Transvaginal mesh short-life working group minutes: May 2020

Attendees and apologies

Attendees

• Terry O’Kelly, Scottish Government (Chair)
• Carolyn McKinlay, NHS Fife
• Klara Ekeval, NHS Forth Valley
• Craig Wheelans, NHS National Services Scotland
• Kelly Macdonald, TVMO Programme Manager
• Karen Ritchie, NHS Healthcare Improvement Scotland
• Alan Mathers, NHS Greater Glasgow and Clyde
• Christine Hemming, NHS Grampian
• Susanna Mendes, NHS National Services Scotland
• Irene Oldfather, The Health and Social Care Alliance
• Jackie Montgomery, NHS Greater Glasgow and Clyde
• Roseanne McDonald, NHS National Services Scotland
• Wael Agur, Independent
• Peter Fowlie, NHS Tayside
• Erin Fyfe, Scottish Government
• Kerry Chalmers, Scottish Government
• David Bishop, Scottish Government
• Alana Dickson, Scottish Government (note)

Apologies

• Sham Konamme, NHS Ayrshire and Arran
• Corinne Love, Scottish Government
• Brian Chittick, NHS Shetland
• Alexandra Stirling, National Services Scotland, ISD
• Marthinus Roos, NHS Orkney
• Colin Fischbacher, NHS Public Health Scotland
• Michelle Watts, Scottish Government
• Alexandra Rice, NHS Lothian
• Ans Khan, NHS Lanarkshire
• Heather Currie, NHS Dumfries and Galloway
• Ibrahim Alsharaydeh, NHS Highland
• Simon Nicholson, NHS Lothian
• Kate Darlow, NHS Borders
• Sara Davies, Scottish Government
• Margaret McKeith, The Health and Social Care Alliance
• Safia Qureshi, NHS Healthcare Improvement Scotland

Items and actions

Welcome and apologies                                                                                          TOK

1. The Chair welcomed everyone and noted apologies.  Members of the Group were reminded that papers for all meetings are confidential and are not for onward circulation until approved and agreed.

Declarations of Interest                                                                                             TOK

2. The Chair reminded Group members of the importance of maintaining accurate, thorough and up-to-date declarations of interest. The Chair asked if anyone had not completed a declaration or had any new interests to declare.

Minutes of meeting on 14 February 2020                                      Paper 1          TOK

3. The minutes of the meeting held on 14 February 2020 were approved, and the Chair confirmed that all action points have either been taken forward or are completed.

4. The Chair confirmed that members did not wish to add anything to the agenda.

Chair’s update                                                                                      TOK

5. The Chair provided an update on a range of issues:

SLWG report

6. The report produced by the Group was presented to Health Board Chief Executives at their meeting on the 10 March 2020. All recommendations contained in the report were accepted without amendment.  However, there was discussion about treatment time guarantee (TTG) and how this would be applied to the proposed national mesh complication service and patients referred for treatment.

7. As well as establishing a national mesh complication service, a key recommendation concerned reducing variation in pathways of care between Health Boards as well as in MDT structure and function. This was also highlighted in the TVMO report.

8. The importance of the patient voice and learning from “lived experience” was emphasised. The Chair noted an intention to ensure that women receive the service they want and need rather than simply accepting what they are given. 

9. The importance of communication and the impact of poor communication had been highlighted in the Scottish Health and Social Care Alliance report.  This led to a recommendation, noted by the Chair, that every service should take forward communication skills training with particular attention on developing empathy towards patients and shared decision making.

The significance of psychological trauma and its contribution to how mesh injured women respond was discussed. This will be considered further at the next meeting. Colleagues from SAMD have offered support with the aim of improving the experience for women. In addition, Irene Oldfather suggested that the PANEL approach could be a useful framework on which to build a communication strategy.

Action 9.1: Irene Oldfather to provide more information about PANEL.  This and the response to psychological trauma will be considered as agenda items at the next meeting.

Action 9.2 : Craig Wheelans and Roseanne McDonald to review provision of psychological support in the new mesh complications centre.

Action 9.3 : Chair to liaise with colleagues from SAMD

Update on the Mesh Fund

11. In the 2020 budget the Scottish Government announced a £1 million hardship fund to help mesh-injured women. The Cabinet Secretary issued an update on the 19th May to give more detail. The scheme, which will be administered by NHS National Services Scotland, will open for applications at the start of July 2020 and run until the end of June 2021. It is intended for women who had mesh surgery performed within, or on behalf of, a Scottish Health Board and who have experienced complications. Successful applicants will receive a one-off payment of £1,000.

12. The views of women themselves were key in deciding how best to use the funds available. The Health and Social Care Alliance canvassed a sample of women about the fund and how they felt it should be allocated. The view expressed was that each woman should be offered the same amount and this should be not be means-tested. Supporting evidence and confirmations will be requited consistent with other funds.

13. The application form and other documents are currently being finalised and will be made available closer to the scheme opening date. Another announcement from the Cabinet Secretary will follow.

