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An Assessment of the Chronic Fatigue Syndrome
Clinical Practice Guidelines

Craig Ellis - May, 2002

This document explains my personal position in relation to the published version of the Australian CFS Clinical Practice Guidelines. It explains why I decided finally to give the guidelines my qualified support with cautious acceptance of the management strategies advocated therein.

I am no longer a Consumers' Health Forum representative on the Royal Australasian College of Physicians working group set up to produce the CFS Clinical Guidelines. My comments in no way reflect any policy of, or endorsement by, these or any other organisations.

I present this document simply as a statement of the processes undertaken during my consideration of the pre- and post-publication guidelines.

The result of problems on the various sides of the debate concerning the guidelines has seen the alienation of the very people in the CFS community who invested the time and effort to make submissions and contribute to the process. Some people have been angered while others, disillusioned. A cynical distrust now permeates some people’s views of the guidelines and the Working Group. This outcome was unnecessary and could have been avoided, or at least reduced; by all parties, notwithstanding the working group management, State CFS Societies and members of ME/CFS Association of Australia Inc.

However, whilst such an observation is easy made in hindsight, such an ideal situation was never achieved. I believe it is now time for us all to move on from the continual and often harmful negativity so evident during the past seven years. It is my belief that the guidelines validate Chronic Fatigue Syndrome as a severe illness while providing a useful, if imperfect, example of scientific evidence-based content and a process upon which others may build, change or rectify.

Introduction

This document explains my position in relation to the published version of the Australian CFS Clinical Practice Guidelines.1 For many weeks prior to their public release, I weighed-up the contents, effects of, and opinions about, the guidelines. This time included many conversations with people whom I judged to have been relatively objective and long-time observers of the guideline-forming process. I finally decided to give the guidelines my qualified support. This included cautious acceptance of the management strategies advocated therein. I could not see that the guidelines would cause more harm than the good such an educative document would provide. Despite the hard work of all those who contributed to them, it is my hope that the guidelines will have a short life! By that I mean that future research will provide the answers to the many questions inherent in these guidelines; thus making revision a definite and more-than-welcome necessity.

• I am indebted to Jim Oakley (one-time President and honorary life-member of the ME/CFS Society of Victoria) for his primary work on this document, for the initial idea of an assessment model, and for allowing me, so generously, to adapt his work to my own purposes.

In order to review the Guidelines as objectively as possible, a three-part assessment guide was devised. First, questions were grouped in four levels of priority. These lists of questions are not meant to be exhaustive, but indicative of the concerns of people with CFS. Secondly, answers to these questions provided a rationale for an interpretation, judgment or assessment of the Guidelines. Thirdly, an assessment is provided which is partly based on experience, knowledge and information provided by CFS health consumers in the guideline-forming process (for example see: Ellis, C.T. A CFS Health Consumer Perspective 1997).

The highest (most important) priority for assessment is assigned to issues classified in Level 1. The lowest (least important) priority is assigned to issues classified in Level 4.

I do not share the philosophy that events of the past will necessarily or directly affect people's actions or life-situations of the future. This philosophy negates the concept of "free will" and one's ability to make independent decisions. Nor do I subscribe to a much-touted theory that the guidelines can be blamed for any malpractice of medical practitioners, or subsequent harm by them of people with CFS. These particular biases of the writer are stated in order to enhance the underlying premise of this document, in agreement with the guidelines,

"…that evidence-based clinical practice involves not only use of the best available research evidence, but also exercise of the practitioner's clinical judgment, taking account of individual patient preferences." 1

LEVEL 1

Questions that determine Level 1 Priority for assessment:

Will the guidelines cause genuine harm to people with CFS?
Will the guidelines benefit people with CFS and be of assistance to their doctors?

A Rationale for giving Level 1 Priority for assessment:

The physicians' maxim is, 'First do no harm', and so it should be with the guidelines. A determination had to be made whether genuine harm could come to people with CFS as a result of methods of diagnosis or management advocated, or as a result of any other statements made in the guidelines. This was a top priority in assessing the document.

The whole purpose of the guidelines is to assist people with CFS by instructing their doctors in appropriate methods of diagnosing and managing the illness, and by educating doctors about different aspects of the illness. If the guidelines do not benefit people with CFS in this way their publication has been a waste of time, effort and taxpayers' money. Therefore, the issue of benefit is also included in the top level of priority.

