‘Recovered' – or do you only feel better?
“I feel so much better today, I’ll go back to work”. Ah, those halcyon days before you had ME. You were ill, you rested, you got better. Put simply, you had recovered.
So when a trial of treatments for people with ME/CFS reports that many of them had “recovered” you would imagine shouts of joy throughout the ME community. But joy there was none and for good reason. “Recovery” as defined in the PACE Trial, involving the use of Cognitive Behaviour therapy (CBT) and Graded Exercise Therapy (GET), is not what you think it is.
In medical trials there are ways of measuring your physical abilities and the SF-36 Function Scale is one that’s often used. It’s useful in comparing the burden of different diseases, differentiating the health benefits produced by different treatments, and in screening individual patients.
A score of 85 or above on that scale indicates that an adult, even one who was previously ill, is able to carry out most everyday tasks. The Pace Trial took as patients, adults with CFS/ME who had a point score of 65 or less, so they were clearly ill. They were given CBT and GET.
Now common sense suggests to me that if the treatments had worked well, those patients would have recovered. Their SF36 score would be 85 or over and off to work they would go. Singing merrily as they went. Well, I was wrong.
Originally PACE said that a score of 85 would indicate their patients had recovered their function but later decided achieving a score of 60 was sufficient. So patients could enter the trial “severely disabled” with a score of 65 or less and exit the trial “recovered” with a score of 60. Yes, you read that correctly.
Some could be as ill at the end of their treatments as they were when they started, yet, says PACE, they had “recovered” their physical function.
PACE does a wonderful sleight of hand here by claiming that as the fatigue score for patients showed improvement then that constituted recovery. Imagine you have just finished treatment for an illness and you’re asked: “How do you feel?” You might say: “I feel much better today thanks”. Feeling “much better thanks” is, as we know, not the same as “recovered”.
If I still can’t go back to work, play football or score my 85 points, then I’m not sure I’d feel “recovered” even if I didn’t feel as knackered as before.
Did PACE check their recovery measures by asking patients scoring 60 if they had recovered? Well, blow me down with a feather, they did not. Here’s a suggestion, dear researchers. Why not go back and ask those patients if they can now do what they did before they were ill.
Why is this important to you? Because the treatment you get from your GP is often based on trials. If those trial results are not founded on common sense but on inappropriate formula on the wrong set of data, what use are they? We live in a world where common sense rules, not in the world of PACE where “recovery” is not what it seems.”
This article first appeared in ME Essential, the quarterly magazine of The ME Association, in February 2014.
Surely this is malpractice? Claiming people are recovered when their scores could have gone down by 5?
Good work, Neil.
Just to point out/remind people, six letters were published (including one by Dr. Shepherd): https://meassociation.org.uk/2013/07/pace-trial-letters-and-reply-journal-of-psychological-medicine-august-2013/
My unpublished letter* in reply to the PACE Trial recovery paper: http://www.ncbi.nlm.nih.gov/pubmed/23363640#cm23363640_751
*I was told I was too late and others had been accepted.
What we have to ask, is how did they ever get away with it?
What a criminal waste of 5 million pounds
Mr Riley very clearly describes a critical flaw within the PACE trial. There are others. For example: Despite Confirmation Bias and Placebo effects, conclusions as to safety and efficacy of treatment were presented to patients as a part of the trial itself. [See Manual for Therapists, CBT].
I do not believe there is mileage in continuing to interact with those who present excuse after excuse to justify research of this quality.
I do believe, however, that there is huge progress to be made within ME research and I would love to see the ME Association objectively and repeatably demonstrate our primary symptom: Post Exertional Malaise. Prove PEM; and any harm to ME patients arising from CBT/GET can be ended. Done. No more.
@batteredoldbook
The PACE trial is bogus; the NICE guidelines are totally unfit for purpose, yet the NHS “CFS” clinics only receive funding on the basis of adhering to NICE guidelines. What a tragic fiasco the whole thing is.