The European Reference Networks (ERN) are required under European Union law to be evaluated on a regular basis and as a minimum before the end of the first 5 year contractual period.
- This page is under construction. Its content will be updated each week.
To help you answer the evaluation, the European Commission has elaborated the following documents:
– Frequently Asked Questions (compiled from the 12th of December webinar)
Self evaluation of health care providers: general information
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Item 8: The minimum number established by the network is available for each group of disease in the list of specific criteria (please see the list of specific criteria below in the section Measurable element 6.1
The HCP has to provide here the results for the following indicators (please see the list below) for the year 2019, the year 2020, the year 2021.
Each HCP team provided this information to the ERN-Skin coordination each year during the European Commission monitoring exercise. If you have lost this information, please send an email to marie.guillou@fondation-r-touraine.org
WARNING: When you answered the monitoring survey, you submitted lists (of publications or clinical practice guidelines for example). For the evaluation, you just need to put a figure. So, for example, if you listed 1 publication in 2019, you just put “1” in the 2019 column.
List of monitoring indicators:
- Patients from January to December
- CPMS
- Education/training activities not accruing higher education
- Educational activities accruing higher educational credits
- Clinical trials
- Observational Prospective Studies / Observational cohort or case-control studies / Case-series studies
- Publications
- Clinical Practice Guidelines (CPG) and other types of Clinical Decision Making Tools not developed by the ERN-Skin but formally agreed and adopted by the ERN-Skin (thematic groups)
- Clinical Practice Guidelines written by the ERN-Skin (thematic groups)
- Clinical Decision Support Tools (CDST: clinical consensus statements or consensus recommendations), developed by the ERN-Skin (thematic groups)
- Congresses/ conferences/ meetings at which the ERN-Skin activities and results were presented
Item 11: Please indicate the results of the clinical indicators agreed in the framework of your Network for last year.
The ERN-Skin clinical indicators are based on the ERN-Skin specific criteria (please see below Measurable Element 6.1). The results of the clinical indicators are positive when the HCP complies with the ERN-Skin specific criteria for a group of disease.
For each group diseases, these clinical indicators refer to :
- Key Diagnostic Tests
- Key Treatment, Resources or Procedures
- Minimum Number of patients treated per year at each HCP
- Minimum Number of new patients diagnosed per year at each HCP
- Necessary human resources and the professional qualifications essential to the quality of patient care (Health Care Professional, Training & Qualifications, Minimum of number of procedures per patient per year)
- Specialized equipment, infrastructure, and information technology
For more detail, please see below Measurable Element 6.1
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Self evaluation (online)
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List of documents and other evidence suggested to be prepared by the HCP
For almost each measurable element, the HCP need to provide evidence. This list is available on p. 109-110 of the technical toolbox. In the right column, you have the name of the document to provide and on the left column the corresponding Measurable Element (ME) number.
Measurable element 1.4.1 – The HCP team routinely measures patient and family satisfaction using the ERN common tool.
The ERN-Skin has developed a patient satisfaction questionnaire. It is available here: https://ern-skin.eu/patient-satisfaction-survey/
This questionnaire aims to measure the level of patient satisfaction after consultation in an ERN-Skin centre, in order to improve their quality of care and performance. It has been elaborated by SKIN ePAG advocates.
The questionnaire has 26 items and it is divided in 4 main sections:
– General information on the patient
– Consultation and follow-up (19 questions)
– Treatment prescription and therapeutic research (5 questions)
– Global satisfaction (2 questions)
A short blank section is available at the end of the questionnaire to add any comments. The data will be processed by the ERN-Skin coordination team.
Measurable element 2.2.1 – The HCP team establishes collaboration with affiliated centres in neighboring countries for cross-border care or for training / dissemination of information for professionals and patients.
- The list of ERN-Skin members is available here: https://ern-skin.eu/reference-centers/
- The list of ERN-Skin affiliated partners is available here: https://ern-skin.eu/affiliated-partners/
The figures included in the file correspond to the panels entered and presented in CPMS, nevertheless many doctors who did not present, participated in some CPMS meetings, for which only you know which meetings you participated to (presenting and participating are both indicators that are taken into account for the reporting exercise).
Measurable element 3.1.1 – The HCP team has a defined set of objectives for its education and training activities aligned with the ERN.
