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GETSET (white) in Lancet 22/06/17

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A long time ago in the forces I reported to sick bay feeling very ill. The very obnoxious orderly did not believe my subjective self-reporting and, being of senior rank to me, was initially able to just cast insults at me. I sorted things very eloquently however - I threw up all over him ... a pretty good objective measure. As he was castigating me and telling me to clear it all up, his senior then stepped in ... but I was too far gone to note any more detail. Turned out I had glandular fever.

Edit: Sorry for thread derail, just realised. Can move to another thread if appropriate.
 
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I think this is a useful document. It was obtained from a freedom of information act request. It lists all the questions for the questionnaires used in the PACE trial. A lot of them are also used in other studies.
http://evaluatingpace.phoenixrising.me/PACE_Protocol.pdf
5. The CDC criteria for CFS (9 symptoms of CFS)
6. The London criteria for myalgic encephalomyelitis
Being as these were not used as eligibility criteria, what was the point of them being part of the baseline assessment? Was any information ever released regarding how many participants actually then met the CDC and/or London criteria?
 

CFS_for_19_years

Hoarder of biscuits
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7.3 Exclusion criteria
...
3. Patients who are considered by the RN in discussion with their centre leader to be
unable to do one or more of the trial therapies or to complete all trial measures ...
So the inclusion criteria were 100% subjective! I'd not quite twigged that the Oxford criteria is wholly subjective, though once you see it's a bunch of psychiatrists (lead author Michael Sharpe) inventing a way to subjectively characterise a physical state, it suddenly becomes no surprise at all. And the Research Nurse also had strong subjective influence on who got in and who did not, as per above.

The exclusion criteria eliminated severely affected patients who weren't able to make the trip for appointments, so the trial results, as dodgy as they were, could only be representative of moderately or mildly affected patients.
 
Messages
2,391
Location
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I think this is a useful document. It was obtained from a freedom of information act request. It lists all the questions for the questionnaires used in the PACE trial. A lot of them are also used in other studies.
http://evaluatingpace.phoenixrising.me/PACE_Protocol.pdf
"Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder
Fatigue Questionnaire score of 3 or less, [27] (ii) SF 36 physical Function score of 85
or above, [46, 47] (iii) a CGI score of 1, [45] and (iv) the participant no longer meets
Oxford criteria for CFS, [2] CDC criteria for CFS [1] or the London criteria for ME.
[my bold]

But CDC and London criteria were not entry criteria anyway (only baseline assessment), so how could they say "no longer meets"! Highly likely some of the participants never met these in the first place, so is this another case of people potentially meeting Recovery criteria at baseline? But presumably we don't have access to the relevant data to check this.
 
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The exclusion criteria eliminated severely affected patients who weren't able to make the trip for appointments, so the trial results, as dodgy as they were, could only be representative of moderately or mildly affected patients.
I suspect it would also have excluded a lot of moderately affected people. A week's actometer readings might give the RN considerable doubt that the person could:-
7.4.5 Eligibility assessment and consent for assessment — visit 1 (research
nurse)
All of the following eligibility criteria must be fulfilled for the patient to participate:
...
8. The patient is able to convince the RN that they will be able to attend hospital
regularly and reliably for the duration of the trial (travel expenses will be given).
[My bold]

No way my wife could convince anyone she could reliably attend specific appointments over the course of a year. If she could rely on herself being able to do that she would be going to work. And my wife is not severely affected.
 
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2,391
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I think this is a useful document. It was obtained from a freedom of information act request. It lists all the questions for the questionnaires used in the PACE trial. A lot of them are also used in other studies.
http://evaluatingpace.phoenixrising.me/PACE_Protocol.pdf
13.2 Confidentiality
No participant identification details will be used in any database. The one exception will be a separate database, held at the Bart's centre only, of name of participant, date of birth, ...
So their own original protocol stated that all the data needed for analyses would be stored completely independently from any personally identifying details. They then spent a quarter of a million pounds of taxpayers money in the FOI action arguing they had violated their own protocol.

I think this also means they have no justification for withholding any of the PACE data from public scrutiny, other than the one database held at Barts containing all the personal information.
 
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2,391
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I think this is a useful document. It was obtained from a freedom of information act request. It lists all the questions for the questionnaires used in the PACE trial. A lot of them are also used in other studies.
http://evaluatingpace.phoenixrising.me/PACE_Protocol.pdf
18.3 Trial Management Group (TMG)
The Trial Management Group (TMG) will be responsible for the day-to-day running and
management of the trial. It is composed of:
...
• Chris Clark (for Action for M.E.)or a nominated deputy
...
So AfME were actually part of the PACE Trial Management Group. Now much clearer to me why they are so shy about criticising anything PACE.
 

user9876

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Dolphin

Senior Member
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Being as these were not used as eligibility criteria, what was the point of them being part of the baseline assessment? Was any information ever released regarding how many participants actually then met the CDC and/or London criteria?
Yes, see Table 1 of the Lancet paper, which I have attached to this message.
 

