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Putting Science into Standards: evidence-based quality assurance - an example for breast cancer

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 Introduction

The European Commission's Initiative on Breast Cancer (ECIBC) aims at establishing a set of essential and evidence-based quality requirements for breast cancer care across Europe while developing the evidence underpinning the scheme, namely the New European guidelines for breast cancer screening and diagnosis. This initiative responds to the Council Conclusions on reducing the burden of cancer (Council Conclusions on reducing the burden of cancer - 2876th EMPLOYMENT, SOCIAL POLICY, HEALTH AND CONSUMER AFFAIRS Council Meeting - Luxembourg, 10 June 2008) and it aims to mitigate the risks connected to inadequate quality of prevention and care.

The JRC was assigned the coordination of ECIBC by DG SANTE with the support of working groups and is in the process of developing a voluntary European quality assurance scheme for breast cancer services (European QA scheme), based on evidence (via guidelines) and underpinned by the Regulation (EC) No 765/2008 on Accreditation, ensuring its consistent application in all countries; placing the woman / patient at the centre of the process and ensuring that appropriate communication and involvement in decisions occur when and as needed.

The European QA scheme will encompass all breast cancer stages: from the first invitation to screening, to diagnosis, surgery, treatment and post-treatment, including rehabilitation, palliative and psychosocial care.

The implementation of the requirements of such a scheme would be not only important for auditees (breast cancer services, e.g. hospitals, medical and screening centres, etc.) and auditors, but mainly for patients, policy makers and reimbursement systems, industrial and academic research and many other stakeholders. The development of breast cancer care standards could play a role in helping to implement the QA scheme.

Understanding how to do this is one of the main objectives of this Conference that is fully in line with the European Commission Work programme for European Standardisation for 2015, where the need to bring together the knowledge and experience of 'clinicians and representatives of regulatory authorities, research and development as well as accreditation and standardisation organisations' is encouraged in order to develop European standards.

Therefore, the proposal of developing a standard based on evidence (via the guidelines and the QA scheme to be developed in parallel on breast cancer under JRC scientific coordination) and with a good potential of uptake, as linked to a European-wide project, can be considered as a basis for an enlarged and inclusive discussion on the way forward and a possible blue-print for other areas, like health technology assessment, health(care) data and health-related tools (e.g. satisfaction questionnaires, apps, etc.), and a bridge towards other already active standardisation fields, like the one on e-health / health informatics.
 

20 October 2015

11:15 - 11:45
Welcome & Opening
11:45 - 12:45
Key Note Presentations
Moderator - Ciarán Nicholl, JRC-IHCP-PHPS
  • The JRC perspective - The ECIBC: a useful example on how Guidelines, QA schemes and, potentially, standardisation can work together - Donata Lerda, JRC
  • The EARTO perspective - Experience of the Austrian initiative for a nationwide screening program to detect breast cancer - Prof. Christian Singer, Professor of Obstetrics and Gynecology, Medical University of Vienna – AIT / EARTO
  • The CEN-CENELEC Perspective - Standardization: an open and transparent process for the benefit of market and society - Karl Grün, Austrian Standards Institute (ASI)
13:45 - 15:40
Session 1: European Policies in the healthcare area and the European Commission Initiative on Breast Cancer
Moderator - Peter Churchill, JRC-Dir A
Rapporteur - Isabell Ladiges, Directorate-General for Health and Food Safety (DG SANTE)-C.1
  • 2003 Council Recommendation on Cancer Screening and the European Initiative on Breast Cancer - Michael Hübel, Directorate-General for Health and Food Safety (DG SANTE)-C.1
  • EU activities in the area of eHealth, interoperability and standardisation - Katja Neubauer, Directorate-General for Health and Food Safety (DG SANTE)-D.3
  • The best standard is the one you do not see - Hein Bollens, Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW)-B.3
  • EA European Accreditation support to the European Commission–Regulation 765:2008–NLF - Andreas Steinhorst, European co-operation for Accreditation (EA)
  • The ECIBC: Overview of QA schemes and ISO standards in Europe for breast cancer care - Silvia Deandrea, JRC - Aslı Ulutürk, JRC
  • Why the quality of quality metrics counts in healthcare: an illustration from breast cancer surgery - Prof. Stefan Cano, Plymouth University Peninsula Schools of Medicine and Dentistry - Prof. Leslie R Pendrill, Researcher, SP Metrology / SP Technical Research Institute of Sweden / EARTO
  • An Independent Patient point of view: the European Breast Cancer Coalition – Europa Donna - Susan Knox, Europa Donna
16:10 - 17:55
Session 2: The methodological framework for incorporating evidence in healthcare policies: the example of ECIBC as a neutral and collaborative platform
Moderator - Charlie McLaughlan, Deputy Chief Executive and Director of Clinical Quality, The Royal College of Anaesthetists
Rapporteur - Martin Underwood, Director, Warwick Clinical Trials Unit, Warwick Medical School, The University of Warwick

