NICE guidelines

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The National Institute for Health and Care Excellence (NICE) is a UK government body that approves treatments for use within the UK National Health Service (NHS) with the mission to improve health and social care through evidence-based guidance.[1]

NICE Guidelines for CFS/ME - CG53 (2007)[edit | edit source]

The NICE guidelines for CFS/ME CG53 for the diagnosis and management of chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) were published in August 2007. They are used by the NHS and other medical professionals in the UK for diagnosing and treating CFS/ME.

Authors[edit | edit source]

The CFS/ME guideline development group consisted of the following members: Richard Baker, Jessica Bavinton, Esther Crawley, Tony Downes, Richard Eddleston, Ute Elliot, Richard Grünewald, William Hamilton, Judith Harding, Frederick Nye, Amanda O'Donovan, Alastair Santhouse, Julia Smedley, David Vickers, Gillian Walsh, Carol Wilson, Philip Wood, Gary Britton, Stefanie Kuntze, Elizabeth Shaw, Nancy Turnbull, and Tanya Harrison.[2]

Definition[edit | edit source]

Healthcare professionals should consider the possibility of CFS/ME if a person has:

  • fatigue with all of the following features:
    • new or had a specific onset (that is, it is not lifelong)
    • persistent and/or recurrent
    • unexplained by other conditions
    • has resulted in a substantial reduction in activity level
    • characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)

and

Healthcare professionals should be aware that the symptoms of CFS/ME fluctuate in severity and may change in nature over time.

Signs and symptoms that can be caused by other serious conditions (‘red flags’) should not be attributed to CFS/ME without consideration of alternative diagnoses or comorbidities. In particular, the following features should be investigated:

  • localising/focal neurological signs
  • signs and symptoms of inflammatory arthritis or connective tissue disease
  • signs and symptoms of cardiorespiratory disease
  • significant weight loss
  • sleep apnoea
  • clinically significant lymphadenopathy

A diagnosis should be made after other possible diagnoses have been excluded and the symptoms have persisted for:

  • 4 months in an adult
  • 3 months in a child or young person; the diagnosis should be made or confirmed by a paediatrician

The diagnosis of CFS/ME should be reconsidered if none of the following key features are present:

Criticism and controversy[edit | edit source]

Charities and patient groups condemned the guidelines as "unfit for purpose".

Add criticism from 2007 here.

The submissions were from:

Invest in ME Submission[edit | edit source]

ME Association Submission[edit | edit source]

August 2007 Submission [Comment on draft NICE guidelines http://www.meassociation.org.uk/2007/01/nice-guideline-mea-response/]

Action for ME Submission[edit | edit source]

Tymes Trust Submission[edit | edit source]

NICE Judicial Review Court Case (2009)[edit | edit source]

Add the court case background and links here.

Some links here http://www.angliameaction.org.uk/NICEJR/

Move to static list (2013)[edit | edit source]

On September 2013 NICE placed the CFS/ME guidelines CG53 on a static list and confirmed they won't be reviewing them [4].

The ME Association opposed the plan to place it on static list and wrote a submission with four reasons including that "Along with most other ME/CFS charities, and people with ME/CFS, we have been unable to endorse the current NICE guideline." [5].

Patients and patient advocacy groups are not in favor of the NICE guidelines and on June 25th 2014 the Forward-ME Group met with Prof Mark Baker, Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence (NICE)]. Professor Baker that the ME/CFS Guideline did not meet patient needs nor those of NICE. He said the Guideline did not promote innovation and only a "passive" intervention such as CBT and Graded Exercise. "There was not much of an evidence base to go on, and in NICE it was evidence that drove guidance."[6]

Doctor Speedy weighs in with Is it NICE guidelines or NONSENSE guidelines? and the ME Association's Dr. Charles Shepherd pointed out during a meeting with Dr. Martin McShane of NHS England "that graded exercise therapy was causing harm to patients and that if a drug was causing harm, guidelines would be reviewed immediately."[7]

NICE 10 year surveillance (2017)[edit | edit source]

In June 2017 stakeholders were advised that NICE would consider reviewing the guidelines [8]. In July NICE stated they decided not to review the guidelines [9].

A petition to NICE 'The NICE guideline for CFS/ME is not fit for purpose and needs a complete revision' gathered over 15,000 signatures

All patient stakeholders requested that guidelines be reviewed.

  • The MEAction Network's response to NICE stated the NICE guidelines be reviewed and "Given the context of this discrimination, we ask that the updated NICE guidelines be made clearer to account for the limitations of the evidence, patient reports of long term relapse following graded exercise, and the importance of genuine patient choice without reprisal" [10].
  • Forward-ME's response to NICE stated the NICE guidelines be reviewedand included "Because the current guideline directs patients squarely towards behavioural management, it clearly does obstruct patients’ access to biological testing, treatment and support. To avoid this ethical violation, we request that the guideline be revised to present a truthful, neutral picture of the current debate about the nature and management of CFS/ME. "[12].
  • Action for ME response to NICE stated the NICE guidelines be reviewed and "strongly disagrees with the proposal not to update the guideline for the following reasons...There is not, at the present time, a conclusive evidence base for treatments for CFS/M.E., including those recommended in the guideline, such as CBT and/or GET."[15].

