Thyroid and Adrenal Testing and Treatment (PE1463)
There are parts of HIS that produce different types of recommendations for NHS Scotland. The committee has already seen some of the outputs in the work from the Scottish health technologies group.
We are also developing a number of approaches to consensus guidelines or recommendations for NHS Scotland where there is a sparse or absent evidence base. Instead of undertaking the systematic review of evidence that SIGN does on an on-going basis, we would bring together a group of a similar composition to that described by Roberta James, and it would reach a consensus on how to manage a condition. If there is no evidence to guide us, we can bring people together who represent all the different groups to work together, according to the scientific methodology that they use, to derive a consensus for the management of a condition. That is a new type of work that we are just developing.
Thank you. Your colleagues should feel free to intervene at any time by catching my eye.
I flag it up to my committee colleagues that, although the witnesses are here to talk about the SIGN process, they are not necessarily experts on the technicalities of the petition. If they happen to be experts on the petition, that is all well and good, but I do not assume that they will be. I do not know all the details of their backgrounds.
I am interested in guideline development. What factors are taken into consideration in that development?
SIGN has an enviable reputation around the world for its high-quality guidelines.
The pressure is always to produce guidelines that are reliable, and the evidence is weighed up in a number of ways in relation to the way that it was gathered; the scientific methodology and its robustness; and whether it has been published in peer-reviewed journals. That means that you end up making guidelines on the basis of high-quality evidence. The strength of a recommendation depends on the quality of the evidence that has been assessed. Therefore, if the evidence is not of a high quality, there is a danger that, if other people did the same investigations, they would not get the same answer. We are keen not to produce guidelines that then prove to be erroneous. A guideline can be written only when you are confident that there is sufficient robust evidence. Otherwise, you make mistakes, which is perhaps a reputational risk.
Absolutely. Almost all our guidelines will include the evidence that was relevant to subsets of patients. That is particularly the case now that we are increasingly looking at multimorbidity as part of our guideline development process.
As John Kinsella said, we accept proposals—which can be made through our website—from healthcare professionals, patient organisations and patients. We take those proposals to the SIGN council and have a scoping search done. We look at the high-level background evidence, and the SIGN council can determine what evidence there is to answer the questions that proposals need to fit, which John Kinsella outlined. That is followed by a process of prioritising topics that we think are suitable for a clinical guideline.
If we think that a topic is unsuitable for a guideline, there are other avenues that we can ask colleagues in Healthcare Improvement Scotland to consider—for example, it might be more suitable to develop a standard, a set of indicators or an evidence note than a guideline. We work with our colleagues in the bigger organisation.
Once we have decided that a topic is suitable for a guideline, we get the SIGN council to appoint a chair, who will be a healthcare professional who works in NHS Scotland. After that, we go about forming a guideline development group, which is a multidisciplinary geographically representative group of people who can ask the pertinent clinical questions and help to examine the evidence that we find.
We have information specialists who take the questions and look at the published literature. We critically appraise all the literature that we find and summarise it so that the guideline development group can look back and see whether it answers the questions that have been asked. We then summarise the evidence and make recommendations, if there is enough evidence and if the evidence is pertinent to the population in Scotland. That is how we end up with a guideline.
That is interesting, but let us return to the question of evidence. Would you call for evidence, or would you specifically ask certain people to supply you with evidence? I ask that because there is evidence from abroad that is different from the evidence in this country. There is a suggestion that, although we have a brilliant NHS—we are much to be envied in many ways—we are working 40 years behind on thyroid issues. That is a problem particularly because there are gender issues to be addressed, given that thyroid conditions are associated with women.
