Dear All, As a stakeholder for the UK NICE 'CFS/ME' Clinical Guideline 53 (CG53) I have today received an email notification from NICE that their review decision has been made and published. The text of the decision is pasted below along with NICE's urls from which the decision document can be downloaded as a pdf. NICE state: "Because of comments received at consultation the review decision on this guideline was suspended until the PACE trial (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome ([PACE]: a randomised trial) reported on the 18th February 2011. The data presented in this study was taken into account to inform the final review decision. ...Through the process no additional areas were identified which were not covered in the original guideline scope or would indicate a significant change in clinical practice. There are no factors described above which would invalidate or change the direction of current guideline recommendations. The CFS/ME guideline should not be updated at this time." It is my view as a stakeholder that the NICE GDG that developed CG53 was not and is not competent to take such decisions and, for NICE to fail to scrap CG53 and appoint a competent and representative GDG to replace it with a document that genuinely represents 'clinical excellence', represents a national disgrace and abandonment of its duty to UK patients, parliament and taxpayers. Documented evidence supporting such views are set out in my recent stakeholder comments in the consultation for this current review, are a must read for anyone wanting to understand the current decision by NICE, and are available in full at: http://www.angliameaction.org.uk/docs/25megroup-nice-cg53-response-nov2010.pdf http://www.angliameaction.org.uk/docs/eame-nice-cg53-response-nov2010.pdf NICE singularly failed to examine all of the evidence and to adhere to proper standards of evidence-based-medicine and guideline development when it produced CG53. Such maladministration by NICE has, in my view, now been compounded in the recent guideline review by giving insufficient weight to stakeholder comment and biomedical evidence submitted in autumn 2010, and by giving undue weight to the psychiatric school's highly controversial PACE Trial. A formal complaint of which has been made concerning the latter and can be read, along with a recent summary of the PACE publication documentation and flaws, at the following web addresses: http://www.meactionuk.org.uk/Hooper-response-to-PACE-Trial-Press-Release.htm http://www.meactionuk.org.uk/magical-medicine.htm Kevin Short Anglia ME Action 14 March 2011. email@example.com [PERMISSION TO REPOST] http://guidance.nice.org.uk/CG53/ReviewDecision/pdf/English http://guidance.nice.org.uk/CG53 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Centre for Clinical Practice Review of Clinical Guideline (CG53) – Chronic fatigue syndrome/ myalgic encephalomyelitis (or encephalopathy): diagnosis and management of chronic fatigue syndrome, myalgic encephalomyelitis (or encephalopathy) in adults and children. 1. Background information Guideline issue date: 2007 3 year review: 2010 National Collaborating Centre: National Clinical Guidelines Centre (formally NCC Primary Care) 2. Consideration of the evidence Literature search -1. From initial intelligence gathering and a high-level randomised control trial (RCT) search clinical areas were identified to inform the development of clinical questions for focused searches. Through this stage of the process 25 studies were identified relevant to the guideline scope. The identified studies were related to the following clinical areas within the guideline: Case definitions of CFS/ME Information and support needs of CFS/ME patients, carers and healthcare professionals Management of CFS/ME -2. Three clinical questions were developed based on the clinical areas above, qualitative feedback from other NICE departments and the CG53 CFS/ME Review Proposal final for web March 2011 views expressed by the Guideline Development Group, for more focused literature searches. In total, 59 studies were identified through the focused searches however, no identified new evidence contradicts current guideline recommendations. -3. No evidence was identified that was relevant to research recommendations in the original guideline. -4. Several ongoing clinical trials (publication dates unknown) were identified focusing on the effectiveness of group CBT for patients with CFS/ME; the efficacy of internet-based CBT for adolescents with CFS/ME and behavioural insomnia therapy for CFS/ME. The results of these trials have not been published at this time but may contribute towards the evidence base relating to management of CFS/ME in the next update review. Guideline Development Group and National Collaborating Centre perspective -5. A questionnaire was distributed to GDG members and the National Collaborating Centre to consult them on the need for an update of the guideline. Ten responses were received with respondents highlighting the FINE (Fatigue intervention by nurses evaluation) and PACE (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome) trials as emerging new evidence. -6. Conflicting evidence on the association between retrovirus and CFS/ME were also highlighted. However, this is considered outside the remit of the original guideline. No published literature relating to the scope of the guideline was specified through the questionnaire which contradicted current guideline recommendations. -7. Seven respondents felt that there is insufficient variation in current practice supported by adequate evidence at this time to warrant an update of the current guideline. Implementation and post publication feedback -8. In total 104 enquiries were received from post-publication feedback, most of which were routine. Key themes emerging from post- publication feedback included enquiries relating to CBT, GET, dietary supplements, complementary therapies and immunoglobulin therapy. This feedback contributed towards the development of clinical question 3 as described above. -9. No new evidence was identified through post publication enquiries or implementation feedback that would indicate a need to update the guideline. Relationship to other NICE guidance -10. NICE guidance related to CG53 can be viewed in Appendix 1. Summary of Stakeholder Feedback Review proposal put to consultees: The guideline should not be updated at this time. The guideline will be reviewed again according to current processes. -11. In total 25 stakeholders commented on the review proposal recommendation during the 2 week consultation period. -12. Nine stakeholders agreed with the review proposal recommendation that this guideline should not be updated at this time, and 5 did not respond to this question. -13. Eleven stakeholders disagreed with the review proposal on the basis that the guideline should focus on the aetiology and pathogenesis of CFS/ME, and that treatments/interventions recommended should be driven by aetiological/biomedical models. However, current literature relating to the aetiology and