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AbstractBackgroundScalable, efficient methods are needed to enroll diverse populations of older adults into AD observational studies and clinical trials. We evaluated preliminary feasibility of a novel, digital, culturally informed approach to recruit and screen participants for the Alzheimer’s Disease Neuroimaging Initiative (ADNI4).MethodsDigital advertising tailored towards Black/African American and Latinx older adults residing near six clinical ADNI sites directed potential participants to a recruitment website (Figure 1). They completed digital surveys of demographics, ADNI exclusion criteria, memory concerns and changes, self‐report cognitive impairment, and the Everyday Cognition Scale (ECog)‐12 item. Participants also completed Novoic Storyteller, a self‐administered speech‐based cognitive test. Digital assessment results were used to prioritize those from minoritized ethnocultural groups, with low educational attainment, and possible Mild Cognitive Impairment (MCI) for remote blood draw at local Quest phlebotomy centers to obtain AD plasma biomarkers. Completion rates and digital assessment performance were compared between minoritized and non‐minoritized groups.ResultsOf 989 participants recruited from digital advertising efforts who provided contact information, 230 (23%) signed consent, and 183 (19%) completed at least one remote assessment (Table 1). 45% were from minoritized ethnocultural groups, 4% had ≤12 years of education, and 53% had evidence of possible MCI from digital assessments. 34 (19%) were referred to the plasma biomarker study, of which 21% completed blood draw. Compared to non‐minoritized participants, minoritized participants were less likely to report a diagnosed cognitive impairment or a family history of AD, less likely to have ECog scores indicative of MCI, and less likely to have a study partner. Minoritized participants had lower ECog and Novoic Storyteller completion rates.ConclusionRecruitment and assessment of a diverse cohort of older adults, including those with possible cognitive impairment, is feasible using culturally informed digital advertising. Improving study engagement and achieving educational diversity are key challenges. This approach is now being scaled up to facilitate recruitment into in‐clinic ADNI4, with the goal of enrolling 500 new participants: >50% from minoritized groups, 40% with MCI, and 80% amyloid positive across diagnostic groups. This approach can be adapted to facilitate recruitment and longitudinal assessment in other AD studies and trials.

Background: The incidence and mortality of anal squamous cell carcinoma (ASCC) are rising, with greater than 80% of cases linked to human papillomavirus (HPV), primarily HPV16. Post-treatment surveillance can be challenging due to the limitations of anoscopy, digital anal rectal exam (DARE), and imaging. Plasma tumor tissue modified viral (TTMV)-HPV DNA has shown strong sensitivity, specificity, and predictive value in detecting the recurrence of HPV-driven oropharyngeal cancer. Here, we investigate the ability of TTMV-HPV DNA for the early recurrence detection of ASCC. Methods: This retrospective clinical case series included 117 patients with HPV-driven ASCC across 7 U.S. centers, monitored with TTMV-HPV DNA during routine clinical care between March 2020 and June 2024. Physician-reported clinical data and biomarker testing data were combined to create a comprehensive, longitudinal dataset for evaluating test performance metrics. Results: Patients had a median age of 63 years and median post-diagnosis follow-up of 19 months. HPV status was primarily confirmed by TTMV-HPV DNA (52%) or p16 immunohistochemistry (39%). Of those tested for TTMV-HPV DNA pretreatment, 85% had a positive result. TTMV-HPV DNA clearance during or within three months post-treatment was associated with significantly better recurrence-free survival. The per-patient surveillance sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 82.8%, 98.4%, 96.0%, and 92.5%. Of 24 patients with a documented recurrence and a positive TTMV-HPV DNA test, the test was the first evidence of recurrence in 14 patients (58.3%), with a median lead time of 59 days (range: 10–536). TTMV-HPV DNA accurately resolved 94.3% of cases with indeterminate clinical findings. Conclusions: TTMV-HPV DNA testing provides a sensitive and specific approach for detecting patients with recurrent ASCC and resolving the status of patients with indeterminate clinical findings.