First, how would you gather the evidence to make a decision? Secondly, could you produce SIGN guidelines that put the patient first? One of the problems with thyroid testing is that the patient’s signs and symptoms are ignored by many medical professionals who simply look at blood tests, which cannot always be relied on. In addition, the results of the blood tests are treated differently in this country. The results of some people’s blood tests would lead to their being immediately put on replacement therapy if they were in America, Cuba or other parts of Europe, whereas in this country that does not happen. A number of people in this country, including some of my relatives, have been told by GPs that they are borderline cases although they clearly have thyroid issues—they suffer weight gain, difficulty in conceiving and hair falling out—and they get no treatment. Could there be a guideline that says that the most important thing is how the patient presents? Dr Anthony Toft says that in some of the evidence that he has written up.
I understand that. Am I right in thinking that Roberta James suggested that we are applying only to English-speaking specialists and that, because of translation costs, we are not looking at what might be produced elsewhere? If so, that seems to be an extremely dangerous situation to be in. Applicable treatments might be available in non-English-speaking countries.
We definitely need further research. The committee knows that the research that Lorraine Cleaver has been doing is quite intense.
I said that you would not necessarily be experts on the petition, so I will try to steer away from the technical aspects of it. If I struggle, I am sure that Elaine Smith will be able to help out. Have the petitioners approached you to develop guidelines in the area that they are concerned about?
You mentioned evidence. As you know, we have done a lot of work in this area. In fact, we had an open session with practitioners and the petitioners. Could evidence include concerns from patients that might not necessarily be accepted by medical practitioners?
When we undertake a systematic review of the evidence, we take evidence from around the world. We do not request that evidence; it is found through searching electronic databases—and medicine has many very high-quality databases that contain evidence from around the world. The only restriction that we place on the evidence is that it must be in the English language, as the cost of translating scientific evidence is phenomenal.
I hope that our guidelines are always patient centred. That is why we have actively included patients, patient representatives and laypersons in the development of the guidelines right from the start. Around the world, we are considered an exemplar in terms of our involvement of patients in guideline development.
English is the language in which the majority of medicine is practised. Almost all the leading journals in the world are in English. Many of the countries in Europe and around the world that produce high-quality evidence publish it in English in their journals. There are few sources of robust evidence that are not in English and have not already been translated.
Lorraine Cleaver’s most recent submission seeks to draw our attention to a perceived inadequate evidence base for the current approach to treating hypothyroidism. She says:
“I urge the committee and SIGN to take particular note of the finding of Healthcare Improvement Scotland’s scoping report on Hypothyroidism that the guidelines on the use of Thyroid Function Tests are based on ‘generally poor quality, non peer reviewed evidence’”.
As we know, SIGN has no current guidelines for hypothyroidism; doctors are guided by the recommendation from the Royal College of Physicians
“that patients with on-going symptoms should be investigated further.”
Will concerns about the evidence base for the standard approach to diagnosis and treatment prompt a review of the current approach?
In the evidence that we have received, it is suggested that SIGN should take particular note of the findings of Healthcare Improvement Scotland’s scoping report on hypothyroidism, which tells us that the guidelines on the use of thyroid function tests are based on
“generally poor quality, non peer reviewed evidence”.
Given that background, how sure can we be that the guidelines will be adequate? You know better than I do that the inadequacy of guidelines could cause further harm to thyroid patients. What auditing goes on? What checks and balances are built in to ensure that the guidelines will be secure and will not cause further harm?
I spoke to a petitioner on the phone a while back and explained how we accept proposals, but I have not yet seen a proposal on the subject of the petition.
We could continue this discussion for a considerable amount of time, but we are just about out of time, so we will move to our summation of the issues. At this stage, we have finished asking questions.
There is a lot of complex information to absorb. I suggest that we ask the committee clerk to analyse the evidence that we have taken today and in the past and to quickly produce a paper that will enable us to consider next steps. Today’s session has given us a useful insight into not only SIGN but other options that might be open to the petitioners. I feel that that is a bit of a breakthrough for the petitioners, following all the work that they have done. However, as always, I am open to suggestions and contrary views from committee members.
