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

Andy

Andy

Senior Member (Voting rights)
Just received the following email

Dear registered stakeholder,

RE: Call for evidence on myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome

We need more information to help us develop this NICE guideline.

We invite registered stakeholders, and other individuals and organisations with an interest to send any relevant published or unpublished information. Details of the information we need and how to submit this are on the guideline web page.

Please send the information by 5pm on Friday 4th October 2019.

We look forward to receiving this information and thank you in advance for your help.
​
Make your suggestions below.
 
From the linked website

What we need

We need evidence from the areas listed below for the guideline we are developing on Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome:

1. Studies that evaluate:
  • Management strategies that are adopted while someone is being assessed for a diagnosis of ME/CFS.
  • Methods of monitoring and/or reviewing people with a diagnosis of ME/CFS
We are looking for trials that compare different strategies or different methods of monitoring and review. Systematic reviews, randomised controlled trials, non- randomised trials that are prospective or retrospective cohort studies will be considered for inclusion in the guideline.

We would like studies that report measurable outcomes on:
  • Mortality
  • Quality of life
  • Fatigue /fatiguability
  • Physical functioning
  • Cognitive function
  • Psychological status
  • Pain
  • Sleep quality
  • Treatment-related adverse effects
  • Activity levels
  • Return to school or work
  • Exercise performance measures.
  • Care needs
  • Impact on families and carers
We cannot accept non comparative studies, promotional material, non-evidence-based assertions of effectiveness or opinion pieces.

2. Evidence on the experience of people who have had interventions for ME/CFS.

We are looking for evidence that explores and evaluates people’s experience of interventions for ME/CFS. Qualitative studies evaluating focus groups and interviews and surveys will be considered for inclusion in the guideline.

We cannot accept case series, case studies, individual accounts of experience, promotional material, non-evidence-based assertions of effectiveness or opinion pieces.

We are particularly interested in information promoting equality of opportunity relating to age, disability, gender, gender identity, ethnicity, religion and belief, sexual orientation or socio-economic status.
 
Is it useful to send them this study about albuterol vs placebo in asthma to illustrate that studies that do not properly control for bias in self-reported outcomes are at risk of producing garbage quality data? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3154208/

This is a double blind randomized crossover study with repeated doses of various interventions over time done to better understand placebo responses. I think it is very relevant to ME/CFS because CBT/GET studies as a rule fail to be properly controlled, and show a similar discrepancy between self-reported and objective outcomes. It is possible (and I think probable) that all or most of the positive effects of CBT/GET are merely reflecting bias rather than improvement in health. Until this is adressed it is not possible to write accurate guidelines.
 
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Andy said:
  • Quality of life
  • Fatigue /fatiguability
  • Physical functioning
  • Cognitive function
  • Psychological status
  • Pain
  • Sleep quality
  • Treatment-related adverse effects
  • Activity levels
  • Return to school or work
  • Exercise performance measures.
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we are totally screwed then because just about the only RCTs/papers on this are done by bPS researchers.
Is there any way to ensure that 'evidence' of this type is accompanied by any papers (eg by Mark Vink) that rebutt the findings/expose the flawed methodology?

(The recent research on the clinics not actually recording Treatment-related adverse effects or rather not seeing the need to as the treatments are judged to be unharmful) TK,BH,GM et al
 
Sly Saint said:
Is there any way to ensure that 'evidence' of this type is accompanied by any papers (eg by Mark Vink) that rebutt the findings/expose the flawed methodology?
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Should also include the full "rebuttal chain" to clarify and expose how BPS researchers' alleged rebuttals are nothing of the sort; far from being watertight, actually leak like sieves. Also avoid them whinging their counter-rebuttals not being presented ... actually they do us a favour.
 
Sly Saint said:
we are totally screwed then because just about the only RCTs/papers on this are done by bPS researchers.
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My thoughts exactly

Is there any way to ensure that 'evidence' of this type is accompanied by any papers (eg by Mark Vink) that rebutt the findings/expose the flawed methodology?
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Another might be the AHRQ 2016 evidence review which demonstrated that the evidence of effect of CBT and GET was based on Oxford definition studies. I appreciate that people see the study methods as the bigger problem but its another angle to combat the inherent bias.
Its helped in the US to highlight the problem with basing conclusions for ME on people who do not have ME. This point was also made in the Gibson Inquiry.