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  • PACEtrial-lancet.pdf
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Dolphin

Senior Member
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Apart from the last one, which isn't particularly exciting, there is no mention of an abnormal response to exercise ins CFS/ME. I have to wonder how ethical this is.

3. NORMAL RESPONSES TO EXERCISE

The following signs and feelings are normal reactions during exercise; they show that the participant is working at the right level to make real positive changes to their body. If they do not feel any of these when exercising, they will not be making any positive changes to their body.

Increased breathing rate
Your breathing will become faster than normal, to a rate that you are able to control. This is to supply your muscles with more oxygen because they are working harder than usual.

Increased heart rate
You may feel your heart rate increasing: Your heart will beat faster in order to pump the extra oxygen around your body to provide for your muscles.

Body parts turning red in colour
Your face, arms, legs, or other body parts may turn red in colour during and after exercise. This is because there is more blood being supplied to the muscles beneath the surface of your skin. It is also because your blood vessels move towards the surface when you are warm to help keep you cool.

Sweating
Sweating is your way of helping to control your body temperature: as you become warmer on exercise, the sweat evaporates and it cools you down.

Increased temperature
You will feel warmer all over your body as your muscles are working harder and giving off more heat.

‘Jelly feeling’, especially in arms and legs.

You may feel like your arms or legs are a little shaky or feel like jelly. When you stop exercise and rest this feeling should gradually reduce and stop. This is a normal response to exercise.

Normal response after exercise
After exercise, your heart and breathing rate will gradually slow down to their normal resting rates. You may also feel the following as part of a normal reaction after exercise:

Heaviness feeling: After your muscles have worked hard, they are likely to feel heavy.

Stiffness feelings in muscles: These come in varying degrees; a mild stiffness is normal and is associated with positive changes. Stiffness should gradually improve and should not last long. A good warm up and warm down will help reduce these feelings.

Stiffness feelings are associated with a build up of a normal by-product of exercise, known as lactic acid. Lactic acid gradually gets washed out of your muscles after exercise by your bloodstream. You can help this process and feel more comfortable by having a long, warm bath followed by gentle stretching exercises. Gentle movement, e.g. walking, can also help.

Natural tiredness: Exercise will make you feel a normal and natural tiredness and will help improve sleep. This tiredness may feel more than usual in somebody with CFS/ME.
 

Dolphin

Senior Member
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Yes, 49% didn't satisfy ME criteria and 33% didn't satisfy the Fukuda/Reeves (2003) CFS criteria.
Also the ME criteria were not very strict and probably not very good.

Title: PACE Trial - 97% of the participants who didn't have a psychiatric disorder satisfied the definition of M.E. used

[I and others have noted these percentages in discussions on the internet before; however, I thought the latest quote brings clarity to the wording in the Lancet paper. Tom]

In the Lancet paper on the PACE Trial (by White et al (2011)), it said: ---------- "Participants were also assessed by international criteria for chronic fatigue syndrome,12 requiring four or more accompanying symptoms, and the London criteria13 for 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)." -----------

I was not 100% sure what "no primary depressive or anxiety disorder (interpreted as an absence of any such disorder)" meant in relation to the percentage we were given for "any psychiatric disorder" i.e. could there be an overlap.

The following is an extract of a letter that clarifies it (see asterisked bit) - the letter was written by PD White, KA Goldsmith, AL Johnson, R Walwyn, HL Baber, T Chalder, M Sharpe, on behalf of all the co-authors (of the PACE Trial)

--------- The trial did not study ME/CFS (pages 12-18)

The selection of patients was for CFS operationalised using the broadest criteria (the Oxford criteria). No sensible neurologist would apply the diagnosis of CFS (or indeed ME) to patients who had "proven organic brain disease", such as Parkinson's disease. For the purposes of this trial ME was not regarded as a "proven organic brain disease". In order to ensure balance between the trial arms in those participants who met alternative criteria for CFS and ME, randomisation was stratified by the International (Centers for Disease Control) criteria (which require additional symptoms) and by the London ME criteria (based on Melvin Ramsay's original description, and which excludes co-existing "primary" psychiatric disorders [****which we interpreted as any psychiatric disorder****] and emphasises post-exertional fatigue). We were provided with the second revised version of the London ME criteria; we did not invent our own. We considered use of the Canadian criteria for ME but we found it impossible to operationalise them adequately for research purposes; to our knowledge they have not been used in a major research trial. We studied the results for differently defined subgroups and they were similar to those in the entire group.

