02 November 2010
Consultation on whether NICE guideline should be reviewed
The National Institute for Health and Clinical Excellence (NICE) has published a provisional three-year review decision about its current guideline on CFS/M.E.
The decision, which is up for consultation from 1-14 November, says no conclusive evidence has yet been identified that would invalidate Clinical Guideline (CG53) – Diagnosis and management of chronic fatigue syndrome, myalgic encephalomyelitis (or encephalopathy) in adults and children (published 2007).
Registered stakeholders for the guideline, including Action for M.E., are invited to comment on the provisional review decision via the NICE website.
Individuals and organisations not registered as stakeholders are asked to “register as a stakeholder or contact registered stakeholder organisation that most closely represents your interests and pass your comments to them.”
Obviously, the timescales for consultation are tight. Please submit any comments you would like to make via Action for M.E. to our Policy Officer, Tristana Rodriguez by Wednesday 10 November.
The following information is extracted from the review consultation document.
How was the draft decision reached?
NICE says: “A questionnaire was distributed to Guideline Development Group 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 and PACE trials as emerging new evidence (results of the PACE trial have not been published at this time) and new research on therapy (therapy not specified).
“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.
“The majority of 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.”
NICE says it has drafted its decision based on focused literature searches which reflect three clinical questions:
(1) What are the existing case definitions for chronic fatigue syndrome in adults and children and what evidence exists to substantiate or validate these case definitions?
(2) What are the support needs of healthcare professionals, patients and carers?
(3) Does the evidence show that any particular intervention or combination of interventions is effective in treatment, management or rehabilitation of adults and children with a diagnosis of CFS/M.E.?
NICE says no identified new evidence contradicts current guideline recommendations and so the guideline should not be updated at this time but should be reviewed again according to current processes.
In response to the first question, which relates to existing case definitions for CFS in adults and children, NICE says:
“Through the focused search 19 studies relevant to the clinical question were identified. Literature relating to case definitions for CFS/ME generally included observational studies with small sample sizes.
“Some studies provided a description of symptoms however, no conclusive evidence providing a definitive case definition was identified. Therefore, no new evidence relating to case definitions for CFS/ME was identified which would warrant an update of the current guideline recommendations.”
In response to the second question, about the support needs of healthcare professionals, patients and carers, NICE says:
“Eight studies were identified through the focused search relating to this clinical question.
“In terms of information and support needs of CFS/M.E. patients, carers and healthcare professionals, most identified studies focused on educational interventions to improve knowledge of CFS/M.E. among healthcare professionals. Identified evidence included small observational studies which added no new area or contradictory information to current guideline recommendations.”
In response to the third question, “Does the evidence show that any particular intervention or combination of interventions is effective in treatment, management or rehabilitation of adults and children with a diagnosis of CFS/ME?” the document says:
“Through the focused search 32 studies relevant to the clinical question were identified. Most identified studies were related to interventions for management of CFS/M.E. The majority of studies focused on cognitive behavioural therapy (CBT) however, identified studies reported results that were in line with current guideline recommendations.
“No new evidence was identified specifically related to graded exercise therapy (GET) or pacing.
“Although the protocol for the PACE trial (an RCT of adaptive pacing, CBT, and graded exercise, as supplements to standardised specialist medical care) was identified, the results of this study were not published at the time of this review (publication date unknown).
“In addition, a study (FINE trial) of pragmatic rehabilitation, supportive listening and General Practitioner treatment as usual reported inconclusive results.
”In terms of pharmacological and dietary interventions, new evidence was identified however this was not contradictory to current guideline recommendations.
“Similarly, evidence related to complementary therapies remains limited in quantity and quality. As such, no evidence was identified which would warrant an update of the guideline recommendations at this time."