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

Cardiovascular:

"Abnormal impedance cardiography predicts symptom severity in chronic fatigue syndrome":

Abstract:
https://www.ncbi.nlm.nih.gov/pubmed/12920435


Full article:
https://pdfs.semanticscholar.org/45f6/9030ef424630a237ff36c3db69994e6c28de.pdf

This study was cited, page 18 of the Canadian Consensus Criteria Overview (CCC) - https://www.mefmaction.com/images/stories/Overviews/ME-Overview.pdf:



Exercise capacity:

"Exercise Capacity in Chronic Fatigue Syndrome":
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/485564



School absence:

"Long-Term Sickness Absence Due to ME/CFS in UK Schools":
https://www.tandfonline.com/doi/abs/10.1300/J092v03n02_04

ETA: all above studies cited in the CCC Overview.

 

I believe somewhat formalised surveys (like the Oxford Brookes/Forward-ME one) probably count in this instance. It doesn't have to be RCTs.

What NICE presumably doesn't want is, say, the maker of a medical device (or whatever) submitting customer testimonials about how amazing their device is.

 

Unfortunately they have the requisite rubber stamping.

 

This is particularly problematic for children.

 

@Jonathan Edwards it seems they are trying to forcibly limit their "evidence" to psychosocial trials, what can we do about this?

 

What about that paper that Graham McPhee and others published recently.

 

Significant evidence from WorkWell Foundation and Leonard Jason on many of these

 

Common Data Elements
it would be a great help for some to go through what's most relevant here
https://www.commondataelements.ninds.nih.gov/Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Please, please please can people look for what's there on very severe ME - what would help Whitney? What would avoid harm?

Mortality

• Mentions of postviral fatigue syndrome (benign myalgic encephalomyelitis), deaths registered in England and Wales, 2001 to 2016 Mentions of postviral fatigue syndrome (benign myalgic encephalomyelitis), deaths registered in England and Wales, 2001 to 2016 https://www.ons.gov.uk/peoplepopula...isdeathsregisteredinenglandandwales2001to2016
• O’Donovan D, Harrower T, Cader S, Findley L, Shepherd C, Chaudhuri A: Pathology of Chronic Fatigue Syndrome: Pilot Study of four autopsy cases. In International Science Symposium 3-4 – Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS). Edited by. Queensland, Australia https://www.meassociation.org.uk/wp...Chronic-Fatigue-Syndrome-Abstract-DGOD-v2.doc

Assessing symptoms

• A definition-based analysis of symptoms in a large cohort of patients with chronic fatigue syndrome, P. De Becker, N. McGregor, and K. De Meirleir. Journal of Internal Medicine 2001;250:234-240.) - Summary in Canadian Consensus Criteria Appendix 2 https://onlinelibrary.wiley.com/doi/pdf/10.1046/j.1365-2796.2001.00890.x
• Patient perceptions of post exertional malaise (2018) https://www.researchgate.net/profil...nt-perceptions-of-post-exertional-malaise.pdf
• Defining the prevalence and symptom burden of those with self-reported severe chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a two-phase community pilot study in the North East of England. 2018 https://bmjopen.bmj.com/content/bmjopen/8/9/e020775.full.pdf

Unpublished trials
* Cortene CT38
https://clinicaltrials.gov/ct2/show/NCT03613129 - trial registered (blog https://www.healthrising.org/blog/2...new-drug-for-chronic-fatigue-syndrome-me-cfs/) * needs results *

Experiences survey

• The ME/CFS and Fibromyalgia “What Would You Have Done Differently” Survey - Health Rising (attached - needs zooming in and cropping, scroll down, 1000+ responses) https://www.healthrising.org/blog/2...tor-treatment-coping-done-differently-survey/

