Transvaginal Mesh Case Record Review

Chapter 8 - Communication, Clarity of Language, and the Process of Information Disclosure and Consent

Introduction

8.1 The importance of communication which is accurate, transparent and understood is the foundation of good clinical care. It applies to a broad range of situations including a common understanding in the use of language and terminology. It also applies to the giving or withholding of consent by people being offered care. Patients expect and are entitled to receive information about their clinical care and can only make an informed decision if they have sufficient information regarding their treatment, any alternatives, and potential risks. They are also entitled to access information that is stored about them in their clinical case records.^[197] How to achieve this, and many other aspects of good communication, is not without its challenges and guidelines can be found both within clinical professional guidelines and the law. This chapter will consider some of these, first more generally, and then specifically in relation to the Panel’s observations and findings following our review of case records.

Clarity of language

8.2 The importance and benefits of using clear and understandable language between a clinician and their patient are well documented. ^{[198] [199]} NHS Scotland has produced a Health Literacy Action Plan for Scotland. ^[200]

8.3 Literature suggests that a significant number of patients leave a consultation unclear as to what has been discussed.^{[201] [202]} It has been generally recognised by medical and nursing Royal Colleges and other health professional bodies that the use of medical ‘jargon’ may be both confusing and unhelpful^[203] and that the use and understanding of a term by a healthcare professional may not be how it is understood by a lay person. The Royal College of GP’s undertook a study in 2014 noting that,

“Doctors can unintentionally use words that are unfamiliar to their patients, without realising that the meaning is not clear. Some concepts familiar and obvious to doctors may be alien to patients.” ^[204]

8.4 This Report has already considered the impact of the loss of trust and how it pervaded so many aspects of the participant’s healthcare and experiences. Since we recognised this, the Panel sought to understand ways in which trust could be re-established. We believe that precise and commonly understood usage of language is imperative. When reviewing the case records, the Panel considered whether what we agreed would be commonly understood usage of language had, in fact, been used. ^[205] There were a number of matters which arose in the review of case records which were reliant on the use, clarity and understanding of language and the Report will consider each of these in the chronology in which they occurred.

Pre-surgery communication

Terminology regarding TVT and TVT-O

8.5 The Panel observed two issues here: firstly, how the mesh devices themselves are defined, and secondly, how they are defined and explained to patients by their clinician.

8.6 With regard to the first, if patients are to receive a polypropylene mesh device – they will receive one of two types, both of which were previously commonly used to treat urinary incontinence. Both are very similar in their name, but have important differences in terms of how they are surgically placed. One is a Tension Free Vaginal Tape (TVT), the other is a Tension Free Vaginal Tape – Obturator^[206] (TVT-O). Both types became widely available as commercially produced kits^[207] and were named and defined by the industry^[208] that created them.

8.7 The surgery required to place these devices differ. The TVT requires two small cuts in the lower abdomen above the pubic bone while the TVT-O requires two small cuts in the groin area. Hence the Panel recommends that the difference between these two procedures (and therefore their potential complications) needs to be made explicit during the consent process.

8.8 When we reviewed the case records, we observed in some cases that the counselling that a patient received prior to surgery used these nomenclatures interchangeably, which was incorrect and created confusion. Given the difference in surgical procedures and the risk attached to each, clear and unambiguous counselling should have been given regarding the difference in these devices and the nature of the surgery that is required to implant them.

8.9 The second issue is the reference ^[209] to the devices being both referred to as a ‘tape’ and a ‘mesh’. Part of this can be explained because ‘tape’ was part of the name given to these devices by the industry who created them (transvaginal tape or transvaginal obturator tape) so clinicians may have been more familiar with that term. However, this matter highlights the importance of language, and how it would most usually be understood in common parlance. When described to them, women spoke of hearing the word ‘tape’ and visualising something completely different; ‘a wee bit of tape didn’t sound too bad’ and did not associate what was being described to them as polypropylene mesh device. They were not informed of the size the device.^[210] Significantly, only one of the women was told that this was a device which was designed to be permanent and not to be removed.

