Transvaginal mesh short-life working group minutes: July 2020

Attendees and apologies

Present

• Terry O’Kelly, Scottish Government (Chair)
• Corinne Love, Scottish Government
• Craig Wheelans, NHS National Services Scotland
• Ans Khan, NHS Lanarkshire
• Karen Ritchie, NHS Healthcare Improvement Scotland
• Cliff Sharp, NHS Borders
• Alan Mathers, NHS Greater Glasgow and Clyde
• Christine Hemming, NHS Grampian
• Margaret McKeith, The Health and Social Care Alliance
• Sham Konamme, NHS Ayrshire and Arran
• Klara Ekeval, NHS Forth Valley
• Jackie Montgomery, NHS Greater Glasgow and Clyde
• Roseanne McDonald, NHS National Services Scotland
• Peter Fowlie, NHS Tayside
• Erin Fyfe, Scottish Government
• David Bishop, Scottish Government
• Alana Dickson, Scottish Government (note)

Apologies

• Kerry Chalmers, Scottish Government
• Carolyn McKinlay, NHS Fife
• Wael Agur, Independent
• Susanna Mendes, NHS National Services Scotland
• Irene Oldfather, The Health and Social Care Alliance
• Brian Chittick, NHS Shetland
• Marthinus Roos, NHS Orkney
• Colin Fischbacher, NHS Public Health Scotland
• Michelle Watts, Scottish Government
• Alexandra Rice, NHS Lothian
• Heather Currie, NHS Dumfries and Galloway
• Ibrahim Alsharaydeh, NHS Highland
• Simon Nicholson, NHS Lothian
• Kate Darlow, NHS Borders
• Sara Davies, Scottish Government
• Safia Qureshi, NHS Healthcare Improvement Scotland

Items and actions

Welcome and apologies

The Chair welcomed everyone and noted apologies.

Declarations of Interest

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 29 May 2020

The minutes of the meeting held on 29 May 2020 were accepted as an accurate record.

Psychology, behaviour and communication 

Psychological trauma and response

At the meeting of 29 May, the issue of communication and how patients had been received when they presented with complications was discussed. This was also an important focus of the IMMDS Review.

The Chair introduced Cliff Sharp, Medical Director NHS Borders. Dr Sharp has an interest in psychological trauma and volunteered to help the Group when its’ report was discussed at a recent Scottish Association of Medical Directors (SAMD) meeting. The following points were raised:

• Psychological trauma should not be dismissed and is equally as important as physical trauma.
• Women are naturally and inevitably more suspicious and cautious following pervious negative experience. This can result from the poor communication, lack of empathy and understanding, as well as the poor outcome of a procedure that was intended to help them. It is vital therefore that subsequent care does not add to the trauma they have already suffered.
• Communication must be open, honest, and transparent. It might not always be possible to make care and treatment a good experience but it can be better than it has been previously.
• ‘Nobody cared’ is a common feeling reported by mesh affected women. Recognition of the trauma experienced and using this to inform our approach to care and psychological help is important. Women with mesh complications are not psychiatric patients, but it should be acknowledged that they have suffered psychological trauma and this needs to be managed alongside their gynaecological and other physical problems..

PANEL framework for communications

The Chair introduced Margaret McKeith, from the Health and Social Care Alliance, to provide information on the PANEL framework for communication, mentioned at the 29 May meeting. PANEL principles and a FAIR approach are at the core of all consultations that the Alliance carry out.

PANEL is a set of principles to follow when applying a human rights approach to communication:

• participation – everyone has right to participate in decisions that impact their human rights
• accountability – effective monitoring as well as effective remedies for breaches of human rights
• non-discrimination – all forms of discrimination must be prohibited and eliminated
• equality and empowerment – individuals and their communities should know their rights
• legality – needs to be recognised that rights are legally enforceable

These principles are supported by FAIR, which is an approach that allows their application (facts, analysing rights, identifying responsibilities, reviewing actions).

Action point 7.1: Margaret McKeith to provide more information about PANEL (prepared by the Human Rights Commission) for circulation to the Group.

The Chair reiterated that communication is crucial and noted that any treatment can fail and when it does, those involved will naturally be disappointed. However, this must not be compounded by a dismissive attitude towards patients. There are good examples from medicine and industry where skilful management and communication can produce positive outcomes from adverse events .

Roseanne McDonald noted that a workshop is being held in NHS GG+C prior to the opening of the new specialist centre in GG+C that will consider communication. The Chair suggested that Cliff Sharp and Margaret McKeith are invited to speak.

It was suggested that a patient with “lived experience” should talk at the workshop. There was discussion about how this could be best achieved and, it was suggested this could be combined with an academic review to examine how effective communication can improve surgical outcomes.

Action point 10.1: Margaret McKeith to consider this further. Cliff Sharp is happy to be involved.

Action point 10.2: Roseanne McDonald to discuss this and the timing of the workshop with the NHS GG+C specialist service.

The Chair noted that “lived experience” is extremely powerful in influencing clinicians, and commented this can be done sympathetically, for instance, by a recorded interview.

Chair’s update

The Chair provided an update on a range of issues.

Dr Veronikis

Dr Veronikis has responded to letters from the Cabinet Secretary and has now decided does not wish to engage with Scotland. A major impediment to him coming to Scotland has been the difference between expectation and the need for both regulatory and contractual compliance.

