BACKGROUND HISTORY OF ME/CFS & FMS DEFINITIONS

 

OCTOBER 1995

 

In 1995 Canada operated an agency under the name Laboratory Centre For Disease Control which was eventually eliminated and now is under the Candian Institutes of Health Research (CIHR).

 

LABORATORY CENTRE FOR DISEASE CONTROL (LCDC)  - CANADA

 

            We had written the LCDC on July 14th, 1995 requesting information as to what LCDC was going to do in Canada now that the new December 1994 definition and criteria had been published from the Centers for Disease Control in Atlanta.  As no reply had been received, we followed up our request asking for a reply which we finally received via Courier on October 19th, 1995 and is quoted in its entirety:

 

            “Thank you for your letter and information package on the above-named subject.  I apologize for the delay in responding.

            While I fully appreciate and share your concern about Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Fibromyalgia (ME/CFS/FM), these conditions, unfortunately, remain a very complex and intriguing group of diseases.  Although many theories have been put forward to explain their causes, there still remains many unresolved issues that need further research and elucidation.

           

To this end, the Laboratory Centre for disease Control (LCDC) held a workshop on CFS/ME in September of 1989, to explore the diagnosis of the illness, its proper case definition and promising areas for future research.  Its proceedings were published in January 1991, and are believed to have assisted the scientific community to formulate research studies to investigate the case of this disorder……”   “As alluded to in the Minister’s letter to you in June, because of budgetary constraints, the Laboratory Centre for Disease Control is not in a position to conduct its own research on these diseases at this point.  We will, however, continue to work with NHRDP and MRC to facilitate research in this important area…..”  Signed:  Dr. J.Z. Losos, MD, DECH, FRCPC, FACPM, Director General, Laboratory Centre for Disease Control

No follow ups were ever instituted after the original workshops in 1989 and 1991

 

MARCH 1997

 

THE NEXT STEP - MEDICAL PROFESSIONALS’ PARTICIPATION - UPDATE

 

            In our last newsletter, we reported that now that the 1994 U.S. ME/CFS Research Definition has been accepted by our Laboratory Centers for Disease Control, we have asked for the help of the medical professionals to join us in requesting the Federal Government to set a standard set of rules for clinically diagnosing ME and FM. A form letter was enclosed with ‘QUEST’ to be signed by your physician(s) and we had asked you to take this form to your doctor’s appointment with you.

 

            We are happy to report that the medical professionals agree with our stand and are therefore signing the letter and returning it to our organization for follow up.  If you did not receive such a form, please contact us and we will be pleased to send it to you. This form letter, with instructions, was also sent to all support groups.

 

AUGUST 1997

 

LABORATORY CENTRE FOR DISEASE CONTROL- UPDATE

 

            We had a meeting with an official of the LCDC on July 28th, 1997 for two hours.  As mentioned above, they were very impressed by the fact that we were able to get the assistance of the medical profession.

 

            We also told them that we were trying to establish approximately how many ME/FM people there are in Canada who are ill with ME and FM through asking every support group to let us know how many people are in their group (whether or not they attend meetings or not). LCDC are very interested in those figures and we therefore again urge all groups to let us know these required figures

 

SEPTEMBER 1997

 

THE NEXT STEP - MEDICAL PROFESSIONALS’ PARTICIPATION - UPDATE

 

            As of September 30th, 1997 we have received 151 replies from doctors across Canada who are diagnosing and treating ME/FM.   Of those 151 replies, only 4 will see new patients as they are swamped.  We hope that as we receive more responses, other doctors are willing and/or able to help more ME/FM patients.

 

            Our Laboratory Centre for Disease Control (LCDC) is very interested in the fact that the medical profession is joining our ‘quest’ for a standardized clinical diagnosis for ME/FM and requested that we keep them advised of developments. 

 

DECEMBER 1998

 

MP SURVEYED DOCTORS IN PEEL REGION RE: ME/FM - 25% Responded

 

            Ms Colleen Beaumier, MP of Brampton West-Mississauga due to contacts by her constituents, did a survey of General Practitioners’ in the Peel Region.  -  (Ms Beaumier uses “ Fibromyalgia / chronic fatigue syndrome” which we have condensed  to ME/FM).  

 

1.  Would you describe ME/FM as a curable psychological illness?  Yes: 12%      No: 79%        

 

2.   Would you describe ME/FM as an organic illness?      Yes:  50%         No: 38%  Uncertain:  6%      

 

3.  Have you ever diagnosed ME/FM in a patient?  Yes:  79%       No: 10%   Uncertain: 6% 

 

4.  Have you ever been requested by an insurance company to provide a secondary opinion as to any illness or injury?

     Yes:           35%    No: 50%

 

5.  In your practice during the past 5 years, how many ME/FM cases have you or are you currently treating? 0: 2%            1-10: 73%                   11-20: 6%       >20: 13%

 

6.  In your experience do most ME/FM patients become     Cured?            0%

     Get Better?            29%   Get Worse? 10%   Stay the same? 62%

 

7.  Are you familiar with the use of tender point identification as a method of diagnosis?           Yes: 94%

 

8.  Are you able to identify the locations of the tender points?       Yes: 85%  No: 12%

 

9.  Which fibromyalgia symptoms do fibromyalgia patients indicate most impacts their ability to function?

 

Widespread Pain:       81%    Headaches: 25%         Chronic Fatigue: 70%           Impaired Memory: 17%

 

Sleep Problems:    67%          Stiffness:    29%         Balance Problems: 6%          Cold Extremities:    5%

 

Irritable bowel:           15%    Irritability: 25%          Depression/anxiety: 40%       Cognitive Problems:17%

 

10.  Which fibromyalgia symptoms are most easily treated? Widespread Pain: 13% Headaches: 9%      

Chronic Fatigue:         -           Impaired Memory2%  Sleep Problems:   29%       Stiffness:   21%  Balance Problems: 2%      

Cold Extremities:-   Irritable Bowel:  7%      Irritability: -  Depression/anxiety: 29%         Cognitive Problems:     2%

 

11.  What seems to work best in treating fibromyalgia?  Antidepressants:  73%    Aerobic exercise: 50%  Chiropractic:  4%          Massage:  21%  Narcotics: -  Painkilling drugs:   6%        Physical Therapy:23%  Psychiatric: 13%

Relaxation:     15%     Rest:    17%     Steroid Injections: -    Support Groups:  40%

Tranquilizers: -            Anti-Inflammatory drugs:  6%   No Treatment works: 4%  Do Not know:2%

 

12.  Does Fibromyalgia cause sufficient disability to prevent people from regular/unadjusted working or

        performing normally? Yes: 69%            No: 12%   Uncertain: 6%

 

13.  Have you ever supported a fibromyalgia patient in a claim for either Long Term Disability or Canada

        Pension Plan?   Yes: 63%          No: 29%

 

14.  Would you agree that your profession would benefit  from a standardized criteria used to diagnose FM?  Yes 75%    

        No: 6%   Criteria already exists: 13%

 

15.  If such a criteria were to be developed, which of the following groups should be asked to provide opinions on the definition?

 

                                         Very Important     Some Importance    No Importance

General Practitioners?                        73%                12%                -          

Insurance Companies?           15%                13%                            38%

Chiropractors?                                   12%                46%                            15%

Mental Illness Specialists?     38%                38%                            6%

Rheumatologists?                   79%                4%                              2%

Others:                                               15%

 

16.  How many tender points, in your opinion, would warrant a diagnosis of fibromyalgia?

 

1-3:  -  4 - 7: 17%   8-10:  21%     11-15:  21%    >15: 6%   Don’t Know: 9%       

Don’t believe to be a significant method: 8%

 

JUNE 1999

 

            Dr. Bruce Carruthers of British Columbia. and Dr. Anil Jain of Ontario kindly and generously donated their time and expertise to the draft of the Canadian Definitions, Diagnostic and Treatment Protocols for Myalgic Encephalomyelitis and Fibromyalgia.  Our Director of Education, Marj van de Sande has worked diligently with these doctors on this draft and compiled the document into an 'easy to locate' format.  They have worked for approximately one year on this document and the 1999/7 draft is now ready for peer-review.