The ME Association petition represents biggest expression of no confidence in a NICE guideline ever recorded. [17]

A letter was also sent to the Chief Executive of NICE Sir Andrew Dillon [18]

Dr David Tuller in his investigation stated NICE did not disclose the names of the topic experts to the Countess of Mar and the ME Association and himself were also awaiting for a response to the names [19]

A letter to the Chief Medical Officer was sent by the MEA [20].

Dr Chalres Shepherd of the MEA wrote to NICE in July 2017 to ask for further information on the team that decided to not review the guidelines but NICE refused [21]. He followed up with another email in August but this also did not respond to the request asked and stated " 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" and correspondence continued [22].

Dr Diane O’Leary, Kennedy Institute of Ethics of Georgetown University, Washington DC, said to the Forward ME Parliamentary meetingthat "Guideline as it stands is unethical" [23].

Dr Tuller's own FOI request was rejected on 31 July 2017 for the names of the experts [24].

Dr David Tuller also wrote to the NICE Chief Executive, Sir Andrew Dillon, with 15 questions of which none were responded to [25].

Dr David Tuller submitted an additional FOI request for the NICE Topic Expert Reports which were provided to him. Tuller examined these and said " this set of comments is the best NICE could drum up in seeking external guidance for this critical review process is deeply worrying."[26].

Due to the shock that the NICE guidelines were not reviewed, MEAction supporters raised a parliamentary petition called an Early Day Motion (271) in September to put further pressure on NICE [27].

Learn more[edit | edit source]

See also[edit | edit source]

References[edit | edit source]

  1. NICE.org.uk
  2. GDG Members' Declaration of Interests
  3. Full NICE Guidelines for CFS/ME (pdf)
  4. http://www.meassociation.org.uk/2013/09/nice-confirm-they-wont-be-reviewing-their-guideline-on-mecfs-any-time-soon-unless-26-september-2013/
  5. http://www.meassociation.org.uk/2013/10/mea-opposes-plan-to-put-review-of-nice-mecfs-guideline-on-hold-23-october-2013/
  6. On June 25th 2014 the Forward ME Group met with Prof Mark Baker, Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence (NICE).
  7. Push to change ME/CFS NICE guideline - MEAction - Oct 10, 2015
  8. http://www.meassociation.org.uk/2017/06/the-nice-guideline-saga-how-we-got-to-where-we-are-24-june-2017/
  9. http://www.meassociation.org.uk/2017/07/breaking-news-me-association-has-heard-back-from-nice-about-the-guideline-review-and-its-not-good-news-05-july-2017/NICE proposed to not update the guidelines
  10. http://www.meaction.net/2017/07/23/nice-2017-response/
  11. http://www.investinme.org/Documents/NICE/comments-form-2%20-%20from%20INVEST%20in%20ME%2023-7-2017.pdf
  12. http://www.forward-me.org.uk/Reports/10%20year%20surveillance%20(2017).pdf
  13. http://hope4mefibro.org/wp-content/uploads/2017/07/Hope-4-ME-Fibro-NI-comments-form-2.pdf
  14. http://www.meassociation.org.uk/wp-content/uploads/MEA-Submission-to-NICE-re-Guideline-Review-21-July-2017.pdf
  15. https://www.actionforme.org.uk/uploads/pdfs/NICE-consultation-response.pdf
  16. http://www.tymestrust.org/pdfs/ttnice201707.pdf
  17. http://www.meassociation.org.uk/2017/07/me-association-petition-represents-biggest-expression-of-no-confidence-in-a-nice-guideline-ever-recorded-26-july-2017/
  18. http://www.meassociation.org.uk/wp-content/uploads/ME-Association-Letter-to-Sir-Andrew-Dillon-24.07.17.pdf
  19. http://www.virology.ws/2017/07/24/trial-by-error-nice-declines-to-disclose-names-of-experts/
  20. http://www.meassociation.org.uk/2017/08/chief-medical-officer-for-england-responds-to-mea-petition-against-nice-guideline-08-august-2017/
  21. http://forums.phoenixrising.me/index.php?threads/nice-committee-to-review-special-mecfs-issue-of-journal-of-health-psychology.53058/#post-879730
  22. http://www.meassociation.org.uk/2017/08/nice-guideline-review-we-hear-back-from-nice-about-the-identity-of-topic-experts-13-august-2017/#Update
  23. http://www.forward-me.org.uk/11th%20July%202017.htm
  24. http://www.virology.ws/2017/07/31/trial-by-error-nice-rejects-my-foi-request/
  25. http://www.virology.ws/2017/08/14/trial-by-error-my-e-mail-exchange-with-nice-chief-executive/
  26. http://www.virology.ws/2017/09/11/trial-by-error-the-nice-topic-expert-reports
  27. http://www.meaction.net/2017/09/15/keep-building-momentum-in-parliament-for-nice-review/