(source: http://www.meactionuk.org.uk/whitereply.htm )

------- The figures from the paper (Table 1) show that, of the 640 participants, 300 (46.9%) had "any psychiatric disorder" and 51.4% (329) satisfied the London criteria*.

This means that of the 340 patients in the trial (i.e. who satisfied the Oxford criteria**, with a principal symptom of fatigue, who did not have a psychiatric disorder), 329 (96.8%) satisfied the London criteria for M.E., the definition of M.E. used in the trial!

This is an amazingly high figure for a definition of M.E. given the "looseness" of the Oxford criteria e.g. unlike the Fukuda CFS criteria or Carruthers ME/CFS criteria, it doesn't require other symptoms apart from fatigue.

It seems to me the definition for M.E., at least as it was used in this trial, is very suspect. And hence it is questionable what can read from into how people with M.E. responded in the trial.

Tom

---------- *One can how the London Criteria were used at: http://bit.ly/lyqddJ i.e. http://s982.photobucket.com/albums/ae301/tkindlon/?action=view&current=Londo n_Criteria_in_PACE_Trial.jpg

** One can how the Oxford Criteria were used at: http://bit.ly/kAh1cg i.e. http://s982.photobucket.com/albums/ae301/tkindlon/?action=view&current=Oxfor d_Criteria_in_PACE_Trial.jpg

Annex 1: We already cannot be sure if the participants are representative of patients in the community based on who refused to take part, were excluded, etc.
 
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Yes, 49% didn't satisfy ME criteria and 33% didn't satisfy the Fukuda/Reeves (2003) CFS criteria.
And still they got completely cr*p results. I guess this is only to be expected when you unleash a bunch of career obsessed psychiatrists investigating a biological illness. Except of course the above suggests no one had much idea what was actually being investigated.

Edit: And yet is a benchmark that NICE treatment guidelines are based on for ME/CFS.
 

Dolphin

Senior Member
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(Maybe just nitpicking)
5. EXPLAINING THE PRINCIPLES OF GRADED EXERCISE THERAPY TO PARTICIPANTS

The principles behind graded exercise therapy as a treatment for CFS are described in the main part of your manual.
However, explaining them in a way that people understand can be challenging.

In relation to your role in guiding people through the GET booklet, explaining what graded exercise therapy is and its benefits, especially in relation to a patient’s particular symptoms and experience, is a good starting point. You can direct them to pages 1&3 of their GET booklet. They may be worried that it will harm them in some way or make them worse. You can reassure them, using the information in your manual about safe and effective exercise, and also normal responses to exercise in this appendix.

Explaining the theory of GET can be complicated, but you can explain the ‘use it or lose it’ theory of physical fitness by using examples in their lives.
I think the "use it or lose it" theory can scare people to exercise when they shouldn't.

Try to illustrate this using specific hobbies they have, or experiences they have been through: For example, if working with a musician, draw parallels with GET theory with learning to play to a high level. You might explain how a beginner will need to start with practising musical scales, learning to read music and learning where to place their fingers on their instrument. They can then learn music to grade 1 level, practise at this level for a while before feeling comfortable trying grade 2. A beginner cannot automatically play in an orchestra. Equally, someone who has not played their instrument since childhood may need to start by reminding themselves how to read music, and to start at a lower playing ability. Such metaphors can be very powerful in getting a participant to understand the theory of deconditioning and reconditioning, and should be tailored to their own interests. Learning a foreign language
or learning to walk or ride a bike can also be useful explanatory concepts. These should be used as a support to GES.
Metaphors can be powerful but they can also be misleading.

You can then explain that GES can be broken down into a 6-step programme. By carefully establishing a baseline of physical activity/exercise that they can do regularly will form the first part of the programme, followed by mutually agreed gradual increments in the duration of exercise at the same level of intensity. You can then tell them that once this can be done comfortably, an increase in intensity will help further strengthen the body.
It may or may not.


This is all in their GET booklet, but may need additional brief explanation.

You can explain that research that shows significant reductions in physical capacity after periods of rest, or relative rest, and how this can equate to their situation.
The evidence I have seen generally relates to severe bed rest rather than what most ambulatory people with CFS/ME do.


Even if they have not had periods of full bed-rest, participants can usually relate to a relative reduction in exercise, activity or physical functioning as a result of their CFS/ME.

You can give them information on previous research trials of GET for CFS/ME that show increases in physical strength, fitness, and functional capacity, sleep, mood and cognition.
The evidence is far less cruel clear-cut. I doubt such spin of the outcomes of drug trials or surgical trials would be allowed.
The role of exercise in general health and the prevention of major chronic diseases, such as stroke, obesity, coronary heart disease, type II diabetes and cancers can also be explained.
Yes all this could scare people to exercise. Which might not be a good thing as it might leave people to do too much.
 
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