• Welcome to Phoenix Rising!

    Created in 2008, Phoenix Rising is the largest and oldest forum dedicated to furthering the understanding of, and finding treatments for, complex chronic illnesses such as chronic fatigue syndrome (ME/CFS), fibromyalgia, long COVID, postural orthostatic tachycardia syndrome (POTS), mast cell activation syndrome (MCAS), and allied diseases.

    To become a member, simply click the Register button at the top right.

NICE GUIDELINE ON ME/CFS WILL BE UPDATED! (Sep 20th 2017)

C

charles shepherd

Senior Member
Messages
2,239
NICE GUIDELINE ON ME/CFS WILL BE UPDATED!

PUBLISHED TODAY ON THE NICE GUIDELINE WEBSITE:

Surveillance report 2017 – Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management (2007) NICE guideline CG53
Surveillance decision
We will plan a full update with a modified scope of the guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) (NICE guideline CG53).

appendix A: pre-consultation summary of evidence from surveillance).

Following a stakeholder consultation on the proposal to not update the guideline, broader issues with the guideline were highlighted that called into question the guideline scope and its current relevance.

After further consideration of information from stakeholders including:

new evidence (see appendix B: summary of evidence highlighted to NICE during consultation,

and appendix C: stakeholder consultation comments table)

alongside the evidence identified through the surveillance review,

NICE has decided to fully update the guideline with a modified scope.

how we made the decision for further information.



This page was last updated: 20 September 2017


Dr Charles Shepherd
Hon Medical Adviser, MEA
 
Cheshire

Cheshire

Senior Member
Messages
1,129
Wow
At least they are taking into account studies that seriously question the Oxford criteria and the efficacy of CBT/GET (amongst them @Keith Geraghty Myalgic encephalomyelitis/chronic fatigue syndrome patients’ reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: Analysis of a primary survey compared with secondary surveys).

Huge thanks to all involved!
 
Hutan

Hutan

Senior Member
Messages
1,099
Location
New Zealand
Scope for (very) cautious optimism? Here are some of the more exciting comments from NICE on the findings from the submissions:


Interventions recommended in the guideline are based on the biopsychosocial model. Stakeholders raised that since 2007, much has changed with respect to biomedical knowledge. Biological models based on measurable abnormalities may need greater consideration.

Severe ME is not well covered in the guideline and can cause profound issues. Some stakeholders indicated that parents of children with severe ME sometimes find that false allegations of child abuse are made against them due to poor understanding of symptoms, care and treatment by healthcare professionals and schools.

Oxford criteria (used to recruit to many studies included in the guideline) and NICE criteria are too broad.

Stakeholders noted that NICE's evidence reviews are not up to date, therefore patients are not receiving the full picture on recommended treatments (such as studies that have shown inefficacy of cognitive behavioural therapy [CBT] or harms of graded exercise therapy [GET]), nor being told about alternative treatments, which may affect informed consent.

Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions. Issues include that some studies only require fatigue in the case definition, which may incorporate other fatiguing conditions with the potential to complicate results.

Pharmacological treatment: rintatolimod, rituximab and anakinra.
Click to expand...

Thanks to all who have contributed to this result.
 
V

Valentijn

Senior Member
Messages
15,786
charles shepherd said:
and appendix C: stakeholder consultation comments table)
Click to expand...
This contains a lot of excellent comments in support of a NICE update, and not only from ME groups. Most of them are very detailed, and cite support for their statements.

The comments of those opposed to an update are quite minimal and often completely blank. But those organizations may offer a good list of those who would most benefit from educational material and accurate scientific information:
British Infection Association:
No comments
Click to expand...

Royal Liverpool University Hospital, CFS/ME services:
No new evidence base
Click to expand...

Royal College of Paediatrics and Child Health:
If there is a definite plan to update the guideline within the next year (not clear from proposal) then the decision may be acceptable.
Click to expand...

Association of British Neurologists:
Neurologists in the UK are not usually involved with the diagnosis and management of CFS/ME but we do see many patients with this condition when it overlaps with other neurological presentations. The Association of British Neurologists also takes an interest in the disorder as one that is common, disabling and distressing and involves abnormal nervous system functioning.

It will be important at some stage to update the guideline to take into account data from several large trials including the PACE trial1 and the GETSET trial2. These tend to strengthen the view expressed in the original guideline that Graded Exercise therapy and Cognitive Behavioural Therapy are moderately effective, and do help some people with CFS, including some that make a recovery.

