS We analyzed data from our online tracking system from 2017 to 2019, pre-pandemic, and 2020-2023, post pandemic. We will also perform a literature review of the impact COVID-19 had on clinical trial enrollment involving childhood cancers in the United States. We will compare these findings to our experience at SLCH. RESULTS In 2020, while non-therapeutic trial enrollments declined to about half of all enrollments compared to 2019, enrollments in therapeutic trials significantly increased to almost three-fold. Overall, when combining non-therapeutic and therapeutic enrollments from 2017-2020, there was a significant decrease in 2020. By 2023, total enrollments nearly recovered to pre-pandemic levels. CONCLUSIONS COVID-19 negatively impacted non-therapeutic studies at SLCH as many trials permanently closed; however, the negative effect on therapeutic studies was minimal.

Meta-analysis of high-power short-duration versus cryoballoon ablation for atrial fibrillation.

The existing literature regarding the treatment strategy for high-power short-duration (HPSD) ablation in patients diagnosed with atrial fibrillation (AF) is currently insufficient. The objective of this study is to perform a comparative analysis evaluating the effectiveness, safety, and procedural efficiency of HPSD versus cryoballoon ablation (CBA) for AF. A comprehensive search was conducted in PubMed, EMBASE, Cochrane Library, Scopus, Web of Science, and ClinicalTrials.gov databases to identify trials comparing HPSD with CBA for AF from their inception until December 25, 2023. Treatment effect measures were expressed as odds ratio (OR), mean difference (MD), accompanied by a 95% confidence interval (CI). The analysis comprised six eligible trials involving a total enrollment of 2481 patients. No statistically significant disparities were observed in recurrent atrial arrhythmia (OR 0.90; 95% CI, 0.71-1.16) or total complications (OR 0.65; 95% CI, 0.38-1.12) between the two ablation techniques examined in this study. However, HPSD technique exhibited a significantly prolonged procedure time (MD 27.42; 95% CI, 19.03 to 35.81). Conversely, no significant differences were observed between the two modalities in terms of total fluoroscopy duration (MD -4.37; 95% CI -10.70 to 1.96) and ablation time (MD 7.95; 95% CI -3.97 to 19.88). Furthermore, HPSD demonstrated significantly higher odds of extrapulmonary vein (PV) trigger ablation compared to CBA (OR 18.86; 95% CI, 5.12-69.49). The subgroup analyses revealed that CBA continued to exhibit superior procedure time (except for the paroxysmal AF subgroup: [MD 29.52; 95% CI -4.25 to 63.60]), while no significant differences in safety and efficacy (except for the HPSD ≥ 70W subgroup: [OR 0.44, 95% CI 0.20-0.97]) outcomes were still observed. Among patients undergoing ablation therapy for AF, both HPSD and CBA demonstrate comparable efficacy and safety profiles; however, HPSD is associated with longer procedural time and higher rates of extra-PV trigger ablation.

Utility of circulating tumor DNA (ctDNA) to inform treatment of patients with metastatic breast cancer.

1042 Background: Circulating tumor DNA (ctDNA) can overcome limitations of tissue biopsy (tbx) in patients with metastatic breast cancer (mBC). While tbx provides a snapshot of a tumor’s molecular profile from one site and time, ctDNA provides a more comprehensive landscape of the tumor genome. Serial liquid biopsies (lbx) can be easily obtained for monitoring clinical response and resistance over time. The Individualized Molecular Analyses Guide Efforts in Breast Cancer (IMAGE) II study evaluates tbx and serial lbx methods for tumor genomic profiling in mBC. Methods: IMAGE II (NCT02965755) is a prospective, multi-center trial to evaluate the clinical utility of lbx versus tbx. Eligible individuals had mBC of any subtype, with progression requiring therapy change. Tbx sequencing per standard of care was required unless biopsy was not technically feasible. Upon enrollment, we collected baseline plasma for tissue-agnostic comprehensive genomic profiling (CGP) by Foundation Medicine. Both lbx and tbx sequencing results were reviewed in real time by the Johns Hopkins Molecular Tumor Board to provide treatment recommendations. Clinical data was recorded. We collected serial lbx samples 1-2 weeks post initiation of next line of therapy, at first restaging, and at progression. Here we present the analysis of data collected at enrollment, and serial lbx results will be reported at a later date. Results: Total enrollment was 199 pts, of whom 194 were women (median age = 57 years, range 27-86 years). There were 140 HR+HER2-, 4 HR-HER2+, 20 HR+HER2+ and 35 triple negative (TNBC) cases. Metastases were found in bone only in 19 pts, or included lung in 99 pts, liver in 97 pts, and brain in 14 pts. Median prior lines of metastatic therapy was 2, with 44 pts (22.1%) having been on 4 or more, including antibody-drug conjugates (14 pts), immunotherapy (2), cytotoxic chemotherapy (74), endocrine (88), and targeted therapy (12). 9 pts were newly diagnosed with mBC at the time of enrollment. 110 pts (55%) had tbx sequencing. In lbx-based CGP results from 190 patients, the genes most frequently altered were TP53(90 patients), PIK3CA (63), ESR1 (54). Copy number amplifications were found in FGFR1 (21 patients) and FGFR3 (12), and copy number losses were found in PTEN in 3 patients. Of the 87 patients whose baseline lbx was profiled using FoundationOne Liquid CDx which allows calculation of ctDNA tumor fraction (TF), 69 (79.3%) pts had detectable ctDNA TF. 60 patients (69.0%) had ctDNA TF at least 1%. We will present the frequency of clinically actionable mutations detected via lbx vs tbx genomic profiling, accounting for sites of metastases, receptor subtype and prior therapy exposure, as well as the association between ctDNA TF and sites of disease. Conclusions: A high rate of ctDNA TF detection in pts with mBC highlights the value of lbx for CGP in this setting for detecting multiple alteration classes across mBC subtypes and metastatic sites. Clinical trial information: NCT02965755 .