8.10 One woman spoke of having a ‘procedure’ with no explanation that this involved any form of implanted device.

8.11 None of the women involved in this Case Record Review were shown an example of the device that was going to be used. The Panel recognise that many women would want to visualise the device that is going to be inserted and the ‘feel’ of the mesh, and that they should be offered the opportunity to see it prior to surgery.

The ‘gold standard’

8.12 All of the participants in this Review reported having urinary incontinence.^[211] 16 out of the 19 women we spoke to said that mesh surgery was described to them as the ‘gold standard’ treatment which would alleviate their symptoms. One lady said it was described to her a ‘miracle cure.’ Women were advised that a significant benefit of this type of surgery was a significantly reduced time in hospital (from a couple of weeks with previous ‘gold standard’ and more complex colposuspension surgery, to having their surgery as a day-case procedure). For those with family and work commitments, as all of our participants had – this was, understandably, a very attractive option.

‘It’s such a minimal thing. You know, it’s literally the choice of the burch^[212] which was going to keep me off work for 6 weeks. I had newly qualified.’

‘I was told it would be really quick. It would be between 20 minutes and half an hour and how it would improve my quality of life. I was told it was the Gold Standard procedure. [The surgeon] really sold it to me because I remember going home and saying to myself this sounds absolutely amazing.’

8.13 So why was this procedure described in such terms? The answer may lie in that not only was the early information that was given to patients largely informed and written by the industry that created the device, but critically, it was described using only positive language. This was because there appears to be no requirement for the information to be explicit regarding disclosure of potential risks.

‘Pharmaceutical manufacturers must include clinical trial evidence, including risks, on the Summary of Product Characteristics (SmPC). Yet there is no specification that device manufacturers need disclose all risks in corresponding Information for Use (IFU) leaflets.’ ^[213]

8.14 The term ‘gold standard’ was quickly in common usage, to such an extent that it features as part of the titles in clinical and legal research ^[214] and can be seen in countless others within the body of their texts.

Mesh revision surgery

8.15 We have used the term ‘mesh revision’ both in our individual reports sent to participants and also in this Report. We use it to describe any surgery to repair, or to remove, part or whole of the mesh device.

8.16 If a case record documents that there was a ‘complete’ removal of mesh, or that mesh was removed in its ‘entirety’, to a lay person (and to most clinicians) this, not unreasonably, would be understood as total removal. That is to say all of it has been removed. From a specialist clinical perspective, the Panel recognise that the language may not necessarily mean the same thing. This may depend on the type and extent of surgery undertaken. If a vaginal-only procedure is performed, only the vaginal or sub urethral portion of the mesh can be removed. ^[215] If the surgical procedure has not involved groin incision or dissection, then no part of the groin portion has been or can be removed.

8.17 The Panel found that in some cases, there was a significant confusion, misunderstanding or inaccuracy in terms of what was documented in the case records and what the women (and some of their clinicians) understood. The women were expecting an outcome which could never have resulted from the type of surgical procedure which was, in fact, undertaken. Again, it is worth reiterating that the Panel only had access to what is written in the case records which may exclude aspects of verbal communication.

‘[On telling a friend], I’ve had a full removal and she said have you got groin incisions? She said let me see and she said that’s not full removal… and she asked if I had any pictures and I sent her a picture. It was confirmed that I had a partial[removal] and my world just fell.’

8.18 The type of surgery to be undertaken has to be made explicit to the patient in any procedure undertaken. Failing to do this mean that the patient does not have all of the material information and therefore cannot make a fully informed decision regarding whether or not to agree to the type of surgery being proposed.

