Transvaginal Mesh Case Record Review

Chapter 2 - Advance Planning

2.1 Once the Panel had been appointed, there was an expected 4-6 months before the Cabinet Secretary was to formally launch the Review. We regarded this as a good opportunity to undertake advance planning and preparations. This chapter outlines what these were. Our starting point was to consider how we were going to make the process workable, understandable and effective for those women who chose to engage with the Review, the tone that we wanted to set, and the framework within which we would work.

Trust and communication

2.2 These are central themes running through this Report. It is generally recognised that trust is an essential component^[43] for a positive and engaged relationship between a patient and their clinician. Conceptualisations of trust within a clinical setting tend to bear the hallmarks of competence and welfare.^[44] As such, they presume a level of professional, technical competence and that they will act in the best interests of their patient. This is also underpinned in ethics and the law. If the patient has trust in their clinician, this has been shown to have a positive effect on adherence to treatment and the continuity of care.^[45]

2.3 Conversely, an erosion or absence of trust can give rise to a spectrum of poor consequences including a reluctance to accept advice about treatment or therapies whose outcomes may be uncertain or high risk. More generally, low levels of trust within therapeutic relationships can also result in overall dissatisfaction with therapeutic options and clinical care. ^[46]

2.4 Like most relationships, those between a patient and their healthcare provider have changed and evolved over time.^[47] Such changes are influenced by a number of factors including changing societal behaviours,^[48] legal outcomes^[49] and clinical practices in themselves. Trying to understand how to promote trust and its clinical attributes has become an especially important part of modern and often complex healthcare.^[50] Studies have shown that a patient’s experience of illness, clinical care, management of possible outcomes and, importantly for this Review, the amount of knowledge that patients and their peer groups have acquired about their condition, can all affect their willingness to trust.^[51]

2.5 The Panel agreed that a significant reason for the commission of this Review had been the consequence of a breakdown of trust. We recognised that this could take several forms depending on the experience that each woman had. For example, a breakdown in the relationship between the individual and her healthcare provider(s) or, a breakdown in trust over her care more generally. Particularly important for us to understand was the evident lack of trust in what had been written in the women’s case records.^[52] Several participants referred to initially being unaware of, but subsequently acquiring more or conflicting information about, the adverse outcomes which may potentially arise following mesh surgery. Not only did this diminish their belief that the clinician was acting in their best interests, but also had an impact in lessening their belief and faith in their healthcare provision more generally.

‘I’ve lost a lot of trust in the NHS and that doesn’t just apply to mesh. It applies to everything’.

2.6 The Panel considered that, for the Review process to be as meaningful and effective as possible, it would be fundamental to find a way to establish, build and maintain trust: both in the individuals carrying out the Review, but also in the Review process itself. It was only the administrator and I who were going to be involved in all the initial and early-stage conversations with the participants. Since we had not met any of them before, this brought some advantage in that we were starting with a clean slate. Both the administrator and I have previous experience in meeting with people who shared a wide range of emotions, and we believed that we could draw upon this to help prepare us for the initial meetings. Being able to establish a relationship from the outset, free from legacy or previous encounter, was important.

2.7 Whilst we were able to put some level of preparation in place, every new project exposes those involved to new experiences and new learning, and we were unprepared for the enduring effect that some of our conversations with the participants have had, and continue to have, upon us. Themes arising from these conversations will be considered in Part ll of this Report.

Women and their healthcare

2.8 Our participants were going to be women who largely had concerns regarding trust, and who had also felt excluded more generally from decision-making regarding their healthcare.

‘Wherever you turn you just don’t feel heard. You really don’t. It’s like here’s another survey or here’s another whatever, you know? The wee bit of energy you’ve got you are trying to fight to help’.