Abstract Purpose Medical student education in geriatrics is a critical need for every doctor-in-training as the population ages, with fewer than 7,000 geriatricians, and older patients, who now approach 20% of the U.S. population, having unique health care needs. This study presents the updated competencies in geriatrics for graduating medical students, framed by the Geriatrics 5Ms (Mind, Mobility, Medications, Multicomplexity, and What Matters Most). Method From 2019–2022, a working group of the American Geriatrics Society (AGS) drafted the updated medical student geriatrics education competencies, using a modified Delphi approach. The working group reviewed the literature, conducted an initial survey of working group members, and drafted and refined proposed updates to the competencies. The 27 resulting competencies were disseminated as a national survey to geriatrics experts and medical school education deans. Following the national survey, the competencies were updated and presented at the 2021 AGS Annual Scientific Meeting and open to public comment before they were finalized. Results The 27 updated geriatrics competencies for medical students included several new competencies, such as a focus on health equity, frailty, deprescribing, and patient priorities. A total of 211 respondents completed the national survey, including geriatrics experts (187/398, response rate: 47.0%) and education deans (24/191, response rate: 12.6%). All 27 proposed competencies met the predetermined threshold of 70% cumulative agreement, with a range of 93.0% (174/187) to 100% (187/187) among geriatrics experts and 87.5% (21/24) to 100% (24/24) among education deans. Conclusions The updated Geriatrics Competencies for Graduating Medical Students met with broad agreement among the geriatrics experts and medical school education deans who responded to the national survey. By focusing on the Geriatrics 5Ms, the competencies highlight key knowledge and skills graduating medical students need for the first day of internship to be prepared to deliver age-friendly care to older adults under their care.

Abstract Few studies have reliable estimates on costs of informal care following hospitalization, including health care use and out-of-pocket costs for family caregivers (FCGs) and their care recipients (CR). This presentation discusses results from a Transitional Palliative Care (TPC) intervention on healthcare use and out-of-pocket spending for both FCGs and CRs. The study used data from the Technology-Enhanced TPC study, a trial comparing the TPC intervention to support FCGs of seriously ill CRs to an attention control condition. TPC FCGs received teaching, guidance, and counseling via video calls for 8 weeks following CR hospital discharge. After discharge, a research assistant called FCGs once a month for up to 6 months or CR death to collect healthcare utilization (e.g. outpatient, emergency department, and hospital), out-of-pocket healthcare spending (e.g. deductibles and coinsurance), and health-related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRR) were estimated using negative binomial regressions. The study included 282 FCG-CR dyads across 3 US states. TPC reduced nights in the hospital for CR (IRR = 0.75; 95% CI = 0.56 – 0. 99). Total out-of-pocket spending was not significantly different for TPC versus control; however, TPC dyads reported lower lodging costs (IRR = 0.71; 95% CI = 0.56-0.89). Across groups, mean out-of-pocket spending for dyads was $1401.85, with healthcare payments contributing $1048.58 and transportation expenses contributing $136.79. This study contributes to evidence that palliative care interventions reduce unnecessary hospitalization for seriously ill patients, yet the financial costs to caregivers remain high.

Abstract Recruiting family caregivers to participate in research, especially caregivers of people with severe or life limiting illnesses transitioning from hospital to home, is challenging. Traditional approaches for recruitment, including recruitment done on site at clinics or hospitals, became impracticable during the COVID-19 pandemic, leading to shifts toward virtual or remote recruitment and consent. In this presentation, Dr. Gustavson will compare the success of these two methodological approaches, in-person and remote recruitment and consent, used in the Technology-Enhanced Transitional Palliative Care (TPC) study. She found that the rate of recruitment and consent done in-person was 28% and the rate of remote recruitment and consent was 23%. Those recruited and consented remotely were more likely to be younger, white, have greater than high school education, and were children of or had another non-spousal relationship to the care recipient. She discusses the limitations and benefits of each recruitment modality, including the impact on representativeness of the study sample.

Abstract In the research literature and amongst grant reviewers, there are persistent questions about whether internet connectivity challenges, especially in rural populations, will limit the potential for virtual or decentralized clinical trials to improve participation of underrepresented groups. In clinical practice, e-health and telehealth advancements have been touted as potential models of care to address health disparities associated with access to care, but without reliable internet connectivity, these disparities may perpetuate or even widen. In this presentation Dr. Holland examines the prevalence of connectivity problems during the Technology-Enhanced Transitional Palliative Care (TPC) study, a virtual clinical trial across three Midwestern states, and provides guidance on the challenges faced. Data are from structured notes from nurse interventionists who documented any connectivity issues in the study’s electronic health record. Of the 1003 visits reviewed, only 11% of visits (115/1003) contained a documented problem with internet connectivity. None of the participants withdrew from the trial due to problems with their internet connections. The findings support the effective use of virtual visits in research involving participants living in rural locations. Virtual randomized controlled trials provide a strategy that enables participation for rural individuals who may not otherwise have access to clinical trials conducted in-person in urban settings. Utilizing internet access to connect with and support people who live in rural areas is critically needed to advance clinical research.

