Official Report 749KB pdf
I welcome the panel of witnesses who have joined us for our next item. Dr Alan Mathers, who is chief of medicine for women and children’s services at NHS Greater Glasgow and Clyde, is joining us online. Dr Wael Agur is lead urogynaecologist at NHS Ayrshire and Arran and a member of the Scottish Government’s mesh complications working group. Dr Anna Lamont is medical director for procurement, commissioning and facilities at NHS National Services Scotland. Terry O’Kelly, who is senior medical adviser to the Scottish Government, is also joining us online.
I welcome all four of you. We will begin with some questions about experiences of referral and access to the complex mesh surgical service. What are the appropriate pathways into the service? How are they communicated to health boards, general practice and relevant specialties? Can more be done to increase awareness of the service?
10:45
The pathway for treatment of mesh complications in women has improved significantly, but there are still areas in which it can be improved. That starts from the GP side, with the GP practices, and goes through to secondary care and the national centre. There are also pathways from GPs directly into the national centre. Ideally, they should first go through the local specialist centre in the local health board that is responsible for the patients, and then to the national centre. However, it is my understanding that there are direct referrals from GPs straight to the national centre. I am not sure how many of those referrals there have been, but I think that I read that somewhere in one of the documents that have been circulated.
An important area in which there is scope for improvement of the pathway is GP awareness of mesh complications. It is my understanding that the Scottish Government has taken significant steps on that, but we need to be clear that GPs deal with a wide and diverse range of conditions, and there needs to be persistent communication to raise awareness of mesh complications, because this is an emerging field. We need to raise awareness that the symptoms that women present with can mimic those of a wide variety of conditions.
There also needs to be a lower threshold for attribution of the presenting symptoms to the presence of a mesh device. Rather than attributing the presenting symptoms to a common condition such as menopause or endometriosis, it is important to look back at the medical history and find out whether there has been a urogynaecological procedure for incontinence and prolapse and whether a mesh device has been implanted. It is important to actually listen to the women if they say, “I think that something has not been quite right since the operation I had.”
Our awareness as clinicians in secondary care and the awareness of GPs have increased, but more improvement is certainly needed, and GPs need to be supported in that regard. It came across in the committee’s survey that more GP awareness is required. That is one aspect of the pathway that could be improved.
In response to the critical feedback that we received from women looking for surgery and support for mesh complications, it is important first of all that I express sincere regret, both on a personal level and on behalf of NSS, for the difficulties that they have experienced. We appreciate the courage that it takes to share such lived experience and the challenge that is involved in sharing such personal information.
It is critical that we acknowledge the difficulties that they have experienced and that we look at the pathway variations between individual boards, the lack of cohesion in referrals and the lack of information around GPs and local specialists that we have heard about. I understand the stress that the women experience in trying to access treatment and the challenge that they describe in their feedback.
Back in June 2022, we established a clear collaborative pathway for referral to independent providers in the US and down in Bristol. As a result of that pathway, which was shared with the boards and with specialists, there have been 37 women referred so far to an independent provider. That does not mean that we are content with that; we want to continue to improve.
If we reflect on the survey responses, we can see that there is, as has been mentioned, a clear need to improve the communication that we have with the women all the way through that pathway, particularly within primary care and in the journey between primary care and the local specialists. Reflecting on that, we should now be looking to communicate more directly with GPs about the need to raise awareness of mesh complications.
It is important that the survey work continues. I am sure that Dr Mathers will describe some of the more recent survey work, but we need to learn from the feedback and to continue to improve. Where we can improve, we will, and we will continue to ensure that the services that we provide are both effective and efficient. I think that we can all agree that that is the least that we can do for those women.
Dr Mathers, would you agree with that assessment? What can be done, in practical terms, to increase awareness of the service?
I echo the two previous speakers’ comments about the difficulties encountered by patients who have been harmed in this way. Just to correct something—or to make it clear—the mesh centre does not now take direct referrals from GPs. There is a historical element to that. It may be that GPs in the health board area refer to one of the urogynaecologists but, in circumstances where the patient requires the mesh centre multidisciplinary team, they are referred by local secondary care using the electronic form that we have insisted on since October 2022.
Obviously, the mesh centre gets referrals in. How those patients are initially seen and triaged and the awareness that there is out there will be very different in different parts of the country. It is a testament to the fortitude of a lot of the patients, who will not take some of the responses that are in the survey for granted, and who push for referral. More national awareness and better local awareness and referral patterns will all help, because the mesh centre is at the top of the pyramid.
Thank you. Mr O’Kelly, would you like to offer an assessment of the current pathways for referral and increasing awareness of them?
Can I make a comment, from where I am sitting in Aberdeen? I think that we are aware of issues—[Inaudible.]—expected that there will be difficulties—[Inaudible.]—patients and clinicians—[Inaudible.]—symptoms to a particular cause.
We are struggling with your sound a bit.
The chief medical officer has already written to primary care regarding that, stressing the importance of patients being listened to when they are reporting symptoms. We have also worked with colleagues in the rest of the United Kingdom. Health Education England has prepared an education programme for primary care concerning mesh and mesh-related complications and that is up and running. The various rights and so on have been addressed.
That programme will be available in Scotland in the very near future. We had hoped that it would be available by now, but unfortunately we have a different electronic platform for learning and education in healthcare in Scotland—the Turas system—so the programme is being modified for that. In the very near future, we will have an education programme available for all in primary care; the chief medical officer will write out to primary care again at that time to advertise and promote the programme.
With regard to the pathway, visibility for patients needs to be improved, and we would like to work with the service in general on that. Whether it is available on the complex mesh centre website or through NHS Inform is perhaps to be decided. There is an upcoming meeting of our accountable officers at which that can be discussed in greater detail. It is very important that the initial interface between patients and clinicians is favourable and that patients feel as though their issues are being taken seriously and that their care is being taken forward in a reasonable fashion.
There is a supplementary question from Dr Gulhane.
It is important to say that I am a practising GP. Dr Agur, you spoke about the pressures on GPs and the number of conditions that we need to be aware of, and I can give examples of those. People have come to the Parliament to press GPs to be more aware of chronic kidney disease and brain tumours, for example.
I am sure that you are aware that we do not always know that patients have had mesh. When we get our letters, we do not know what surgical procedure has taken place; all we know is that someone went into urology and has come out. Is it not better to also have a central access point for women to be able to call directly if they know that they have had surgery and they have had problems since then? That is an easy one—if someone tells me, “I have had problems since surgery,” my first thought is, “Surgery.” However, common things are common, and surgery is not always our first thought.
