Incomplete Toxicity Reporting and Use of Toxicity-Minimizing Language in Phase III Oncology Trials.

Purpose: This study aimed to determine complete toxicity reporting (CTR), and the use of subjective toxicity-minimizing language (TML) among phase III oncology trials.

Methods: Two-arm superiority-design phase III oncology trials published from 2002 to 2020 were reviewed for toxicity data. CTR was defined as reporting total adverse events (TAEs), total serious adverse events (SAEs), total deaths, and study therapy discontinuations because of toxicity.

Whole grain modified Nova ultra-processed food (UPF) definitions: a cross-sectional analysis of the impact on cardiometabolic risk measures when excluding high whole-grain foods from the UPF category in Australia.

Ultra-processed foods (UPF), defined using the Nova classification system, are associated with increased chronic disease risk. More recently, evidence suggests the UPF subgroup of whole-grain breads and cereals is in fact linked with reduced chronic disease risk. This study aimed to explore associations of cardiometabolic risk measures with Nova UPF intake versus when foods with ≥25% or ≥50% whole grain are excluded from the definition.

Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States.

Introduction: In September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage.

Health Care Financing Practices Among U.S. Amish.

The Amish are a rapidly growing Christian ethnoreligious group located in the U.S. and Canada.

Justification, margin values, and analysis populations for oncologic noninferiority and equivalence trials: a meta-epidemiological study.

Background: Noninferiority (NI) and equivalence trials evaluate whether an experimental therapy's effect on the primary endpoint (PEP) is contained within an acceptable margin compared to standard-of-care. The reliability and impact of this conclusion, however, is largely dependent on the justification for this design, the choice of margin, and the analysis population used.

Methods: A meta-epidemiological study was performed of phase 3 randomized NI and equivalence oncologic trials registered at ClinicalTrials.