TThe project, funded by Horizon 2020, in which 20 institutions from 12 countries participated, sought to understand the risk factors associated with prematurity through the combined analysis of data from a fairly large number of individuals born preterm in Europe, who have been followed over several years in cohort studies.
The Instituto de Saúde Pública da Universidade do Porto (ISPUP) and the Instituto de Engenharia de Sistemas e Computadores, Tecnologia e Ciência (INESC-TEC) were involved in the development of the European project RECAP preterm – Research on European Children and Adults born Preterm.
Funded by the Horizon 2020 programme with 9 million and 700 thousand euros through the course of four years (from 2017 to 2021), RECAP has contributed to an increasingly better understanding of how to ensure better health and more quality of life for children and adults born very preterm (less than 32 weeks of gestation) or with very low birth weight (less than 1500g), particularly in Europe.
Although very preterm or very low birth weight births constitute less than 2% of all births in Europe, they account for half of all perinatal and infant deaths in the continent. Children born preterm have an increased risk of developing neurological, behavioural or personality abnormalities, as well as cardiovascular and metabolic problems, compared to those born full-term. These babies are also at greater risk of developing chronic non-communicable diseases as they get older and of having fewer employment opportunities in adulthood.
RECAP preterm has helped to understand the circumstances that give rise to preterm births and how to change them through the development of the RECAP preterm Cohort Platform – a sustainable, geographically diverse and multidisciplinary data storage, processing, cataloguing and analysis system of 20 European cohorts of children and adults born very preterm.
A cohort is a group of individuals who share a similar characteristic and are followed over time, traditionally through questionnaires and face-to-face assessments, in order to better understand the evolution of their health. This data collection provides essential information for epidemiological and public health research.
Cohort studies of people born very preterm or with very low birth weight exist in several European countries. However, these isolated studies are too small to allow for more complex analyses, such as determining the effectiveness of neonatal treatments or finding out what helps these individuals live a life with fewer complications.
By combining data from European cohorts that have been following very preterm and very low birth weight infants until adulthood for several years, the RECAP Preterm Cohort Platform allows, for example, to increase the power of statistical analysis and identify universal factors that can help improve the lives of these people across several countries.
The platform, developed with the contribution of INESC-TEC, and which will remain active even after the end of the project, compiles thousands of data, distributed over a network of 14 servers in Europe, which allows doctors and researchers to conduct studies using a data source with a high geographical and cultural coverage.
By harmonising and combining this data, RECAP Preterm “allows us to contribute to the analysis, for instance, of the development of rare diseases or the evolution in the care and survival of people born very preterm”, says Artur Rocha, researcher at INESC-TEC.
Furthermore, “this infrastructure serves as a basis for numerous scientific publications that are being developed within the scope of studies on very preterm and very low birth weight children and adults”, he adds.
The platform allows for federated statistical analysis of data located in repositories of different countries, without the need to transmit the data to third parties. The analyses are performed in each of the repositories in a distributed and parallel manner, with the analyst having access to aggregated data which allows, even so, to obtain the same statistical results that would be obtained if the data were physically together in the same repository.
Currently, this federated approach is increasingly in use, particularly in statistical analyses using Machine Learning techniques.
But this important database only exists thanks to the contribution of the participants who voluntarily accept to take part in these longitudinal studies, altruistically helping science.
However, maintaining their participation is a challenge. The loss of participants in these studies, due to both their unwillingness to answer questionnaires and to attend periodic face-to-face assessments, is a concern for researchers.
In the RECAP preterm project, ISPUP researchers were particularly involved in how to motivate the continued adherence of very preterm or very low birthweight infants to these longitudinal studies, as well as in examining ways to improve data collection and ensure follow-up of participants over time.
The use of digital follow-up solutions and remote monitoring of participants was one of the possibilities tested to motivate individuals to stay in the cohort studies. These solutions are beneficial not only for the participants, who avoid travelling, but also for the researchers, who do not need to build expensive structures to carry out the various follow-up assessments.
In collaboration with INESC TEC and other partners, ISPUP tested two solutions: an application for mobile devices – RECAP_MY Life – a means of data collection applied to the area of mobile health (mhealth), and the creation of an international e-cohort – HAPP-e (Health of Adult People born Preterm – an e-cohort pilot study).
In particular, the HAPP-e e-cohort has demonstrated that there is huge potential to conduct follow-up assessments of participants in a unique way, using online mediums.
The e-cohort was launched in December 2019 by researchers from ISPUP and INESC-TEC. All adults born preterm, worldwide, could participate in the study by answering online questionnaires on the project platform.
From its launch until December 2020, HAPP-e counted on the participation of a significant sample of adults born preterm from 34 countries, covering a wide variety of socio-demographic and health characteristics.
According to Henrique Barros, President of ISPUP, involved in the RECAP project, “this pilot study confirmed a great potential for recruiting an extensive and diverse sample of preterm born adults worldwide, thus bringing possible research advances on this segment of the population. At the same time, it allowed us to realize that this is an effective way to capture participants for cohort studies, something that is essential for the implementation of concrete public health measures.”
Following the construction of the RECAP preterm platform, emerged the idea of facilitating and promoting the interconnection of health and education data from cohort participants with premature birth records from hospitals, the National Health Service, schools, the Ministry of Health and Education, among other institutions that collect data on prematurity.
This record linkage process at a European level has been greatly encouraged by ISPUP, given the added value it represents for research. The interconnection of a large volume of data makes it possible to answer a wide variety of questions that would otherwise not be feasible.
However, to make this process possible, some legal barriers, related to the protection and privacy of the data of the people whose information is shared, have to be overcome. In the European Union, member states, such as Portugal, attach great importance to the self-determination of information and the explicit consent of individuals who provide data, which makes it difficult to share it among the various institutions.
ISPUP researchers believe that the harmonisation of rules related to privacy and data protection in the European Union and the European Economic Area could be useful to facilitate the record linkage process. However, they stress that this harmonisation should not be detrimental to countries that already allow this exchange of data without explicit consent, for the sake of research and the common good.
Even after the end of the project, the researchers intend to continue leveraging the record linkage process, which can be applied not only to the study of prematurity, but also to research in other areas, such as COVID-19 and chronic diseases. This multidisciplinary approach will be encouraged by ISPUP in order to improve research and optimise health policies.
The RECAP preterm platform will remain active. It is hoped that, in the long term, it will serve as a model for the development of similar resources for research on population cohorts outside of prematurity.
The RECAP preterm project ended in September 2021, four years after it started. The final meetings of the project took place on 28-29 September, online.
Besides ISPUP and INESC TEC, other participating institutions were TNO (Netherlands), the University of Warwick (UK), INSERM (France), the University of Leicester (UK), THL (Finland), EFCNI (Germany), the Norwegian Univeristy of Science and Technology (Norway), the University Hospital of Bonn children’s Hospital (Germany) Karolinska Institutet (Sweden), University of Helsinki (Finland), Pediatric Hospital Bambino Gesù, IRCC (Italy), Amager Og Hvidovre Hospital (Denmark), Philipps University Marburg (Germany), University of Tartu (Estonia), Concentris Research Management (Germany), Extensive Life Oy (Finland) and Stichting MLC Foundation (The Netherlands).
For more information on RECAP preterm, please visit the website.
