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Introduction
The Working Group
The development process
The community's response
Draft Guidelines, Version 2
Release of the final document
The Draft Clinical Practice Guidelines on the evaluation of prolonged fatigue and diagnosis and management of CFS (another copy of V.1 [PDF]) were developed by a Working Group of the Royal Australasian College of Physicians and released for public comment in December 1997. The purpose of the Guidelines was said to be to assist doctors - mainly general practitioners - to diagnose and treat CFS patients, by providing information and "intervention strategies".
Assoc. Prof. Andrew Lloyd, one of the members of the Working Group, described the Guidelines as "a document which basically is reviewing all of the published evidence about the process of diagnosis and the process of management and expectations for recovery" [interview on the Norman Swan "Life Matters" show on ABC radio, May 12, 2000] .
In fact the exercise has seemed to many observers to be more about legitimising psychiatric theories of CFS, and cutting Medicare costs by discrediting most current medical treatments and tests used by CFS doctors.
Despite the apparently balanced composition of the Working Group on paper, quite a few members took little or no part, and the appointment of Professor Ian Hickie (from the University of NSW School of Psychiatry) and his colleagues Associate Professor Andrew Lloyd and Professor Denis Wakefield made the Working Group's recommendations a foregone conclusion. Known in some circles as the "Sydney researchers" they have been publishing together for years with the support of Government research funds (see "Five years' funding for Sydney CFS researchers"). In the early 1990's they were researching the immunological features of CFS compared to depression. At that time, they concluded that although depression is a feature of the illness, it is not a cause [1] and that CFS is not a psychiatric disorder [2]. More recently they have done a turn around. They are now major proponents of the psychiatric illness theory of CFS, and have been outspoken in their criticisms of doctors who still take the search for physical causes seriously. Parts of the text of the draft Guidelines, written by associate Dr Robert Loblay, are closely based on their work and will be familiar to anyone who has read their papers. (See this Critique of the Sydney Researchers by Ted Shaw.)
By contrast, the input of the Working Group's consumer representative Rev. Craig Ellis was largely ignored. Nominated by the Consumer Health Forum of Australia, Rev Ellis consulted among patients and patient groups and produced a CFS Health Consumer Perspective to:
"convey to the RACP Working Group, in summary form, the issues, comments, and concerns of CFS health consumers which need to be included in an explicit manner within the Exposure Draft and, later, within the finished Guideline document."
Quotes from the Consumer Perspective were scattered throughout the draft Guidelines in boxes called "Perspectives" giving the impression that patient concerns had been taken on board. A closer look at the actual text of the Guidelines revealed this to be untrue.
The process for developing clinical practice guidelines is laid down by the National Health and Medical Research Council. After a "systematic review of the scientific literature," all studies and research reports are assigned "quality of evidence ratings" from I to IV.
Recommendations may only be based on Level I and Level II evidence, replicated results from controlled trials. "Consensus opinions of respected authorities, based on clinical experience and/or descriptive reports" is the very lowest level of evidence that may be considered at all reliable. Under these ratings, the clinical experience of a physician such as Dr Richard Schloeffel of NSW- who recently appeared with Dr Lloyd on an ABC radio program because he specialises in treating people with CFS * - would not be considered a reliable level of evidence and would be mere "conjecture".
Critics of the Guidelines say that despite this show of objectivity, the research was selected and interpreted to support a particular point of view. In applying quality of evidence ratings to the remaining data, there was a bias towards studies that purport to show the effectiveness of cognitive behavioural therapy and graduated exercise. Inconsistencies and methodological problems (such as, whether the subjects met the criteria for CFS) were overlooked.
On the other hand, many studies showing organic, physical abnormalities were judged not good enough to include as evidence - which is why some prominent names are missing from the bibliography. And the "exhaustive review and evaluation of the relevant scientific literature" [Ch 6] specifically excluded overlapping syndromes such as fibromyalgia or irritable bowel syndrome, which for many sufferers are an integral part of their illness.
The result is that the Guidelines do not give a complete or accurate picture of the illness. They over-emphasise fatigue, and portray CFS as a neuropsychiatric disorder linked to depression. A quick review of the published articles of the Sydney team is enough to show that they have been writing along these lines for a considerable time. And it is surely no coincidence that the Working Group's research assistant was a colleague of Dr Hickie's at the Uni of NSW School of Psychiatry and co-author of some of those papers.
