NICE Guideline may be placed on 'static' list - and only reviewed every 5 years

[Firestormm]

The CFS/ME Guideline might be placed on the 'static' list and then only routinely reviewed every 5 years. NICE are consulting with stakeholders:

Dr Shepherd ME Association Facebook:

"The NICE guideline on ME/CFS was published in August 2007. There was a surveillance review in March 2011 - just after the PACE trial results were published in The Lancet.

I need to go through all the small print in this correspondence but from what I have read so far NICE appear to be saying that there is no need for any further review until March 2016 - unless some important new information/trial data appears in relation to management.

In other words the PACE trial results support the current recommendations re CBT, GET and Pacing, and there isn't anything else relevant in relation to research or clinical trials that has been published - so there is no need to have another NICE review this year."

25 September 2013
NICE consults on clinical guideline static list

NICE is consulting on the first set of clinical guidelines to be moved to a static list, where they will not be updated as often as the rest of NICE's clinical guidelines. Guidelines moved to the static list will be reviewed less often either because no quality standard is to be produced on that topic, or because the last review didn't identify any relevant evidence likely to be produced in the next 3-5 years.

Following changes to NICE´s clinical guideline development process it was found that routine reviews at three years were not the most efficient and effective means of maintaining relevant guidance. For example, in areas where there are a number of new drugs becoming available, such as type 2 diabetes, shorter reviews after around 2 years are needed.

Conversely, there are other clinical guidelines where no new evidence is expected to be produced for a number of years. It is these guidelines that will be placed on the static list and only reviewed every 5 years.

"Placing a guideline on the static list will not mean that it is forgotten about," says Christine Carson, Programme Director for NICE's Centre for Clinical Practice. "They will continue to undergo surveillance, although less often than clinical guidelines on the active list, and they could still be updated earlier if new evidence or information from clinical practice comes to light that is likely to require changes to the recommendations."

The ability to create a static list has been part of NICE's guideline manual since 2009, but with the changes to the clinical guidelines programme including the significant increase in the volume of clinical guidelines that will require review after two years, and the changing priorities in health and social care, it has not been considered as an option before now.

Guidelines will be placed on the static list if a previous guideline review resulted in a 'no update' decision and no major research on that topic is due to be published within the next three to five years. They may also be placed on the list if no quality standard is commissioned on that topic. Stakeholders and the public will be able to comment before any decision is made to place a guideline on the list.

The consultation on the first batch of guidelines to be placed on the static list will run for four weeks until 23rd October.

1st Floor
10 Spring Gardens
London
SW1A 2BU

Tel: 0845 003 7780
Fax: 0845 003 7784

www.nice.org.uk

Dear Stakeholders,

NICE is consulting on transferring 27 clinical guidelines onto a static list.

Consultation dates: 25th September 2013 to 5pm on 23rd October 2013

In December 2012 the NICE Board agreed a new programme for reviewing clinical guidelines should be developed. As part of that proposal it was agreed that NICE would create a list of candidates to put on a static list to ensure sustainability and efficiency of the programme. In August 2013 NICE’s Senior Management Team (SMT) agreed the first list of candidate topics for stakeholder consultation.

Below is the relevant link where you will find all the instructions and documents needed in order to get involved and make your comments: http://www.nice.org.uk/...

I’d be grateful if you could ensure all responses are provided using the comments proforma (ensuring all relevant fields are completed, including your organisation’s full name) and forward this electronically by 5pm at the latest on 23rd October to: staticlist@nice.org.uk

Please also be reminded that we can only accept comments from registered stakeholders. To register as a stakeholder please fill in a short form on our wesite here: http://www.nice.org.uk/getinvolved/sh/shreg_form.jsp

The interim process and methods manual for the routine surveillance of clinical guidelines was agreed by NICE Board in July 2013 and can be found here: http://publications.nice.org.uk/...

If you have any further queries on this consultation, please contact anthony.gildea@nice.org.uk .

Many thanks and kind regards,

Oliver Bailey

Project Manager

Centre for Clinical Practice

National Institute for Health and Care Excellence

Posted by Dr Charles Shepherd, ME Association Facebook:

In August 2013 NICE's Senior Management Team (SMT) agreed the first list of candidate topics for stakeholder consultation.

The following criteria have been applied to identify suitable guidelines to be placed on the static list:

No quality standard commissioned
or
A previous full review which yielded a ‘no update' decision and at that time no major ongoing studies/research was identified as due to be published in the near future (that is within the next 3-5 years)​

Clinical guidelines placed on the static list will be reviewed every 5 years to determine if they should remain on the static list.



Routine surveillance every 2 years (as per the process for active guidelines) would not be carried out on guidelines transferred to the static list.