 

ME/FM CLINICAL DEFINITIONS PRESENTED TO LCDC/MINISTER OF HEALTH

 

            At a July 21, 1999 meeting at the Laboratory Centre for Disease Control (LCDC) in Ottawa, we presented this draft definitions/protocols document to the Minister of Health's representatives.  At this meeting, we were advised that there were no funds available for the peer-review as Health Canada has not allocated any funds for ME/FM. This came as a shock to us.   In the Honourable Allan Rock's  May 31, 1999 letter to us he stated, "The development of draft clinical definitions for ME/FM is a milestone in the fight against this complex and tragic condition."

 

OCTOBER 1999

 

ME/FM CLINICAL DEFINITIONS/PROTOCOL - UPDATE

 

            We are pleased to advise that on Wednesday, January 5, 2000 we have a meeting with the Director General of the Laboratory Center for Disease Control, and who will also represent the Minister of Health    On the agenda for this meeting is a discussion of funding for a peer-review of the ME/FM clinical definitions and treatment protocols and funding for the dissemination of the information to the Canadian doctors.

 

              The clinical definitions and treatment protocols are necessary because, to date, there are no standardized protocols followed across Canada.  The 1994 ME definition established by the U.S. Centers for Disease Control is a research definition not a clinical one.  Once a clinical definition has been established, it will give doctors the knowledge necessary to diagnose and treat.

 

DECEMBER 1999

 

ME/FM CLINICAL DEFINITIONS/PROTOCOL - UPDATE - ANNOUNCEMENT

 

As you know, the National ME/FM Action Network has been working with Dr. Anil Jain, Dr. Bruce Carruthers to establish a draft standardized clinical definition for ME/FM.  Ms Marj van de Sande, our Director of Education, has coordinated all their efforts into the draft which has taken over a year to accomplish.

 

This draft clinical definition was presented to the Minister of Health through the Laboratory Center for Disease Control in July 1999.  Since then we have been in even closer contact with the LCDC and Health Canada in an effort to get the definitions peer-reviewed by experienced ME/FM doctors.

 

FEBRUARY 2000

 

PEER REVIEW PANEL FOR DEFINITION/PROTOCOLS DOCUMENT 

 

Are you a doctor or do you know of doctors who would be qualified for the Peer Review Panel for the ME/FM Definition/ Protocols document? Doctors should be experienced in diagnosing/treating ME/FM patients or in related research and should be open-minded and have an attitude that will encourage consensus. If you have suggestions, please send  any name, address, phone and fax numbers along with the area of specialty and the reasons for the recommendation.

 

APRIL 2000

 

MINISTER OF HEALTH NEEDS TO HEAR OUR UNITED VOICE

 

            Enclosed please find a letter addressed to the Honourable Allan Rock, Minister of Health.  Please sign the letter and mail it to: Hon. Allan Rock, Minister of Health

            We must show the Minister of Health that you support the important work that we are doing in establishing a standardized clinical definition for ME and FM and Treatment Protocol.  We need to send him a loud and united message expressing the importance of having the Canadian Clinical Definitions and Treatment Protocol peer-reviewed by experienced doctors in ME/FM at the Symposium

 

 

OCTOBER 2000

 

SYMPOSIUM OFF BUT PEER REVIEW OF ME/FM CLINICAL DEFINITIONS ON SCHEDULE

 

The Canadian ME/FM Clinical Definitions and Treatment Protocols are scheduled to be peer-reviewed on March 30th to April 1,2001.  Once a consensus has been reached, preparations will take place to have the results published in a Canadian medical journal.

 

Our Board of Directors has always preferred that we hold a Symposium after the ME/FM Clinical Definitions and Treatment Protocols are peer reviewed and published so that doctors across Canada can gather together and share the information.  However, when Health Canada invited us to participate in the planning of a Symposium, we took the opportunity to do so. Our main goal has always been the peer review of the ME/FM clinical definitions and treatment protocols.

 

On November 28th, 2000 after serious consideration, the Planning Committee for the First National Symposium on Multiple Chemical Sensitivities (MCS), Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM) reached the decision to cancel the Symposium based on a number of considerations, including lack of secured funding. Although the Symposium will not take place in March, the peer-review of the ME/FM Clinical Definitions and Treatment Protocols will take place.

 

SYMPOSIUM OFF BUT PEER REVIEW OF ME/FM CLINICAL DEFINITIONS ON SCHEDULE

 

The Canadian ME/FM Clinical Definitions and Treatment Protocols are scheduled to be peer-reviewed on March 30th to April 1,2001.  Once a consensus has been reached, preparations will take place to have the results published in a Canadian medical journal.

 

Our Board of Directors has always preferred that we hold a Symposium after the ME/FM Clinical Definitions and Treatment Protocols are peer reviewed and published so that doctors across Canada can gather together and share the information.  However, when Health Canada invited us to participate in the planning of a Symposium, we took the opportunity to do so. Our main goal has always been the peer review of the ME/FM clinical definitions and treatment protocols.

 

On November 28th, 2000 after serious consideration, the Planning Committee for the First National Symposium on Multiple Chemical Sensitivities (MCS), Chronic Fatigue Syndrome (CFS) and Fibromyalgia (FM) reached the decision to cancel the Symposium based on a number of considerations, including lack of secured funding. Although the Symposium will not take place in March, the peer-review of the ME/FM Clinical Definitions and Treatment Protocols will take place.

 

JANUARY 2001

 

UPDATE: PEER-REVIEW  OF DRAFT OF THE CANADIAN ME/FM CLINICAL DEFINITIONS

AND TREATMENT PROTOCOLS TO TAKE PLACE MARCH 30TH TO APRIL 1, 2001

 

We are delighted to announce that the Peer-review of the Canadian ME/FM Clinical Definitions and Treatment Protocols, drafted by Dr. Bruce Carruthers of British Columbia and Dr. Anil Jain of Ontario will take place this March 30th to April 1st, 2001 in Toronto, Ontario. Canadian and International doctors, experienced in diagnosing and/or treating ME/FM or doing ME/FM research, were selected to do the peer-review by a committee of doctors using guidelines developed by  Health Canada.  Crystaal Corporation of Mississauga is the sponsor of this historical event and they have hired Science & Medicine Canada Inc., a management company, to help the National ME/FM Action Network run this event.

 

HOW THE DRAFT DEFINITIONS WERE REVIEWED BY PANEL BEFORE OFFICIAL MEETING

The Expert Medical Subcommittee established by Health Canada selected two Expert Medical Consensus Panels, one for ME/CFS and one for FMS.  This subcommittee of Health Canada also established the "Terms of Reference" for the panels.  One of the stipulations was that at least one member of each panel must be nominated by each of the five stakeholder groups of government, universities, clinicians, advocacy and industry.  The twenty-five doctors who were selected received over 80 nominations representing numerous nominations from each of the stakeholder groups.  Four doctors from outside Canada were allowed to sit on each panel.  A wide range of expertise was represented on the panels including rheumatologists, specialists in internal medicine and infectious disease, a neurosurgeon/ neuroresearcher, a haematologist, etc.  There were treating clinicians, teaching university professors and researchers including world-renowned researcher, Dr. Kenny De Meirleir of Belgium who has approximately 300 scientific publications.  His research on the dysfunction of the RNase L antiviral defense pathway may lead to a clinical marker for ME/CFS.

 

The panels have been reviewing the documents since December 2000.  The consensus meetings were held in Toronto on March 30 to April 1, 2001. 