As part of our guideline development process, we actively seek and engage with patient groups so that patient information is included. Patient concerns come under qualitative research and we would include them. When the guideline development groups determine the recommendations to be made on the basis of the evidence, patient concerns would be actively reviewed as part of that process.
In theory, there is nothing that jumps out at you to indicate that there could not be a guideline on thyroid and adrenal disorders or that SIGN could not do work on that area.
I presume that you compare and contrast with your colleagues across not just Europe but the world—that you look at what is happening in the World Health Organization, the European Commission and so on. Is that an active part of your day-to-day job as you develop guidelines?
There is a difference between the evidence that is out there and the product that SIGN produces. We use the clinical evidence from clinical trials, investigations and research that is carried out on patients in a clinical environment, which tests and compares investigations or treatments, to synthesise guidelines. The guideline itself is not evidence. It is a synthesis of evidence and a summary and recommendations based on that evidence.
We therefore have a difficulty: if in the wider world there are no good-quality clinical studies, when we come to do a guideline, we are not in a position to make high-quality recommendations.
I might have misunderstood what you said. Are we asking SIGN to go off and prepare draft guidelines?
Could you give a more in-depth description of the make-up of a guideline development group? To what extent are patient opinion groups involved?
No.
We actively seek information that is in the public domain from across the world—that includes information from WHO and other organisations. If the information is in the public domain and it is pertinent to the question, it will be considered.
We could ask the committee clerk to do an in-depth look at next options. We have heard from our witnesses that it is competent for us to refer the petition to SIGN at this point. We can do both things—we can ask the clerk to do an in-depth analysis and we can refer the petition to SIGN immediately.
I thank the witnesses for coming along. You mentioned the ways in which proposals can be made. Could a committee make a request to you?
There are particular characteristics in Scotland, but I assume that, compared with the rest of the world, the day-to-day health of Scots is not that different.
If a guideline was being developed on stroke, we would have stroke physicians, specialist nurses, clinical psychologists, neurologists and so on. The group would be made up of all the people who would see a patient on their journey. We would then have our lay representatives. They might be previous patients, carers or representatives from Chest, Heart and Stroke Scotland, for example. We have had all those people in the past. We try to include on a group a representative of everyone who would see a patient during their care journey, including GPs and pharmacists.
You asked about the patient’s voice. If we are developing a guideline and we find that the patient group is difficult to reach—children with autism, for example—we take further steps to do some focus groups or work with schools or patient organisations to get more of an opinion from patients and carers.
You will have heard my previous comments about pipelines and how long it takes for things to be done, so I suggest that we do as you suggest and ask SIGN to produce guidelines now, notwithstanding the parallel work of the clerk to produce an in-depth report.
Absolutely. Anybody can make a request.
That is right.
If the petitioners do not succeed in getting a SIGN guideline, are there any alternative routes that they can take?
I agree with that suggestion. Given that the petition has been dragging on for some time, and that time is of the essence, we should immediately refer it to SIGN.
That is useful to know.
I invite contributions from my colleagues.
Agenda item 2 is consideration of a current petition. We will take evidence from the Scottish intercollegiate guidelines network—SIGN—as part of our consideration of PE1463, by Lorraine Cleaver, on effective thyroid and adrenal testing, diagnosis and treatment. Members have a note from the clerk and the submission from the petitioner.
I welcome the representatives from SIGN: John Kinsella, the chair; Sara Twaddle, the director; and Roberta James, the programme lead. I welcome also Elaine Smith MSP, who has had a long-standing interest in the subject. I thank you all for coming along and helping the committee in its consideration of the petition. I invite Mr Kinsella to make a brief opening statement of two to three minutes, after which we will move to questions.
On that point, would the big issues around vitamin D deficiency, for example—which also affects patients with thyroid problems—make the whole issue more pertinent to Scotland?
Also, the scoping report on hypothyroidism that Healthcare Improvement Scotland carried out for the committee says that desiccated thyroid hormone
“can be prescribed on a National Health Service (NHS) prescription as a specials product.”
