UK House of Lords/ House of Commons Questions

Alun Cairns Conservative, Vale of Glamorgan
To ask the Secretary of State for Health and Social Care, for what reasons the National Institute of Health and Clinical Excellence postponed the publication of the guidelines on (a) myalgia encephalomyelitis, (b) chronic fatigue syndrome and (c) post viral fatigue syndrome.

Jo Churchill The Parliamentary Under-Secretary for Health and Social Care
The Department of Health and Social Care has indicated that it will not be possible to answer this question within the usual time period. An answer is being prepared and will be provided as soon as it is available.
 
Patrick Grady Scottish National Party, Glasgow North
To ask the Secretary of State for Health and Social Care, what discussions he has had with representatives of the National Institute for Health and Care Excellence on the time taken to publish updated guidance on Myalgic encephalomyelitis (ME).

Jo Churchill The Parliamentary Under-Secretary for Health and Social Care
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for developing its guidelines in line with its established methods and processes.

NICE has advised that it plans to host a roundtable event in September to gain support for the guideline to ensure effective implementation.
 
Sly Saint said:
Jo Churchill The Parliamentary Under-Secretary for Health and Social Care
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for developing its guidelines in line with its established methods and processes.

NICE has advised that it plans to host a roundtable event in September to gain support for the guideline to ensure effective implementation.
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Do I understand it correctly that this is an answer from Mrs. Churchill/her departement?

Because then I also like the reminder that NICE is "responsible for developing its guidelines in line with its established methods and processes".
 
ukxmrv said:
Given that It may be put off until October now I don't have much faith in the reply sadly.
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By "It" you mean the roundtable?

I'm not very familiar with UK political structure, but I find it rather encouraging for a "Parliamentary Under-Secretary for Health and Social Care" to specifically mention that it is expected by them that NICE will be following its own rules and protocol. (Politicians are usually very aware of which language they use to deliver a message.)

It will hopefully mean that if NICE does go rogue due to pressure from vested interests (which is still no certainty although it did take some discouraging steps), they will have to account for themselves/explain themselves because questions will be asked.

It's unpleasant, but in that light it doesn't matter if the roundtable will be next week or in January, at some point they will have to explain themselves to Parliament if they ditched their own "established methods and processes".
 
Arvo said:
Do I understand it correctly that this is an answer from Mrs. Churchill/her departement?

Because then I also like the reminder that NICE is "responsible for developing its guidelines in line with its established methods and processes".
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This is an answer from the Secretary of State/Department of Health and Social Care - the Westminster system seems to allow for the appointment of under-Secretary of State but it's still the answer from the Secretary of State/Department.
In practice the minions (civil servants) draft the replies and these are cleared (generally by the Ministers private office/special advisor) before they are issued.
 
I was thinking of sending this* to the APPG on ME/CFS and Long covid - copying in Prof. Gillian Leng (NICE chief executive) and the Secretary of State for Health and Social Care (which funds NIHR and NICE), MECFS & Long covid charities. Might be better if inaccuracies were identified here rather than those I'm sending it to!

*"This month Prof. Gillian Leng (NICE chief executive) announced that NICE "have signed a collaborative agreement with Cochrane. Cochrane has a well established reputation for producing high quality systematic reviews which take into account the very latest evidence".
As part of the review/revision of the NICE guideline on the diagnosis and management of Chronic Fatigue Syndrome (CFS), NICE reviewed the available studies e.g. PACE (use of Graded Exercise Therapy and CBT). These studies were rated by NICE as "low or very low" quality i.e. unsuitable as evidence to recommend treatments. The reason was that they were unblinded and used subjective outcome criteria (questionnaires), rather than objective criteria (activity monitoring using FitBit type devices).
In contrast Cochrane found these studies to be "moderate" quality evidence.

You can imagine the disbelief, in the ME/CFS community, to find that rather than introducing systems to address the systemic failure of Cochrane reviews, NICE has "signed a collaborative agreement with Cochrane".

The situation creates a risk not just to those with ME/CFS but to those with Long covid and other poorly understood diseases which are labelled as having a psychological component. Inevitably "low or very low" quality studies, labelled as "moderate" quality by Cochrane, will be used to support the use of exercise and CBT as treatments for Long covid. No doubt those who carried out the PACE study etc. are already submitting applications to NIHR for funding re the use of exercise and CBT as treatments for Long covid - leaving out objective criteria (activity monitoring using FitBit type devices) so they can use questionnaires to show exercise and CBT work!"
 
Your letter makes a good point about the relationship between NICE and Cochrane, while Cochrane has such low standards for its research evaluation.

FMMM1 said:
These studies were rated by NICE as "low or very low" quality i.e. unsuitable as evidence to recommend treatments. The reason was that they were unblinded and used subjective outcome criteria (questionnaires), rather than objective criteria (activity monitoring using FitBit type devices).
In contrast Cochrane found these studies to be "moderate" quality evidence.
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I haven't got around to looking properly at GRADE but I understand from others that the fundamental flaw of unblinded+subjective outcomes may not have been able to adequately contribute to the rating of low quality due to some inadequacies in GRADE. Nevertheless, the studies had plenty of other flaws including indirectness, so they still qualified as low quality. So, I think the reason you give for the low ratings may be be wrong.

crosspost
 
Hutan said:
Your letter makes a good point about the relationship between NICE and Cochrane, while Cochrane has such low standards for its research evaluation.