 

APRIL 2001

 

CANADA  MAKES  HISTORY  IN  ME/CFS  AND  FMS

CONSENSUS MEETING:  A RESOUNDING SUCCESS

 

 

Canada makes history in ME/CFS and FM as both expert panels came to UNANIMOUS consensus on their clinical definition /protocols document.

 

It will take several months before these documents will be published.  The documents have to be finalized and sent back to the panels and then published in a reputable medical journal.  Once they are published, we will be able to release the definitions and diagnostic and treatment protocols to the public.

 

The existing U.S. Center for Disease Control (CDC) definition for CFS and the American College of Rheumatology (ACR) definition for FM were established for research purposes.  While these definitions serve a purpose for research, they are too restrictive in the clinical setting.  The focus of the clinical definitions is to have the physician look at the whole spectrum of pathologies of these illnesses.  The definitions are backed up in the documents by research findings. There are sections on diagnostic protocols and treatment protocols.  This means that the family physician will have a "manual" that explains how to diagnose and treat these patients.  Having the documents reviewed and endorsed by panels of experts gives them credibility and will empower the doctors treating these illnesses.  For the patient, it means earlier diagnosis and appropriate treatment which is essential in order to lessen the impact of these illnesses. 

 

The Honourable Allan Rock, who was unable to attend the consensus meeting, sent a written congratulatory message that was read at the meeting. The atmosphere of the welcome reception had an aura of excitement and the positive energy was absolutely electrical.  Crystaal Corporation, which sponsored the consensus meeting, was awed at the enthusiasm of the doctors.  They said that in all their years of working with the medical community they had never experienced such positive, productive and professional panels! 

 

Dr. Jon Russell and Dr. Thomas Romano, who were both members of the panel that developed the existing ACR research definition for FM, add to the credibility of the clinical definition document.   Dr. Nancy Klimas was excited about the unanimous agreement on the ME/CFS clinical definition and told me she previously had been on two panels in the United States to develop a clinical definition but they could not come to an agreement.  When Dr. Dan Peterson, a recognized world expert in ME/CFS and was a treating physician for the Lake Tahoe epidemic, was asked what he thought of the clinical definition document for ME/CFS, his response was, "I love it, I love it, I love it!"

 

I would like to thank Lydia Neilson for her vision of clinical definitions, her commitment and her ongoing lobbying of Health Canada.  I would also like to thank her for giving me the honour of introducing Dr. Jain and Dr. Carruthers at the Consensus Meeting.  The National ME/FM Action Network would like to thank Health Canada for selecting excellent consensus panels. A very special thank you to all the members of the Expert Medical Consensus Panels for their enthusiasm and productive work, with a huge special thanks to Dr. Carruthers and Dr. Jain.  Their dedication is overwhelming and they have been truly wonderful to work with. 

 

FIBROMYALGIA EXPERT CONSENSUS PANEL: Dr. Steven Barron; Dr. Bruce Carruthers; Dr. Stu Donaldson; Dr. James Dunne; Dr. Emerson Gingrich; Dr. Dan Heffez, USA; Dr. Anil Jain; Dr. Frances Leung; Dr. Daniel Malone, USA; Dr. Thomas Romano, USA; Dr. Jon Russell, USA; Dr. David Saul; Dr. Donald Seibel.

 

MYALGIC ENCEPHALOMYELITIS / CHRONIC FATIGUE SYNDROME EXPERT CONSENSUS PANEL: Dr. Allison Bested;  Dr. Bruce Carruthers; Dr. Kenny De Meirleir, Belgium; Dr. Pierre Flor-Henry; Dr. Anil Jain;  Dr. Pradip Joshi; Dr. Nancy Klimas, USA; Dr. Martin Lerner, USA; Dr. James Mc Sherry; Dr. Dan Peterson, USA; Dr. Peter Powles; Dr. Jeff Sherkey.

 

OCTOBER 2002

 

NEWS RELEASE

 

CANADA LEADS THE WORLD WITH A CLINICAL DEFINITION FOR MYALGIC ENCEPHALOMYELITIS /

CHRONIC FATIGUE SYNDROME (ME/CFS)

 

A Clinical Definition (clinical diagnostic criteria) for ME/CFS has been developed by an Expert Consensus Panel.  Although created to standardize research, the American Centers of Disease Control (CDC) Definition is being used in Canada and most other countries to diagnose ME/CFS.  There has been a growing demand for diagnostic criteria designed for a clinical setting.  In response to a survey by the National ME/FM Action Network, doctors across Canada overwhelming concurred that a clinical definition, along  with diagnostic and treatment guidelines, would be the most helpful items in diagnosing and treating ME/CFS patients.  In addition to the clinical definition, the consensus document includes a discussion of the prominent symptoms, clinical practice diagnostic and treatment guidelines based on the best available research evidence, and an overview of research on ME/CFS.  Dr. Bruce M. Carruthers of B. C., lead author, stated that  “The Clinical Definition will enable clinicians to make an early diagnosis which may assist in lessening the impact of ME/CFS in some patients.   It will reduce the expensive problem of patients being sent to many specialists before being diagnosed, and will allow patients to receive appropriate treatments in a timely fashion.”  

A definition was developed and published in 1988 and later revised in 1994 under the aegis of the CDC.  These definitions along with the Australian and Oxford, U.K definitions were developed to standardize research and not designed to be used for clinical settings.

The CDC definition requires that the patient must have persistent or relapsing fatigue that lasts more than six months and four of eight other criteria.  One problem with this definition is that fatigue is a symptom of many diseases.  By making other cardinal symptoms optional, it increases the diagnostic difficulty of distinguishing the pathological fatigue of ME/CFS from other fatiguing illnesses with overlapping symptoms.

The Expert Consensus Panel developed a clinical case definition that provides a flexible, comprehensive framework.  More of the prominent symptoms are compulsory and symptoms that share a common region of pathogenesis are grouped together to give clarity and completeness.  In addition to severe prolonged fatigue, the definition includes the hallmark symptoms of post-exertional malaise and/or fatigue, sleep dysfunction, pain, two or more of the given neurological/cognitive manifestations, and at least one of the given symptoms from two of the categories of autonomic, neuroendocrine and immune manifestations.  The illness must persist for at least six months.  Diagnostic exclusions and common co-morbid entities are also mentioned.

The Expert Consensus Panel felt that the Clinical Case Definition more adequately expresses the complexity of symptoms in a given patient’s pathogenesis.  It should reflect ME/CFS as a distinct medical entity and help distinguish it from other overlapping medical conditions in the absence of a definitive laboratory test. The eleven physicians, who made up the Expert Consensus Panel, have between them diagnosed and/or treated more than 20,000 ME/CFS patients.   All authors approved the Consensus Document.

According to a large American study by Dr. Leonard Jason, approximately 422 per 100,000 people (approximately 150,000 Canadians) suffer from ME/CFS compared to 26 per 100,000 women who have breast cancer.  ME/CFS is a severe illness that can be debilitating. There is no known cure.   It often begins with a viral type infection such as an acute respiratory or flu-like illness.  But instead of recovering, the person’s health deteriorates and many other symptoms appear.  A number of viruses have been studied but so far there is no conclusive support for any one pathogen causing the illness.  Numerous studies have confirmed that there is a biochemical breakdown of one of the body’s defense pathways used to fight viruses, which supports the theory that ME/CFS is triggered by an infection.  Other triggers and mechanisms are also being investigated. 

The development of a clinical definition, and clinical diagnostic and treatment guidelines is a milestone in the fight against this complex and often debilitating illness!

 

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols – A Consensus Document was published in Volume 11, Number 1, 2003 in the Journal of Chronic Fatigue Syndrome and Published by The Haworth Medical Press © ISSN: 1057-3321

 

Fibromyalgia Syndrome: Canadian Clinical Working Case Definition, Diagnostic and Treatment Protocols – A Consensus Document was published in Journal of Musculoskeletal Pain (11(4):3-107, 2003.  Co-Published simultaneously in The Fibromyalgia Syndrome: A Clinical Case Definition for Practitioners, pp. 3-108 ISBN: 0-7890-2574, Published by © Haworth Press Inc.

