NICE guideline on ME/CFS: Stakeholder consultation submissions (July 2017)

[Keela Too]

It seems the server is down on our website. It should be up again, but it might take a couple of days!!! Bad timing or what!

Anyway here is another link to our submission. @charles shepherd could you add it to the top post please (leaving the old one which I hope will soon get restored). Thank you.

https://app.box.com/s/ncod2mzi8dvyjkegtnb9uangme9b6chg

 

[Luther Blissett]

A quick tip for changing the colours in a pdf file if you have a problem reading black on white text.

Adobe Reader

• Open the PDF
• Go to Edit Menu
• Go to Preferences
• Look for and click the 'Accessibility' tab
• Enable the ‘Replace Document Colors’ option.
• select ‘Use High-Contrast Colors’ and select a color scheme from the presets available

Document Viewer (Linux)

• Open the PDF
• Go to 'View Options' (next to the percentage box on the top right (logo is page and spanner))
• Choose 'Inverted Colors'

Depending on the program used, changes might still be selected the next time you open PDF. If so, you will have to manually turn the options back off to return the settings back to default.

An example of a pdf in Document Viewer with colours inverted:

 

[charles shepherd]

RE: NICE refuse to release the names of their expert group following a request from the MEA

I have replied to Alex at NICE as follows


27 July 2017

Dear Alex

Thank you for your detailed reply to my request for details of membership of the expert group that has reviewed the evidence for NICE.

You say that:

"We do not routinely publish the identities of topic experts because, while they may express an opinion, they are not part of the decision making body."

The word "routinely" indicates that while publication of names of topic experts is not done as a matter of course, this is something that NICE could do if it wanted to.

And there is nothing in your reply to indicate that membership details of the group have to remain confidential.

Our request to NICE is not "routine".

Earlier this week The MEA sent a letter to Sir Andrew Dillon with a petition signed by over 15,000 people calling for a review of the NICE guideline on ME/CFS. This appears to be the largest ever public vote of no confidence in a NICE guideline by the people it is designed to help.

The fact that these experts are "not part of the decision body" has nothing to do with publishing or refusing to publish the names. They are playing a key role in the decision making process.

So please could you clarify if NICE is actually refusing to disclose this information.

And if so on what grounds.

This is a perfectly reasonable request. The ME/CFS patient community expects transparency from NICE in the decision making process on an issue of great importance to their health and this is not happening here.

Regards

Dr Charles ShepherdHon
Medical Adviser, MEA

MEA letter (pdf) to Sir Andrew Dillon, Chief Executive at NICE, containing the 15,000 signature petition:

http://www.meassociation.org.uk/wp-...tion-Letter-to-Sir-Andrew-Dillon-24.07.17.pdf




26 July 2017



Dear Dr Shepherd,

Thank you for contacting the National Institute for Health and Care Excellence (NICE) regarding our guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (CG53).


In reaching our provisional decision the surveillance review team undertook extensive searches to identify any new primary and secondary studies, including any economic studies. The focus is on the scope of the published guideline, but any additional areas or changes in practice that are identified during the process are also considered, if they fall within the referral of the published guideline. A literature search is conducted across a range of sources, selected according to their relevance to the topic and are based on those used in the published guideline.


We can’t provide the names of the surveillance team but it is made up of a Technical Analyst, Technical Adviser, Clinical Adviser and the Associate Director – Surveillance.


Topic experts, including members of the original guideline committee, are asked for their opinion, in their personal capacity, on the relevance of the published guideline, recent developments in the topic area and their knowledge of any new important evidence since publication of the guideline. Guideline committees are responsible for the development of guidelines and we publish the membership of them. We do not routinely publish the identities of topic experts because, while they may express an opinion, they are not part of the decision making body.

The review proposal is made by the review team and the decision on whether to update the guideline is made by our Guidance Executive. The Guidance Executive considers and signs off guidance and implementation for publication. It meets every week and is made up of NICE executive directors, guidance centre directors and the communications director. Its current membership can be found on the NICE website.

I hope this information has answered your question.


Kind regards,


Alex


Alexander Smith
Communications Executive (Corporate Communications)
National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom

 

[MEMum]

""This is a perfectly reasonable request. The ME/CFS patient community expects transparency from NICE in the decision making process on an issue of great importance to their health and this is not happening here."

I think that transparency or justice/listening to patients/looking at biomedical research/....is not what we expect any more but so pleased you are asking for it Dr Shepherd!