Yes—I totally agree. It is the case not only that some GPs will not be able to know whether a mesh device has been inserted but that some women themselves do not know that. Some women present with a common complaint such as bleeding after the menopause; they are investigated for post-menopausal bleeding and we find, incidentally, that it is mesh exposure that is causing the bleeding instead of the most common cause for post-menopausal bleeding.
There used to be a central helpline. The Scottish Government put in a national helpline for women to contact; I think that that was at the height of the crisis a few years ago—perhaps Terry O’Kelly can correct me on that. When there was more awareness UK-wide of the crisis, the national helpline became a UK national helpline. I am not sure whether the helpline is still going on. My understanding is that the national helpline was more of a supportive and signposting service for the women. It is also my understanding that the women who engaged with the helpline found it incredibly helpful. What I am not sure about just now is whether it is on-going and active and whether there is still someone at the end of the line answering patient questions. The person answering used to be a specialist nurse who was mesh aware. The service was first provided by the nurses here in Glasgow and then it moved to England.
What is important is that, if no one is sure whether mesh has been implanted, if a woman calls the helpline, they need to be able to find out.
For a national helpline to find out, the staff need to be able to go into the patient’s record. Those who have access to the hospital records are clinicians such as me, so I need to know whether the patient who is presenting with problems in relation to mesh has had a mesh device or not. Clinicians in the local hospital or health board are best set to find out that piece of information to support a woman and her GP and to receive the referral when it happens. Therefore, I am not sure how a central helpline or the existing helpline would support that.
11:00
A central helpline is useful when there is public awareness. I emphasise that I am also a practising GP. It is challenging for all clinicians to be aware of all complexities and details, which is one reason why the pathway is for a referral from a specialist. However, we can do more to improve awareness.
We also have to consider the fact that, if a specialist helpline is made available, women need to know that they have to access it. The first step is the critical one.
A central helpline would also not have access to people’s records. So, although it could be reassuring, supportive and helpful and could guide people, it would not be able to provide the critical information that is required. As has already been said, accessible resources, such as NHS Inform, should be where people would expect to find them and that is where such information should be put.
There is a challenge with information and guidance for GPs in Scotland. The introductory statements mentioned an educational platform for doctors and the ways in which they access information.
A helpline is only useful if people have already realised that they need to phone it. The information must be provided in an accessible form.
We also need to learn from the women themselves. We have looked at the evidence and we have feedback about people’s journeys and their experiences of those journeys. Before we put any kind of educational support in place for women, we need to hear from them about how they look for information and how they come to understand that they need it.
We must also recognise that GPs cannot be specialists in every area. They need awareness, so that someone who presents with a concern can be referred to a specialist who can take a more critical view.
Mr O’Kelly, do you want to raise any points?
The NHS established and staffed a helpline at the height of the concerns about mesh, during the period of maximum activity and publicity from 2015 to 2018, but the number of calls dropped off quite dramatically and remained at a low level that made it unreasonable to continue, so the helpline was withdrawn. There are now information pages on NHS Inform.
We may be bigging up our practice, but, speaking as a practising surgeon in secondary care, I think that patient care in the NHS works best when it is integrated across primary and secondary care. I am a great believer in a patient’s best advocate being their GP. Their first contact, whether medical or non-medical, should be with primary care so that they can explain problems and find ways to move forward. That is when the interaction with secondary care is important.
If we dismantle that—which, sadly, we are now seeing in the NHS because of post-Covid issues—the integration breaks down and we end up with communication problems and problems for patients who might have many intercurrent issues. If those are overlooked or not taken into account, we will end up practising poor medicine, which we must avoid if at all possible.
To go back to what Dr Agur said about a patient who might present with post-menopausal bleeding, that is a reason why a patient should be assessed and referred and it might become apparent that mesh is the underlying cause.
One would like to think that standard practice would assist, but it is important that general practitioners and primary care are tied into on-going patient management. Otherwise, we will end up with poor medicine and patients will suffer as a consequence.
Evelyn Tweed has some questions about waiting times and referrals.
I have some questions for Mr O’Kelly regarding his comments about educating GPs. Those comments were really difficult to hear, but I think that the sound has been amended and it is now much better, so I will go back to what he was saying.
There is obviously an issue with referrals. GPs do not always know how to deal with them, which is having a knock-on effect on when people are seen. Did you say that the Scottish Government has an education programme to help GPs? What are you doing immediately to help them?
The chief medical officer has already written to primary care providers drawing their attention to issues with regard to mesh and alerting them that patients may present, that they need to be listened to and that issues need to be acted upon.
We have also worked with colleagues across the United Kingdom. Health Education England has developed an education and training package for primary care. Unfortunately, the electronic platform for medical education here in Scotland is different from that in England, and at the moment the programme is being modified. As I said, I had hoped that it would already be in the domain of primary care for education and training. We expect it to be available very soon. I apologise that there has been a delay in its coming.
Once the programme is available, the chief medical officer will write to general practitioners again, advertising it and drawing their attention to it. We hope that that, in addition to what has gone before, will help to address the issues that have been described. All that we can do is to promote that education and then canvas opinion from primary care providers and patients as to whether they still have the same issues with colleagues in primary care. If they do, we will need to make some modifications.
Why are there such long waits between appointments? I put that question to anyone who would like to comment.
I ask for a bit of clarity on the question. We need to recognise the differences between different stages of the appointment. There is a referral from a specialist to the complex mesh service. There have been delays in that process, but the capacity of the complex mesh service has recently increased, the number of people that it is seeing per clinic has improved and the waiting time is coming down. I will let Dr Mathers speak more about that.
There is then the waiting time from a decision to have surgery to that surgery being undertaken. That has been reducing and, after this month, the service is offering surgery within 12 weeks of a decision being taken.
However, I point out that a large part of the complex mesh surgical service is not about surgery. We talk about it being the complex mesh surgical service, but more women, after speaking to the service and understanding the complexities and challenges of surgery, what they might and might not gain and what issues they might have with it, opt not to have surgery or to have some other form of treatment. It is really important to understand that the complex mesh surgical service is about more than surgery; it is also about deciding positively not to have surgery, or perhaps to delay having it. Surgery is not a procedure without cost to the women. We talk about the financial cost, but it is also important to understand the time and the recovery period that are involved, as well as the complications that might happen after surgery.