2.9 There is a growing body of literature which attests to this, and it is not confined to experiences with mesh.^[53] Many of the women eligible to be part of this Review had also been interviewed for the Cumberlege Review^[54] where they had stated they were disbelieved,^[55] ignored,^[56] and/or not listened to.^[57]

‘When we’ve asked questions, I felt that they closed the doors and the patient has become the person who is at fault when all I did was I wet myself when I coughed and sneezed’.

2.10 It was necessary not only to try to understand what impact these experiences may have had, but also to recognise the doubts and scepticism that some of the women would have had when considering whether or not to engage in this Review.

2.11 In general terms, autonomy refers to a person's ability to act in their own interests and on their own values. The principles of autonomy and self-determination^[58] within a clinical setting have been extensively written about, but that does not mean that they are necessarily any easier to understand. In an attempt to bring about clarity and context, in healthcare settings, autonomy is often contained or quantified within a notion of what is referred to as ‘informed consent’ which will be considered in greater detail in chapter 8.^[59] In reality, autonomy should mean much more. It is also not a solitary principle. One person’s autonomy is dependent on relationships with others and the nature, equality, and experience of the parties within any encounter influences and impacts upon each person’s own autonomy.^[60]

2.12 As part of the Review process, we wanted the participants to feel they could discuss issues as fully and freely as they wished; matters that were important to them, and what they wanted to get from the Review process. This was not an exercise in ticking boxes but a continuum of dialogue and engagement. We wanted the women who participated to feel that we were listening to them and hearing what they were saying to us.

2.13 As discussed in Chapter 1, this was the first time that a review of this nature had been conducted in Scotland and as such, were finding our way.

Ideology behind the Review Process - Restoring Trust

2.14 We considered literature which touched upon issues of relevance to our remit, and we have been able to draw upon their content throughout our deliberations. Some literature was familiar to us, some less so. One recurring suggestion was to consider adopting an approach around the ideology of what has become generically known as ‘restorative practice’, we have refined the term a little to one of restoring trust.

2.15 The principles behind this ideology refer to the restoration of harmony, or repair of something or someone who has been harmed. Evolving throughout the 1990s, its application was originally seen more frequently within the criminal law and concepts of ‘justice’^[61] but it has also been used effectively as a means to rebuild relationships.^[62] It is this latter element that is pivotal to the Review process.

2.16 Whilst its origins may lie within the criminal law, its application has been diverse and used within healthcare as a means to share experiences. This has included the development of mental health services in England,^[63] but of particular interest in designing our Review, was a study from New Zealand in 2019, which focussed on hearing and responding to the lived experiences of those who had described adverse events following their mesh surgery.^[64] This study will be considered in more detail in Chapter 6 of this Report, but some analysis was undertaken following its completion which concluded that:

[The] restorative approach supported substantive, psychological and procedural needs to be met during the Listening and Understanding phase of the project. The preservation of dignity, validation of experience, and respectful communication was experienced by most people…. Inclusion of multiple methods for storytelling ensured that a safe and supportive environment was experienced by the majority.^[65]

2.17 Given the report of such positive outcomes, the Panel could see potential merit in applying the principles of restorative practice within our Review process albeit on a smaller scale. The Panel recognised the importance of providing an environment where our participants would feel as physically and emotionally comfortable as circumstances allowed to describe their experiences: a chance for them to talk, and for us to listen. This included having adequate time available to share their experiences, and to raise matters of concern to them.

Impact of Covid-19

2.18 Other aspects of advance planning were more challenging to oversee and the changing nature of the impact of Covid-19 was one of them. Whilst we had been planning for this Review, we had been in lockdown since March 2020. As we drew towards the end of 2020, there was, what turned out to be, some misplaced optimism that we would still be able to meet with the participants and as a Panel face to face. By January 2021, we had to accept that this was not going to be the case.

