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11 January 2016

11:00 – 13:00 PHE Wellington House, London

Present

TMG Members

Professor Julietta Patnick (Chair)

Professor Dame Valerie Beral

Mrs Claire Borrelli

Mrs Jacquie Jenkins

Professor Iain Lyburn

Ms Kath Moser

Dr Hongchao Pan

Professor Sir Richard Peto

Professor Malcolm Reed (by phone conference)

DMEC Members

Professor Janet Darbyshire

Professor Gillian Reeves

Ms Jenny Rusby

Visitors

Professor David Heymann (PHE)

Ms Anne Stevenson (PHE)

In attendance

Mr Keith Shaw

Ms Krys Baker

Apologies

Professor Kevin Fenton

Professor Sir Mike Richards

Dr Lucy Carpenter

Mrs Margot Wheaton

Dr Rosalind Given-Wilson (DMEC)

Professor Tom Meade (DMEC)

1. Welcome and Introductions

New members, Professor Iain Lyburn (Consultant Radiologist), Claire Borrelli (Radiographer and Education & Training Manager) and Jacquie Jenkins (National Breast Screening Programme Manager), were welcomed to the meeting. Visitors Professor David Heymann (Chair of Public Health England) and Anne Stevenson (National Programmes Lead for the Young Person and Adult Screening Programmes - representing Prof Kevin Fenton) were also welcomed. Introductions were made from all committee members.

Apologies were received from Prof Kevin Fenton (KF), Prof Sir Mike Richards (MR), Dr Lucy Carpenter (LC), Margot Wheaton (MW), Dr Rosalind Given-Wilson (RGW) and Prof Tom Meade (TM).

DH needed to leave the meeting early and so it was agreed to bring agenda item 4 forward.

2. Minutes of the last meeting (28th Jan 2015) and matters arising

The minutes of the last meeting were accepted as an accurate record.

Matters arising:

TMG members found the mid-year newsletter useful. A similar communication will be sent to TMG and DMEC members in 2016. There was a discussion about how many participants were required to produce a reliable result from the trial. It was agreed that randomisation needed to continue until the mid 2020s to inform policy.

The trial website is up and running with web address www.agex.uk

Action: Send mid-year newsletter to TMG and DMEC members later in 2016

4. Screening women throughout their 70s

  • The TMG agreed that scientifically it makes sense for the older women to be invited for additional screenings beyond 71-73.
  • It would take time for screening units to implement adding the older age group into their batches and there will also be implications on staffing and resources within BSU’s.
  • PHE said that the trial budget was fixed
  • The priority for PHE is to make sure that the BSUs prioritise the clinical work and do not miss their targets.
  • The PHE budget is currently being prepared for the 2016/17 financial year.It was agreed that the TMG need to see a breakdown of the funds being allocated to all units. PHE agreed to provide these figures.
  • Software would need to be written to implement any change.
  • Ethics approval would need to be sought for any changes.

Actions: A timeline was agreed as follows:

  1. In the next month the budget will be reviewed by PHE. They will provide the budget to the TMG well before April 2016.
  2.  In the next month Cancer Epidemiology Unit (CEU) will provide estimates of numbers of women in their 70s by BSU.
  3. IL, CB and JJ will assess the workload and clinical implications at the local BSU level.
  4. The application for ethics approval for additional invitations to women in their 70s will be prepared over the next month.
  5. 3-5 units to be selected to pilot extending screening to women in this age group. The pilot will begin when ethics approval has been granted and funding for the pilot is available.
  6.  A further pilot will be conducted in one of the units currently inviting all women aged 47-49 (paid for out of trial funds but not contributing to the trial) to assess the feasibility and acceptability of being requested to no longer invite this age group and withdrawal of the associated funds.
  7.  By March 2017 it was hoped that all participating units should be inviting for screening the trial women aged 74+
  8.  PHE to assess the possibility of providing screening on request for women aged 47-49 in BSUs not participating in the trial who are being requested to stop inviting all women in this age group for screening.

3. Trial Update

  • As at the end of December 2015, 65 out of the 69 breast screening units due to take part in the trial had started randomising. Of the 4 remaining units which had not yet started, 3 plan to commence randomisation in 2016.
  • 2.4 million women had been randomised as at Dec 2015
  • The study population data for the first 6 years of the trial was described. 10,229 screening batches had been randomised during this period, which included 1,974,712 trial participants. Currently around 500,000 women are being randomised per year.
  • The screening data for the first 5 years of the trial was described; date of first offered appointment, screening date, recall, biopsy, etc - for the women randomised in.
  • The surgical procedures data were discussed and further detail requested.

Action: Further information on surgical procedures (from HES if possible) will be prepared for the next meeting

It was confirmed that all screening is now digital.

Action: Self-referrals derived from screening history data to be prepared for next meeting.

Action: Uptake by breast screening units using routine screening data, to compare with trial data, to be prepared for next meeting.

Action: Use screening history data to investigate whether women invited aged 47-49 in the trial come back when routinely invited for screening aged 50-52.

6. Any other business

Future Publications

Interim analyses and publication of protocol requested by JP and KM. RP suggested that the protocol should be published in a major journal such as Lancet Oncology once the revision of adding the 74-79 age group has been approved. It was also agreed to add the protocol to the website once published, and in the meanwhile a summary may be added to the website once ethical approval has been obtained.

Meeting for participating BSUs

It was agreed that a meeting would be arranged during 2016 for all participating BSUs, to feedback information about the trial including some interim numbers.

Action: Arrange meeting during 2016 in Oxford for participating BSUs

HSCIC

The study is currently awaiting approval from HSCIC for release of HES data, the application is being reviewed in the next couple of weeks.

Leaflet (PIS)

When putting together the next ethics application, to include changed wording of the PIS to ask those invited for screening to cancel appointment if they do not wish to attend screening.

7. Date of next meeting

Feb 2017 KB will send doodle poll

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