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Overview

1. Background of the project

Annually, 15 million infants are born preterm worldwide. (1) Even in Europe, preterm birth is one of the leading causes for neonatal mortality and accounts for more than half of all infant deaths. Although survival rate for preterm infants is continuously improving, thanks to advances made in medical science, preterm birth is a remaining challenge with differing trends in Europe: While the preterm rate decreased between 2010 and 2015 in countries like Norway, Sweden, Germany, the Czech Republic, and Denmark, it increased in countries like Cyprus, Portugal, Ireland, and Italy, and remained on a steady level in several other countries. (2)

As the treatment for preterm and ill newborn infants is very complex, it requires specially trained healthcare professionals. Unfortunately, the organisation of care, the education of healthcare professionals, and the structure and provision of neonatal care varies widely across Europe. Differences in healthcare systems range from access to, funding of, and organisation of healthcare, from education of healthcare professionals to organisation of treatment. These variations are not limited to national borders: Differences are also observed at regional and hospital level. For many areas in newborn health, national – not to mention European – guidelines do not even exist, and the subjects covered by the respective national guidelines vary from country to country.

Europe needs new ideas and solutions to address the disparities in the care of preterm and ill infants. The European Standards of Care for Newborn Health (ESCNH) project addresses these disparities by developing standards for a wide range of topics in newborn health.

 

2. About the European Standards of Care for Newborn Health project

The European Standards of Care for Newborn Health project is an interdisciplinary collaboration that addresses the disparities in provision and quality of care existing in Europe by developing reference standards, which are basically covering the most important topics associated with preterm birth and neonatal morbidity. To address the complexity of the wide range of topics in neonatal care, the field was divided into 11 areas, the so-called Topic Expert Groups (TEG), in which the standards were developed. For the first time, standards are not only developed for the (medical) care of patients but go further beyond to areas such as NICU design, follow-up and continuing care, infant- and family-centred developmental care, and ethical-decision making.

Driven by the power of parents, it is a true patient-centred project, and for the first time, patients are involved in absolutely every step in the development of standards.

The project joins forces with about 220 healthcare professionals of different areas, and parent representatives from more than 30 countries. Additionally, NGOs, healthcare societies, media, and industry representatives, as well as political decision makers have been part of the project in terms of knowledge exchange, financial support, promotion, and project and information management.

The central decision-making body of the project was formed by the Chair Committee. It consisted of 36 members: 25 Chairs of the different TEGs, eight members of the EFCNI´s Parent Advisory Board, and the three Executive Board members of EFCNI. The Chair Committee steered the project, defined the project objectives, its design and methodology, developed the standards template, decided on the issues for standardisation and their prioritisation, and discussed and voted on the standards in the 11 overarching topics. After approval of the standards by the Chair Committee, they were submitted to topic relevant international, European and national healthcare societies and organisations for support and are now published on the project website.

 

3. About the developed European Standards of Care for Newborn Health – the standards themselves

Within the European Standards of Care for Newborn Health project, reference standards are developed that are intended to be used as a source for a national development of respective binding and implemented guidelines, protocols or laws (depending on the local situation).

A standard is defined as a systematically developed statement with the purpose to support decision making of physicians and patients for adequate care regarding specific health problems. These standards serve as a benchmark and blueprint for the development of standards in each individual country.

 

3.1 The standard template and specific project definitions

To facilitate a harmonised format and structure of the standards, a specific template was created by the Chair Committee for the standard development process.

The most important part of the template is the component table, which displays the standard per se, separated in a section for parents and family, for healthcare professionals, for neonatal units, for hospitals, and for health services. These core standard components need to be fulfilled to meet the standard. The standards need to be read as a whole and not only the components for a respective group, as tasks might interact with the different groups. The single components are graded according to their level of evidence (see below) and indicators of meeting the standards are included for each component (see below).

The ‘Where to go’ table displays the future developments of care, in case a hospital already meets all core components of the standard. For those hospitals where the components or some of the components seem to be beyond the current levels of care, initial steps are defined in the ‘Getting started’ table.

