By David Tuller, DrPH
In the last few years, the Journal of Health Psychology has provided a valuable platform for researchers, academics, and other experts who have challenged the claims made in the discredited PACE trial and other research from the CBT/GET ideological brigades. Last month, the journal published a revealing and useful paper from four authors–three smart members of the patient/advocacy community, along with an academic psychologist.
The paper is called “Monitoring treatment harm in myalgic encephalomyelitis/chronic fatigue syndrome: A freedom-of-information study of National Health Service specialist centres in England.” It documents serious limitations in how or even whether NHS specialist services educate patients about about potential treatment harms and how or whether these services monitor such harms.
I asked the lead author–Graham McPhee–for a description of what he and his co-authors did and why they did it and what they found. (His co-authors are Adrian Baldwin, Tom Kindlon, and psychology professor Brian Hughes.) He sent me the following on behalf of the entire group.
For years, patients with ME/CFS have complained that CBT, or more often GET, made their condition very much worse. The number of complaints, shown consistently through surveys, indicate that centres should certainly be aware of such patients. We decided to look at how clinics monitored and recorded such outcomes, to see how they dealt with harms from the treatments.
We wrote to 57 specialist NHS ME/CFS centres in England: some were no longer operating as centres, some were being operated by private contractors and so were not obliged to answer our questions, some did not reply, despite a reminder, and two stated that they did not offer any rehabilitative therapies. That left us with the answers from 38 centres, which we analysed.
Surprisingly, of the 17 clinics that provided data on harms, all reported that no harms had occurred in their clinics in the year-long period that we’d asked about. But surveys done by ME charities show that large numbers of patients report deteriorating after CBT and GET – and so do the clinics’ own data, according to a recent study conducted by Simon Collin and Esther Crawley:
So this claim by the clinics in our survey that no harms occurred seems a bit optimistic. Why the mismatch?
One possibility may lie in the fact that, in every one of the few clinics that were able to report their drop-out figures to us, all had patients who dropped out of the therapies for unknown reasons. How many of these patients could have been harmed by CBT or GET but found it easier to drop out than to report it? In addition, a number of clinics reported tailoring each patient’s treatment individually, and we do not know whether a patient would be counted as a dropout if they felt worse on GET and chose to stop it but continued to see the therapist as part of their individualised therapy.
Also, no clinic reported telling patients explicitly that they could be worse after their course of therapy than before. This raises doubts as to whether many clinics are even on the lookout for adverse side-effects to their therapies, and whether patients feel able to raise such concerns. Indeed one booklet on GET advised, “If GET is correctly undertaken it will not harm you.” Patients might take that to imply that if they are harmed by GET, it’s the patient’s fault for doing it incorrectly – making it less likely that a patient will report the harm.
Another possibility for clinics reporting zero harms is that patients have tried to report harms but that clinics haven’t recognised the harms as such and so haven’t recorded them. Only one clinic reported having guidance for staff on how to recognise harm. It was worrying to find one centre stating, in response to our question about numbers of patients harmed, “This is making an assumption that treatments we provide are harmful. If any treatment is contraindicated we would not provide it.” This seems to imply scepticism as to whether harm is even possible.
Several clinics reported warning patients about ‘setbacks’ or temporary worsening. But the fact that none mentioned warning patients about the possibility of being made worse after a course of CBT or GET raises the question of informed consent. If patients are to give properly informed consent to treatment, they surely need to be informed about the results of surveys showing deterioration after CBT and – especially – GET.
ME/CFS centres need to develop standardised methods for warning patients about harms, anticipating harms, preventing, and, where necessary, recording and remedying them. The clinics should stop rehabilitative therapies for any patient experiencing harm. The time seems to have come for a national system for reporting harms from rehabilitative treatments, similar to the UK’s Yellow Card system for drugs and medical devices.
CBT and GET and their variants are currently being reconsidered by NICE. We hope that our findings will feed into that decision-making process and that we have cast some light on what is going on in the specialist NHS ME/CFS centres.