Science for ME submission to the NICE draft ME/CFS guideline consultation, December 2020, and submission on substantive errors, August 2021

Thanks to everyone involved. Looks like a truly monumental task.

 

I'm so sorry that after my initial involvement & comments, my personal life blew up & i wasnt able to engage any more, & have only been able to read the general summary comments of the submission, but it looks amazing! I am massively grateful for all the long hard effort that went into this sterling work. You are heroes all.

 

Thank you for all your hard work in producing such a comprehensive write-up. As JemPD said, you are heroes!

 

This is a thorough and outstanding piece of work, my immensely grateful thanks to everyone who spent their precious energy working on it, and also to everyone who contributed their thoughts as well. This would have been a major undertaking for any group, let alone one with members in such poor health. Whatever the outcome, you’ve done us all proud. Thank you so, so much.

 

Profuse thanks to everyone involved.

High quality submissions such as these are not just intrinsically valuable for their intended purpose. They also substantiate the scientific probity, discipline and knowledge of community contributors.

Two birds, one stone.

 

Haven't been able to follow it but huge thank you to you all.

 

grateful thanks. Kx

 

Heartfelt thanks for the vast amount of work which has gone into this submission.

I hope you had all recovered enough to enjoy Christmas / festivities.

Hopefully common elements picked up on and this reinforced by other stakeholders will help plug the loopholes and BPS pushback.

 

Thank you so much to everyone who contributed and to those who put so much into drawing up the submission.

 

Brilliant piece of work. I am very grateful to all those who have been involved in creating and submitting this response.

 

Science for ME's Feedback on substantive errors in the August 2021 version of the Guideline
Submitted to NICE on 11 August 2021

1/3

We have studied the final guideline carefully and provide here a list of corrections and point out some substantive errors.

We wish to make it clear that although our list is quite long, and we are disappointed with some of the changes to the draft, we believe that this guideline is a significant improvement over the previous 2007 guideline [CG53], and are grateful to NICE and the guideline committee for their work in reviewing the evidence thoroughly.

We consider points 5, 8, and 22 of this email, concerning removal of the words 'treatment' from certain recommendations, including those not to offer CBT or therapy based on physical activity or exercise as a treatment or cure for ME/CFS, to be among the most critical substantive errors we have highlighted and we hope that these will be rectified in the final guideline.

1.2 Suspecting ME/CFS:

1. Page 8, 1.2.2: Box 2 currently requires the presence of both 'Unrefreshing sleep and sleep disturbance (or both)'. The bracketed 'or both' suggests just one of unrefreshing sleep or sleep disturbance should be sufficient. This is supported by the wording used in the Rationale and impact (p.55). Therefore the criterion should be:
'Unrefreshing sleep or sleep disturbance' (or both)'

1.8 Access to care and support

2. Page 19, 1.8.4: The word 'noise' at bullet point three of 1.8.4 should be changed to 'sound' in keeping with the use of 'sound' throughout the rest of the guideline.

1.10 Multidisciplinary care

3. Page 22, 1.10.1: The wording of bullet point 6 of recommendation 1.10.1 should presumably read 'managing activities of daily living (e.g., accessing dental care)'.

4. Page 23, 1.10.4: The following phrase in recommendation 1.10.4, 'contact about any concerns about their child’s health..' should read, 'contact about the child or young person's health..', as this recommendation specifies supplying details of a named professional directly to the child or young person.

1.11 Managing symptoms

5. Page 24, 1.11.1: To accurately reflect the evidence review findings that there are no effective treatments for ME/CFS, recommendation 1.11.1 should state there is currently no treatment for ME/CFS, as was stated in the draft guideline recommendation 1.11.1 (p.24). Failure to include such a statement constitutes a substantive error. The embargoed guideline only specifies there is 'currently no cure (non-pharmacological or pharmacological)'. A statement that there is currently no treatment (or cure) for ME/CFS would be consistent with the acknowledgement in embargoed guideline recommendation 1.11.1 that ME/CFS symptoms can be managed.

Incorporating physical activity and exercise (1.11)

6. Pages 27-28: The clinical effectiveness evidence was rated low or very low quality for all graded exercise therapy outcomes, and rated very low for other exercise intervention outcomes in the review of evidence. (Evidence Review G, pp. 147-182, 386, 391). Accordingly, there is no reliable evidence of sufficient methodological quality to support inclusion in the guideline of physical activity or exercise programmes as a treatment (or cure) for ME/CFS or its symptoms, or as a means of managing ME/CFS or its symptoms.

