Tag: critique

NICE behaviour: ME guideline is unworkable

Comment on: Diagnosis and management of chronic fatigue syndrome or myalgic encephalomyelitis (or encephalopathy): summary of NICE guidance. [BMJ. 2007]

 

The National Institute for Health and Clinical Excellence (NICE) recommends that everyone with mild or moderate myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) should be offered a course of either cognitive behaviour therapy (CBT) or graded exercise therapy (GET).1

This is despite published evidence remaining weak (especially for group CBT) and inconsistent 2. Patient evidence submitted to the chief medical officer’s report concluded that CBT produced “no change” in 67% of cases and made the condition “worse” in 26% of cases.3 Around 50% of respondents reported that inappropriate exercise therapy had also made their condition “worse.”3

When the NICE estimate on prevalence is used this controversial recommendation will affect some 200 000 people. A one to one course of CBT covering 12 to 16 sessions will cost well over £1500. The cost of a professionally supervised exercise therapy programme is also likely to be substantial.

So where is around £300 million of new money going to come from at a time when very limited funding for some of the newly established NHS clinical services for people with ME/CFS is now being cut?4 And where are all the therapists going to come from? Those already in post often cannot even cope with their current workload.

These are important questions that I raised at a NICE implementation and planning meeting in October 2006—but nobody from NICE could provide a convincing answer. These recommendations are going to be of no value whatsoever to many people with ME/CFS. They are also going to be impossible to implement owing to a lack of both funding and human resources.

You can read the rest of this comment here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1976494/

 

Source: Shepherd CB. NICE behaviour: ME guideline is unworkable. BMJ. 2007 Sep 15;335(7619):528. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1976494/ (Full article)

 

How common is chronic fatigue syndrome; how long is a piece of string?

Comment on: Prevalence of chronic fatigue syndrome in metropolitan, urban, and rural Georgia. [Popul Health Metr. 2007]

One of the most difficult tasks in medicine is to accurately measure how common illnesses are. Why do we do it? Justifications include being able to plan health care and public health priorities, as well as highlighting specific diseases for extra funding for both health care and research. Yet the jobbing physician at the sharp edge of clinical practice cares little about the exact prevalence of a disease or illness, since this is all too obvious from the frequency of the problems presented by patients who come through the door.

You can read the rest of this comment here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1904177/

 

Source: White PD. How common is chronic fatigue syndrome; how long is a piece of string? Popul Health Metr. 2007 Jun 8;5:6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1904177/ (Full article)

 

Chronic fatigue syndrome

I have just read the review of treatments for chronic fatigue syndrome (CFS) in the October issue of the JRSM. It included my study, but some of the details were inaccurate and the overall judgement was unfair and potentially misleading.

In the original ‘York’ review of the various treatments for CFS, my study received a validity score of two. However, after clarification regarding the statistical analysis, this was changed to three (Kleijnen, personal communication). Chambers et al. were clearly not aware of the ‘correction’ and published the original score. It’s a minor issue, but it wasn’t the only one.

Another example relates to the assessment of the results. According to the table (p. 511), the programme had no overall effect—but as the authors noted in their recent review for NICE (http://www.nice.org.uk/page.aspx?o=368933, appendix 1, p. 423), there were ‘significant differences between groups for fatigue… and somatic symptoms’. They would also have been aware that 82% of the patients rated themselves as ‘better’ or ‘much better’ and that 23% had improved to such a degree that they were discharged.

To summarize, patients reported less fatigue, fewer somatic symptoms, less anxiety and depression after six months compared to the controls, and the improvements were maintained at follow-up. Yet the authors judged the treatment had ‘no overall effect’.

My study is one of the few which has assessed an alternative to the CBT-based programmes. It’s also one of the few controlled trials to include pacing, a strategy which many patients regard as a particularly helpful way of managing their limited energy. In my opinion, it deserved an accurate evaluation and a fair summary of the outcome. It didn’t get that.

You can read the rest of this comment here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761664/

Comment on: Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. [J R Soc Med. 2006]

 

Source: Goudsmit EM. Chronic fatigue syndrome. J R Soc Med. 2007 Jan;100(1):7. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761664/ (Full article)

 

A step backwards for the patients

During the publication of the report on the diagnosis and treatment of chronic fatigue syndrome / myalgic encephalomyelitis (CFS / ME) 9.6.2006 I expressed strong concerns that the report would have negative consequences for patients. Especially I expressed the requirement to undergo graded exercise and cognitive behavioral therapy for the granting of benefits would have disastrous consequences for those affected.