 

[trishrhymes]

The focus is on the scope of the published guideline, but any additional areas or changes in practice that are identified during the process are also considered, if they fall within the referral of the published guideline. A literature search is conducted across a range of sources, selected according to their relevance to the topic and are based on those used in the published guideline.

I don't understand this paragraph, but it makes me uneasy. The phrase 'relevance to the topic and are based on those used in the published guideline' is confusing.

Does it possibly mean that they will only consider new evidence on the treatments already recommended in the guideline? In that case, perhaps that is their excuse for ignoring any new biomedical evidence or treatments beyond those already in the guideline such as rituximab, LDN and other drugs.

Does this explain why we seem to be only waiting on FITNET as possible new evidence? At least is should include the critiques of PACE... maybe?

Can anyone help me out here?

 

[dangermouse]

@charles shepherd thats a good letter.

 

[charles shepherd]

I don't understand this paragraph, but it makes me uneasy. The phrase 'relevance to the topic and are based on those used in the published guideline' is confusing.

Does it possibly mean that they will only consider new evidence on the treatments already recommended in the guideline? In that case, perhaps that is their excuse for ignoring any new biomedical evidence or treatments beyond those already in the guideline such as rituximab, LDN and other drugs.

Does this explain why we seem to be only waiting on FITNET as possible new evidence? At least is should include the critiques of PACE... maybe?

Can anyone help me out here?

When NICE carry out one of these evidence searches, or a proper review, they normally employ an academic to do a thorough literature search for any new papers from any reputable medical publications that are relevant to clinical assessment, diagnosis, diagnostic criteria and management (i.e. clinical trials) of the condition

As I have pointed out previously, NICE are not really focussed on causation of disease - their remit is to provide guidance on to health professionals on diagnosis and management based on published evidence

CS

 

[MEMum]

@trishrhymes .
Following sentence is from Charles Shepherd post 41 on
http://forums.phoenixrising.me/inde...y-2017-until-friday-21-july-2017.52380/page-3


"And it's important to note that NICE are not really interested in research into causation of ME/CFS - they provide guidance to doctors on clinical assessment, diagnosis and management of illnesses"

Don't know if this helps.

 

[ukxmrv]

NICE we asked by the DWP to prepare the Guideline originally. I did a FOI on it some years ago but it's not to hand.

However IiME included it in one of their document as follows

"Remit: "To prepare for the NHS in England and Wales, guidance on
the assessment, diagnosis, management of adjustment and coping,
symptom management, and the use of rehabilitation strategies
geared towards optimising functioning and achieving greater
independence for adults and children of CFS/ME. "

In the current "consultation" NICE have a section on the comments form for I think this type of concern

"Do you have any comments on areas excluded from the scope of the guideline?"

 

[charles shepherd]

NICE we asked by the DWP to prepare the Guideline originally. I did a FOI on it some years ago but it's not to hand.

However IiME included it in one of their document as follows

"Remit: "To prepare for the NHS in England and Wales, guidance on
the assessment, diagnosis, management of adjustment and coping,
symptom management, and the use of rehabilitation strategies
geared towards optimising functioning and achieving greater
independence for adults and children of CFS/ME. "

In the current "consultation" NICE have a section on the comments form for I think this type of concern

"Do you have any comments on areas excluded from the scope of the guideline?"

We have had detailed discussions with both Professor Mark Baker (NICE) and Dr Martin McShane (Long term conditions - NHS England) as to who sets the process of setting up and/or reviewing a NICE guideline in progress

There has been a significant shift in direction here in recent years - so the decision making process (in the case of ME/CFS) now involves NHS England

I don't think the DWP have been having any input into the current review and evidence gathering process

CS

 

[charles shepherd]

FRom the Minutes of meeting held on 15 July 2015:



3. Discussion.

3.1 The Chairman referred to Professor Mark Baker of NICE who had told Forward-ME that he could not do anything about the NICE Guideline on ME/CFS but that NHS England could. Dr Charles Shepherd added that Prof Baker had said ME/CFS was not on the “library” or list of medical conditions whose NICE guidance might be reviewed. How could we get ME/CFS on to that list? Dr McShane said that NICE’s remit had expanded a lot; it now included social care, for example, and quality standards. There was undoubtedly a capacity issue. Capacity, resources and a huge agenda meant that NICE guidance on a large number of conditions was unlikely to be reviewed for a long time.


