The Center for Health Outcomes in Medicine Scholarship and Service (HOMES): Fostering and Supporting Physician-Initiated Research.

ProblemThe U.S. physician scholar workforce, currently comprising less than 1.

Neurologic dance training and home exercise improve motor-cognitive dual-task function similarly, but through potentially different mechanisms, among breast cancer survivors with chemotherapy-induced neuropathy: Initial results of a randomized, controlled clinical trial.

Background: Dual-task function is compromised among individuals with prodromal Alzheimer's disease (AD) and others at risk of developing AD. While exercise has been studied as a therapeutic candidate, the activity of social dance might promote dual-task rehabilitation as well or better than conventional exercise.

Objective: Compare effects of social dance versus home exercise on dual-task function and intervention adherence among individuals with increased risk of developing AD: survivors of breast cancer (BC) with chemotherapy-induced neuropathy (CIN).

The role of heparan sulfate in enhancing the chemotherapeutic response in triple-negative breast cancer.

Background: Breast cancer, one of the most common forms of cancer, is associated with the highest cancer-related mortality among women worldwide. In comparison to other types of breast cancer, patients diagnosed with the triple-negative breast cancer (TNBC) subtype have the worst outcome because current therapies do not produce long-lasting responses. Hence, innovative therapies that produce persisting responses are a critical need.

Effect of minocycline on changes in affective behaviors, cognitive function, and inflammation in breast cancer survivors undergoing chemotherapy: a pilot randomized controlled trial.

Purpose: Minocycline suppresses chemotherapy-induced neuroinflammation in preclinical models, but its effects in cancer survivors are unknown. This study evaluated the longitudinal effects of minocycline on affective behaviors, cognitive functions, and inflammation in women with breast cancer (BC) undergoing chemotherapy.

Methods: This is a pilot, double-blind, randomized controlled trial of oral minocycline (100 mg BID) versus placebo for chemotherapy-induced affective disorders in women initiating chemotherapy for stage I-III BC.

Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial.

Introduction: Dance has been proposed to support superior intrinsic motivation over non-dance forms of therapeutic physical activity. However, this hypothesis has yet to be evaluated empirically, particularly among populations living with neuropathology such as survivors of cancer with neurologic complications from chemotherapy treatment. Questions about motivation are relevant to clinical outcomes because motivation mediates neuroplasticity.

Advance Care Planning (ACP) in Medicare Beneficiaries with Heart Failure.

Background: Heart failure is a leading cause of death in the USA, contributing to high expenditures near the end of life. Evidence remains lacking on whether billed advance care planning changes patterns of end-of-life healthcare utilization among patients with heart failure. Large-scale claims evaluation assessing billed advance care planning and end-of-life hospitalizations among patients with heart failure can fill evidence gaps to inform health policy and clinical practice.

How Ohio public library systems respond to opioid-related substance use: a descriptive analysis of survey results.

Background: Public libraries in the United States have experienced increases in opioid-related substance use in their communities and on their premises. This includes fatal and non-fatal overdose events. Some libraries have adopted response measures in their branches to deter substance use or prevent overdose.

Survival outcomes seen with neoadjuvant chemotherapy in the management of locally advanced inflammatory breast cancer (IBC) versus matched controls.

Inflammatory breast cancer (IBC) poses an ongoing challenge as rates of disease recurrence and mortality remain high compared to stage-matched controls. However, frontline therapy has evolved through the years, including the widespread use of neoadjuvant chemotherapy (NAC) given the prognostic importance of pathologic complete response (pCR). Due to these sweeping changes, we need new data to assess current recurrence and survival outcomes for locally advanced IBC in the context of matched non-inflammatory controls.

Genetic counseling and testing for females at elevated risk for breast cancer: Protocol for the randomized controlled trial of the Know Your Risk intervention.

Background: Genetic counseling and testing have an important role in the care of patients at elevated risk for breast cancer. However, conventional pre- and post-test genetic counseling is labor and time intensive, less accessible for patients living outside major urban centers, and impractical on a large scale. A patient-driven approach to genetic counseling and testing may increase access, improve patients' experiences, affect efficiency of clinical practice, and help meet workforce demand.

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD.

Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates.

The Immunomodulatory Effects of Dexamethasone on Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer.

Introduction: The immunomodulatory impact of corticosteroids and concurrent chemotherapy is poorly understood within triple-negative breast cancer (TNBC). On a biochemical level, steroids have been linked to the signaling of chemotherapy-resistant pathways. However, on a clinical level, steroids play an essential role in chemotherapy tolerance through the prevention of chemotherapy-induced nausea and vomiting (CINV) and hypersensitivity reactions.

The Evolution of Primary Care Telehealth Disparities During COVID-19: Retrospective Cohort Study.

Background: Telehealth has become widely used as a novel way to provide outpatient care during the COVID-19 pandemic, but data about telehealth use in primary care remain limited. Studies in other specialties raise concerns that telehealth may be widening existing health care disparities, requiring further scrutiny of trends in telehealth use.

Objective: Our study aims to further characterize sociodemographic differences in primary care via telehealth compared to in-person office visits before and during the COVID-19 pandemic and determine if these disparities changed throughout 2020.

Controlling the false-discovery rate when identifying the subgroup benefiting from treatment.

One common goal of subgroup analyses is to determine which (if any) types of patients-sets of patients sharing a vector of baseline covariates-benefit from a particular treatment. Many approaches involve testing, implicitly or explicitly, hypotheses about many patient types which are nonexchangeable. Methods of controlling family-wise Type I error rate inflation in such approaches are available.

