NICE 'CFS/ME' CLINICAL GUIDELINE 53 REVIEW DECISION.


How outrageous !!!!

NICE 'CFS/ME' CLINICAL GUIDELINE 53 REVIEW DECISION.

Kevin Short

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.
contact@angliameaction.org.uk

[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

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