Returning to your question about waiting times, I note that time is also involved if a decision is made to refer someone to an independent provider—I refer to Dr Veronikis or Professor Hashim. At the moment, an MDT will make that decision. The decision will then be referred back to the local consultant specialist, who will come to the national services division—the NSD—with a request to refer out of the area to the US or Bristol. Typically, that decision will be taken within 48 hours and we will then make a referral. Dr Veronikis has been very good about booking appointments and working with the women to find a date that works for them, and we will organise travel. That time is typically a lot less than six weeks.
The waiting time, which I think people tend to focus on, and quite rightly so, is the time from referral to the complex mesh service to being seen. We acknowledge the challenges in that, and some of that is reflected in the survey responses. The situation is improving. The time from a decision on surgery to having that surgery is certainly a lot better than it was.
Would you like to comment, Dr Mathers?
As the papers demonstrate, we are reducing waiting times for first assessment. Something that came out of our feedback was that women were finding the way in which the initial referrals were being made quite overwhelming, with patients being seen by a large number of clinicians at one time. As I said, the feedback was that that was overwhelming for some individuals, so we have adjusted the process.
As with every other specialty, we are trying to manage quite considerable waiting pressures. However, although I am still very uncomfortable at the length of time that people are having to wait, I think that we have a good news story in that, as you will see from the data that we have presented, the waiting time has been going down steadily, and we expect it to have reduced by a further eight weeks by the summer.
What treatment is being offered to patients on these long waiting lists? What happens to these women while they are waiting?
The women will have been referred by the GP to secondary care and, through that, to the mesh centre, and the problems that they will face in that time will be pain management, psychological issues and issues requiring physiotherapy. They do not have to wait until they are seen at the mesh centre to have those aspects managed locally, but the fact is that every part of the health system has differential waiting times with regard to the more holistic side of things as opposed to the functional aspect of simply identifying with an individual patient whether she would prefer surgical treatment of some form.
Thank you very much for the information that you have given, which is much appreciated. I wonder whether Dr Lamont or Dr Mathers can clarify something for the record. You have provided some information, but it would be useful to know the average waiting time and the longest waiting time. How long have the women who have been waiting the longest had to wait to be seen by the service?
As you will see from the survey, there are patients who have been waiting ostensibly for years. One of the problems is with knowing exactly which route an individual should take into the service. We have quoted an average waiting time in our submission, but there is a huge range, simply because there will be some people with problems that have been identified as requiring more urgent treatment and other patients for whom other needs will have arisen and who will, as a result, defer their appointments.
As far as the longest wait is concerned, we have to take the evidence from the women’s survey that some have waited for years. However, with the reset of the establishment of the mesh centre, we are trying to consistently bring that waiting time down and identify why there are long waiters. Indeed, we do the same for all the other gynaecological services—and, I am sure, all the board’s services.
11:15
Women are referred to the service, but we cannot be clear why they have not been seen yet—it is sometimes just a long process. Is that what you are saying?
If a woman is electronically referred to the service through the process that was introduced in October 2022, they will be put into that process. In 2021-22, the average wait for the service was 72 weeks. We have moved it down to 55 weeks and we expect it to be 47 weeks by June 2023. That partly reflects increased capacity. It is also an acknowledgment that we were overwhelming women because they were seeing an awful lot of individuals when they attended. No one is suggesting in any way that coming to be seen in the service, with the long history of problems that these women have had, can be dealt with in a short appointment.
Dr Lamont, do you have anything to add?
As the commissioner of the complex mesh service, we have exact details of median waiting times, longest waiting times and shortest waiting times on a quarterly basis. That detailed data can be provided on request if that is what is being looked for. When we look at this, though, we also need to acknowledge that the Covid and winter pressures have impacted on the Glasgow service. That is not to excuse what has happened; it is to explain why there has been, perhaps, a bit of a pause and a delay in terms of catch-up.
I also want to acknowledge the efforts that the Greater Glasgow and Clyde health board and the complex mesh service have made this year in catching up and improving the access time. The outpatient clinic has doubled its capacity and it is now seeing double the number of women weekly that it was seeing last year. That is the number that is critical. The surgery waiting time has also improved and it is now going to be under 12 weeks. However, the fact that the outpatient clinic is seeing that number of women means that the waiting list will be coming down.
The longest waiting time is not always the best measure. I can understand why it is a measure that is of interest, but sometimes people will choose to delay appointments. Sometimes the timing does not work for women and it needs to be changed. We therefore tend to work by the median waiting time each quarter. I can provide you with that detailed information.
I would really appreciate getting that data. People come to us as individuals as well, and it is important for us to be able to feed back. These long, long waits for women have been going on for years and it is our job to scrutinise things and make sure that everything is being done.
Where women have chosen the other option—to go down south or across to Dr Veronikis—is anybody currently waiting for a referral on in the system or has everyone who has requested that option to date had a referral on?
The pathway that I spoke about is a referral. The MDT will work with the women to understand what their preference is. We have a preference service, which is unique, whereby women can say whether they wish to be referred to an independent provider, and they have a choice of which independent provider they wish to go to. So far, 37 women have made a choice and they have been referred. Of those 37 women, 29 have been referred on.
The reason for the difference between the numbers is that a number of women are with local health boards awaiting referral to NSD for financial approval and for arranging the transport and surgery. That typically takes 48 hours. Before the meeting, I asked the team whether they were aware of any cases that had taken more than 48 hours, and they were not. Within 48 hours, we will approve the referral and we will then get in touch with Dr Veronikis. A clear pathway has been worked out with the boards. We have a mechanism by which the information is shared with Dr Veronikis and he will then contact the women.
So far, only one surgery has taken place with Professor Hashim, but that relates to the patient preference for the date of surgery. I am confident that no significant delay is taking place between the decision being taken for referral to an independent provider and that being arranged.
Do the figures that you quoted mean that eight women, who have chosen a different pathway, are waiting to get their final referral?
The MDT, which is the multidisciplinary team—I apologise for using acronyms; we are used to them in the NHS—and the complex mesh service work with the women to decide whether that is the route that they wish to go down. The referral is then passed back to the local specialist service, because the complex mesh surgical team is not able to make that referral itself. It has to come from the women’s own health boards. Once the referral is made, it comes to NSS and we will then authorise it and make arrangements. There is a short delay—usually a matter of days or a week or so—between the referral coming back from the MDT and it being returned to us at NSD.