An Assessment of the Level 1 Priority - Benefit

I believe the guidelines will significantly help doctors in the diagnosis and management of CFS, and give them a much better appreciation of many other aspects of the illness. Whilst conservative in nature, the chapter on diagnosis is in line with international practice and recommendations. Taken as a whole, the management strategies (including pharmacological interventions) - if implemented according to the guidelines - will definitely be of benefit to some, even many, people with CFS

An Assessment of the Level 1 Priority - Harm

In the view of CFS health consumers who made submissions to the Working Group, the greatest potential for harm arising from the use of the guidelines lies in the application of the management strategies of graded exercise therapy (GET), cognitive behaviour therapy (CBT) and sleep management.

In addressing the first two of these, I note that the guidelines:

• Stress the need for a collaborative approach between the patient and doctor.
• Advocate a strategy individualised according to the patient's level of disability and personal preferences, and subsequently modified according to the response of the patient to treatment.
• Advise that new activities should be stopped before they produce a significant exacerbation of symptoms.
• Provide three different conceptual frameworks for management that can be utilised according to the preferences of the patient and the expertise of the doctor.
• Promote the concept of self-monitoring of key symptoms and associated disability.
• Acknowledge most of the limitations of the available evidence. This includes the fact that in published papers, improvement with CBT/GET has not been observed in all patients or in all studies. It also includes the fact that it is difficult to extrapolate the results to patients with more severe disability; and that many studies have significant refusal and dropout rates, which may reflect on the acceptability of the treatment regimens.

In assessing the appropriateness of CBT/GET as presented in the guidelines, one must acknowledge that these therapies are now firmly on the agenda for the management of CFS, not just in Australia but in other countries as well. In 2001 a major systematic review was published in the Journal of the American Medical Association, which evaluated published trials for CFS, and concluded that:

"Interventions that have shown promising results include CBT and GET." 2

This review was a combination of two conducted independently by the University of York in England and the University of Texas in the USA. Given the growing evidence base, I concur with the statements in the guidelines that CBT/GET "may be effective for some people with CFS."

• The main issue to consider was whether the implementation of these management strategies according to the methods described in the guidelines would cause genuine harm to people with CFS, or to a subgroup of people with CFS. I believe that, given the points noted above, there are enough safeguards in place to protect people with CFS from genuine harm when these therapies are administered in accordance with the content and intent of the guidelines. I believe that "genuine harm" would mean anything more severe than a minor/moderate exacerbation of symptoms for a couple of days at most. It is, therefore, reasonable for the guidelines to state that "sustained improvements are rarely achieved without some setbacks and exacerbations of symptoms along the way." Minor exacerbations cannot be defined as "genuine harm."

• The use of CBT/GET appears to be accepted even by researchers who have a firm belief in the pathophysiological basis of the illness. In relation to CFS, Professor Anthony Komaroff of Harvard Medical School - an internationally respected researcher, and his co-authors, who have spent many years studying the pathology of CFS - have said that:

  "Cognitive behavioural therapy should be used on an individual basis if possible. A consistent pattern of living - including work, rest, sleep and physical activity - should be applied, and a slow increase of daily activities introduced. It should be explained that even a slow increase in physical exercise can cause an exacerbation of symptoms, but often these subside with time and there is improvement." 3

  and

"Recently, cognitive behaviour therapy has been shown in randomised, controlled trials to be an acceptable, effective treatment for CFS; of importance is the fact that improvements are sustained and continue over 6-12 months of follow-up." 4

• People with CFS can face years - even decades - of illness, and many endure an incredible amount of suffering. Apart from the physical and psychological effects of the illness itself, other factors such as financial difficulties and relationship problems resulting from the illness can cause further hardship. If anything can help to alleviate this suffering, it should be considered as an important management option. At present, the limited amount of available research evidence supports the use of CBT/GET above any other treatment strategy for people with CFS.