In addition there are several papers which show that outcomes in routine clinical practice are similar to those seen in trials3,4. The latter study shows that the outcomes are better in the Netherland than the UK4. A very recent evaluation of specialist services across the UK was conducted, for example, of 440 patients at 1 year again showing that outcomes are similar to those seen in trials5. Such studies also reinforce the idea that recovery does occur in some patients even though in others it remains a chronic condition 6

1 White PD, Goldsmith K a, Johnson a L, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 2011;377:823–36.
2 Clark L V., Pesola F, Thomas JM, et al. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): A pragmatic randomised controlled trial. Lancet 2017;6736:1–11.
3 Stahl D, Rimes KA, Chalder T. Mechanisms of change underlying the efficacy of cognitive behaviour therapy for chronic fatigue syndrome in a specialist clinic: a mediation analysis. Psychol Med 2014;44:1331–44.
4 Worm-Smeitink M, Nikolaus S, Goldsmith K, et al. Cognitive behaviour therapy for chronic fatigue syndrome: Differences in treatment outcome between a tertiary treatment centre in the United Kingdom and the Netherlands. J Psychosom Res 2016;87:43–9.
5 Collin SM, Crawley E. Specialist treatment of chronic fatigue syndrome/ME: a cohort study among adult patients in England. BMC Health Serv Res 2017;17:488.
6 Flo E, Chalder T. Behaviour Research and Therapy Prevalence and predictors of recovery from chronic fatigue syndrome in a routine clinical practice. Behav Res Ther 2014;63:1–8.
Click to expand...

Royal College of Psychiatrists:
We support the view that the guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) should not be updated. The surveillance was brought forward to 2017 following a challenge based on potentially important new evidence. Evidence from a total of 155 reports was assessed by the surveillance team and topic experts. We found that the reporting of how the assessments were undertaken was rigorous and transparent; for example the controversy over PACE data was discussed and the PACE data was set aside when considering other evidence from RCTs and systematic reviews. The results of these other studies remained in-line with NICE guidelines on GET and CBT.

Graded Exercise Therapy (GET) is shown to reduce post-exertion fatigue more than control treatments (White et al 2011), and Graded Exercise Self-help (GES) is also shown to be a safe treatment that may reduce fatigue (Clark et al 2017).

Several recent papers show that outcomes in routine clinical practice are comparable to those seen in trials (Stahl et al 2013; Worm-Smeitink et al 2016). The latter study shows that the outcomes are better in the Netherland than the UK (Worm-Smeitink et al 2016). An evaluation of specialist services country wide following current NICE guidelines on assessment and treatment was conducted (Collin & Crawley 2017), showing significant benefit for around a third of patients a year after treatment.

On these grounds we can see no rationale for updating the current NICE guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy).
Click to expand...

University of Manchester - FINE Trial:
No comments
Click to expand...

Royal College of Physicians:
We would like to endorse the responses submitted by the Association of British Neurologists and Royal College of Psychiatrists
Click to expand...

Regional Public Health Agency for Northern Ireland:
Despite widespread criticisms of the PACE trial, NICE’s consultation document states that, even without its inclusion in the evidence review, the remaining published evidence points in the direction of symptom management as currently described in the guideline.

The suggestion to ask Cochrane to revisit its systematic review including the PACE trial on the other hand appears bizarre in this context- what benefit could possibly come from doing this with a discredited trial?
Click to expand...

Feedback on removal from the static list is a lot more jumbled. Some don't seem to understand what it entails, and some want it removed from the list so new psychobabble can be incorporated in the near future.
 
V

Valentijn

Senior Member
Messages
15,786
It is absolutely huge that NICE is acknowledging this:
Oxford criteria (used to recruit to many studies included in the guideline) and NICE criteria are too broad.
Click to expand...
Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions. Issues include that some studies only require fatigue in the case definition, which may incorporate other fatiguing conditions with the potential to complicate results.
Click to expand...
Without the Oxford fatigue trials, there is no support for GET or illness-denial CBT.
 
Cheshire

Cheshire

Senior Member
Messages
1,129
How we made the decision

Of the responding organisations, 9 agreed (none of which were patient associations) with the decision not to update the guideline and 30 disagreed. In addition to specific comments on the detail of the consultation document, approximately 300 pieces of evidence were highlighted, 13 of which met criteria to be included in the evidence summary for the surveillance review (see appendix B: summary of evidence highlighted to NICE during consultation for details of the potential impact of this additional evidence on the guideline).
Click to expand...