3.2 The Chairman recognised the difficulty but pointed out that there had been misdiagnosis in about 40% of patients said to have ME. In many cases the true cause of illness could be successfully treated instead of the patient languishing in the “ME dustbin”. This misdiagnosis represented a huge cost to the taxpayer. All that was being offered to ME patients was CBT or GET which were often ineffective. Jane Colby added that parents get blamed if children with ME don’t improve after receiving CBT or GET, and in many cases this had led to Child Protection issues. Charles Shepherd pointed out that NHS England were keen on patient evidence; the ME/CFS patient representative groups had an abundance of evidence gathered from patients about CBT and GET. We were very supportive of change, and we had received a strong message from Prof Mark Baker that if NICE was so advised by NHS England they would seriously consider changing the guidance on ME/CFS. Dr McShane responded that he could ask about this, but the Department of Health (DH) would have to be involved too. The Chairman pointed out that both NICE and DH had said the responsibility was with NHS England.


3.3 Janice Kent referred to Dr McShane’s point about mental health patients not being treated for their co-morbidities (para 2.2 above). She had been at a CCG meeting the day before when the point was made that mental patients have shorter life expectancy than those with purely physical illnesses. The drugs they are given often have undesirable side effects such as desire to overeat or smoke. She said a lot of ME patients also had co-morbidities that were not being addressed.


3.4 Hannah Clifton said they had a lot of evidence of effective treatments at Burrswood, but providers said that NICE permits only CBT or GET. Dr Mc Shane said that there was a problem with the “one size fits all” approach. We should be moving to Personalised Health and Care needs. The funding should follow the person rather than the person following the funding. That might take some time to achieve – it would involve a huge change.

3.5 Sonya Chowdhury said that plans like House of Care were admirable although hugely ambitious. A major problem reported by ME patients was that GPs did not seem to understand the illness. There was a need for this subject to be included in the training and education of GPs. What should we as charities be doing to improve that situation? Dr McShane said it was important to collect facts and figures on the impact of the illness. He had recently led a task force on the mental health of children and young people. They had discovered that about 40% of chronic mental illness starts before the age of 14.

He quoted more figures to support the economic case for appropriate mental health interventions. The Treasury was definitely interested. This was the sort of information that was needed from the ME community.


3.6 Janice Kent pointed out that the ME charities had been supplying such information for years. They had provided it in the Report to the CMO. Christine Harrison agreed; she listed a number of working groups to which she had provided such information, including NICE. She disagreed with Dr McShane about biomedical treatment. The most important requirement for ME patients was a good doctor providing good biomedical treatment. Dr McShane agreed that the most important person in the provision of good treatment and care was the doctor in the front line.


3.7 Jane Colby agreed that the ME charities had been supplying information for years. In 1997 a big study of children had shown that ME was the biggest cause of long term sick absence in school children. The effect of the illness on children had been reported on many occasions since then, and yet only recently she had been involved in a case in Scotland where parents had been threatened with court action because their child, who had ME, was absent from school. The authorities did not seem to realise that the child was too ill to be at school. She also pointed out that absence from school was not the same thing as absence from education. Home tuition can be provided. This was a matter that ought to be emphasised in NICE.


3.8 Dr McShane said seeking changes to NICE guidance was problematical. There were so many different bodies claiming so many priorities. He could pass on Forward-ME’s demand for a review of the Guideline, but he would then be asked where ME stood in relation to diabetes, cancer and numerous other conditions which were subjects of NICE guidance.


3.9 Dr Charles Shepherd asked Dr McShane whether he could write to NICE saying that in the view of NHS England the NICE Guidance was in need of review. Dr McShane said he had received similar requests from people representing other illnesses, but he could reflect to NICE the intensity of our concerns about the need for review. However, he could not tell them that ME should have priority over other conditions. Dr Shepherd observed that if patients reported a drug was causing harm the position would be reviewed immediately. In this case they were reporting that GET was causing harm.


3.10 Jane Colby said it was important to realise that ME was not just fatigue. The pain could be intense. A child had said “my legs won’t do what I tell them to do”. She herself had been confined to a wheelchair for a long time. Anita Williams said her daughter had ME but the GP said he was unable to find anything and asked “what do you want me to do?