New York's experience with building an insurance marketplace: A decade of success and lessons learned

AbstractThis article reviews New York's experience with building an insurance marketplace after passage of the Affordable Care Act in 2010. Some of the article draws from the experiences of the authors, all of whom were, and some still are, involved with the New York State of Health (NYSOH). NYSOH has largely been a success if measured by total enrollment, affordability, and its ability to keep people enrolled during the recent unwinding. Factors that contributed to this success are important to document so that policymakers can note what elements of the administrative design and operation contributed to the increase in New Yorkers obtaining and staying insured.

Three-year disease-free survival after transanal vs. laparoscopic total mesorectal excision for rectal cancer (TaLaR): A randomized clinical trial.

3516 Background: Transanal total mesorectal excision (taTME) has gained significant traction as an effective approach for treating rectal cancer. Many previous studies reported positive relevant short-term results, histopathological results and associated complications of taTME compared to laparoscopic total mesorectal excision (laTME). Nonetheless, long-term oncological outcomes of taTME remain controversial. This study aimed to compare the 3-year DFS of taTME with laTME. Methods: We conducted a phase 3, randomized, open-label, noninferiority trial to compare the survival outcomes of taTME versus laTME in patients with rectal cancer located below the peritoneal reflection. This trial encompassed 16 hospitals across 10 provinces in China, with a total enrollment of 1,115 patients. We set the 3-year disease-free survival (DFS) and 5-year overall survival (OS) as the primary endpoints for analysis. The analysis of the 3-year DFS was conducted following a predefined modified intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT02966483. Results: The taTME group exhibited a 3-year DFS rate of 83.42%, and the laTME group achieved a 3-year DFS rate of 82.86%. The marginal difference of 0.56% between the DFS rates of the two groups (97.5% CI, −4.83 to 5.95, P &lt; 0.0001 for noninferiority) suggests comparable outcomes. Moreover, the rates of local recurrence were 3.90% in the taTME group and 3.62% in the laTME group, indicating similar degrees of localized tumor control. Regarding overall survival, the taTME group demonstrated a rate of 94.50% compared to 92.01% in the laTME group. In the taTME group, patients who are male or underwent neoadjuvant showed a higher 3-year OS than that in the laTME group. Conclusions: In patients with mid-low rectal cancer, the 3-year DFS of taTME is not inferior to that of laTME. This study provides evidence supporting the clinical effectiveness of taTME in the treatment of rectal cancer. Clinical trial information: NCT02966483 .

