Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce.., 2018, Dunn et al

It is forgotten now with all the problems with the published PACE results but while it was being set up we felt that the whole thing was designed to make sure they got the best result possible. I fully expected them to get an astounding success rate which we would have to fight by pointing out all the problems in the way it was set up. Instead the results were so bad they had to fiddle with them to make them seem positive. It must have come as a great shock to them.

I never expected them to find that GET and CT were useless for everyone. It may be that people in the clinics were not included in their tricks and patients actually did have CFS not just tired all the time or a depression which could be helped by exercise.

 

Oh yes of course, sorry, I was forgetting that bit . I suppose with the whole-mind-body approach, so long as people say things are getting better, then the whole-mind-body must obviously getting better.

 

Oops!

 

Whilst pondering this fascinating puzzle, a thought occurred to me that may be valid, though not the answer to this particular problem I suspect.

If someone is genuinely deconditioned, and you apply treatments that successfully start to reverse the deconditioning, why would the deconditioning stop reversing, if you persist with the treatment? Isn't it in the nature of deconditioning that reversing it becomes a virtuous circle? As you become less deconditioned, persisting with the treatments makes it even easier to become less and less deconditioned?

But with PACE their treatment that supposedly led patients to reverse their deconditioning, still flattened out. Are they saying that their success cases were also their failures? They succeeded to the point of partially reversing their deconditioning, but then had a change of heart and then decided they were going to not succeed any more? They can't have it both ways surely. If their treatments only marginally improved the ailment they were purporting to fix, does that in itself not show it could not have been deconditioning?

Edit: Added last sentence.

Edit 2: Corrected "partially deconditioning" to "partially reversing their deconditioning"

Does this hold water @Jonathan Edwards ?

 

Although this can’t be directly inferred from the available PACE trial data, one could also argue that it is when the therapies have been most effective at changing cognitions and/or short-term behaviours that they are most likely to have caused harms. If a patient receives CBT/GET but refuses to change their “unhelpful beliefs” and/or short-term behaviours, they are not going to keep pushing on. But if a patient is persuaded that there is at least a chance that the therapist is correct, that they will not be harmed by exertion, and that pushing on with exercise/activity despite a perceived increase in symptoms may help them to recover, that is when the deteriorations following therapy which have been reported in surveys are most likely to have occurred. If that were so, the safety of the therapies would be inversely proportional to their effectiveness at changing cognitions and/or short-term behaviours.

NB I say “and/or short-term behaviours” as a patient may be persuaded to try to increase their activity without necessarily having their cognitions altered. For example, they may fear the consequences of non-compliance, or they may be motivated by wanting to demonstrate the negative effects of exertion.

 

Great point. Like hailing the success of therapy that manages to convince people they can fly and washing themselves of responsibility for those who tried their newfound power, that they never claimed the participants should actually try it, only that they would believe it.

Incredibly irresponsible and would never be accepted if exemptions were not carved to allow this research to benefit from the looser standards of psychology along with the strength of evidence of competent clinical trials.

 

To summarise the ways of looking at PACE

1. If you take their results as first acclaimed, 30% of patients recovered. This means the treatment was ineffective for 70% of people with CFS/ME/whatever they were testing. Which patients would benefit they were unable or unwilling to predict and they had already discarded hundreds of candidates as not suitable for the trial while the severely affected and/or ill for many years were not even considered. So taken at face value CBT and GET would not make any difference to a great majority of patients.

2. They actually disproved their hypothesis because even when the subjective results were good, the objective results showed no change. Patients did not become fitter even if they were classed as recovered or improved therefore deconditioning could not be the cause. Those who improved or recovered in the CBT group did not return to work in great numbers so faulty cognitions were not keeping them ill.

3. The trial was so badly set up and the statistics were so badly handled that the results are meaningless and no useful information can be gleaned.

So the trial failed on all levels.