ERN-Skin set of objectives for its education and training activities:
- Improve the management of patients with rare skin diseases in the scope of the ERN-Skin
- Improve the organization and skills of the multidisciplinary team
- Create strong links between HCPs of the ERN-Skin and participate in a better integration of ERN-Skin partners within ERN-Skin’s activities
- Involve Member States with insufficient number of patients or lacking technology or expertise
- Share and spread harmonized best practices
- Help patients acquire or maintain the skills they need to manage their life with a rare skin disease in the best possible way
ERN-Skin set of specific objectives for its education and training activities:
- To asses at HCP level resources available for training and patient education
- To organize live training
- To organize e-traininng activities and develop an e-training platform
- To organize webinar
- To support travel and accommodation for health care providers from Member States with an insufficient number of patients or lacking technology or expertise to participate in the ERN-Skin courses
- To support the participation of ERN-Skin HCP to the Mobility Programme
- To promote patient education programmes and tools (for more information see the enclosed document)
Measurable element 3.1.4 – The HCP team participates in the training activities organised by the ERN.
List of the ERN-Skin training activities:
Live training
- 1st ERN-Skin course, May14-15, 2017 in Helsinki (Finland)
- 2nd ERN-Skin course, November 23, 2018 in Rome (Italy)
- 3rd ERN-Skin course, October 4, 2019 in Paris (France) in cooperation with the ERN-Eye
- 4th ERN-Skin course, December 16, 2019 in Ghent (Belgium) Accredited by the UEMS
- 1st World Congress on Rare Skin Diseases, February 23-25, Paris France (postponed to June 2022)
E-training: e-training platform with e-training modules offering for a specific disease or a group of diseases (Definition, Diagnosis,Treatment options and Future)
- DNA repair disorders (4 modules)
- Epidermolysis Bullosa (4 modules)
- Mosaicism (6 modules)
- Pemphigus (4 modules)
- ToxiTEN (4 modules)
Monthly webinars: One hour monthly research update by each thematic group:
- Thematic group on Ichthyosis & Palmoplantar Keratoderma: Genetic discoveries in ichthyosis – Keith Choate, 29 June 2021
- Thematic group on Inherited Epidermolysis Bullosa and skin fragility syndromes Darier, Hailey-Hailey: Combined cell and gene therapy for Epidermolysis Bullosa – Michele De Luca, 6 July 2021
- Thematic group on Cutaneous Mosaic Disorders – Nevi & Nevoid Skin Disorders and Complex Vascular Malformations and vascular Tumours: Nevus pathophysiology, Melanoma risks and therapeutic expectations – Sarah Guégan, on 28 September 2021
- Thematic group on Severe cutaneous drug reactions: Cytokines of the IL-1 family in severe cutaneous adverse drug reactions – Emmanuel Contassot, on 26 October 2021
- Thematic group on Hidradenitis suppurativa – PAPA, PAPASH, PASH, PASS, SAPHO-, Behçet, Degos: Adamantiades-Behcet’s disease – Andreas Altenburg, on 30 November 2021
- Thematic group on Mendelian connective tissue disorders: Pathways to address cutis laxa syndromes presented by Bert Callewaert, on 14 December 2021
- Thematic group on Cutaneous diseases related to DNA repair disorders: Reduced levels of prostaglandin I2 synthase: a distinctive feature of the cancer-free trichothiodystrophy presented by Donata Orioli, on 25 January 2022
- Thematic group on Ectodermal Dysplasias including Incontinentia Pigmenti and p63-associated disorders: Opposite Sides of a Spectrum: Oral Wound Healing vs Chronic Non-healing Wounds, Presented by Maria Morasso, Laboratory of Skin Biology, NIAMS, Bethesda, USA on 22 February 2022
Support for travel and accommodation for health care providers from Member States with an insufficient number of patients or lacking technology or expertise to participate in the ERN-Skin live courses
- 15 participants
Mobility Programme
- 41 ERN-Skin healthcare providers have benefited from the ERN mobility programme
Measurable element 3.2.1 – The HCP team leads and/or participates in research activities and clinical trials, at both national and international level, within the ERN’s area of expertise.
Measurable element 3.2.7 – The HCP team is contributing to disseminate the ERN activities.
Please find the list of the ERN-Skin dissemination activities here.
Measurable element 4.3.1 – The HCP team uses a standardised information and coding system for rare or low prevalence complex disease(s) or conditions(s), agreed within the ERN.
The ERN-Skin, when possible at the clinical unit level, encourages the use of Orphacodes.
Measurable element 5.2.1 – The HCP team adopts and implements clinical practice guidelines and decision-making tools developed or adapted by the ERN.
Please find the list of the clinical practice guidelines and decision-making tools developed or adapted by the ERN-Skin here.
Measurable element 6.1 – The HCP team maintains its clinical competence in the ERN’s area of expertise.
