IiME letter to Mark Baker (NICE) re: CBT & GET as recommended treatments

Indigophoton said:
The Oxford Criteria has a number of exclusions, for example, anaemia and schizophrenia. Presumably 1088 people had conditions which prevented them from being included.
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How exactly did they report on the exclusions in PACE and were the exclusions done on objective measures or subjective ones and also could they overrule such patients previous diagnosis and did they test for or ask for proof of previous tests before excluding people.
 
Valentijn said:
The problem is that dealing with NICE guidance is not about PACE. It's about a bunch of studies, some of which show objective improvements. The ones which show objective improvement use Oxford and have indications that patients were not physically disabled at baseline. How do we argue that those trials are not relevant to ME/CFS, except by arguing that the criteria used did not recruit ME/CFS patients?
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Important point. Can you point me to what you think is the objective evidence here. I think one may be able to unstitch that but I need to have another look.

I agree that using Oxford can be heavily criticised on grounds of there being a serious risk of not getting a representative population and that may need to be flagged up. My push back has been against the suggestion that using Oxford is 'scientifically unsound' for a priori reasons, which I think is doubtful.
 
how could anyone not meet the criteria.
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It isn't at all clear whether they had other conditions that had not been spotted (such as sleep apnoea), which could account for up to half of the patients screened, or whether their fatigue was not the major symptom. Their description of the Oxford criteria requires "fatigue to be the main symptom, accompanied by significant disability, in the absence of an exclusionary medical or psychiatric diagnosis..."

How exactly did they report on the exclusions in PACE
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You need to look at figure 1 on the original 2011 report, then read through the section on Methods (page 2). You'll end up with more information, but few answers!
 
large donner said:
How exactly did they report on the exclusions in PACE and were the exclusions done on objective measures or subjective ones and also could they overrule such patients previous diagnosis and did they test for or ask for proof of previous tests before excluding people.
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According to the original paper,
We selected participants in accordance with Oxford criteria for chronic fatigue syndrome.11 These criteria require fatigue to be the main symptom, accompanied by significant disability, in the absence of an exclusionary medical or psychiatric diagnosis(psychosis, bipolar disorder, substance misuse, an organic brain disorder, or an eating disorder).11 All participants were medically assessed by the specialist clinic doctors to exclude alternative diagnoses.2,12 Research assessors used the structured clinical interview from the Diagnostic and Statistical Manual of Mental Disorders IV to diagnose exclusionary and comorbid psychiatric disorders (ie, mood and anxiety disorders).10,14

Other eligibility criteria consisted of a bimodal score of 6 of 11 or more on the Chalder fatigue questionnaire15 and a score of 60 of 100 or less on the short form-36 physical function subscale.16 11 months after the trial began, this requirement was changed from a score of 60 to a score of 65 to increase recruitment.

We excluded patients who were younger than 18 years or at significant risk of self-harm, unable to attend hospital appointments, unable to speak and read English, had medical needs that made participation inappropriate, had previously received a trial treatment for their present illness at a PACE trial clinic (we initially excluded anyone who had received a trial treatment, but found the nature of treatment given elsewhere hard to establish).10 Participants were also assessed by international criteria for chronic fatigue syndrome,12 requiring four or more accompanying symptoms, and the London criteria13for myalgic encephalomyelitis (version 2), requiring postexertional fatigue, poor memory and concentration, symptoms that fluctuate, and no primary depressive or anxiety disorder (interpreted as an absence of any such disorder).
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http://www.sciencedirect.com/science/article/pii/S0140673611600962
 
Jonathan Edwards said:
Important point. Can you point me to what you think is the objective evidence here. I think one may be able to unstitch that but I need to have another look.
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https://www.nice.org.uk/guidance/cg53/evidence/full-guideline-appendix-1-196524110 contains the evaluations of the evidence, and a summary of diagnostic criteria as well.

Summaries of study results are pages 54-56 (CBT), 57-59 (GET).

Data extraction from CBT/GET trials is on pages 275-317.

Validity assessments of RCTS are on pages 437-439, and controlled trials are pages 440-441.
 
Valentijn said:
The bigger problem comes with the claim that "exercise is beneficial for people with fatigue, ergo it must be beneficial in ME." How do we argue that ME is not a subset of fatigue, especially with the disease being characterized as chronic fatigue syndrome? Alternatively, how to we argue that ME is a subset of fatigue where the usual rules of fatigue don't apply?
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Like replacing the knackered plugs in my car helps it go fine again, so lets replace the plugs on yours which is also a bit fatigued. If you then tell the other person their car is sorted and they just have to put their foot down and go ... if the real problem is the handbrake is stuck on, you will just burn the brakes out.
 
@Jonathan Edwards - Here's my notes regarding the GET evidence:

  • Fulcher 1997 (1++) - 66 patients, Oxford, 2.7 years ill, 12 weeks GET v flexibility, GET 50% max heart rate
  • Moss-Morris 2005 (1+) - 49 patients, Fukuda, 12 weeks CBT/GET v SMC, GET group 2.26 years ill & control group 5 years ill, P-values > 0.01
  • Powell 2001 (1++) - 148 patients, Oxford, 48 months ill, 3 types of GET + 1 control
  • Powell 2004 (1++) - 2 year followup - controls had crossed-over, no longer controlled?
  • Wallman 2004 (1-) - 61 patients, Fukuda, unknown illness duration, GET + Pacing v controls, 6 with MDD, reduced exercise if relapse, objective outcomes compared within groups instead of with controls
  • Wearden 1998 (1++) - 136 patients, Oxford, 28 months ill, fluoxetine or HR-based GET, 40 drop outs with 11 due to adverse events

There are problems other than using Oxford, but Oxford seems to be the biggest problem and the easiest to attack, especially since it could take down a lot of trials at once.
 
Graham said:
It isn't at all clear whether they had other conditions that had not been spotted (such as sleep apnoea), which could account for up to half of the patients screened, or whether their fatigue was not the major symptom. Their description of the Oxford criteria requires "fatigue to be the main symptom, accompanied by significant disability, in the absence of an exclusionary medical or psychiatric diagnosis..."
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The thing is as the BPS crowd think they can just look at someone and declare them x y or z they could have been excluding left and right to narrow the entry participants down to a cohort they could claim to be Oxford for their trials but anyone who turned up with walking difficulty etc could have been excluded, or they could just say, "ah you look a bit pasty you have anemia, you are excluded" etc until they end up with a bunch of people who had a single complaint of "fatigue", which was the minimum requirement for the trial.
 
large donner said:
The thing is as the BPS crowd think they can just look at someone and declare them x y or z they could have been excluding left and right to narrow the entry participants down to a cohort they could claim to be Oxford for their trials
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@large donner - Stretching speculation a bit far imo. I prefer to stick with what can be evidenced. That's bad enough.
 
Indigophoton said:
@Alvin, yes, but, whatever the authors actually did, PACE was anyway a bust scientifically in so many ways that we've an embarrassment of riches as far as discrediting it goes, so it ought to be impossible for NICE to justify using it it in the new guidelines.
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I agree, i do like to know details though, its always good to have many avenues to work with, you never know which one will be the Achilles heel
 
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