Terms of Reference

A review of case records commissioned by the Scottish Government to address concerns about transvaginal mesh raised by women at their meeting with the First Minister in November 2019

Remit

The Transvaginal Mesh Case Record Review will consider the concerns raised by women about their medical case records. It is intended to address specific concerns about whether a woman has undergone full or partial removal of transvaginal mesh and aims to provide clarity on individual case records and the mesh removal procedure performed. The remit will be met by following the provisions contained within the Terms of Reference. In some cases, it may be appropriate to consider and address other concerns to ensure that all women invited are able to participate.

Terms of Reference

This review is intended for the women in Scotland who have had transvaginal mesh implants and who attended the meetings with the First Minister in November 2019[1]. The purpose is to address the concerns they expressed about their clinical care and how this is documented in their case records and/or how this care has been communicated to them. In particular, the review will address concerns about the clarity of documentation regarding full and partial removal of mesh. It is understood that some women who attended the meetings do not fall in to this category, and do not have concerns about full and partial removal of mesh. These women are also welcome to participate in the review, and the Panel will endeavour to address the different concerns that they have about their medical records.

The review is not intended as an examination of the women’s entire case history and will not make any specific recommendations about further treatment. For those women invited and who participate (referred to here as “participants”), the review will include an examination of the relevant case records and an open discussion with the reviewing team for the purposes of explanation and mutual understanding. There will be a subsequent opportunity, after a period of reflection, for any follow-up comment and questions. A written report will be provided for each participant, summarising the findings, which will then be added to their case records so that those involved in their future care are aware. Finally, and subject to the outcome of appropriate evaluation, consideration will be given to offering a review of this nature to other women who have had transvaginal mesh implants and who may have similar or other concerns.

If a participant is concerned about other aspects of their clinical care which are not addressed by their participation in this review, they should direct these concerns to the Health Board in the first instance. Information on how to raise a complaint with the Health Board will be made available to participants if required. Following this, if the participant remains dissatisfied with the response from the Health Board, they can ask the Scottish Public Services Ombudsman (SPSO) to investigate their complaint. Participation in this review does not affect the participant’s rights to raise a complaint or commence legal proceedings.

As the review is not intended to make any specific recommendations for further treatment, participants should continue to engage with their GP and clinicians to ensure that they receive the appropriate ongoing care.

Report

The Review will produce two outcomes :

  1. A report for each participant based on the Panel’s findings on their case records and subsequent discussion.
  2. A qualitative methodological assessment of the review process and its value.  The initial review (as described) will be regarded as a “proof of concept” to make practical recommendations for requesting, scoping, and conducting any larger future review.

Membership

The review will comprise of five Panel members. This will include three clinicians, a moderator and an administrator. Members of the Panel will be appointed on the basis of their individual attributes and expertise, including their knowledge, authority and stature, in line with the needs of the review.

  • Panel members services will be contracted to complete this work.
  • Each Panel member will be expected to make a contemporary and full declaration of their interests. These will be made available for scrutiny by the participant and other Panel members and will be placed in the public domain.
  • Panel members will conduct themselves in a professional manner. The opinions they express will also reflect this. Discussions within the Panel will be confidential and members will adhere to decisions made. The Panel will collaborate to achieve a consensus opinion.
  • Members of the Panel must express their own opinions which should be given in a manner which is independent of views expressed by their employers and other organisations.
  • The role of the moderator will be to foster an open and respectful environment, and maintain order during discussions.
  • It will remain the responsibility of the moderator to coordinate and compile each report with the input and agreement of the other Panel members.

The Panel

  • Moderator: Alison Britton – Professor of Healthcare and Medical Law, Glasgow School for Business and Society, Glasgow Caledonian University
  • Administrator: Irene Brown – Administrator, Directorate of School Professional Services, Glasgow Caledonian University
  • Clinicians:
    Professor Anthony Smith
    Professor of Urogynaecology (Manchester Academic Health Sciences Centre) and Consultant Gynaecologist, Manchester (retired)

    Mr Ian Currie
    Consultant Obstetrician & Gynaecologist, Buckinghamshire Hospitals NHS Trust : 1997 – Present
    Vice President RCOG – 2011-2016

    Dr Carey Lunan MBE
    GP, NHS Lothian
    Chair of Royal College of GPs, Scotland, 2017-2020

Structure and process of the review

The Case Record Review will be conducted in the spirit of the 2018 Britton Review[2].