Impact of industry funding on atrial fibrillation clinical trials: insights and implications

Abstract Background/Introduction Commercial industry is an important source of funding for atrial fibrillation clinical trials, the implications of which have not been analyzed. Purpose The purpose of this study is to describe the characteristics of contemporary AF clinical trials and to evaluate their association with funding source. Methods We systematically assessed all completed atrial fibrillation trials registered in ClinicalTrials.gov between conception to September 1, 2022, and extracted publicly available information including funding source, trial size, race, ethnicity, sex, intervention, location, and publication status. Trial characteristics were compared using the Wilcoxon rank sum test and Fisher’s exact test for continuous and categorical variables, respectively. Results Of the 253 clinical trials assessed, 171 (68%) reported industry funding. Industry funding was associated with a greater median total enrollment (172 vs. 80; P &amp;lt; 0.001), publication rate (56.7% vs. 42.7%; P = 0.04), participation in device trials (48.0% vs. 24.4%; P &amp;lt; 0.001), and multicontinental recruitment location (25.2% vs. 2.4%; P &amp;lt; 0.001) when compared to non-industry funded clinical trials. However, industry funding was not associated with a significant difference in median impact factor (7.7 vs. 7.7; P = 0.723) or median number of citations (60.0 vs. 29.0; P = 0.09). The overall proportion of industry funded trials did not change over time (P = 1.00) since inception of the ClinicalTrials.gov database. Participant demographics remained relatively uniform over time across both industry-funded and non-industry-funded trials. Conclusion(s). Industry funded clinical trials in atrial fibrillation are often larger, more frequently published, multicontinental, and device-focused. Industry funding was found to be associated with significant differences in study enrollment, publication metrics, and study interventions. Insights from this study inform trial design, regulation, and policy considerations in the evolving landscape of AF research.TableFigure

The Effects of Unified School Enrollment Systems on School Demographics and Outcomes: Evidence From New Orleans’ Transition to a Centralized School Lottery

Unified enrollment (UE) systems were designed to improve efficiency, equity, and transparency in school choice processes, but research has focused on efficiency gains. This study examines whether moving from decentralized enrollment processes to UE mitigates or exacerbates racial segregation that often occurs in choice systems. Specifically, we examine a subset of charter schools in New Orleans that had enrolled disproportionately high numbers of White students prior to entering UE. We find that UE entry was associated with increased enrollment of non-White students in these schools without offsetting declines in White enrollment, facilitated by schools also increasing total enrollment after entering UE. We find no meaningful impacts of UE on school accountability measures, student or teacher mobility, or student discipline.

Women and rural people’s participation in tertiary education through Internet resources in India

India has a large formal higher education system, however the enrolment of women and rural people in universities is not substantial. Women enrolment in tertiary education was reported only 41.5% of the total enrolment in the academic year 2010-2011 and only 7% population in rural areas have a higher education. Many socio-cultural barriers prevent people from accessing higher education in India. The integration of the Internet into the higher education sector has the potential to improve access to tertiary education in India regardless gender and area. Using personal narrative and interview data, this article explores how Internet resources can be used to enhance women and rural people’s participation in tertiary education in India.

A randomized trial of retropubic vs single-incision sling among patients undergoing vaginal prolapse repair

The choice of midurethral sling type may impact efficacy and complications in women undergoing transvaginal native tissue repair of pelvic organ prolapse. The primary aim was to determine if the single-incision sling is noninferior to retropubic sling for the management of stress urinary incontinence among patients undergoing reconstructive or obliterative native tissue vaginal repair. The secondary aims were to compare adverse events and surgeon ease of use with sling assignment. A multicenter, noninferiority, randomized trial of women with ≥ stage II pelvic organ prolapse and objectively confirmed stress urinary incontinence undergoing reconstructive or obliterative vaginal repair was performed. Women were randomized to concomitant single-incision (Altis sling, Coloplast Minneapolis, MN) with suprapubic sham incisions or retropubic slings. The primary dichotomous outcome was abnormal lower urinary tract function within 12 months postsurgery, defined as bothersome stress urinary incontinence symptoms (>1 Pelvic Floor Distress Inventory question no. 17); retreatment for stress urinary incontinence or treatment for urinary retention. Secondary outcomes were adverse events, Patient Global Impression of Improvement of bladder function, and surgeon ease of use (1, worst; 10, best). All subjects completed validated questionnaires and underwent a Pelvic Organ Prolapse Quantification, cough stress test, and postvoid residual preoperatively, at 6 weeks and 12 months postoperatively. Assuming a subjective cure rate for retropubic of 82%, 80% power, and 1-sided 5% significance level, we estimated that 127 patients in each arm were needed to declare noninferiority of the single-incision sling if the upper bound of the 95% confidence interval for the between-group difference per protocol in abnormal bladder function was <12%. Assuming a 10% loss to follow-up, the total enrollment goal was280. Between December 2018 and January 2023, 280 subjects were enrolled across 7 sites, and 255 were randomized: 126 were for single-incision, and 129 were for retropubic sling. There were no preoperative or operative characteristic differences between groups. Overall, 81% had reconstructive, and 19% had obliterative native tissue repairs. The primary outcome, abnormal lower urinary tract function at 12 months, occurred in 29 (25%) of single-incision vs 24 (20%) of the retropubic sling group (risk difference, 0.04472 [95% confidence interval,-0.03 to 0.1133]; P=.001 for noninferiority). Bothersome stress urinary incontinence occurred in 20% vs 17% (P=.27) and was retreated in 4% vs 2% (P=.44) of single-incision vs retropubic groups, respectively. Adverse events were reported in 24 (16%) of single-incision vs 14 (9%) of the retropubic group (95% confidence interval, 0.95-3.29; P=.70) and included de novo or worsening urgency incontinence symptoms, urinary tract infection, mesh exposure, need for prolonged catheter drainage, and de novo pain, without differences between groups. Patient Global Impression of Improvement (very satisfied and satisfied) was 71% vs 67% (P=.43), and median surgeon ease of sling use was 8 (7-10) vs 9 (8-10), P=.03 in single-incision vs retropubic, respectively. For women undergoing vaginal repair, single-incision was noninferior to retropubic sling for stress urinary incontinence symptoms, and complications, including treatment for urinary retention, did not differ.

