Periodic Reporting for period 3 - RECAP preterm (RECAP preterm: Research on European Children and Adults born Preterm)
Periodo di rendicontazione: 2020-01-01 al 2021-09-30
Infants born very preterm (VPT, before 32 weeks of gestational age or very low birth weight VLBW, less than 1500 grams) represent 1-2% of all babies in Europe, accounting for up to half of perinatal and infant deaths. Survivors of VPT birth face risks of health and developmental problems, including suboptimal health, quality of life, partnering, family life, employment chances and wealth in adulthood. However, evidence on outcomes from sufficiently large samples across different contexts was missing.
Aim of the RECAP Preterm Project was to improve health, development and quality of life of VPT/VLBW survivors by optimizing data for healthcare, social and education policy. Objective was to create a data platform on VPT/VLBW children and adults from multiple cohorts and registers. Demonstration projects regarding long term outcome after VPT/VLBW were planned. Novel methodologies for data collection, management and analysis on current and future VPT/VLBW cohorts were to be created, including strategies to reduce loss to follow-up.
Aim of the RECAP Preterm Project was to improve health, development and quality of life of VPT/VLBW survivors by optimizing data for healthcare, social and education policy. Objective was to create a data platform on VPT/VLBW children and adults from multiple cohorts and registers. Demonstration projects regarding long term outcome after VPT/VLBW were planned. Novel methodologies for data collection, management and analysis on current and future VPT/VLBW cohorts were to be created, including strategies to reduce loss to follow-up.
Three main tasks were accomplished during the project’s lifespan:
Building a sustainable research platform – Meta-data were collected from the cohorts, a schema for catalogues established, as well as an architecture and an interface between technical and conceptual specifications. In total 27 studies, 87 datasets and 11,866 variables were harmonised and uploaded to the RECAP Preterm Platform, enabling data nodes for the European cohorts to come online as functional parts of the federated data platform.
The Platform is a network of nodes hosted across Europe by the participating partners who have full control over their data and software. Each node provides open source data storage, harmonisation and analysis resources, searchable catalogues and solutions for data management, analysis and dissemination of epidemiological studies (OBiBa (obiba.org)). Analyses use the privacy protecting software DataSHIELD.
Methods developed included multiple imputation for loss to follow-up and survival analysis. A mobile application and an e-cohort for VPT adults was piloted. The Nordic registers have meta-data on the Platform, expanding the platform with high volumes of data. Cohorts from the Adult Preterm International Collaboration (http://www.apic-preterm.org/) were participating in mapping and harmonizing data for analysis of protective and resiliency factors.
Launching the RECAP Preterm research agenda on the consequences of very preterm birth -Three research strands made up the research agenda: (i) hypothesis-driven research on priority themes within child cohorts, (ii) research on universal outcomes and protective factors and resiliency within adult cohorts (iii) life-course research on VPT birth developed using Nordic register data.
The priority themes were identified by a consensus process within the consortium and an external panel of 64 stakeholders. This led to the selection of 3 projects: Care and outcomes of extremely preterm birth; Growth and nutrition; Impact of social circumstances on outcomes and 2 areas for further development (Education; Parental stress). Differences were investigated between cohorts in the timing of mortality risk of babies born extremely preterm at the limits of viability, validated measures of intrauterine and postnatal growth restriction and showed the consistency of low maternal educational level as a risk indicator for impaired cognition across 15 cohorts. Nine research manuscripts have been accepted and 15 are on-going. This work also produced four research proposals with multi-institutional involvement to promote continued and expanded research on the platform.
The research strand on adults included meta-analyses on functional outcomes (e.g. neuro-cognition, mental health and quality of life) and also on employment, receipt of social benefits, independent living, social relationships and support. Systematic reviews on statistical approaches to Individual Participant Meta-analyses (IPD) and longitudinal testing for protective and promotive factors and resiliency were completed. IPD’s on IQ in adulthood, other functional (e.g. mental health) and life course measures (e.g. social relationships) have been published or are under review. The comparison of studies that have assessed similar childhood functioning within countries (Germany, the Netherlands, Finland) is completed or underway. This is to determine how changes in care may have affected quality of survival in various eras of neonatal care (1980s versus 2000s). More than 15 manuscripts have been published on adult outcomes and mechanisms after VPT/VLBW birth and another 10 are being finalised. Several research proposals to funding agencies have been submitted.
The strand of life course research using the 4 Nordic population registers combined registry-based datasets and provided access to 10,000,000 index persons, yielding high statistical power in studying the spectrum of gestational ages. Research has been carried out on very preterm mortality, autism-spectrum disorder, educational attainment and obstructive respiratory diseases. Multiple scientific articles have been published and a dozen are being finalised and research proposals for funding submitted.
Dissemination to stakeholders and promotion of patients and public involvement - The European Foundation for the Care of New born Infants (EFCNI), a patient organization, ensured that parental and patient perspectives were integrated into the platform. A “living” stakeholder map was set up to encourage stakeholder engagement and the RECAP Preterm Project was discussed with parent organizations across Europe. EFCNI promoted the project at several conferences which they co-organized, drafted policy briefs to healthcare professionals and policy-makers and has planned an outreach strategy with the informal European Parliamentary interest group on maternal and neonatal health.
