Time saved in activities of daily living and whole-brain volume: Post hoc analysis of a randomized feasibility trial of gamma oscillation treatment in participants with mild or moderate Alzheimer's disease.

Introduction: Gamma oscillations in the brain are necessary for normal cognitive function, sensory processing, and memory consolidation, and are reduced in Alzheimer's disease (AD). In a 6 month, randomized, feasibility trial in participants with mild-to-moderate AD (OVERTURE [NCT03556280],  = 76), a non-invasive method for sensory-evoked brain gamma oscillations outperformed sham on the secondary outcomes of slowing decline on the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) functional scale, magnetic resonance imaging measures of whole brain volume and the Mini-Mental State Examination (MMSE) cognitive outcome, despite not showing statistical significance on the primary outcome (Mild and Moderate Alzheimer's Disease Composite [MADCOMS]), a composite cognitive-functional score. In this post hoc analysis of OVERTURE, we evaluated the effects of investigational sensory-evoked gamma oscillation treatment in terms of time saved, as an estimate of slowing in disease progression, on ADCS-ADL, MMSE, and whole-brain volume.

Circulatory prostate cancer proteome landscapes and prognostic biomarkers in metastatic castrate resistant prostate cancer.

Background: Plasma-based high-plex proteomic profiling were performed in prostate cancer (PC) patients using the Olink® Explore Proximity Extension Assay to identify plasma proteins associated in different PC states and to explore potential prognostic biomarkers. The progressive PC states include local, organ-confined PC (local PC), metastatic hormone-sensitive PC (mHSPC) and metastatic castrate-resistant PC (mCRPC).

Methods: Plasma samples were uniformly processed from 84 PC patients (10 patients with local PC; 29 patients with mHSPC; 45 patients with mCRPC).

Clinical Implications of Slope of GFR in Clinical Trials of CKD Progression.

Key Points: Acute effects impact the clinical endpoint independently of treatment effects on the chronic slope. Our findings support the 3-year total slope as the primary slope-based outcome in randomized trials.

Background: Slope of the GFR is considered a validated surrogate endpoint for CKD trials.

The Association Between Body Composition, Overall Survival, Treatment Decisions, and Patient-Reported Outcomes in Metastatic Non-Small-Cell Lung Cancer.

Introduction: The purpose of this study was to evaluate the association between body composition, overall survival, odds of receiving treatment, and patient-reported outcomes (PROs) in individuals living with metastatic non-small-cell lung cancer (mNSCLC).

Methods: This retrospective analysis was conducted in newly diagnosed patients with mNSCLC who had computed-tomography (CT) scans and completed PRO questionnaires close to metastatic diagnosis date. Cox proportional hazard models and logistic regression evaluated overall survival and odds of receiving treatment, respectively.

Challenges and lessons learned in recruiting participants for school-based disease prevention programs during COVID-19.

Schools provide an ideal setting for delivery of disease prevention programs due to the ability to deliver health education and counseling, including health behavior interventions, to large numbers of students. However, the remote and hybrid learning models that arose during the coronavirus (COVID-19) pandemic created obstacles to these efforts. In this article, we provide insights on collaborating with schools to deliver disease prevention programming during the height of the COVID-19 pandemic, and in subsequent years.

Multigene Copy Number Alteration Risk Score Biomarker-Based Enrichment Study Designs in Metastatic Castrate-Resistant Prostate Cancer.

Purpose: A composite multigene risk score derived from tumor-biology alterations specific to metastatic castrate-resistant prostate cancer (mCRPC) state was evaluated as a classifier to design biomarker-based enrichment clinical trials.

Methods: A plasma cell-free DNA copy number alteration risk score based on alterations in 24 genes was simulated to develop a biomarker classifier-based clinical trial design enriched for high-risk patients to detect a survival advantage of a novel treatment (hazard ratio of 0.70 with 80% power).

Augmenting Prognostication: Utilizing Activity Trackers to Enhance Survival Prediction in Metastatic Non-Small Cell Lung Cancer.

Introduction/background: Prognostication by performance status (PS) assessment is a fundamental element of treatment decisions and clinical trial design in oncology, but it is limited by subjectivity and potential miscommunication between patient, physician, and family. Activity tracker offers the potential to collect a broad range of patient-generated data to supplement the assessment of PS.

Patients And Methods: Patients with metastatic NSCLC (mNSCLC) participated in a single institute, prospective, observational feasibility study conducted at Huntsman Cancer Institute.

Capturing Chemotherapy and Radiotherapy Dose Among Breast Cancer Patients With the Utah All-Payer Claims Database Compared With Gold-Standard Abstraction.

Objective: To evaluate the validity of the Utah statewide All-Payer Claims Database (APCD), we compared breast cancer-specific treatments and dosages with gold-standard abstraction of medical records.

Study Design: In this pilot study, breast cancer treatments were abstracted by a certified tumor registrar at the Utah Cancer Registry (UCR) for patients diagnosed in 2013 with breast cancer. The abstraction of medical records was the gold standard for comparison with treatments identified in the APCD.

Genitourinary cancer and family: The reverberating psychological and cardiovascular effects of a genitourinary cancer diagnosis on first-degree relatives and spouses.

Background: The psychological and cardiovascular health impacts on family members of patients who have been diagnosed with cancer have not been well characterized. The purpose of this study is to determine whether a family member's cancer diagnosis influences the risk of psychological illness and cardiovascular disease in first-degree relatives and spouses of patients affected by cancer.

Methods: This retrospective cohort analysis evaluated the risk of psychological illness and cardiovascular disease in first-degree relatives and spouses of patients diagnosed with a genitourinary cancer between 1990 and 2015 compared to relatives of those not diagnosed with a genitourinary cancer.

