Study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
The Program Support Center on behalf of the Office of the Assistant Secretary of Health (OASH) within the Department of Health and Human Services intends to negotiate and award a contract to the National Academies (Institute of Medicine) on a sole source basis under the authority of FAR 6.302-1 to support a study committee to recommend clinical diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria. In collaboration with CFSAC ex officio agencies, OASH will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS. This study would also demonstrate HHS' commitment and aggressive pursuit of solutions to this poorly-understood and disabling condition.
In response to a request from the OASH, the Board on the Health of Select Populations of the Institute of Medicine will establish a study committee of thought leaders and stakeholders to comprehensively evaluate the current status of criteria for the diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
The Committee will consider the various existing definitions for chronic fatigue syndrome and develop consensus clinical diagnostic criteria for this disorder. Widely accepted clinical diagnostic criteria and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic and translational research. The Committee will also distinguish between disease subgroups, develop a plan for updating the new criteria, and make recommendations for its implementation.
No solicitation document is available. All responsible sources that have the requisite qualifications to perform the work described above may submit a statement of capabilities electronically to Jennifer Eskandari at Jennifer.eskandari@psc.hhs.gov. Responses must be double-spaced with 1" margins on allsides and use a standard font no smaller than 12 point. The response must be sequentially numbered, beginning on the first page after the table of contents. Responses are due by August 30, 2013 by 4:00 pm EST. Responses will not be accepted after the due date. If no capability statements are received which specifically demonstrate the ability to perform the requirements above, the Government shall proceed with negotiating a sole source contract to the National Academies (Institute of Medicine).
Given the admitted failings of the system it staggers belief that we should still be looking at same old, same old the condition with a thousand names and no further forward than fifty years ago in effective treatment or understanding.
Written by
Ian123
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One of the first definitions of ME/CFS originated from the work of Dr. Melvin Ramsay. According to Ramsay's definition, the three principal clinical elements of ME/CFS are:
1) A Unique Form of Muscle Fatiguability: where muscle power can take days to recover; and muscle tenderness together with twitchings or spasms can regularly occur.
2) Circulatory Impairment: encompassing cold extremities, heightened sensitivity to climatic change and excessive sweating.
3) Cerebral Dysfunction: encompassing deterioration in memory and concentration; as well as other cognitive difficulties, sleep disturbances and emotional changes.
New Definitions Emerge
Following such definitions, a number of medical researchers and doctors went on to construct their own definitions of the condition. Unfortunately, this has inevitably created some degree of confusion as some emphasize particular symptoms and elements differently. Amongst these include, the U.S. Centre for Disease Control (C.D.C) Criteria devised in 1987 the Oxford Criteria, developed in 1991 by a group of UK experts; and the Australian group of researchers, led by Professor Lloyd, whose criteria placed extra emphasis on neuropsychological symptoms.
CDC Criteria
Centre for Disease Control (CDC) Criteria
CFS is a syndrome characterised by fatigue that is:
-medically unexplained (i.e. not caused by conditions such as anaemia)
-of new onset (i.e. not lifelong)
-of at least 6 months duration
-not the result of ongoing exertion (e.g. overwork or athletic over-training)
-not substantially relieved by rest
-causing a substantial reduction in previous levels of occupational, educational, social or personal activities.
In addition, there must be four or more of the following symptoms:
-self-reported problems with short-term memory or concentration (cognitive defects)
-sore throats
-tender neck (cervical) or armpit (axillary) glands
-muscle pain (myalgia)
-headaches of a new type, pattern or severity
-unrefreshing sleep
-post-exertional malaise lasting more than 24 hours
-multi-joint pain (arthralgia) without swelling or redness
Conditions which would exclude a diagnosis include:
-established medical disorders known to cause chronic fatigue
-major depressive illness with psychotic or melancholic features (but not anxiety states, somatisation disorder or non-melancholic/psychotic depression)
-any medication which causes fatigue as a side-effect
-eating disorders - anorexia, bulimia or severe obesity
-alcohol or substance abuse
The 1991 Oxford Criteria for CFS with emphasis on a psychosocial condition
Fukuda 1994 Definition for Chronic Fatigue Syndrome
A thorough medical history, physical examination, mental status examination, and laboratory tests must be conducted to identify underlying or contributing conditions that require treatment. Diagnosis or classification cannot be made without such an evaluation. Clinically evaluated, unexplained chronic fatigue cases can be classified as chronic fatigue syndrome if the patient meets both the following criteria:
1. Clinically evaluated, unexplained persistent or relapsing chronic fatigue that is of new or definite onset (i.e., not lifelong), is not the result of ongoing exertion, is not substantially alleviated by rest, and results in substantial reduction in previous levels of occupational, educational, social, or personal activities.
2. The concurrent occurrence of four or more of the following symptoms:
substantial impairment in short-term memory or concentration;
sore throat;
tender lymph nodes;
muscle pain;
multi-joint pain without swelling or redness;
headaches of a new type, pattern, or severity;
unrefreshing sleep; and
post-exertional malaise lasting more than 24 hours.
These symptoms must have persisted or recurred during 6 or more consecutive months of illness and must not have predated the fatigue.
Conditions that Exclude a Diagnosis of CFS
1. Any active medical condition that may explain the presence of chronic fatigue, such as untreated hypothyroidism, sleep apnea and narcolepsy, and iatrogenic conditions such as side effects of medication.