Emma Harper might have a supplementary and some questions on communication.
I will go directly to the communication theme. I am looking at the NSS website and the NHS Greater Glasgow and Clyde website. The NSS website is quite clear on the pathway and what the process would be, but the NHS Greater Glasgow and Clyde website is a bit clunky for finding the information that people need—that is obviously not something that you can control, Dr Lamont.
I am interested in how women are communicated with, from the start of the process through to referral and as the process goes on. Is there open dialogue and does it happen by contact with the direct clinical nurse specialist, for instance? What is the process for communicating to keep people feeling that they are well informed?
The responsibility for communication and care rests with the women’s own health boards. The initial decision around referral is with the MDT from Greater Glasgow and Clyde. Women will therefore be aware that that referral decision has been made, and their own specialist will then communicate with them about it.
As soon as we receive that referral at NSS, we establish a direct line of communication with the women—Dr Veronikis and Dr Hashim directly contact the women, too, and arrange a surgical date based on the women’s preference. We continue that contact around arranging transport, travel, expenses and contact the women again when they return to ensure that surgery has taken place. Information is also passed back from Dr Veronikis and Dr Hashim to the local health board and the women’s specialists about their patient stay.
However, given the feedback from both the critical survey and the continuing feedback that we receive, we are not resting on our laurels. We need to look at where we can improve communication. We can continue to improve websites. In particular, after the return from the US or Bristol, it is about improving the handover of care to the women’s GPs and specialists. Although that is not an area that we can directly influence, we can share the feedback and look at how to make that pathway better. As I said in my opening statement, where we can improve, we will improve and we have a responsibility to do so.
How are women advised about waiting times, for instance, or what they should expect? Do you have feedback around the processes? Is the communication done electronically or by letter or telephone call? How do we ensure that each individual feels that their preferred way of communicating is what is used?
Regarding communication around waiting times and the pathway before the referral reaches NSS, I refer you to Dr O’Kelly and Dr Mathers, whose responsibility is primarily around that part of the pathway.
NSS contacts women directly by telephone. Sometimes, we have communication by email, but we generally try to avoid it because of the sharing of personal information; we are very sensitive to the challenge that those women have with regard to sharing information, and we want to make sure that we are consistent.
Dr Veronikis arranges Teams video calls for consultations, and checks in with the women by video consultation once they have come back. Primarily, our part in that communication is by telephone, but I defer to my colleagues about communication on waiting times.
Mr O’Kelly, do you want to come in?
[Inaudible.]
Sorry, will you start again? You were muted for a few seconds.
I apologise, and I am sorry that I am joining you remotely, but there are reasons for that.
Anna Lamont has concentrated on the pathway in communication between the patient services, NSS, Dr Veronikis and Professor Hashim. Of course, the majority of patients come from secondary care under their local clinicians to the complex mesh centre in Glasgow. They follow an NHS route.
I draw the committee’s attention to the work of the patient engagement and public involvement team in Glasgow, who have looked at communications specifically as one of the domains in their surveys. I hope that you have seen that. Clearly, they have shown that they have asked questions and have listened to what patients have said, and they have made changes in Glasgow.
From the results of that survey—another iteration is due soon—it appears that the performance of the outcomes is now at a very high level, with very significant results when it comes to patient satisfaction. Alan Mathers may want to say more about that.
Dr Mathers, will you come in on that point?
I confirm that, when the patients are seen at the mesh centre and elect to have their treatment, we either send a standard letter to the referring consultant to ask for a referral to the relevant party, or we will list them for care at GGC if they wish to have their surgery in the mesh centre. Because we insist on an electronic referral pattern, we can get those outcomes faster.
I will follow on from that, Dr Mathers. You, I think, referred earlier to the amount of information that women receive as a result of going down that pathway. How is that information followed up? Is there a standard way of communicating in writing, or is there another way to ensure that, after an initial appointment, women can digest that information in a way that is accessible for them?
The short answer is that we are always trying to improve communication, but I do not have specific data to tell you the degree of that. Feedback suggests that we are doing well—we have had two cycles of feedback and will have another two by June 2023. I would be grateful if I could take that question away and find out more.
No problem.
That would be useful.
I wonder whether my next question might need the same treatment. How do you communicate how women can keep themselves well and receive alternative support while they are on waiting lists? After all, many will be experiencing pain and a variety of other symptoms, and long waits will exacerbate those things and those presentations will continue. Is there a standard way in which women receive information about where to seek additional support or how to keep themselves well while waiting for appointments or surgery?
11:30
Obviously, individual women will see a range of specialists, including psychologists and doctors, depending on their needs. We will deal with some people more urgently than others, because they might have a septic issue or have been triaged into a more urgent phase.
The other aspect of this is that one has to be careful when women have comorbidities. They have not just a mesh issue; they will come with rheumatic problems, diabetes and so on, and they will potentially have a whole stack of different medicines. As a result, one must be very careful, and general practitioners, who have a much better handle on drug interactions, ensure that there is no risk of our causing medical problems by intervening in areas that we should not be primarily responsible for. The centre attempts to deliver a holistic approach to a wide-ranging problem, and surgery is not always the offered or preferred solution to it.
Does that answer your question satisfactorily?
Yes, it does. Thank you.
I invite Mr Torrance to lead on the next theme.
Good morning to the witnesses.
I think that my question is for Dr Mathers. For how many women seen by the service was surgery not advised and other forms of management or treatment advised instead? The committee did ask for that information before today’s meeting.
I have data on the patients who elected to have—and had—surgery, but I do not have at my fingertips the answer to the precise question that you have posed. I am sure that we can look into that.
It is probably also worth emphasising that some women are given an offer and then go and think about it, sometimes for as long as a year. If someone is waiting but has not yet determined whether to have surgery, we have a system of follow-up contact and, after a year, seek their re-referral, simply to ensure that they are not lost.
I do have the data. In financial year 2021-22—and so far in 2022-23, too—59 patients out of the 165 first assessments seen by the complex mesh service have opted either for conservative treatment or to defer the decision on surgery. As of 31 March, 56 surgeries have been carried out; 13 were on the waiting list for surgery in Greater Glasgow and Clyde and we have had 37 independent provider referrals.
Thank you for that.
