Transvaginal Mesh Case Record Review

Chapter 3 - Preparation of Documentation and Templates

Introduction

3.1 The Panel recognised that any initial communication would be highly influential as to whether a woman would decide to participate in the Review. We designed initial correspondence which took the form of a Letter of Invitation^[78] from the Moderator to participate in the Review which explained why the Review had been commissioned^[79] and what it would consider. The Letter of Invitation was accompanied by a consent form which, if returned to us, would confirm agreement to an initial engagement in the Review process. A short, Plain Language Statement, containing our terms of reference and remit was made available. These documents were approved by the Plain English campaign and received a ‘crystal mark’.^[80]

3.2 The Scottish Government launched a website ^[81] to accompany the Review on the 21^st February 2021. This coincided with the Cabinet Secretary announcing the start of the Case Record Review. The website contained information regarding names and designations of the Panel members, Terms of Reference and contact details. It also included a Declaration of Interests for each member of the Panel. I asked at the beginning of each meeting whether members had any new Declaration of Interests to declare which were then updated as required, throughout the work of the Review.

The First meeting

3.3 On receiving a participant’s agreement to be part of the Review, the administrator invited her to meet with us. As well as introducing ourselves, the purpose of these initial meetings was to provide a verbal overview of the purpose of the Review and encourage the participants to ask any questions. We then checked with all participants that they were still willing to continue to engage with the Review. These meetings allowed the administrator and I to get to know and begin to understand each participant’s lived experience and to identify where their concerns lay regarding their case records.

3.4 We found that some participants were wary of engaging in the process. Their initial questions often were around the independence of the Panel, our relationship with the Scottish Government and whether we had any potential association with the NHS or other government agencies.^[82] Out of the 47 women on our list who had previously met with the First Minister in 2020, 19 women contacted us, 18 of whom ultimately agreed to have their records reviewed. The 19^th participant wanted to meet with us to share some of her experiences but did not want a review of her case records. All 18 participants remained engaged with the review process until the culmination of our review of their records and the production and receipt of their individual report.

3.5 We encouraged all participants to have someone accompany them to these meetings. Seven participants were accompanied. Two had spouses present, one had one of their children with them and four chose to be accompanied by other women who were also participants in the Review. Prior to the start of our conversation, we asked each participant if they were comfortable having their supporters with them for the entirety of the meeting or if they would want some private time with us. All declined private time, and the supporter remained with the participant throughout the duration of our meetings. We could see the benefits for the participant, it appeared to give them confidence, assist them with recalling parts of their story and generally making them appear to be more comfortable engaging with us. The Panel considered if there might be any unintended consequences of being accompanied, in terms of independence, for example, or the ability to speak freely. We subsequently designed a form^[83] containing information and questions for the participant to consider so that they could decide whether this was best option for them.

We view this as a valuable part of the process and recommend the incorporation of appropriate support/ advocacy for any future case record review.

3.6 We wanted each participant to feel unhurried so the suggested duration of the initial meeting was two hours. We also wanted to make each participant feel that we were really listening, not least because we needed to understand where their concerns lay but we anticipated that, for some women, they would have to draw upon their emotional resources to tell us their stories. We did not want them having to retell a story because we were unable to recall some aspect of it, so we decided to record these meetings, transcribe them and return them to the participant for their agreement and any comment.

3.7 Some women had excellent recall and/ or had noted some details down in advance of the meeting. One participant had written exactly what she wanted to say to us and read it out. Others were a little more hesitant in their recall and the chronology of their treatment experiences were a little more fractured. This was another benefit of having recorded the conversation as we could then make sure that the transcript captured our conversations into a logical order which would make it easier for the participants to review. Some of the transcripts were 35 pages in length and our administrator transcribed each of them. Whilst a time-consuming task, many participants appreciated the cathartic nature of seeing their stories written down in such detail. The administrator and I found it invaluable in getting to know the participants and having a better understanding of what was important to them.

3.8 Finally, we wanted to provide reassurance that our engagement with the participants did not need to be confined to a ‘one off’ meeting but that we were able to engage with them in an ongoing capacity in whatever form suited them. We would work with them at their own pace, using their own words.

3.9 Once ready, the transcripts were shared only between the participant, the administrator and myself. Occasionally, having had time to reflect, participants provided additional information which had not been part of the original discussion. We included this in their file. Once a final version was agreed, we moved onto the next stage.