It was unfortunately not many weeks before the statement was true – discounts in insurance law with reference to the findings of the report. In the meta-analysis of the Knowledge Centre  is included internationally criticized studies. They have methodological weaknesses, partly because treatment trials are done on heterogeneous populations (selection bias). It is problematic to generalize findings to patients with myalgic encephalomyelitis, because one cannot know which patients in a heterogeneous group that has benefited from the treatment. Those who wrote the report chose knowingly omitting information about major user surveys showing that graded exercise therapy and cognitive behavioral therapy generally either do not work or are injured.

You can read the rest of this comment here:  http://tidsskriftet.no/2006/10/brev-til-redaktoren/et-tilbakeskritt-pasientene

 

Source: Stormorken E. A step backwards for the patients. Tidsskr Nor Laegeforen. 2006 Oct 19;126(20):2688-9; author reply 2689. [Article in Norwegian] http://tidsskriftet.no/2006/10/brev-til-redaktoren/et-tilbakeskritt-pasientene (Full article)

With the back to the future

Health care is confronted regularly with patients we understand little of and where our advice is inadequate. Chronic fatigue syndrome is one such condition. It is now more important to think than to summarize the discouraging research findings that have emerged so far.

You can read the rest of this comment here:  http://tidsskriftet.no/2006/10/kommentar/med-ryggen-mot-fremtiden

 

Source: Bruusgaard D. With the back to the future. Tidsskr Nor Laegeforen. 2006 Oct 19;126(20):2686. [Article in Norwegian] http://tidsskriftet.no/2006/10/kommentar/med-ryggen-mot-fremtiden (Full article)

 

Treatment of patients with the chronic-fatigue syndrome

Abstract:

In the last few years, the chronic-fatigue syndrome has been recognised as an important health problem. In a recent report, the Health Council of the Netherlands suggested that the capacity for treatment be increased. Cognitive behavioural therapy and graded exercise training are treatment options of first choice.

A recently published, uncontrolled evaluation of a Dutch clinical rehabilitation programme based partly on these methods proved to be successful. Unfortunately, due to the uncontrolled character of the study, it remains unclear which elements in the treatment were responsible for the success. Which patients should be included in a costly clinical rehabilitation programme also remains unclear. More in general, there is room for empirical studies of treatment allocation, not in the least because of the frequently occurring comorbidity. Good progress has been made in the treatment of the chronic-fatigue syndrome, but we are still far removed from evidence-based, stepped care, treatment programmes.

Comment on: [Favourable results of a rehabilitation programme with cognitive behavioural therapy and graded physical activity in patients with the chronic-fatigue syndrome]. [Ned Tijdschr Geneeskd. 2006]

 

Source: Jonker K, van Hemert AM. Treatment of patients with the chronic-fatigue syndrome. Ned Tijdschr Geneeskd. 2006 Sep 23;150(38):2067-8. [Article in Dutch] https://www.ncbi.nlm.nih.gov/pubmed/17036854

 

Myalgic encephalopathy–an inexact report with doubtful conclusions

Norwegian Knowledge Centre for Health Services was recently commissioned to clarify the scientific basis for the diagnosis and treatment of Myalgic encephalopathy (ME). The report is unfortunately imprecise and conclusions questionable.

Myalgic encephalopathy (ICD-10: G 93.3) is a disease or a spectrum of diseases which are described in many clinical reports internationally. Patients have symptoms of multiple organ systems, often with widespread pain and neurocognitive disorders, and they have an abnormal response by physical or mental activity, with sometimes extreme fatigue and worsening of symptoms and long recovery time. The etiology is unclear.

You can read the rest of this comment here: http://tidsskriftet.no/2006/08/brev-til-redaktoren/myalgisk-encefalomyelopati-upresis-rapport-med-tvilsomme-konklusjoner

 

Source: Eriksen W. Myalgic encephalopathy–an inexact report with doubtful conclusions. Tidsskr Nor Laegeforen. 2006 Aug 24;126(16):2144; author reply 2144-5. [Article in Norwegian] http://tidsskriftet.no/2006/08/brev-til-redaktoren/myalgisk-encefalomyelopati-upresis-rapport-med-tvilsomme-konklusjoner (Full article)

Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution

Abstract:

BACKGROUND: A recent article by Reeves et al. on the identification and resolution of ambiguities in the 1994 chronic fatigue syndrome (CFS) research case definition recommended the Checklist Individual Strength, the Chalder Fatigue Scale, and the Krupp Fatigue Severity Scale for evaluating fatigue in CFS studies. To be able to discriminate between various levels of severe fatigue, extreme scoring on the individual items of these questionnaires must not occur too often.