3.11 Dr McShane confirmed that he would write to NICE. The Chairman asked if we could see a copy of his letter. He agreed. Sonya Chowdhury said that AFME had a huge amount of patients’ experiences, surveys, and costings which they could supply. Any suggestions NHS England might have about how that information might be used would be gratefully received. Dr Charles Shepherd handed Dr McShane a copy of the MEA’s recent patient survey. The Chairman and members thanked Dr McShane for his talk and for dealing with our points and questions.

 

[Wonko]

So...my understanding of all that is this;

NICE won't review the guidelines for M.E. because they don't have the resources (e.g.the time, the people etc.) to do so, any time they were to allocate to reviewing the guidelines for M.E. would have to be taken from the time used to do it for other conditions and they just don't consider that M.E. is as important as, say, diabetes.

Did I get it right?

 

[Esther12]

NICE we asked by the DWP to prepare the Guideline originally. I did a FOI on it some years ago but it's not to hand.

However IiME included it in one of their document as follows

"Remit: "To prepare for the NHS in England and Wales, guidance on
the assessment, diagnosis, management of adjustment and coping,
symptom management, and the use of rehabilitation strategies
geared towards optimising functioning and achieving greater
independence for adults and children of CFS/ME. "

In the current "consultation" NICE have a section on the comments form for I think this type of concern

"Do you have any comments on areas excluded from the scope of the guideline?"

Googling that quote brought this up:

Chronology
16. The origin of the Guideline was a request from the Secretary of State for Health and the Welsh Assembly to NICE in February 2004:

To prepare for the NHS in England and Wales, guidance on the assessment, diagnosis, management of adjustment and coping, symptom management, and the use of rehabilitation strategies geared towards optimising functioning and achieving greater independence for adults and children with CFS/ME.

https://high-court-justice.vlex.co.uk/vid/and-53869911

 

[Dolphin]

Googling that quote brought this up:

Chronology
16. The origin of the Guideline was a request from the Secretary of State for Health and the Welsh Assembly to NICE in February 2004:

To prepare for the NHS in England and Wales, guidance on the assessment, diagnosis, management of adjustment and coping, symptom management, and the use of rehabilitation strategies geared towards optimising functioning and achieving greater independence for adults and children with CFS/ME.

https://high-court-justice.vlex.co.uk/vid/and-53869911

A Welsh ME/CFS group requested the guidelines. It seems to me an example of it being important to be careful what you wish for. The only treatments that NICE was likely to recommend were CBT and GET and they were always likely to recommend against other therapies as they generally require at least two positive randomised controlled trials.

 

[Snow Leopard]

Penny-wise, pound foolish. It is clear there is a lack of leadership and responsibility in NICE towards ME & CFS and also a pervasive attitude that our views don't matter.

Just watch as all the noteworthy submissions this time are simply ignored.

 

[charles shepherd]

Reply from NICE to my further email dated 14 August:

Dear Dr Shepherd


In relation to your first two questions, as you are aware, we are in the process of reviewing the results of the consultation and will make our final decision in due course. We will make the decision public, together with any other statements we think will be helpful to contextualise it.

Until then, we don’t intend to respond to enquiries about the provisional decision. It may be that our final decision, when placed in the public domain, will help you with some of your questions, but if not, we will endeavour to answer them as best we can at that time.


Regarding the decision not to disclose the names of the topic experts, I confirm that the following two exemptions from the Freedom of Information Act were applied:


Section 40 – personal information

Section 38 – health and safety


The National Institute for Health and Care Excellence (NICE) is a non- departmental public body (NDPB).

As such we are accountable to our sponsor department, the Department of Health, but operationally we are independent of government.

You can read more about the relationship between NICE and the Department of Health in the framework agreement which sets out roles and responsibilities, what accountability and governance arrangements are in place, and describes how the Department of Health is assured that NICE's role is being fulfilled efficiently and effectively.

The agreement also describes the specific guidance and other rules set by DH and central government that NICE must comply with.

The ministerial lead for NICE is the Parliamentary Under Secretary of State for Health (Lords), the current holder of this role is Lord O'Shaughnessy.


I hope this is helpful. Please tell us how we did by completing our short survey. It will only take you a couple of minutes.