Abstract In this presentation, Dr. Griffin will describe the Technology-Enhanced Transitional Palliative Care (TPC) study, a randomized controlled trial testing the efficacy and cost-effectiveness of an intervention to address FCGs’ unmet needs in order to improve their health and well-being. Nurse interventionists use video visits to teach, guide and counsel FCGs in rural areas caring for someone receiving palliative care and transitioning form hospital to home. In addition to providing background on the importance of addressing unmet family caregiver needs during care transitions for patients receiving palliative care, she will describe the study design, sample, intervention and control group procedures, including the use of video visits, and outcomes assessed. This presentation will provide necessary context for the remaining presentations.

Abstract Estimates of patient care costs often overlook the economic value of unpaid caregiving. This study aims to quantify the economic value of unpaid caregiving by rural FCGs. Using data from a multi-site randomized controlled trial evaluating Transitional Palliative Care (TPC) intervention for FCGs, this study quantifies the economic value of family caregiving in the six months following seriously ill care recipients’ hospital discharge using three valuation methods. Caregiving hours were self-reported by FCGs. The proxy cost approach assigned value to FCG hours using the national median home health aide wage. The unadjusted opportunity cost approach assigned value using the national median wage, by sex and education level. The adjusted opportunity cost approach assigned value by work force participation, using opportunity cost if employed and proxy cost otherwise. Of 282 FCGs, 94% were non-Hispanic White, 71% had a college degree, 56% were spouses, and 51% were in the workforce. FCG cost did not differ by treatment arm. FCGs of decedents compared to survivors reported significantly more hours per person-month (392 vs. 272, p< 0.001), resulting in higher median opportunity cost ($12,653 vs. $8,843, p< 0.001), proxy cost ($5,689 vs. $3,955, p< 0.001), and adjusted opportunity cost ($9,490 vs. $6,443, p< 0.001) per person-month. Proxy cost may undervalue FCG time, while opportunity cost may perpetuate labor market inequities. Policymakers must weigh trade-offs of different valuation methods. The high intensity of unpaid post-acute care, especially end-of-life, should be considered when designing policies and interventions to support unpaid FCG due to the economic impact on FCGs and employers.

Trends in diagnostic biopsy sample collection approaches for primary bone sarcomas have shifted in the past 2 decades. Although open/incisional biopsies used to be the predominant approach to obtain diagnostic material for Ewing sarcoma and osteosarcoma, image-guided core needle biopsies have increased in frequency and are safe for patients. These procedures are less invasive and reduce recovery times but have potential limitations. The quantity and quality of tissue obtained through these procedures vary between institutions. Acquired viable tissue volumes can be low, limiting the conduct of downstream expanded clinical workup, molecular analyses, and research. Patients with advanced Ewing sarcoma and osteosarcoma continue to have overall poor outcomes despite dose-intensive cytotoxic chemotherapy. The biology of treatment resistance is not currently well understood, partly due to limited availability of relevant tissue to study. There is a need for access to quality tumor specimens for molecular and other analyses to identify high-risk tumor subsets and drive discovery to improve patient outcomes. Given broad variability in bone tumor tissue procurement and processing across member institutions, the Children’s Oncology Group Bone Tumor Committee convened a multidisciplinary group of experts to outline the current and near-future tissue needs for optimal clinical care and access to research platforms. The goal of this working group was to provide high-level guidance on biopsy practices that safely meet these evolving needs. Harmonizing tissue collection practices is paramount to improving the care of children, adolescents, and young adults diagnosed with Ewing sarcoma and osteosarcoma.

Abstract The overall goal of the Alzheimer's Disease Neuroimaging Initiative (ADNI) is to optimize and validate biomarkers for clinical trials while sharing all data and biofluid samples with the global scientific community. ADNI has been instrumental in standardizing and validating amyloid beta (Aβ) and tau positron emission tomography (PET) imaging. ADNI data were used for the US Food and Drug Administration (FDA) approval of the Fujirebio and Roche Elecsys cerebrospinal fluid diagnostic tests. Additionally, ADNI provided data for the trials of the FDA‐approved treatments aducanumab, lecanemab, and donanemab. More than 6000 scientific papers have been published using ADNI data, reflecting ADNI's promotion of open science and data sharing. Despite its enormous success, ADNI has some limitations, particularly in generalizing its data and findings to the entire US/Canadian population. This introduction provides a historical overview of ADNI and highlights its significant accomplishments and future vision to pioneer “the clinical trial of the future” focusing on demographic inclusivity. Highlights The Alzheimer's Disease Neuroimaging Initiative (ADNI) introduced a novel model for public‐private partnerships and data sharing. It successfully validated amyloid and Tau PET imaging, as well as CSF and plasma biomarkers, for diagnosing Alzheimer's disease. ADNI generated and disseminated vital data for designing AD clinical trials.