However, general practitioners do not prescribe it for various reasons. I think that if SIGN guidelines looked into that, GPs would prescribe it.
The report also stated:
“At the end of the study 49% of patients preferred DTE”.
A lot of that preference for desiccated thyroid extract was to do with weight. Weight issues are a major problem in Scotland on their own, without considering tiredness and everything else. If SIGN guidelines allowed GPs to perhaps think about prescribing desiccated thyroid hormone, that might have a big effect on weight. Apart from the fact that there may be issues that are particular to Scotland, healthcare is devolved to Scotland in the first place.
My other point goes back to what my colleague Chic Brodie was asking about. It is admitted that 15 per cent of patients with thyroid problems are unwell. What are we doing about that 15 per cent of patients? There is an issue here for those people.
We have received lots of in-depth information and written reports from across the world. It goes without saying that we will provide SIGN with all the evidence that we have taken, which those who are with us today might not be party to.
I am happy to go along with the recommendations.
Good morning. I am professor of critical care at the University of Glasgow and chairman of the Scottish intercollegiate guidelines network.
SIGN was set up in 1993, with a council made up of representatives of the royal colleges and their faculties, and other interested bodies. That remains to this day. I chair the council, which is the decision-making body on SIGN guidelines. In 2005, SIGN became part of NHS Quality Improvement Scotland, which is now Healthcare Improvement Scotland.
We produce clinical guidelines for clinicians and patients based on an evaluation of the evidence. A guideline group is set up in response to a request for a guideline. The group consists of clinicians and people who are not clinicians, such as health economists and lay representatives. Over two years, the group produces a comprehensive guideline on specific clinical questions. The clinical questions have to be pertinent to Scotland. There has to be a health need and some evidence for that. There also has to be a reasonable expectation that a guideline will produce changes in healthcare and improve the health of the relevant patient group.
It might be helpful if I went into a bit more detail about how a guideline is developed, as that would address all your questions. The proposal just gives a broad remit of what the guideline should cover. Once we get the multidisciplinary group together, with all the people involved—the healthcare professionals, all the lay input and the other professionals such as health economists—round the table, we start asking the questions.
The questions that you asked are the kind of questions that people will bring up, because when we bring together GPs, patients and people who are working at the coalface, they see the questions that they need answers to, and those are the questions that will ultimately appear in the guideline to be answered. The flipside of that, as Sara Twaddle said, is that if you ask those questions and we are not able to find any evidence to answer them, we are not able to make a recommendation. Any recommendation would be that further research was needed in those areas.
10:45
I thank committee members. We are actively dealing with the petition. We will ask our clerk to produce a comprehensive report on the options that are open to us but, immediately, we will refer the matter to SIGN so that it can consider potential guidelines. We will pass on all the information that we have had sight of.
I thank the members of the panel for coming along today. This has been an informative meeting and we appreciate people giving up their time for it. Obviously, our aim is to do as good a job as we can for the petitioners, who have given us some harrowing stories of the difficulties that they have faced over many years. I again thank Elaine Smith for coming to the meeting to offer her guidance in relation to this tricky and involved petition.
I suspend the meeting for two minutes to allow a change of witnesses.
10:59 Meeting suspended.
Good morning. Having looked at the petition, I am very supportive of it.
Thyroid Patient Advocacy claims that patients with on-going symptoms often go on to be misdiagnosed. Is there any scope for guidelines to be developed for a specific subset of patients—in other words, those with on-going symptoms?
When it comes to how we develop guidelines, the crucial thing is that there is an evidence base on which to base recommendations. As Roberta James described, we would undertake a systematic review of the evidence and if there was evidence that was pertinent to particular subgroups, that could be included. Essentially, it is not possible to produce an evidence-based guideline without having an evidence base to base it on.
Have there been any other circumstances in which subsets of patients with particular diseases or illnesses have been looked at by SIGN?
Previous
New PetitionNext
New Petition