Biomedical research is rapidly adopting artificial intelligence (AI). Yet the inherent complexity of biomedical data preparation requires implementing actionable, robust criteria for ethical and explainable AI (XAI) at the "pre-model" stage, encompassing data acquisition, detailed transformations, and ethical governance. Simple conformance to FAIR (Findable, Accessible, Interoperable, Reusable) Principles is insufficient. Here, we define criteria and practices for reliable AI-readiness of biomedical data, developed by the NIH Bridge to Artificial Intelligence (Bridge2AI) Standards Working Group across seven core dimensions of dataset AI-readiness: FAIRness, Provenance, Characterization, Ethics, Pre-model Explainability, Sustainability, and Computability. Conformance to these criteria provides a basis for pre-model scientific rigor and ethical integrity, mitigating downstream risks of bias and error prior to AI modeling. We apply and evaluate these standards across all four Bridge2AI flagship datasets, spanning functional genomics to clinical medicine, and encode them in machine-actionable metadata bound to the datasets. This framework sets a benchmark for preparing ethical, reusable datasets in biomedical AI and provides standardized methods for reliable pre-model data evaluation.
Freezing of gait (FOG) is among the most debilitating symptoms of Parkinson disease and related disorders, often resulting in falls and a loss of independence. FOG has an episodic and heterogeneous nature that makes it difficult to measure and treat. The field currently lacks a consensus on how to precisely define this phenomenon. For this reason, the International Consortium for Freezing of Gait convened a group of experts to establish an updated ‘clinical’ definition of FOG for use in the clinical setting and a ‘technical’ definition for assessors to use when scoring FOG episodes from video recordings as an outcome in fundamental research and clinical trials. Guidelines on how to classify people with Parkinson disease into subgroups of those with or without FOG (non-FOG) are also provided. This position paper presents these new definitions and guidelines, offering a foundation for harmonizing the study and management of FOG. Freezing of gait (FOG) is among the most debilitating symptoms of Parkinson disease. This Consensus Statement from the International Consortium for Freezing of Gait presents new guidelines for the definition and assessment of FOG, with the aim of harmonizing the study and management of the condition.
RATIONALE:Prior clinical trials established the safety but not the efficacy of bone marrow-derived mesenchymal stromal cells (MSCs) in acute respiratory distress syndrome (ARDS). OBJECTIVES:To compare the efficacy of bone marrow-derived MSCs versus placebo in ARDS. METHODS:Prospective, double-blind, multicenter, randomized phase 2b clinical trial of one dose of intravenous MSCs (10 × 106/kg predicted body weight) versus placebo in 120 ventilated patients with ARDS (PaO2/FiO2 ratio <250 mm Hg). The primary endpoint was change in oxygenation index during the 36 hours after baseline. MEASUREMENTS AND MAIN RESULTS:Enrollment began in January 2020. Because of the coronavirus disease (COVID-19) pandemic, ARDS developed from COVID-19 in the majority of subjects (101 of 120; 84%). There were no significant baseline differences in severity of illness between patients treated with MSCs and those who received placebo in the entire cohort of 120 patients or in the 101 patients with COVID-19 ARDS. There were no differences in the primary endpoint of change in oxygenation index from baseline during the 36 hours after study product administration for the entire cohort or the COVID-19 subgroup, nor were there significant differences in mortality at 14, 28, 60, or 180 days. Plasma protein biomarker and gene expression analyses identified subgroups of patients with differential treatment responses in terms of clinical outcomes. CONCLUSIONS:This phase 2b clinical trial identified no physiologic or clinical benefit from a single dose of MSCs in patients with ARDS, including those with COVID-19 ARDS. In future trials, baseline plasma biological markers may help identify patients who are more likely to benefit from MSC therapy.Clinical trial registered with www. CLINICALTRIALS:gov (NCT03818854).
Recent technologic advances in neonatal dialysis have changed current dialysis practices. The goal of this study was to define demographics, diagnoses, initial dialysis modality, modality changes, and outcomes of neonates receiving dialysis. Retrospective, multicenter cohort of neonates (≤ 30 days of age) from 26 U.S. centers, who received dialysis between 6/2017 and 5/2022. Measures of central tendency were calculated to describe the cohort stratified by the primary dialysis-related diagnosis including acute kidney injury requiring dialysis (AKI-D), stage 5 chronic kidney disease (CKD 5), hyperammonemia, and other causes. The primary outcome was death during the initial hospitalization. For the 405 neonates in this cohort, AKI-D (57
