FAILURES OF PROCESS
RACP CFS CLINICAL PRACTICE GUIDELINES DEVELOPMENT 1996–2002

In 1996 the RACP WG committed to
"following the procedures laid down in the recently published NHMRC Guidelines for the Development and Implementation of Clinical Practice Guidelines".[1]

This commitment cannot be substantiated.

The process does not conform to NHMRC Guidelines in major areas, including

• The inconsistency and biased selectivity of scientific evidence
• The inadequate recording and incorporation of key consumer issues
• The failure to pretesting/piloting in a selection of relevant settings

Application for NHMRC accreditation has not proceeded.

The absence of terms of reference

The composition of the Working Group (WG)

• Imbalance with three members of one research team, and two of the team, Dr Andrew Lloyd and Professor Ian Hickie, responsible for both the literature search and the writing of Draft 1 raises questions of "conflict of interest"
• apparent limited participation of many other members who, while representing speciality areas, had little CFS expertise to critically evaluate the "evidence"
• under–representation of clinicians who provide care for patients with CFS in their daily practice, over the long term
• under–representation of the consumer voice reflecting a broad perspective/experience

The failure to address key consumer issues

• direct intervention by the RACP WG in the selection and appointment of the single consumer representative
• dismissal of the need for a consumer focus group to ensure full account of the consumer perspective on specific issues of concern such as cognitive behaviour therapy, graded exercise and the recognition of the broad spectrum of CFS including severity

Despite funding approval in early 1996, the obscure and delayed notice (23 November 1996) of the RACP CFS Clinical Practice Guidelines WG and the request for submissions with a two week closure date (5 December 1996)

Allocated response times to drafts were always brief, and disadvantaged clinicians and consumers despite the length of process.

The change of the original brief from

"guidelines on the most clinically relevant and cost effective methods of diagnosing and treating chronic fatigue syndrome" [2]

to

"the evaluation of prolonged fatigue and the diagnosis and management of chronic fatigue syndrome" (Draft 1 1997)

The broadening of the brief to give particular emphasis to fatigue, is of special concern. The psychiatric aspects of fatigue states encompasses the prolific research publications of three research team members of the WG, in particular Professor Ian Hickie.[3]

Two of these same members were responsible for both the literature search and the writing of Draft 1 1997.

While the prevalence of chronic fatigue is common with estimates of 2,316 per 100,000 population, chronic fatigue syndrome requires 6 month persistence of symptoms to meet specific criteria for diagnosis with estimates at 98–267 per 100,000.

The wide access and promotion of the RACP Draft 1 has led to many reported instances of harm, illustrated in documents appended outlining the serious case of a very ill young girl removed from her family for five years by court proceedings despite a specialist diagnosis of severe CFS. (Case of Stacey Appendix 4)

Serious ethical questions arise from the dissemination of the RACP Draft 1 CFS Guidelines and the role of the Medical Journal of Australia (MJA)

• The MJA's continuous publication of the original RACP Draft 1 on its website since December 1997, promoting it to doctors with the words "Because many readersŠ have found it useful the MJA will continue to make it available here".
  While acknowledging
  "the great deal of feedback from health professionals and people with CFS"
  the MJA completely disregards the overwhelmingly negative criticism of the draft by consumers, clinicians who treat CFS, and international researchers, for its bias and potential to lead to harm
• the premature promotion of the RACP Draft 1 by a member of the WG who is quoted under headlines "RACGP approval for chronic fatigue guide" in the January 1997 Medical Observer, saying "As a college we welcome this initiative... and have been particularly impressed with the content of the guidelines". Doctors were then guided to the MJA website
• in the January 24, 2002 Congressional Hearing the US government's Dr William Winkenwerder stated that they would have
  "patient–centered evidence based clinical practice guidelines"
  implemented this month—Veteran's Health Administration (VHA) and Department of Defence (DOD) "Clinical Practice Guideline for the Management of Medically Unexplained Symptoms: Chronic Pain and Fatigue".
  "Version 1.0 pending approval" (dated July 2001) Section E lists under Information Sources .
  "4. Royal Australasian College of Physicians' Clinical Practice Guidelines on the Evaluation of Prolonged Fatigue and the Diagnosis and Management of Chronic Fatigue Syndrome; http: //www.mja.com.au/public/guides/cfs/cfs1.html"
  Importantly, no reference is made to the draft status or 1997 publication date of the document. Professor Ian Hickie is listed as a member of the Working Group.

In 1996 the Commonwealth Department of Health and Aged Care (Medicare Branch) provided the initial grant of $130,000 later extended to $200,000, to the RACP. The "conditions of grant" were for an initial 6 month period with the expectation that the process would take at least 12 months, therefore an application for extension could be made at the appropriate time.

The specific "conditions of grant" and the numbers of applications for extension have not been made public. Nor has the allocation funds spent

Limited discussion

WG face to face meeting and teleconferences were held

21 September 1996 – Sydney
12 December 1996 – Teleconference
8 February 1997 – Sydney
26 July 1997 – Sydney
31 March 1998 – Teleconference
9 April 1998 – Teleconference (for those not able to make 31 March teleconference)

Only five meetings were held in more than 6 years and none in the last four years despite strong requests from clinicians and consumers for major revision

The failure of the Commonwealth Government and Department of Health and Aged Care to ensure the RACP complied with the "conditions of grant", and completed the project in a reasonable time.

1. Dr Robert Loblay — CFS Clinical Practice Guidelines 25 February 1997
2. Dr Michael Wooldridge, Minister for Health Hansard p.3843 10 September 1996
3.

• Hickie IB, Hooker AW. Hadzi – Pavlovic D etal Fatigue in selected primary care settings : sociodemographic and psychiatric correlates. MedJAust 1996;164: 585–588
• Hickie I, Kochera A, Hadzi — Pavlovic D. etal The temporal stability and comorbidity of prolonged fatigue : a longitudinal study in primary care. PsycholMed 1999; 29: 855–861
• Hadzi — Pavlovic D. Hickie IB, Wilson AJ etal Screening for prolonged fatigue syndromes : statistical and longitudinal validation of the SOFA scale. Soc Psychiatry Epidemiol 2000; 35: 471–479
• Hickie I, Hadzi–Pavlovic D, Ricci C. Reviving the diagnosis of neurasthenia. PsycholMed 1997; 27: 989–994

4. Buchwald D, Umali P, Umali J, etal Chronic fatigue and chronic fatigue syndrome: Prevalence in a Pacific North West health care system. Annals of Internal Medicine 1995;12: 81–88

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