Many people in the CFS community were very angry about what the Guidelines said, and extremely concerned about the implications for the treatment of people with CFS in Australia if they were introduced. At a presentation on the draft Guidelines at the Sydney CFS Conference in February 1998, both health consumers and doctors expressed vocal opposition. Ted Shaw highlighted the main issues in his Patients' Day speech.
Over 200 submissions commenting on the draft were sent to the Royal Australasian College of Physicians in response to their request for feedback. Some of them were long and carefully argued. In my opinion many were far superior to the draft, which seemed to many to be a disjointed, poorly researched and curiously inconsistent document.
The effort expended by sick people to write these submissions by the extended deadline was remarkable, and for many people (including me!) it was an exhausting last-ditch effort.
The consensus, with people independently picking out the same points for criticism, was striking. Aspects of the draft that people objected to include:
Although the Guidelines had been put out as an "exposure draft" - supposedly to canvass the issues and provoke discussion - they were quickly circulated to GPs around the country with the approval of the Royal Australian College of General Practitioners. The director of research at the RACGP, Dr Ian Steven, was quoted in the Medical Observer saying that the College welcomed them and was "particularly impressed" by their content. (The article did not mention that he was a member of the Working Group.) In other quarters too, Centrelink for example, the draft appears to been adopted as if it were a final version.
The planned date for the release of the final report, May 1998, passed with no final document being produced. For more than three years the draft was listed among the clinical guidelines, consensus statements and position papers on the MJA website, with a note that: "Comments received are now being considered by the Working Group, who are preparing a final version".
Successive deadlines for the final version came and went. At one stage we were told the Guidelines would be published in final form in the August 21st, 2000, issue of the Medical Journal of Australia. The next date given for the final to appear was "end of April 2001" - this date was confirmed as late as February 2001 in a letter from the Minister for Health to the Chair of the National ME/CFS Association. (See the chronology of the Guidelines on the Alison Hunter Memorial Foundation website for more details.)
In April 2001 the introduction to the Guidelines on the MJA website was rewritten, suggesting that plans to produce a final version had been dropped:
This document was produced as an exposure draft by a Working Group seeking constructive criticism from doctors and other health professionals, learned professional bodies, people with CFS and their carers, and any others with an interest in this condition. The Working Group received a great deal of feedback from health professionals and people with CFS, but did not produce another draft of the guidelines.
Because many readers who commented on the draft have found it useful, the MJA will continue to make it available here.
Eventually however, after three years of delay and false alarms, Dr Robert Loblay resumed work on the document, assisted by the original project officer from the Royal Australasian College of Physicians, Victoria Toulkidis.
A letter from the Minister for Health to the Chair of the National ME/CFS Association dated 27 February announced: " ... the Guidelines document has been revised to take into account more recent information, and is due to be distributed to members of the Working Group for final comment by late February 2001. It will then be circulated to stakeholders for further comment by mid April 2001, with a view to public release around the end of April 2001."
The State ME/CFS Societies and the National ME/CFS Association were accordingly on alert, expecting a brief opportunity to read and comment on the revised draft before the final version was published in the Medical Journal of Australia.
At the end of April, an email went out to Working Group members - including the consumer representative, Consumer Health Forum appointee Craig Ellis - telling them they would shortly receive the second draft and would have precisely one week to comment. This timeline, difficult enough for the Working Group, would effectively have cut the consumer groups out of the consultation process altogether. It hardly allowed enough time for them to get copies of the document, never mind read it and report back. The Consumer Health Forum asked for more time. As a result it was agreed to extend the period for comment to four weeks and organise for copies to go direct to consumer groups. The revised draft (Version 2) was finally issued for comment at the end of June 2001, with a closing date for comments of 31 July. - August 2001
As at every other stage of the development of the Guidelines, there were delays with the release of the final version in the Medical Journal of Australia. Publication was first planned for February 2002 but was postponed due to the MJA moving offices. The next date of 15 April also slipped. Eventually the Guidelines appeared as a special supplement in the 6 May 2002 edition of the MJA (Volume 176 Supplement S17-S55).
REFERENCES
* ABC "Nightlife" radio program, 7 May 2001
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