7. Page 27: Although they are not used in direct recommendations to offer an intervention, inclusion of the words 'offered' and 'offer' in 1.11.12 and 1.11.13 respectively do not comply with the requirement that the wording reflect the strength of the recommendation (Developing NICE guidelines: the manual [PMG20], 9.2 Wording the recommendations) and erroneously create the impression there is evidence to support offering such programmes.

8. Page 28: The draft guideline recommendation that people with ME/CFS should not be offered any therapy based on physical activity or exercise as a treatment for ME/CFS has been removed in the embargoed guideline, which now only states such interventions should not be offered as a cure for ME/CFS. As all clinical effectiveness evidence for outcomes for GET and exercise interventions was rated low or very low quality in the review of evidence (Evidence Review G, pp. 147-182, 386, 391), the position that therapies based on physical activity or exercise may be effective as a treatment for ME/CFS or its symptoms is not supported by the evidence. Failure to make a clear statement that such programmes should not be offered as a treatment for ME/CFS or its symptoms therefore constitutes a substantive error. Draft guideline recommendation 1.11.16 should be reinstated in the final guideline: 'Do not offer people with ME/CFS: any therapy based on physical activity or exercise as a treatment or cure for ME/CFS'.

9. Page 28, 1.11.14, third bullet point: It is is insufficient to recommend that programmes based on fixed incremental increases should not be offered to people with ME/CFS, as potentially harmful programmes may continue to be offered provided they can be shown to have some form of flexible component and prima facie meet the requirements of 1.11.13. GET is not an example of a programme that 'uses fixed incremental increases in physical activity or exercise' (per 1.11.14), as it can be seen from evidence review G that descriptions of GET intervention studies included flexibility (Broadbent, 2016; Clark, 2017; Wallman, 2004).

10. Pages 27-28: As noted by the committee, 'the term "exercise" should also be avoided as this could easily be misinterpreted by patients and practitioners and could lead to people undertaking non-ME/CFS-specific exercise programmes that could be harmful to them.' (Evidence Review G, p.387) This consideration overrides the possibility of 'confusion' that may arise by not including the term, and we consider that inclusion of the term 'exercise' creates the impression that it may generally be appropriate to consider exercise programmes for which the evidence review makes clear there is no reliable evidence, leading to significant potential for harms. The terms 'exercise' and 'exercise programme' should be removed from the final guideline.

11. Page 28, 1.11.14: The term 'exercise intolerance' at bullet point four of 1.11.14 should presumably read 'exercise avoidance'.

1.12 Symptom management for people with ME/CFS

12. Pages 29-36, 1.12: Several internal links located in 1.12 that point to the Rationale and impact section of the guideline do not appear to work. We trust all hyperlinks will be checked by NICE prior to final publication.

Rest and sleep

13. Pages 29-30, 1.12.2 - 1.12.4: The committee acknowledged the lack of evidence for sleep management and 'agreed it was hard to be confident in recommending any advice when there was not any evidence and lack of consensus in the area' (Evidence Review G, p.400). However, three recommendations on sleep management advice and strategies (1.12.2 - 1.12.4) have been added to the final guideline. 1.12.2 recommends that sleep advice is given to people with ME/CFS and specifies what this should include. Inclusion of recommendations 1.12.2 - 1.12.4 is not supported by evidence. Recommendations 1.12.2 - 1.12.4 should be removed from the final guideline.

14. Page 29, 1.12.3: 1.12.3 recommends thinking about a sleep disorder or dysfunction and whether to refer to a specialist if sleep management strategies do not improve the person's sleep. Unrefreshing sleep and sleep disturbance are Box 2 (1.2.2) symptoms that are required in order for ME/CFS to be suspected. The possibility of sleep disorder should be contemplated at diagnosis stage, if appropriate. The assumption inherent in this recommendation that a core ME/CFS symptom may be attributable to a different condition because it does not improve with a sleep management intervention for which no evidence was identified in the review risks degrading the integrity of the core criteria for suspicion of ME/CFS and renders this aspect of the guideline internally inconsistent. Recommendation 1.12.3 should be removed from the guideline.

 

2/3

Medicines

15. Page 32, 1.12.15 There are no medicines or supplements that have been shown to be an effective treatment for ME/CFS. Therefore the removal of the word 'treat', present in the draft recommendation, 'do not offer any medicines or supplements to treat or cure ME/CFS' does not reflect the findings of the review of evidence. A recommendation that medicines or supplements should not be offered to treat or cure ME/CFS could be qualified by acknowledging that medicines may be useful for people with ME/CFS to manage their symptoms. Draft recommendation 1.11.29 should be reinstated in the final guideline: 'Do not offer any medicines or supplements to treat or cure ME/CFS.'

