October 25, 2018
Our updated comment can be found at the bottom of the article.
The final version of the National Institute for Clinical Excellence (NICE)’s scope for its revised guideline on M.E./CFS was published on Tuesday 16 October, along with consultation comments and committee appointments. After reviewing the documents, we are pleased to see that NICE has addressed a number of the concerns raised by Action for M.E. during the consultation in July. This includes highlighting the fluctuating nature of M.E./CFS, and important information about post-exertional malaise.
Action for M.E.’s view is that the published scope offers a robust foundation on which the guideline can be developed.
In reviewing the evidence on treatments cognitive behaviour therapy (CBT) and graded exercise therapy (GET) it is vital that NICE listen to patient voices and experiences. Key evidence for these approaches include the PACE trial and Cochrane review. Serious concerns about the PACE trial are well documented, with repeated questions raised about its methodology and the reliability of its results, while the Cochrane review journal recently stated its intention to temporarily withdraw its review of evidence of GET and CBT.
(Since our article on the NICE guideline scope and committee member appointments, Cochrane has decided not to withdraw a review that claims exercise therapy is effective for M.E. and CFS. This is disappointing as 40 academics and clinicians had signed a letter in support of their original decision to withdraw. We will await the author’s commitment to respond to questions concerning the methodology of the review and the studies it surveys with interest and will post an update at that time.
M.E. Action's article discusses this in more detail.)
To provide a true and accurate picture of how people with M.E. have been impacted by these treatments, the guideline committee must review all relevant evidence, most essentially the experiences of people with M.E. Having highlighted this in our response to NICE’s consultation on its draft scope, we are pleased to see NICE set out its intention to “review the published evidence on patient experience and conduct a call for evidence so that harms are identified and taken into account by the committee.”
Action for M.E. is committed to supporting people with M.E. to respond to this call for evidence as effectively as they can, and we will continue to share updates online and in our membership magazine, InterAction.
NICE has made two rounds of announcements regarding appointments to the guideline development committee, chaired by Dr Peter Barry, Consultant Paediatric Intensivist, University Hospitals of Leicester.
The ability of individual members to acknowledge their own bias, and critically evaluate the evidence presented to them – especially patient experience – will be essential.
We are particularly encouraged to see the appointment of five lay members – that is, people with lived experience of M.E. or “experts by experience,” as the committee’s Vice Chair, Baroness Illora Finlay, has suggested they be called. Usually, guideline committees have two lay members at the most.
The remaining professionals bring a range of clinical and research experience to the table. We are particularly pleased to see the inclusion of Dr Luis Nacul, part of the UK’s M.E./CFS biobank team – you can watch a recording of his presentation on this essential biomedical research resource from last month’s UK CFS/M.E. Research Collaborative conference.
Thank you for your comments. Our Head of Communications and Engagement, Clare Ogden, says: “I understand the concerns expressed here – and absolutely share them – about the urgent need for the guideline development committee to produce a guideline shaped by the experiences of people with M.E., one that offers unmistakable clarity about the potential harm caused by behavioural treatments for M.E.
“As we made clear in our response to the NICE guideline scope consultation, Action for M.E. would not accept recommendations of any approach based on the deconditioning hypothesis, the notion of false illness beliefs, or in which patients’ legitimate concerns about the consequences of exercise are dismissed or ignored.
“So far, the Chair and/or Vice Chair have recruited ten professional committee members, and five lay members (ie. people with lived experience of M.E.). Clearly there is some anger about the majority of the professional appointments, and a lack of trust (which is entirely unsurprising given the lack of progress in the field) in the process, and specifically in some of these individuals.
“While entirely understandable, given issues with the PACE trial and the unhelpful responses from scientists involved in, I do not think it is realistic to accurately judge anyone’s commitment to upholding the Nolan principles (to which all committee members are required to adhere) based solely on selected information found online, anecdotal accounts, and their apparent working relationships with other professionals.
“Instead, I think it would be helpful to understand more about the current views and recent experiences of every committee appointment, and their relationship with people living with M.E. My team and I will be contacting them to ask if they would be willing to share this with us – and you, via our website and social media channels.”
“I also want to make it very clear to the five lay members of the Committee – Saran Bonser, Sally Burch, Nicola Kidby, Adam Lowe and Dorinda Jack – that we believe your voices, and your experience, to be a crucial and powerful part of this review. Having attended the two NICE workshops on the guideline so far, and having been in touch with the technical team to share feedback from people with M.E. about the recruitment process, I believe the committee’s Chair and Vice Chair are sincere in their determination to produce a guideline that is fit for purpose, and patient-led.”