On June 25th 2014 the Forward ME Group met with Prof Mark Baker, Director of the Centre for Clinical Practice at the National Institute for Health and Clinical Excellence (NICE).
From the minutes:
Professor Mark Baker, NICE
2.1 The Chairman [Countess of Mar] to guidelines in the NHS. In March 2012 a Library of Quality Standards Topics was established; it included a number of NICE guidelines but ME/CFS was not among them and he did not know why. It was not feasible to update or change guidelines not in the Library until at least 2017. The Library was now the responsibility of NHS England, not of the Department of Health.
2.2 Turning to the ME/CFS Guideline specifically, the Professor said that it did not meet our needs and it did not meet theirs (NICE’s) either. The pressure for guidance started in about 2002 when the then CMO, Sir Liam Donaldson, wanted the subject “put to bed” in the form of advice to doctors that ME/CFS was a real illness and what they should do about it.
It did serve a purpose because it was the only bit of guidance in the NHS on ME/CFS, but it was limited in its scope. It was designed to get patients seen and helped, but it assumed there were specialists who knew what to do – and there were not.
2.3 The Guideline had been reviewed twice, but not much change had been observed, and when it was last looked at in 2013 it was decided to put it on the static list. Subjects on the static list were still reviewed, but only every five years compared with every two years for those on the active list. If anything important were to come up in the way of evidence it could be taken off the static list.
Prof Baker said he sympathised with our position. The Guideline was not comprehensive guidance and it did not promote innovation. It referred to only “passive” interventions such as CBT and Graded Exercise. There was not much of an evidence base to go on, and in NICE it was evidence that drove guidance.
2.4 In summary, Professor Baker said:
- He sympathised with the position we were in with the Guideline
- The Guideline failed to address the real issues in ME/CFS
- It does not promote innovation
- It had a disappointing impact on specialist care and commissioning issues.
3. Questions 3.1 The Chairman referred to people being given an incorrect diagnosis of ME/CFSconditions. How could this be brought to the attention of GPs? Prof Baker said that the pendulum appeared to have swung from under-diagnosis to over-diagnosis, with some very serious conditions being misdiagnosed as ME/CFS.
The Chairman agreed and mentioned Addison’s Disease and Pituitary Tumour as examples of this misdiagnosis. Prof Baker listed several conditions for which some guidance was to be developed including medically unexplained symptoms and persistent pain (as in fibromyalgia).
3.2 The Chairman then turned to the provision in NICE that people with ME/CFS have the right to refuse or withdraw from any aspect of their care plan. Suppose Social Services wanted to take a child with ME into care. What force had the NICE Guideline in law? The Professor said that a judge had ruled that you can’t ignore NICE Guidance just because you don’t agree with it. You must have carried out a robust review of the case in question. This, he said, seems to give NICE Guidance rather more force than was originally intended. He would try to find the case reference for the Chairman.
3.3 Sue Waddle asked about NICE’s position on the ICD classification. Did they apply it to all cases? Prof Baker replied that they were not necessarily tied by the ICD. In fact they did not normally start their deliberations by saying “This is the definition of X”. Sue said that what many of us were seeking was guidance which set out the seriousness of the illness whilst still taking in the ICD provision. Prof Baker commented that whenever he read responses to any consultation on this subject his initial reaction was “We should stand this down”. But to take it away completely would probably do more harm than good. Christine Harrison added that during the development of the Guideline Tanya had done her best to have the WHO classification included to address the misunderstanding of ME and CFS.
3.4 Dr Charles Shepherd referred to the high number of patients who were found to be suffering from conditions other than the ME/CFS that had been originally diagnosed. There ought to be guidance which would alert doctors to the possible alternatives. He had brought an abstract of Prof Julia Newton’s paper which showed that 40% of supposedly ME patients referred to a specialist service were found to have other conditions. Other members supported that proposal.
3.5 Janice Kent asked if there was some way in which, without review, a passage could be put into the Guideline requiring all patients to be diagnosed by a specialist ME doctor. Prof Baker replied that you couldn’t “fiddle” with the Guideline!
Following on from this Sonya Chowdhury referred to a patient decision-making aid that had been developed for stroke/atrial fibrillation. Could we work together on something similar for ME/CFS? Prof Baker commented that the stroke/AF aid was the first of its kind produced by a new body – the NICE Implementation Collaborative. It was a possibility for ME/CFS.
Sonya said that AFME was prepared to put some resources into developing it as it would directly build on work they had already started on a guide for patients to use with GPs when they are diagnosed with ME or it is suspected. Prof Baker said he would look into the possibility. Anyone could develop a decision-making aid for patients and clinicians and they might develop a method of accrediting decision-making aids.
3.6 Christine Harrison referred to the list of possible symptoms in the NICE Guideline to consider ME/CFS which was being used erroneously as “criteria” for ME/CFS by some East of England SHAs which were surveyed in 2011, which was not appropriate. She asked whether NICE could put out a statement to that effect. Professor Baker said that he was unable to do that, but confirmed that there was no such thing as NICE criteria for ME/CFS.
Christine explained the work done by BRAME and other patient representatives in Norfolk and Suffolk. She asked Professor Baker for reassurance that, in all the work they had been doing, they had done nothing wrong in not following the NICE Guideline if it addressed a local need. He confirmed that this was correct and said that a guideline is basically a tool to help professionals and patients – a decision-making aid.
3.7 The Chairman asked Prof Baker if he would take on board what Sonya had suggested. Prof Baker agreed and said that we needed something to steer patients away from “dangerous neglect” and towards expert diagnosis and treatment. Dr Charles Shepherd and the Chairman asked who we might speak to about this at NHS England. Prof Baker suggested Martin McShane. Sonya Chowdhury said she was prepared to take this project forward. Janice Kent said we would need names other than charities to promote it. Prof Baker suggested the Royal College of General Practitioners.
3.8 The Chairman wondered whether we might approach the Chief Medical Officer. Janice Kent suggested Duncan Selbie at Public Health England. Prof Baker commented that the CMO retains a lot of clout. He was not sure what interest Public Health England might have, but we could try.
3.9 The Chairman thanked Professor Baker for being so helpful and candid.
