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?

As the work on ECIBC proceeds towards its completion, the Commission has decided to start the development of a new initative on colorectal cancer.

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

The issue of potential conflict of interests is addressed methodically and rigorously. Conflicts of interest are dealt with along the Commission rules. 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. 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/or voting.

03. 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.

04. Is the European Commission competent on health?

The EU's action on health 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 develop a European quality assurance scheme for breast cancer services supported by evidence-based guidelines.

05. 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 evidence, covering the first two steps of breast cancer care (screening and diagnosis).

These European Breast Guidelines aim to:
1- provide women and healthcare providers with clear and objective information on breast cancer screening and diagnosis, and
2- guide healthcare managers and policymakers 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 internationally developed guidelines.

 

06. 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.

07. What is the issue?

The European Commission, upon the request of the Council of the EU (formed by the EU Member States governments’ Ministries), is developing the “European Commission Initiative on Breast Cancer” (ECIBC).

ECIBC has four specific objectives:

  • evidence-based recommendations on breast cancer screening and diagnosis (European Breast Guidelines);
  • a Platform of guidelines (Guidelines Platform) covering the breast cancer care processes after diagnosis;
  • a voluntary European Quality Assurance Scheme for Breast Cancer Services (European QA scheme);
  • European template of training on digital mammography.

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.

08. 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.

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

09. 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.

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

Breast cancer 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.

The EU takes action also to tackle other cancers, diseases and health related issues.

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

The first group of recommendations was published at the end of November 2016. All recommendations are released as they are finalised by the expert working groups and the full set will be made publicly accessible during 2019.

 

02. 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.

03. 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).
 

04. 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.

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.

More on methodology.

01. 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.

02. 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.

03. How are you developing the European QA scheme?

The Quality Assurance Development Group (QASDG) is a multidisciplinary team, selected through an open call,working on a voluntary basis. The QASDG represent an inclusive range of competences. The Group includes medical doctors, nurses, quality managers, healthcare managers, patients’ advocates, and legal experts. Under the co-ordination of the JRC, they work 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”. Overview of the methodology.

04. 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.

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