Diagnosis
  • Oxford criteria (used to recruit to many studies included in the guideline) and NICE criteria are too broad.

  • Newer diagnostic guidelines from the US Institute of Medicine (2015) and International Consensus Criteria (2011) are different from NICE criteria. Specific paediatric criteria have also recently been proposed.

  • Late diagnosis is an issue.

  • Concerns have been expressed over misdiagnosis and overlap with other conditions e.g. pernicious anemia, Ehlers-Danlos syndrome, and Postural Tachycardia Syndrome.

  • Consideration of new research on metabolomics and biomarkers may be warranted.
Implementation, and information and support needs
  • There is variation in primary care management, and there is evidence of unequal access to specialist services.

  • Stakeholders noted that NICE's evidence reviews are not up to date, therefore patients are not receiving the full picture on recommended treatments (such as studies that have shown inefficacy of cognitive behavioural therapy [CBT] or harms of graded exercise therapy [GET]), nor being told about alternative treatments, which may affect informed consent.

  • Greater support for GPs (many of whom feel ill-equipped in this respect) is needed to help with diagnosis, to provide accurate information (for example evolving evidence on risk and benefit of treatments), and to consider what an 'individualised management plan' might look like in practice.
Click to expand...

CBT and GET
  • Against CBT and/or GET


    • The US Centers for Disease Control and Prevention have dropped CBT and GET from their list of recommended treatments for CFS/ME.

    • Evidence was cited of harms of GET, and pacing should be considered as an option.

    • Key trials (particularly PACE [Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation], but also Cochrane reviews of CBT and GET) have been criticised for inflating the efficacy of interventions. Issues include that some studies only require fatigue in the case definition, which may incorporate other fatiguing conditions with the potential to complicate results.

    • There may be distinctions between people with CFS and with ME that should be accounted for.

    • Patient surveys appear to contradict findings from randomised controlled trials and systematic reviews regarding the safety and efficacy of CBT, GET and pacing.
  • In favour of CBT and/or GET


    • Large randomised controlled trials such as PACE and GETSET, and Cochrane reviews, appear to support the guideline recommendations on CBT and GET.

    • A hospital department supplied data that patient reported outcome measures completed by patients receiving >18 sessions of CBT and/or GET improved 60% on the SF-36 (a patient-reported general health outcomes scale).
Click to expand...

https://www.nice.org.uk/guidance/cg...we-made-the-decision#how-we-made-the-decision
 
A.B.

A.B.

Senior Member
Messages
3,780
It is now very obvious that patients and patient organizations reject CBT/GET and dispute that the evidence shows them to be effective.

Hopefully heads will roll. PACE authors have inflicted harm on patients first with bad science then with refusing to acknowledge what patients were telling them the whole time. The idea that only a vocal minority was against CBT/GET is another fabrication by them.
 
V

Valentijn

Senior Member
Messages
15,786
charles shepherd said:
new evidence (see appendix B: summary of evidence highlighted to NICE during consultation,
Click to expand...
NICE is rating some of the submitted evidence from the comments as being relevant to changing the guidelines for diagnosis and treatments. In general, it undercuts the use of Oxford, and recommendations for CBT/GET:
evidence summary 1.jpg


evidence summary 2.jpg


evidence summary 3.jpg


I think the psychobabblers are starting to look pretty screwed, this time around :D
 
trishrhymes

trishrhymes

Senior Member
Messages
2,158
I celebrate the decision to review and am very grateful for all the organisations who made this happen, but...

with the organisations representing Neurologists, Psychiatrists and Physicians all opposing update and clearly supporting the BPS model and GET/CBT, we are really up against it.

So who is actually going to do the review?

If it's the same people as before, change won't happen.
 
Last edited:
C

charles shepherd

Senior Member
Messages
2,239
Official confirmation to NICE guideline stakeholders - just arrived!

20/09/2017

raw

Level 1A, City Tower
Piccadilly Plaza
Manchester
M1 4BT

Tel: 0300 323 0140
Fax: 0845 003 7784

www.nice.org.uk



Dear Colleague

RE: NICE guideline on CG53 Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy): diagnosis and management

I am writing to let you know that, following stakeholder consultation, we have decided to update this guideline. Information about the decision has been published on our website.

We would like to thank you for your continued support and your interest in NICE guidelines.

Kind regards,

Surveillance Team


Surveillance Reviews
NICE Centre for Guidelines
National Institute for Health and Care Excellence Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BT | United Kingdom
www.nice.org.uk
 
You must log in or register to reply here.