Quality of life - Stigma

• Stigma and the term chronic fatigue syndrome: Results of surveys on changing the name (2004) http://www.academia.edu/download/41...tigue_syndrome_Surv20160120-32101-1ohsghz.pdf
• Assessing attitudes toward new names for chronic fatigue syndrome (2001) https://www.researchgate.net/profil...e_Syndrome/links/0046351acfd6e6fa4e000000.pdf

Psychological status / exercise

• Chronic fatigue syndrome: lack of association between pain-related fear of movement and exercise capacity and disability 2004 https://www.ncbi.nlm.nih.gov/m/pubmed/15283620/?i=10&from=/19848558/related

Methods of monitoring and/or reviewing people with a diagnosis of ME/CFS

• The Utility of Patient Reported Outcome Measures among Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, 2016 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5336422/
• NINDS CDE Project Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Fatigue Subgroup https://www.commondataelements.nind.../files/Doc/MECFS/Fatigue_Subgroup_Summary.pdf
• Hummingbirds' Foundation M.E. Ability and Severity Scale - please push strongly for this since hardly anything captures severe ME vs very severe ME - especially if deteriorating https://www.hfme.org/themeabilityscale.htm

Physical functioning

• Norwegian severe ME survey - charts including profound ME
• Paralysis, a qualitative study of people with Severe Myalgic Encephalomyelitis (2013) - 46 severe ME patients making this an unusually large severe ME survey https://carersfight.blogspot.com/2013/08/paralysis-qualitative-study-of-people.html?m=1
• Defining the prevalence and symptom burden of those with self-reported severe chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a two-phase community pilot study in the North East of England. 2018 https://bmjopen.bmj.com/content/bmjopen/8/9/e020775.full.pdf
• Hummingbirds' Foundation M.E. Ability and Severity Scale - please push strongly for this since hardly anything captures severe ME vs very severe ME - especially if deteriorating https://www.hfme.org/themeabilityscale.htm

Care levels

• Norwegian severe ME survey - charts including profound ME

Patient experiences / psychological / protection from harm

• KNOWLEDGE IN THE HOPE OF PROTECTING M.E. SUFFERERS FROM UNNECESSARY SECTIONING - Preventing the unnecessary forced mental health sectioning of severely ill patients - The Grace Charity for M.E. with 25% ME Group - help prevent deaths like Sophia Mirza's https://25megroup.org/download/2527/

Equality / Disability

• Yet another insanely short deadline from NICE, who could have given us these questions last month and keep ignoring the fact we are ill
• NICE 2007 guidelines - zero requirements for CFS out-patient clinics to be wheelchair accessible (some are not)
• NICE 2007 guidelines - any CFS out-patient service can deny treatment purely because a person is housebound
• NICE 2007 guidelines - CFS out-patient services are NOT required to by led by doctors or even to employ them. Some have none. (s4me - message if you want an example)
• Social support needs for equity in health and social care: a thematic analysis of experiences of people with chronic fatigue syndrome/myalgic encephalomyelitis https://equityhealthj.biomedcentral.com/articles/10.1186/1475-9276-10-46

Carers

• Caring for People with Severe Myalgic Encephalomyelitis: An Interpretative Phenomenological Analysis of Parents’ Experiences 2016 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4675701/

Psychological

• Sexual abuse, physical abuse, chronic fatigue, and chronic fatigue syndrome: a community-based study. https://www.ncbi.nlm.nih.gov/m/pubmed/11708672/
• Childhood maltreatment and the response to cognitive behavior therapy for chronic fatigue syndrome. https://www.ncbi.nlm.nih.gov/m/pubmed/22118383/
• Rethinking childhood adversity in chronic fatigue syndrome", Fatigue: Biomedicine, Health & Behavior, 2017 doi:10.1080/21641846.2018.1384095

 

Re: BELIEFS

Any interventions that specifically aim to target beliefs about the illness are totally unacceptable and would not be tolerated for any other illness.

This has been one of the most damaging things, and has led to persistent gaslighting by professionals who attempt to bully patients into accepting ridiculous beliefs, for example the "fear of exercise" belief we are told we have.