Kind regards

Janet


Janet Fahie

Communications Executive

Corporate Communications

National Institute for Health and Care Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United Kingdom




------------------- Original Message -------------------
From: Charles Shepherd
Received: 14/08/2017 12:26
To: Countess of Mar; NICE Mail
Subject: Re: NICE enq ref EH83201 (follow up to EH82697) - CFS/ME review

Dear Janet
Thank you for your reply which explains the background as to how and why the group consisting of topic experts and previous guideline development members was put together, along with the role of the NICE surveillance team.
We do, however, remain very disappointed that NICE is unwilling to release the names of members of a group who have been involved in producing what is a very unpopular conclusion regarding the possible updating of the NICE guideline on ME/CFS.

I would be grafeful if you could answer three questions that follow on from your reply:

Firstly, as you will be aware, over 15,000 people have signed the MEA petition calling for an update/review of the NICE guideline on ME/CFS. The Forward ME Group of Charities, chaired by the Countess of Mar (copied in), has also called for a review of the guideline.
Am I therefore correct in concluding that the patient representative on the topic expert group, who presumably agreed with the recommendation to not update the guideline, was not a representative of one of the national ME/CFS charities, and was not put forward by one of these charities.

Secondly, we are surprised and concerned to see that the topic expert group consists of three psychiatrists, only two neurologists and no physicians from any other key clinical areas that ME/CFS involves - infection and immunology in particular. ME (and CFS) is classified by the World Health Organisation in ICD10 as a disease of the central nervous system - a classification that is accepted by the Dept of Health. ME/CFS is not a psychiatric illness. Why, then, did NICE decide that they required more psychiatrists than physicians and no other clinicians apart from two neurologists?
Thirdly, you state that there is exemption from disclosure of names under two sections of the Freedom of Information Act. Please could you state which sections these are.
If you are unable to answer these questions please could you refer them to someone who can.

Finally, I have not been able to find out who NICE is actually accountable to following the decision to change its status as a Special Health Authority that was previously accountable to the permanent secretary at the Department of Health
Please could you therefore clarify who NICE is now accountable to at the Department of Health in its role as a non departmental public body.

Yours sincerely

Dr Charles Shepherd

Hon Medical Adviser, MEA

 

[slysaint]

Section 40 – personal information

Section 38 – health and safety

any chance you could ask which bit/s of section 40 was considered to be the problem :
https://ico.org.uk/media/for-organi...0-and-regulation-13-foia-and-eir-guidance.pdf
and the grounds/evidence for use of section 38:
https://ico.org.uk/media/for-organisations/documents/1624339/health-and-safety-section-38-foia.pdf

"
The endangerment test under section 38
11.
In order to engage this exemption the public authority must demonstrate that there is a causal link between the
endangerment and disclosure of the information
.
12.
The public authority must also show that disclosure would or would be likely to have a detrimental effect
on the physical or mental health of any individual, or the safety of any individual.
The effect must be more than trivial or insignificant.

13.
The term “would...endanger” means that it is more likely than not to occur (ie a more than 50% chance).
“Would be likely to endanger” is a lower threshold; this means that even if there is below a 50% chance, there must be a real and significant likelihood of the endangerment occurring.
The authority must decide the likelihood of endangerment arising on the facts of the case.
For more details on this, please see our guidance on the prejudice test.
14.
The assessment of endangerment is relevant to the public interest test. Note that the choice between “would” and “would be likely” is important because it affects the balance of factors in the public interest test. The greater the likely endangerment to the physical or mental health of any individual, or the safety of any individual, the stronger the public interest in not disclosing the information requested."

What about the physical and mental wellbeing of the patients that these people are passing judgement on?

 

[lilpink]

The endangerment test under section 38

Seems to be at odds with the ICO Tribunal findings.

 

[lilpink]

I don't know if anyone has highlighted this document before, apologies if they have. From "Great Yarmouth & Waveney Joint Health Scrutiny Committee 4 April 2017 Item no 7 "


[PDF]Great Yarmouth & Waveney Joint Health Scrutiny Committee 4 April ...


On page 52 (big) -

" A recent review of the evidence of interventions for ME/CFS seriously questioned the validity of CBT, GET and other psychological therapies, when studies using the Oxford Criteria (Sharpe, Archard et al. 1991) were excluded [Agency for Healthcare Research & Quality (AHRQ), 2016]. " etc .......

......" The treatment outcomes in these studies may well have been overestimated by the use of Oxford criteria, (Green, Cowan et al. 2015). It is expected that the next NICE revision will reflect the reappraisal of the evidence." (my emboldening)

 

[MEMum]

Woohoo, that's exciting!