Abstract PO4-11-07: Early response to Adaptive Nutrition and Exercise Weight loss (A-NEW) Study for Breast Cancer Survivors with Overweight or Obesity

Abstract BACKGROUND: Obesity is associated with inferior survival and increased risk of recurrence in breast cancer (BC) survivors. In the Look AHEAD trial, 45% of patients attained ≥5% weight loss at 2 months, and those who lost 3-6% of weight at 2 months had higher odds of &amp;gt;5% weight loss at 1 year. Behavioral weight loss (BWL) studies consistently demonstrate that only half of BC survivors lose &amp;gt;5% weight, emphasizing the need for new approaches to aid those not benefiting from BWL alone. We hypothesized that early weight loss could identify BC survivors with excess body weight who may not benefit from BWL alone, and my benefit from the addition of a FDA-approved anti-obesity pharmaceutical agent. METHODS: Women with stage 0-III BC and BMI &amp;gt;27 kg/m2 who completed recommended local therapy and chemotherapy were enrolled in a 6-month BWL program consisting of remote coaching, an online curriculum, and tracking of diet, activity and weight. Patients completed demographic surveys and were weighed in clinic at baseline and 2 months. We used an adaptive design utilizing weight loss at 2 months to identify those with greater likelihood of weight loss at 6 months with BWL alone. Patients with and without ≥5% weight loss at 2 months were stratified as FAST-BWL and SLOW-BWL, respectively. Those in FAST-BWL continued BWL alone for 4 months, while those in SLOW-BWL also receive anti-obesity medication (Contrave®) until end of study. We anticipate 55% of 55 subjects enrolled will be in the SLOW-BWL group, resulting in a sample size of approximately 30 SLOW-BWL women and 25 FAST-BWL women. Simon's two-stage minimax design was used for the SLOW-BWL group. The null hypothesis that the true rate of attaining ≥5% weight loss is 10.9%, which is chosen based on the rate of women attaining ≥5% weight loss in the self-directed arm in the previously conducted POWER-remote study. The null hypothesis will be rejected if 7 or more women are observed in the 30 patients who attain ≥5% weight loss. This design yields a power of 80% at type I error rate of 5% when the true rate of attaining ≥5% weight loss of the baseline weight for the SLOW-BWL women is 29%, a clinical meaningful rate for the SLOW-BWL women group. We performed a descriptive analysis and evaluated outcomes at 2 months. RESULTS: Total enrollment is complete, and at time of presentation, 54 of 55 participants will be at end of study. Mean age at enrollment was 56 [30 -73], and majority were white (73%), postmenopausal (84%), had an ECOG of 0 (77%) and were employed (69%). The median time from diagnosis to enrollment was 3.9 years [0.6-10.0]. Over half received chemotherapy (54%), radiation (73%), and current endocrine therapy (75%); only 13% received prior antiHER2 therapy. Mean baseline weight was 213 (SD 30) pounds and baseline BMI was 35.5 (4.7). Mean HbA1c, total cholesterol, LDL, and triglycerides were 5.6% (0.4), 203 (29), 120 (26), and 135 (64), respectively. After 2 months of the BWL intervention, 14 (27%) attained ≥5% weight loss (FAST-BWL) and 38 (73%) did not (SLOW-BWL). CONCLUSIONS: We have successfully enrolled to this novel adaptive design and will present full data at the conference. Understanding predictors of successful weight loss inform populations that may benefit from anti-obesity medication, and design future studies that allow more patients to achieve significant weight loss. Citation Format: Jennifer Sheng, Amanda Montanari, Jennifer Trost, Mengyang Lu, Justin Mahosky, Sheetal Parida, Amanda Blackford, Dipali Sharma, Marci Laudenslager, Kimberly Gudzune, Janelle Coughlin, Vered Stearns. Early response to Adaptive Nutrition and Exercise Weight loss (A-NEW) Study for Breast Cancer Survivors with Overweight or Obesity [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-07.