It is difficult to find much, if anything, on the harmful impact of this.

 

This isn't true. As mentioned above, the Forward-ME/Oxford Brookes survey is specifically the kind of thing they're looking for here.

You can send in any trial, including biomedical ones, which you think address the areas NICE wants further evidence for. You probably can't send in individual anecdotes.

 

Seems to me that NICE are likely to see a lot of duplication as we don't know what papers they have looked at already. I assume that they won't, but it would help all concerned if they revealed what papers have been included already.

 

They have been incredibly thorough and I've been sending them studies too. But I would veer on the side of caution and send again, in any case. Duplication isn't really a problem. It's better that they have to ignore stuff they've already seen than missing out on something important, but that's just my view.

 

I should also add that the committee can also raise things that fall through the cracks (e.g., anecdote, polls, etc) if they're relevant, so keep tagging me in things on here.

 

http://nandsme.blogspot.com/p/patient-survey.html

Survey



Evaluated by leading ME researchers and doctors;
Dr Pheby, Dr. Derek F. H. Pheby, BSc, MB, BS, LLM, MPhil, FFPH, is a Visiting Professor of Epidemiology, Buckinghamshire New University, Wycombe, England, United Kingdom. He served as the Project Coordinator of the National ME Observatory, a collaborative project involving three universities, aiming to fill gaps in research knowledge.[1] He was a former member of the Chief Medical Officer’s Working Group on CFS/ME and former trustee of Action for ME.[

Dr. Nacul and Lacerda from LSHTM BioBank and

Professor Bernie Carter
Professor of Children’s Nursing
PhD, PGCE, PGCE, BSc, RSCN, SRN

Faculty of Health and Social Care
H217a, FOHSC Building
bernie.carter@edgehill.ac.uk
01695 657771

2009 Patient Survey Report

This report is lengthy, but it does justice to the efforts that you made in completing the surveys. This couldn't have happened without you!

See the full survey report [pdf]

A results summary can be found on page 5 with key messages on page 6 and recommendations on page 7. Page 9 onwards looks at the results in detail and features many comments from individual respondents.

Summary
NHS services for people with ME and CFS in Norfolk and Suffolk are being re-designed. NHS Gt Yarmouth & Waveney had not carried out any patient satisfaction surveys regarding the current ME and CFS Service. Patient Representatives wanted to find out in detail what people think of the current ME and CFS Service and what they want and don’t want from the new service. We therefore launched the 2009 Patient Survey in January 2009. The NHS was invited to participate, but declined.

Patient and Carer Representatives would like to thank everyone who participated in our 2009 Patient Survey. We would also like to thank all local ME and CFS support groups for taking part in this initiative.

Great Yarmouth and Waveney NHS wanted to provide a service based on the NICE Guidelines. This is despite the fact that the Guidelines have been condemned as ‘unfit for purpose’ by virtually all patient groups and charities. The Norfolk and Suffolk ME and CFS Service 2009 Patient Survey provides detailed evidence that:

• The current level of service provision is inadequate
• A service based on the NICE Guidelines will not meet the needs of people with ME and CFS in Norfolk and Suffolk

The survey has demonstrated that respondents want:

• A biomedical consultant led service
• A team of healthcare professionals who have the skills and expertise to care for people of all ages, of all levels of severity and complexity
• Ongoing care for all with reviews between 1 month and 6 months depending on severity and need
• Treatment and management to consist of:
  • Self management, e.g. pacing, activity management
  • Pharmacological treatment
• Clinics closer to home, the option to self refer and a prescribing service
• Support for patients and carers including liaison with employers, education services, voluntary services, DWP and JCP
• Information to facilitate informed choice regarding treatment options
• Access to aids and equipment
• Onward referral to other services e.g. pain clinic
• GP training to ensure prompt recognition of ME and CFS and prompt referral
• Support for people with ME and CFS

Respondents found the most helpful and least harmful interventions were:

• Pacing, rest, relaxation and meditation
• Medication for symptoms, massage and dietary changes are also worth considering

Respondents found the least helpful and most harmful interventions were:

• Graded Exercise Therapy
• Cognitive Behavioural Therapy

Respondents were significantly more satisfied with the service provided by Occupational/Physiotherapists than with GP’s with a Special Interest in ME/CFS.

