Tag: NICE guidelines

NICE sets out steps NHS must take to implement ME/CFS guidelines

Abstract:

The National Institute for Health and Care Excellence has issued an unprecedented implementation statement setting out the practical steps needed for its updated guideline on the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS) to be implemented by the NHS.

Such statements are only issued when a guideline is expected to have a “substantial” impact on NHS resources, and this is thought to be the first. It outlines the additional infrastructure and training that will be needed in both secondary and primary care to ensure that the updated ME/CFS guideline, published in October 2021, can be implemented.

The statement is necessary because the 2021 guideline completely reversed the original 2007 guideline recommendations that people with mild or moderate ME/CFS be treated with cognitive behavioural therapy (CBT) and graded exercise therapy (GET). Instead, the 2021 guideline says that CBT should be only offered to support patients to manage their symptoms and that any exercise programme should be overseen by an ME/CFS specialist team.

Many areas have no or very limited specialist ME/CFS services, meaning that services must be commissioned, specialist health professionals need to be trained to deliver these services, and GPs need training in how to care for their patients. “With no nationally commissioned service for ME/CFS in either primary or secondary care, it will be for local systems to determine how to structure their services to achieve the aims of the guideline,” said Paul Chrisp, director of the Centre for Guidelines at NICE.

The 2007 recommendations were overturned during a long and difficult guideline development process. Patient groups had long argued that the recommendations were inappropriate, ineffective, and potentially harmful, and hindered research into the disease. But health professionals raised concerns about the proposed guidelines and the process that underpinned them. Just weeks before the final guideline was due to be published three members of the development committee resigned, royal colleges and other professional bodies signalled that they would not support it, and NICE had to delay publication. The guideline was finally published after a meeting was arranged with stakeholders to iron out differences, but concerns among medical leaders persisted.

When the 2021 guideline was published, Charles Shepherd, honorary medical adviser of the ME Association, told The BMJ that the recommendations were “something that currently cannot be coped with.” After publication of the implementation statement, he said, “I think NICE have gone as far as they can. It is now up to individual clinical services to reposition what they do in order to comply with the recommendations and for commissioners to start setting up new clinical services where none currently exist—especially in Wales and Northern Ireland.

“A lot of people with ME/CFS are clearly not getting the medical care and support that they need in both primary care and secondary care, especially those who are severely affected and do not have access to any form of domiciliary service or a dedicated inpatient facility.” He added: “It would obviously be helpful if the royal colleges could also express their support for implementation of the changes, as it’s not clear whether they remain unhappy with the recommendations downgrading CBT and the removal of GET.”

The same day NICE published its implementation statement, Sajid Javid, health and social care secretary, announced the publication of research priorities for ME/CFS by Action for ME, a charity that supports people with ME.  “We are committed to funding research into this important area,” he said. Javid and his chief scientific adviser, Lucy Chappell, will co-chair an advisory board of experts on ME/CFS, including patients, to discuss what needs to happen next and liaise with the devolved nations.

“We will be developing our own delivery plan later this year and will be working with stakeholders to understand how we can improve experiences and outcomes for people with these debilitating conditions,” he said. “At the heart of the delivery plan will be two core principles. Firstly, that we do not know enough about ME/CFS, which must change if we are to improve experiences and outcomes. Secondly, we must trust and listen to those with lived experience of ME/CFS.”

The BMJ asked three royal colleges for a response to the implementation statement, but none responded before publication.

Source: Ingrid Torjesen. NICE sets out steps NHS must take to implement ME/CFS guidelines. BMJ 2022;377:o1221. https://www.bmj.com/content/377/bmj.o1221

The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS

Abstract:

The British National Institute for Health and Care Excellence (NICE) recently published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded, after an extensive review of the literature, that graded exercise therapy (GET) is harmful and should not be used, and that cognitive behavioural therapy (CBT) is only an adjunctive and not a curative treatment. Leading proponents of the cognitive behavioural model (CBmodel) find it difficult to accept this paradigm shift.
In, for example, an article in The Lancet, they try to argue that the new NICE guideline is based on ideology instead of science. In this article we reviewed the evidence they used to support their claims. Our analysis shows that the trials they used in support suffered from serious flaws which included badly designed control groups, relying on subjective primary outcomes in non-blinded studies, including patients in their trials who didn’t have the disease under investigation or had a self-limiting disease, selective reporting, outcome switching and making extensive endpoint changes, which created an overlap in entry and recovery criteria, using a post-hoc definition of recovery which included the severely ill, not publishing results that contradict their own conclusion, ignoring their own (objective) null effect, etc.
The flaws in these trials all created a bias in favour of the interventions. Despite all these flaws, treatments that are said to lead to recovery in reality do not lead to objective improvement. Therefore, these studies do not support the claim that CBT and GET are effective treatments. Moreover, the arguments that are used to claim that NICE was wrong, in reality, highlight the absence of evidence for the safety and efficacy of CBT and GET and strengthen the decision by NICE to drop CBT and GET as curative treatments for ME/CFS.
Source: Vink M, Vink-Niese A. The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS. Healthcare. 2022; 10(5):898. https://doi.org/10.3390/healthcare10050898 https://www.mdpi.com/2227-9032/10/5/898/htm (Full text)

ME/CFS: Exercise goals should be set by patients and not driven by treatment plan, says NICE

Letter:

Rapid Response:

Patient reports of harm from GET cannot be ignored

Dear Editor

Professor Trudie Chalder from King’s College Hospital states that:

“The NICE guidelines for CFS/ME are at odds with the research evidence. Researchers from different institutions in different countries have found graded exercise therapy and cognitive behaviour therapy to be effective for some patients with CFS.