2. Some diagnosable illnesses may relapse or may not have completely resolved during treatment. If the persistence of such a condition could explain the presence of chronic fatigue, and if it cannot be clearly established that the original condition has completely resolved with treatment, then such patients should not be classified as having CFS. Examples of illnesses that can present such a picture include some types of malignancies and chronic cases of hepatitis B or C virus infection.
3. Any past or current diagnosis of a major depressive disorder with psychotic or melancholic features;
bipolar affective disorders
schizophrenia of any subtype
delusional disorders of any subtype
dementias of any subtype
anorexia nervosa
or bulemia nervosa
4. Alcohol or other substance abuse, occurring within 2 years of the onset of chronic fatigue and any time afterwards.
5. Severe obesity as defined by a body mass index [body mass index = weight in kilograms ÷ (height in meters) equal to or greater than 45. [Note: body mass index values vary considerably among different age groups and populations. No "normal" or "average" range of values can be suggested in a fashion that is meaningful. The range of 45 or greater was selected because it clearly falls within the range of severe obesity.]
Any unexplained abnormality detected on examination or other testing that strongly suggests an exclusionary condition must be resolved before attempting further classification.
Conditions that do not Exclude a Diagnosis of CFS
1. Any condition defined primarily by symptoms that cannot be confirmed by diagnostic laboratory tests, including fibromyalgia, anxiety disorders, somatoform disorders, nonpsychotic or melancholic depression, neurasthenia, and multiple chemical sensitivity disorder.
2. Any condition under specific treatment sufficient to alleviate all symptoms related to that condition and for which the adequacy of treatment has been documented. Such conditions include hypothyroidism for which the adequacy of replacement hormone has been verified by normal thyroid-stimulating hormone levels, or asthma in which the adequacy of treatment has been determined by pulmonary function and other testing.
3. Any condition, such as Lyme disease or syphillis, that was treated with definitive therapy before development of chronic symptoms.
4. Any isolated and unexplained physical examination finding, or laboratory or imaging test abnormality that is insufficient to strongly suggest the existence of an exclusionary condition. Such conditions include an elevated antinuclear antibody titer that is inadequate, without additional laboratory or clinical evidence, to strongly support a diagnosis of a discrete connective tissue disorder.
A Note on the Use of Laboratory Tests in the Diagnosis of CFS
A minimum battery of laboratory screening tests should be performed. Routinely performing other screening tests for all patients has no known value. However, further tests may be indicated on an individual basis to confirm or exclude another diagnosis, such as multiple sclerosis. In these cases, additional tests should be done according to accepted clinical standards.
The use of tests to diagnose CFS (as opposed to excluding other diagnostic possibilities) should be done only in the setting of protocol-based research. The fact that such tests are investigational and do not aid in diagnosis or management should be explained to the patient.
In clinical practice, no tests can be recommended for the specific purpose of diagnosing chronic fatigue syndrome. Tests should be directed toward confirming or excluding other possible clinical conditions. Examples of specific tests that do not confirm or exclude the diagnosis of chronic fatigue syndrome include serologic tests for Epstein-Barr virus, enteroviruses, retroviruses, human herpesvirus 6, and Candida albicans; tests of immunologic function, including cell population and function studies; and imaging studies, including magnetic resonance imaging scans and radionuclide scans (such as single-photon emission computed tomography and positron emission tomography
The ICC is good enough; what do they think they will achieve by trying to continually create new criteria?
ICC is for Myalgic Encephalomyelitis only and incorporates objective biomedical abnormalities as well as specific tightly defined criteria imcluding symptoms as tied to body ststems and underlying impaired physiological functions (based on available research and clinical findings). It is properly evidence based and includes worldwide expert consensus.
It also establishes that anyone who meets this criteria should be removed from the Reeves Empirical Criteria for CFS and from NICE definition of 'CFS/ME' so it clearly differentiates myalgic encephalomyelitis.
I for one really do not see what else is needed.
Any effort that seeks to define new criteria seeks to hide the biomedical basis of classic ME which is explicit in the ICC criteria.
The ICC criteria are for use in clinical medicine AND for research purposes; this provides ideal consensus.
Anyone who does not meet ICC criteria for ME can be diagnosed with CFS under other criteria within which there may be other sub-groups yet to be identified.
Myalgic encephalomyelitis as defined by both Ramsey and more recently ICC is a distinct disease and there are no known sub-groups.
Studies like this are wasting funds which could be spent on research into the disease itself and identifying potential treatments.
Fukuda was intended for research not clinical diagnoses in either 1994 or 2004 guise the purpose was isolating groups for research which explains why it's not fit for purpose as a clinical tool no matter how hard they try forcing the issue. Ruling out co morbid conditions has no scientific basis it was a matter of convenience for researchers attempting a simple rather than complex sample. Having ME gives no immunity from other conditions in fact quite the reverse is true of a damaged immune system a major flaw in using exclusion diagnosis real life is not as simple as picking a sample group for research.
Exclusion diagnosis has created the "dustbin diagnosis" where anything that does not tick the boxes of a known treatable condition is placed in the dustbin a lazy practice that history will judge the medical profession for, though this is of little comfort for those abandoned now.
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