8.19 We are aware that we have said this throughout this Report but it bears repeating - a further consequence of a failure to clearly communicate is the impact that this will have on the patient-clinician relationship. Trust may be diminished or eroded altogether. It is vital to be clear from the outset about what the patient should expect following a surgical procedure and that they are informed, as soon as possible following the surgery, of its outcome. If the patient is left uncertain, they may subsequently turn elsewhere for information for example, to social media, to other women who have had the surgery, or to established support groups. Although the Panel recognised the significant support that these options can potentially bring, we cannot underestimate the lasting impact of the erosion of trust or the patient’s willingness to engage in the future with healthcare, should they then experience adverse outcomes. This results in patients not being given the opportunity to discuss the medical, surgical or psychological treatments that are available to help them.

8.20 Some of the case records documented discussions where the participant was advised it was not possible to remove all of the mesh. We reviewed a case record which stated that it ‘cannot be guaranteed to obtain a 100% removal’. This is not correct. Whilst the mesh revision surgery may not be without challenge, it is not accurate to say that the totality of the mesh cannot be removed.

8.21 Some records provided more of a mixed message noting discussions and counselling with the patient that they would undergo a ‘total’ removal of mesh, with subsequent documentation in the operation note that ‘most’ of the mesh had in fact been removed or ‘as much as was possible’ of the mesh had been removed.

‘Every time I saw [the surgeon] who said “‘Well, I’m not really sure how much is left”’. I said “My discharge letter says about 1 mm” and [the surgeon] said “Well, no. We had 6 cm from your right side and 4 cm from your left”.’

8.22 One participant recalled waking up from the anaesthetic, and seeing the surgeon giving them a ‘thumbs up’, and saying that it had ‘all gone’. In some cases, it was difficult to ascertain from participant’s case records when exactly they subsequently became aware that all of their mesh had not been removed.

8.23 All of these women described their euphoria in believing that all their mesh had been removed, and their profound disbelief and dismay when they found that this was not in fact the case.

8.24 The Panel are in complete agreement that operation notes must exactly reflect the complexity and outcome of the surgery. If a dissection has been difficult there has to be absolute clarity about this in the surgical notes, even if that clarity involved uncertainty with regard to outcome. If it is stated in the surgical notes that there is confidence that all the mesh has been removed, then that must be accurate. If there is uncertainty, then that should be clearly documented too – and subsequently explained to the patient. It is not appropriate after reading the operation note to be left in any doubt as to what surgical procedure has taken place.

8.25 The Panel recommends that there needs to be a clear understanding and precision regarding the language used to describe the procedure being proposed. If there is discussion regarding a potential procedure to remove mesh, it has to be made explicit what type of surgery is to be undertaken and the proposed extent of what is going to be removed.

Redacted materials

8.26 We have included the matter regarding redacted materials in this section because correspondence that is redacted affects the quality of communication that passes between a patient and their healthcare provider. More specifically, in this piece of work, the quality of the information that passes between the data guardians (the organisations holding the medical records, be they Health Board or general practices) and the Panel undertaking the case record review. Whilst an individual’s case record will predominately be about them, it is likely to comprise other personal data too. For example, it may contain the names of the clinicians providing their care, and it may contain the names of third parties in their personal life.

8.27 In practice, redaction usually means that information has been blacked out or removed from a case record. Traditionally this is done manually by a member of the care team, based on judgement of what is appropriate to remove, but it can also be performed using software packages. Redaction is used to remove identifying information that relates to third parties, or to remove information which could cause ‘serious harm’ to the mental or physical health ^[216] of the individual to whom the records apply or others,^[217] if it were disclosed. The Data Protection Act provides an assumption of ‘reasonableness’ in relation to disclosure when the third party is the patient’s clinician (i.e., this information would normally be made available) otherwise ‘reasonableness’ remains to be decided on a case by case basis when it refers to other third parties.

8.28 Professional organisations acknowledge that identifying which third party information should be removed, and how much information should be subject to redaction, can be challenging:

8.29 There is no established standard or guidance for removing third party information and every person approaches this process differently. The provisions of the Data Protection Act 2018, leaving it up to each organisation to come to a decision.

