NICE Guideline on ME/CFS – 2010 review process

Having been led to believe that the proposed review of the 2007 NICE guideline on ME/CFS would be starting in August 2010 The ME Association wrote to NICE to seek clarification in the absence of any official announcement being made during August.

We received the following reply on 24 August:

Thank you for contacting the National Institute for Health and Clinical Excellence (NICE).

The review date which you refer to is the date at which we plan to begin the review process.  We are currently beginning to gather evidence and opinions to inform our review proposal.  If there has been a large amount of new evidence produced since the original guidance was produced, the review proposal may be to conduct a full review, which can take over a year.  On the other hand, if there has not been very much new evidence produced, we may propose to delay the review.

The review proposal will be posted on our website for consultation in the months following the ‘review date’ listed in the guidance. To be notified of additions to web pages relating to your area of interest, including review proposals, you may like to sign up for our web alert system. You can do this via the following page of our website:

http://www.nice.org.uk/registration/index.jsp?action=registration

I am sorry that I do not have any more definitive information at this stage.

Regards

Carla Springl
Communications Administrator (Enquiry Handling)
National Institute for Health and Clinical Excellence
Level 1A | City Tower | Piccadilly Plaza | Manchester M1 4BD | United Kingdom
Web: http://nice.org.uk

We also know that members of the original guideline development group have been asked for their opinion as to whether there is sufficient new evidence to justify a review at this time.

The important phrase here is large amount of new evidence produced since the original guidance was produced.

In NICE-speak. this means results from randomised controlled trials into any aspect of management that have been published in reputable peer-reviewed medical journals since August 2007.  The NICE guideline is primarily concerned with the clinical assessment and management of ME/CFS and does not get involved in coming to conclusions about causation – although NICE obviously has to take note of developments relating to causation, including the findings relating to XMRV and MLVs.

Having managed to fight off a Judicial Review of the ME/CFS guideline, NICE will be feeling confident that its guidance is sound and acceptable to both patients and doctors – a position which many patient support organisations, including the MEA, obviously strongly disagree with.  And with very little in the way of new evidence being published in relation to the treatment of ME/CFS, and the fact that results from the PACE trial are fast approaching, it seems likely that NICE may decide to defer this review until later in the year, or even 2011, when they have this information – which could well strengthen their controversial recommendations regarding cognitive behaviour therapy (CBT) and graded exercise therapy (GET).

It should also be noted that NICE will not want to re-open the debate about existing evidence (ie results from clinical trials that were published up to the time of the 2007 guideline) – they want to look at new evidence.

The ME Association will obviously be challenging the current recommendations regarding the use of CBT and GET and to support out case we will be making use of the patient evidence (approx 4,500 respondents) from our 2010 Management Report – the largest ever survey of patient opinion ever carried out in the UK, probably in the world.  This report can be accessed on-line here:

MEA survey report 2010 (409.99 KB)

We are also consulting with various experts, including those with statistical knowledge, about how best to present our case to the review.

For information purposes the following explanation of how recommendations contained in a NICE guideline should be interpreted by clinicians when making decisions about patient management is worth noting. It clearly contradicts the mistaken view of some doctors that NICE guidelines are almost mandatory and as a result they are no longer able to exercise their clinical judgement where this is may not be entirely consistent with a guideline position.

NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. Clinical guidelines represent the view of NICE, and are arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer, and informed by the summary of product characteristics of any drugs they are considering.

Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties.

With regards to technology appraisal guidance, this type of guidance contains recommendations on the use of new and existing medicines and treatments within the NHS. The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals, usually within 3 months of guidance being published.

ME Association
1 September 2010

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