Consideration to transfer a clinical guideline back to the active surveillance list may occur in the following circumstances:

• The high level review at 5 years yields new evidence which may impact on the guidance
• Stakeholders notify NICE of relevant new evidence which may impact on guidance at any time point, for example safety data.
• A quality standard is commissioned that relates to a guideline on the static list

​

Proposed Static List Clinical Guidelines

The following table is a list of guidelines that meet all of the criteria..
Table 1:CGs that meet all criteria

Guideline Publication date Last surveillance review date Criteria - meets all (no QS and no update + no expected evidence)

• Dental recall (CG29) Oct 2004 Sept 2012 Yes
• PTSD (CG26) Mar 2005 Dec 2011 Yes
• OCD & BDD (CG31) Nov 2005 Mar 2011 Yes
• CFS/ME (CG53) Aug 2007 Mar 2011 Yes
• Surgical management of OME (CG60) Feb 2008 Aug 2011 Yes
• Prophylaxis against infective endocarditis (CG64) Mar 2008 Sept 2011 Yes
• Respiratory tract infections (CG69) Jul 2008 Jun 2012 Yes
• Critical illness rehabilitation (CG83) Mar 2009 Jun 2012 Yes
• Donor breast milk (CG93) Feb 2010 Dec 2012 Yes

 

[biophile]

Even without rocking the boat with the current recommendations i.e. CBT/GET for mild to moderately affected CFS patients, the NICE guidelines should still be updated to reflect the evidence that these therapies do not generally lead to improvements in physical activity levels, employment, or total service costs etc, with poor outcomes for the walking test.

I do not recall exactly what the NICE guidelines say about the expected outcomes for CBT/GET, and someone could still argue that subjective improvements for a minority of patients is still the best "evidence based" treatment available, but the above caveats are important for providing context to the evidence and making expectations more accurate.

 

[Wildcat]

.
.
The only Charities or 'Patient Groups' who 'approved' the NICE Guidelines, were AFME, AYME and The Sussex CFS Society Charity.

All other ME Groups and charities rejected the NICE Guidelines as 'Unfit for Purpose';

 

[Wildcat]

.
What relevence is NICE - When we have the 2003 Canadian Concensus Criteria (the CCC)!
..

. The CCC has now been in use as diagnostic and Research Criteria for a full decade.

.

 

[MeSci]

If I remember correctly, the last review was postponed, so the guideline could be said to be overdue for review already.

The section of the guideline here about treatment says:

An individualised, person-centred programme should be offered to people with CFS/ME. The objectives of the programme should be to:

• sustain or gradually extend, if possible, the person's physical, emotional and cognitive capacity
• manage the physical and emotional impact of their symptoms.

Cognitive behavioural therapy and/or graded exercise therapy should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.

This section says

Setbacks/relapses may be triggered by factors such as unexpected/unplanned activities, poor sleep, infection or stress. Healthcare professionals, in discussion with the person with CFS/ME, should try to identify the cause(s) of a setback/relapse, but it should be recognised that this may not always be possible.

1.7.2.2 When managing a setback/relapse, the management plan should be reviewed.

Healthcare professionals should discuss and agree an appropriate course of action with the person with CFS/ME, taking into account:

• the person's experience
• possible causes of the setback/relapse, if known
• the nature of the symptoms
• the severity and duration of the setback/relapse
• the current management plan.

1.7.2.3 When managing setbacks, healthcare professionals should put strategies in place that:

• Include relaxation and breathing techniques.
• Maintain activity and exercise levels if possible, by alternating activities with breaks and pacing activities, as appropriate.

I'll look at some more but will post this now as I am having trouble with formatting and don't want to lose it!

 

[MeSci]

A few more 'gems' from the Guideline.

From previous link:

People with CFS/ME should be advised to minimise daytime sleep periods. However, healthcare professionals should recognise that this is not always possible, depending on the severity of a person's symptoms and the setback.

After a setback/relapse, healthcare professionals should review the person's activity levels to re-establish a baseline and review the management plan. A gradual return, when possible, to previous exercise and functional routines should be encouraged. Activity should be increased gradually.

1.7.3.2 Healthcare professionals should advise on:

Slowly decreasing the frequency and duration of rest periods.

People with severe CFS/ME should be offered a summary record of every consultation because of their cognitive difficulties.

From another page

Are intervention strategies that have been shown to be effective in mildly to moderately affected adults also effective in children and in people (adults and
children) with severe CFS/ME?

Why this is important

There is limited evidence for the use or effectiveness of strategies recommended in this guideline in these two patient groups. Population data suggest that these groups constitute a significant percentage of the population with CFS/ME. Some patient experience suggests that some of these interventions may be harmful and/or not effective.

It is not known how best to measure improvement scientifically for people with CFS/ME, and how much of an improvement is significant. More information is needed on functional outcomes such as return to work or education, return to normal family life or social activities, or increased self-esteem, to inform future estimates of the cost effectiveness of treatment.