 

About the Journal of Chronic Fatigue Syndrome

The Journal of Chronic Fatigue Syndrome presents original research, practical clinical management, case reports, and literature reviews that provide a comprehensive understanding of CFS. The journal is edited by Dr. Kenny DeMeirleir, organizer of the World Congress on Chronic Fatigue Syndrome and Related Disorders, co-editor of Chronic Fatigue Syndrome: Critical Reviews and Clinical Advances (Haworth), and a board member of the American Association for Chronic Fatigue Syndrome; and Dr. Neil Roland McGregor, author of a large number of published papers, conference presentations, and conference abstracts on chronic pain, chronic fatigue and chronic neurological diseases.

 

FEBRUARY 2003

 

 ACCOLADES AND SUPPORT FOR THE

ME/CFS CLINICAL WORKING CASE DEFINITION, DIAGNOSTIC & TREATMENT PROTOCOLS

 

Dr. Ellie Stein, MD FRCP(C) Alberta, Canada:  " I have now received all 6 copies that I ordered of the guidelines (ordered extra so I can educate my colleagues).  I am very pleased with the paper, it really validates much of what I believe and have read and they avoided sliding down the CBT/GET slope.  Very impressive.  I have already quoted Appendix 12 (my personal favorite) in one letter for a patient. "

 

Maryann Spurgin, PH.D, ME Society of America, U.S.A:  "This case definition is a vast improvement over the 1994 CDC Fukuda criteria. The Fukuda criteria makes ‘fatigue’ a compulsory symptom but downplays and makes optional post-exertional sickness and other cardinal symptoms. Because of this, the Fukuda criteria has led to tremendous misunderstanding in research, clinical care, and treatment protocols by fostering the selection of patients with chronic fatigue and fostering the view that exercise is an appropriate therapeutic approach.

“In sharp contrast, the new Canadian clinical case definition specifically selects patients who worsen with exercise. The clinical definition makes it very clear and compulsory that in order to meet the diagnostic criteria, the patient must become symptomatically ill after exercise (this is termed ‘post-exertional malaise’), and must also have neurological, neurocognitive, neuroendocrine, dysautonomic (for example, orthostatic intolerance), and immune manifestations. That is, worsening with exercise, and many symptoms other than fatigue, must be present for a patient to meet the diagnostic criteria. This case definition will go a long way to help distinguish ME/CFS patients from chronic fatigue patients, depressed patients, and patients with other illnesses who do improve with exercise. The Canadian definition specifically states that patients ‘become worse after exercise rather than better.’ This counters the view being put forward by persons such as Dedra Buchwald and Simon Wessely who hold that the disease is a behavioral problem leading to deconditioning. Unfortunately, such work does not even give patients the now-respectable status of a psychiatric illness, but rather refers to vague terms like ‘perception’ and ‘interpretation of symptoms’. The new case definition, much of which is backed by research, is a strong counter statement to the view held by Buchwald and Wessely.

 

“We encourage patients and patient groups to urge acceptance of this case definition in government documents so that appropriate research into the pathophysiology of the disease can be implemented and inappropriate, possibly harmful treatments will not be fostered.  This case definition strengthens the ability to select and diagnose ME/CFS by sharpening the definition. We hope that patients will promote this definition by taking it to their primary care physicians, donating copies to medical libraries, and contacting their local media.

“We would like to thank Lydia Neilson and her group, The National ME/FM Action Network, the physicians
from Canada and the USA, and the Journal of Chronic Fatigue Syndrome, all of whom worked together to bring this case definition to fruition."

 

The Myalgic Encephalomyelitis Association of Ontario:  "Congratulations to the National ME/FM Action Network for achieving this remarkable consensus document published in the Journal of Chronic Fatigue Syndrome Volume 11 (1) by Haworth Press, New York. A special thanks to Marj van de Sande for the tremendous amount of work and energy involved for her to coordinate the project. We can all hope that this publication will increase having our voices heard on the severity of the symptoms of our illness, bring clarity and understanding of ME/CFS and stimulate more research. Thank you Lydia for having the fortitude to keep focused on achieving the completion of this project. Congratulations again and job well done!!"

 

MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME – CLINICAL CASE DEFINITION AND TREATMENT PROTOCOLS – IMPACT ON ASSESSING OCCUPATIONAL DISABILITY -                        

 

By: Hugh Scher, Barrister & Solicitor

 

Recent publication of the clinical case definition and diagnostic and treatment protocols, which was reached on consensus of a panel of Canadian, American and European experts on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), represents a significant achievement in the understanding of this illness, and its effects on the daily lives of those affected by it.  The panel’s experts include specialists in internal medicine, physiology, cardiology, microbiology, immunology, infectious diseases, haematological pathology, sleep disorders, psychiatry and family practice.  The multifaceted, multidisciplinary approach of the consensus document will benefit clinicians involved in the diagnosis, assessment, and treatment of patients with ME/CFS.

The clinical case definition and diagnostic and treatment protocols have significant implications for the manner of assessment and adjudication of disability benefits’ claims.  Firstly, the clinical case definition sets out specific criteria for the diagnosis and assessment of ME/CFS, which are more encompassing than the CDC criteria that were developed to standardize research.  The clinical definition includes the prominent features of severe, prolonged fatigue, post-exertional malaise, sleep and neurocognitive dysfunctions, pain, and manifestations of dysfunction involving the endocrine, immune, and central and autonomic nervous systems.

Secondly, the consensus document makes it clear that there is no known cure or magic bullet for the treatment of ME/CFS.  The publication sets out guidelines for management and treatment programs. The paramount role of the primary treating physician in directing rehabilitation efforts is stressed. It emphasizes that the patient’s impairments/limitations and activity boundary fluctuations are part of the pathophysiology of the illness and they must be respected and reflected in any management, treatment, or rehabilitation program.  The management section sets out a series of practical life-style practices and self-help therapies that may assist in alleviating some of the often severe and debilitating symptoms associated with the illness and ameliorate the patient’s ability to cope with their functional impairments. 

As post-exertional malaise is a hall-mark feature of ME/CFS, the expert panel stresses the importance of a thorough patient evaluation with special attention to risk factors and optimizing medical management before considering any exercise program. The expert panel emphasizes that great care must be taken in prescribing any exercise program, as severe or prolonged exacerbation of symptoms will worsen symptoms and can cause the patient to relapse.  Therefore, exercise programs must be individualized to the patient’s abilities/limitation and total illness burden, and attempt to ameliorate the patient’s function in daily living activities. 

The concrete set of recommendations provided will serve as a useful tool for medical assessors, lawyers and adjudicators involved in the assessment and adjudication of entitlements related to occupational disability and benefits. The expert panel highlights the importance of a realistic functional assessment of disability based on the consistency of subjective complaints of patients over time and the consistency of subjective and objective findings of treating clinicians. The document serves to debunk many myths about ME/CFS and the methods used to assess disability in these patients. Such methods are often based on the erroneous premise that the patient’s disability and symptoms are illegitimate, without known etiology, incapable of objective assessment, and thus incapable of restricting patient functions from activities of daily living, work or other related functions.  Further, the expert panel documented the negative effects of many methods presently being used, especially by disability adjudicators, such as Functional Abilities Evaluations (FAE), Graduated Exercise Therapy (GET), Cognitive Behavioral Therapy (CBT), work-hardening programs, and one-shot functional assessments.  The expert panel, in its collective wisdom and experience, believes such programs must be critically assessed as they may be inappropriate and contrary to pathophysiology of the illness, as well as the well-being of most ME/CFS patients.