It is pointless waiting for medical research to find a pharmacological 'cure' or significant treatment for most people with CFS because this is likely to take at least another ten years (or longer) based on the current inadequate funding levels and the small number of researchers studying the illness. Biomedical research into CFS needs to be encouraged and promoted as a matter of real importance and urgency, but the development of an effective treatment is necessarily a medium to long term goal. This is of little comfort to people with CFS who need help now.

• When there is no cure, the ideal situation for anyone with a chronic disease is to experience just the disease itself without all the accumulated stresses and problems that compound the difficulty of managing the condition. Factors such as social isolation and loss of confidence are not trivial in the context of long-term disability; similarly, the adverse pathophysiological consequences of extended periods of inactivity cannot be dismissed lightly. This is why the guidelines state that

  "... people with CFS should be encouraged to adopt the widest possible view of the medical, physical, and psychological management strategies to assist in coping with the illness."1

The non-pharmacological management strategies advocated in the guidelines address issues that are common to chronic illness. That is, issues that are overlaid on the disease process itself. For example, exercise - graded or non-graded - has been shown to be helpful for at least some people in several chronic diseases that are associated with severe fatigue and other symptoms well known to people with CFS. These diseases include post-polio syndrome, rheumatoid arthritis, multiple sclerosis and fibromyalgia.

• A controversial issue is the potential for graded exercise programs to cause harm to people with CFS, particularly those at the more severe end of the disability spectrum. Recently, media attention focussed on a young man with CFS who was advised by his doctor to undertake half an hour of vigorous walking each day. He tried to comply with this program but his condition deteriorated significantly.

This was obviously not a graded exercise program. The approach taken by this doctor falls well outside the approach advocated in the guidelines (which were not available in their present form when these unfortunate circumstances occurred). Mistreatment could still occur, even now that the revised guidelines have been published!

• The real issue is whether the problem lies with the guidelines themselves, or with individual practitioners who do not follow the recommendations in the guidelines. For example, with just about any prescription drug it is possible to harm people by giving them a dose that is higher than that recommended. The approach taken in our society is not to ban medical drugs because of their potential for harm if misused, but to deal specifically with those doctors who do not comply with recommended dosage levels.

If graded exercise programs are misused or misinterpreted by some doctors, the problem clearly lies with those doctors and not with the guidelines. The guidelines do recommend a cautious approach and do discuss limitations in the available evidence. The focus should be on those doctors who abuse the therapy, as it would be if any other form of medical malpractice had been inflicted on a patient.

In reality, it is a futile exercise to try and eliminate graded exercise from the CFS agenda. A much more constructive approach is to educate doctors and patients about its appropriate use in a primary care setting.

• The issue of sleep management is not particularly well covered in the guidelines. However, the guidelines now properly acknowledge that evidence for the effectiveness of sleep management strategies in CFS is lacking, and just provide suggestions based on what has been found to be helpful in other illnesses. The guidelines are now trying to be helpful rather than dogmatic. I believe that if the content and intent of the guidelines are followed, the implementation of the sleep management strategies will not cause genuine harm to people with CFS. The acknowledged lack of evidence means that doctors and patients who try different sleep management strategies cannot justifiably have pre-determined expectations of what the outcome should be. If, by cutting out daytime naps, a patient's condition deteriorates to the extent that there is more than a short term, minor exacerbation of symptoms, there is no basis in the guidelines for the doctor to insist that this strategy should be maintained in the hope of improvement in the future.

Thus, my overall conclusion is that the CBT/GET/sleep management strategies contained in the guidelines are now presented in such a way that, if implemented according to the guidelines, should not cause genuine harm to some to people with CFS. I acknowledge the subjectivity of these judgments. Some people may feel that there are definitely not adequate safeguards in place to prevent harm from coming to people with CFS. There is no 'right' or 'wrong' answer here.

I believe that the published version of the guidelines falls within the lower end of the range of acceptable approaches to the management of CFS. What is being advocated is a new approach to managing CFS in general practice, and it necessarily entails some uncertainties; hence my attitude to the management strategies is one of 'cautious acceptance'.

As for the rest of the document, I do not believe it contains anything that could cause genuine harm to people with CFS. While some statements in the guidelines may portray people with CFS somewhat inaccurately, their impact is likely to be small in the overall context of the document.

LEVEL 2

Questions that determine Level 2 Priority for assessment:

a) Do the guidelines address issues of importance to people with CFS?