METHODS: We derived an expression that allows us to compute a lower bound for the number of items with the maximum item score for a given study from the reported mean scale score, the number of reported subjects, and the properties of the fatigue rating scale. Several CFS studies that used the recommended fatigue rating scales were selected from literature and analyzed to verify whether abundant extreme scoring had occurred.

RESULTS: Extreme scoring occurred on a large number of the items for all three recommended fatigue rating scales across several studies. The percentage of items with the maximum score exceeded 40% in several cases. The amount of extreme scoring for a certain scale varied from one study to another, which suggests heterogeneity in the selected subjects across studies.

CONCLUSION: Because all three instruments easily reach the extreme ends of their scales on a large number of the individual items, they do not accurately represent the severe fatigue that is characteristic for CFS. This should lead to serious questions about the validity and suitability of the Checklist Individual Strength, the Chalder Fatigue Scale, and the Krupp Fatigue Severity Scale for evaluating fatigue in CFS research.

Comment on: Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. [BMC Health Serv Res. 2003]

 

Source: Stouten B. Identification of ambiguities in the 1994 chronic fatigue syndrome research case definition and recommendations for resolution. BMC Health Serv Res. 2005 May 13;5:37. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1175848/ (Full article)

 

Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: data are insufficient and conclusion inappropriate

Comment on: Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. [BMJ. 2005]

 

Editor—I have concerns about the design and interpretation of the study reported by Stulemeijer et al on cognitive behaviour therapy for adolescents with chronic fatigue syndrome.1 The trial arms were not matched for the number of contacts with healthcare professionals. Experience from larger and more carefully controlled randomised interventional trials of patients with chronic fatigue syndrome has clearly shown that short term improvement in symptoms is related directly to the maintenance of regular contacts with healthcare professionals rather than the therapeutic effect of the intervention itself and consequently, the improvement is not sustained once the contact is lost.2

The authors did not offer patients in their waiting list the opportunity to meet therapists regularly for five months but without having cognitive behaviour therapy. Few follow up data on patients in the intervention arm show that the specific treatment benefit was carried forward without regular contacts with the therapists. A cautious approach is essential in inferring direct benefit from cognitive behaviour therapy in the intervention arm (as opposed to short term benefit from close contact with therapists). The level of activity in some of their participants whom the authors considered to be passive remained unclear.

You can read the rest of this comment here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC555921/

 

Source: Chaudhuri A. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: data are insufficient and conclusion inappropriate. BMJ. 2005 Apr 2;330(7494):789-90; author reply 790. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC555921/ (Full article)

 

Patients with chronic fatigue syndrome are being ignored

Comment on: What causes chronic fatigue syndrome? [BMJ. 2004]

 

Editor—Earlier this year more than 28, 000 people signed a petition calling for urgent government funded research into the physical causes of myalgic encephalomyelitis and chronic fatigue syndrome. Such is the frustration of people who do not believe that their views are being listened to by the medical establishment.

So White’s editorial reviewing the possible causes of myalgic encephalomyelitis and chronic fatigue syndrome should be welcome news.1 But is it?

Many doctors support the idea of a disease model with predisposing, precipitating, and perpetuating factors. However, White does not offer any innovative suggestions as to how this could be used to better understand an illness that now covers a wide variety of clinical presentations and an equally diverse range of patho-physiological findings. Having created this mess, the medical profession must now accept that this heterogeneous group of patients is unlikely to have the same pathoaetiology and respond to the same form of treatment, be it pharmacological or behavioural.

What is needed is thought provoking research that dispenses with the oversimplistic view that myalgic encephalomyelitis and chronic fatigue syndrome entail little more than a vicious circle of abnormal illness beliefs and behaviour, inactivity, and deconditioning. The World Health Organization now classifies both myalgic encephalomyelitis and chronic fatigue syndrome as neurological disorders in section G93.3 of ICD-10. The time has come to look at the neurology of central fatigue—instead of pouring yet more money into the bottomless pit of psychological research.

You can read the rest of this article here:  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC535506/

 

Source: Shepherd C. Patients with chronic fatigue syndrome are being ignored. BMJ. 2004 Dec 11;329(7479):1405. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC535506/ (Full article)