Dr Veronikis gave evidence to the IMMDS Review. The subsequent report highlights the need for collaboration by clinicians to reach consensus on how patients are advised about mesh removal, as well as the techniques used.

Mesh fund

The Chair advised that this fund is now accepting applications. Accountable Officers have received a letter from NSS informing them of this development.

International Archives of Urology and Complications (Authors response)

The Group noted the response from the authors that was published in April 2020.

IMMDS review

The Chair noted that the review and the report now published will have a major impact on the way care is delivered in the United Kingdom. Patient safety, regulation, consent and communication are significant topics addressed.

There was discussion about the relevance of the Report to developing the service in NHS GG+C. The lack of evidence and consensus regarding mesh removal was highlighted. NSS has discussed this with NHS England and a clinical meeting to build consensus is planned for the end of September. Scottish clinicians will attend.

The review also contained details a high vigilance protocol for mesh removal, with emphasis on shared decision making and consent, as well as the need for a decision aid. The Chair noted that NHS Lothian produced a document on mesh complications which had been accredited by the TVMO Group. The development of a single decision aid for use throughout the UK will be crucial. The decision aid for primary surgery produced by Dr Agur and NHS A+A was complimented by IMMDS and it is important they are involved in future work.

Action point 20.1: Roseanne McDonald to discuss a high vigilance protocol with NHS GG+C and incorporate it into it to the service level agreement for the new specialist centre.

Action point 20.2: Karen Ritchie (HIS) to engage with RCOG/BSUG and NICE to determine if they are developing a relevant patient decision aid. Karen Ritchie to liaise with NHS Lothian regarding their information document for complications.

Action point 20.3: NHS England are holding a meeting with patients and clinicians regarding shared decision making. Representatives from the NHS GG+C specialist centre are attending this meeting. Roseanne McDonald to look at attendance and if this can be broadened.

The Chair commented that Queensland, Australia, has established a complication service and noted that most of the women who have engaged with the service have not undergone mesh removal surgery, but instead have benefited from social and psychological support.

The need for research into the long-term outcomes of surgical and non-surgical treatment of mesh complications was discussed. Craig Wheelans will take this forward.

Action point 22.1: Craig Wheelans to work-up research proposal

Update on the specialist centre

The Chair invited Roseanne McDonald and Craig Wheelans to provide an update on development of the Specialist Centre:

• work is ongoing with NHS GG+C to complete the SLA and establish the service in line with the COVID-19 recovery programme
• recruitment is underway and it is expected that the service will have the required multi-disciplinary team by early 2021
• Scottish Government officials and NSS are working with NHS Digital to develop a database and registry of pelvic floor surgery, complications and mesh removal
• a workshop is planned with NHS GG+C and referring Health Boards to ensure that the referral process is suitable for both clinicians and patients. In-person referral by clinicians to the receiving MDT is proposed and was supported by the Group. A protocol for cross-border referrals will also be established for women who would like a second opinion or who do not wish to access the service in Scotland. This workshop will also look at how an effective MDT functions and what development is required in the new specialist centre to achieve this
• surgery is only part of the care pathway for women with mesh complications. To ensure high quality care can be accessed across Scotland in an equitable fashion, NSS are looking at developing clinical networks. The Alliance and HIS will provide guidance where appropriate
• following discharge from the specialist centre, care will then be provided as close to the patient’s home as possible. The need for collaboration and careful liaison between local services (chronic pain, psychology and gynaecology) and the specialist centre was highlighted, and there will need to be robust and clear lines of communication. Development a “hub and spoke” model of service and care delivery is required and this was encouraged by the Group

Following on from earlier discussions, the importance of having a psychologist with experience of trauma as part of the specialist service MDT was emphasised and this will be explored.

Action points 23 and 24: Craig Wheelans and Roseanne McDonald to progress.

Mesh database

The Chair advised that Paper 2 had been shared with the Group by NHS Digital and was not for onward circulation.

The Chair noted that Scottish Government officials had been engaging with NHS Digital on the development of a UK-wide mesh database/registry. The database will be modular in nature and will capture the necessary patient demographics, surgeon and hospital details, both clinical and operative Information.

Information will be obtained for all operations performed in the United Kingdom. This will allow comparison of outcomes and review of performance, both essential for quality assurance and quality improvement.

The Chair confirmed that funding for the database has been agreed and there was a firm commitment to take this forward.

NHS Grampian and NHS Fife have indicated they are willing to participate in a pilot. Christine Hemming, Accountable Officer in NHS Grampian, has offered to lead a working group with assistance from clinical colleagues as well as ISD, Scottish Government and others as appropriate. It is important that Accountable Officers are engaged in this work.

Information from all interventions for SUI and POP will be captured.

Action point 29.1: Christine Hemming to liaise with Roseanne McDonald on working group.

Case record review

The Chair gave a brief update on the Case Record Review. Through dialogue, this is intended to provide explanation and understanding for a group of women who have raised concerns about their mesh removal surgery and how this has been documented. The Chair noted that the issue was described in the IMMDS report and possible misunderstanding caused by reliance on confusing terminology was highlighted.

Accountable Officers were reminded that they will be contacted and have previously agreed to help provide the evidence that the women want reviewed by the Clinical Panel. Patient and clinician identifying information will need to be redacted appropriately before being forwarded by the Health Board.

AOCB

None.

Next meeting

Date of next meeting to be confirmed.