• Do they treat CFS as a serious illness?
• Do they treat people with CFS with respect and empathy?
• Do they treat CFS as a medical illness, a psychological illness, or something in between?
• Do they adequately describe CFS as experienced by the patient?
• Do they encourage a cooperative and supportive patient-doctor relationship?
• Are the management strategies advocated presented in such a way that they are of practical use?
• Are the management strategies advocated presented with appropriate cautions about the uncertainties in the evidence and the potential harmful effects of the treatments?
• Are day-to-day problems, as experienced by people with CFS, adequately acknowledged?
• Is the feedback provided by consumers to the Working Group reflected in the guidelines?
• Overall, are people with CFS given a 'fair go'?

b) Do the guidelines address issues of importance to doctors?

• Are major issues such as diagnosis and management adequately addressed?
• Is the scope of the document appropriate?
• Is the presentation of the document user-friendly?
• Are the guidelines comprehensive?
• Are they well referenced?
• Are they up to date?
• Are strategies presented to help facilitate a beneficial doctor-patient relationship?

A Rationale of Level 2 Priority for assessment:

The second level of priority includes typical issues that are important to people with CFS, and to doctors, respectively. These are the aspects of the guidelines that are particularly relevant to each of these groups. The answers to the questions will determine how each group perceives the guidelines. Again, this list of questions is not meant to be exhaustive, but indicative.

There are also some major themes which run through the guidelines, and one significant grouping of Tables, which I have included in Level 2 because of the potential they have to influence readers.

An Assessment of Level 2 Priority issues:

• Previously the question 'Do the guidelines address issues of importance to people with CFS?' was asked. I believe, the answer is a qualified 'yes'. However, some of the issues I listed for assessment are not covered adequately. For example, the guidelines do not describe CFS adequately and as experienced by the patient. Only core symptoms are discussed. There is no acknowledgment that fatigue is not necessarily the most disabling or most distressing symptom. The feedback provided by consumers to the Working Group has only been incorporated partially into the guidelines. Overall, I believe that the guidelines do a satisfactory job of addressing the major issues of concern to the majority of people with CFS in the general population.

• Regarding the question 'Do the guidelines address issues of importance to doctors?', my agreement is more emphatic. This opinion has been gained from reading the feedback provided by medical colleges and societies, and by individual clinicians and researchers, to the Working Group after the release of the first and second drafts. Most of the respondents rated the format and scope of the document as good or very good. The major focus of the guidelines is on diagnosis and management, and this should be of significant assistance to doctors. Furthermore, the guidelines are reasonably well referenced, and they are up to date: 181 (34%) of the 528 papers in the list of references were published after the release of the first draft, that is, in 1998 or later. The guidelines also emphasise the need for a beneficial patient-doctor relationship and provide some guidance to doctors on how to facilitate this. Overall, the guidelines may be received well by doctors who are, after all, the target audience.

Major Themes: One of the major themes running through the guidelines is that fatigue states occur on a continuum, and it is only those at the more severe end of the continuum who would receive a diagnosis of CFS. This is one way of looking at it, although there are other ways of interpreting the diversity in illness severity and duration. Not all fatigue states may be part of the same pathophysiological continuum as CFS; no one knows yet. Therefore, this theme is not 'wrong', but it may reflect the views or biases of those on the Working Group.

Groups of Tables: Tables 1.3 to 1.6 are where the medical research findings are summarised. While there are some omissions from these tables (e.g. research into erythrocyte deformation, the aerobic capacity of people with CFS, and the possible role of some microbial agents such as parvovirus B19 in causing the illness), they nonetheless provide a very good summary and will give doctors and other readers a rapid appreciation of the current state of research findings. These tables reflect the often-contradictory findings that are reported by different CFS research groups.

• The statements and comments contained in these tables are consistent with major reviews of the biology of CFS presented in the medical literature. For example, consider the following quotations relating to CFS made in one review 3:

  "[T]he link between infections and CFS remains uncertain."
  "These studies indirectly suggest the presence of a chronic viral infection, but are far from constituting proof of such infection."
  "So far, no microbes have been isolated and correlated to symptoms."
  "Although not specific for CFS, depressed NK cell function has been consistently seen. The clinical implications of this finding remain uncertain."
  "Other markers of immune activation also have been found…It is not clear that these abnormalities have any relationship to the symptoms reported by patients with CFS."…………

  "Thus, there is considerable evidence of abnormalities in the CNS, particularly the limbic system, in patients with CFS. The aetiology of the abnormalities, and their relationship to the symptoms of CFS, remains obscure."

