I added the following as comments to the Virology Blog post, but because of the restrictions of DISQUS I had to divide it into small sections. A couple of my points have already been raised above. My feeling is that the note reflects major concerns about Dr Brown's understanding and attitude to the issues. I would be interested if others feel I am just being over pickey because of my antipathy to the actual paper or if these are relevant points.
Thank you David for continuing to pursue this serious issue. I may be pedantic but I have further concerns about the wording of Dr Brown's editorial 'note'
- "used widely but never formally tested" Given that this note fails to outline any of the many criticism of this study, this out of context may suggest to some as a partial endorsement of the 'Lightening Process' suggesting that many people are using it
- "children and young people with chronic fatigue" Despite any reservations one might have about Prof Crawley's understanding of the distinction between the symptom 'chronic fatigue' and the condition 'chronic fatigue syndrome', the study claims to be investigating CFS/ME so to describe participants in relation to just the one symptom, means either Dr Briwn has failed to read the study properly or is whether intentionally or not belittling a profoundly disabling condition
- "analysis suggested benefit in terms of physical functioning" This is not strictly true in that the suggestion was of an improvement in self reported physical function, which is not the same. The mention of a scale may to those in the know alert them to this, but to the lay and much of the general clinical audience the implication is that this is an objectively quantifiable improvement which is not the case. Further given the intervention evaluated, effectively instructs the children to lie about their symptoms, any subjective measure in this context is doubly inappropriate. Further given the methodological problems in this study it is impossible to meaningly interpret any change as benefit.
- "the study has been criticised for failing to meet ... ... ..." The policy and guidance are referenced but not the reasons the study fails to meet then. Why were the eliding of a feasibility study into a full trial, the consequent preregistration recruitment of subjects, the outcome switching midtrial, the confusions relating to ethical approval resulting from these and the obfuscation of all these issues in the paper itself not stated, as this leaves the reader with no insight into the seriousness of these points, nor does it inform them of the many other significant criticisms of the methodology and the intervention as tantamount to child abuse, that render the study unacceptable over and above the major failings of the journal to spot the issues very obliquely alluded to here and their failure to act for many months after they were first pointed out.
- "We have acknowledged these comments and reviewed our process" To my knowledge they acknowledge the correspondence, but that is not the same as acknowledging the actual comments. This reads that they have indicated they read and understood the comments and informed the commenters of this, but so far there is no clear indication that they have understood them or reported them to any one other than the Journal's editorial team and the paper's authors. Also so far their review of their processes so far is hardly open or transparent. Dr Brown is effectively implying the issues have been adequately dealt with without giving any actual evidence that this the case.
- "In addition, we have received clarifications from the authors which are under editorial consideration" This has the problems that David has already pointed out, but also what is the need for any consideration when either there was or was not preregistration recruitment of subjects which unambiguously would preclude this study from publication in this journal. Why then this delay.
Further on the website itself Dr Brown has placed a note declaring he has no conflict of interest. It is very strange that a journal's editor should feel it necessary to indicate that he has no conflict of interest when he has a prima facie conflict of interest by virtue of being the journal's editor.
I may seem to be being pedantic, but this is a very important issue, and one would expect a BMJ journal to exercise more than ordinary care in relation to a very questionable intervention involving the Lightening Process that has been the subject to controversy and official investigation over many years. Even at this stage the editor is falling short of linguistic precision and the openness we should be entitled to.
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