The complex mesh surgical service submission states that its service is primarily a surgical service. To what extent are the witnesses confident that women who engage with it are given a clear understanding of what treatment it can and cannot provide?
I will pass the question to my colleague Dr Mathers in a moment to speak specifically for Greater Glasgow and Clyde, but you are right to highlight that the service has been commissioned as a surgical service. Indeed, we talk about the complex mesh surgical service, so we tend to think of it as a surgical service.
However, a significant part of that is about assessment. It is about the experience and about assessing how much mesh might remain after partial removals as well as the contribution of mesh to other complexities—we have heard people talk about comorbidities, by which we mean other concerns and problems. It is also about recognising that mesh would have been inserted to address a concern in the first place. A significant part of the service is about the expertise in assessing women who have complicated and complex concerns and understanding what can be done to help them.
The mesh service provides the assessment, the scanning, the psychological support and the pharmacological support with regard to which medicines can help with pain and other complications. Obviously, it provides that centre of expertise for surgery.
I made the point earlier and I will reiterate it: although we talk about it being the complex mesh surgical service, it is really the complex mesh service. I want to acknowledge that, for the women who have been harmed by mesh, it is about the whole system—it is a complex form of complaint; it is not just about doing the surgery. If we could do surgery for all these women to solve all their problems, that would be quite a simple service, but it is far more complex than that, and the complexity of the service reflects that.
I support what Anna Lamont said. When we undertook the work back in 2019-20 on the need for a centre for management of mesh complications, it was thought that surgery would be the answer for most women. However, over time, it has become clear that, for a number of women, mesh removal is not necessarily the best way forward. Clearly those decisions are made by sharing information and through conversations between clinicians and patients, so that patients are empowered to make decisions about themselves and their health.
The service was developed with a holistic foundation, which will be important as we go forward. I suspect that more women who come to the service might not go down the path of having surgery. Certainly, that is the experience of the other centres across the United Kingdom. The mesh centres had a summit in London in December, and it was very interesting that one of the key messages that came forward was that surgery might be an answer for some but not for all. However, even in the case of surgery for full mesh removal, patients will need non-surgical care and other interventions in the future, so it is important that we have that expertise.
I would like to emphasise that the patients who elect not to have surgery are not left bereft of care. A GG and C patient might see a urogynaecologist in the mesh centre but, if they elect not to have surgery, they can still be referred to a urogynaecologist sub-specialist in the service. The same would be the case for someone coming from Lothian—they would go back to a specialist in that area, because as Dr Lamont said, it is not just about pain; some women will have continence issues, recurrent urinary tract infections and things that will require on-going specialist care.
One of the respondents to the committee’s survey mentioned the identity of the service, and I think that everyone agrees that it is not just a surgical service. It is a holistic service, as we have been saying. Whether that holistic service is delivered in the mesh service or in the local health board, that needs to be communicated very clearly to the women, so that they do not feed back in a subsequent survey that there are still concerns about the identity of the service. That could come in the mesh centre information leaflet or perhaps in the information leaflet that we provide locally in the hospital. It is about a holistic service, and surgery is just part of that. Perhaps we should also consider whether we need to keep “surgical” in the title.
You have said that it is about a holistic approach. As I read the papers, I saw information about continuing feelings of being let down, of prolonged and continued anxiety and of disappointment, because the expectations were already low and they were not being met. It seems that there is also conveyance of lack of empathy for their experiences. It is almost like there needs to be a Maggie’s centre equivalent for people who have had mesh injuries. It is quite difficult to read some of what has been presented. How would you describe the holistic approach? I know that psychologists and clinical nurse specialists are involved. How would you see progress being taken forward based on feedback from surveys about people’s experiences?
In response to the survey, I said earlier—personally and on behalf of NSS—that we sincerely regret that that has been the experience. You asked about how we progress; I believe that we have progressed, but that is not to be complacent. I believe that the surveys that have been published in the past week, and those that will be published by Greater Glasgow and Clyde, show that we have progressed. I can certainly point to the information that we have in the feedback about providing an independent provider pathway.
I express my thanks to the Scottish Government and to my colleagues here for highlighting and progressing the issue and for making it possible to have the independent provider pathway, which is one option, and also the specialist service, which continues to be responsive.
I believe that the continued survey responses will show how we are responding. Dr Mathers can speak about how specific pieces of feedback have been acted on in order to change the way that care is being delivered in the service. As I have said, where we can improve, we will improve—and we are improving.
I am not sure whether Dr Lamont or Dr Agur would be the best person to answer this. Dr Mathers referenced the urogynaecological specialist, but there has been a vacancy since July 2022. There is no consultant in post. How does that impact the service?
I would probably refer that back to Dr Mathers, but I note that there is active recruitment for that position. We are also looking at how the service can be supported by other areas in Scotland to fill that position. The number of women who are being seen surgically through the clinic at the moment is below the capacity that could be seen if we were functioning under a system that had recovered entirely from Covid pressures. At the moment, I do not believe that that vacancy is significantly affecting the waiting list. That is reflected in improvement in waiting times. However, as I said, that is not to be complacent. We are actively recruiting, and we are also looking at how that support can be provided from elsewhere.
I agree with that. There are already urogynaecologists in the service. There are also two colorectal surgeons, which is absolutely wonderful. However, the absence of a urologist is a concern. I am not part of the service, but I refer to the service. The vast majority of the mesh devices are implanted close to the bladder, which is where the urology specialist comes in. Clearly, there has been engagement with urology before. There was a urology member in the service before, and it is important that the service ensures that someone from urology joins the team, because that will improve confidence in the care for both clinicians and patients.
11:45
I want to be very clear that we have urogynaecologists, who come from gynaecology, and urologists. At present in the UK, both those services are having a great deal of difficulty with recruitment and appointments. As Dr Agur mentioned, we had an arrangement with NHS Lothian, through which we have developed a specialist in Lothian, who we hope will be able to work in Glasgow as part of their contract with NHS Lothian. We continue to sculpt in trying to attract a urologist to the current post. We are in no way complacent about the need to have urologists in the service.
Dr Lamont, I do not want to get into a comparison, but I am looking for reasoning. NHS England has established a number of specialist services for women with mesh complications. How many of those services have been rolled out? What differences do they have? If there are no differences, why is that?