At least the last bit makes sense, but the rest indicates that they really don't get it. I reckon most, perhaps all, of us would benefit from printouts of consultations - not just the severely-affected. (Ditto people with many other conditions too)

The bit about some interventions being thought of as harmful appears in the section about severe ME, but it's not clear whether they are citing more general ME/CFS patient groups.

Maybe others can pull out some other interesting sections - I'm a bit too tired now.

 

[Firestormm]

MeSci et al.

I think the point is that by October 23 (?) stakeholders need to submit EVIDENCE that might sway NICE from taking this Guideline into Static Status.

I believe the MEA will be making a submission of patient evidence based on the comprehensive patient survey they carried out last year, and will be making further submissions from e.g. Julia Newton's paper on misdiagnosis. In order to change anything in the Guideline they will require EVIDENCE.

Something like the results from that survey will help, as NICE as meant to take note of patient evidence too; but research evidence that runs contra to the NICE Guideline is pretty scant.

IN 5 years time - 2016 - consider what might be available. Even if before then something 'breaks' then NICE will consider it if it is important enough e.g. Rituximab.

Kind of finding it hard now to think of anything of significance that has been produced since 2011 which might fundamentally change the guideline though.

Any thoughts?

 

[Roy S]

I'm wondering how long this has been publicly stated and why it hasn't been properly researched. It seems rather important.
　
"It is not known how best to measure improvement scientifically for people with CFS/ME, and how much of an improvement is significant. More information is needed on functional outcomes such as return to work or education, return to normal family life or social activities, or increased self-esteem, to inform future estimates of the cost effectiveness of treatment."
　
　
(clears throat) and on a more important subject... Why is the National Institute for Health and Care Excellence referred to as NICE instead of by the accurate acronym NIHCE? "Nice"? Isn't "nicey" good enough? How about "nicey nice" or if one letter is omitted how about IHCE "icy"?
　
I've long wondered whether George Orwell had a good sense of humor.

 

[MeSci]

Why is the National Institute for Health and Care Excellence referred to as NICE instead of by the accurate acronym NIHCE?

The answer is rather boring and historical. It was originally the National Institute for Clinical Excellence, if I remember rightly, but the government is trying to integrate the health and care systems so changed the long name, but that makes it hard to pronounce so people continue to pronounce it 'nice'.

Maybe we could suggest a better name...let's see...Nitwits who Ignore Credible Evidence, also known as the Nitwits who Implement Crap Evidence? I'm sure this can be improved - I'm looking for a word beginning with C that means scientific or similar, but my brain is still half-asleep.

 

[peggy-sue]

My favourite was from a member of another forum, called Dolphinsezzy. I'm not sure she isn't here under another name.
Nincumpoops Implementing Crap Evaluations.

Folk are aware of the definition of a "centre of excellence" aren't they?

It means they have a certain number of academic staff. I'm not sure what the number is, but it is just a number of staff.

Abolutely nothing to do with high standards.

This part of the guidelines must be removed, it is positively harmful. (underlining mine)

"1.7.2.3 When managing setbacks, healthcare professionals should put strategies in place that:

• Include relaxation and breathing techniques.
• Maintain activity and exercise levels if possible, by alternating activities with breaks and pacing activities, as appropriate."

 

[MeSci]

This part of the guidelines must be removed, it is positively harmful. (underlining mine)

"1.7.2.3 When managing setbacks, healthcare professionals should put strategies in place that:

• Include relaxation and breathing techniques.
• Maintain activity and exercise levels if possible, by alternating activities with breaks and pacing activities, as appropriate."

Absolutely. People having setbacks need to REST.

Another thing that is totally inappropriate to ME and based on little or no evidence is advice to limit daytime sleep. This is part of 'sleep hygiene' theory.

Most people with ME should, IMO, sleep when they feel the need. It is very important for health to get enough sleep, and if our sleep hormones are so upside-down that we can't get enough at night, we should be allowed - indeed encouraged - to make up for it during the day if we can. I am not aware of any evidence that the imbalances and diurnal-rhythm disturbances typical of ME can be re-set using 'sleep hygiene'. 'Sleep hygiene' also typically says that you mustn't read or watch TV or use computers in bed. Personally I have often found that things like this actually help me sleep, and I have fallen asleep with the radio on quite a few times. It relaxes me and distracts me from worries and physical discomforts.

I don't know whether those who are sleeping for most of the day should be advised not to. I would like to see evidence for what works and what doesn't before endorsing something that may be harmful.

 

[peggy-sue]

I agree completely.
For those of us who need to sleep loads - well, we need to sleep loads.
For those of us who cannot sleep, we have to grab whatever sleep we can, whenever it is possible.