Effects of Prenatal DHA Dose on Infant Visual Attention.

Prenatal supplementation with docosahexaenoic acid (DHA) has been reported to improve cognitive outcomes in infancy and early childhood in some studies. Existent studies have examined the effects of some dose of DHA against a true placebo; this report is the first to describe the effects of different doses of prenatal DHA on infant visual attention at 4 and 6 months of age. In a follow-up to a Phase III registered clinical trial (NCT02709239) designed to evaluate the effects of two prenatal doses of DHA supplementation (200 or 800 mg daily) on maternal physiology and fetal neurodevelopment, we assessed 215 infants delivered to these mothers at 4 and 6 months on a visual habituation task augmented with heart rate (HR) to assess visual stimulus processing, and a gap-overlap task to assess engagement and disengagement of attention.

Developing subscale threshold scores for the nutrition literacy assessment instrument (NLit).

Objective: Understanding a patient's nutrition literacy weaknesses may aid in improving the patient's nutrition literacy and diet quality. The Nutrition Literacy Assessment Instrument (NLit) was developed to fill this knowledge gap. Global NLit cutoff scores were previously developed; however, subscale NLit cutoff scores are needed.

Ethnicity modifies the relationship between added sugars and fructose exposure in the first 1000 days and offspring body composition at 24 months.

Added sugars (AS) and fructose intake are linked to obesity. Hispanic populations experience high AS intake and obesity rates. It is underexplored if early sugars exposure influences offspring growth, especially across ethnic groups.

Exclusion criteria in randomized clinical trials of subarachnoid hemorrhage.

Introduction: Exclusion criteria are designed to optimize the scientific yield and safety of clinical trials. However, periodic analysis is necessary to understand the impact on trial complexity, enrollment, generalizability, and costs. We analyzed the types of exclusion criteria used among clinical trials performed in subarachnoid hemorrhage (SAH) patients and impact upon exclusion of patients.

Optimal Delay Time to Initiate Anticoagulation After Ischemic Stroke in Atrial Fibrillation: A Pragmatic, Response-Adaptive Randomized Clinical Trial.

Importance: Clinical practice guidelines recommend initiation of anticoagulation within 2 weeks after stroke with atrial fibrillation. It is unknown whether there is an optimal starting day within the 14-day period that balances the risks of recurrent embolic events against serious hemorrhagic events.

Objective: To determine if there is an optimal delay time to initiate treatment with a direct oral anticoagulant after atrial fibrillation-related stroke that minimizes the risk of a composite outcome of ischemic or hemorrhagic events.

Enhancing DHA supplementation adherence: A Bayesian approach with finite mixture models and irregular interim schedules in adaptive trial designs.

Docosahexaenoic acid (DHA) supplementation has proven beneficial in reducing preterm births. However, the challenge lies in addressing nonadherence to prescribed supplementation regimens-a hurdle that significantly impacts clinical trial outcomes. Conventional methods of adherence estimation, such as pill counts and questionnaires, usually fall short when estimating adherence within a specific dosage group.

Overcoming challenges in conducting early phase breast cancer prevention trials: Bazedoxifene and conjugated estrogens vs waitlist control.

Background: The combination of bazedoxifene 20 mg (BZA) and conjugated estrogens 0.45 mg (CE) marketed as Duavee® is approved for vasomotor symptom relief and osteoporosis prevention. Our pilot study suggested it had potential breast cancer risk reduction, and we proposed a multisite Phase IIB primary prevention trial assessing change in breast imaging and tissue risk biomarkers.

Evaluating the strength and quality of evidence in American heart association/American stroke association's guidelines for aneurysmal subarachnoid hemorrhage and spontaneous intracerebral hemorrhage.

Background: Clinical practice recommendations guide healthcare decisions. This study aims to evaluate the strength and quality of evidence supporting the American Heart Association (AHA)/American Stroke Association (ASA) guidelines for aneurysmal subarachnoid hemorrhage (aSAH) and spontaneous intracerebral hemorrhage (ICH).

Methods: We reviewed the current AHA/ASA guidelines for aSAH and spontaneous ICH and compared with previous guidelines.

The Effect of Prenatal Docosahexaenoic Acid Supplementation on Offspring Fat Mass and Distribution at 24 Months Old.

Background: Excessive gestational weight gain (GWG) is related to increased offspring fat accrual, and increased fat mass (FM) is related to obesity development. Prenatal DHA supplementation has been linked to lower levels of offspring FM; however, conflicting data exist.

Objectives: This study aimed to determine if there is a protective effect of prenatal DHA supplementation on offspring fat accrual and adipose tissue deposition at 24 mo in offspring born to females who gain excessive weight compared with nonexcessive weight during pregnancy.

A Regional Study to Evaluate the Impact of Coal-fired Power Plants on Lung Cancer Incident Rates.

Background: Lung cancer is the leading cause of cancer related deaths. In Kansas, where coal-fired power plants account for 34% of power, we investigated whether hosting counties had higher age-adjusted lung cancer incidence rates. We also examined demographics, poverty levels, percentage of smokers, and environmental conditions using spatial analysis.

Improved mortality analysis in early-phase dose-ranging clinical trials for emergency medical diseases using Bayesian time-to-event models with active comparators.

Emergency medical diseases (EMDs) are the leading cause of death worldwide. A time-to-death analysis is needed to accurately identify the risks and describe the pattern of an EMD because the mortality rate can peak early and then decline. Dose-ranging Phase II clinical trials are essential for developing new therapies for EMDs.