AHRQ also found evidence of harms from GET and pointed out that studies requiring PEM were "blatantly missing" - might be worth citing that as well.

Another is "The cognitive behavioural model’ of chronic fatigue syndrome: Critique of a flawed model" by Geraghty et al is also useful (link) -covers the study flaws, harms, etc but also the invalidity for ME of the disease model behind CBT and GET and the failure of the model to account for evidence of biological pathology
 
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InitialConditions said:
Have S4ME submitted a response to such a request before? And if so are these documents available to view?
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From our annual report
Science For ME said:
NIH/CDC Common Data Elements review

We submitted member written comments on measures for PEM here and the problems with the Chalder fatigue questionnaire here.

PACE

Members wrote a summary of issues with the PACE trial that has proved popular and has been submitted to the Scottish Parliament here.

NICE

As the NICE review was announced we registered S4ME as a stakeholder. We were represented at the initial stakeholder meeting by Jonathan Edwards and the scoping meeting by Jonathan and MEMarge.
We submitted a summary of issues with the scoping document to NICE based on comments and feedback from members here.
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InitialConditions said:
I assume S4ME make a submission to these types of requests. Can someone briefly outline how this works?
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We have no written procedure but broadly based on those we have done previously, we'd collect ideas in this thread, a group formed of those members who want to be involved in the writing process would be given access to a private area of the forum in order to write a submission without interruption, once that submission is finalised it is presented to the forum members who would then vote on whether it should be sent as an official S4ME submission or not.
 
strategist said:
Is it useful to send them this study about albuterol vs placebo in asthma to illustrate that studies that do not properly control for bias in self-reported outcomes are at risk of producing garbage quality data? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3154208/
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Yes!
RESULTS
Among the 39 patients who completed the study, albuterol resulted in a 20% increase in FEV1, as compared with approximately 7% with each of the other three interventions (P<0.001). However, patients’ reports of improvement after the intervention did not differ significantly for the albuterol inhaler (50% improvement), placebo inhaler (45%), or sham acupuncture (46%), but the subjective improvement with all three of these interventions was significantly greater than that with the no-intervention control (21%) (P<0.001).
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Firstly to avoid confusion, note their statement "as compared with approximately 7% with each of the other three interventions" actually means "other three arms", including the non-intervention arm.

The objective findings showed negligible FEV1 differences between sham interventions and no interventions, 0.2% and 0.4%.

Change in FEV1 for the active intervention, compared to control, was 13%.

It's clear here that a small (but inadequate) objective change of around 7% did occur even with no intervention at all. Maybe this suggests there is just something about trial conditions that fosters this anyway? Possibly motivation to just try that tiny bit harder, maybe even egged on a bit more by therapists at the end compared to the start? Maybe more practised at doing the measurement procedure? Maybe other trial environmental things? If so, then the very minor 6mwt changes in the GET arm of PACE were swallowed up in the noise of any such effect, and in the light of this asthma trial could be argued even less significant than their already known insignificance.

Yet all participants receiving an intervention perceived a 50% improvement thereabouts, compared to 21% with no intervention. Even the no-intervention group's perception was 3x their objective outcome. And the sham intervention's perception was 7x.

The big problem convincing people about PACE's unblinded-interventions-with-subjective-outcomes, is that many still believe it is a wholly subjective illness, and so only subjective outcomes are of any consequence. And I think they therefore believe that if there do happen to also be any objective symptoms, then the subjective outcomes will be a good indication anyway. Clearly demonstrating the huge disparity between subjective and objective outcomes, but for a disease where the objective indications are very well understood and accepted, just might help break that Catch-22.

The findings of this asthma study seriously reinforces what people have been saying (@Jonathan Edwards probably being the first) that the PACE findings are quite simply uninterpretable, and thereby valueless.
 
