By David Tuller, DrPH
On November 10th, the National Institute of Health and Care Excellence published a draft of new clinical guidelines for ME/CFS. The draft represented a blunt rejection of the argument that the combination of â€œunhelpful cognitionsâ€ and deconditioning drives the illness. Under this once-hegemonic framework, indicated therapies include cognitive behavior therapy to overcome the unhelpful cognitions and graded exercise therapy to reverse the deconditioning. A review of the literature published along with the NICE draft assessed the quality of evidence from dozens of CBT and GET studies as â€œlowâ€ or â€œvery low.â€
On December 10th, the journal Clinical Child Psychology and Psychiatry published an article called â€œPaediatric chronic fatigue syndrome: 25 year perspective.â€ Two of the four authorsâ€”Professor Trudie Chalder of Kingâ€™s College London and Professor Esther Crawley of Bristol Universityâ€”have long been leaders in the field. In particular, the article highlights CBT as an effective intervention. It cites some of the research that NICE has assessed as yielding only “low” or “very low” quality evidence.
Last year, after an official investigation of her work, Professor Crawley was asked to make corrections in the ethics statements of almost a dozen papers. Also last year, Archives of Disease in Childhood, a BMJ journal, slapped a 3,000-word correction on her report of a major pediatrics trial of the Lightning Process as a CFS treatment. Professor Chalder was a lead investigator of the PACE trial for CFS, which is increasingly viewed internationally as an astonishingly bad piece of research–an example of how not to conduct a clinical trial. (Disclosure: I had something to do with these developments.)
The authors do not mention the new NICE draft in the paper. Hello? Talk about looking clueless and out-of-step! This omission is jarring. Perhaps they did not see the NICE draft until it was too late to make changes, given the article’s publication time-frame. But this 25-year review already smells like an antique.
The absence of any mention of GETâ€”even though Professor Crawley has been involved in such research–is odd. Perhaps the authors anticipated or learned that GET was likely to be discarded in the NICE draftâ€”as it has been. Perhaps they thought some form of CBT would be able to be preserved in whatever new guidelines NICE developed. It’s hard to tell what went into the calculus here.
Conflating “chronic fatigue” and “chronic fatigue syndrome”
In the introductory section, one sentence explains why much of the findings described over the last 25 years are questionable: â€œHere, we predominantly draw on evidence from clinical cohorts with a confirmed CFS diagnosis and evidence from general population studies of chronic debilitating fatigue, not necessarily formally assessed and diagnosed CFS.â€ This group of authors has a long history of conflating â€œchronic fatigueâ€ and â€œchronic fatigue syndrome,â€ blurring boundaries in ways that make research hard to interpret. Professor Crawleyâ€™s prevalence research, in particular, is fraught with this methodological problem.
From what I have observed, members of the BPS ideological brigades love to interpret any association as if it were proof of their causal hypothesis–even when it is clear that they are likely interpreting the relationship backwards. When investigators routinely deploy associations to bolster their pre-existing conclusions without entertaining other possibilities, it becomes hard to take their work seriously.
The following paragraph, for example, includes multiple associations that, from the perspective of the authors, represent avenues for intervention:
Cognitively, adolescents with CFS are more likely to have negative thoughts about their symptoms that are potentially unhelpful for recovery than adolescents with asthma, including endorsing high levels of fear avoidance beliefs (e.g. fearing that activity will make the symptoms worse). These thoughts may reflect the reality of their experience but may also get in the way of recovery. Some of these patterns of thinking, particularly damage beliefs (e.g. believing that symptoms themselves show that damage is being caused to the body) and catastrophizing (e.g. believing that they will never feel right again), are associated with subsequent fatigue and functioning. Parentsâ€™ beliefs about their adolescent offspringâ€™s symptoms are associated with the adolescentâ€™s own beliefs.
To these authors, the associations suggest that a program designed to effect changes in the identified cognitions constitutes a treatment for the overall condition. As the article notes, â€œCBT for fatigue targets cognitive processes such as symptom focusing and fear avoidance.â€ (Incidentally, this sentenceâ€™s reference to â€œfatigueâ€ further demonstrates the unfortunate and unhelpful conflation between â€œchronic fatigueâ€ and â€œchronic fatigue syndrome.â€ They seem to believe the two are more or less the same thing.)
Interestingly, the article also highlights other â€œpromisingâ€ interventions with CBT elements, specifically highlighting the Lightning Process–based, of course, on Professor Crawley’s problematic and now-corrected study. In that study, Professor Crawley and her colleagues recruited more than half the subjects before trial registration, then engaged in outcome-swapping that led to improved reported results. In the paper, they failed to disclose these violations of core scientific principles.
Archives of Disease in Childhood would presumably have rejected the manuscript had the investigators been honest in how they described their research. Nevertheless, the journal white-washed this misbehavior after-the-fact with its very lengthy correctionâ€”a decision that many besides me found disturbing. In fact, the NICE draft specifically recommended against the Lightning Process, with the research review rating the quality of all the evidence from Professor Crawley’s study as “low” or “very low.”
Defenders of the BPS approach to what they still prefer to call CFS face a challenging environment. Like Miss Jean Brodie, they and their ideas have passed their prime. Professor Crawley, Professor Chalder and their colleagues seem to recognize that they’re on the wrong side of this quickening paradigm shift. Thatâ€™s probably an uncomfortable and scary place to be.