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Definition of a standard

Within the European Standards of Care for Newborn Health project, 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.

The standards developed within the project are reference standards that need to be translated into national binding guidelines/standards/recommendations (depending on the respective national situations).

The overall aim of the European Standards of Care for Newborn Health is to ensure that across Europe, the care for preterm and ill babies is harmonised.

Standard development process – overview

Till November 2018, 96 standards have been developed by about 220 experts from all over Europe. Click on the graphic below to receive an overview on the development process for the standards, starting with the decision on the standard topics until their official launch. It even goes beyond, including the planned lifecycle (see below) of the standards and extension of topics.

Standard development process – in detail

The drafting, review, and editing process

In a first step the standard topics are decided by the Chair Committee , the project’s Steering Committee and decision-making body. After the development of the standard template by the Chair Committee, the members of the interdisciplinary Topic Expert Groups (TEGs) work towards the first standard drafts for their topics. In every TEG several standard topics are covered and written by one or more responsible authors. This is followed by a peer review process during which the standard drafts pass through at least one feedback loop with all other TEG members. The TEGs’ exchange during this period happens virtually via telephone and video conferences or via email.

A further supporting body on request is the Parents’ Knowledge Forum – represented by EFCNI’s worldwide parent- and patient organisation’s network – which can be consulted for additional user perspectives on specific questions.

Before the standards enter the editing process, the Chair team , responsible for the TEG, reviews the proposed standard texts and checks the content for correctness. Once approved by the Chairs of the TEGs, each standard is revised by the editorial team, including a native speaker, to ensure a common wording as well as a similar structure. This version is passed back to the authors of the respective standards for approval. In case the authors don’t approve the edits, or in case there are any questions, the feedback loop with the whole TEG starts again.

The approved final version then passes a last formatting process by EFCNI.

 

The voting and endorsement process

Every single standard has to be voted on separately by the Chair Committee. There are three options: “Yes”, “No”, or “Abstain”. When voting “No” or “Abstain”, one has to give the reason for this decision, which will be passed to the authors and Chairs of the respective standards for incorporation in the revised version of the standard. The acceptance and publication of a standard requires an 80 percent majority of all “Yes” and “No” votes.

During the voting period in July/August 2018, 97% of all voting members of the project voted on the standard, and all initially developed 96 standards got 93-100% of the votes.

 

Endorsement process

All approved standards are sent to European and national healthcare societies and organisations, as well as parent and patient organisations to receive their official support for the newly developed standards. This invitation has been accepted by 108 healthcare societies and organisations as well as 50 parent and patient organisations (status November 2018). Further organisations are cordially invited to join the supporters throughout the life-span of the project.

 

Official launch of the standards

The official launch of the standards takes place in the European Parliament in Brussels on 28 November 2018. From that day on, the standards are available for free download here.

More information on the launch event, the agenda as well as a short summary will be provided shortly.

 

Call to Action for Newborn Health in Europe

A central document of the European Standards of Care for Newborn Health project is the Call to Action for Newborn Health in Europe. It is directed at various stakeholders and consists of 11 plus 3 demands – one for each of the eleven topics plus three general demands. Policy makers, hospital administrators, insurers, professional societies, patient associations, and industry are called upon to work together to pave the way for the implementation of the standards. The demands show which overall aspects need attention in order to improve newborn healthcare across Europe.

At the launch event in the European Parliament, all participants are invited to symbolically sign the Call to Action for Newborn Health in Europe giant posters. Additionally, printed brochures of the Call to Action for Newborn Health in Europe are handed out to every participant. The Call to Action for Newborn Health In Europe is available in around 20 different languages. You can find the different digital versions of the Call to Action for Newborn Health in Europe here.

 

Life cycle of the standards

As medical care is a very fast-developing area, the standards need to be revised regularly. Therefore, the Chairs together with the authors have determined a certain interval (3, 5, or 10 years), after which each standard needs to be revised. Of course, if the authors or the Chairs see the need to revise a standard in between a lifecycle interval, an earlier revision is always possible. New standards will be worked on during the next years following the same methodology to enlarge the standard package.

Starting from November 2018 on, each standard is “valid” for a certain time interval (life cycle). One year before this determined interval, EFCNI will contact the respective Chairs and authors for a review and decision what needs to be adapted because of new developments that have happened in the meanwhile. Chairs and authors will have one year time (revision period), during which they can update the standard document. The revised standards will then again be voted on by the Chair Committee. After the voting, the life cycle will start again.

Standards template

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 hospitals, and for health service. These sections can be adapted according to the respective parties involved in a certain area of care. The single components are graded according to their level of evidence (see below) and indicators of meeting the standard are included for each component (see below).

Two other tables display the future developments of care, in case a hospital already meets all core components of the standard, as well as initial steps, for those hospitals where the components or some of the components seem to be beyond the current levels of care.

Click on the graphic below to receive explanations on the different sections the standards template is divided into.

Grading of evidence

The components of the standards are selected based on scientific evidence or practical expert experience, for which a specific grading of evidence framework has been developed by the Chair Committee.

The system includes three categories of evidence, each with different quality levels:

Category A refers to scientific evidence generated by systematic research on the basis of the GRADE approach (1). As several components of individual standards are not based on scientific evidence but on shared cultural values or on best practice experiences, category B was introduced. The third category (C) implies evidence from legal certainties such as laws, regulations, or court practice.

A. Scientific evidence is judged in terms of methodological flaws, consistency of results across different studies, generalisability of research results, and effectiveness of treatments and is accordingly assigned to a specific quality level i.e. high, moderate, low, and very low. The four levels reflect the strength of a recommendation. (1)

B. Levels of cultural values derived evidence are assessed by the geographic scope of these shared values as judged by the project’s experts:

  • High quality: Based on cultural values that are shared within the geographical Europe
  • Moderate quality: Based on cultural values that are shared on a national level, in one or more countries within Europe
  • Low quality: Based on cultural values that are shared on a local level within a country within Europe
  • Very low quality: Based on cultural values that are subjective at the hospital or individual level

C. As a third category evidence from laws, regulations, or court practice is used. This type of evidence is also assessed based on the geographic scope of the legal source.

  • High quality: Required by EU wide valid laws, regulations and other legal sources
  • Moderate quality: Required by national laws, regulations and other legal sources

 

1Guyatt 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.

Indicators

Quality measurement is extremely important in medical care, as without measuring there is not option to evaluate if certain measure result in an improvement of care or not. In order to make the components of standards and implementation activities measurable, 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
  • Training documentation
  • Clinical records