Abstract PO4-18-07: A dose escalation and cohort expansion study of the CDK9 inhibitor KB-0742 in triple negative breast cancer and transcriptionally addicted relapsed or refractory solid tumors

Abstract Background: MYC deregulation is a hallmark of triple negative breast cancer (TNBC) and is associated with aggressive tumors and poor clinical outcomes. Although MYC remains undrugged, targeting of its cofactors has emerged as an attractive strategy to inhibit MYC oncogenic activity. Cyclin-dependent kinase 9 (CDK9) is a critical regulator of oncogenic MYC expression and an important MYC cofactor. KB-0742 is an oral CDK9 inhibitor that demonstrates promising preclinical activity against TNBC. In a real-world cohort, TNBCs have higher MYC expression and higher rates of MYC genomic amplification than other breast cancer subtypes. In primary patient-derived cell lines, KB-0742 treatment results in stronger cytotoxic effects in TNBC as compared to other subtypes. In patient-derived organoids and patient-derived xenografts, CDK9 inhibition by KB-0742 drives antiproliferative and anti-tumor growth effects, including in models that are resistant to standard of care. KB-0742 strongly downregulates MYC protein levels at doses that only partially inhibit CDK9 activity, suggesting a therapeutic window for tumor-specific activity (Saffran, D.C. et al, 2021). KB-0742 is currently being evaluated in a phase 1/2 dose escalation and cohort expansion study in patients with TNBC and other transcriptionally addicted tumors (NCT04718675). Trial design: This phase 1/2 study includes two parts: dose escalation (part 1) and cohort expansion (part 2). Part 2 includes cohort A (solid tumors with high prevalence of MYC overexpression including TNBC, non-small cell lung cancer and ovarian) and cohort B (other transcriptionally addicted tumor types including sarcomas, adenoid cystic carcinoma, nut midline carcinoma and small cell lung cancer). KB-0742 is dosed orally once daily for 3 consecutive days, followed by 4 days, off on a weekly basis in 28-day cycles until unacceptable toxicity or disease progression. Eligibility criteria: Part 1 dose escalation is open to patients with relapsed or refractory solid tumors. Part 2 is defined by tumor indications in cohorts A and B. Eligibly criteria include age &amp;gt; 18 years (≥ 12 years old and with a body weight ≥ 40 kg part 2 for cohort B), acceptable organ function, and ECOG PS &amp;lt; 2. Specific aims: Primary objectives include evaluation of pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, preliminary anti-tumor activity, and identifying a maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). PK measurements include Cmax, tmax, AUC0-last, accumulation ratio (Racc) and t1/2. Safety data will be evaluated per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. The Modified Continuous Reassessment Method (mCRM) (Goodman et al., Stat Med 1995) will guide dose escalation and MTD. RP2D nomination is informed by PD in peripheral blood mononuclear cells using assays to evaluate phosphorylation of the CDK9 substrate serine 2 on the RNA Polymerase II C-terminal domain (pSER2) and CDK9-responsive gene expression. Radiographic tumor response to KB-0742 in patients is assessed every other cycle starting from cycle two after treatment using RECIST 1.1 criteria. Target accrual: Targeted total enrollment is 170 patients. For additional information, contact clinicaltrials@kronosbio.com Citation Format: Monica Mita, Alain Mita, Miguel Villalona-Calero, Noah Federman, Drew Rasco, David Spigel, Jia Luo, Gregory Cote, Richard Cutler, Pavan Kumar, Crystal MacKenzie, Charles Lin, Jorge DiMartino, Elizabeth Olek, Brian Van Tine. A dose escalation and cohort expansion study of the CDK9 inhibitor KB-0742 in triple negative breast cancer and transcriptionally addicted relapsed or refractory solid tumors [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-18-07.