 

The clinical case definition, and diagnostic and treatment protocols reflect a culmination of modern research and clinical experience.  It would be expected that application of the principles set out in the clinical case definition and treatment protocols will serve to enhance clinicians’  understanding of this illness, and will assist patients in their efforts to cope with the impact of the disorder and its symptomology.  The consensus document will also serve to provide benchmarks for disability benefits adjudicators and rehabilitation providers in a manner consistent with sound research, clinical experience and sound medical practice.   In time, it would be expected that this enhanced understanding of ME/CFS and its functional effects will lead to an enlightened clinical approach to ME/CFS with a view to improving patient function, enhancing quality of life and addressing the underlying medical symptomology and root causes of the disorder.  In this regard, appropriate assessment and rehabilitation will hopefully serve to enhance patient opportunities to overcome occupational disability, implement appropriate accommodations within the workplace to address the needs and requirements of disabled employees.  This will lead to a more enlightened adjudication process as regards disability benefits’ entitlements based on a principled approach grounded on the best available research, rather than conventional methods.

 

Note:  Hugh R. Scherpractices law under the firm name Scher Law in Toronto.

 

ACCOLADES AND SUPPORT FOR THE

ME/CFS CLINICAL WORKING CASE DEFINITION, DIAGNOSTIC & TREATMENT PROTOCOLS

 

Dr. Ellie Stein, MD FRCP(C) Alberta, Canada:  " I have now received all 6 copies that I ordered of the guidelines (ordered extra so I can educate my colleagues).  I am very pleased with the paper, it really validates much of what I believe and have read and they avoided sliding down the CBT/GET slope.  Very impressive.  I have already quoted Appendix 12 (my personal favorite) in one letter for a patient. "

 

Maryann Spurgin, PH.D, ME Society of America, U.S.A:  "This case definition is a vast improvement over the 1994 CDC Fukuda criteria. The Fukuda criteria makes ‘fatigue’ a compulsory symptom but downplays and makes optional post-exertional sickness and other cardinal symptoms. Because of this, the Fukuda criteria has led to tremendous misunderstanding in research, clinical care, and treatment protocols by fostering the selection of patients with chronic fatigue and fostering the view that exercise is an appropriate therapeutic approach.

“In sharp contrast, the new Canadian clinical case definition specifically selects patients who worsen with exercise. The clinical definition makes it very clear and compulsory that in order to meet the diagnostic criteria, the patient must become symptomatically ill after exercise (this is termed ‘post-exertional malaise’), and must also have neurological, neurocognitive, neuroendocrine, dysautonomic (for example, orthostatic intolerance), and immune manifestations. That is, worsening with exercise, and many symptoms other than fatigue, must be present for a patient to meet the diagnostic criteria. This case definition will go a long way to help distinguish ME/CFS patients from chronic fatigue patients, depressed patients, and patients with other illnesses who do improve with exercise. The Canadian definition specifically states that patients ‘become worse after exercise rather than better.’ This counters the view being put forward by persons such as Dedra Buchwald and Simon Wessely who hold that the disease is a behavioral problem leading to deconditioning. Unfortunately, such work does not even give patients the now-respectable status of a psychiatric illness, but rather refers to vague terms like ‘perception’ and ‘interpretation of symptoms’. The new case definition, much of which is backed by research, is a strong counter statement to the view held by Buchwald and Wessely.

 

“We encourage patients and patient groups to urge acceptance of this case definition in government documents so that appropriate research into the pathophysiology of the disease can be implemented and inappropriate, possibly harmful treatments will not be fostered.  This case definition strengthens the ability to select and diagnose ME/CFS by sharpening the definition. We hope that patients will promote this definition by taking it to their primary care physicians, donating copies to medical libraries, and contacting their local media.

“We would like to thank Lydia Neilson and her group, The National ME/FM Action Network, the physicians
from Canada and the USA, and the Journal of Chronic Fatigue Syndrome, all of whom worked together to bring this case definition to fruition."

 

The Myalgic Encephalomyelitis Association of Ontario:  "Congratulations to the National ME/FM Action Network for achieving this remarkable consensus document published in the Journal of Chronic Fatigue Syndrome Volume 11 (1) by Haworth Press, New York. A special thanks to Marj van de Sande for the tremendous amount of work and energy involved for her to coordinate the project. We can all hope that this publication will increase having our voices heard on the severity of the symptoms of our illness, bring clarity and understanding of ME/CFS and stimulate more research. Thank you Lydia for having the fortitude to keep focused on achieving the completion of this project. Congratulations again and job well done!!"

 

MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME – CLINICAL CASE DEFINITION AND TREATMENT PROTOCOLS – IMPACT ON ASSESSING OCCUPATIONAL DISABILITY -                        

 

By: Hugh Scher, Barrister & Solicitor

 

Recent publication of the clinical case definition and diagnostic and treatment protocols, which was reached on consensus of a panel of Canadian, American and European experts on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), represents a significant achievement in the understanding of this illness, and its effects on the daily lives of those affected by it.  The panel’s experts include specialists in internal medicine, physiology, cardiology, microbiology, immunology, infectious diseases, haematological pathology, sleep disorders, psychiatry and family practice.  The multifaceted, multidisciplinary approach of the consensus document will benefit clinicians involved in the diagnosis, assessment, and treatment of patients with ME/CFS.

The clinical case definition and diagnostic and treatment protocols have significant implications for the manner of assessment and adjudication of disability benefits’ claims.  Firstly, the clinical case definition sets out specific criteria for the diagnosis and assessment of ME/CFS, which are more encompassing than the CDC criteria that were developed to standardize research.  The clinical definition includes the prominent features of severe, prolonged fatigue, post-exertional malaise, sleep and neurocognitive dysfunctions, pain, and manifestations of dysfunction involving the endocrine, immune, and central and autonomic nervous systems.

Secondly, the consensus document makes it clear that there is no known cure or magic bullet for the treatment of ME/CFS.  The publication sets out guidelines for management and treatment programs. The paramount role of the primary treating physician in directing rehabilitation efforts is stressed. It emphasizes that the patient’s impairments/limitations and activity boundary fluctuations are part of the pathophysiology of the illness and they must be respected and reflected in any management, treatment, or rehabilitation program.  The management section sets out a series of practical life-style practices and self-help therapies that may assist in alleviating some of the often severe and debilitating symptoms associated with the illness and ameliorate the patient’s ability to cope with their functional impairments. 

As post-exertional malaise is a hall-mark feature of ME/CFS, the expert panel stresses the importance of a thorough patient evaluation with special attention to risk factors and optimizing medical management before considering any exercise program. The expert panel emphasizes that great care must be taken in prescribing any exercise program, as severe or prolonged exacerbation of symptoms will worsen symptoms and can cause the patient to relapse.  Therefore, exercise programs must be individualized to the patient’s abilities/limitation and total illness burden, and attempt to ameliorate the patient’s function in daily living activities. 

The concrete set of recommendations provided will serve as a useful tool for medical assessors, lawyers and adjudicators involved in the assessment and adjudication of entitlements related to occupational disability and benefits. The expert panel highlights the importance of a realistic functional assessment of disability based on the consistency of subjective complaints of patients over time and the consistency of subjective and objective findings of treating clinicians. The document serves to debunk many myths about ME/CFS and the methods used to assess disability in these patients. Such methods are often based on the erroneous premise that the patient’s disability and symptoms are illegitimate, without known etiology, incapable of objective assessment, and thus incapable of restricting patient functions from activities of daily living, work or other related functions.  Further, the expert panel documented the negative effects of many methods presently being used, especially by disability adjudicators, such as Functional Abilities Evaluations (FAE), Graduated Exercise Therapy (GET), Cognitive Behavioral Therapy (CBT), work-hardening programs, and one-shot functional assessments.  The expert panel, in its collective wisdom and experience, believes such programs must be critically assessed as they may be inappropriate and contrary to pathophysiology of the illness, as well as the well-being of most ME/CFS patients.