A key component of the dissemination plan was the digital summer school which took place in 2021. It provided registered participants with an overview of VPT cohorts and collaborative research principles and techniques through 11 online modules, consisting of 58 video contributions with, in total, 15 hours of e-learning and presented by 42 speakers. Some 160 participants from 21 countries registered. The on-line program continues to be freely availability for stakeholders interested in learning about the platform.
A short project video was produced that describes the aims and structure of the platform designed to be accessible to a broad audience, including users and policy-makers.
https://www.youtube.com/watch?v=fu7D18WgfCc&t=4s.
Building a sustainable research platform – Meta-data were collected from the cohorts, a schema for catalogues established, as well as an architecture and an interface between technical and conceptual specifications. In total 27 studies, 87 datasets and 11,866 variables were harmonised and uploaded to the RECAP Preterm Platform, enabling data nodes for the European cohorts to come online as functional parts of the federated data platform.
The Platform is a network of nodes hosted across Europe by the participating partners who have full control over their data and software. Each node provides open source data storage, harmonisation and analysis resources, searchable catalogues and solutions for data management, analysis and dissemination of epidemiological studies (OBiBa (obiba.org)). Analyses use the privacy protecting software DataSHIELD.
Methods developed included multiple imputation for loss to follow-up and survival analysis. A mobile application and an e-cohort for VPT adults was piloted. The Nordic registers have meta-data on the Platform, expanding the platform with high volumes of data. Cohorts from the Adult Preterm International Collaboration (http://www.apic-preterm.org/) were participating in mapping and harmonizing data for analysis of protective and resiliency factors.
Launching the RECAP Preterm research agenda on the consequences of very preterm birth -Three research strands made up the research agenda: (i) hypothesis-driven research on priority themes within child cohorts, (ii) research on universal outcomes and protective factors and resiliency within adult cohorts (iii) life-course research on VPT birth developed using Nordic register data.
The priority themes were identified by a consensus process within the consortium and an external panel of 64 stakeholders. This led to the selection of 3 projects: Care and outcomes of extremely preterm birth; Growth and nutrition; Impact of social circumstances on outcomes and 2 areas for further development (Education; Parental stress). Differences were investigated between cohorts in the timing of mortality risk of babies born extremely preterm at the limits of viability, validated measures of intrauterine and postnatal growth restriction and showed the consistency of low maternal educational level as a risk indicator for impaired cognition across 15 cohorts. Nine research manuscripts have been accepted and 15 are on-going. This work also produced four research proposals with multi-institutional involvement to promote continued and expanded research on the platform.
The research strand on adults included meta-analyses on functional outcomes (e.g. neuro-cognition, mental health and quality of life) and also on employment, receipt of social benefits, independent living, social relationships and support. Systematic reviews on statistical approaches to Individual Participant Meta-analyses (IPD) and longitudinal testing for protective and promotive factors and resiliency were completed. IPD’s on IQ in adulthood, other functional (e.g. mental health) and life course measures (e.g. social relationships) have been published or are under review. The comparison of studies that have assessed similar childhood functioning within countries (Germany, the Netherlands, Finland) is completed or underway. This is to determine how changes in care may have affected quality of survival in various eras of neonatal care (1980s versus 2000s). More than 15 manuscripts have been published on adult outcomes and mechanisms after VPT/VLBW birth and another 10 are being finalised. Several research proposals to funding agencies have been submitted.
The strand of life course research using the 4 Nordic population registers combined registry-based datasets and provided access to 10,000,000 index persons, yielding high statistical power in studying the spectrum of gestational ages. Research has been carried out on very preterm mortality, autism-spectrum disorder, educational attainment and obstructive respiratory diseases. Multiple scientific articles have been published and a dozen are being finalised and research proposals for funding submitted.
Dissemination to stakeholders and promotion of patients and public involvement - The European Foundation for the Care of New born Infants (EFCNI), a patient organization, ensured that parental and patient perspectives were integrated into the platform. A “living” stakeholder map was set up to encourage stakeholder engagement and the RECAP Preterm Project was discussed with parent organizations across Europe. EFCNI promoted the project at several conferences which they co-organized, drafted policy briefs to healthcare professionals and policy-makers and has planned an outreach strategy with the informal European Parliamentary interest group on maternal and neonatal health.
A key component of the dissemination plan was the digital summer school which took place in 2021. It provided registered participants with an overview of VPT cohorts and collaborative research principles and techniques through 11 online modules, consisting of 58 video contributions with, in total, 15 hours of e-learning and presented by 42 speakers. Some 160 participants from 21 countries registered. The on-line program continues to be freely availability for stakeholders interested in learning about the platform.
A short project video was produced that describes the aims and structure of the platform designed to be accessible to a broad audience, including users and policy-makers.
https://www.youtube.com/watch?v=fu7D18WgfCc&t=4s.
The RECAP Preterm Platform goes beyond the state of the art by making data findable, accessible, interoperable and reusable (FAIR). Over 20 studies are on-going and multiple proposals have been submitted for support. The 48 publications demonstrate the vast potential of the Platform in yielding impactful results, improving health and quality of life of VPT children and adults.