8.30 Some participants described to us that they had requested information regarding their care and treatment and of then subsequently receiving correspondence which had been significantly redacted. Some of the women provided examples of these for the Panel and we agreed that the redactions had indeed been significant. The redactions were not confined to one or two sentences, but in some cases entire paragraphs had been blacked out. Women described feeling confused and upset as to why this had occurred. The Panel are of the view that withholding information, regardless of how valid a reason to do so, without explicit explanation will leave a cloud that something is hidden.

8.31 The Panel recommends that, if requested by the patient, the organisation provides an explanation to the patient (or person authorised by the patient to request it on their behalf), why certain information has been redacted.

Consent - the legal landscape

8.32 The development of the case law in the area of consent and information disclosure has been a long slow burn dating from the mid-1950s^[219] where legal tests^{[220] [221]} relied on ‘reasonableness’ to define the both the duty and standard of care that a healthcare professional owed to their patient. Initially the courts afforded a huge amount of latitude to the medical profession to decide exactly what this standard was.

8.33 In the 1990s this started to change through a series of cases which not only saw the courts claim their right^[222] to determine the standard of care but also acknowledge human rights^[223] and the ‘autonomous’ individual. The legal axis moved away from the reasonable professional determination of what a patient should be told, to what the reasonable patient had a right to know.^[224]

8.34 This gradual movement culminated in the case of Montgomery^[225] in 2015 which swept away any previous legal determination of what constituted information disclosure. A test of ‘materiality’^{[226] [227]} replaced it, focussing on that particular, individual patient and what they would want to know. In other words, what is important to the particular patient in terms of investigations, treatments, including alternatives and importantly, an explanation of the likelihood of the risk of complications.

8.35 The consequences of this shift have been far-reaching. Literature suggests that while the rate of increase of other clinical negligence claims has remained steady, cases relating to consent have risen four times as fast since the Montgomery decision and where failure to inform was added as a contributory claim, the rise was nearly ten-fold.^[228]

8.36 It has a significant impact on financial cost to the NHS. A study considered costs for the four-year period before and after the Montgomery case, which concluded that NHS (England) costs due to settled claims for failure to inform increased from £25 million/year to £28 million/year and in the subsequent 4 years to £62 million/year.^[229] The increase has not been due to an increase in the cost per claim, but due to the increase in the number of claims. The Royal College of Surgeons (England), in a press release considering the implications of the Montgomery case suggested that, NHS Litigation Authority,^[230] paid out more than £1.4 billion in claims during 2015/16. This is an increase of approximately £320 million over the preceding year.^[231] Whilst this is significant, a longer-term view will allow a fuller analysis to be undertaken in this regard.

8.37 In the meantime, the remedy is not simple and can be time-consuming. A signed consent form from a patient does not amount to valid consent for treatment and is not sufficient evidence of such in a court of law. Consent is a culmination of process comprising many strands, all of which require to be detailed within the case records. Language, as ever, is important, and it is wrong to speak of the patient being ‘consented’ because it describes something being done to the patient as opposed to a decision taken by the patient.^[232]

8.38 One such solution is to ensure that contemporaneous medical notes and correspondence properly detail the informed consent process undertaken.^[233] This has many advantages for both the clinician and for the patient. Should there be a need to review the case records, it would provide a record not only of the decision taken but how that decision was reached. Case records are at the heart of modern case law regarding information disclosure and the courts have questioned^[234] how a clinician could confidently answer important questions, often many years later, without having the benefit of a contemporaneous set of detailed notes.

8.39 Keeping a detailed set of medical notes of the dialogue, including what leaflets were given (and including a copy of these in the records), what counselling and advice was given about the procedure, and which risks and potential complications were discussed that led to an informed decision being made. This should then be replicated in a letter to the patient and copied to the patient’s GP. The Panel are aware that this is an approach which has already been supported by professional bodies and in their guidelines, and is being increasingly adopted in clinics, Trusts and Boards. ^[235]

8.40 The Panel recommend keeping a detailed set of medical notes of the dialogue, including what leaflets were given (and including a copy of these in the records), what counselling and advice was given about the procedure, and which risks and potential complications were discussed that led to an informed decision being made. This should then be replicated in a letter to the patient and copied to the patient’s GP.