21 October 2015

09:00 - 10:55
Session 3: Stakeholders’ views, needs and expectations on how to promote the implementation of the quality assurance scheme for breast cancer services
Moderator - Karen Benn, Europa Donna
Rapporteur - Gian Luca Salerio, Italian Organization for Standardization (UNI)
  • How standardisation can contribute in Cancer care - Per Kr. Andersen, Norwegian Directorate of Health
  • Standardization and societal needs: ANEC experience - Michela Vuerich, The European consumer voice in standardisation (ANEC)
  • Challenges for Colorectal Cancer Screening–a biomarker with no standards - Stephen Halloran, Professor Emeritus, University of Surrey
  • Improving outcomes through quality certification of breast units - Alberto Costa, European CanCer Organisation (ECCO)
  • EC-JRC initiative on BCS: EA BCS WG accreditation / certification standards proposal for high quality care services: screening and diagnosis process - Jan van der Poel, European co-operation for Accreditation (EA)
  • The emergence of quality surveillance for breast cancer services in England over the last ten years - Simon Pain, NHS England
11:15 - 12:45
Session 4: Innovations, new technologies, future trends and perspectives
Moderator - Prof. Leslie R Pendrill, Researcher, SP Metrology / SP Technical Research Institute of Sweden / EARTO
Rapporteur - Stefano Rapi, AOU Careggi, Toscana & SIBiOC
  • Challenges of risk-adjusted prevention strategies for breast cancer - Rita Schmutzler, UniKlinik Köln
  • Implementation of nation-wide molecular testing in oncology in the French Health care system: quality assurance issues & challenges - Frédérique Nowak, Institut National du Cancer
  • From standardizing patients to standardizing for patients. Precision approaches to the "holistic" patient - Erik Briers, Past secretary Europa Uomo and patient advocate
  • New technologies in diagnostics - Claudio Galli, MedTech Europe
  • Standardisation needs for the measurements of genetic biomarkers - Liesbet Deprez, JRC-Institute for Reference Materials and Measurements (IRMM)
13:45 - 14:00
Event’s evaluation
14:00 - 15:30
Conclusions and open discussion for identifying and agreeing on a way forward and next steps
Moderator - Donata Lerda, JRC - Peter Churchill, JRC-Dir A
  • Session 1 rapporteur's presentation - Isabell Ladiges, Directorate-General for Health and Food Safety (DG SANTE)-C.1
  • Session 2 rapporteur's presentation - Martin Underwood, Director, Warwick Clinical Trials Unit, Warwick Medical School, The University of Warwick
  • Session 3 rapporteur's presentation - Gian Luca Salerio, Italian Organization for Standardization (UNI)
  • Round-table and open discussion (Different perspectives: Commission, Patients, Concerned services, Professionals, EA, CEN-CENELEC, etc.)
  • Consensus on roadmap and agenda for action
15:30 - 15:45
Closure of the meeting