 

The clinical case definition, and diagnostic and treatment protocols reflect a culmination of modern research and clinical experience.  It would be expected that application of the principles set out in the clinical case definition and treatment protocols will serve to enhance clinicians’  understanding of this illness, and will assist patients in their efforts to cope with the impact of the disorder and its symptomology.  The consensus document will also serve to provide benchmarks for disability benefits adjudicators and rehabilitation providers in a manner consistent with sound research, clinical experience and sound medical practice.   In time, it would be expected that this enhanced understanding of ME/CFS and its functional effects will lead to an enlightened clinical approach to ME/CFS with a view to improving patient function, enhancing quality of life and addressing the underlying medical symptomology and root causes of the disorder.  In this regard, appropriate assessment and rehabilitation will hopefully serve to enhance patient opportunities to overcome occupational disability, implement appropriate accommodations within the workplace to address the needs and requirements of disabled employees.  This will lead to a more enlightened adjudication process as regards disability benefits’ entitlements based on a principled approach grounded on the best available research, rather than conventional methods.

[Hugh R. Scher , Scher Law Professional Corporation practicing Employment, Human Rights and Disability Law in Toronto, Ontario.  He is also the Legal Counsel for the National ME/FM Action Network. and contributed to the occupational disability section of the consensus document. 

 

DECEMBER 2003

 

THE GUIDELINES ADVISORY COMMITTEE OF THE ONTARIO MEDICAL ASSOCIATION AND THE ONTARIO MINISTRY OF HEALTH AND LONG TERM CARE REVIEWS THE ME/CFS CONSENSUS DOCUMENT

 

Alison Bested, MD, FRCP(C), who was a member of the Expert Consensus Panel for the ME/CFS Consensus Document; and a representative of The Myalgic Encephalomyelitis Association of Ontario, met with Dr. David McCutcheon, Assistant Deputy Minister, Health Services Division, Ministry of Health and Long-Term Care for Ontario to discuss whether the Ontario Medical Association and the Ontario Ministry of Health and Long Term Care would review the ME/CFS Consensus Document.  Dr. McCutcheon agreed to have the Guidelines Advisory Committee of the Ontario Medical Association and Ontario Ministry of Health and Long Term Care evaluate the ME/CFS Consensus Document.

 

We are pleased to report that the Guidelines Advisory Committee of the Ontario Medical Association and the Ontario Ministry of Health and Long Term Care gave “Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols”, Journal of Chronic Fatigue Syndrome 11(1):7-116, 2003 a three out of four-apple rating.  In a letter from the Guidelines Advisory Committee, the chairman reported, “Three apples denote a very good guideline”. Dr. Davis continued, “three-apple guidelines are well produced and useful for practicing clinicians". The chairman added, "We hope that this information proves useful as you deliberate on how to ensure the early diagnosis and medical care of patients with chronic fatigue syndrome."

 

JANUARY 2004

Excerpt from: IN THE SPOTLIGHT : THE TYMES TRUST VIEW  ON THE ME/CFS: CLINICAL WORKING CASE DEFINITION, DIAGNOSTIC AND TREATMENT PROTOCOLS – A CONSENSUS DOCUMENT

B y: Jane Colby, Executive Director, Tymes Trust, the United Kingdom’s National Voluntary Charity for Children and Young People with ME and their Families PO Box 4347, Stock, Ingatestone, Essex, CM4 9TE Tel/Fax : 01245 401080  - www.tymestrust.org 

 

     Tymes Trust has issued a Statement on the Canadian Definition of ME/CFS (2003). “In our opinion it is the best contemporary definition. It was developed for clinical practice and was compiled by physicians who have seen over 20,000 patients.

     It addresses many misunderstandings caused by 'catch-all' definitions, which have so disastrously affected research into treatments and clinical practice.

     We believe that under the Canadian Definition it is harder for people with 'chronic fatigue' to be misdiagnosed with ME/CFS. We also endorse the use of the name Myalgic Encephalomyelitis as used by the World Health Organization along with Chronic Fatigue Syndrome, listed as a neurological disease under ICD10 G93.3. To use another name means there is no official categorization. There are arguments both for and against the 'itis' ending, meaning 'inflammation' but in our opinion the WHO name and categorization should be respected.

 

Winter 2004

 

Comparing the Canadian Clinical Definition and the Fukuda Criteria For Chronic Fatigue Syndrome

 

By  Dr. Leonard Jason

 

(Dr. Jason published the results of his comparison study between the Canadian Clinical Definition and the Fukuda [CDC] criteria in Jason LA, Torres-Harding SR, Jurgens A, Helgerson J.  “Comparing the Fukuda et al. Criteria and the Canadian Case Definition for chronic Fatigue Syndrome”. Journal of Chronic Fatigue Syndrome  12(1):37-52, 2004. )

 

None of the current CFS case definitions have been empirically derived or prospectively contrasted with one another. Studies examining sources of diagnostic unreliability have shown that subject, occasion, and information variance account for only a small portion of diagnostic reliability.  However, criterion variance, differences in the formal inclusion and exclusion criteria used by clinicians to classify patients' data into diagnostic categories, accounts for the largest proportion of diagnostic unreliability.  Case definitions would be improved if more attention was devoted to developing operationally explicit, objective criteria and standardized interviews.  

The selection of diagnostic signs and symptoms has major implications for which individuals are diagnosed with CFS and how seriously the illness is viewed by health care providers, disability insurers and rehabilitation planners, and patients and their families and friends. Diagnostic criteria also have implications for whether research based on varying definitions can be synthesized.  Our investigation examined differences between CFS as defined by Fukuda et al. (1994) and a set of criteria that has been proposed for  a clinical Canadian Case definition. Dependent measures included:  work status, psychiatric co-morbidity, symptoms, and functional impairment.  People meeting the Fukuda et al. and Canadian criteria were compared with people who had a chronically fatiguing illness explained by a psychiatric condition.  The Canadian criteria group, in contrast to the Fukuda criteria group, had more variables that significantly differentiated them from the psychiatric comparison group. 

The findings suggest that both the Canadian and Fukuda et al. case definitions select individuals who are significantly different from psychiatric controls with chronic fatigue, with the Canadian criteria selecting cases with less psychiatric co-morbidity, more physical functional impairment, and more fatigue/weakness, neuropsychiatric, and neurological symptoms. The overall findings  suggest that the  Canadian clinical criteria appear to select a more symptomatic group of individuals than the CFS criteria, and these individuals do  demonstrate less current and lifetime psychiatric impairment than those selected according to the CFS  criteria. In contrast, the CFS group was not significantly different from the Chronic fatigue-psychiatric group in psychiatric impairment. Predictably, the Chronic fatigue-psychiatric group evidenced the highest frequency of current and lifetime psychiatric disorders.

Overall, there were 17 significant symptom differences between the Canadian and Chronic fatigue-psychiatric group, but only 7 significant symptom differences between the CFS and Chronic fatigue-psychiatric group.  Findings suggest that the Canadian criteria select a group of patients with more symptoms, and the Canadian criteria identify a group with higher levels of physical functional impairment and less psychiatric co-morbidity. Findings from the present study indicate that the Canadian criteria does capture many of these cardiopulmonary and neurological abnormalities, which are not currently assessed by the current CFS case definition (Fukuda et al., 1994). However, it is worth noting that when the Fukuda et al. (1994) CFS case definition was conceived, the research had not yet been done investigating these abnormalities. In combination with symptom patterns, it is possible to conclude that the Canadian group does select individuals with greater impairment, particularly given the physical composite score, fatigue/weakness, neurological and neuropsychiatric symptoms, as these symptoms can interfere with daily living and occupational performance. Results from this present investigation highlight the importance of contrasting different diagnostic criteria in order to gain a greater understanding of the syndrome now known as CFS.  The findings do suggest that the Canadian criteria point to the potential utility in designating post-exertion malaise and fatigue, sleep dysfunction, pain, clinical neurocognitive, and clinical autonomic/ neuroimmunoendocrine symptoms as  major criteria for future attempts to define this syndrome.