Evidence has shown they reduce fatigue and improve functioning without harm, if delivered by trained therapists in specialist clinics. Being a clinician and researcher in this field, I can’t help but think clinicians will be confused by this message from a respected organisation.”

Having carefully reviewed all the very extensive evidence on efficacy and safety for graded exercise therapy (GET) from relevant clinical trials, medical experts and from people with ME/CFS, the NICE guideline committee concluded that in addition to there being no sound evidence for efficacy for GET there was also consistent patient evidence of harm, sometimes serious and persisting, occurring.

Read the rest of this letter HERE. 

Source: Charles Shepherd. BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2643 (Published 29 October 2021) BMJ 2021;375:n2643

Science In The Age of Dogma: A Conversation with Dr. William Weir

by Bronc

Dr. William Weir is a retired infectious disease consultant who worked at the Royal Free Hospital in London. He has long been involved in treating myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS) patients and has been a consistent critic of the psychological approach to treating ME/CFS.

From 1998 to 2002 Dr. Weir assisted the U.K. government’s CFS/ME Working Group, which produced a comprehensive advisory report for the U.K. Chief Medical Officer, Sir Liam Donaldson.

Along with Dr. Nigel Speight, Dr. Weir recently authored a paper entitled “ME/CFS: Past, Present and Future,” in which the authors reflect upon the history and controversy surrounding ME/CFS:

“Throughout history, a pattern tends to repeat itself when natural phenomena require explanation. Dogma usually arrives first, then it is eventually replaced by scientific understanding. The same pattern is unfolding in relation to ME/CFS, but supporters of the psychological dogma surrounding its causation remain stubbornly resistant, even in the face of compelling scientific evidence to the contrary.”​
—Dr. William Weir and Dr. Nigel Speight​

Over the last two years Dr. Weir has served on the U.K. government’s ME/CFS Guideline Development Group, tasked with developing official treatment guidelines for the National Institute for Health and Care Excellence (NICE). These clinical guidelines are especially important as they provide a framework of recommendations for health and social care services throughout the U.K.

Read the rest of this interview HERE.

Source: Phoenix Rising, Sept 12, 2021

UK health standards body delays new ME guidance in therapy row

The National Institute for Health and Care Excellence (Nice) has withdrawn long-awaited landmark guidance on ME hours before its planned publication amid a backlash from medical groups.

Charities and patient groups fighting for greater recognition of the poorly understood condition as a medical illness rather than a psychological problem had welcomed the planned guidance, which was due to stop advising doctors to administer a controversial therapy.

This disputed therapy, called graded exercise therapy (GET), involves incremental increases in physical activity to gradually build up tolerance. Patient groups have argued its use suggests those with ME have no underlying physical problem but are having symptoms due to inactivity.

Read the rest of this article HERE.

Charities, patients, and researchers are working together to find the cause and effective treatments for ME/CFS

People with ME/CFS feel let down by the medical establishment because almost all biomedical research until recently has been funded by the charity sector. Almost all government funding has gone into research based on a flawed psychosocial model of causation involving abnormal beliefs and behaviours and deconditioning. This research resulted in the current NICE guideline recommendations, published in 2007, for cognitive behavioural therapy (CBT) and graded exercise therapy (GET).3

Having reviewed clinical trial and patient evidence for these interventions,4 NICE now states in the introduction to the draft of its updated guideline on ME/CFS5 that “because of the harms reported by people with ME/CFS, as well as the committee’s own experience of the effects when people exceed their energy limits, the draft guideline says that any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy (GET), should not be offered for the treatment of ME/CFS.” It also emphasises that CBT is not a treatment or cure for ME/CFS.

Read the full article HERE.

Source: Shepherd C B. Charities, patients, and researchers are working together to find the cause and effective treatments for ME/CFS BMJ 2021; 374 :n1854 doi:10.1136/bmj.n1854 https://www.bmj.com/content/374/bmj.n1854.full

Exclusive: Four members of NICE’s guideline committee on ME/CFS stand down

Four members of the NICE guideline development committee for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) left the group just weeks before the final guideline was due to be published, The BMJ has learnt.

The departures suggest divisions within the committee over the guideline’s final content, which is an update on 2007 guidance on diagnosing and managing ME/CFS. Three have resigned, and one has been removed by NICE.