My understanding is that nine specialist services have been developed in NHS England, and that number reflects the difference in population sizes between England and Scotland. There is the option for a referral between the specialist mesh service in Glasgow and the specialist mesh services in England. Certainly, for NHS England, there is an option—which is similar to the independent provider pathway—whereby, if a woman does not wish to have surgery, she can be referred up to NHS Greater Glasgow and Clyde, although I am not aware of any women who have taken that option yet. I think that that reflects the evolution of the services. The service in Greater Glasgow and Clyde is a very advanced service and its expertise is recognised nationally across the UK, not just in Scotland. Therefore, I am confident that our service in Scotland is UK leading.
Certainly, as Terry O’Kelly mentioned, there have been recent conferences and there are shared experiences. There is a move to credentialling, which has not been spoken about so far today, but I want to acknowledge that that work continues to be developed. There is an expectation that, once that is up and running, all the surgeons in GG and C will meet the requirements and will be, in effect, credentialled as well.
I have one final and, I hope, quick question for Dr Agur. We are talking about mesh specifically in this environment, in relation to all the concerns that we have and the specialist mesh service, but people are also concerned about the implantation of other devices and types of mesh in other types of surgery. Do you feel that those patients having mesh in different scenarios is safe and something that they should not be overly worried about?
I am sorry—could you repeat the question?
We have a specialist service here for women who have suffered complications with mesh, and I am looking at the difference between that and the use of other types of mesh in other types of surgery. When people hear the word “mesh”, they think that it applies to absolutely all mesh and all types of surgery. I am looking for your opinion as to whether we can reassure women that the use of mesh in other circumstances is very different and safe.
As a gynaecologist, I can comment only on mesh that is used for gynaecological procedures; I am unable to comment on the use of mesh for hernia surgery, for example. I am aware that there is a petition in front of the Citizen Participation and Public Petitions Committee with regard to the use of mesh devices in other areas, but I am unable to reassure women about those issues.
Since September 2018, when the then Cabinet Secretary for Health and Sport confidently suspended the mesh procedures, no mesh devices have been implanted vaginally. However, abdominal mesh procedures are being performed for gynaecological surgery. The risks with that are different—they are perceived to be lower. However, we have gone far in providing information and offering alternatives to abdominal surgery for prolapse.
While I have my own views on that, the standard in Scotland now is that mesh for gynaecology can be implanted only abdominally, after full informed consent has been given and the patient has fully understood the alternative. That is a significant improvement since the height of the crisis around nine years ago.
I think that Mr O’Kelly wanted to come in.
To go back to the mesh centres in England, we have worked closely with development of those. It should be recognised that the centre in Scotland was established almost a year prior to the publication of the Cumberlege report. We recognised the need for that, so we were forerunners.
Colleagues in Glasgow are to be congratulated on the work that they have done, and now on the evidence that they have gained from patient engagement and public involvement in the improvement team and on the performance that they are registering.
On Dr Lamont’s comments about the Glasgow centre being a leader, I think that that is right in a number of fields, such as taking forward credentials and so on for full mesh removal surgery. Colleagues are to be congratulated on that. It should also be pointed out that they have achieved all that at a time of intense scrutiny both from the media and in Parliament. That has been very difficult for them, and we should recognise that.
With regard to the use of mesh in other sites, your colleague on the committee—he can correct me if I am wrong—spoke in a debate in Parliament on mesh being used in other sites, in particular in hernia repair. That issue has been considered at length. The Scottish Health Technologies Group undertook two reviews: one into inguinal hernia repair, predominantly in men, because men are affected, and subsequently into hernia sites elsewhere, involving more women. The conclusion was that, in hernia repair, mesh should be used, although alternatives should be available, and the use of mesh in other sites should be supported.
We know from the longevity of mesh that has been inserted for hernia repair that there are not the same issues, in the same volume, that we are seeing with women. To go back to Dr Agur’s comments about transvaginal mesh, there is a halt to the use of that, and there is no prospect that that will be removed; the cabinet secretary has reiterated that point.
With regard to the use in gynaecology of mesh through the pelvic or abdominal routes, that is subject to a high vigilance protocol. The accountable officers—Alan Mathers is one of them—are responsible for ensuring that there is attention to detail, with dotting of i’s and crossing of t’s, to ensure that patients understand. In those cases, mesh can be used only where there really are no reasonable alternatives, and where there is a high degree of scrutiny in order to ensure that patients completely understand what is going to happen and why it is happening, and that they have had the information and are empowered to make decisions for themselves.
I call Tess White.
My question is for Terry O’Neill.
Mr O’Neill, there should be scrutiny, and it is about more than just dotting the i’s and crossing the t’s. What I read in the papers for this meeting was harrowing. What has happened to many of these women is harrowing. Has the service for women in Scotland been set up in line with the NHS England service specification? If not, why not?
My name is Terry O’Kelly, rather than Terry O’Neill.
The commissioning of services in England is different, as you know. In England, certainly, there have been a number of commissioned specialist services for women who suffer from stress urinary incontinence and pelvic organ prolapse. I think that there are 40 of those, and within that, nine centres have applied for and been designated as able to manage mesh removal surgery, should that be required.
Therefore, the commissioning is different and the payment is different in England. As you know, commissioning is done through health boards here in Scotland. Each health board in Scotland has an accountable officer, and we have been meeting accountable officers since 2018-19. They are either medical directors or very senior medical managers, such as Alan Mathers, who are responsible for ensuring that the care for women goes forward in the way that they need and in a way that is commensurate with their problems. I am absolutely not complacent about the management of these women’s care. In fact, I am probably at the Raab-esque end of the spectrum of engagement and demand.
The stories that women tell are absolutely harrowing, and I have great sympathy for them because of what has happened to them. However, we need to move forward, and we need to ensure that the services that we provide for women and the way in which we communicate with them are at a level where women feel not only supported and empowered to make decisions about their treatment but that, when that treatment goes forward, it is provided at the highest possible level.
We have worked very hard with the boards and clinicians to ensure that that is the case. However, I am sorry and I was very concerned to read the Scottish Parliament information centre report. I was very troubled by it. It is not clear whether all the comments are contemporary, and it would be helpful to spend some time looking at that. I draw your attention to the work that has been done—it is on-going in Glasgow—with the patient experience and public involvement team. It is addressing those issues, and it appears, given the satisfaction that patients are reporting, that a lot of what has gone on before has been addressed and corrected. I hope that that answers your question.
It does not really answer it, Mr O’Kelly. Can you say what has been set up in line with the provision in NHS England and, if that has not happened, can you say why? I would be grateful if you would answer that question.
