United Kingdom: 2007 NICE CFS/ME GUIDELINE

Sbag said:
2. They are using data from the PACE trial even though it has not been published.

I'm sure I have read somewhere that for a particular type of research to be considered there needs to be two publications giving the same results and that they have to use published research.

from minutes #10
Envelope theory is about being constantly below maximum capacity. Pending the publication of the PACE trial, we ought to make a recommendation which can be amended in future.​
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That might just reflect their knowledge that PACE was underway, rather than prior knowledge of any unpublished results?
 
Sly Saint said:
Can someone take a look at this video
Click to expand...

Okay. I tried, but it meanders about a fair bit.

Essentially, she did a study and this study was included in the considerations for the NICE guidelines.

When her work was included there was an error of significance what was .013 became .13 which makes a big difference.

She contacted the CRD (?) and informed them. They told her her data couldn't be used because she had adjusted it - apparently she had one outlier and adjusted for that.

She points out that the Deal et al study, whose data, was included was also adjusted (for outliers presumably).

I'm not sure exactly what her point is here - that there was an error of significance in some of the data that informed the guidelines and/or they were inconsistent in whether statistical adjustment was allowed in the data used.
 
This is an interesting method of diluting patients input. Given that there were only 3 patients on the GDG. Just something to be aware of next time as a strategy that they may try

3. Group Work GDG split into four pre-allocated Groups.

A member of the methodological team was in each to guide the work. 
Diagnosis and Investigations (XXXXX) 
Behavioural Interventions (XXXX) 
Complementary Therapies (XXXX) 
Pharmacological / Immunological (XXXX)

GDG06 Minutes 251105 (1).pdf (From one of the documents in Esther's first post)

Then from later on the Behavioural subgroup is still meeting in June 06 and we have no idea if there were any patients reps on this group and if so, how many?

"NOTE: the behavioural interventions sub-group: XXXX, XXXXX, XXXXX, XXXX and XXXXX, met prior to the GDG meeting beginning to discuss the management/behavioural interventions toolkit content boxes. This meeting was facilitated by XXX"
 
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Then use poor criteria to define the disease

"Discussion Definition of CFS/ME 
Broad or narrow definition of CFS/ME? Canadian vrs Oxford.
Generally agreed that it should be broad as it is doing no harm if you apply a broad based definition and this may in turn lead to an earlier intervention. In addition you will gain family approval as it is less contentious go for a broad based. The narrow definition contains the need to have more symptoms whereas the wider definition requires less symptoms.
As early identification and treatment is extremely important, broad is preferable. Conversely, a wide definition may risk not considering other diagnoses.

and maybe?

"Recommendation 33 The group conveyed some concern over the scope of diagnosis and requested that the inclusion of people of milder cases as well as the more severe"
 
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Keep pushing the desired result in the official minutes from an early stage and before treatments for adults have been discussed and agreed (my bold)

"As the labour intensive interventions appear to be the most effective (e.g. CBT), the GDG should consider whether less expensive interventions could be used in certain circumstances (e.g. Computerised CBT). GDG were asked if this example was a viable option for discussion (CCBT). GDG felt that there was no evidence in this population group and would be unwilling to use it. Although the possibilities for CCBT to be used as an adjunct for follow up or relapse prevention were hypothesised."
 
Split the Guideline into sections some of which have very little published research giving the impression that lifestyle factors are important

"It was suggested that the guideline be separated into three major chapters. These are general advice (sleep, rest, pacing, work, education, nutrition, diet etc), symptom control and therapeutic interventions."

and agree on a "Biopsychosocial assessment section"

There was some disagreement with the title and a suggestion of ‘holistic care assessment’ but as the 3 elements of the original word describe the content the original title was not changed. This will need to be re-visited by GDG to decide on a heading
 
Throw in some psychobabble on "positive attitude"

"The consensus was that there should be a balance between realism and optimism, recognising that a positive attitude may affect prognosis"

and from the section reporting back on CBT

"Same concerns about the trials as with GET. A lot of what XXX and the GDG have discussed is just common sense. People will do better if they have a positive attitude which is common to all chronic illnesses."

and

"It is imperative that we make the guideline optimistic but temper it with realisation that not everyone will. Even more severely affected patients can improve. Would be wrong if we adopted a philosophy of merely supporting patients in their disability. We must change this feeling of hopelessness.

and

"The guideline should take an optimistic but realistic approach, in that most but not all people will improve"
 
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Put more power into the hands of the people who sell CBT and GET and let them conspire away from the patients and without being minuted

" Therapists in the GDG have been asked to go away to look at various sections. This group meet after the meeting to discuss co-ordinating their work."
 
Keep pushing all through the development process that GET and CBT are proven therapy with real benefits

"It is noted that there is a danger in changing the name of GET as the wider medical community may not recognise it and the benefits demonstrated in the trials are clear meaning we would be moving away from the evidence base."

