European Commission Initiative on Breast Cancer (ECIBC) MEETING OF THE MONITORING & EVALUATION subgroup Somma Lombardo, 9 February 2017 (8.

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1 EUROPEAN COMMISSION DIRECTORATE GENERAL JOINT RESEARCH CENTRE Directorate F Health, Consumers and Reference Materials Unit F1 Health in Society European Commission Initiative on Breast Cancer (ECIBC) MEETING OF THE MONITORING & EVALUATION subgroup Somma Lombardo, 9 February 2017 (8.30am-10am) Minutes Document history Version Date Drafted by Comments 0 22/02/2017 Nicola DAVENPORT Initial draft version proposed by RETELL 1 28/02/2017 Nadya DIMITROVA To be approved by JRC 2 03/03/2017 Nadya DIMITROVA For comments from the participants in the meeting 3 21/03/2017 Nadya DIMITROVA Including comment from the participants in the meeting Page: 1 of 9

2 List of Participants in Annex I The Agenda is available at Meeting was chaired by Mireille Broeders This meeting was organised to discuss progress regarding review of screening indicators and collaboration with the QASDG to avoid overlap and ensure synergy. The following objectives had been set: - to discuss the draft protocol for the rapid review of screening indicators - to present a proposal for collaboration with the QASDG regarding the work related to screening indicators - to discuss the methods that will be used for selecting relevant screening indicators and reference ranges - to agree on how to move forward. The preliminary work done by CCIb regarding review of screening indicators was presented. CCIb looked at the published literature for implemented screening indicators, but it was suggested to include also published reports from established screening programmes. The purpose of reviewing reports from selected screening programmes is to identify the screening indicators that they use and as a next step to choose the most relevant ones, i.e. those that are most likely related to programme effectiveness. A list of selected countries with established screening programmes was proposed by the GDG experts to be considered in the review (Annex II). A discussion on the cut-off date for studies led to agreement on using 1990 onwards, as the earliest programmes started around As long time series as possible will be needed for the analysis of the associations between the screening performance indicators and the main outcome measure(s) of the population-based screening programme. Moreover, the time lag, unclear how long, between the screening performance estimates and its potential effect on the main outcome measure has to be considered. Regarding reports from the screening programmes, it was suggested to review only the most recent ones, because they usually contain time trends for indicators, and include reports from previous years only if necessary. Only indicators used in organised screening programmes will be considered; opportunistic screening indicators will not be reviewed. It was suggested that performance indicators related to professionals, e.g. radiologists, should also be included. QASDG responded that this aspect is being covered by the Training subgroup and by the QA scheme, which deals with indicators at the breast cancer service level. In contrast to this the GDG Monitoring and evaluation group is looking for indicators on the population level. CCIb will update the protocol for the review of screening indicators, considering the comments and decisions of the experts. Once a list of all available screening indicators has been created, the next step is to look at the relationship between the levels of selected indicators for performance of breast cancer screening programmes and breast cancer mortality trends in the countries that have published indicators so as to analyse the relationship between the two. Since the breast cancer mortality trends are dependent on the Page: 2 of 9 File Plan: File Name: Library > Joint space > Meetings > Minutes > February ECIBC_monitoring evaluationsubgroup_ minutes_final

3 trends in breast cancer incidence, this issue needs further discussion. Associations between levels of selected performance indicators and other relevant outcomes could be explored, as well. A methodology for such a study has not yet been developed, and input from methodologist was requested on how to perform the Consensus panels. Two separate protocols for consensus panels are needed 1) to select the most relevant indicators and 2) to select levels for the indicators, including modelling. It was proposed to use the EUROSCREEN literature search strategy to identify European studies on population-based screening programmes and their impact on breast cancer mortality (screening effectiveness). The GDG experts also had to decide which methodology to apply for selecting the relevant screening indicators from the list of all available indicators and how to collaborate with the QASDG in order to avoid overlap of the work and to ensure synergy. JRC proposed a strategy to address these issues (Annex III). It was suggested as a first step to describe the available indicators (e.g. type, purpose, nominator/denominator an example of an indicators sheet was distributed) and to evaluate them for their relevance, using Consensus panel. The next step would be to evaluate the relevant indicators for their feasibility, using evidence-informed Delphi methodology in order to set up an adequate reference range for each indicator, based on the results from the study for associations between levels of indicators and health-related outcomes. Several QASDG experts can participate together with the GDG in the Delphi rounds to ensure that the work done by both groups is not overlapping or contradicting. The experts agreed that a similar format for describing indicators, as shown in the example sheet, would be useful. However, Delphi methodology might not be suitable for setting reference ranges for performance indicators as they should not be based on consensus but on hard facts. Thus for identifying relevant indicators (already existing and including new ones) Delphi methodology might be suitable, but not for setting thresholds, so the proposal in Annex III was not adopted as such. Data modelling was suggested instead for setting reference ranges for indicators, which has to be discussed further. This requires a second Consensus panel and a second protocol, as mentioned above. Regarding timeline, it was agreed to discuss the indicators, identified by the review of published literature and screening programmes reports, in an extra meeting (possibly in June) separate from the all-gdg meeting in May Then also the protocol for the first Consensus panel should be available before the meeting in May 2017 in order to facilitate the selection of the most relevant indicators. Decision about data modelling for setting reference ranges for indicators has to be taken in the meantime and a second protocol has to be prepared and discussed at the June meeting. Summary report for the selection of indicators should be prepared after the June meeting. Reference ranges/thresholds could be compiled by the end of Page: 3 of 9

