NICE Guideline review: Call for evidence on myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome, deadline 16th Oct 2019

They are also intentionally excluding criticism articles such as lists of harms, unless these are in survey forms which of course they are not - surveys are on if harm occurred not what type.

 

You can't send in individual patient testimonies (case studies, anecdotes, individual complaints, etc), but you could send in aggregate data (surveys, unpublished papers, published papers we might have missed).

Data doesn't have to be qualitative, though I know that's the example given. The Forward-ME/Oxford Brooke survey includes quantitative and qualitative data, for example, so I think both are fair game.

Anecdote is, 'I experienced this...' A survey would be, '58% of patients described their experiences as this...' or '83% of patients improved/worsened as a result of...' The latter two examples are more useful because it can't be dismissed as 'well that's one person's opinion'.

 

Not Healthwise Adam, Healthwatch.
Trafford
https://www.healthwatch.co.uk/news/...g-experiences-people-chronic-fatigue-syndrome

Lancashire
https://healthwatchlancashire.co.uk/wp-content/uploads/2014/06/REPORT_ME-CFS_June2017.pdf

 

Those are the ones. Thank you!

 

Monitoring
Showing Chalder Fatigue Scale "Fatigue Scale" and all others are inadequate, but not criticizing DPSQ (Leonard Jason's De Paul Symptom Questionnaire) which was not available then or the Hummingbirds' Foundation M.E. Ability and Severity Scale (unable to find any studies on that)

• The Measurement of Fatigue in Chronic Illness: A Systematic Review of Unidimensional and Multidimensional Fatigue Measures (2009) https://www.jpsmjournal.com/article/S0885-3924(08)00560-5/fulltext - states FS (Chalder Fatigue Scale) not sensitive enough to detect change over time
• Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review (2012) https://www.academia.edu/24509066/Q..._encephalomyelitis_CFS_ME_a_systematic_review - states "Evidence of ceiling effects was reported for 6/14 items of the ChalderFS following completion by a large group of CFS/ME patients [99].", and "Although the expected association was not defined, ahead-to-head comparison of the ChalderFS (index anddomain scores) and FSS following completion by a large patient group (n=166) reported very low correlations between the two measures, suggesting that they measure different aspects of fatigue [100]. The FSS had stronger correlations with variables reflecting CFS severity and the generic Short-Form 36-item Health Survey (SF-36) [101],leading the authors to suggest that the FSS provides a more comprehensive reflection of fatigue-related severity, symptomology and functional disability than the ChFS", also critical of HADS

• The Utility of Patient Reported Outcome Measures among Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (2017) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5336422/ - recommends De Paul Symptom Questionnaire
  

Exercise

• Exercise – induced changes in cerebrospinal fluid miRNAs in Gulf War Illness, Chronic Fatigue Syndrome and sedentary control subjects (2018) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5681566/ - "miR-let-7i-5p, miR-93-3p and miR-200a-5p were significantly diminished after exercise in START, STOPP and CFS, but not SC (Fig. 9). This was consistent with a cardinal finding in CFS and GWI: function may appear normal when rested, but will deteriorate after a physiological stressor"
• Exercise-induce hyperalgesia, complement system and elastase activation in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome–a secondary analysis of experimental comparative comparative studies, 2019 https://www.degruyter.com/view/j/sjpain.2019.19.issue-1/sjpain-2018-0075/sjpain-2018-0075.xml - immune and pain changes after exercise

Pain

• Endogenous pain modulation in response to exercise in patients with rheumatoid arthritis, patients with chronic fatigue syndrome and comorbid fibromyalgia, and healthy controls: a double‐blind randomized controlled trial. Pain Practice, 15(2), 98-106. https://www.ncbi.nlm.nih.gov/pubmed/24528544/ - exercise helps pain in RA but not CFS and may increase pain
• A randomized, placebo-controlled, double-blinded trial of duloxetine in the treatment of general fatigue in patients with chronic fatigue syndrome. (2015) https://www.ncbi.nlm.nih.gov/m/pubmed/25660434/ - Duloxetine helps pain and Cognitive function but not fatigue, this drug of licensed for nerve and muscle pain
• Chronic musculoskeletal pain in patients with the chronic fatigue syndrome: a systematic review. (2017) - https://www.ncbi.nlm.nih.gov/m/pubmed/16843021/ - concludes exercise causes pain
• Muscle injections with lidocaine improve resting fatigue and pain in patients with chronic fatigue syndrome 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499959/
• Exercise-induce hyperalgesia, complement system and elastase activation in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome–a secondary analysis of experimental comparative comparative studies, 2019 https://www.degruyter.com/view/j/sjpain.2019.19.issue-1/sjpain-2018-0075/sjpain-2018-0075.xml - immune and pain changes after exercise