PROpwr: a Shiny R application to analyze patient-reported outcomes data and estimate power.

Patient Reported Outcomes (PROs) are widely used in quality of life (QOL) studies, health outcomes research, and clinical trials. The importance of PRO has been advocated by health authorities. We propose this R shiny web application, PROpwr, that estimates power for two-arm clinical trials with PRO measures as endpoints using Item Response Theory (GRM: Graded Response Model) and simulations.

Implementation of statistical features of a Bayesian two-armed responsive adaptive randomization trial with post hoc analysis of time trend drift.

Bayesian adaptive designs with response adaptive randomization (RAR) have the potential to benefit more participants in a clinical trial. While there are many papers that describe RAR designs and results, there is a scarcity of works reporting the details of RAR implementation from a statistical point exclusively. In this paper, we introduce the statistical methodology and implementation of the trial Changing the Default (CTD).

Evaluating the impact of delayed study startup on accrual in cancer studies.

Background: Drug development in cancer medicine depends on high-quality clinical trials, but these require large investments of time to design, operationalize, and complete; for oncology drugs, this can take 8-10 years. Long timelines are expensive and delay innovative therapies from reaching patients. Delays often arise from study startup, a process that can take 6 months or more.

Using Bayesian hierarchical modeling for performance evaluation of clinical trial accrual for a cancer center.

Introduction: Slow patient accrual in cancer clinical trials is always a concern. In 2021, the University of Kansas Comprehensive Cancer Center (KUCC), an NCI-designated comprehensive cancer center, implemented the Curated Cancer Clinical Outcomes Database (C3OD) to perform trial feasibility analyses using real-time electronic medical record data. In this study, we proposed a Bayesian hierarchical model to evaluate annual cancer clinical trial accrual performance.

A high fiber diet intervention during pregnancy: The SPROUT (Single goal in PRegnancy to optimize OUTcomes) protocol paper.

Background: Interventions to prevent excessive gestational weight gain (GWG) have had a limited impact on maternal and infant outcomes. Dietary fiber is a nutrient with benefits that counters many of the metabolic and inflammatory changes that occur during pregnancy. We will determine if a high dietary fiber (HFib) intervention provides benefit to maternal and infant outcomes.

Conducting a bayesian multi-armed trial with response adaptive randomization for comparative effectiveness of medications for CSPN.

Background: Response adaptive randomization is popular in adaptive trial designs, but the literature detailing its execution is lacking. These designs are desirable for patients/stakeholders, particularly in comparative effectiveness research, due to the potential benefits including improving participant buy-in by providing more participants with better treatment during the trial. Frequentist approaches have often been used, but adaptive designs naturally fit the Bayesian methodology; it was developed to deal with data as they come in by updating prior information.

DHA, nutrient intake, and maternal characteristics as predictors of pregnancy outcomes in a randomised clinical trial of DHA supplementation.

Purpose: To investigate the relationships among docosahexaenoic acid (DHA) intake, nutrient intake, and maternal characteristics on pregnancy outcomes in a phase III randomised clinical trial designed to determine the effect of a DHA dose of 1000 mg/day compared to 200 mg/day on early preterm birth (<34 weeks gestation).

Methods: A secondary aim of the phase III randomised trial was to explore the relationships among pregnancy outcomes (maternal red blood cell phospholipid (RBC-PL) DHA at delivery, preterm birth, gestational age at delivery, labor type, birth anthropometric measures, low birth weight, gestational diabetes, pre-eclampsia, and admission to a neonatal intensive care unit) in participants (n = 1100). We used Bayesian multiple imputation and linear and logistic regression models to conduct an analysis of five general classes of predictor variables collected during the trial: a) DHA intake, b) nutrient intake from food and supplements, c) environmental exposure to tobacco and alcohol, d) maternal demographics, and e) maternal medical history.

Using a Bayesian model of the joint distribution of pain and time on medication to decide on pain medication for neuropathy.

The PAIN-CONTRoLS trial compared four medications in treating Cryptogenic sensory polyneuropathy. The primary outcome was a utility function that combined two outcomes, patients' pain score reduction and patients' quit rate. However, additional analysis of the individual outcomes could also be leveraged to inform selecting an optimal medication for future patients.

Selection of a statistical analysis method for the Glasgow Outcome Scale-Extended endpoint for estimating the probability of favorable outcome in future severe TBI clinical trials.

The Glasgow outcome scale-extended (GOS-E), an ordinal scale measure, is often selected as the endpoint for clinical trials of traumatic brain injury (TBI). Traditionally, GOS-E is analyzed as a fixed dichotomy with favorable outcome defined as GOS-E ≥ 5 and unfavorable outcome as GOS-E < 5. More recent studies have defined favorable vs unfavorable outcome utilizing a sliding dichotomy of the GOS-E that defines a favorable outcome as better than a subject's predicted prognosis at baseline.

Micronutrient Gaps and Supplement Use in a Diverse Cohort of Pregnant Women.

Background: Micronutrition in pregnancy is critical to impact not only fetal growth and development but also long-term physical and psychiatric health outcomes.

Objective: Estimate micronutrient intake from food and dietary supplements in a diverse cohort of pregnant women and compare intake to the Dietary Reference Intakes (DRIs).

Design: Secondary analysis of women enrolled in a multi-site clinical trial of docosahexaenoic acid (DHA) supplementation who provided their dietary intake using the diet history questionnaire-II ( = 843) or multiple 24 h recalls ( = 178) at baseline and their intake of nutritional supplements at baseline through 30 days postpartum.