Measuring PEM:

1) Workwell Foundation:

About Workwell:
https://workwellfoundation.org


Publications:
http://workwellfoundation.org/resources/#publications


Research and Latest News:
https://workwellfoundation.org/research-latest-news/


Workwell Foundation letter to health professionals:
http://workwellfoundation.org/wp-content/uploads/2019/07/MECFS-GET-Letter-to-Health-Care-Providers-v4-30-2.pdf



2) Dr. Betsy Keller:
"Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO2peak indicates functional impairment"
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4004422/


"Cardiopulmonary Exercise Test Methodology for Assessing Exertion Intolerance in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome"
https://www.frontiersin.org/articles/10.3389/fped.2018.00242/full

From this article:

"Background

"A 2-day cardiopulmonary exercise test methodology (2-day CPET) was cited by the Institute of Medicine (IOM) (1) as a potentially useful tool to aid in the diagnosis and assessment of functional capacity in patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The IOM report concluded that ME/CFS is a neuroimmune pathology that affects multiple systems and contributes to exertion intolerance or an inability to recover normally following physical, cognitive or emotional exertion (1, 2). The IOM determined that “ME/CFS patients often have a level of fatigue that is more profound, more devastating, and longer lasting than that observed in patients with other fatiguing disorders” (1). The fatigue in ME/CFS differs from that experienced by controls and is unlike the fatigue associated with deconditioning. It is often described as “flu-like” and frequently includes “brain fog” or cognitive difficulties and other symptoms. This abnormal response to exertion is a hallmark symptom of ME/CFS referred to as post-exertional malaise (PEM). PEM is among the primary debilitating symptoms of ME/CFS, as well as fatigue-related impairment lasting more than 6 months, unrefreshing sleep, and usually cognitive impairment (brain fog) and/or dysautonomia. Muscle and/or joint pain often accompany these other symptoms, any of which could force a person with ME/CFS to stop work, avoid physical activity and, consequently, further reduce functional ability." (emphasis mine)


3) Vermeulen et al.:

Patients with chronic fatigue syndrome performed worse than controls in a controlled repeated exercise study despite a normal oxidative phosphorylation capacity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2964609/


4) MEpedia on 2 day CPET:

https://www.me-pedia.org/wiki/Two-day_cardiopulmonary_exercise_test


Functional Status:

Functional Status and Well-Being in People with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Compared with People with Multiple Sclerosis and Healthy Controls: https://www.ncbi.nlm.nih.gov/pubmed/29536371


The functional status and well being of people with myalgic encephalomyelitis/chronic fatigue syndrome and their carers
https://bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-11-402


Perhaps other potential studies from Dr. David Systrom and Dr. Lenny Jason - upright too long- OI has kicked in will sign off...
 
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Barry said:
Presumably, provided we can avoid:

"We cannot accept case series, case studies, individual accounts of experience, promotional material, non-evidence-based assertions of effectiveness or opinion pieces."
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Well surely all BPS research results are opinion based, with patients giving their opinion as to whether they think CBT/GET have helped or not.

https://www.thefreedictionary.com/opinion
Opinion - A belief or conclusion held with confidence but not substantiated by positive knowledge or proof

So why do they give any credence to any of it?
 
Quality and acceptability of patient-reported outcome measures used in chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME): a systematic review
2012
Abstract
Purpose To review the quality and acceptability of condition-specific, domain-specific and generic multi-item patient-reported outcome measures (PROMs) used in the assessment of adults with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Methods Systematic literature searches were made to identify PROMs.

Quality and acceptability was assessed against an appraisal framework, which captured evidence of both the thoroughness and results of evaluations: evidence of measurement (reliability, validity, responsiveness, interpretability, data quality/precision) and practical properties (feasibility, patient acceptability), and the extent of active patient involvement was sought.
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Results A total of 11 CFS/ME-specific, 55 domain-specific and 11 generic measures were reviewed. With the exception of the generic SF-36, all measures had mostly limited evidence of measurement and/or practical properties.
Patient involvement was poorly reported and often cursory.
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Conclusions The quality and acceptability of reviewed PROMs is limited, and recommendations for patient-reported assessment are difficult.
Significant methodological and quality issues in PROM development/evaluation were identified by the appraisal framework, which must be addressed in future research.
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Clear discrepancies exist between what is measured in research and how patients define their experience of CFS/ME. Future PROM development/evaluation must seek to involve patients more collaboratively to measure outcomes of importance using relevant and credible methods of assessment.
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https://www.jstor.org/stable/41411309?seq=1#page_scan_tab_contents

eta: sort of covers most, if not all, bPS research
 
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