4 Action points Task Who is responsible Deadline Further develop the protocol for review of screening CCIb March 2017 indicators Final report on results from the review of screening CCIb April 2017 indicators Prepare indicators sheets and send to subgroup Subgroup co-chairs May 2017 members Draft protocol for Consensus panel in order to select Subgroup methodologist March 2017 the set of screening indicators (H. Schunemann) Develop protocol for Consensus panel to select the Subgroup methodologist May 2017 levels of the indicators, including modelling (H. Schunemann) Design and perform a study on associations between CCIb, GDG Summer 2017 levels of screening indicators and health-related relevant outcomes Facilitate communication between CCIb and GDG, and organise necessary meetings JRC Ongoing Page: 4 of 9

5 ANNEX I: List of participants B. Borisch, M. Broeders, X. Castells, L. Cataliotti, C. de Wolf, M. Follmann, L. Giordano, P. Giorgi Rossi, C. Kaufman, R. Mansel, L. Nystrom, V. Rodrigues, H. Schunemann, S. Siesling, A. Ponti, M. Autelitano GDG Monitoring and evaluation subgroup members absent S. Hofvind, A. Lebeau, R. van Engen, K. Young Other participants A. Bramesfeld (JRC), N. Dimitrova (JRC), P. Alonso Coello (CCIb), N. Davenport (Retell) Page: 5 of 9

6 ANNEX II: List of selected countries with established screening programmes Country Denmark Finland Germany Netherlands Norway Sweden UK Italy Spain Australia Canada New Zealand GDG member Peter Rabe Mireille Broeders Solveig Hofvind Lennarth Nyström Stephen Duffy Livia Giordano Paolo Giorgi Rossi Xavier Castells Website https://www.erasmusmc.nl/public-health/publicationscollaborations/reports/evaluatie-borstkanker/ https://www.kreftregisteret.no/en/screening/breast-cancer-screening- Programme/ https://www.gov.uk/topic/population-screening-programmes/breast Centre for Screening Monitoring (Osservatorio Nazionale Screening ONS-) https://www.ncbi.nlm.nih.gov/pubmed/ Regional programmes Regional programmes, such as: https://www.cancercare.on.ca/pcs/screening/breastscreening/ https://www.nsu.govt.nz/breastscreen-aotearoa Page: 6 of 9

7 ANNEX III: Collaboration with the QASDG Defining Screening Indicators Problem: Indicators for screening are both within the responsibility of the QASDG, developing the European QA scheme and the GDG Monitoring subgroup. How to avoid overlap and guarantee for synergies? Developing screening indicators GDG Monitoring group 1. Searching for indicators in major population based screening programmes (Germany, UK, Italy, Norway, others?) a. Criteria: indicator assesses quality and effectiveness of screening programme and is implemented. 2. Group indicators according to subject what they assess (which quality target? which quality potential?). 3. Work them up in indicator sheets, showing: purpose of indicator (quality target), nominator/denominator, variations of this indicator, type of indicator (process, outcome) 4. Evaluate indicators for their relevance to assess the quality and effectiveness of a screening programme. Methodology: consensus panel on understandability and relevance. A consensus panel rather than a Delphi panel (see methodology link_) is used for deciding on the relevant indicators for the following reasons: population based screening programmes are rather standardised across health systems, mandatory indicators are already implemented and have proven their relevance in these programmes. Thus it is not so much the question to develop new indicators, but to choose from the already implemented indicators those that are most relevant. Any new indicators identified in this process, will be worked up by Delphi-methodology of QASDG. 5. Evaluate indicators identified to be understandable and relevant for feasibility. Reference ranges key screening indicators should be set in relation to the reduction of mortality. Such indicators may have an enormous impact on European women because of a) the huge number of women undergoing screening in Europe and b) the political impact on the European Breast Guidelines indicator thresholds for national screening policies. Therefore, the choice of target values for indicators should be done with explicit methods. The GDG Monitoring group should: a. Propose a strategy for the identification of the best reference ranges. Sources may be: literature review (targeted to trials and/or observational studies and/or modelling studies), survey from major population based screening programmes, etc. b. Using an evidence-informed Delphi methodology in order to set up an adequate reference range for each indicator, on the basis of the results of searches at point a. Expert panel to work on screening indicators: GDG monitoring experts and screening experts from QASDG, at least one patient from GDG and one from QASDG. Developing screening indicators QASDG Be aware of indicators developed by GDG for screening Page: 7 of 9

8 Check whether from the literature review available to QASDG further indicators, in particular on "soft" processes related to patient-centeredness, to be also assessed at service/organisation level should be included. Check whether in respect to quality potentials further indicators would need to be developed, in particular on "soft" processes related to patient-centeredness. Develop these. Identify indicators understandable, relevant and feasible using the methodology already established in the QASDG for this. Expert panel to work on screening indicators: QASDG and max 3 experts from GDG monitoring group. Timeline: April 2017: Indicator sheets Early May 2017: Sending indicator sheets to group May 2017: Identifying relevant indicators Summer 2017: Compiling reference ranges December 2017: Training panel members early 2018: Delphi round reference ranges Jan 2018: Online Delphi round Feb 2018: Onsite Delphi round March 2018: Summary Report Page: 8 of 9

9 Annex IV: Processes for developing indicators for screening Page: 9 of 9

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