White's trouble with burdens of professionalism
Why is it that whenever I read or hear about stringent ME/CFS research being an impractical burden, Peter White is involved?!
This is a large post. To help break up the text I quote the beginning of each topic and answer underneath ...
Crawley & Miller & White (
http://www.meassociation.org.uk/?p=7156) claim that applying the Canadian criteria would be "a significant burden to patients and doctors", supposedly due to assessment of too many symptoms and comorbidities.
As Barba Bright points out in the rapid replies "
the discrete symptoms in the CCC are so simple to recognise that a GP working through the list with the patient would be able to reach an outline diagnosis under these criteria within ten minutes" (
http://www.bmj.com/content/342/bmj.d3956/reply).
They do concede that: "The one advantage of the Canadian criteria over alternative diagnostic criteria is that they require what many would regard as the characteristic feature of CFS, post-exertional malaise. This is something that may need incorporating in future definitions to help differentiate CFS from more general fatigue."
White on the other hand has previously portrayed PEM not as a pathological disease process but the ordinary effects of "deconditioning" and/or psych-behavioural disturbed homeostasis. There is ambiguity in the term "post-exertional fatigue and/or malaise", ranging from mild fatigue after exercise that shouldn't occur in a healthy person (and could be due to illness or obesity or deconditioning), to a full blown abnormal biomedical response to trivial activity with an incapacitating array of symptoms and signs. The revised Canadian definition states: "
Jason et al. (1999a) found that post-exertional fatigue or malaise for individuals with CFS ranged from 93.8-40.6% depending on how the question was asked." (
http://thescipub.com/pdf/10.3844/ajbbsp.2010.120.135)
The rich description of post-exertional symptoms in the Canadian definition, which is lacking from all other CFS criteria, was further refined in the ME-ICC description as "post-exertional neuroimmune exhaustion". Those that experience "PEM" do not necessarily meet criteria for PENE and those that do not meet PENE criteria cannot be diagnosed with ME. I doubt White would endorse the strict description of PENE or even the PE-F/M of the original Canadian definition, perhaps he would allow something similar to the watered-down pseudo-mandatory version found in the NICE 2007 guidelines.
Crawley & Miller & White are also concerned that "'symptoms' such as ataxia, 'palpitations with cardiac arrhythmias', and 'loss of thermostatic stability' count towards the diagnosis, rather than suggesting alternative diagnoses".
White has dissed the Canadian criteria before in a similar manner. In a video presentation (
http://rsm.mediaondemand.net/playersp1.aspx?EventID=1291) he complains about possible neurological signs and symptoms, and mentions his self-confessed inability to understand or define what "emotional overload" is despite being a psychiatrist (which is probably just a snide comment).
AFAIK White doesn't accept the notion of ME/CFS with neurological features or Canadian defined ME/CFS, so there remains a grey area limbo between classical neurological signs and symptoms versus the more subtle manifestations of neurological dysfunction which may not result in a diagnosis of a traditional neurological disease but may exclude a patient from a CFS diagnosis by White, and he would probably want to exclude this grey area as much as possible to get a "cleaner" biopsychosocial cohort with presumed functional illness that will respond better to CBT/GET.
In White's response to Hooper via Horton of the Lancet regarding the PACE trial: "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." (
http://www.meactionuk.org.uk/whitereply.htm).
Meanwhile two large studies used the Canadian criteria were recently listed on PubMed:
(1) A team of researchers in Spain conducted a study in which 824 consecutive cases were examined using both Fukuda and Canadian criteria. They concluded: "
In the evaluation of the patient, it is very important to apply the Canadian criteria and to assess comorbidity." and "
The different groups of symptoms defined by the Canadian consensus showed that CFS is a homogeneous entity." (
http://www.ncbi.nlm.nih.gov/pubmed/21794854)
(2) A team of researchers in the UK conducted a study in which after searching a GP database, Canadian criteria was assessed in 265 cases. They concluded, "
We suggest combining the use of both the CDC-1994 and Canadian criteria for ascertainment of ME/CFS cases, alongside careful clinical phenotyping of study participants. This combination if used systematically will enable international comparisons, minimisation of bias, and the identification and investigation of distinct sub-groups of patients with possibly distinct aetiologies and pathophysiologies, standing a better chance of translation into effective specific treatments." (
http://www.ncbi.nlm.nih.gov/pubmed/21794183)
Neither team of researchers were "burdened" by the Canadian criteria nor found them "impossible" to implement. Instead these researchers' results highlighted the usefulness of the Canadian criteria. Compare their comments about it to White's "fear avoidance" away from it, claiming that using them is impossible and impractical.
