The Open Hand Initiative: Facilitating the Use of Real-World Evidence in Regulatory Submissions Through Collaboration and Transparency.

Real-world data (RWD) collected to generate real-world evidence (RWE) holds promise for expediting patient and healthcare provider access to new in vitro diagnostics (IVDs) by serving as evidence to demonstrate test performance or utility. However, uncertainties remain for IVD developers (device manufacturers), regulators, and other healthcare stakeholders on the specifics of collecting fit-for-purpose RWD and using RWE for regulatory decision-making. We report on a unique approach to medical device regulatory review called the Open Hand Initiative, by which the US Food and Drug Administration (FDA) and device manufacturers collaborate to ensure the appropriate use of RWD/RWE to support regulatory decision-making.

A machine-learned model for predicting weight loss success using weight change features early in treatment.

Stepped-care obesity treatments aim to improve efficiency by early identification of non-responders and adjusting interventions but lack validated models. We trained a random forest classifier to improve the predictive utility of a clinical decision rule (>0.5 lb weight loss/week) that identifies non-responders in the first 2 weeks of a stepped-care weight loss trial (SMART).

Video-rate two-photon microendoscopy using second harmonic resonance fiber scanning.

We present a 2.5-mm-diameter resonant fiber scanning two-photon microendoscope with a 30-mm long forward-viewing rigid probe tip that enables video-rate imaging (20 Hz frame rate) suitable for hand-held imaging of tissues without motion artifacts. Higher-order harmonic oscillation scanning techniques are developed to significantly increase the frame rate compared to prior published fiber scanning microendoscopy designs while maintaining the field-of-view (∼125 µm), the optical resolution (1.

Effect of Time-Restricted Eating on Circulating Levels of IGF1 and Its Binding Proteins in Obesity: An Exploratory Analysis of a Randomized Controlled Trial.

Unlabelled: Obesity is associated with alterations in circulating IGF1, IGF1-binding proteins (IGFBPs), insulin, inflammatory markers, and hormones implicated in cardiovascular disease, diabetes, cancer, and aging. However, the effects of 4 and 6 h time-restricted eating (TRE) on circulating IGF1 and IGFBPs is uncertain.

Objective: This study aimed to investigate the effects of TRE on plasma IGF1, IGFBP1, IGFBP2, and IGFBP3, and whether these effects were mediated by weight loss or body composition changes.

The Triple E project: a factorial randomised controlled trial to enhance engagement with eHealth approaches to improve health risk behaviours among adolescents.

Background: Digital, or eHealth, interventions are highly promising approaches to help adolescents improve their health behaviours and reduce their risk of chronic disease. However, they often have low uptake and retention. There is also a paucity of high-quality research into the predictors of eHealth engagement, and a lack of studies that have systematically evaluated existing engagement strategies in adolescent populations.