Are you talking about people with mesh complications or the treatment of patients—the care for patients who are presenting with stress urinary incontinence and pelvic organ prolapse?
I am talking about the latter.
We have worked with the health boards—with accountable officers—and we have looked at the provision of services for those patients. The work is on-going, but I have no reason to suspect that what we are asking of health boards and what they are delivering is any less than what is being delivered in NHS England. I have been part of a pelvic floor oversight group that has been looking at that.
Thank you.
Carol Mochan will lead questions on options for non-surgical treatment.
For me, today’s meeting has raised the issue of the importance of the non-surgical side of treatment. I am sure that the same is true for other members, so I really appreciate the fact that the witnesses have spoken about that. A lot of the issues have been covered as we have gone through the evidence session.
Do we need to do anything on communication with health boards around that? Should there be an expansion of the multidisciplinary team in relation to pain management? A lot of work is being done on pain management in the community and with other services that provide that. Would that be helpful for women who cannot, or choose not to, go down the surgical route?
12:00
I hope that you would recognise from what I have been saying—I think that you have—that we really value that non-surgical approach and all the elements of it: not only the pain management and the psychological support, but providing people with an explanation and an understanding of what has happened to them. Sometimes, as the survey reflects, there is difficulty with communication and with understanding what has actually happened.
We see women who have had multiple surgeries—multiple partial removals. The question is asked about what has happened to them—what is left? A significant part of this process is about re-establishing trust. That is reflected by the fact that we have these committees and these meetings. A lot of it is about establishing that trust relationship with women again and about them understanding what the mesh was in there for in the first place. Why was it put in? What were we trying to do by putting it in? No one put the mesh in with the intent to harm. No doctor would have done that. Everything that was done was done in the true belief that that was going to help the women. It is a sad reflection to think about the harm that has happened, as was covered in the Cumberlege report.
We cannot undo the harms, but we can try to do the best that we can for these women. The GG and C centre has some state-of-the-art scanners that work in a different way from the scanners that other specialist services have, which allow us to see exactly what is there and what can be done.
There is also the point about the need for skills around interpreting that information and being able to convey it. A lot of the feedback that the GG and C service has had is in relation to the number of MDT members. In fact, in response to the survey, the service is ensuring that not everybody in that multidisciplinary team is there in the room every time, because that can be a bit overwhelming. Another big change that has been made is about delivering the information in a steady way; people may need to come back and have that information repeated.
We have spoken about pain control and psychological support, and there is dedicated pharmacy support around that within the GG and C team.
Obviously, there are historical issues that affect the women’s level of confidence in the service and we fully understand why many of these women describe communication issues, empathy issues, lack of trust and so on.
One way of improving that level of confidence is by reassuring them that we are communicating well within the multidisciplinary team, that we know everything about them and we are communicating well from the local hospital to the national centre. That is easy when we talk about surgical issues—it is easy to communicate that a particular surgery has been done locally and that the patient then wants to have surgery done nationally or outside Scotland. What is difficult is the communication around the non-surgical treatment.
When the patient is referred from the local health board to the national centre, the national centre will not know exactly what sort of non-surgical treatment happened locally. One of the reasons for that is that we do not communicate that to the national centre. We could say, “Yes, the patient has been referred to the psychologist,” but that does not explain what has actually happened. What was the response of the patient to that referral? We could say, “The patient has been referred to the physiotherapist,” but that does not explain whether that improved things for the patient. It will probably not have improved things, because she requires a referral to the national centre.
I propose that we have a multidisciplinary team discussion and the local clinician and the national team talk about those patients and explain exactly what we have done. There are things that I can communicate to a clinician colleague that the electronic form will not communicate. We used to have that level of communication, as I covered in the paper that I circulated to the committee a few days ago. It is a historical paper—it describes practice that is probably from a decade ago—but it shows what happens when we talk to each other, either virtually or when we are present in the same room. Most of these meetings were done virtually, by the way, a few years before Covid. We were able to communicate well and we had the trust of the women because a woman could ask, “Oh, have you spoken to this person that I am going to see in Glasgow?” and we could say, “Yes, I have.”
That is a good approach and would also reduce the waiting times. In the patient leaflet provided by NSS I can see that there are two steps in the pathway that could be replaced by an in-person meeting, a virtual meeting or an invitation to the local clinician who referred from the local hospital to the national centre to attend that part of the national mesh MDT meeting that discusses their patient. At that meeting, I would be able to present my patient to the team and tell them what sort of treatment the woman had locally and what her wishes are. That interface between secondary care and the national centre would boost patient confidence, and hopefully that will be reflected in the next survey.
That was very helpful. Thank you.
I am interested in going right back to the beginning, knowing what we now know about complications caused by mesh implanted for stress urinary incontinence. As a nurse who worked in the operating theatre, I participated in anterior and posterior pelvic floor repair operations. However, before we even go there, is there work being done to encourage continence nurses, physios, midwives, and so on, to talk about things such as pelvic floor exercises? That advice would be free. Are we measuring whether that work, which might mitigate the need for any surgical intervention in the first place, is happening?
Yes, there is engagement with non-surgical treatment for conditions that are induced by childbirth injuries—such as incontinence and prolapse. The first non-surgical options are physiotherapy and continence advice. Physiotherapists and continence nurses are an integral part of MDTs in almost every health board. Their intervention has prevented many women from having surgery. The MDT, which includes myself and other surgeons and gynaecologists, would discuss surgical options for the women for whom those interventions do not work.
However, yes—that system is there. I am not sure whether there is anything at the Government level. Perhaps Terry O’Kelly will be able to answer that part of the question. Pelvic floor education could be done on a larger scale—for example, in schools, even before the reproductive period—because planting this seed at the beginning is important.
One of my former colleagues teaches Pilates, and she also does pelvic floor exercises as part of that, to destigmatise the issue. She sees young women in schools and is breaking down the barriers of conversation. Do you support taking education out to schools before young women start having experiences that might lead to urinary incontinence?
Yes, there is no doubt about it. Many women come to us after childbirth with damage that has caused incontinence and prolapse, and the reason that the mesh was introduced in the first place is that when they came in many of them did not even know what the pelvic floor was or how to contract it and engage it. That is why physiotherapists spend a lot of time with them, educating them. If that happened at school, it would mean that if they were unlucky and developed these conditions during their reproductive career, they could at least know what was going on and could perhaps engage better with physiotherapy services.
