Discussion in 'PsychoSocial ME/CFS Research' started by Tom Kindlon, Jul 23, 2019.
The corresponding author, P. Glasziou, is the co-author, together with the three principal investigators of the PACE trial, of the withdrawn Cochrane individual patient data review (protocol) on exercise therapy for CFS:
The online dictionary just told me that, in the UK, this time of the year is also called 'silly season'.
I'm sure there is no discussion whatsoever about the problem of bias and subjective outcomes. Can anyone check?
anybody have the full study?
At a glance it looks similar or the same as the RACGP version linked in Tom's post:
He is also an 'expert' on evidence based medicine and writes articles with Cochrane founder Iain Chalmers on how not to make mistakes when designing trials.
@Tom Kindlon @dave30th @Graham @Jonathan Edwards
From the abstract re surveys of harms noted, the authors say:
"However, this finding is believed to be due to inappropriately planned or progressed exercise programmes, possibly undertaken independently or under supervision from a person without appropriate experience."
"believed" and "possibly" are not facts, they are of course suppositions or assumptions.
Question for the more scientifically qualified members of this forum: wouldn't it be helpful to be able to address this "inappropriately planned or progressed exercise programmes" argument by surveying pwME post NHS/GET/CBT clinic experience?
Then, BPS campaigners would not be able to say it was inexperienced or independent therapists/therapy providing GET and CBT.
The authors of the study have re-jigged the CDC criteria. They describe the criteria: "The Center for Disease Control diagnosis for CFS has three criteria...[and] Four or more of the following..."
"Four or more of the following" is, if I'm not mistaken, wording from the out-dated Fukuda criteria. This wording is not in the CDC criteria.
PEM, a core symptom for the CDC is designated optional by the study authors.
Sleep problems are a core symptom for the CDC, and an optional one for the study authors.
They entirely omit the CDC's core symptoms of "Problems with thinking and memory", and "Worsening of symptoms while standing or sitting upright."
According to the CDC, of these last two, one needs to be present: " In addition to these core symptoms, one of the following two symptoms is required for diagnosis."
The authors also shorten the CDC's "Other Common Symptom list", and eliminate, "chills and night sweats", "allergies and sensitivities to foods, odors, chemicals, or noise", and "digestive issues, like irritable bowel syndrome".
IMO the CDC should take exception to this re-write of its ME criteria.
ETA: my bolding
ETA #2: punctuation.
ETA #3: Fukuda CFS criteria
In comparing to the Fukuda criteria, the list of optional symptoms is the same as the list for the study in question, with the exception that "short-term memory or concentration" on the Fukuda list has been left off the study list.
CDC Fukuda definition of CFS[edit | edit source]
Clinically evaluated, unexplained, persistent or relapsing chronic fatigue that is:
of new or definite onset (has not been lifelong);
is not the result of ongoing exertion;
is not substantially alleviated by rest;
and results in substantial reduction in previous levels of occupational, educational, social, or personal activities.
The concurrent occurrence of four or more of the following symptoms:
substantial impairment in short-term memory or concentration;
tender lymph nodes;
multi-joint pain without swelling or redness;
headaches of a new type, pattern, or severity;
unrefreshing sleep; and
post-exertional malaise lasting more than 24 hours.
These symptoms must have persisted or reoccurred during 6 or more consecutive months of illness and must not have stated before the fatigue.
From MEpedia: https://me-pedia.org/wiki/Fukuda_criteria#CDC_Fukuda_definition_of_CFS
ETA: Essentially, the authors are using the Fukuda criteria minus "substantial impairment in short-term memory or concentration". This study in 2019 using outdated criteria; the CDC revision to new criteria was made in 2017.
I feel quite shocked that someone could write this and an editor could publish it. As a paper it seems completely unaware of the literature in the area. It makes vague unjustified statements such as around safety (blaming GET that is badly done but with no evidence and there is now evidence to the contray). Also claiming high compliance due to low numbers of drop outs without actually quoting figures
He also tweeted about my original Trial by Error series that it was an "ad hominem attack," if I remember correctly.
I'm finding it difficult to understand but it seems that this is the HANDI working group.
Curiouser and curiouser . . . they seem to be connected to the insurance industry also.
That is a European group. Looks different to the HANDI group based in Australia.
Ah, sorry. Thought I might have got it wrong. Immediately forgot what I read.
So this would be it then: https://www.racgp.org.au/clinical-r...(handi)/about-handi/what-is-the-handi-project
That makes zero sense. Unless he didn't actually read any of it, which is hardly better.
The simple truth is they have no sound scientific counter arguments to criticisms of their science, and so instead resort to what they do best - attack the people and not their criticisms. They just dress up their own ad hominem campaigns to sound convincing to the gullible.
Would it be worth it writing a response?
I briefly wrote down my thoughts but not really in-depth. Perhaps others could add arguments and references (or delete bad ones).
1) “the most prominent symptom of CFS is fatigue, which results in avoidance of exercise, exercise intolerance.”