Addressee groups

The tables are each separated in a section for parents and family, for healthcare professionals, for the neonatal unit, for the hospital, and the health service. If applicable, the sections could be combined or adapted to the respective standard topic.

When in a standard the neonatal unit is mentioned, this standard does not only refer to infants until the age of 6 weeks, but later on as well. In countries, where infants might then be transferred to another unit (e.g. paediatric unit) or where neonatal units don´t exist, the standard components for the addressee group “neonatal unit” apply in the place where preterm born and ill infants are cared for after birth until their discharge or in case of a rehospitalisation.

The addressee group health service includes several groups, such as professional healthcare societies, insurers, payers, and health system, depending on the national health system.

Guideline

The term guideline in the context of the standards stands for a binding, implemented document that is worked according to. This might be a standard operating procedure, a directive, a policy, a regulation, a principle, or anything that is used as a document that determines what (healthcare) experts have to do in their clinical routine.

Management

The management of a certain disease/condition mentioned in several standards refers to a very holistic concept of taking care of the specific disease or condition. Management in this context includes diverse activities that are not specified in detail in order to keep the standards relatively short, but need to be accomplished in order to comprehensively handle the situation.

Sufficient resources

Often, sufficient resources, such as money, human resources, rooms, time, equipment, etc. are needed to implement and fulfil a standard. Please note, that the necessary resources are not explicitly mentioned in every standard as they apply to most of the standards and depend on the current local situation. They have to be identified in the course of the local standard implementation.

 

3.2. Grading of evidence

Detailed information on how the evidence was graded according to the level of scientific evidence, cultural values and laws is available in the methods section.

 

3.3. Indicators

Quality measurement is extremely important in medical care, as without measuring there is no option to evaluate, if certain measure result in an improvement of care. In order to make the components of standards and implementation activities measureable, suggestions for later benchmarking and verification activities to measure whether a component is met are provided next to each component. Some examples used as indicators:

  • Patient information sheet
  • Training documentation
  • Audit report
  • Guideline
  • Clinical records

 

3.4. Other important facts to consider when reading the standards

Infant- and family-centred developmental care (IFCDC) is a generic term for a framework of neonatal care that incorporates the theories and concepts of neurodevelopment, neuro-behaviour, parent-infant interaction, parental involvement, breastfeeding promotion, environmental adaption, and change of hospital systems. Adequate IFCDC trained healthcare professionals who receive counselling and regular clinical supervision in communicating with and providing emotional support for parents is the prerequisite for efficient IFCDC. This concept is the basis of all standards, and thus parents are considered the primary caregiver during neonatal care even if not mentioned. If parents are not able to care for their infant, the legal authorities are responsible. Furthermore, there is a whole Topic Expert Group that developed standards on education and training of the multidisciplinary team working in neonatology. Apart from these standards, training on specific tasks is of course relevant in every single standard. Therefore, in the components table in the section on healthcare professionals there is always a part on training, which needs to be attended by all responsible healthcare professionals, ensuring that tasks are fulfilled only by staff who is trained in them. Without the support of the hospital, training is often not possible. This is reflected by having in every standard one component in the hospital section on training, which states that the hospitals need to ensure the training. Please note, that data security should be guaranteed within the implementation of all standards.

4. Outlook

With the launch of the standards, the project is not finished, and continues with the implementation process. In the long run, the project´s mission is to ensure equitable and high levels of care throughout Europe by facilitating and harmonising neonatal care and its neighbouring medical areas. The project aims at achieving and catalysing a systematic change for harmonisation and quality improvement of newborn care by changing the framework conditions in the respective countries. On a political level, addressing European Standards of Care for Newborn Health will stimulate a new debate that can help questioning existing structures, identify gaps and deficiencies, and advance national healthcare systems. For a sustainable change of newborn health practices and structures in line with the new standards, various steps are undertaken to support and accelerate their implementation. For a sustainable change of newborn health practices and structures in line with the new standards, various steps are and will be undertaken to support and accelerate their implementation on a national level:

EFCNI Academy: Within the EFCNI Academy EFCNI creates standardised training opportunities for healthcare professionals in collaboration with renowned universities and healthcare societies. Currently, the pilot project on the topic of human milk banks is ongoing and very well received. In the next years, EFCNI wants to establish a comprehensive academy curriculum covering diverse topics. If you are interested in the current activities on human milk banks, have a look here.