Professional Guidelines

8.41 The courts were not in isolation as movement towards a patient-centred practice had already started to occur pre-Montgomery. Following the legal outcome of the case, a number of organisations including the medical royal colleges updated their guidelines and information to reflect the judicial decision.^[236]

8.42 The Royal College of Physicians and Surgeons, Glasgow produced guidance which clearly acknowledges that signing a consent form is not enough and that ‘consent is more than signature and more than a form.^[237]’ It continues that:

‘the only way to know what a patient wants is to talk to them, to ask them and, most importantly of all, to listen to them.’^[238]

8.43 There is recognition from the professional organisations and beyond that this requires additional work and time that, for clinicians, is already at a premium.^[239] Whilst no healthcare practitioner is exempt from adhering to this professional and legal duty,^[240] the challenges and impact cannot be underestimated and there is an extensive literature addressing this matter.^[241] Constrained resources^[242] and the impact of Covid-19 does nothing to relieve the pressure on healthcare professionals. Some of this may be tempered by the fact that the General Medical Council’s (GMC) patient-centred duty was in fact highlighted in Montgomery which cited passages from the GMC's 2008 and 2013 guidelines^[243] indicating that patient-centred duties were already well embedded into professional guidelines. Even if professional duties were already there, it is recognised that they have been expanded.

8.44 Following Montgomery, the GMC also issued new guidance to doctors entitled “Decision Making and Consent’,^[244] replacing its guidance on consent last issued in 2008. The GMC note that the guidelines are framed around seven principles of decision-making and consent, namely: the process should: (i) be patient-centred; (ii) be based on meaningful dialogue specific to the individual patient; (iii) the patient has a right to be listened to and allowed the necessary time and information to reach a decision; (iv) share relevant information about the benefits and harms of proposed options and reasonable alternatives, including the option to take no action; (v) be offered to all patients, irrelevant of presumed capacity; (vi) advocate the patient’s best interest if they lack capacity; and (vii) patients whose right to consent is affected by law should be supported to be involved in the decision-making process, and to exercise choice if possible. There are clear echoes of Montgomery in the wording. The emphasis is clear in these guidelines, and with the others above, that the emphasis is on patient centred care and the principle of shared decision making. What does this mean in practice?

8.45 Patients medical records are discussed in section 50 of the GMC Guidance where it states:

‘ Keeping patients’ medical records up to date with key information is important for continuity of care. Keeping an accurate record of the exchange of information leading to a decision in a patient’s record will inform their future care and help you to explain and justify your decisions and actions.’^[245]

and continues in section 51 noting that:

‘[Clinicians] should take a proportionate approach to the level of detail you record.^[246] Good medical practice states that you must include the decisions made and actions agreed - and who is making the decisions and agreeing the actions - in the patient’s clinical records. This includes decisions to take no action.’^[247]

Consent and information disclosure - the approach of the Panel

8.46 The Panel also based our assessment of the consent process in each of the individual participant reports on the principles described in the GMC’s “Decision Making and Consent” Guidelines (2020).^[248] We adopted a chronological approach which encompassed the different strands of the consent process. These included:

• Were conservative options and investigations exhausted prior to any discussion of surgical options?
• What options were discussed in terms of alternative treatments?
• What discussion was documented in relation to potential risks involved with surgery (if relevant) and at what stage were these added?
• Was there evidence of discussion and counselling documented in the case records?
• Was that supported with any written information, for example patient decision making aids?
• Who signed the consent form (if present), and when was it signed?
• Was there adequate time for the patient to reflect on the discussions, and the opportunity given to ask further questions between the initial discussion and signing the consent form?

8.47 We recognised that at the time that some of the earlier surgeries took place, it was common practice to use a ‘generic’ consent form that did not specifically have a section to document the risks and complications relating to the surgery. That is to say, the consent forms were not specifically written for the purpose of any particular surgical procedure and they lacked a specific space on the form to note the risks and possible complications. Consequently, there was a lot of variation in what was included on consent forms, with specific risks sometimes being added in a handwritten format. This does not mean that any discussion did or did not take place but it was difficult to ascertain what had been discussed. Consent forms have evolved considerably over time and post the case of Montgomery and for the reasons described above, there is an increased use in procedure specific consent forms.

