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.