Frequently Asked Questions

The Frequently Asked Questions collected here have been developed from the perspective of women, patients and more generally not-specialist profiles. With your help we may increase this collection, so please do not hesitate to contact us if your question is not yet answered.

General Guidelines QA scheme

 

01. Does the Commission intend to set up similar portals for other diseases?

ECIBC focuses on breast cancer. The application of the ECIBC blue-print model for other common cancers or other diseases may be possible. As from 2017 the Commission has decided to start the development of a similar initiative focusing on colorectal cancer: ECICC.

02. How do you deal with possible conflict of interests?

The issue of potential conflict of interests is addressed methodically and rigorously: At the stake there are the reputation and validity of the whole Initiative. Conflicts of interest are dealt with along the Commission rules. And in particular, within ECIBC potential conflicts of interests are managed according to the rules of procedure.

Every working group member declares annually interests and those declarations are publicly available the respective team page. Based on those declarations, JRC performs a global evaluation to ensure that no unmanageable conflict exists. Moreover a specific declaration of interests is completed before each meeting addressing topics included in the agenda: if a potential conflict is detected, the expert may be requested to abstain from discussion and voting.

On top of this, and with the aim to maximise the independency of ECIBC, indirect measures are also taken: for instance systematic reviews, searches, feasibility studies, etc. are outsourced, and documents and databases are normally collected in a transparent way via open calls. 

03. How ECIBC will improve the current situation?

ECIBC provides high quality, evidence-based support for healthcare providers and health policies for breast cancer. In developing this Initiative, patients’ associations are involved in all aspects, permitting the future outcomes to be truly person centred. The requirements for the accreditation scheme will address patients’ needs: the feedback from citizens will be an essential element to be kept into account for preventive or corrective actions, for example via certification schemes requirements asking for the systematic collection and follow-up of breast cancer services users' views.

The completely restructured, dynamic, modular, web-based European Breast Guidelines have intelligent navigation and search options to mimic the patients’ walk-through the care stages.

This website will host information for citizens and stakeholders, dynamically incorporating feedback received from users.

 

04. How this initiative will help European women?

Breast cancer is the most common cancer in Europe: it is the leading cause of death from cancer in women in Europe (92 000 deaths in 2013 in the EU, EUROSTAT). But mortality rates still differ greatly across European countries and not always in proportion to incidence rates. Discrepancies in mortality rates are associated also to inequalities of care that must be corrected by the wider application of evidence-based guidelines and quality assurance schemes (European QA scheme).

Once the European QA scheme and the European Breast Guidelines will be publicly available on this website they could be easily used by patients and professionals.

On this very website women will find user-friendly information on where to go and how to receive care compliant with the most up-to-date European standards. Professionals and policy makers will find the most updated care standards for breast cancer screening and care, with associated tools and reference documents, most updated evidence based guidelines and, the digital screening training template to offer to professionals.

05. I am a general practitioner, how can I help my patients through ECIBC?

On this website you will be able to find updated information on breast cancer services certified according to the European QA scheme requirements and suggest your patients on where to go and how to receive care compliant with the most up-to-date European standards. You may also find tools supporting you in your dialogue with concerned women and their families and more in general useful information regarding breast cancer screening and care. 

06. I am a patient / someone in my family has breast cancer, how can I help her?

The European Commission supports and coordinates ECIBC aiming to reduce the burden of breast cancer and inequalities of care. However, the European Commission does not have a mandate to recommend any type of treatment for breast cancer in any of the EU Member States.

If you, or someone you know, have been diagnosed with breast cancer, you may find in this page some useful links but you should go to your doctor and seek there the information you need.it is important to find out what to expect from services, get information, practical advice and support where you live while waiting for the European QA scheme to be publicly available.

Once the European QA scheme will be operative, you will find on this website an updated list of those breast cancer services that demonstrated their compliance to the requirements.

07. Is the European Commission competent on health?

The EU does not define health policies, nor the organisation and provision of health services and medical care. Instead, its action serves to complement national policies and to support cooperation between member states in the field of public health. The EU works for better health protection through its policies and activities within the remit of Article 168 of the Consolidated Treaty of the EU. It is within this spirit that the Council of the EU has invited the Commission to initiate this ground-breaking initiative to develop a European quality assurance scheme for breast cancer services supported by evidence-based guidelines.

08. The ECIBC concept paper is dated 2015, will there be a new edition?

The ECIBC concept paper is being updated and will include feedback received from the online open calls and from the discussions within the experts working groups.

09. This Commission website is public or restricted?

The ECIBC web hub is public and thus open to everyone. The evidence based recommendations, grouped according to the clinical care process (e.g. diagnosis, treatment, follow-up etc.) will be publicly available on ECIBC.

