Intravenous iron for heart failure, iron deficiency definitions, and clinical response: the IRONMAN trial.

BACKGROUND AND AIMS: What is the relationship between blood tests for iron deficiency, including anaemia, and the response to intravenous iron in patients with heart failure? METHODS: In the IRONMAN trial, 1137 patients with heart failure, ejection fraction ≤ 45%, and either serum ferritin < 100 µg/L or transferrin saturation (TSAT) < 20% were randomized to intravenous ferric derisomaltose (FDI) or usual care. Relationships were investigated between baseline anaemia severity, ferritin and TSAT, to changes in haemoglobin from baseline to 4 months, Minnesota Living with Heart Failure (MLwHF) score and 6-minute walk distance achieved at 4 months, and clinical events, including heart failure hospitalization (recurrent) or cardiovascular death. RESULTS: The rise in haemoglobin after administering FDI, adjusted for usual care, was greater for lower baseline TSAT (Pinteraction < .0001) and ferritin (Pinteraction = .028) and more severe anaemia (Pinteraction = .014). MLwHF scores at 4 months were somewhat lower (better) with FDI for more anaemic patients (overall Pinteraction = .14; physical Pinteraction = .085; emotional Pinteraction = .043) but were not related to baseline TSAT or ferritin. Blood tests did not predict difference in achieved walking distance for those randomized to FDI compared to control. The absence of anaemia or a TSAT ≥ 20% was associated with lower event rates and little evidence of benefit from FDI. More severe anaemia or TSAT < 20%, especially when ferritin was ≥100 µg/L, was associated with higher event rates and greater absolute reductions in events with FDI, albeit not statistically significant. CONCLUSIONS: This hypothesis-generating analysis suggests that anaemia or TSAT < 20% with ferritin > 100 µg/L might identify patients with heart failure who obtain greater benefit from intravenous iron. This interpretation requires confirmation.

The Social and Emotional Education and Development intervention to address wellbeing in primary school age children: the SEED cluster RCT.

Background: Stronger social and emotional well-being during primary school is positively associated with the health and educational outcomes of young people. However, there is little evidence on which programmes are the most effective for improving social and emotional well-being. Objective: The objective was to rigorously evaluate the Social and Emotional Education and Development (SEED) intervention process for improving pupils' social and emotional well-being. Design: This was a stratified cluster randomised controlled trial with embedded process and economic evaluations. Thirty-eight primary schools were randomly assigned to the SEED intervention or to the control group. Hierarchical regression analysis allowing for clustering at school learning community level was conducted in R (statistical package). Setting: The SEED intervention is a whole-school intervention; it involved all school staff and two cohorts of pupils, one starting at 4 or 5 years of age and the second starting at 8 or 9 years of age, across all 38 schools. Participants: A total of 2639 pupils in Scotland. Intervention: The SEED intervention used an iterative process that involved three components to facilitate selection and implementation of school-based actions: (1) questionnaire completion, (2) benchmarked feedback to all staff and (3) reflective discussions (all staff and an educational psychologist). Main outcome measure: The primary outcome was pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score when pupils were 4 years older than at baseline. Results: The primary outcome, pupils' Strengths and Difficulties Questionnaire-Total Difficulties Score at follow-up 3, showed improvements for intervention arm pupils, compared with those in the control arm [relative risk -1.30 (95% confidence interval -1.87 to -0.73), standardised effect size -0.27 (95% confidence interval -0.39 to -0.15)]. There was no evidence of intervention effects according to deprivation: the results were significant for both affluent and deprived pupils. Subgroup analysis showed that all effect sizes were larger for the older cohort, particularly boys [relative risk -2.36 (95% confidence interval -3.62 to -1.11), standardised effect size -0.42 (95% confidence interval -0.64 to -0.20)]. Although there was no statistically significant difference in incremental cost and quality-adjusted life-years, the probability that the intervention is cost-effective at a willingness-to-pay threshold of £20,000 per quality-adjusted life-year was high, at 88%. Particularly valued mechanisms of the SEED intervention were its provision of time to reflect on and discuss social and emotional well-being and its contribution to a culture of evaluating practice. Limitations: It was a challenge to retain schools over five waves of data collection. Conclusions: This trial demonstrated that the SEED intervention is an acceptable, cost-effective way to modestly improve pupil well-being and improve school climate, particularly for older boys and those with greater levels of psychological difficulties. It was beneficial during the transition from primary to secondary school, but this diminished after 6 years. The SEED intervention can be implemented alongside existing systems for addressing pupil well-being and can be complementary to other interventions. Future work: Assess whether or not the SEED intervention has a beneficial impact on academic attainment, is transferable to other countries and other organisational settings, would be strengthened by adding core training elements to the intervention process and is transferable to secondary schools. Understand the gender differences illustrated by the outcomes of this trial. Conduct further statistical research on how to handle missing data in longitudinal studies of complex social interventions. Trial registration: This trial is registered as ISRCTN51707384. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 10/3006/13) and is published in full in Public Health Research; Vol. 12, No. 6. See the NIHR Funding and Awards website for further award information.

We studied the Social and Emotional Education and Development (SEED) primary school intervention to see if it could improve the social and emotional well-being of pupils in Scotland. The SEED intervention is a process with several elements. We collected information from school pupils, staff and parents, and assessed if the schools involved were happy, safe and caring environments. We sought to highlight any strengths or weaknesses in how each school approaches social and emotional well-being. The SEED intervention also measures the social and emotional well-being of pupils. This includes pupils' strengths and difficulties, confidence, understanding of emotions and quality of relationships. We gave the information back to each school to help them decide what they can do to improve the social and emotional well-being of their pupils. We gave schools a guide to available resources, reviewed according to how well they are known to work elsewhere. The same social and emotional well-being measurements were repeated every 1 or 2 years, to see if any improvements had been made, and to guide any further adaptions of activities. The study ran in 38 schools over 7 years; half of the schools were randomly selected to receive the SEED intervention and half carried on as normal. Two age groups of pupils were recruited; the younger group was aged 4 or 5 years and the older group was aged 8 or 9 years at the start of the study. We found that the SEED intervention did slightly improve social and emotional well-being. Improvements were greater for older pupils, in particular for boys, and lasted beyond their transition from primary to secondary school. We also found that it was cost-effective for schools to run the SEED intervention. Schools valued the structure and shared ownership associated with the process. We concluded that the SEED intervention is an acceptable way to modestly improve pupil well-being and school ethos.