"It is difficult to separate all the interventions when evaluating them. The real question is - what is it behind GET or CBT that makes the difference"

"Evolution of GET over the last 10 years means that it has been adapted based on what has worked for patients"

"York graded some of these trials as good quality, and it is clear that they had a beneficial effect. The issues seem to be in poorly delivered therapies. Would be opposed to changing the title as this is where the benefit is"

" Looking at York’s review, CBT is the most researched intervention with good and consistent results. There is variable quality out in the field but the studies show that there is good results and need to move toward them"

and

"There are a basket of treatments including CBT, GET/GAT, Pacing and Lifestyle management which can be used."

and

"The paediatricians said that paediatricians provide very good CBT for children and for patients with CFS/ME."

and

"A group member added that the drop out rates are documented in the trials and the RCT evidence suggests that people with CFS/ME are likely to get better rather than worse."

and

"Goal (page 7 of Paper 4) Discussion centred around the exercise goal and whether it should be emphasised that this is an aspiration goal rather than a ‘push the patient’ goal. Never-the-less, it was pointed out that the rationalisation behind the goal narrative was because it was supported by trials and the evidence suggests that benefits are associated with this goal. The group acknowledged this"

and

"Commented that the group want patients to have choice but sometimes they need guidance about the different techniques. For patients whose current priority is functional improvement, they are the only two treatments where there is evidence of functional improvement."

and

"It was also noted that under the ‘important notes’ heading the wording is changed to ‘CBT is a recognised approach to augment management in many other health conditions including cancer, diabetes and cardiac disease’

and from towards the end of the process

"GDG member comments: Looking through guidelines a lack of balance i.e. not enough focus on therapy. Idea we have lost site of benefits of therapy. Suggestion of new recommendation to of the patient’s main goal is to return to activity, point to evidence which is suggestive of the benefit of CBT and GET. GDG agrees on suggested recommendation."
 
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Pretend that patients will have a real choice and use this as a way of explaining away and absolving responsibility in harms and lack of effectiveness. Also blame patients and their "beliefs" if it doesn't work and lie about this being a normal part of medical treatment

"Important to remember that very few treatments are universally successful. There is a question about effectiveness which can become a matter of selection in trials. Even some positive patient results mean it is a successful trial of a treatment that can work. Patient reports show that certain subgroups are very sensitive to outside stimuli – light, stress, etc… Report of an independent study suggested that patient perceptions can influence the outcome. For example, if Page 6 of 18 the patient perceives that the illness in due to an immune deficiency then they are less likely to have successful outcomes from a behavioural intervention. This is usual across all medical treatment. Patient choice is important when deciding on which treatments to use."
 
Keep putting off important issues into well into the process and have long discussions on things like health economics first. A good way of exhausting patients and overloading them without getting to what is important

"We still don’t have a case definition and haven’t discussed aetiology."
 
Push the idea that research into physical treatments is useless

" Please note there is a call from patient groups to call a halt to the trials and put money into finding the cause. How much further do the intervention trials get people? You get well and then go down again."
 
Explain away harms of CBT and GET as being justified

"When evaluation medical trials: a) expect to see some harm but that doesn’t mean there isn’t benefit."

and justify lying to them over risks and exaggerate benefits using this thinking

"Patients need to believe that the treatment is useful, or there is no point is treating them."

and try the argument that patients just don't understand

"Some of the patients’ negativity towards CBT and GET can be attributed to misconceptions over what they are and how to provide them. Much of this confusion should be addressed when the GL includes detailed descriptions –behavioural subgroup work."
 
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Not sure if this made it through to the end Guidelines and if it didn't - why not?

"There are several papers that say that people who have been severely affected for 5 years have little chance of recovering. This is not about just chronic fatigue there are other symptoms. While you may get an improvement in some symptoms it might exacerbate others."
 
And obviously this only applies if it is CBT or GET

"Our job is to try and identify a range of treatments that may be helpful. They are not/should not be mandatory for patients to take them up. Just because we they don’t suit everyone does not mean they do suit some."
 
and keep pushing all through the guideline development process that there is a one unified "professional view" that is opposed to what patients experience but is still correct of course

" Is there a ceiling effect? – CFS/ME community say there is an underlying illness this puts a ceiling on the amount of recovery. There is this professional view that there is infinite recovery in many cases."
 
Ensure that your patient reps are overloaded and may have to leave just when it gets interesting. Then split into 3 groups with only 2 remaining patients left

"BREAK [Note XXXXXXX needed to leave the meeting at this stage to rest –rating of evidence statements will be done electronically post meeting]

8. Drafting recommendations in subgroup splits GDG break into 3 groups… each lead by the interventions sub-group leads –as follows:

1) GET – XXXXXX
2) CBT – XXXXXX Page 15 of 18
3) Graded Activity
 
Muddy the waters by introducing somatoform disorders

"Thank you for finding this paper – written by a GP on somatoform disorders. We are still proceeding without a proper definition of what CFS/ME is and what causes it. We need to look at things in different ways to understand what is going on."

and explain away patients concerns as being over "stigma" only

"The danger is that the article puts CFS/ME into psychological terms. There is a stigma and there is a fight for the status of the disorder. This is new science that it is looking at the derangements in the system. Could help us to understand the symptoms, and it is a shame that a stigma falls on these definitions"
 
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