These statements were made in a November 1999 review co-authored by Professor Anthony Komaroff Like those in the guidelines, the comments in this review reflect the uncertain significance associated with many pathophysiological findings in CFS. This does not mean that there is not a pathophysi-ological basis to CFS, but simply that the research is 'work in progress' and it is too early to draw firm conclusions about the exact nature of the pathophysiological processes responsible for making people sick.

Another example of this is found in the paper by Professor Kenny De Meirleir and colleagues published in the American Journal of Medicine. This study examined the distribution of 2-5A binding proteins in the cells of people with CFS and controls. The findings are very interesting and warrant further research; however, the authors note in their paper that:

"The biological significance of these 2-5A binding protein in patients with chronic fatigue syndrome is not known." 5

Overall, I give the guidelines at least a satisfactory rating for Level 2 priority issues.

LEVEL 3

Questions that determine Level 3 Priority for assessment:

Are individual paragraphs, statements and tables in the guidelines accurate, fair and reasonable? Are they supported by appropriate references?

A Rationale for Level 3 Priority assessment:

There are instances in the guidelines where individual statements or paragraphs may not be accurate, fair or reasonable. When these occur in isolation (i.e. they are not part of themes running through the guidelines), I have given them a Level 3 priority. They are still important, but they do occur in isolation and their impact on the reader is likely to be limited.

An Assessment of Level 3 Priority issues:

The majority of paragraphs, statements and tables in the guidelines are accurate, fair, and reasonable. Some are not. These have been documented in submissions received by the Working Group and are Level 3 issues: individual statements or isolated paragraphs, which are either biased, inaccurate or misrepresentative. In my view, the Level 3 issues alone are not of sufficient importance or impact to cause me to withdraw support for the guidelines.

LEVEL 4

Questions that determine Level 4 Priority for assessment:

Are the referencing and proofreading accurate and complete?
Was the process of developing the guidelines appropriate?

A Rationale for Level 4 Priority issues:

Here I have placed minor issues such as referencing and proofreading. These do need to be accurate and complete, and therefore should be included in an overall assessment of the guidelines. However, even if the referencing and proofreading are poor, the impact on doctors and people with CFS is likely to be small. I believe this justifies the low priority ranking.

In addition, in Level 4 process issues, such as the functioning of the Working Group, have been considered as well as the relationship and information flow between the Working Group and other stakeholders such as patient groups and clinicians.

• There are two main reasons why I have given a Level 4 ranking to process issues. Firstly, one doubts that even if all aspects of the process of guideline-formation had been conducted impeccably, with perfect consultation with stakeholders, adherence to a timetable and so on, the contents of the final guidelines would have been significantly different from the final product. There has been much input, which has influenced the contents of the guidelines. These include the literature review conducted by members of the Working Group; the personal views and knowledge of the members of the Working Group; and the written submissions received by the Working Group, amongst others. Concerns were conveyed to the Working Group via submissions, letters, telephone conversations, the CHF representative, and media publicity. There is absolutely no doubt that, even with the controversial process that was actually followed, the Working Group was fully informed about the concerns of people with CFS and some clinicians in relation to the contents of the two public drafts.

Whatever process had been followed by the Working Group, cognitive behaviour therapy and graded exercise would still be included as management strategies in the final document. The chapter on diagnosis would essentially be the same. Only minor aspects of the guidelines may have been different if the process had been different. For example wording, expression, table inclusions etc.

Secondly, for ranking process issues in Level 4, for the overwhelming majority of people with CFS, and for the overwhelming majority of doctors, the process by which the final guidelines were completed is of no relevance. It is only the contents of the guidelines that will affect them or be of interest to them.