The other improvement that could be made is in postpartum physiotherapy immediately after delivery. My understanding is that, at the moment, the programme for that is relatively short. It would be possible to improve that programme to enable prevention by extending it or having more regular sessions that are supervised by the physiotherapist in the first few weeks after delivery.
Mr Torrance wants to cover some points on local and national services.
What are the benefits of a national service over a local one in supporting women who are affected by transvaginal mesh?
Nationally commissioned services are highly specialist services that it would not be possible to provide in 14 different territorial health boards. There are nine specialist centres across the entirety of England and one in Scotland. The NSD, as part of NSS, commissions approximately 150 highly specialist services for Scotland, which are funded through the individual boards but all contribute to that national service, and which reflect where there needs to be highly specialised services that can provide competence and confidence in a national service.
We would not be able to have these conversations about confidence and trust if we tried to provide those services from multiple places that would only see a small number of cases. Primarily, we need to concentrate that expertise to be able to provide it as a national service, both to attract people into those services but also to convey confidence and competence to the people who are using them.
In the current financial circumstances, is it feasible for bespoke services to be established in every health board or region?
I refer to my previous answer. It is neither possible nor desirable to try to establish a bespoke service in every single centre, because you would not have the number of cases to be able to provide that level of experience, expertise and confidence. We have to recognise, too, the value to the NHS and to the women who are accessing those services. As part of the responsibilities of the NHS, we need to provide highly effective and efficient services, and providing those highly specialised and competent services in individual centres is a mechanism to achieve that.
We would love to be able to provide highly specialised services that are accessible and at short distances from home for everybody. However, the demographics and geography of Scotland do not allow us to be able to provide those services in every centre of the country—that is the reality that we all face when we look to arrange services.
In the petitions committee, of which I am a former member, we heard evidence from Dr Netto from the Shouldice hospital in Ontario in Canada, who made a similar point about the need for centralised services to provide that sufficient scale of experience and critical mass of expertise. Did you undertake any international benchmarking on service design when considering how to develop the service in Scotland?
Under our service agreement, the national services are under continual review and we have a regular cycle of review.
As Dr O’Kelly has already mentioned, the service in Glasgow was the first service in the UK to be set up. We have talked about whether we are following England, but in many respects, what is being done in England is following what has happened in Scotland.
We are at a very early stage in relation to that benchmarking idea. It has already been mentioned that national committees are in place. Primarily, the mechanism towards that benchmarking is credentialing, which is the route that we are going down. It will take time because it has not been done specifically in Scotland. However, there is a commitment to that credentialing from the team within NHS Greater Glasgow and Clyde, which has already progressed and applied for it, with the expectation that all those in NHS Greater Glasgow and Clyde will then qualify for it.
I think that Mr O’Kelly wants to make a point.
It is just to say that I recognise the point about Shouldice hospital.
The recommendation for establishing the centre was the outcome of the short-life working group, which engaged with all necessary stakeholders, health boards, patients and other clinical groups. The decision was taken to support continued development of the specialist service in Glasgow. As has been noted, that came a year before the conclusions in the independent medicines and medical devices safety review report were produced.
Anna Lamont mentioned credentialing, which will be really important in order to benchmark clinicians in Scotland against a curriculum and framework that has been published by the Royal College of Obstetricians and Gynaecologists and will involve working with the Royal College of Surgeons in England, with specialist associations and with the patient reference group. The documents have been out for wide consultation, including public review, and I encourage people to look at that.
12:15We will soon introduce a registry to look at not only patients who are having mesh removal surgery but those who are having primary surgery for stress urinary incontinence and pelvic organ prolapse. All procedures will be captured on that UK-wide registry. It will allow us to look at our activity and our outcomes, including patient-reported outcomes, for all the procedures, and that will allow benchmarking comparison. The hope is that that will build further confidence in the centre in Glasgow and in care for patients across Scotland.
Does Dr Agur want to make a point?
No, thank you—Terry O’Kelly has just made the point that I would have made.
That is fine. Does Ms Harper want to make a supplementary point?
Yes—I have a quick point. The deputy convener mentioned the Shouldice approach. A Shouldice repair has strict criteria such as losing weight, having no alcohol and being able to exercise. It might be difficult to apply that in Scotland, where people who present as needing an inguinal hernia repair that uses mesh, for instance, might have additional comorbidities. We cannae compare apples wi oranges.
Again, the question is outside my expertise, because I am not a general surgeon. I have done only two hernia repairs in my whole life, and that was before I specialised as a gynaecologist. I am not qualified enough to give you a full answer, but I will answer in general.
The Shouldice repair is a non-mesh repair that has had a wonderful outcome in Shouldice hospital. People there have managed to save the vast majority of their patients from having to have a mesh device implanted for ever, which can cause problems in the future.
Hernia mesh appears to induce fewer mesh-related complications than mesh that is used for gynaecological reasons does. There are many reasons for that. However, if we compare the populations in Scotland and Canada, I do not believe that the presence of, or any perception of, a difference in comorbidities should prevent a Shouldice-like approach here in Scotland. We should at least start building the native tissue approach and allow the surgical technique to evolve, which will allow our surgeons to improve their skills and be more confident in offering native tissue non-mesh surgery. The selection criteria for patients who would benefit best from the Shouldice repair will need to be clinically based.
Such evolution needs to start as soon as possible. It involves clinical decisions about individual clinical patients, which will definitely consider comorbidity. That needs to be supported by local and national Government.
I am not an expert in this area, but that is how I see things. I had a Shouldice hernia repair, and the two hernia repairs that I have done were Shouldice repairs.
Before we conclude the session, do any panellists wish to make any final burning points?
I am not sure whether this is the environment for discussions about the Shouldice approach, which have been well rehearsed. One thing that we have not mentioned is the major issue of patients waiting in Scotland and in the United Kingdom. We have not touched on programmes such as waiting well and fit for surgery. I am part of the waiting list team in the Scottish Government and I advertise and promote those initiatives.
There are opportunities for patients to make lifestyle changes and get fit in the time that they are coming to surgery. Evidence from around the country suggests that the long-term health benefits of that can be substantial. Colleagues in Glasgow know about those programmes, but we should probably consider and promote them.
I thank all our panellists for their attention, expertise and contributions, which we as parliamentarians value hugely. We show our appreciation for that. I wish you a good afternoon.
12:20 Meeting continued in private until 12:44.