 

SPRING 2005

 

The Importance of Clinical Definitions for Defining and Studying Syndromes

Bruce M. Carruthers, MD, CM, FRCP(C)

 

[Dr. Carruthers is Lead Author of the Canadian ME/CFS Clinical Consensus Document, Co-Editor of the FMS Consensus Document, and is one of the Medical Advisors to the National ME/FM Action Network.  The following article describes the importance of not looking at symptoms in isolation, as is usually done in research definitions.  A syndrome involves determining the symptoms and how they interact, and how a cluster of symptoms interacts as a group.  The establishment of this interaction is essential in clinical practice.]

 

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome and Fibromyalgia are syndromes which until recently have been identified and organized by research definitions, where they are defined as  entities, static collections of symptoms or manifestations of a coherent disturbance, to be distinguished from a background of noncoherent disturbances.  This coherence is assumed to express an underlying pathogenesis or causal sequence, whether known or unknown, and is essential to provide a clear and consistent target for research. However such definitions of a clinical entity need to be updated as research progresses, and can block clinical progress if retained too long.  If too narrow a view of such a  research oriented clinical entity is taken, important components of the syndrome can be missed or misquantified (such as is commonly the case for cognitive fatigue).  If  too broad a view of the entity is taken and neglects sub-grouping, the clinical concept can become too loose and heterogeneous, incorporating a confusing number of causal chains (such as confounding psychogenic fatigue with neurogenic fatigue and overlooking immunogenic, hormonogenic and circulatory fatigue contributions).

 

Entity driven research definitions thus tend to be static, and to overlook the dynamic implications inherent in the Greek origin of the term syndrome which comes from “running together”. Syn- is together and -drome is a track or structure for running. Observing a syndrome means establishing the tracks along which a patient’s syndrome components are traveling and observing the travel.  Thus critical and definitive dynamic features of the actual clinical syndromes, as lived by patients, have been ignored in these research definitions, and even if mentioned have been downplayed.

 

One such critical difference that can only be observed dynamically follows - in normal life, fatigue and pain are connected directly to their causal actions which are usually evident and allow the person to adjust activity/rest rhythms accordingly. As they live their symptoms of fatigue and pain, ME/CFS and/or FMS patients have delayed and reactive dynamic features which disconnect them from their explanatory causal chains. If inadequate rest/activity rhythms are followed, they lead automatically and inexorably to such distinctive syndromic features as cumulative pain/fatigue and “crashing”- dynamic feat res that patients know well but practitioners don’t.

 

Activities/Rests over Time

These pattern breaks have not been ignored in more recent clinically based definitions, which include features such as how the illnesses are experienced by patients as symptom clusters. Such dynamic features of the fatigue and pain found in ME/CFS and FMS have been made criterial in the new Canadian Consensus Clinical Definition of ME/CFS, and discussed in the new Canadian Consensus Clinical Definition Protocols for FMS (1,2). They go a long way towards explaining why syndromic physical fatigue, cognitive fatigue and pain are distinctly different from normal pain and physical fatigue and cognitive fatigue, and why they can be so disabling.  Pattern breaks such as those described above can be quantified as they occur on line in the mixed subjective/objective context of the real world of clinical practice, as against being diverted into artificial partial worlds which attempt to simulate those of scientific research by excluding subjectivity (which they can never actually succeed in doing). However it is of interest that recent research shows that  postural cardiac output abnormalities (objective) correlate well with the degree of reactive fatigue and overall severity  (mixed context) in ME/CFS patients(3). This could supply a badly needed objective marker for fatigue severity and duration, and help explain why it can be so disabling.

 

In modeling the real world of clinical experience and paying attention to its dynamic patterns, clinical definitions have brought needed attention to distinctive features of the fatigue and pain of ME/CFS and FMS, and brought ways of quantifying the severity of their intrusion into normal life activities. They have brought attention to the importance of observing dynamically the whole cluster of symptoms constituting a patient’s syndrome, how these symptoms are inter-related with additive effects and how disruptive they can be to the patient’s life over long periods of time. 

[Dr. Carruthers - #2, 3657 West 16 Ave, Vancouver, BC V6R 3C3.  Phone: 604-224-1515]

1.      Carruthers B, Jain A, et al. “Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols” J Chronic Fatigue Syndrome, 2003, 11: 7-115.

2.   Jain A, Carruthers B, et al, “Fibromyalgia Syndrome: Clinical Case Definition, Diagnostic and Treatment Protocols-A Consensus Document” J Musculoskeletal Pain, 2003, 11: 3-107.

3.      Peckerman, J et al, “Abnormal Impedance Cardiography Predicts Symptom Severity in Chronic Fatigue Syndrome”.  AmericanJournal of the Medical Sciences, 2003, 326: 55-60

SUMMER 2008

Definition and Aetiology of Myalgic Encephalomyelitis(ME):

 How the Canadian Clinical Definition of ME Works

 

By Bruce M. Carruthers, M.D., C.M., FRCP(C)

 

A perspective on the various definitions of ME and the process of discovering its aetiology has been taken. The importance of clinical guidelines has been emphasised to encourage clinicians to provide the clear descriptions of their individual patients required for proper clinical activity; diagnosis, estimation of severity of impact, prognosis, treatment, and rehabilitation. This individual knowledge is informed by general and (hopefully) publicly confirmed knowledge resulting from scientific research during the second person interaction which lies at the core of the clinical encounter. Both types of knowledge are essential.

 

Definitions of a medical disorder must serve two divergent functions; both necessary, yet mutually exclusive because of their fundamentally different observational contexts - one dealing with groups of patients who can be approached scientifically and the other with individuals in a clinical context.

 

Research definitions (1-3) provide researchers with (relatively) homogenous groups of patients to allow meaningfully isolated and controlled observations as they follow various hypotheses in the hope of confirming/refuting them. In the context of research, all knowledge is under review; both what is explicitly in doubt and what is supposed to have been confirmed. Thus the observational context is one of general uncertainty, but grounded in trust that the scientific method can generate reliable (third-person) knowledge, and one has to start somewhere. As each patient must be viewed as a member of a selected set, methodologically they cannot be viewed as individuals.

 

At the risk of exhibiting “anecdotage”, I would like to argue that another context of observation is critical to the clinical endeavour, one that depends on the anecdotal, viewpoint-including, first-person experience of a patient. This is not merely consideration of a list of symptoms. It uses what is regarded as established third-person medical knowledge (graded into several categories of certainty/uncertainty), and matches this knowledge with that being provided by the individual patient, in the certainty of her/his illness experience. These two types of (what is regarded to be) certain knowledge meet in a second-person interchange between physician and patient involving the basic clinical activities of individual diagnosis, individual prognosis, individual treatment and individual prevention (4), also including an assessment of its impact on the patient’s individual life (degree of disease and disability, or deviation from the state of ease and ability which we call health).

 

The observational context of clinical activity is thus more complex and begins from the first-person viewpoint generated by the deictic (5,6) co-ordinates of the individual patient, which then meet the observational and empathic skills of the physician, as well as the generalised third-person coordinates of established public knowledge backed by various forms of evidence, in the doctor patient relationship within a second-person interaction. This knowledge then must be reapplied within the deictic co-ordinates of the individual patient, viewpoints and all. But this is “anecdotal” certainty, and hence irrelevant to science. But, however anecdotal, this clinical work is essential; the patient’s unique clinical entity must be identified by being observed accurately and adequately within its proper context. The relevant variables to follow within the entity must be sorted out from the irrelevant ones, and similarly with those in its background. The symptoms and signs expressing this dynamic entity must be observed minutely to see how their qualitative and quantitative changes are developing. Interactions within and without the entity must be observed in order to find conciliant and causal chains to assign symptom priority. The individual effects of treatments must be observed and such effects may trump the statistical results of ‘evidence based’ treatments within the clinical context.