I haven't got around to looking properly at GRADE but I understand from others that the fundamental flaw of unblinded+subjective outcomes may not have been able to adequately contribute to the rating of low quality due to some inadequacies in GRADE. Nevertheless, the studies had plenty of other flaws including indirectness, so they still qualified as low quality. So, I think the reason you give for the low ratings may be be wrong.

crosspost
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If we have an expert re why NICE downgraded the assessment of PACE then it would be useful if they stepped forward.

I've had a brief look (it's difficult to untangle). On page 317 NICE sets out the following:
"23 The majority of the evidence was of low and very low quality. The main reasons for 24 downgrading were risk of bias, indirectness and imprecision. There was a lack of blinding in 25 the studies due to the nature of the interventions. This, combined with the mostly subjective 26 outcomes, resulted in a high risk of performance bias. The committee considered this an 27 important limitation when interpreting the evidence."
https://www.nice.org.uk/guidance/GID-NG10091/documents/evidence-review-7

So if you look at PACE it was:
  • unblinded ---- risk of bias (or worse since participants were told the intervention was effective); and
  • used subjective outcome criteria which are known to be unreliable as a method of assessing activity levels, resulting in a risk of bias and I assume, indirectness (you are not actually measuring activity pre/post intervention).
If you consider the proposed PACE protocol [they were supposed to use actimetry] then you'll see that the use of objective outcome criteria would reduce the risk of bias (i.e. versus questionnaires) and I assume, would not be downgraded for indirectness i.e. since you are measuring activity not a poor surrogate (questionnaires).

You can see the power imbalance here - the folks at NICE/PACE authors ---- understand this stuff; I'm trying to pick it up as I go along.

Came across this:
"29 The committee acknowledged the lack of existing objective outcome measures of 30 effectiveness of interventions for ME/CFS and the limitations of subjective measures (see 31 Professor Edwards expert testimony – Appendix 3: Expert testimonies). Only validated 32 outcome measurement scales were included in the evidence review".
 
Yes, hopefully someone who has looked at this in detail will comment. But, my understanding is that 'indirectness' in relation to the PACE trial relates to the percentage of people who did not have ME/CFS (i.e. did not have the core symptom of PEM).

e.g. this comment about a study:
"Serious population indirectness – 1994 CDC criteria used; PEM is not a compulsory feature."
 
Sent this* - used a bit of a shotgun approach.

"This month Prof. Gillian Leng (NICE chief executive - cc) announced that NICE "have signed a collaborative agreement with Cochrane. Cochrane has a well established reputation for producing high quality systematic reviews which take into account the very latest evidence".
The recent review by NICE, of studies relating to the use of psychological interventions to treat myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), found that they were "low and very low quality"* evidence. Cochrane found these studies to be "moderate" quality evidence i.e. despite the fact that they were unblinded/inadequately blinded and used subjective outcome criteria (questionnaires) - rather than objective outcome criteria (FitBit type devices which reliably monitor activity).
NICE's use of Cochrane reviews also creates a risk for those with Long covid, and Lyme disease, i.e. since "low and very low quality" evidence will be considered "moderate" quality - suitable evidence to support the use of psychological interventions like CBT.

I ask those on the APPG for ME and APPG for Coronavirus, NICE (Prof. Gillian Leng) and others, to consider how the issue of NICEs reliance on flawed Cochrane reviews can be addressed.
Thank you in advance for your assistance,
Xxxx
*Page 317 - https://www.nice.org.uk/guidance/GID-NG10091/documents/evidence-review-7
 
(asked on 7th September 2021) - View Source
Questioner
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Kerry McCarthy
(Labour - Bristol East)


Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent discussions he has had with NICE on the timeline for the publication of clinical guidelines on myalgic encephalomyelitis and chronic fatigue syndrome.

Answered by
4362-15x15lores.jpg

Edward Argar
Minister of State (Department of Health and Social Care)
This question was answered on 1st October 2021
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for developing its guidelines in line with its established methods and processes. NICE the Department regarding its publication of an updated guideline on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). NICE now plans to host a roundtable event in October to determine how it can gain support for the guideline to ensure effective implementation.

Services for CFS/ME are commissioned locally by clinical commissioning groups to plan the provision of services subject to local prioritisation and funding. NICE’s existing guideline on CFS/ME provides guidance on diagnosing and managing the condition. Health and care professionals should continue to take this into account until the updated guideline is published.
 
Sly Saint said:
(asked on 7th September 2021) - View Source
Questioner
1491-15x15lores.jpg

Kerry McCarthy
(Labour - Bristol East)


Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what recent discussions he has had with NICE on the timeline for the publication of clinical guidelines on myalgic encephalomyelitis and chronic fatigue syndrome.

Answered by
4362-15x15lores.jpg

Edward Argar
Minister of State (Department of Health and Social Care)
This question was answered on 1st October 2021
The National Institute for Health and Care Excellence (NICE) is an independent body and is responsible for developing its guidelines in line with its established methods and processes. NICE the Department regarding its publication of an updated guideline on chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). NICE now plans to host a roundtable event in October to determine how it can gain support for the guideline to ensure effective implementation.

Services for CFS/ME are commissioned locally by clinical commissioning groups to plan the provision of services subject to local prioritisation and funding. NICE’s existing guideline on CFS/ME provides guidance on diagnosing and managing the condition. Health and care professionals should continue to take this into account until the updated guideline is published.
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missed an additional question

Kerry McCarthy Shadow Minister (Transport)
To ask the Secretary of State for Health and Social Care, what support his Department is providing to people with myalgic encephomyelitis and chronic fatigue syndrome pending the publication of updated clinical guidelines for that condition.



so the second part of his response is in reply to this question; namely that healthcare professionals should continue to use the existing guidelines.
 
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