The Centers for Disease Control and Prevention (CDC) no longer use the Fukuda case definition as presented in this paper. Instead, they recommend the diagnostic criteria published by a 2015 report by the Academy of Medicine which describes ME/CFS as a “systemic exertion intolerance disease”. In this report, post-exertional malaise is described as a characteristic symptom of the illness, not a consequence of fatigue.
2) “GET has been shown to reduce fatigue, prevent physical deconditioning, and improve physical functioning, sleep, cognition and mood.”
There is little evidence that GET has any influence on physical deconditioning (Vink & Vink-Niese, 2018). The Cochrane review on GET indicated there is no evidence that GET improves mood or depression (analyses 1.8 and 1.9), while effects on fatigue and physical functioning are not sustained at follow-up (analyses 1.2 and 1.6). This review is currently being revised for presenting the effects of GET too optimistically.
3) “Surveys by patient groups of their members have suggested that GET may be harmful to some people with CFS. However, this finding is believed to be due to inappropriately planned or progressed exercise programmes, possibly undertaken independently or under supervision from a person without appropriate experience.”
It is unclear on which source this statement is based. The argument was once made by Clark & White, 2010., referencing a survey by Action for ME. Unfortunately the results of the survey were misrepresented as these indicated that more ME/CFS patients reported harms by GET when they were guided by a physiotherapist, than when they had no professional guidance (see graph below).
In a later survey by Action for ME there was little difference in the reported rate of harms by GET whether the treatment was delivered by a NHS specialist (31%), the GP (45%) or others (29%). In a 2015 survey of the ME Association, “GET courses held by therapists stated to have an ME/CFS specialism made symptoms worse for 57% of respondents.” To our knowledge, there is no data indicating that the reported harms of GET are due to inappropriate delivery of the treatment.
4) “Most trials have found few dropped out of GET, and no more than other treatments”
This is an overstatement. The Cochrane review reported that the results of drop-out in GET-trials are “inconclusive” with moderate heterogeneity.
In Wearden et al. 1998., participants dropped-out at a greater rate with GET (37%) than in other intervention groups (22%), a statistically significant difference. In Powell et al. (2001), 16,6% dropped out of the exercise groups compared to 5,8% in the control group. Larger drop-outs in the GET-group than in the control condition were also reported by Moss-Morris et al. (2005), Wearden et al. (2010) and Clark et al. (2017) while in other trials such as Jason et al. (2007) drop-outs were high in all intervention groups.
(Remark: calculated the drop-outs really quickly to get an overview, so don't take the figures in the graph above as fact.)
5) “increased rest is not recommended and should be strongly discouraged.”
It is unclear to which ME/CFS studies this statement refers. Recommendations by The HANDI Working Group should be evidence-based.
6) “More than two-thirds of patients with CFS meet diagnostic criteria for mental health disorders”
This also seems to be an overstatement. In the PACE-trial 44% of patients were identified as suffering from a co-morbid psychiatric disorder by a clinician, and 56% according to structured interview (Lawn et al. 2010). In a population-based study of ME/CFS, “60.9% persons with available medical records had at least one lifetime psychiatric diagnosis of mood disorder, anxiety disorder, or somatoform disorder, according to the SCID psychiatric interview” (Torres-Harding et al. 2002).
It’s not clear to me that they will publish responses: https://journals.sagepub.com/pb-assets/cmscontent/INO/N7JA676 - INO Flyer_web.pdf
In any case, a complaint could be made to the RACGP. Maybe it's something Emerge could put together? @Simone
@Michiel Tack, that's an impressive start to a response. Re item 6 about the frequency of mental health disorders:
The recent study of 164 Australian adolescents discussed here:
So only about 40% of these patients had reported mental health disorders.
Might also be worth talking about the current status of the Cochrane GET meta review.
There seems to be a problem with their evidence assessment system. GET was rated with the highest evidence level (NHMRC level of evidence I )
"The RAGCP currently use the NHMRC levels of evidence and in the future we will move to a GRADE process."
Don't know anything about their assessment processes or what GRADE might be and am not able to read more now, but NHMRC level of evidence I is the highest level of evidence, generated from systemic reviews.
I think it would be worthwhile to have a look at some of the other treatments they have rated as highly evident, to show that this seems to be a more general problem.
In addition, I was thinking it could be helpful to know a few studies on treatments like exercise, physiotherapeutic or psychological interventions that do comply with standards for drug interventions, i.e., randomized, adequately controlled, and blinded and, especially when blinding is not possible, measuring objective outcomes. Ideally, this should be studies on illnesses for which objective outcomes seem difficult at a first glance, too.
Comparing the ME GET and CBT studies to such 'best practice' studies could be an argument against the idea that 'we' just don't like exercise and psychotherapies or, to the more rationally arguing PACE & Cochrane defenders, that it is not possible to measure objective outcomes in some illnesses like ME.
Anyone knows such studies on other illnesses, perhaps studies that really used objectively measured employment rates or school attendance?
Who comprise the HANDI group and what are their interests.
Interesting re timing of this piece
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