A Bayesian Interpretation of CABANA and Other Randomized Controlled Trials for Catheter Ablation in Patients With Atrial Fibrillation.

Background: Catheter ablation improves symptoms and quality of life in atrial fibrillation patients, but its effect on adverse cardiovascular outcomes and mortality remains uncertain. Bayesian analysis of randomized controlled trials offers a deeper understanding of treatment effects beyond conventional p-value thresholds.

Methods: We conducted a post hoc Bayesian reanalysis of CABANA and four similar trials to estimate catheter ablation's effect on cardiovascular and survival outcomes.

Unsupervised clustering approach to assess heterogeneity of treatment effects across patient phenotypes in randomized clinical trials.

Background: Primary results from randomized clinical trials (RCT) only inform on the average treatment effect in the studied population, and it is critical to understand how treatment effect varies across subpopulations. In this paper we describe a clustering-based approach for the assessment of Heterogeneity of Treatment Effect (HTE) over patient phenotypes, which maintains the unsupervised nature of classical subgroup analysis while jointly accounting for relevant patient characteristics.

Methods: We applied phenotype-based stratification in the ENGAGE AF-TIMI 48 trial, a non-inferiority trial comparing the effects of higher-dose edoxaban regimen (direct anticoagulant) versus warfarin (vitamin K antagonist) on a composite endpoint of stroke and systemic embolism in 14,062 patients with atrial fibrillation.

Reduced ovarian cholesterol and steroid biosynthesis along with increased inflammation are associated with high DEHP metabolite levels in human ovarian follicular fluids.

The plasticizer di(2-ethylhexyl) phthalate (DEHP) is known to have endocrine-disrupting properties mediated by its many metabolites that form upon exposure in biological systems. In a previous study, we reported an inverse association between DEHP metabolites in the human ovarian follicular fluid (FF) and the responsiveness of the follicles to controlled ovarian stimulation during in vitro fertilization (IVF) treatments. Here, we explored this association further through molecular analysis of the ovarian FF samples.

Polybrominated diphenyl ethers and gestational weight gain: a multi-center prospective cohort study.

Objective: To evaluate the associations of plasma polybrominated diphenyl ether (PBDE) concentrations in early pregnancy with gestational weight gain (GWG).

Design: Prospective cohort study.

Setting: US-based, multicentre cohort of pregnant women.

Race and ethnicity in multiple sclerosis phase 3 clinical trials: A systematic review.

Background: Distinctive differences in multiple sclerosis (MS) have been observed by race and ethnicity. We aim to (1) assess how often race and ethnicity were reported in clinical trials registered on , (2) evaluate whether the population was diverse enough, and (3) compare with publications.

Methods: We included phase 3 clinical trials registered with results on between 2007 and 2023.

Estimating and presenting hazard ratios and absolute risks from a Cox model with complex nonlinear interactions.

Interaction analysis is a critical component of clinical and public health research and represents a key topic in precision health and medicine. In applied settings, however, interaction assessment is usually limited to the test of a product term in a regression model and to the presentation of results stratified by levels of additional covariates. Stratification of results often relies on categorizing or making linearity assumptions for continuous covariates, with substantial loss of precision and of relevant information.

Cohort profile: the Environmental Reproductive and Glucose Outcomes (ERGO) Study (Boston, Massachusetts, USA) - a prospective pregnancy cohort study of the impacts of environmental exposures on parental cardiometabolic health.

Purpose: Pregnancy and the postpartum period are increasingly recognised as sensitive windows for cardiometabolic disease risk. Growing evidence suggests environmental exposures, including endocrine-disrupting chemicals (EDCs), are associated with an increased risk of pregnancy complications that are associated with long-term cardiometabolic risk. However, the impact of perinatal EDC exposure on subsequent cardiometabolic risk post-pregnancy is less understood.

Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Left Main Disease With and Without Diabetes: Findings From a Pooled Analysis of 4 Randomized Clinical Trials.

Background: Diabetes may be associated with differential outcomes in patients undergoing left main coronary revascularization with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The aim of this study was to investigate outcomes in patients with left main disease with and without diabetes randomized to PCI versus CABG.

Methods: Individual patient data were pooled from 4 trials (SYNTAX [Synergy Between PCI With Taxus and Cardiac Surgery], PRECOMBAT [Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease], NOBLE [Nordic-Baltic-British Left Main Revascularisation Study], and EXCEL [Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization]) that randomized patients with left main disease to PCI or CABG.

Medication use and risk of amyotrophic lateral sclerosis: using machine learning for an exposome-wide screen of a large clinical database.

Background: Accumulating evidence suggests that non-genetic factors have important etiologic roles in amyotrophic lateral sclerosis (ALS), yet identification of specific culprit factors has been challenging. Many medications target biological pathways implicated in ALS pathogenesis, and screening large pharmacologic datasets for signals could greatly accelerate the identification of risk-modulating pharmacologic factors for ALS.

Method: We conducted a high-dimensional screening of patients' history of medication use and ALS risk using an advanced machine learning approach based on gradient-boosted decision trees coupled with Bayesian model optimization and repeated data sampling.

Racial and ethnic disparities in preterm birth: a mediation analysis incorporating mixtures of polybrominated diphenyl ethers.

Background: Racial and ethnic disparities persist in preterm birth (PTB) and gestational age (GA) at delivery in the United States. It remains unclear whether exposure to environmental chemicals contributes to these disparities.

Objectives: We applied recent methodologies incorporating environmental mixtures as mediators in causal mediation analysis to examine whether racial and ethnic disparities in GA at delivery and PTB may be partially explained by exposures to polybrominated diphenyl ethers (PBDEs), a class of chemicals used as flame retardants in the United States.

Association between chemical mixtures and female fertility in women undergoing assisted reproduction in Sweden and Estonia.

Objective: Women of reproductive age are exposed to ubiquitous chemicals such as phthalates, parabens, and per- and polyfluoroalkyl substances (PFAS), which have potential endocrine disrupting properties and might affect fertility. Our objective was to investigate associations between potential endocrine-disrupting chemicals (EDCs) and female fertility in two cohorts of women attending fertility clinics.

Methods: In a total population of 333 women in Sweden and Estonia, we studied the associations between chemicals and female fertility, evaluating ovarian sensitivity index (OSI) as an indicator of ovarian response, as well as clinical pregnancy and live birth from fresh and frozen embryo transfers.

Polybrominated diphenyl ethers in early pregnancy and preterm birth: Findings from the NICHD Fetal Growth Studies.

Background: Studies suggest associations between exposure to individual polybrominated diphenyl ethers (PBDEs) with preterm birth (PTB) and shorter gestational age. Little is known about exposure to PBDE mixtures and these outcomes. We evaluated associations of multiple PBDEs in early pregnancy with gestational age at delivery and PTB.

A Multipollutant Approach to Estimating Causal Effects of Air Pollution Mixtures on Overall Mortality in a Large, Prospective Cohort.

Background: Several studies have confirmed associations between air pollution and overall mortality, but it is unclear to what extent these associations reflect causal relationships. Moreover, few studies to our knowledge have accounted for complex mixtures of air pollution. In this study, we evaluate the causal effects of a mixture of air pollutants on overall mortality in a large, prospective cohort of Dutch individuals.