 

A primary clinical entity cannot be a static object. It is necessarily subjective in part (since it observes at least itself), and like the primary illness experience that participates in it, is an undivided, individual, as yet unnamed whole, and of the nature of a real process, not to be confused with the set of concepts used to name and describe it (see problem of realism/nominalism(7)). Note that all of these clinical practices depend to a large extent on the assumption of the accuracy and adequacy of the patient’s experience of illness as it unfolds under the observation of the physician. If the observational discipline of Western painting is based on the disavowal of deictic reference (8), then it is no wonder that clinical observation skills are atrophying. But it is the dynamic clinical entity, of necessity both subjective and objective, which orient the field of clinical activity, if clearly and adequately observed.

 

If such clarity and adequacy are not achieved, several types of smudging may result. In other words, if the generalisations from the medical model are too generic, they have no chance of adequately meeting the patients’ illness experience, and much relevant data may be overlooked and/or misinterpreted. Thus the move from a more specific clinical concept such as ME or Fibromyalgia to a more generic concept such as Chronic Fatigue Syndrome or Chronic Pain Syndrome entails missing a lot of the information that makes the syndrome as a name match the syndrome as an experience. The syndrome as an experience is a coherent entity whose parts run together as a process - as the word syndrome indicates etymologically - and whose causal interactions are sensed directly in the mode of causal efficacy (9). This entity arises against a background which is treated as a nonentity for the purposes of the observation. Thus the attempt to organise clinical activity around a nonentity, such as in Somatization Disorder and Munchausen Syndrome(10,11), where diagnosis depends on the absence of an entity, may interfere with proper clinical activity by importing a misplaced forensic attitude towards a patient’s illness experience, discounting or distorting its relevance. The move towards ignoring the distinctions between primary and secondary which designate sensed causal directions within a clinical entity, whether applied to depression, anxiety, infection or fibromyalgia, add to the confusion and impede the elucidation of a properly dynamic clinical entity. The widespread use of the holistic biopsychosocial model of disease (12-14) without any distinction between a clinical entity and its background encourages the “drowning” of clinical entities by risk factors which can proliferate endlessly in a nominalist fury without orientation as to their state of relevance or lack thereof with respect to a real entity (7).

 

The Canadian consensus case definition and diagnostic protocol for ME (15) has been influenced by the clinical method of Sydenham (16), which is to provide a fuller and richer framework to fit the patient’s illness experience into a framework that is specific and complete enough to match the patient’s experience, yet consonant with the large body of public and confirmed results that have been obtained by the research activity stimulated by earlier definitions. It tries to be more adequate to the clinical activity that each patient’s unique clinical situation demands. It facilitates a precise and adequate observation of the unique clinical entity arising in a patient in contrast to its contextual background. This is necessary to orient clinical activities, to guide the quantification of the events, both syndromal and contextual, which may be of particular relevance, as well as sorting out their causal direction and priority. It tries to remain close enough to be adequate to the illness experience of the patient and thus invariant to the changes in interpretation of this experience as science evolves over the years (16). Unless a disease entity is ‘eliminated’ by better understanding and better technology, it will continue to require clinical attention, whatever we hypothesize its ‘natural kind’ to be.

 

To improve clinical observation, the Canadian definition and diagnostic protocol lays out a number of regions of patho-physiological dysfunction, as necessary components of the syndrome of ME, but the particular expression of symptoms within each region is contingent between individuals, and their specific pattern is left open to be decided by clinical observation of the individual and later diagnostic classification. These component regions include fatigue, which must be severe and prolonged and of a certain dynamic pattern (delayed, prolonged reactive), and significant dysfunction must be observed in the following realms - sleep, pain, neurological/cognitive, and at least one of the following 3 realms - autonomic nervous system, neuroendocrine, and immune system. This approach facilitates the identification of the patient’s individual clinical entity or syndrome, how its parts fit together and interact, as well as its impact on the patient’s life - seen as disability and disease - and leading to a more accurate and adequate diagnosis. It allows estimates of the clinical course and prognosis, decisions regarding treatment, estimation of the treatment effects, and search for successful preventive and rehabilitative strategies. With its flexible combination of necessary and optional features, the definition allows the diagnosis to fit the patient rather than the other way around (as with Procrustes, an innkeeper from Greek mythology who stretched the guests to fit his bed!).

 

The possible aetiology of ME is under scientific observation. This is done by experiment and by controlled observation. Many observers are following various lines of investigation and observation as to the aetiology of ME, which we are all following with interest.

 

There are some problems. A hypothesis is a cognitive structure necessary to organise one’s experimental efforts. When rigorously tested independently and often enough, your hypothesis can be regarded as tentatively confirmed. But within the context of research, you should work to disprove your hypothesis. As noted by Sydenham (16), to arrange reality to save it can cause much error. I quote “In writing the history of a disease, every philosophical hypothesis whatsoever, that has previously occupied the mind of the author, should lie in abeyance. This being done, the clear and natural phenomena of the disease should be noted - these and these only. They should be noted accurately, and in all their minuteness; (….) No man can state the errors that have been occasioned by these physiological hypotheses. Writers, whose minds have taken a false colour under their influence, have saddled diseases with phenomena which existed in their own brains only; but which would have been clear and visible to the whole world had the assumed hypotheses been true.”

 

The opposite problem of importing a context of doubt into the clinical arena, which is heavily dependant on deictic certainties, can result in the disruption of the second person clinical observation structure and subsequent clinical practices, as observed with the “smudge” diagnoses mentioned earlier.

 

The problem of cultivating a holistic view without adequately structuring the field with a proper clinical entity can lead to great confusions of relevance, where contextual and syndromal features are confounded with no way of clinically quantifying their relative impacts. Choose the right kind of entity or you may end up only considering background factors with no clinical entity left that they  are the background of - see the fate of the Cheshire cat in Alice in Wonderland, where the cat

fades, leaving only the smile! (17)

 

References

 

1.Holmes GP, Kaplan JE, Gantz NM, et al. Chronic fatigue syndrome: a working case definition. Ann Intern Med. 1988;108(3):387-9.

2.Sharpe MC, Archard LC, Banatvala JE, et al. A report - chronic fatigue syndrome: guidelines for

research. J R Soc Med. 1991;84(2):118-21.

3.Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The chronic fatigue

syndrome: a comprehensive approach to its definition and study. International Chronic Fatigue

Syndrome Study Group. Ann Intern Med. 1994 Dec 15;121(12):953-9.

4.McDermott W. Evaluating the Physician and His Technology. In “Doing Better and Feeling

Worse: Health in the United States”, ed, Knowles JH. Norton, New York, 1977, pp.142-156.

5.Tallis R. The Raymond Tallis Reader. Ed, Grant M. Palgrave Macmillan, New York, 2000.

6.Bryson N. Vision and Painting. Yale University Press, New Haven, 1983, p.87.

7.Hacking I. The Social Construction of What? Harvard University Press, Cambridge, 1999, pp.80

84; 96-99; 174; 205-6.

8.Bryson N. Vision and Painting. Yale University Press, New Haven, 1983, p.89.

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Note: Both the ME/CFS and FMS Consensus Documents are available on the website of the National ME/FM Action Network at www.mefmaction.net

The National ME/FM Action Network is a Canadian, registered charitable organization of volunteers reaching out internationally and dedicated to helping the medical, legal and general public in spreading awareness for Myalgic Encephalomyelitis / Chronic Fatigue Syndrome and Fibromyalgia (ME/CFS and FMS) through support, advocacy, education, and research and the publishing of a quarterly newsletter “QUEST” which is included with an annual membership fee.