International Cost-Effectiveness Analysis of Durvalumab in Stage III Non-Small Cell Lung Cancer.

Importance: Standard of care for unresectable locally advanced non-small cell lung cancer (NSCLC) involves definitive chemoradiotherapy followed by maintenance therapy with durvalumab. However, the cost of durvalumab has been cited as a barrier to its use in various health systems.

Objective: To evaluate the cost-effectiveness of durvalumab vs placebo as maintenance therapy in patients with unresectable stage III NSCLC from 4 international payer perspectives (US, Brazil, Singapore, and Spain).

A matching-based machine learning approach to estimating optimal dynamic treatment regimes with time-to-event outcomes.

Observational data (e.g. electronic health records) has become increasingly important in evidence-based research on dynamic treatment regimes, which tailor treatments over time to patients based on their characteristics and evolving clinical history.

Urban relatives ameliorate survival disparities for genitourinary cancer in rural patients.

Introduction: Patients living in rural areas have worse cancer-specific outcomes. This study examines the effect of family-based social capital on genitourinary cancer survival. We hypothesized that rural patients with urban relatives have improved survival relative to rural patients without urban family.

Protocol for a cluster-randomized trial of a school-based skin cancer preventive intervention for adolescents.

Background: Adolescents infrequently use sun protection and engage in intentional tanning more frequently compared to other age groups, leading to increased ultraviolet radiation (UVR) exposure that heightens skin cancer risk across the lifespan. High schools are therefore an ideal setting for offering skin cancer preventive interventions. Yet, there are limited UVR protection interventions for high school students, especially those that are personalized, tested using randomized designs, and include long-term outcome assessment to determine the durability of intervention effects.

Comparing Bayesian hierarchical meta-regression methods and evaluating the influence of priors for evaluations of surrogate endpoints on heterogeneous collections of clinical trials.

Background: Surrogate endpoints, such as those of interest in chronic kidney disease (CKD), are often evaluated using Bayesian meta-regression. Trials used for the analysis can evaluate a variety of interventions for different sub-classifications of disease, which can introduce two additional goals in the analysis. The first is to infer the quality of the surrogate within specific trial subgroups defined by disease or intervention classes.

Preliminary effects of a rural skin cancer prevention intervention for youths.

Objectives: To pilot and assess the feasibility, acceptability, and preliminary effects of the Rural Adult and Youth Sun (RAYS) protection program, a multilevel skin cancer preventive intervention for young children living in rural U.S. communities, delivered through community-organized team sports.

Clinical Impact of Multiplex Molecular Diagnostic Testing in Children With Acute Gastroenteritis Presenting to an Emergency Department: A Multicenter Prospective Study.

Background: Multiplex molecular diagnostic panels have greatly enhanced detection of gastrointestinal pathogens. However, data on the impact of these tests on clinical and patient-centered outcomes are limited.

Methods: We conducted a prospective, multicenter, stepped-wedge trial to determine the impact of multiplex molecular testing at 5 academic children's hospitals on children presenting to the emergency department with acute gastroenteritis.

Mental health outcomes in a population-based cohort of patients with prostate cancer.

Background: Few studies have evaluated mental health disorders comprehensively among patients with prostate cancer on long-term follow-up. The primary aim of our study was to assess the incidence of mental health disorders among patients with prostate cancer compared with a general population cohort. A secondary aim was to investigate potential risk factors for mental health disorders among patients with prostate cancer.

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

Background And Aims: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC).

Design: This study was a pilot single-blinded multi-site randomized trial.

Handling missing within-study correlations in the evaluation of surrogate endpoints.

Rigorous evaluation of surrogate endpoints is performed in a trial-level analysis in which the strength of the association between treatment effects on the clinical and surrogate endpoints is quantified across a collection of previously conducted trials. To reduce bias in measures of the performance of the surrogate, the statistical model must account for the sampling error in each trial's estimated treatment effects and their potential correlation. Unfortunately, these within-study correlations can be difficult to obtain, especially for meta-analysis of published trial results where individual patient data is not available.

Low-Value Prostate Cancer Screening Among Young Men With Private Insurance.

Introduction: No professional society guidelines recommend PSA screening in men younger than age 40; however, data suggest testing occurs at meaningful rates in this age group. The purpose of this study was to identify the rate of PSA testing in men under 40.

Methods: This is a population-based, retrospective cohort study from 2008 to 2017.

New-Onset Diabetes after an Obesity-Related Cancer Diagnosis and Survival Outcomes in the Women's Health Initiative.

Background: Individuals diagnosed with an obesity-related cancer (ORC survivors) are at an elevated risk of incident diabetes compared with cancer-free individuals, but whether this confers survival disadvantage is unknown.

Methods: We assessed the rate of incident diabetes in ORC survivors and evaluated the association of incident diabetes with all-cause and cancer-specific mortality among females with ORC in the Women's Health Initiative cohort (N = 14,651). Cox proportional hazards regression models stratified by exposure-risk periods (0-1, >1-3, >3-5, >5-7, and >7-10 years) from ORC diagnosis and time-varying exposure (diabetes) analyses were performed.

Clinical Impact of Multiplex Molecular Diagnostic Testing in Children with Acute Gastroenteritis Presenting to An Emergency Department: A Multicenter Prospective Study.

Background: Multiplex molecular diagnostic panels have greatly enhanced detection of gastrointestinal pathogens. However, data on the impact of these tests on clinical and patient-centered outcomes are limited.

Methods: We conducted a prospective, multicenter, stepped-wedge trial to determine the impact of multiplex molecular testing at five academic children's hospitals in children presenting to the ED with acute gastroenteritis.