Toolkit:

A comprehensive toolkit supporting the implementation of the standards on a national level is available since September 2019. The toolkit “Shaping the future – Combining forces to improve newborn health” offers a full range of concepts, resources, support, ready-to-use tools, as well as clear milestones and objectives by which progress in the implementation of the standards can be assessed. You can access the toolkit here.

Free access to the standards:

As it is EFCNI’s philosophy to disseminate information free of charge, all standards are freely available for download.

Life cycle:

In order to ensure that the standards are always up to date, a life cycle of 3, 5 or 10 years is included at the end of the standards document, after which the respective documents will be reviewed and updated. In the course of this life cycle also new standards can be developed and added to the full set of standards.

Fellowship programme:

During the last years, EFCNI has trained parent organisations from all around Europe to become influential stakeholders in the area of newborn and maternal health. During these trainings detailed information on the project, its background, its aims, the need for standards and of course also on the standards themselves were shared with the parent representatives. Further comprehensive trainings on different skills (e.g. fundraising, how to organise a roundtable, research, how to read a scientific paper and find evidence-based information) will follow during the next years.

Call to Action for Newborn Health in Europe:

The Call to Action is directed at various stakeholders: European and national policy makers, hospital administrators, insurers, professional and patient associations, as well as industry representatives. It consists of 11 plus 3 demands: One demand for each of the eleven topics of the project, which can be seen as a summary of what every specific topic is about and express the most pressing needs in this area. The three general demands show which overall aspects need attention in order to improve newborn healthcare across Europe.

Set of neonatal outcome standards:

EFCNI supports the International Consortium for Health Outcomes Measurement (ICHOM), in the development of worldwide health outcome measurements that matter most to families of preterm and hospitalised neonates. The transdisciplinary working group is led by Professor Dr Andreas W. Flemmer (Ludwig Maximilian University, Munich, Germany). It consists of international clinical and registry leaders, as well as patient representatives. They review current measurement initiatives, existing literature and gather patient input through guided discussions and validation surveys. The standard set on preterm and hospitalised neonates will allow healthcare providers to use clinician and patient-reported outcomes to evaluate the quality of care, develop care plans and treatment pathways. The standardised outcome data can be used for global benchmarking, to learn from each other and improve care protocols.

Information and education materials:

EFCNI develops diverse information and education material in relation to the European Standards of Care for Newborn Health project: factsheet, information brochure, project report, Call to Action for Newborn Health in Europe leaflet etc. All these materials are available for download.

Self-assessment:

During the next years, EFCNI will develop a self-assessment based on the standards that can be used by hospitals to check if they fulfil the standards and to what extent.

Research:

In order to prove that the implementation of the standards improves neonatal care and thus the outcomes of preterm and ill infants, EFCNI will do research on the implementation of the standards. This is currently in the preparation phase. If you want to learn more about EFCNI’s research ambitions, please contact us.

We hope that in the future all relevant stakeholders will join forces and work together on the implementation of the standards in order to ensure the best start in life for all infants across Europe and beyond.

Sources

  1. Althabe F, Howson CP, Kinney M, Lawn J, World Health Organization. Born too soon: the global action report on preterm birth [Internet]. 2012 [cited 2018 Jan 31]. 
  2. Euro-Peristat Project. European Perinatal Health Report. Core indicators of the health and care of pregnant women and babies in Europe in 2015. [Internet]. 2018 [cited 29. November 2018]. 
  3. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008 Apr 26;336(7650):924–6.