Retrospective cohort study of scalp cooling in breast cancer patients.

For patients with cancer, alopecia is a common side effect that negatively impacts personal identity, body image, self-esteem, quality of life, and medical decision-making. Scalp cooling is a technique used to prevent alopecia in patients undergoing chemotherapy in which patients wear a cooled cap during chemotherapy infusions, causing localized vasoconstriction of blood vessels on the scalp. Because of the recent emergence of scalp cooling, there is a need to explore further the reasons why patients pursue this treatment.

Development of a web-based, theory-guided narrative intervention for women at elevated risk for breast cancer.

Objective: To describe the development of a web-based, theory-guided narrative intervention that replaces conventional pre-test genetic counseling for women at elevated breast cancer risk.

Methods: We used an iterative process that was guided by health behavior theory and feedback from multiple stakeholder groups including: 1) content input from genetic experts; 2) study team input; 3) review of video storyboards, video example, study logo, recruitment materials, post-test patient preference counseling survey, and additional study surveys; 4) video series development; and 5) intervention review and finalization of study-related materials.

Results: The intervention is patient-centered providing convenience and an opportunity for an individual's preferences for post-test counseling delivery.

Randomized double-blind placebo-controlled proof-of-concept trial of resveratrol for outpatient treatment of mild coronavirus disease (COVID-19).

Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N = 105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol.

Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19).

Resveratrol is a polyphenol that has been well studied and has demonstrated anti-viral and anti-inflammatory properties that might mitigate the effects of COVID-19. Outpatients (N=105) were recruited from central Ohio in late 2020. Participants were randomly assigned to receive placebo or resveratrol.

Adverse Events and Perception of Benefit From Duloxetine for Treating Aromatase Inhibitor-Associated Arthralgias.

Background: Duloxetine effectively treats aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) in women with breast cancer but causes low-grade toxicities. This secondary analysis examines the relationship between adverse events (AE) and patient-perceived benefit, based on patient self-report that the treatment received was beneficial despite side effects. We hypothesized that duloxetine had a favorable effect on patient-perceived benefit, even among duloxetine-treated patients who experienced AEs and who, had they been treated with placebo, would have experienced none.

Monte Carlo approaches to frequentist multiplicity-adjusted benefiting subgroup identification.

One common goal of subgroup analyses is to determine the subgroup of the population for which a given treatment is effective. Like most problems in subgroup analyses, this benefiting subgroup identification requires careful attention to multiple testing considerations, especially Type I error inflation. To partially address these concerns, the credible subgroups approach provides a pair of bounding subgroups for the benefiting subgroup, constructed so that with high posterior probability one is contained by the benefiting subgroup while the other contains the benefiting subgroup.

Palliative Care Referral Patterns for Adolescent and Young Adult Patients at a Comprehensive Cancer Center.

Palliative care (PC) serves a valuable role throughout the disease trajectory for adolescents and young adults (AYAs) living with cancer. A 3-year retrospective chart review was performed to characterize AYA PC referral patterns in patients aged 18-39 years to identify strategies for improving PC access. Despite known benefits, AYA referrals to PC during oncologic treatment occurred only for a small percentage of eligible patients (8.

A Framework for Safety Evaluation Throughout the Product Development Life-Cycle.

Evaluation of the safety profile of medicines is moving from a more reactive approach, where safety experts and statisticians have been primarily focusing on the review of clinical trial data and spontaneous reports, to a more proactive endeavor with cross-functional teams strategically evolving their understanding of the safety profile. They do this by anticipating the ultimate benefit-risk profile and its related risk management implications from the start of development. The proposed approach is based on assessments of integrated program-level safety data.

Modeling the role of carrier and mobile herds on foot-and-mouth disease virus endemicity in the Far North Region of Cameroon.

Foot and mouth disease virus (FMDV) is an RNA virus that infects cloven-hoofed animals, often produces either epidemic or endemic conditions, and negatively affects agricultural economies worldwide. FMDV epidemic dynamics have been extensively studied, but understanding of drivers of disease persistence in areas in which FMDV is endemic, such as most of sub-Saharan Africa, is lacking. We present a spatial stochastic model of disease dynamics that incorporates a spatial transmission kernel in a modified Gillespie algorithm, and use it to evaluate two hypothesized drivers of endemicity: asymptomatic carriers and the movement of mobile herds.

Evaluation of a Rapid Assessment Questionnaire Using a Biomarker for Dietary Intake of n-3 Fatty Acids.

While there is considerable evidence supporting health benefits of consuming diets high in omega-3 (n-3) fatty acids, there is no quick and effective tool to measure n-3 intake. The objective of this study was to evaluate the accuracy of a rapid assessment questionnaire (the Omega-3 Checklist) used to quantify intake of n-3 fatty acids. This was done by comparing n-3 intakes to blood biomarkers of n-3 exposure in a population of healthy men and women.

Higher tumor mass and lower adipose mass are associated with colon‑26 adenocarcinoma‑induced cachexia in male, female and ovariectomized mice.

Cachexia is responsible for nearly 20% of all cancer‑related deaths, yet effective therapies to prevent or treat the disease are lacking. Clinical studies have shown that male patients lose weight at a faster rate than females. Additionally, an 'obesity paradox' may exist where excess adiposity may confer survival to patients with cancer cachexia.