I must admit - and I have only been following this saga from the sidelines really - I thought IOM were charged with producing recommendations. That it would be HHS who would adopt something. So, IOM could therefore, recommend CCC as a means of diagnosis; but that would not be the end of their recommendations brief. There is more to it than recommending a set of criteria, the criteria need 'operationalising'.
I suspect the IOM will review all criteria currently in use in a similar fashion to the review by NICE.
@
jspotila Jennie you might be interested in this bit. I say 'might'
See Full NICE Guideline, Chapter 5, for the review completed by the Clinical Guideline Group, who also considered a similar process completed in New Zealand:
http://www.nice.org.uk/nicemedia/live/11824/36191/36191.pdf
From pp. 124 you can see/read the review they completed of the recommended tests for example, and the criteria including the criteria advanced by the Independent Working Group on CFS/ME who forwarded a
Report to the Chief Medical Officer in 2002. A report that is referred to throughout the NICE Guideline, and was formed in association with 'stakeholders' including patients.
Anyway, you can read for yourselves what they thought of the criteria such as existed at the time...
Bottom line was that many of the criteria were not robust enough and the same applied to the various tests advanced - including those that might now be used for exclusionary diagnoses.
You might also like to remind yourselves of the NICE Criteria. Some seem to think it doesn't include PEM, some might think PEM needs to be more specific:
Page 7:
http://www.nice.org.uk/nicemedia/live/11824/36190/36190.pdf
Box 1 Symptoms that may indicate CFS/ME
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 life long)
– 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
- one or more of the following symptoms:
– difficulty with sleeping, such as insomnia, hypersomnia, unrefreshing sleep, a disturbed
sleep–wake cycle
– muscle and/or joint pain that is multi-site and without evidence of inflammation
– headaches
– painful lymph nodes without pathological enlargement
– sore throat
– cognitive dysfunction, such as difficulty thinking, inability to concentrate, impairment of
short-term memory, and difficulties with word-finding, planning/organising thoughts and
information processing
– physical or mental exertion makes symptoms worse
– general malaise or ‘flu-like’ symptoms
– dizziness and/or nausea
– palpitations in the absence of identified cardiac pathology.
The symptoms of CFS/ME fluctuate in severity and may change in nature over time.
It is not my intention to argue over the merits of the NICE Guideline. I do think however, that advocates in the US need to turn their focus to considerations about how your preferred CCC might get past the IOM review i.e. how you can 'operationalise' it. And how the CCC might now appeal when in 2005-2007 it didn't appeal at least to the NICE Guideline Development Group.
I also don't think the Canadian Criteria will be adopted in full, without at least a change in name. Perhaps it is easier in the UK because we have a National Health Service, so a standard set of Clinical Guidelines can be rolled out in the way that NICE have done.
But, if the IOM recommend something to HHS, and HHS adopt the recommendation, will it then be rolled out across the US? Will all US Physicans be obliged to assess, test, diagnose and treat patients in line with the HHS Clinical Guideline?
How does it work? In the UK for example, a GP is still able to treat his patient as an individual. For example - NICE does not mandate any pharmaceutical symptom management - well beyond I think the one drug it mentions. A GP and/or consultant attached to an ME Service can prescribe based on the individual.
Until such time as more research can go into assessing effectiveness of existing non-ME specific drugs, and/or new ME drugs, I doubt if any drugs will feature in a set of Clinical Guidelines: which is a shame I think.
In terms of treatment and the proposed HHS Clinical Guideline, I realise you are all concerned it will contain no more than GET, CBT and Activity Management i.e. be reflective of the NICE Guideline. I tend to think of Activity Management as being similar to 'Pacing' unless of course you want to argue a particular 'line' or expert opinion about Pacing.
Will IOM/HHS be able/or even consider, rolling out Specialist ME Centres across America? NICE went to quite some lengths to consider costings in terms of delivery of care and treatment when writing and then publishing its Guideline.
Would specialist centres - for assessment, diagnosis, onward referral, and treatment - be something you chaps would consider advocating for? Would it be something that should form part of any Guideline consideration?
It's hard for me to look at the UK and compare to the US when I know so little about your system of healthcare delivery.
I would though recommend to any advocate in America, that they set aside some time to properly read through the full NICE Guideline and accompanying documents.
I'd be interested in hearing some more discussion about how a national clinical guideline could be rolled out in the US and how it might affect things over there - good and bad.
Of course, in the UK, we did have a headstart I suppose, before NICE was published I think, in that £7 million was granted for the establishment of those specialist centres. Trouble has been holding on to the good ones. Funding is so tight - we have to really fight to retain the expert staff and the service itself...
Edit: Link added to Independent Working Group Report to Chief Medical Officer 2002.