Use of online communications

2.19 Face to face interviews have long been the preferred technique for qualitative research such as this.^[66] We had originally planned to arrange generic locations with suitable private access and facilities, and invite participants to meet with us. Where these were held would depend on where the participants lived. Recognising that there may have been some participants whose current circumstances prevented this, we would have arranged to conduct the meeting in either a different venue (including a home visit if they wished) or by telephone. The most immediate consequence of the Covid-19 pandemic and the restriction on face-to-face meeting, was the need to find an alternative solution.

2.20 We agreed that meetings would be held via the Microsoft conferencing platform ‘Teams.’^[67] The use of Teams facilitated not only all meetings with the participants but also for meetings of the Panel, whose members were based in different locations across the UK. Communicating in this way is known to bring both advantages and disadvantages.^[68]

2.21 For the work of the Review, the main advantage was the flexibility it allowed in arranging and conducting meetings. There was no need for participants or for us as a Panel to travel to a particular venue and, since they and we could remain in our own homes, there was no risk of Covid-19 transmission. Being in familiar surroundings, without the need to configure rooms, it was also easier to address any needs that the participant may have had to keep them as comfortable as possible for the duration of the meetings. If the participant wished to have an advocate or supporter who was not residing in the same household, then this could also be safely accommodated.

2.22 It brought advantages for Panel meetings too. The five of us were in various locations across the UK,^[69] so it made it easier to for us to conduct our meetings with the logistics of travel removed.

2.23 The main disadvantages were due to the limitations that arise through engagement via any online communications platforms.

2.24 Any face to face interaction relies not only on verbal signals but also vital non-verbal signals, including, for example, gesture, posture and facial expression. There are many ways to pick up nuances of communication and conversation perhaps through the proximity of a reassuring nod or the reciprocity of a smile.^[70] The benefits of such interaction are well documented.^{[71] [72]} In contrast, using online platforms can result in a lack of spontaneity and reduces such interaction to one dimensional; whether it is through a laptop, personal computer or mobile telephone.

2.25 During these initial meetings, the biggest disadvantage that the administrator and I found was the lack of personal physical interaction between ourselves and the participants. Unsurprisingly, the ability to read body language, physical expression was significantly reduced or even lost altogether. During the initial meetings I was aware that I tended to exaggerate gestures of reassurance in an attempt to make a participant more at ease, due to the sensitivity and personal nature of the subject being discussed. We also attempted to supplement this online discussion by offering other means of communication. For example, we made it clear that participants were welcome to contact us either by email or by telephone. Many participants availed themselves of this invitation and we were able to maintain an ongoing communication with the majority of participants and about one third of these for two years. We continued to provide updates for those who chose not to avail themselves of this option.

2.26 Disadvantages of a more technical nature also had to be addressed, particularly that of online connectivity issues or lack of confidence in the use of the technology. Conducting a meeting which already had the potential to be stressful and emotionally challenging for participants was not helped by the enforced remoteness of our meetings and our engagement. There was an inevitability of network connectivity and issues relating to poor audio or video, or worse, being susceptible to being ‘dropped’ altogether. Whilst this was out with our control, it was not conducive to building rapport or confidence.

2.27 By the time we convened, as a Panel, all members had become quite familiar with forms of remote working in their professional lives, with some Panel members more adept than others. This mirrored our experiences in engaging with the participants; some of them were very confident in their use of technology and others a little more hesitant. In the latter cases, it was far from ideal to conduct an initial meeting when someone was struggling to hear or see us due to issues with their camera or microphones. In some cases, participants did not have access to a laptop or PC, so we conducted these meetings via their mobile devices.

2.28 Privacy and confidentiality of online meetings with the participants brought both an advantage and a disadvantage. Management of participants’ privacy and their data remained of paramount importance throughout this review. Given that we had chosen to record all interviews and then transcribe them, we considered carefully how we would record them and store that recording securely. We chose not to use the ‘record’ function available via Teams. Instead, we used a simple dictation machine so that there was no data stored in any virtual environment outwith our oversight or control. Prior to switching on the recording device, we introduced ourselves to the participant, and explained the purpose of the meetings and the reasons for recording and transcribing them. The participants could then ask any question prior to deciding whether or not to agree to proceed. It was only if, or when, the participants gave their consent, that we switched on the recording device. At the participant’s request it could also be paused at any time and restarted without disrupting the flow of our conversations. The recording device remained with the administrator at all times and once the meeting had been transcribed and confirmed as accurate by the participant, the recording was deleted.