Click here to view the full 2009 Patient Survey [pdf]

 

http://nandsme.blogspot.com/p/patient-survey.html

All Party Parliamentary Group on ME
In March 2010 part of our survey was included in the All-Party Parliamentary Group on ME 'Inquiry into NHS Service Provision for ME/CFS' (p6).

The APPG commented on page 8 of their report:
'While the APPG recognises that it is impossible for all treatments in any disease area to be side-effect free, if CBT and GET were licensed medication, this number of patients claiming devastating side effects would undoubtedly have led to a review by NICE. The same standards should apply to CBT and GET.' It is vital to provide information regarding potential benefits and adverse effects of interventions so that patients can make informed choices regarding their care.


ME Association Survey - May 2010
A total of 3,494 people answered the questions on-line. Another 723 completed the paper questionnaire. The results of the survey 'Managing my ME' can be found here


Action for ME Survey - May 2008
A survey of over 2,760 people with ME was carried out focusing on their health and welfare. To read the report please click here


Survey - People with Severe ME/CFS
In 2007 a survey was undertaken in conjunction with the 25% Group to gather the views and experiences of those in our area who are severely affected by ME/CFS. For a copy of the report please click here

 

I hope that NICE are being made aware that the CFQ
(used as key measurement in just about all bPS research except Crawleys research on children, where it was found to be 'not applicable', and is currently being 'reviewed' in Bristol)
is not fit for purpose particularly in relation to ME.
https://www.s4me.info/threads/s4me-...-with-the-chalder-fatigue-questionnaire.2065/

 

Systematic reviews are allowed, and other comparative studies. The FINE trial's nil outcome can be used.

It makes no sense to ask for trials/reviews about management strategies during assessment, or monitoring / reviewing a diagnosis - how can either be a trial, review or comparative study?

How can you have a trial / comparative study about monitoring pain or PEM?

I don't really understand what they want.

 

These are useful. Do send them in officially so there's a record.

 

Should especially include the infamous "we prefer" supposed rebuttal by MS.

I appreciate @dave30th's endeavours would fall outside the scope of what is allowed for NICE evaluation, but there are a hell of a lot of good hard facts in there, showing how unscientific the PACE scientists have been. Could these facts be distilled out in some way to provide something usable with NICE?

Even the "we prefer" (supposed) rebuttal is solidly factual ... it is an unequivocal written statement by a PACE author which clearly contravenes all well accepted standards of scientific trials methodology, and on its own deeply undermines their integrity as scientists, and the integrity of their published PACE results.

 

You could study which tools are most useful to measure a symptom or not, and how often symptoms change or evolve to suggest frequency of review. Basically, the question is: when should we review patients, how often, and by which measures?

As for initial assessment: they're looking for evidence of early interventions and what they might look like, how to prevent delayed interventions, warning signs around future severity, etc. In other words: how do we best help people in the early days of their illness, and avoid delays in diagnosis or treatment?

The bit about patient responses to treatments could include improvement/worsening, suitability, provision (or lack of) and patient preference. It could also relate to general quality of service delivery and strengths/failures of existing clinics. For example, the Trafford Healthwatch report on ME treatment provision in Manchester and the Suffolk and Norfolk survey above would probably count.

There may be more systems and reports like those out there, done on a local, regional or national level, which weren't published scientific papers but which could be instructive in their own way. Now is the time to collate them. Local groups probably have a wealth of info on their local areas which could contribute to a fuller picture of what's going on around the country.

These are all really important questions; they're just written in bureaucrat speak.

Edited: Wrote Healthwise, but meant Healthwatch.