  1. Women who attended or responded with their intention to attend the meetings with the First Minister in November 2019 and who had surgery involving the use of transvaginal mesh will be invited to take part in this review. Participation will be by return of a completed consent form, confirming the participant’s wish to be involved in the review.
  2. As noted on page one, this review is about discussion for the purposes of explanation and mutual understanding. This is not a legal or statutory review and does not in any way compromise a participant’s right to raise a complaint with the Health Board, the SPSO or to pursue litigation if they so wish.
  3. Women will be invited to a virtual meeting with the moderator, assisted by the administrator. The moderator will explain what the review entails and what it seeks to achieve. There will be ample time for discussion. These meetings may be recorded, with the participant’s permission, for transcription purposes only and then destroyed. A note of the meeting will be shared with the participant.
  4. Participants will then be asked to outline their area(s) of concern in writing, including what evidence they would like reviewed. A form will be provided to the participants to help provide structure. Participants are asked to return their completed form to the administrator.
  5. It is important that women feel supported and as such, participants are encouraged to have someone accompany them, for example a friend or relative. Advocacy nurses will be available through the Scottish Independent Advocacy Alliance for further assistance during the review process, should a participant wish.
  6. Participant’s form’s will be collated and reviewed by the moderator, assisted by the administrator. If required, clinical pagination services will be used to organise the case records.
  7. The relevant Accountable Officer will be the primary contact at the Health Board. Based on the concerns raised by the participant, entries in the case record will be obtained with the assistance of the Accountable Officer. The clinician responsible for the original case records will be made aware and given the opportunity to give their own perspective on the entries in the record[3]. Any comments made by the clinician responsible for the case records will not be shared with the clinical Panel until they have reached their initial decision. Thereafter any clinician comments will be available for viewing by the Panel to allow a consensus decision to be made in an appropriate context.
  8. Any information which identifies a participant or clinician, such as names and addresses, will be redacted. The CHI number will also be partially redacted to remove the date of birth. For this purpose, redaction will be obscuring the particular word(s) on the case records. This is so the Review Panel neither know whose medical records they are reviewing nor the clinician who was responsible. No other information will be redacted.  
  9. Redaction in this manner is a standard practice if records are being distributed for review and this will occur in the Health Board before records are passed to the moderator. If the Panel believes that something has been redacted unnecessarily or if something is perceived to be missing, the moderator will discuss this with the Health Board to resolve this. It is important to note that no permanent change will be made to the original entry in the record.
  10. The moderator, assisted by the administrator, will hold another virtual meeting with each participant after receiving the information from the Health Board[4]. There will be a discussion about the entries that have been retrieved from the Health Board to ensure that there is agreement on these before they are sent to the clinical Panel members for review. Participants may request to view the records that have been provided at this time. Again, this meeting may be recorded for transcription purposes only and then destroyed.
  11. Thereafter the redacted records, along with the participant’s form, will be shared with the clinical members of the Panel. They will appraise the material independently of each other and will contact the moderator for all matters if required. In every case, and within an agreed timeframe, each clinician will complete a clinical form to give their opinion. The form will be in Plain English and will be returned to the administrator.
  12. The moderator will review the clinical forms and liaise with the Panel as appropriate.
  13. A date will be set for the meeting with participants. Ideally this will be in person, face-to-face. However, with COVID 19 restrictions, there may be a need to work flexibly and these meetings may have to be held virtually. The process set out below will be adapted to fit a virtual setting if necessary.
  14. Written information will be provided to the participant in advance of the meeting including who will attend and how the meeting will be conducted (i.e. “what to expect”).
  15. Meetings with each participant will be preceded by a meeting of the Panel to consider opinion and reach a consensus decision. This and the subsequent meeting with the participant will each last no more than one hour. Physical presence of all Panel members will not be required. Once an initial decision has been reached by the Panel, any comments from the original clinician will be shared, discussed and included in the final participant’s report.
  16. A further meeting will be held between the participant, her supporter(s), the moderator and one clinician. The administrator will also be in attendance. The clinicians will share attendance at these meetings. The moderator will act as chairperson and will be responsible for ensuring a report is written and sent to the participant detailing findings, conclusions and agreements.
  17. The Panel will not make specific recommendations about further treatment.
  18. At the end of each meeting, “next steps” will be explained. This will include the opportunity for feedback or comment, once the report has been received. In addition, advice will be given about further options for support if this is required.
  19. If there are entries in the case records which are inaccurate or ambiguous, and which raise concern for the Panel, this will be conveyed to the Health Board Responsible Officer. There is a standard process in place to address concerns with regards to a clinician’s practice and the Responsible Officer would be expected to consider the evidence and take appropriate action[5]. The measures taken will be reported back to the Panel. If the Panel believed there was a major breach of normal practice, consistent with their professional responsibilities, they may report an issue directly to the General Medical Council (GMC), as Regulator. The action necessary will be assessed on a case-by-case basis.   
  20. The report that is produced for the participants by the Panel will be added to the participant’s case records. In addition and if necessary, the specific entry in the case records which requires clarification will be flagged so that those involved in a woman’s future care can see that they have taken part in the Review. There will be no amendments made to original records. This addendum will be made by the Health Board following liaison with the Responsible Officer. Health Boards will be asked to notify patients when this has occurred. Women will also be encouraged to have a copy of the report sent to their GP.
  21. Participants will be asked to evaluate the review by returning a standardised questionnaire. All participant feedback will be collated and presented as a report that will inform recommendations for an extended future review.