• If the results of overseas epidemiological studies are applicable in Australia, then it can be expected that between 40,000 and 140,000 Australians will meet research criteria for CFS at any one time. An even greater number of people will have idiopathic chronic fatigue, and these people will also come under the influence of the guidelines. However, the number of submissions received by the Working Group from CFS health consumers (patient organisations and individuals) in response to the release of the first draft was only about 200 (and about 70 from health professionals and their organisations). Even if every member of every patient organisation falling under the umbrella of the ME/CFS Association of Australia was keenly interested in the guidelines and the process by which they were developed, this would amount to 7,000-8,000 people at most. It is, therefore, clear that the overwhelming majority of people with CFS had little or no interest in the guidelines-formation process and would not have contributed to this process.

An Assessment of Level 4 Priority issues:

The proofreading, referencing and presentation of the guidelines are fine. In contrast, the guideline-development process had many problems. For example, to name a few, overall time of the project (over six years) was too long, the project was "on hold" for two years and "momentum" was lost. There were only three face-to-face working group meetings and two teleconference calls. Working group contact and debate was very limited, with often-unrealistic timetable demands for written CFS health consumer responses.

The result of these problems has been the alienation of the very people in the CFS community who invested the time and effort to make submissions and contribute to the process. Some people have been angered while others, disillusioned.

A cynical distrust now permeates some people's views of the guidelines and the Working Group. This outcome was unnecessary and should have been avoided.

Qualifications

Because there are aspects of the guidelines that could be improved significantly, it is difficult to give them unqualified support. The following points represent my major concerns with the published version of the document:

• Discussion of the spectrum of severity of CFS, and the symptoms that may be associated with the illness, is poor. This will not necessarily affect the process of diagnosing CFS, but doctors may be confronted with symptoms they do not associate with CFS, which could cause unnecessary confusion.
• It would have been more helpful if the guidelines contained a table detailing the outcomes of CBT/GET trials. This would have allowed both doctor and person with CFS to make better-informed decisions about the effectiveness, relevance and appropriate use of these therapies.
• The detection and treatment of neurally mediated hypertension could have legitimately been discussed in Chapter 3, and would have potentially given GPs another avenue by which to help some of their CFS patients. Treatment options other than fludrocortisone do exist.
• Far more CFS health consumer "evidence," as provided in written submissions could have been included. This inadequacy calls into question the interpretation and use of the National Health and Medical Research Council's "levels of evidence" as required in evidence-based guidelines. CFS health consumer experience can often be seen to be ahead of research projects and agenda. Such experience needs to be treated more seriously. Other suitable formats within the guidelines could have been used to enable their expression. It could also be used to pre-empt suitable research projects.

Overall Assessment

The guidelines receive at least a satisfactory grade for the issues listed as Level 1 and Level 2 priorities, as discussed previously. For Level 3 priority issues I believe some problems still exist, but in the overall context of the guidelines these problems are generally minor (but annoying nonetheless). For Level 4 priority issues, the guidelines receive an unsatisfactory grade owing to problems with the guideline-development process. However, as I discussed above, the impact of the process on the content of the guidelines - and thus on the overwhelming majority of people with CFS - is very limited.

June 2002

Consumer Health Forum representative, December 1996 - June 2002
Member, CFS Guidelines Working Group, December 1996 - May 2002
Member, ME/CFS Society of Victoria Inc.

References

1. The Royal Australasian College of Physicians CFS guideline working group, Chronic Fatigue Syndrome Clinical Practice Guidelines - 2002, The Medical Jour-nal of Australia, Supplement, 6 May 2002, Vol. 176.

2. Whiting P, Bagnall A-M, Snowdon AJ et al. Interventions for the Treatment and Management of Chronic Fatigue Syndrome. A Systematic Review. JAMA 2001; 286: 1360-1368.

3. Evengard B, Schacterle RS, Komaroff AL. Chronic fatigue syndrome: new insights and old ignorance. Journal of Internal Medicine 1999; 246(5): 455-469.

4. Komaroff AL, Buchwald DS. Chronic Fatigue Syndrome: An Update. Annu. Rev. Med. 1998; 49: 1-13.

5. De Meirleir K, Bisbal C, Campine I et al. A 37 kDa 2-5A Binding Protein as a Po-tential Biochemical Marker for Chronic Fatigue Syndrome. Am J Med. 2000; 108: 99-105.

Craig Ellis (2002) All Rights Reserved

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