White was the lead author in the PACE trial and had the opportunity to help resolve a crucial question: whether CBT/GET results in objective increases in activity as presumed by proponents. They even purchased the necessary equipment and took baseline measurements from the patients. Before the trial began, the authors were repeatedly asked by people within the ME/CFS community to take a measurement at 52-weeks too. The authors declined (
http://www.biomedcentral.com/1471-2377/7/6/comments), "Although we originally planned to use actigraphy as an outcome measure, as well as a baseline measure, we decided that a test that required participants to wear an actometer around their ankle for a week was too great a burden at the end of the trial."
This decision/(excuse) was given before the trial began, but as it turns out, also just happened to coincide with data (then unpublished but acquired years before the PACE trial began) from their biopsychosocialist associates which showed that CBT does not actually lead to objective increases in activity as presumed for about 20 years (
http://www.ncbi.nlm.nih.gov/pubmed/20047707). Seriously, what is the more likely scenario: (a) it would have been too much of a burden for patients to wear an ankle device for one week to collect important data at followup in order to answer a crucial unresolved question in research, despite being made to do it at the beginning of the trial anyway; (b) data for a measurement which could have embarrassed the CBT/GET approach
would have been too much of a burden on the authors' reputations and the biopsychosocial approach so it just wasn't collected.
According to Hooper: White on radio (see
http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm or
http://www.meactionuk.org.uk/Whiter_than_white.htm) ...
When asked by the interviewer about the Canadian Guidelines, he said he did not like them:
"The problem is, and the reason why I don't use them, is they're very complicated to use and would require me to actually do tests on my patients that I don't think I ethically should be doing on my patients, and I don't find them useful, and if Guidelines aren't useful, then we don't use them."
The interviewer said: "You mentioned tests that you don't think it's right for you to do, such as ?" to which White responded: "Such as the tilt table test I would have to exclude a condition called POTS (where the blood pressure falls on standing up). I don't think that's justified."
The interviewer asked: "So you think they're unethical because they're too demanding?", to which White's immediate answer was: "Yes."
Apart from the fact that in the Canadian criteria POTS is not an exclusion but actually listed as a symptom under "Autonomic Manifestations", POTS and orthostatic intolerance in general are relatively common (and potentially treatable?) problems in ME/CFS (for example see
http://www.cfids.org/about-cfids/orthostatic-intolerance.asp and
http://www.ncbi.nlm.nih.gov/pubmed/18805903) so it may be unethical NOT to do such tests when indicated. In one small study, Head Upright Tilt Table Testing was positive in 13/15 patients (
http://www.iacfsme.org/BULLETINSPRING2010/Spring2010ABSTRACTLevine/tabid/430/Default.aspx). People argue that CFS patients don't show abnormalities in "routine testing" so there's no point doing any more testing. This convenient advice borders into willful (and possibly criminal) negligence if these abnormalities are known to exist and be relevant.
As Hooper explains (
http://www.bmj.com/content/342/bmj.d3956/reply#bmj_el_267520) in his BMJ rapid response, the symptoms White dismisses as being of dubious validity are important "
for a diagnosis of ME as stipulated by 26 international experts from 13 countries who between them have 400 years experience of diagnosing over 50,000 patients. [...] When did the careful assessment of sick people stop being part of the practice of medicine, especially when the disorder in question is known to be a complex multi-system disorder?"
Within the last few years the Canadian criteria has been discussed much more than before. This is an encouraging sign, and the resistance to their utilisation can be expected from certain people. It should deeply touch my heart that White is so concerned about easing patients' burdens, but I bet most patients would not find these procedures a burden if it helped them understand more about their illness and possible treatments or even more appropriate alternative diagnoses rather than dumped in a wastebasket. So one wonders where the real easing of burden lies, with patients who want and deserve the appropriate medical care, or certain researchers who are reluctant to adopt methodology which is more stringent and complex than they are used to and which also threaten their ideologies?
I like a bit of humour to help ease the frustrating and soul-destroying aspect of ME/CFS analysis, and I found v99's comments on this issue (from the related ME/CFS Forums thread) amusing and relevant enough to include here as well:
Maybe it is just laziness. | Fatigue - tick. Off to the country club for lunch. | Multiple symptoms - oh no I have to work for a living and I don't understand.
http://www.mecfsforums.com/index.php/topic,8453.msg100088.html#msg100088
I half-joked in a previous post: White (et al) may need CBT to correct their "abnormal illness beliefs" regarding ME and to overcome the "fear avoidance" and "psychosocial barriers" that prevent them from accepting the need for and implications of biomedical research, and
may need GET to increase their activity levels so they are fit enough to use stringent Canadian criteria for research without complaining about "burden" and enable them to perform "demanding" and "unethical" tilt-table tests etc on the significant proportion of patients who will show abnormalities and who justify such tests being done.