10. What are the Guidelines?

Among the ECIBC’s objectives there is the development of European Guidelines for Breast Cancer Screening and Diagnosis (European Breast Guidelines) based on most up-to-date knowledge and evidence, covering the first two steps of breast cancer care (screening and diagnosis).

These European Breast Guidelines will:
1- provide women and healthcare providers with clear, objective and independent guidance on breast cancer screening and diagnosis, and
2- guide healthcare managers and policy-makers when planning and organising services for breast cancer screening and diagnosis.

For the successive steps of care (treatment, rehabilitation, follow-up & survivorship, palliative care), a Platform for breast cancer guidelines is being developed to host existing high quality and evidence-based recommendations.

For more detail on guidelines please visit the dedicated FAQs section.

11. What is breast cancer?

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumour that can often be seen on an x-ray or felt as a lump. The tumour is malignant (cancerous) if the cells can grow invading surrounding tissues or spread (metastasize) to distant areas of the body. Breast cancer occurs almost entirely in women, but men can get it, too. For more medical aspects please refer to the World Health Organisation.

12. What is the issue?

The European Commission, upon the request of the Council of the EU (formed by EU Member States governments’ Ministries), is developing the “European Commission Initiative on Breast Cancer” (ECIBC): a person centred action that will strongly impact on breast cancer care in Europe.

Our four 4 specific objectives are:
•    evidence-based recommendations: the European Guidelines for Breast Cancer Screening and Diagnosis (European Breast Guidelines);
•    a Platform of guidelines (Guidelines Platform) covering all care processes, from screening to end-of-life care;
•    a voluntary European Quality Assurance Scheme for Breast Cancer Services (European QA scheme);
•    European template of training on digital mammography for professionals.


ECIBC is supported by two working groups composed by medical doctors, researchers, patients and health authorities’ representatives, who joined on a voluntary basis. You can “meet” the members of the working groups in their specific pages: the “Guidelines Development Group” (GDG) and the “Quality Assurance Scheme Developing Group” (QASDG).


ECIBC is coordinated by the Commission’s Joint Research Centre (JRC), based on an agreement with the Commission’s Directorate-General for Health and Food Safety (DG SANTE) which holds the policy leadership in health related matters.

13. What is the Quality Assurance Scheme?

ECIBC is developing a Quality Assurance scheme for Breast Cancer services (European QA scheme) which will set the requirements covering every step of breast cancer (from screening to palliative care) based on the best available scientific evidence.

The European QA scheme puts the person’s need and sensitivity at the centre of its scope and therefore will be designed to include, beyond clinical recommendations, aspects such as patient values, communication needs and support. The European QA scheme will be piloted in selected breast centres around Europe to undergo a deep assessment on its functioning in different context and circumstances to correct potential weakness. Then it will become available to all on voluntary basis. The breast cancer services wishing to adhere to it will have to demonstrate the capacity to attain its requirements.

Once the European QA scheme will be operative, you will find on this website an updated list of those breast cancer services compliant to the requirements.

14. Which is the working method?

The working groups’ members discuss and draft the European Breast Guidelines and the European QA scheme either from “remote”- within virtual working environments - either face to face in meetings organised, generally, every three months.

The documents drafted by the Working Groups are then subject of open Calls for Feedback launched online. The Calls remain open for at least three weeks. The feedback collected is then again object of internal groups’ discussions until consensus is reached and the draft finalised.

15. Why breast cancer and not the other type of cancers?

The Council of EU aims to reduce the burden of cancer. But breast cancer requires rapid action: it is the most common cancer in Europe. It is the most deadly cancer in women: 1 out of every 6 women with cancer will die from breast cancer. In addition, incidence and mortality rates for breast cancer widely range across countries suggesting the presence of major inequalities, including diverse quality of care. Hence, the EU institutions recognised there is considerable potential to reduce the burden of such cancer and inequalities at European level.

But the EU takes action also to tackle other cancers, diseases and health related issues. At the JRC we are in particular engaged in working on rare diseases  and for the establishment of a European Network of Cancer Registries. Moreover ECIBC is designed to be a model that in future will be possibly used to create quality assurance requirements to be use by services caring for other cancers, such as for example colorectal cancer.

 

01. Who will own the guidelines contained in the Platform?

The Commission will request permission to host or link the guidelines in the Platform. The ownership of the guidelines included in the Platform shall be clearly stated and will remain with the respective developer as well as copyright and intellectual property rights (IPR).

02. When will ECIBC evidence-based guidelines be available?

JRC will publish the first group of recommendations from mid-December 2016. This is the indicative planning scheduled for the releases of the recommendations:
•    November 2016
•    April 2017
•    October 2017
•    March 2018

 

03. What will the Guidelines Platform contain?

The Guidelines Platform will include evidence-based recommendations for key breast cancer care processes after diagnosis, that is, for treatment, rehabilitation, survivorship, and palliative care.  The Platform will be as inclusive and comprehensive as possible while ensuring that contains only high-quality, evidence-based guidelines.