Considerations

Venue

It is our ambition to meet face-to-face with participants but it is recognised that this may not be possible due to the COVID 19 restrictions. If this is the case, we will hold the meetings virtually to ensure that participants can take part in the review.

It was previously envisaged that individual meetings would take place in a non-hospital setting in locations geographically close to the participants involved in the Case Record Review. The chosen venues would be fully accessible and any particular needs of the attendees taken into account.

Oversight of the review

i.          The Scottish Government has been involved in the design and production of the review. Once the review commences, the Scottish Government will not have involvement in the review itself, however, will still have responsibility for organisation of venues and other needs as appropriate.

ii.         The Case Record Review has been co-designed and co-produced with the major stakeholders and the Alliance who have been representing participant views.

The Terms of Reference have been subject to extensive engagement and discussion with stakeholders and advisory bodies. This has included the Alliance, the GMC, Accountable Officers, the Short Life Working Group on mesh complications, the Royal College of Obstetricians and Gynaecologists, the SPSO, We Consult, the Central Legal Office, Scottish Government and Panel members. This has helped to shape, redefine and clarify the review.

iii. The review will be led by a moderator who will act independently of Scottish Ministers.

Assurance and Complaints:

i.          Complaints raised about the Case Record Review will be dealt with by the Panel, in line with the SPSO model complaint handling procedures.

ii.         There will be a two stage approach to complaint resolution, and thereafter, the participant will be able to refer their complaint to the SPSO directly. Complaints about the Review itself will be handled by this process. However   complaints about the case records, or any other concerns about clinical care should be directed to the Health Board. The moderator will facilitate this. Thereafter, this complaint can also be directed to the SPSO.

Media arrangement

All the participants in the Case Record Review will be asked to respect a media embargo until the review has concluded. The start of the review process will be made public through a brief news release. No other information about the review will be given until the process has concluded and the final evaluative report published.

All media enquiries will be directed to the Scottish Government who will liaise with the Panel members as appropriate.

Discussion format and care of participants including ethical considerations

A short Plain English information sheet and accompanying infographic will be sent to each participant. This will detail the terms of reference, the remit of the Panel and process of the review. A consent form will accompany this information. It will be made explicit that participation in all or any part of the review is voluntary.

The consent form and privacy notice will detail the use of participants’ data.

Contact details will be provided so that there will be an opportunity to ask any questions and participants will be made aware that they can withdraw from the discussions at any time. The data collected will be stored securely, safely and in accordance with the Data Protection Act 2018. Confidentiality will remain an absolute priority.

[1] Those who responded with their intention to attend the meetings in November will also be eligible to participate.

[2] An Investigative Review into the process of establishing, managing and supporting Independent Reviews in Scotland – gov.scot (www.gov.scot)

[3] In rare cases where the Accountable Officer is also the responsible clinician, the relevant case records will be requested from a similar senior officer, such as the Medical Director.

[4] This virtual meeting is entirely optional.

[5] If the Responsible Officer is also the clinician responsible for the original case records, the Panel will approach a similar senior officer, such as the Medical Director.