Professor Keith R Laws, Professor of Cognitive Neuropsychology, Sunday, 1 November 2015:
This week Lancet Psychiatry published a long term follow-up study of the PACE trial assessing psychological interventions for Chronic Fatigue Syndrome/ME - it is available at the website following free registration
On reading it, I was struck by more questions than answers. It is clear that these follow-up data show that the interventions of Cognitive behavioural Therapy (CBT), Graded Exercise Therapy (GET) and Adaptive Pacing Therapy (APT) fare no better than Standard Medical Care (SMC). While the lack of difference in key outcomes across conditions seem unquestionable, I am more interested in certain questions thrown up by the study concerning decisions that were made and how data were presented.
A few questions that I find hard to answer from the paper...
1) How is 'unwell' defined?
The authors state that “After completing their final trial outcome assessment, trial participants were offered an additional PACE therapy. if they were still unwell, they wanted more treatment, and their PACE trial doctor agreed this was appropriate. The choice of treatment offered (APT, CBT, or GET) was made by the patient’s doctor, taking into account both the patient’s preference and their own opinion of which would be most beneficial.” White et al 2011
But how was ‘unwell' defined in practice? Did the PACE doctors listen to patient descriptions about 'feeling unwell' at face-value or did they perhaps refer back to criteria from the previous PACE paper to define 'normal' as patient scores being “within normal ranges for both primary outcomes at 52 weeks” (CFS 18 or less and PF 60+) . Did the PACE Doctors exclude those who said they were still unwell but scored 'normally' or those who said they were well but scored poorly? None of this seems any clearer from the published protocol for the PACE trial.
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