Cognitive

• A randomized, placebo-controlled, double-blinded trial of duloxetine in the treatment of general fatigue in patients with chronic fatigue syndrome. (2015) https://www.ncbi.nlm.nih.gov/m/pubmed/25660434/ - Duloxetine helps pain and Cognitive function but not fatigue
• Multimodal and Simultaneous Assessments of Brain and Spinal Fluid Abnormalities in Chronic Fatigue Syndrome and the Effects of Psychiatric Comorbidty (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393352/ - "Thus, this study joins several prior others that found that the presence of psychiatric illness is not related to illness severity as reflected by illness course16,17, cognitive processing18, or physical function19. This result is very important because it indicates that neither the phenomenology of CFS nor its biology is driven by psychiatric diagnosis."

Fatigue

• Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome – A randomized, controlled, double-blind trial 2016 https://www.sciencedirect.com/science/article/pii/S0261561415001892
• Muscle injections with lidocaine improve resting fatigue and pain in patients with chronic fatigue syndrome 2017 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5499959/

Psychological

• Randomised, double-blind, placebo-controlled study of fluoxetine in chronic fatigue syndrome. Lancet Lond Engl. 1996 https://www.sciencedirect.com/science/article/pii/S0140673696913458 - fluoxetine doesn't help, depression in CFS may have different mechanisms to depression in other illnesses
• Multimodal and Simultaneous Assessments of Brain and Spinal Fluid Abnormalities in Chronic Fatigue Syndrome and the Effects of Psychiatric Comorbidty (2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5393352/ - "Thus, this study joins several prior others that found that the presence of psychiatric illness is not related to illness severity as reflected by illness course16,17, cognitive processing18, or physical function19. This result is very important because it indicates that neither the phenomenology of CFS nor its biology is driven by psychiatric diagnosis."

Treatments

• Current therapeutic strategies for myalgic encephalomyelitis/chronic fatigue syndrome: results of an online survey. Deftereos, Vernon, Persidis, 2016 https://www.tandfonline.com/doi/abs/10.1080/21641846.2015.1126025

 

You don’t need to be a registered stakeholder to make submission so I’d encourage people to simply fill in the form and submit what you think might be relevant.

 

Given the rollout of the IAPT Medically Unexplained Symtoms 'management services', with the CFS category using the Chaldler Fatigue Scale and giving all these patients a 'somatising' ICD code, if anyone is able (unfortunately beyond me with my current circumstances) it would be good to submit any suitable 'counter' evidence on these issues.

It's really worrying to the extent I now feel very negative about the whole NICE guideline review. I doubt that NICE's evidence review experts would be looking at this agenda critically.

See the below thread for the relevant IAPT MUS discussion:

https://www.s4me.info/threads/mus-s...er-mus-related-issues.8318/page-8#post-196254

 

It doesn't matter how the evidence review experts see it. The decision rests with the committee. Don't be too disheartened.

 

It's the insiduous way that IAPT is taking over that I worry about. It still seems to be expanding 'under the radar' as far as I can tell. It's only being on this forum that enabled me to see what's happening in this area. Where are all the ME charities on this? Not only is it GET type CBT, but also the categorising of ME/CFS patients with an offical ICD somatising code - really manipulative and sinister stuff. How can this be medically ethical - patients will be told they are being referred for mental health support (for anxiety and/or depression), whilst in reality they will be slapped with this somatising code on their medical records.

It seems like the IAPT MUS agenda began to be developed immediately after the original 2007 CFS/ME NICE guideline was published. So it's been over 10 years in the making.

I do recognise all the great work that you and the other 'lay' members on the NICE group are doing. But I still feel it's a David and Golith situation. There is alot of politics/economics involved in the BPS movement in the NHS, that go far beyond the ME/CFS patient community. Prehaps the best we can do is try to protect ourselves from the worst of it and hope other patient communities start to see what is happening and respond accordingly.

