Guidelines

We have established an ERN eUROGEN Guidelines Expert Panel – an overarching group formed of representatives from our healthcare providers, ERN Patient Advocacy Group, and Supporting Partners.  This panel commissions guideline subgroups and oversees guideline development.

The European Commission funded a project dedicated to providing assistance to the ERNs and their healthcare providers in the process of development, appraisal and implementation of clinical practice guidelines (CPGs) and clinical decision support tools (CDSTs) and to improve the capacity of the networks to produce these and adhere to high quality standards.

The consortium running the project produced materials that are the outcome of an extensive literature review and consultation process. The presented methodology is based on the current international “gold standards” that have been developed and used by key international and national bodies and organisations specialised in the development of CPGs and CDSTs.

A 2024 review of this project to assess the quality of its work and deliverables concluded that they were of a very good quality and that the methodology which was proposed for developing guidelines is sound.

The materials can be downloaded by clicking the links below:

• Quick Guide
• Introductory Document
• Summary of the Project
• Summary of the Handbooks
• Handbook #1: Prioritisation of Rare or Low-Prevalence and Complex Rare Diseases that Require CPGs or CDSTs
• Handbook #2: Appraisal of Existing CPGs and CDSTs for Rare or Low-Prevalence and Complex Diseases
• Handbook #3: Adaptation and Adoption of Clinical Practice Guidelines and Clinical Decision Support Tools for Rare or Low-Prevalence and Complex Diseases
• Handbook #4: Methodology for the Development of Clinical Practice Guidelines for Rare or Low-Prevalence and Complex Diseases
• Handbook #5: Methodology for the Development of Clinical Consensus Statements for Rare or Low-Prevalence and Complex Diseases
• Handbook #6: Methodology for the elaboration of Evidence Reports for rare diseases
• Handbook #7: Methodology for the Development of Diagnostic, Monitoring and Therapeutic Pathways for Rare or Low-Prevalence and Complex Diseases
• Handbook #8: Methodology for the Development of Evidence-Based Protocols for Rare or Low Prevalence and Complex Diseases
• Handbook #9: Methodology for the elaboration of Do’s and Don’ts Factsheets for rare diseases
• Handbook #10: Methodology for the Development of Quality Measures for Rare Low-Prevalence
• Handbook #11: Methodology for the Elaboration of Patient Information Booklets for rare diseases
• Handbook #12: Implementation and Evaluation of the Uptake of CPGs and CDSTs for rare diseases
• Handbook #13: Patients’ involvement in the development of Clinical Practice Guidelines (CPGs) and Clinical Decision Support Tools (CDSTs) on rare, low-prevalence and complex diseases: a guide for the chair and members of Guidelines Development Groups (GDGs)

This material is an important step forward for the ERN guidelines programme and a key tool for the work of the ERNs in the production, adaptation, adoption and appraisal of CPGs and CDSTs.

The EU Academy is an EU-owned online hub containing first-hand knowledge, high-quality educational resources and valuable insights directly produced by the EU institutions for individuals whose work is related to its sphere of action.

A training module on “Development of Clinical Practice Guidelines” has been developed within the framework of the ERN Guideline Programme. It aims to improve the capability of ERN healthcare professionals, CPG developers, and expert panel members to develop, appraise, and implement ERN CPGs and CDSTs effectively and efficiently.

To use the EU Academy, you will need an EU login account. In case you do not have one yet:

• Go to the EU login landing page: EU Login.
• Click on Create Account.
• On the page that opens up, fill in the required information: First Name, Last Name, E-Mail and Verification Code.
• Click on Create an account.
• Once the account is created, the next step is to log in and link a mobile phone to the account to receive verification codes for two-factor authentication.
• Once this is done, the EU Academy is prepared to be used.

EURORDIS has produced an ePAG guide to “Patient Involvement in Clinical Practice Guidelines and Other Clinical Decision Support Tools“.

An ERN eUROGEN Expert Working Group adapted existing Dutch guidelines on anorectal malformations (ARM). Work began with guidance from the agency assigned to ERN eUROGEN by the Spanish consortium appointed by the European Commission to facilitate ERN guidelines. Once this support ended, Qualicura supported ERN eUROGEN’s experts to ensure the highest scientific quality was in place throughout the methodology to produce the adapted clinical practice guideline (CPG) on ARM. Our European experts, including patient representatives, have thoroughly reviewed this.

Part one of the work on diagnosis and treatment is available here.

Part two of the work on follow-up and transition is available here.

The European Association of Urology, European Society for Paediatric Urology, ERN eUROGEN, ERN ITHACA, ERN ERKNet, and the International Federation for Spina Bifida and Hydrocephalus formed a working group to standardise the approach of care for paediatric patients with spinal dysraphism through the development of a Clinical Practice Guideline (CPG).

The EAU Guidelines Office and EAU Paediatric Guidelines Panel led the process, ensuring that the methodology met the standards set by the EC as provided by the Aragon Health Sciences Institute (IACS) on behalf of the ERNs. The Memorandum of Understanding is available here, and the methodology is included in the appendices.

📖 The final Clinical Practice Guidelines for Spinal Dysraphism in Children & Adolescents is available here.