The recommendations will be identified through frequent searches run by the Iberoamerican Cochrane Centre and through open calls for guidelines. Therefore, there will be a process in place that will allow maintaining the Platform up-to-date.

This Platform, together with the European Breast Guidelines, will provide the evidence-base to develop the requirements and indicators of the European Quality Assurance scheme for breast cancer services.

04. What is the methodology to develop the Guidelines’ recommendations?

The Guidelines Development Group (GDG) prepared a list of well-built questions using the PICO structure (Population, Intervention, Comparison, Outcomes). A PICO question compares the effects (Outcomes) of an action (Intervention), for example, a specific medical examination, as compared to other action (Comparison), such as doing nothing, on a determined group of people (Population), for example, women above a certain age.

For each question, the Iberoamerican Cochrane Centre reviewed all the relevant scientific literature. Based on the evidence retrieved, the GDG used Evidence-to-Decision frameworks to formulate the final recommendations. More on the methodology.

05. What is the meaning of a ‘strong’ or ‘conditional’ recommendation?

The European Breast Guidelines develop the recommendations with GRADE. GRADE classifies the recommendations as “strong” or “conditional” according to several factors, such as the certainty of the evidence, or the values and preferences of patients.

In strong recommendations the guideline panel is confident that the desirable effects of an intervention outweigh its undesirable effects (strong recommendation for an intervention) or that the undesirable effects of an intervention outweigh its desirable effects (strong recommendation against an intervention).A strong recommendation implies that most or all individuals will be best served by the recommended course of action (GRADE Handbook). Therefore, all healthcare professionals should follow a strong recommendation unless a clear and compelling justification for an alternative approach is extraordinarily present.

In a conditional recommendation the desirable effects probably outweigh the undesirable effects (conditional recommendation for an intervention) or undesirable effects probably outweigh the desirable effects (conditional recommendation against an intervention) but appreciable uncertainty exists.
conditional recommendation implies that not all individuals will be best served by the recommended course of action, and that there is a need to consider more carefully than usual the individual patient’s circumstances, preferences, and values. For conditional recommendations healthcare professionals need to allocate more time to a shared decision making, making sure that they clearly and comprehensively explain the potential benefits and harms to the patient. Alternative names for “conditional” recommendations are “weak”, “discretionary”, or “qualified” recommendations (GRADE Handbook).
 

06. What do the European Breast Guidelines contain?

The European Breast Guidelines  include evidence-based recommendations for screening and diagnosis of breast cancer. The Guidelines Development Group (GDG), supported by the Iberoamerican Cochrane Centre, develops the recommendations according to the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. More on methodology

The European Breast Guidelines are web-based. Moreover, they have a modular approach, which allow updating each module of the guidelines as the new evidence emerges.

07. Are the European Breast Guidelines the new edition of European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis?

No. The GDG is not developing a new edition of any past guidelines.

The European Guidelines for Quality Assurance in Breast Cancer Screening and Diagnosis (2006) were an essential tool for professionals involved in screening and diagnosis. However, there will not be a new version of these guidelines. The technical aspects included in the 2006 edition (and 2013 supplements) will not be addressed by the European Breast Guidelines, but they will be covered by other documents included in the ECIBC web-hub.

01. What is the Quality Assurance Scheme?

ECIBC is developing a Quality Assurance scheme for Breast Cancer services (European QA scheme) which will set the requirements covering every step of breast cancer (from screening to palliative care) based on the best available scientific evidence.

The European QA scheme puts the person’s need and sensitivity at the centre of its scope and therefore will be designed to include, beyond clinical recommendations, aspects such as patient values, communication needs and support. The European QA scheme will be piloted in selected breast centres around Europe to undergo a deep assessment on its functioning in different context and circumstances to correct potential weakness. Then it will become available to all on voluntary basis. The breast cancer services wishing to adhere to it will have to demonstrate the capacity to attain its requirements.

Once the European QA scheme will be operative, you will find on this website an updated list of those breast cancer services compliant to the requirements.

02. If the European QA scheme is one, will its structure be too rigid to adapt to different women’s needs?

On the contrary: the European QA scheme is being developed with a person centred approach. While the medics and professional staff will be instructed by the scheme on the procedures, the women/patient will be informed at each step, empowering her of well-informed own decision-making.