Times article – Johnson & Johnson settlement

14. This was included for information. The Scottish Government does not intend to comment further.

Dr Veronikis

15. Following a visit to Dr Veronikis by the Chief Medical Officer and Scottish clinicians in November 2019,  a reciprocal visit was anticipated in spring 2020 in order to further develop professional relationships. The Chief Medical Officer has written again to Dr Veronikis to re-affirm her invitation and intentions.  At the time of the meeting there has been no response.

Update on the Specialist Centre                             Paper 2 & 3,  NSS , Paper 4 & 5, TOK       

16. NSS provided an update on the proposed specialist mesh complication service in Glasgow. There has been an ongoing dialogue with the team in Glasgow, and a Service Level Agreement (SLA) has been drafted (Paper 3). The Group noted this is an initial draft that will require modification.

Action 16.1 : Group members to read the MESH Complex Surgical Service - Service Agreement with NHS Greater Glasgow & Clyde (Paper 3), and provide feedback to Erin Fyfe by Friday 5th June.

Action 16.2 : Meeting to be arranged between the Chair, SG and NSS colleagues to review the content of the SLA.

17. The need to deal with Covid-19 has delayed NHS England making further progress with commissioning and establishing a network equivalent specialist centres. The Chair noted it will be important for the centre in Scotland to link with other UK centres to assure quality, to facilitate service improvement and ensure governance. A clinical collaborative involving all UK centres would be ideal.

Action 17.1 : The Chair, SG and NSS colleagues to liaise with NHS England

18. Management of Covid-19 has affected both routine elective inpatient and outpatient activity, with an inevitable impact on waiting times. Treatment of patients with mesh complications in the recovery phase from Covid-19 will be determined by clinical priority. Also, it will be important to take account of patient concerns, especially in those who have been shielding or are bereaved. In addition, and in relation to reservations raise by Board Chief Executives, opinion is being sought regarding the treatment time guarantee (TTG). It appears that to exempt the new service from the current TTG will require amendment of the existing legislation. Careful consideration is required and other ways of addressing the issue will be examined.

Action 18.1 : The Chair, SG and NSS colleagues to take forward

19. A peer reviewed paper detailing management of mesh complications by Scottish clinicians was tabled together with associated correspondence from Dr Agur (also published). A response from the authors of the original paper is required but the importance of scientific scrutiny and the need to build patient trust were emphasised.

Action 19.1 : Alan Mathers to liaise with authors and provide an update for the next SLWG meeting.

Action 19.2 : The Chair, SG and NSS colleagues to take forward

Mesh Database                                                          Paper 6 (& annexes)            TOK                                                                                        

20. Establishing a registry of surgical treatments of SUI and POP, together with information about their outcome is a key priority. This is being taken forward on a UK national basis with involvement of all stakeholders. Data relating to all procedures must be collected, mesh and non-mesh, as well as treatment of complications. The importance of integrating historical data into the new database is also recognised.

21. Colleagues in England are leading, and developing a database is a crucial initial/interim step. NHS Digital envisage a modular IT solution for this and the latest proposals were shared with the Group. This builds on existing IT processes and architecture, and trials will start soon.  Scotland, together with the other devolved nations, is actively engaged and work is on-going to address both data governance and data handling issues

22. The relevance of patient experience (PREMS) was highlighted as well as patient recorded outcomes (PROMS). Concern was raised about a lack of validated measurement and assessment of the former but work is on-going to address this. In the short term it was proposed that current surveys of patient experience should be utilised as this methodology is available and it will reflect behaviours as well as communication.

Action 22.1 : The Chair, SG and NSS colleagues to take forward

Transvaginal Mesh Implants Oversight Group (TVMO) Report                         TOK

23. Recommendations made by the TVMO were acknowledged a number have already  been addressed. Reducing variation in pathways of care is identified as a key issue and requires further action.

Action 23.1 : Development of consistent pathways of care to be added as an agenda item for discussion at the next SLWG meeting.

Action 23.2 : Chair to meet with Healthcare Improvement Scotland to discuss their future involvement.                                               

Case Record Review                                                                                    TOK

24. The Chair emphasised that the First Minister has committed to undertake a review of the case records of women who met with her in November 2019, and who raised specific concerns about the accuracy of written information that documents their treatment.

25. Work is on-going, involving co-design and co-production, on a process that will foster discussion, seek explanation and aid understanding for the women taking part. Involvement of relevant stakeholders, including Health and Social Care Alliance, RCOG, GMC and SPSO, was noted.

26. It is envisaged that women participating will be asked about the specific concerns they have and would like to be addressed, and the evidence they wish to be reviewed. This evidence will then be retrieved from their case records and it will then be assessed by a panel of clinicians. The panel, assisted by a Moderator will then meet to agree a consensus opinion. This will be presented to the participant in a face-face meeting with the Moderator and one of the clinicians. There will be the opportunity for follow up.

27. The women will be fully supported throughout and they will be provided with a written report. The process will be evaluated in a prospective manner.

28. Meetings with women will be held in neutral settings and will commence once Covid-19 restrictions allow.

Action 28.1 : Terms of Reference will be made available to the Group in due course.                  

AOCB and next meeting                                                                                          T O’K              

AOCB

29. None

Date of Next Meeting

30. Baroness Cumberlege is due to publish her report on the 8th July and recommendations will be important for the service. Meeting proposed for end of July 2020 but date to be confirmed.