Information gathering

3.10 The next stage was to in-gather the issues that the participant wanted the Panel to review. Given that Clinco has the expertise in which information was essential to the retrieval of records, we agreed that they took the lead in drafting what we called the ‘information gathering’ form. Along with the transcripts from the meetings with the participants, and to present as full a picture as possible regarding any concerns, we agreed that we should be guided by the participants as to which areas of their mesh care and treatment that they wanted us to review.

3.11 We designed a template which contained first, boxes for essential details required for the retrieval of records. These included name, date of birth, community health index (CHI) number,^[84] name of GP/ surgery and location(s) where treatments took place. The following boxes then provided for areas that the participants wished the Panel to review. The template set these out in a chronological manner starting with ‘before treatment’ which included matters pertaining to information disclosure and consent. The next section considered ‘the treatment’ followed by a section ‘remedial treatments and aftercare’. Finally, there were template boxes for the participant to summarise where their concerns lay. These were subdivided into ‘completeness of your case records’, ‘accuracy of your case records’ and ‘any other aspect of your case records’.

3.12 We took the view that asking the participant to complete this form in their own words allowed a personal expression of their specific concerns. However, some preferred that I completed the form on their behalf, extracting the information from our first meeting and the resulting transcript. If this was the case, it was completed and then returned to the participant for approval. Once approved, the administrator asked the participants for confirmation that the form could be forwarded to Clinco.

3.13 This part of the process was facilitated solely by me and the administrator. Clinco had no engagement with the participants until the form was completed and sent to them.

3.14 This form was also approved by the Plain English campaign and received a ‘crystal mark’.^[85] Despite our best endeavours to keep the form clear and uncomplicated, we are of the view that some participants did find its completion an onerous and challenging task. Sometimes this was the practical consequence of not having access to a computer. Additionally, it did not view clearly on a mobile device. For others, it was simply the task of having to complete the form. We reflected on whether this could be streamlined in some way for any future work, but recognise it is a question of finding the right balance between providing the necessary level of detail to correctly identify and retrieve the relevant case records, whilst not placing an undue burden on the participants.

Consent form and questions and answer sheet for retrieval of case records

3.15 We wanted the participants to be absolutely clear which information was going to be retrieved on their behalf. It was agreed that, once Clinco had received their information gathering form, there would be a second consent form sent to the participants from Clinco that explained which case records would be retrieved on their behalf. It also served to introduce the participant to Clinco and to highlight the next stage of the review process where Clinco would have a more prominent role. The consent form was accompanied by an information sheet which explained how the records were to be obtained, and why. The participant was advised that they could withdraw their consent at any time and that their records would then be deleted. To avoid an over reliance on technology, this was sent by post to the participant with a stamped addressed envelope provided. We believed that this additional request for consent provided a further opportunity for the participants to ask any questions and to reflect on their continued engagement with the Review.

Digital transfer of sensitive information

3.16 Once Clinco was engaged with the participants, they adopted the same referencing format that the administrator had designed and used from the outset of the Review. To avoid identifying a participant by name, they were each given a corresponding participant number. This was allocated in terms of the chronological order of when they first engaged with us. The first participant we met became participant one and so forth. For all communications during the Review, we continued to use this identifier and reference format. All emails and communications between the Panel that contained sensitive information were sent as password-protected via a secure file transfer system. Throughout the Review, only Clinco, the administrator and I knew the names of our participants, as only the CHI number and the participant number were shared with the clinical members of the Panel.

Anticipated size of the case record files

3.17 To allow us to prepare and allocate time to review each set of records, the Panel had to have some understanding of the format and volume of case records that we were likely to receive. Based on Clinco’s experience, they advised us that case records would be indexed into volumes, of around 375 pages per volume. This was traditionally the number of pages which fit into a standard lever arch file, although it is now more common practice to create digital sets. The clinicians were familiar with reviewing records in a digital format, so we agreed that we would receive all records in this way.

3.18 File sizes depended on the extent of the medical history, which varied between participants. We anticipated that the files would be a minimum of 375 pages, and up to 2000 pages in some cases. This turned out to be a reasonable estimate as we requested in excess of 40,000 pages of records throughout the Review. We also recognised that case records are not purely text, as they can include handwriting, diagrams etc, and the size of a digital volume can vary between 10,000-40,000 KB. Any radiology files are much larger as something like a CT scan is very intensive with regard to digital storage space. These have tended, until very recently, to be kept on disc, but the pandemic has moved most users on to a secure portal link, which we also used.^[86]