Dietary management and strategies

16. Page 34, 1.12.24 In order to accurately reflect the findings of the review of evidence, recommendation 1.12.24 should include the term 'treatment' as follows: 'there is not enough evidence to support routinely taking vitamin or mineral supplements as a treatment or cure for ME/CFS, or for managing its symptoms'.

Lightning process

17. Page 34, 1.12.27: Recommendation 1.12.27 states: 'Do not offer people with ME/CFS therapies based on the "Lightning process".' However it does not explicitly state that the Lightning Process itself should not be offered to people with ME/CFS, only that therapies based on it should not be. A clear statement that the Lightning Process should not be offered to people with ME/CFS should be inserted in this section of the final guideline.

18. Page 34, 1.12.27: By not including the draft guideline recommendation wording that people with ME/CFS should not be offered therapies derived from osteopathy, life coaching and neurolinguistic programming, the final guideline does not prevent people with ME/CFS (notably children and young people) from being offered therapies similar to the Lightning Process (though not based on it) with a different name but a similar potential to gain apparent legitimacy and traction in medical or research settings. Such therapies may involve components for which the committee has expressed concern, including secrecy and 'pushing through' symptoms, potentially leading to harm (Rationale and impact p.74). The following part of the fifth bullet point of draft recommendation 1.11.16 should be reinstated: 'Do not offer people with ME/CFS: therapies derived from osteopathy, life coaching and neurolinguistic programming'.

Cognitive behavioural therapy

19. Pages 35-36: Clinical effectiveness evidence for CBT was rated low or very low quality for all outcomes, including physical functioning, quality of life, general symptom scales, and activity levels (Evidence Review G, pp. 81-129, 376). Accordingly, there is no reliable evidence of sufficient methodological quality to support inclusion in the guideline of cognitive behavioural therapy as a treatment for ME/CFS or its symptoms, or as a means of managing ME/CFS or its symptoms.

20. Page 35, 1.12.29: Use of the word 'offer' at 1.12.29 is not consistent with the low and very low quality ratings of CBT outcomes in the evidence review. Developing NICE guidelines: the manual [PMG20] states, 'NICE uses "offer" (or words such as "measure", "advise", or "refer") to reflect a strong recommendation, usually where there is clear evidence of benefit.'

21. Page 36, 1.12.32: Clinical effectiveness evidence for CBT was rated low or very low quality for all outcomes, including physical functioning, quality of life, general symptom scales, and activity levels (Evidence Review G, pp. 81-129, 376). Therefore it is misleading to include the statement in 1.12.32, 'Explain that CBT for people with ME/CFS: aims to improve their quality of life, including functioning, and reduce the distress associated with having a chronic illness.' This statement should be removed, as its inclusion strongly implies CBT has been found to be effective for these outcomes, making such inclusion a substantive error.

22. Pages 35-36: The draft recommendation, 'do not offer CBT as a treatment or cure for ME/CFS' has been removed in the final guideline. (There is now a recommendation (1.12.28) to explain it is not curative.) As all clinical effectiveness evidence for CBT was rated low or very low quality in the review of evidence (Evidence Review G, pp. 81-129, 376), the position that CBT may be effective as a treatment for ME/CFS or its symptoms is not supported by the evidence. Failure to make a clear statement that CBT should not be offered as a treatment or cure for ME/CFS or its symptoms therefore constitutes a substantive error. It is insufficient to state that CBT is not curative. The following statement in draft guideline recommendation 1.11.43 should be reinstated in the final guideline: 'Do not offer CBT as a treatment or cure for ME/CFS.'

Responses by NICE in the stakeholder comments table include the statement:
'CBT is not a treatment for ME/CFS but could be useful for some people with ME/CFS with supporting them in managing their symptoms.' At a minimum, this statement should be included in the Cognitive behavioural therapy section of the guideline itself to prevent the interpretation that CBT can be discussed and considered as a treatment for ME/CFS.

23. Page 46, 1.17.13: Evidence Review G (p.378) states: 'The committee noted that none of the evidence [on CBT] included or reflected the needs of people with severe or very severe ME/CFS.' Therefore, we repeat our feedback that the guideline should specify that CBT should not be offered to people with severe or very severe ME/CFS to 'help manage their symptoms' or with the aim 'to improve their quality of life, including functioning, and reduce the distress associated with having a chronic illness', because there is no evidence to support considering CBT for people with severe or very severe ME/CFS, and to do so may lead to harms.

