Laura H. Hendrix
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View article: P-1924. Impact of the SARS-CoV-2 Pandemic on Medically Attended Acute Gastroenteritis Incidence and Health Care Utilization in the U.S
P-1924. Impact of the SARS-CoV-2 Pandemic on Medically Attended Acute Gastroenteritis Incidence and Health Care Utilization in the U.S Open
Background The SARS-CoV-2 pandemic has altered the epidemiology of certain infectious diseases and general utilization of health care services. The goal of this work was to compare the incidence and characteristics of medically attended ac…
View article: P-598. Attitudes toward a potential Norovirus vaccine among patients with medically-attended acute gastroenteritis in the US
P-598. Attitudes toward a potential Norovirus vaccine among patients with medically-attended acute gastroenteritis in the US Open
Background Clinical trials for norovirus (NoV) vaccines are underway. Prior research has found generally positive attitudes toward a potential NoV vaccine, but there is limited understanding of how the COVID-19 pandemic may have impacted a…
View article: The Association of Diabetes and Obesity With Prostate Cancer Progression: HCaP-NC
The Association of Diabetes and Obesity With Prostate Cancer Progression: HCaP-NC Open
BACKGROUND: The role of race in modifying the association among diabetes, obesity, and prostate cancer (CaP) progression is not well studied. We evaluated diabetes and obesity in association with time to CaP progression in White Americans …
View article: Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease
Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease Open
Aim: Herein, we report safety outcomes for varenicline solution nasal spray (VNS) within the context of clinical trial discontinuation, contrasting those with discontinuation outcomes from topical cyclosporine and lifitegrast clinical tria…
View article: OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2
OC-01 (Varenicline Solution) Nasal Spray for the Treatment of Dry Eye Disease Signs and Symptoms in Subjects with Autoimmune Disease: Integrated Data from ONSET-1 and ONSET-2 Open
OC-01 VNS demonstrated consistency in improving both tear production and patient-reported symptoms in subjects with AID, consistent with pivotal ONSET-1 and 2 trial results. Further investigation is warranted, and results may further suppo…
View article: Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes?
Does Dry Eye Disease Severity Impact Efficacy of Varenicline Solution Nasal Spray on Sign and Symptom Treatment Outcomes? Open
SIGNIFICANCE There is a clinical necessity for dry eye disease treatments that perform across a broad range of presenting patient severities. Varenicline solution nasal spray (VNS), a unique cholinergic agonist ocular surface–sparing nasal…
View article: Matching-adjusted indirect comparison of phase 3 clinical trial outcomes of OC-01 (varenicline solution) nasal spray and lifitegrast 5% ophthalmic solution for the treatment of dry eye disease
Matching-adjusted indirect comparison of phase 3 clinical trial outcomes of OC-01 (varenicline solution) nasal spray and lifitegrast 5% ophthalmic solution for the treatment of dry eye disease Open
BACKGROUND: Matching-adjusted indirect comparison (MAIC) is a methodology for cross-study comparisons after adjusting for baseline characteristic imbalances. It is a comparative analytical approach used across therapeutic areas abse…
View article: Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials
Does Menopausal Status Affect Dry Eye Disease Treatment Outcomes with OC-01 (Varenicline Solution) Nasal Spray? A Post Hoc Analysis of ONSET-1 and ONSET-2 Clinical Trials Open
View article: Matching-adjusted indirect comparison of phase 3 clinical trial outcomes: OC-01 (varenicline solution) nasal spray and cyclosporine a 0.05% ophthalmic emulsion for the treatment of dry eye disease
Matching-adjusted indirect comparison of phase 3 clinical trial outcomes: OC-01 (varenicline solution) nasal spray and cyclosporine a 0.05% ophthalmic emulsion for the treatment of dry eye disease Open
BACKGROUND: Matching-adjusted indirect comparison (MAIC) is a validated and widely accepted statistical method that derives indirect comparisons between treatments when head-to-head studies have not been performed. OBJECTIVE:…
View article: Cancer Screening Rates in Individuals With Different Life Expectancies
Cancer Screening Rates in Individuals With Different Life Expectancies Open
IMPORTANCE: Routine cancer screening has unproven net benefit for patients with limited life expectancy. OBJECTIVE: To examine the patterns of prostate, breast, cervical, and colorectal cancer screening in the United States in individuals …
View article: Use of Bone Scan During Initial Prostate Cancer Workup, Downstream Procedures, and Associated Medicare Costs
Use of Bone Scan During Initial Prostate Cancer Workup, Downstream Procedures, and Associated Medicare Costs Open
For patients with a high likelihood of having metastatic disease (high-risk prostate cancer), bone scan is the standard, guideline-recommended test to look for bony metastasis. We quantified the use of bone scans and downstream procedures,…
View article: Serial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy
Serial Analysis of Circulating Tumor Cells in Metastatic Breast Cancer Receiving First-Line Chemotherapy Open
Background We examined the prognostic significance of circulating tumor cell (CTC) dynamics during treatment in metastatic breast cancer (MBC) patients receiving first-line chemotherapy. Methods Serial CTC data from 469 patients (2202 samp…
View article: The association of diabetes and obesity with prostate cancer aggressiveness among Black Americans and White Americans in a population-based study
The association of diabetes and obesity with prostate cancer aggressiveness among Black Americans and White Americans in a population-based study Open
Few studies have investigated the role of race in the association of diabetes and obesity with prostate cancer aggressiveness. Here we evaluate the independent association between diabetes and obesity with prostate cancer aggressiveness in…
View article: Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor–Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance)
Phase II Single-Arm Study of Preoperative Letrozole for Estrogen Receptor–Positive Postmenopausal Ductal Carcinoma In Situ: CALGB 40903 (Alliance) Open
PURPOSE Primary endocrine therapy for ductal carcinoma in situ (DCIS) as a potential alternative to surgery has been understudied. This trial explored the feasibility of a short-term course of letrozole and sought to determine whether trea…
View article: Performance of multiplex serology in discriminating active vs past <i>Helicobacter pylori</i> infection in a primarily African American population in the southeastern United States
Performance of multiplex serology in discriminating active vs past <i>Helicobacter pylori</i> infection in a primarily African American population in the southeastern United States Open
Purpose To feasibly analyze associations of Helicobacter pylori ( H. pylori ) with disease in large cohort studies, assays are needed to assess H. pylori prevalence in existing biospecimens. However, serology has traditionally been unable …
View article: Simulated Costs of the ASCO Patient-Centered Oncology Payment Model in Medicare Beneficiaries With Newly Diagnosed Advanced Ovarian Cancer
Simulated Costs of the ASCO Patient-Centered Oncology Payment Model in Medicare Beneficiaries With Newly Diagnosed Advanced Ovarian Cancer Open
PURPOSE: Efforts to curb the rising costs of cancer care while improving quality include alternative payment models (APMs), which offer incentives to reduce avoidable spending and provide high-quality and cost-efficient care. The impact of…
View article: Incidence of Ductal Carcinoma <i>In Situ</i> in the United States, 2000–2014
Incidence of Ductal Carcinoma <i>In Situ</i> in the United States, 2000–2014 Open
Background: In absence of definitive molecular risk markers, clinical management of patients diagnosed with ductal carcinoma in situ (DCIS) remains largely guided by patient and tumor characteristics. In this study, we analyzed recent tren…
View article: Serologic Response to Helicobacter pylori Proteins Associated With Risk of Colorectal Cancer Among Diverse Populations in the United States
Serologic Response to Helicobacter pylori Proteins Associated With Risk of Colorectal Cancer Among Diverse Populations in the United States Open
View article: Validation of a Blood Biomarker for Identification of Individuals at High Risk for Gastric Cancer
Validation of a Blood Biomarker for Identification of Individuals at High Risk for Gastric Cancer Open
Background: Helicobacter pylori is the leading cause of gastric cancer, yet the majority of infected individuals will not develop neoplasia. Previously, we developed and replicated serologic H. pylori biomarkers for gastric cancer risk amo…
View article: Antibody Responses to <i>Streptococcus Gallolyticus</i> Subspecies <i>Gallolyticus</i> Proteins in a Large Prospective Colorectal Cancer Cohort Consortium
Antibody Responses to <i>Streptococcus Gallolyticus</i> Subspecies <i>Gallolyticus</i> Proteins in a Large Prospective Colorectal Cancer Cohort Consortium Open
Background: Antibody responses to Streptococcus gallolyticus subspecies gallolyticus (SGG) proteins, especially pilus protein Gallo2178, have been consistently associated with colorectal cancer risk. Previous case–control studies and prosp…
View article: Social Relationships, Inflammation, and Cancer Survival
Social Relationships, Inflammation, and Cancer Survival Open
Background: Social stressors, such as social relationship deficits, have been increasingly linked to chronic disease outcomes, including cancer. However, critical gaps exist in our understanding of the nature and strength of such links, as…
View article: The Association of Diabetes and Obesity With Prostate Cancer Progression: HCaP‐NC
The Association of Diabetes and Obesity With Prostate Cancer Progression: HCaP‐NC Open
BACKGROUND The role of race in modifying the association among diabetes, obesity, and prostate cancer (CaP) progression is not well studied. We evaluated diabetes and obesity in association with time to CaP progression in White Americans (…
View article: The association of diabetes and obesity with prostate cancer aggressiveness among Black Americans and White Americans in a population-based study
The association of diabetes and obesity with prostate cancer aggressiveness among Black Americans and White Americans in a population-based study Open