8.48 The majority of earlier cases that we reviewed contained generic consent forms. The Panel recognise that this would have been the standard consent form at that time and we saw from our own review of case records that later cases were beginning to document more detail regarding discussion potential alternative treatments and noted the occurrence of discussion and support pre- surgery. We found this to be encouraging in terms of improvement in practice with increasingly robust processes in place.

8.49 The Panel observed some recurring themes in relation to the consent process which will now be addressed.

Patient Information Leaflets / Decision making aids- merits of having a version control.

8.50 The benefits of having patient information leaflets, or decision-making aids, as a way of enhancing shared decision-making and enhancing patient understanding regarding the merits of proposed interventions is undisputed.^[249] They should not be a substitute for dialogue and discussion^[250] but serve to assist with recall regarding conversations that took place during a consultation. ^[251] They have also been shown to both improve adherence to treatments but conversely to play a role in deciding whether or not to undergo a treatment. So, whilst there is an underpinning agreement that such decision aids are a valuable part of the shared decision-making process, there is less consensus about what this means in terms of the information that such decision-making aids should contain.

8.51 UK National Institute for Health and Care Excellence (NICE) recommend the use of high-quality patient decision aids in clinical practice. ^{[252] [253]} National Guidance^[254] provides that the information contained in these leaflets should be updated to reflect evidence-based best practice.^[255] Recognising the importance of having a systematic development process in place, The Cumberlege Report concluded that it;

“sees no reason for there ever to be more than one collaboratively produced and agreed patient decision-making aid for each surgical procedure or medical intervention and that NICE should lead in facilitating that clinical consensus.”^[256]

8.52 The Panel are in full agreement with this and note that NICE published their patient decision aid- Surgery for stress urinary incontinence – Patient decision aid, in 2019.^[257]

8.53 The Panel noted NICE did not include a version control element in their patient leaflets within this patient decision aid. Leaflets produced should contain the date when they were first written and then any subsequent revisions should result in a new version of the document being produced. This, in turn should be dated and numbered to reflect the version. This, in turn allows them to be accurately recorded in the case note, which version of a leaflet is given to the patient.

8.54 On reviewing the case records, we observed that where it was noted that the patient was given an information leaflet, a copy of exactly what they had received was rarely to be found in the case notes. Without this, it was difficult to know what the patient has been advised regarding the risks, benefits or alternatives to treatment. Knowing which version was shared would indicate which format the leaflet took, and exactly what information was contained within it. It is recognised that this approach has now been adopted by many Health Boards. ^[258]

8.55 Decision-making aids do not need to be confined to the written word and digital diagrams which can include details, animations and diagrams providing a clear visual to the patient on what their proposed surgery would involve, are also now available.^[259] The information is given to the patient but is also mapped digitally so there is a contemporaneous record of the information being given, that it was received, that it was opened and then there are prompts for the patient to confirm that they have read it, and to ask if they have any questions. If these digital diagrams are also stored digitally, it means that the record cannot be lost or misplaced as would have potentially been the case with a paper diagram.

The Panel recommends:

8.56 Surgical units should keep a version control of their patient information Leaflets and that this should be noted in the case records so that when looking back, it can be seen precisely what information was given to a patient at any point in time.

8.57 The use of patient decision-aids, checklists and information leaflets should be provided in advance of the consultation, so that the time available in the consultation can be optimised. This helps to ensure that patients are empowered with the information they need to decide and have shared responsibility for their care.

8.58 The creation of a national specific consent form, for use across the country, to reduce variation, and improve consistency of information covered during the counselling process.

8.59 To create the conditions in the NHS to enable an informed consent process, namely adequate training, and adequate time, supported by high quality decision aids and consent forms.