03. What is the relation between ISO standards and the European QA scheme?

The European QA scheme will cover many healthcare processes, some of them will regard testing and examination activities. To ensure consistency along the processes, two main harmonised standards have been chosen: the ISO 15189:2012 (Medical laboratories -- Requirements for quality and competence) which specifies requirements for quality and competence in medical laboratories for the testing activities and the ISO/IEC 17065:2012 (Conformity assessment -- Requirements for bodies certifying products, processes and services). Both standards will be directly used by the National Accreditation Bodies: the first for accrediting testing activities (e.g. laboratories) associated to breast cancer services, and the second for accrediting certification bodies that should certify that that service fulfils all the specific requirements of the European QA Scheme. For more on ISO standards

04. What does the European QA scheme require? Which are the provisions?

The European QA scheme is a collection of requirements and indicators. Its implementation guarantees that compliant breast cancer services can offer to users (women, patients and carers) top quality and most updated procedures for breast cancer screening and care. The requirements focus on the person’s needs and are based on the most updated evidence-based guidelines. The European QA scheme will also provide doctors, nurses and healthcare professionals with the most updated professional best practices, with proven validity and accepted by the ECIBC experts after a third party evaluation according to rigorous pre-set criteria.
All the requirements will strive to reflect a right balance between the continuous improvement of quality of care and local feasibility and applicability of the scheme.

 

05. What does it mean that the European QA scheme application is voluntary?

The application of the European QA scheme is not mandatory by law. Interested breast cancer services can implement it on the basis of their resources, programme and will.

06. When the list of breast cancer services accredited by the European QA scheme will be published?

In 2018 the European QA scheme will be available to all interested breast cancer services (hospitals, clinics, diagnostic centres, etc.) in any Countries. The final version available in 2018 will be the result of a pilot phase to be conducted in 2017 in a maximum of 15 structures selected through an open call for pilot. The piloting phase will assess the functioning and feasibility of the draft scheme in different contexts and Countries and from the result we will be able to improve it, if necessary. The draft scheme manual may be made publicly available during the piloting phase. On this website you will eventually find all accredited breast cancer services as soon as they will implement the European QA scheme.

07. Which type of entity can apply the European QA scheme?

Any breast cancer service which covers the full extent of breast cancer management: from screening to treatment until palliative care.

08. How does the Commission control the effective compliance of a Breast Cancer Service with the European QA scheme’s requirements?

The inspections will be carried out by representatives of the national accreditation bodies and the conformity assessment bodies. These entities function within the European accreditation framework. The breast cancer service will be audited to assess its compliance with the European QA scheme requirements. Those services will be asked to collect indicators (data) that will be centrally evaluated and, if need be, the QA scheme may be revised. In addition, feedback from users.

09. How are you developing the European QA scheme?

A wide team of experts, the Quality Assurance Development Group (QASDG), who work on a voluntary basis, without been remunerated, have been selected through an open call with a transparent procedure. These experts represent an inclusive range of competences; in fact, they include medical doctors, nurses, quality managers, healthcare managers, patients’ advocates, and legal experts. Under JRC co-ordination, they are all pulling together their competences, working both from remote and in face to face meetings usually held every three months. Their discussions are carried out using a method called “Delphi Round”. When consensus is reached and then the draft published on this website, anybody is invited to give feedback through a public open call for feedback.

Overview of the methodology.

10. How do I know if the service I go for screening is compliant with the European QA scheme?

If it appears in list/map on this website it means it applies the European QA scheme. Moreover you will be able to see in their site the certification of compliance (conformity assessment).

11. How the accredited European QA scheme breast centres differ from the others which are not? / If my hospital is not compliant with the European QA scheme mean is not good enough?

If a breast cancer service applies the European QA scheme means that it implements the most updated evidence-based requirements and protocols and that its compliance is regularly checked and evaluated by external entities. In addition, it means that it is able to offer to its users the best quality services currently available.

If your hospital does not apply it yet, it just means that its management did not yet take the strategic decision to implement it for any organisational reason or because the small size of the structure does not permit to develop such complete care pathway then it has decided to refer breast cancer patients to other accredited structures.

12. What is the added value of the European QA scheme accreditation?

  • For the users (women and patients) choosing a European QA scheme accredited breast cancer service means: (1) having the guarantee to be assisted according to the best quality evidence-based criteria, (2) having the possibility to follow a person centred care pathway completely designed to meet the woman/patient’s needs and (3) receiving all necessary information and support to take aware decision regarding own health.
  • For the breast cancer services being accredited with the European QA scheme means: (1) meeting patients’ expectations for the highest quality healthcare, (2) benefiting from frequent audits and peer reviews aiming to constant improvement of the services offered, (3) being framed into a scheme which guarantees adherence to most up-to-date evidence-based requirements.

 

13. Does the European QA scheme guarantee also the professional personnel is qualified?

The European QA scheme is supported by three pillars: (1) evidence-based guidelines on screening and diagnosis (European Breast Guidelines), (2) Platform of Guidelines covering every process of breast cancer care, (3) Digital Mammography Training template.This last one is being developed for the radiologists and radiographers in the screening programmes and it is meant to be a requirement in the European QA scheme.