 

3/3

1.17 Care for people with severe or very severe ME/CFS

24. Recommendations on 'Severe and very severe ME/CFS' have been moved into a single section (1.17) at the end of the guideline, separating them from related recommendations they should be read in tandem with and creating the possibility relevant recommendations in other sections may be overlooked. ME/CFS can fluctuate significantly in severity, meaning recommendations for severe and very severe ME/CFS are not only relevant for a small subset of patients who can be considered separately, but may also become relevant at any time for people with mild and moderate ME/CFS.

We strongly suggest the sections on severe and very severe ME/CFS be moved back to their original positions in the draft. (Section 1.17 could remain as a series of hyperlinked headings for those who wish to read all the specific guidance about severe and very severe ME/CFS together.) In the alternative, we suggest each part of section 1.17 Care for people with Severe and very severe ME/CFS should be directly linked from its exact original position in the draft guideline, and linked back again. Although links are currently provided throughout 1.17 to the main guideline section headings, our suggestion would make it much quicker for clinicians to navigate directly to the relevant recommendations.

Terms used in this guideline

Graded exercise therapy:

25. Page 49: In the second line of the definition of graded exercise therapy, the term 'exercise intolerance theories' should presumably read 'exercise avoidance theories'.

26. Page 49: In the second line of the definition of graded exercise therapy, chronic fatigue syndrome is mentioned but not myalgic encephalomyelitis.

27. Page 49: 'Graded exercise therapy' is a new inclusion in the Terms used in this guideline section (p.49). A warning should be added to the definition that GET should not be offered as a treatment or cure for ME/CFS. Without such a caveat, anyone reading the list of terms in order to familiarise themselves with key concepts in ME/CFS would be left with the mistaken impression that GET is a part of current treatment recommendations. If such a warning is not added, a direct link to to 1.11.14 on page 28, which specifies that GET should not be offered, should be added to the definition.

28. Page 49: The definition for Graded exercise therapy states: 'Graded exercise therapy is defined in this guideline as therapy based on the deconditioning and exercise intolerance [sic] theories of chronic fatigue syndrome.' The requirement for presence of a theoretical basis to meet this definition of GET is not evidence based and inclusion of this requirement means that on a literal interpretation of this definition, a therapy that would otherwise be defined as GET would not meet this definition if its theoretical basis differed or it had no theoretical basis, regardless of its potential for harm.

29. Page 49: It is clear from the descriptions of several GET studies included in the review of evidence that the interventions in these studies both used the term 'graded exercise' and included flexibility in levels of activity:

i. reducing exercise intensity if symptoms increased until participants felt ready to manage progression (Broadbent, 2016),
ii. if symptoms increased after an incremental change, maintaining activity at the same level until symptoms had settled before considering another incremental increase. (Clark, 2017),
iii. shortening or cancelling the next exercise session if subjects had a relapse and reducing subsequent sessions to a length subjects felt was manageable (pacing) (Wallman, 2004).

Therefore, it is incorrect to describe GET as involving 'fixed incremental increases in the time spent being physically active'. The definition of GET should be revised to reflect that such programmes may involve flexibility, to ensure that potentially harmful exercise programmes may not continue to be offered to people with ME/CFS if they can be shown to have some form of flexible component and operate under a name other than 'graded exercise therapy'.

30. Page 49: It should be made clear in the definition of graded exercise therapy that explanations based on deconditioning and avoidance of activity, and the sentence, 'These changes result in the deconditioning being maintained and an increased perception of effort, leading to further inactivity.' are not evidence based.

Rationale and impact:

31. Page 75: The rationale and impact section for CBT indicates that the terms 'cure' and 'treatment' are inappropriately used interchangeably. Highlighting that CBT is not a cure in the guideline is said to be 'based on criticisms in the qualitative evidence of CBT being described as a "treatment" (cure)'. (Rationale and impact, p.75; Evidence Review G, p.376). Criticisms of CBT being described as a treatment in the qualitative evidence is basis for highlighting that CBT is not a treatment or cure for ME/CFS, and that it should not be offered as such. It does not reflect the qualitative evidence as suggested here if it is highlighted that CBT is not a cure, but not highlighted that it is not a treatment for ME/CFS.

Context

32. Page 82: The wording of the second paragraph of page 82 should be updated to reflect that the review of evidence has now been completed. Text suggesting the evidence needs to be reviewed should be deleted.

Thank you for considering the above points. The work of NICE and the guideline committee in producing this guideline is much appreciated, and we look forward to publication on the 18th August 2021.


____________
End