pathogenesis of CFS/ME is inconsistent and inconclusive whilst interventions recommended in the original guideline, such as CBT and GET, were described as the interventions for which there is the clearest evidence-base of benefit. This is supported by the recently published PACE trial (comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome among 641 patients, published February 2011). The review of literature undertaken to inform the review proposal also did not identify any research which would invalidate or change the direction of current guideline recommendations, -14. Literature was submitted through stakeholder consultation relating to: -A survey of illness management requirements for people with CFS/ME and their carers -Multidimensional programmes for management of CFS/ME -Biomedical and vascular aspects of paediatric CFS/ME -CBT and GET for management of CFS/ME -GP attitudes and knowledge of CFS/ME -The biology and pathophysiology of the retrovirus XMRV 15. During consultation, areas to consider for review in any future update of the guideline were highlighted including: -Diagnosis of CFS/ME (in particular relating to case definitions, clinical utility of diagnostic tests and recommended blood tests) -Management of CFS/ME -Practical guidance on pacing for CFS/ME 16. During consultation, new areas to consider in any future update of the guideline were highlighted including: -Aetiology and pathogenesis of CFS/ME -Inclusion of the World Health Organization’s ICD10 classification -Diagnosis of postural orthostatic tachycardia syndrome (POTS) in association with CFS/ME -The inclusion of ferritin as a marker in basic blood screening for CFS/ME -An emphasis on the multidisciplinary approach for CFS/ME management and rehabilitation -The use of mindfulness therapy for people with CFS/ME -The inclusion of the new blood donation policy for ME/CFS patients which was introduced from 1st November 2010 17. Because of comments received at consultation the review decision on this guideline was suspended until the PACE trial (Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome ([PACE]: a randomised trial) reported on the 18th February 2011. The data presented in this study was taken into account to inform the final review decision. In the study, patients were randomly allocated to standard medical care (SMC) alone or SMC plus cognitive behavioural therapy (CBT), graded exercise therapy (GET) or adaptive pacing therapy (APT). Assessments of fatigue and physical function, social adjustment scores, sleep disturbance, anxiety, depression and adverse events were undertaken at baseline, 12 weeks (mid-therapy), 24 weeks (post- therapy) and 52 weeks after randomisation. The results of the study indicated that either CBT or GET, when added to SMC, are moderately effective treatments for CFS. The results of the study are in line with current NICE guideline recommendations on the management of CFS/ME. Anti-discrimination and equalities considerations 18. No evidence was identified to indicate that the guideline scope does not comply with anti-discrimination and equalities legislation. The original scope is inclusive of diagnosis, treatment and management of mild, moderate or severe CFS/ME in children (aged 5 years and upwards, including young people in transition to adulthood) and adults. The guideline covers care in primary and secondary care, and in specialist centres/teams. 19. The following equalities issues were highlighted during stakeholder consultation. These issues should be taken into consideration during the scoping process for any future update of this guideline: Equal access to healthcare for all patients with CFS/ME Conclusion 20. Through the process no additional areas were identified which were not covered in the original guideline scope or would indicate a significant change in clinical practice. There are no factors described above which would invalidate or change the direction of current guideline recommendations. The CFS/ME guideline should not be updated at this time. Relationship to quality standards 21. This topic is not currently being considered for a quality standard. Fergus Macbeth – Centre Director Sarah Willett – Associate Director Emma McFarlane – Technical Analyst Centre for Clinical Practice March 2011
Re : Roberts D (2016) Diagnosing and managing chronic fatigue syndrome Nursing in Practice 89 http://www.nursinginpractice.com/article/diagnosing-and-managing-chronic-fatigue-syndrome
Every nurse has a duty to speak up about wrong practice, or the potential to do harm, I have grave concerns over the serious errors and the misrepresentation of Myalgic Encephalomyelitis (ME) contained
in the article "Diagnosing and managing chronic fatigue syndrome".
Last year I was awarded third place in the BJN Nurse of the Year Award, for my contribution to and advocacy for Severe ME. My article “Supporting people with severe myalgic encephalomyelitis”
(Crowhurst 2005) is referenced by NICE. In 2006 I represented people with Severe ME in parliament at the Gibson Inquiry (Hooper 2006). I have conducted a national (Crowhurst 2005) and local survey of Severe ME. (Crowhurst
2007) I am the author of "Severe ME, featuring justice for Karina Hansen" (Crowhurst 2013) and "Severe ME, …
Joint Commisioning Panel for Mental Health has recently published
for commissioners of services for people with medically unexplained
symptoms, specifically listing Myalgic Encephalomyelitis as a "Functional Somatic Disorder". This
is not the first time that an incorrect reclassification has been
attempted. In October
attempt was made to have ME ‘unofficially’
reclassified, as a mental disorder in a U.K adaptation of a WHO
publication, the ‘WHO Guide to Mental Health in Primary Care’, developed by the Collaborating Centre of the Institute of
Psychiatry, London and included under the classification F48.0
After a reprimand from the WHO, an erratum was eventually issued,
acknowledging that the
anyone wishing to challenge this report, the following may be of
Encephalomyelitis (ME) has
by the World Health Organisation since
as an organic neuro…
Myalgic Encephalomyelitis, a neurological disease with multi-system dysfunction is continuing to
disappear from view, lost in a fatigue focus that does not
clinically represent the reality of this severely disabling chronic disease.
There should, you would think, be no compromise on identifying and separating Myalgic Encephalomyelitis from other conditions and recognising the
need for a full medical service with a biomedical pathway, for people with Myalgic Encephalomyelitis (ME).
This is sadly not the case and that has profound implications for those people who have ME especially the most severely affected, who are so isolated as to be almost
invisible to health services, social services and society generally, too ill to engage with them.
It is unlikely that anyone outside the situation really know what life is like for people with Severe and Very Severe ME, who
are house and or bed bound, unable to interact in a normal way and separated from ordinary life by acute environmental hy…