The draft guidance, published in November 2020,1 included significant changes to the 2007 recommendations2 and raised questions about how the evidence could have shifted so substantially.

In 2007 NICE recommended interventions such as cognitive behavioural therapy and graded exercise therapy for people with mild or moderate ME/CFS, whereas the draft update cites a “lack of evidence for the effectiveness of these interventions.” …

Source: BMJ 2021;374:n1937

The draft updated NICE guidance for ME/CFS highlights the unreliability of subjective outcome measures in non-blinded trials

Abstract:

The National Institute for Health and Care Excellence (NICE) recently published its draft updated guideline on the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded that ME/CFS is a complex multisystem chronic medical condition for which graded exercise therapy should not be used and cognitive behavioural therapy is only a supportive therapy and not a treatment or cure. The draft guidance also highlighted the unreliability of subjective outcome measures in non-blinded trials. High quality randomised controlled ME/CFS trials are now needed to find pharmacological treatments that lead to substantial objective improvement and restore the ability to work.

Source: Vink M, Vink-Niese A. The draft updated NICE guidance for ME/CFS highlights the unreliability of subjective outcome measures in non-blinded trials. J Health Psychol. 2021 Jan 28:1359105321990810. doi: 10.1177/1359105321990810. Epub ahead of print. PMID: 33506707. https://pubmed.ncbi.nlm.nih.gov/33506707/

What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise

Abstract:

BACKGROUND: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), in its most severe clinical presentation, can result in patients becoming housebound and bedbound so unable to access most available specialist services. This presents particular clinical risks and treatment needs for which the National Institute for Health and Care Excellence (NICE) advises specialist medical care and monitoring. The extent of National Health Service (NHS) specialist provision in England for severe CFS/ME is currently unknown.

OBJECTIVES: To establish the current NHS provision for patients with severe CFS/ME in England.

SETTING AND PARTICIPANTS: All 49 English NHS specialist CFS/ME adult services in England, in 2013.

METHOD: Cross-sectional survey by email questionnaire.

PRIMARY OUTCOME MEASURES: Adherence to NICE guidelines for severe CFS/ME.

RESULTS: All 49 services replied (100%). 33% (16/49) of specialist CFS/ME services provided no service for housebound patients. 55% (27/49) services did treat patients with severe CFS/ME and their interventions followed the NICE guidelines. The remaining services (12%, 6/49) offered occasional or minimal support where funding allowed. There was one NHS unit providing specialist inpatient CFS/ME provision in England.

CONCLUSIONS: Study findings highlight substantial variation in access to specialist care for patients with severe presentation of CFS/ME. Where treatment was provided, this appeared to comply with NICE recommendations for this patient group.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

 

Source: McDermott C, Al Haddabi A, Akagi H, Selby M, Cox D, Lewith G. What is the current NHS service provision for patients severely affected by chronic fatigue syndrome/myalgic encephalomyelitis? A national scoping exercise. BMJ Open. 2014 Jul 1;4(6):e005083. doi: 10.1136/bmjopen-2014-005083. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4078780/ (Full article)

 

Overcoming the barriers to the diagnosis and management of chronic fatigue syndrome/ME in primary care: a meta synthesis of qualitative studies

Abstract:

BACKGROUND: The NICE guideline for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) emphasises the need for an early diagnosis in primary care with management tailored to patient needs. However, GPs can be reluctant to make a diagnosis and are unsure how to manage people with the condition.

METHODS: A meta synthesis of published qualitative studies was conducted, producing a multi-perspective description of barriers to the diagnosis and management of CFS/ME, and the ways that some health professionals have been able to overcome them. Analysis provided second-order interpretation of the original findings and developed third-order constructs to provide recommendations for the medical curriculum.

RESULTS: Twenty one qualitative studies were identified. The literature shows that for over 20 years health professionals have reported a limited understanding of CFS/ME. Working within the framework of the biomedical model has also led some GPs to be sceptical about the existence of the condition. GPs who provide a diagnosis tend to have a broader, multifactorial, model of the condition and more positive attitudes towards CFS/ME. These GPs collaborate with patients to reach agreement on symptom management, and use their therapeutic skills to promote self care.

CONCLUSIONS: In order to address barriers to the diagnosis and management of CFS/ME in primary care, the limitations of the biomedical model needs to be recognised. A more flexible bio-psychosocial approach is recommended where medical school training aims to equip practitioners with the skills needed to understand, support and manage patients and provide a pathway to refer for specialist input.

 

Source: Bayliss K, Goodall M, Chisholm A, Fordham B, Chew-Graham C, Riste L, Fisher L, Lovell K, Peters S, Wearden A. Overcoming the barriers to the diagnosis and management of chronic fatigue syndrome/ME in primary care: a meta synthesis of qualitative studies. BMC Fam Pract. 2014 Mar 7;15:44. doi: 10.1186/1471-2296-15-44. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3973969/ (Full article)