 

That's the problem I have with this request. There's nothing to compare outside of the CBT/GET paradigm or its even more dubious offshoots. Though FINE did make it clear that the very model used by the NHS, "rousing reassurance" is a complete bust.

Although to be fair, the conclusions from PACE that "no differences in outcome between trial arms at long-term follow-up" make it clear that they are worthless as treatments. Same with all the prior trials, as you mention with FINE and especially the emphasis, including PACE, that even the slight short-term questionnaire bias, after spending months trying to influence the responses on those questionnaires, is not validated as applying to ME (much more participants who did not fit the diagnostic criteria than the few who could be argued may have had a small subjective improvement) and specifically does not apply to anyone but the mildest cases. Disease severity spectrum is not taken into account.

But still, only research from the PACE gang and their like-minded colleagues ever bothered to compare anything.

Except the Rituximab trial, of course, which found a comparable subjective "benefit" than PACE did, making it clear that they are placebo responses on self-reported outcomes and therefore not even remotely close to be reliable.

 

Would the recent paper showing there is no outcome monitoring in the fatigue clinics be relevant?

Technically it can be argued that it's comparing the current services with nothing and showing there is no way to determine which is better since there is explicitly no outcome monitoring. The health department replied many times that monitoring is the responsibility of the clinics, which they do not bother with. It shows there is no interest in practice to compare the effectiveness of those services and that it all essentially amounts to exactly the same as nothing.

Because after 12 years, the burden of evidence is on the current guidelines to show they are better than nothing, as is the case in most countries. The money that goes into those services would be put to much better use in research and genuine expert services, right now evidence suggests it has been a massive waste since no quantifiable improvements of any kind can be shown.

As they stand, there is no way to argue that the psychosocial services used in practice deliver anything different than nothing at all, which should kind of count as a comparison, even if it's the fact that there isn't any, a major problem on pretty much every useful metric.

 

IMO, older and current biomedical studies fitting the requested categories would all potentially be useful. Well run older studies may show, if the reader cares to see, that the organic nature of ME has been deliberately ignored for decades.

 

I anticipate that this may be used to close the 'specialist CFS/ME' services and replace them with the IAPT MUS-CFS ones, since every CCG must now commission these (whereas many do not even have any specialist 'CFS/ME' services) and the IAPT model has been built on 'monitoring outcomes'. I know we know that these 'outcomes' are manipulated and clinically worthless, but they are still very much beefed up and promoted within the NHS frameworks.

This is one of the main reasons I am so concerned with the IAPT agenda and rollout. It will be a case of jumping out of the pan into the fire.

 

Thank you. I can't say more at this stage but I hope we can do everyone proud!

 

Remember that David won. And Adam does a quite good David impression.

 

Sorry, my Braincell is not up to scratch at present, but @Andy @adambeyoncelowe , would some/any/all papers written by Cure M.E. be suitable to add to the SfME submission to NICE?

https://cureme.lshtm.ac.uk/about-us/publications/

 

Yes. I suspect the LSHTM team will be on that already. But again, it doesn't hurt to send things in twice.

 

https://twitter.com/user/status/1167795573161959424


https://twitter.com/user/status/1167847005634408449

https://twitter.com/user/status/1167847253144428544

 

Evidence the IOM used, for example, the OI and sleep evidence would be helpful. The committee looked at some 9,000 studies - impossible for one pwME to list - maybe the NICE committee should just receive a copy of the full report:https://www.nap.edu/read/19012/chapter/1#xxi

IOM/NAM website: http://www.nationalacademies.org/hmd/Reports/2015/ME-CFS.aspx

However, I don't know if they would accept the report in it's format, or want things presented differently.

The OI work by Dr. Peter Rowe would fit in here - and he was one of the panel who presented the IOM report.


This seems like an early deadline for evidence, since the decision isn't out until October 2020. Is this the only deadline? Or will more privileged personages have a later date to work to?

I noted Dr. David Systrom's phase 3 trial plans completion on October 15:https://www.clinicaltrials.gov/ct2/show/NCT03674541?term=david+systrom&rank=1

 

My middle name is actually David, too!