This list of specific criteria will help you to answer the measurable element 6.1
- In 2016 and 2017, the chairs of the thematic group defined specific criteria for each ERN Skin group of diseases. Each ERN-Skin member has to fulfill these criteria. These criteria are realistic/reasonable while ensuring a high level patient management. They are based on the evidence and consensus of the scientific, technical and professional community.
| LIST OF SPECIFIC CRITERIA |
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Specific Criteria for ALLOCATE (Hidradenitis supportiva – PAPA, PAPASH, PASH, PASS, SAPHO – Behçet, Degos)
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Specific Criteria for Autoimmune Bullous Diseases
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Specific Criteria for Cutaneous Diseases related to DNA Repair Disorders & photosensitivity
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Specific Criteria for Cutaneous Mosaic Disorders – Nevi and Nevoid Skin Disorders and Complex Vascular Malformations and vascular Tumours
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Specific Criteria for Ectodermal Dysplasias including Incontinentia Pigmenti and p63-associated disorders
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Specific Criteria for Icthyosis and Palmoplantar Keratoderma
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Specific Criteria for Inherited Epidermolysis Bullosa High Level Patient Management Group
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Specific Criteria for Mendelian Causes of Connective Tissue Disorders
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Specific Criteria for ToxiTEN – Severe cutaneous drug reactions
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Measurable element 6.1.3 – The HCP team regularly collects, and monitors process and outcome indicators as established in the ERN.
- participation to internal meetings and conference calls
- participation to executive committee meetings (chairs of the thematic groups and Skin ePAG representatives)
- participation to board meetings (board members and Skin ePAG representatives)
- participation to thematic group meetings (thematic group members)
- contribution to survey on resources
- contribution to survey on patient needs
- Inherited Epidermolysis Bullosa and skin fragility syndromes – Darier, Hailey-Hailey
- Ichthyosis & Palmoplantar Keratoderma
- Ectodermal Dysplasias including Incontinentia Pigmenti and p63-associated disorders
- Mendelian Causes of Connective Tissue Disorders
- Cutaneous Mosaic Disorders – Nevi & Nevoid Skin Disorders and Complex Vascular Malformations and vascular Tumours
- Cutaneous diseases related to DNA Repair Disorders & photosensitivity
- Autoimmune bullous diseases
- ToxiTEN – Severe cutaneous drug reactionsAllocate – Hidradenitis suppurativa – PAPA, PAPASH, PASH, PASS, SAPHO – Behçet, Degos
- contribution to the definition of specific criteria to ensure high level of patient management
- participation to internal meetings and conference calls
- e-training development
- clinical practice guidelines development (including participation to the ERN Clinical Practice Guidelines (CPGs) and Clinical Decision Support Tools (CDSTs) Program
- clinical decision tools development (such as emergency cards and forms, tutorials, patient journeys, COVID 19 vaccine recommendations etc.)
- organization and hosting live trainings
- e-training development
- contribution as speakers
- contribution as member of scientific committee
- Contribution as scientific committee members or speakers for
- 2021 Scientific Day
- 2022 Scientific Day
- Monthly scientific webinars
- Contribution to the updates and modifications of ORPHA codes for the classification of rare skin diseases
- Contribution to the European Joint Programme for Rare Diseases (Pillar 2 “Innovative coordinated access to data and services for transformative RD Research and Pillar 4 “Accelerating the translation of high potential projects and enhancing the use of best methodologies for new therapies”)
- Contribution to the European Rare Disease Research Coordination and Support Action consortium (ERICA)
- Contribution to the monitoring for research activities that involve ERN-Skin members from two different Member States (clinical trials, observational studies, publications)
- Contribution to ERN-Skin publications
- ERN-Skin contribution to the ERN research group
- ERN-Skin presentation in congress and conferences
- Support to the international art contest to raise awareness on rare skin diseases https://thestoryofmyskin.org/
- National societies of dermatology
- National societies of pediatric dermatology
- European Academy of Dermatology and Venereology (EADV)
- EADV Genodermatoses Task Force
- EADV Autoimmune Bullous Diseases Task Force
- EADV Hidradenitis Suppurativa Task Force
- European Dermatology Forum (EDF)
- EDF Geneskin group
- European Society of Pediatric Dermatology (ESPD)
- Internatonal Society for Pediatric Dermatology (ISPD)
- European Hidradenitis Suppurativa Foundation
- Fondation René Touraine (FRT)
List of the HCP ERN-Skin selected to be visited for onsite audits
The objective of the audits is to obtain information on those criteria that the source of information is either an interview with patients or professionals or the medical record. Furthermore, the evaluation team can also include a document review session if they consider that the information included in the self-evaluation should be completed.
*For the guidelines to prepare onsite/online audits, please see p.120-124 of the “technical toolbox”.