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Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TS

Por: Delmas · C. · Wang · X. X. · Pelloux · A.-S. · Caeymaex · L. · Bouaziz · N. · Aegerter · P. · Jung · C.
Introduction

Autism and neurodevelopmental disorders (NDDs) are complex conditions that manifest as significant impairments in social communication and behaviour. Early detection and intervention play a pivotal role in improving outcomes, largely due to the high brain plasticity in infants. The PRECO-TSA study aims to validate the effectiveness of systematic use of the Prévention de l’Autisme (PREAUT) grid for early screening and referral strategies for autism and NDDs in infants, focusing on a coordinated approach that integrates maternal and child protection centre with medical-psychological centres. The goal is to evaluate a streamlined referral system to improve early detection and facilitate effective interventions for children at higher risk of autism.

Methods and analysis

The PRECO-TSA study is a prospective, pragmatic, multicentre, cluster-randomised controlled trial using an incomplete stepped-wedge design, which maximises external validity. The study includes a 6-month baseline phase, a 3-month semiobservation phase and a 6-month follow-up phase. The 36-month patient inclusion period is followed by a 48-month passive follow-up through the National Health Data System, data collection includes demographic and clinical information, with hierarchical mixed models used to analyse the impact of early screening and referral for autism and NDDs.

Ethics and dissemination

This study was funded by the French Ministry of Health (PREPS-20-0186) and was approved by Ile de France I Ethics Committee CPP (number CPPIDF1-2023-DI29-Cat2). The results will be submitted for publication in peer-reviewed journals.

Trial registration number

NCT05815095.

1-year survival in critically ill elderly medical patients treated with a conservative or an invasive approach (OCTO-REVERSE study): a nationwide observational study

Por: Leclaire · C. · Georges · A. · de Stampa · M. · Aegerter · P.
Objective

To determine whether an invasive approach is associated with favourable long-term outcomes among elderly medical patients in the intensive care unit (ICU), compared with a conservative approach.

Design

Nationwide observational study (OCTO-REVERSE study) using data prospectively collected in the National French Healthcare Database (covering 99% of the population, 66 million people).

Setting

Comprehensive multicentre study through the linkage of large-scale national registries (including all public or private facilities) from 2013 to 2018 to avoid ambiguities related to the COVID-19 pandemic.

Participants

All non-surgical patients aged 80 years or older admitted to an ICU in France during the period (n=107 014 patients at 822 hospitals).

Outcome measures

The main outcome was the 1-year survival rate. The association of the two approaches with 1-year survival was estimated using a time-dependent Cox model and a propensity score (PS) adapted to time-to-event analysis, yielding the average treatment effect in the treated and extended weighted Kaplan–Meier curves.

Results

107 014 patients were categorised into two groups based on the type of care received: invasive (n=51 680 (48%) received invasive ventilation and/or vasopressor support) or conservative (n=55 334 (52%) received neither). 1-year survival rate was significantly lower in the invasive group than in the conservative group (27% vs 59% estimated with extended time-dependent Kaplan–Meier method). The risk of death in the invasive group remained significantly higher after time-dependent PS weighting (HR 1.64; 95% CI 1.60 to 1.69; p

Conclusion

Among the whole population of critically ill elderly medical patients in France, the invasive approach was unknowingly associated with end-of-life care in nearly three quarters of cases. Further research is needed to align intensive care with compassionate goals.

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