The participants & decisions regarding the requesting and collating of their case records

2.29 Our remit was to speak with those who had decided that they would like to work with the Panel to have their case records reviewed. The Panel received a list of the names of 47 women who had previously met with the First Minister^[73] in November 2019, and had supposedly all undergone either a partial or full removal of their mesh. This was not in fact the case. This list correctly included women who attended the meetings, but the majority of those women did not have concerns about full or partial removal of mesh since they had not undergone either of these surgeries; their concerns lay elsewhere, and in the majority of cases, were much more broadly about the content of their case records. Given our original remit and terms of reference, we were not expecting to have to address this.

2.30 Given the importance of establishing trust and confidence as discussed earlier, one of our immediate tasks was to contact these women to reassure them that they were all welcome to participate in the Review, whether or not they had received surgery to remove either all or part of their mesh. The Terms of Reference subsequently had to be revised to accommodate this more complex remit.

2.31 This also meant that the case records that we were to review would no longer be focussed on just one aspect of the case records - namely the full or partial removal of mesh. For many women, their focus and concerns would be considerably broader, covering the spectrum of their care from their initial consultations and investigations, treatment options (including any conservative treatments), and initial mesh implant surgery, to any subsequent mesh-revision surgery and care.

2.32 This had significant implications for the scope and duration of our work. We were going to have to decide how we were going to request, retrieve and collate the potentially much larger volume of records required, to address the more complex concerns that some of the participants would be likely to raise.

2.33 The process which is generally referred to as a collation of medical case records draws together an ‘indexed bundle’ or bundles relating to some or all aspects of a patient’s health care. This usually involves filtering large volumes of information which can amount to hundreds and sometimes thousands of pages. Given that for some of the participants, their care spanned more than a decade, or across different Health Boards, or countries, in terms of volume, we knew that their case records were likely to be more towards the latter.

2.34 Case records usually comprise a mixture of handwritten or typed notes, images, and diagrams. To draw together large volumes of documentation like this requires an expert who can undertake this task with meticulous precision.^[74] It is also an extraordinarily time-consuming process. Whist the Panel had originally believed that we could undertake this task when it was anticipated that there would be a relatively small and focussed amount of case records to review, this was no longer the case. We did not have the capacity, or the expertise. At the conclusion of the Review, I remain unconvinced whether we would ever have had the capacity and required expertise to collate and index even the smaller and more focussed case records that were first anticipated.

2.35 The Panel agreed that we needed expert assistance and that we would require to engage a clinical collation records service. This would allow us to have professional expertise not only to assist in the retrieval of records, but importantly, given the volume of records that we would be required to review, to also collate and index those case records, making them more accessible, accurate and readable for the Review Panel.

2.36 We chose Clinco.^[75] Based in England, this removed them from the proximity of Scotland and any prior knowledge of the cases that would form part of our Review. They had not previously met nor worked with any members of the Panel. They also met the data protection standards within which we were to conduct the Review.^[76] Clinco’s Legal Director, Sarah Wallace and I met a number of times to discuss our remit and to create a bespoke provision which aligned to the terms of reference of the Review. Having discussed the nature, extent and scope of the work, it was agreed that that Clinco would retrieve, collate, index, paginate and provide chronologies for each individual participant. Their contribution exceeded our expectations and our initial brief and Sarah and her colleagues were a constant source of support and advice for the duration of this Review, not only for the Panel, but also in working in a collegiate, transparent and reassuring manner with the participants.^[77]