Saturday, February 14, 2009

Summary of High Court Proceedings - Judicial Review of NICE Guidelines

http://www.meassociation.org.uk/content/view/791/161/


MAY BE REPOSTED



Judicial Review
summary of High Court proceedings



The Judicial Review of the NICE guideline on
ME/CFS took place on Wednesday and Thursday,
11th and 12th February, at the Royal Courts of
Justice in London.  The hearing was held in Court
76 - a large modernised courtroom tucked away
on the third floor of this historic maze of legal
activity.


Unlike the preliminary hearing in June last year,
there was plenty of room to move around along with
comfortable non-squeaking seats and wheelchair
access - although it was difficult at times for those
at the back to hear precisely what was being said by
barristers representing the two sides.

Around 50 members of the public, along with
occasional brief visits from journalists, packed Court
76 to witness the proceedings.  At times, a 'Court
Full' sign had to be posted up.  Not surprisingly,
there did not appear to be a single person with
ME/CFS who had come up to London to support the
NICE guideline.

Outside the main entrance in The Strand, where all
the TV news bulletin shots of the High Court are
taken, a small peaceful demonstration against the
NICE guideline took place over lunch.  This managed
to attract quite a lot of legal and public interest.

Almost all of Wednesday was taken up with a legal
presentation from barrister Jeremy Hyam on behalf of
the two claimants who suffer from ME - Kevin Short
from Norfolk and Douglas Fraser from London.

In relation to the effects of the NICE guideline on
practical patient care, two key issues were
examined:

Firstly, the procedures by which the NICE guideline
development group (GDG) had come to the
conclusion that the only treatments worth
recommending for people with ME/CFS were two
behavioural interventions, namely cognitive
behaviour therapy (CBT) and graded exercise therapy
(GET), and this was to the exclusion of all others.

Secondly, the fact that a number of medical/drug and
supplement interventions, which may be helpful in
selected cases, were not therefore being
recommended by NICE.  As a result of not being
recommended, doctors would not be willing to
consider using them, and healthcare providers (ie
PCTs) would not be willing to pay for them.  Some
people with ME/CFS would therefore be denied forms
of treatment that could be of benefit.


In relation to the way in which a judicial review is
there to examine procedures rather than actual
decisions, it was argued that the decision making
process had been based on a foundation of
insufficient evidence of clear benefit being available
to recommend the widespread use of CBT and GET.

In particular, was the way in which a systematic
review of results from randomised controlled trials
involving CBT and GET (ie the York Review) had
failed to demonstrate the sort of robust  consistent
evidence that could stand alone and satisfy the
requirements for this type of recommendation to be
made in a NICE guideline.

Counsel for the claimants also argued that
insufficient weight had then been given to certain
other key sources of evidence further down the
hierarchy of evidence that were made available to
the guideline development group - in particular the
results of patient questionnaires and stakeholder
feedback which had reported that in a significant
proportion of people with ME/CFS these treatments
were either ineffective or even harmful.

When it came to the final analysis it was argued that
with several members of the GDG being involved in
clinical trails involving these two treatments, or
expressing support for their use, there was an
appearance of bias in the way that the GDG decided
to recommend CBT and GET as the only forms of
effective treatment.

To support the appearance of bias reference was
made to comments contained in a letter from a
patient representative on the GDG (Tanya Harrison)
who had resigned from the group as a result of what
she believed was bias towards the psychosocial
model. It was also argued that the appearance of
bias towards CBT and GET was compounded by the
absence of any health professionals on the GDG who
were known to be in favour of the biomedical model
of ME/CFS


The final part of the first day's hearing, and almost
all of Thursday morning, was taken up by counter
arguments being presented by the barrister
representing NICE, namely that the research
evidence in favour of CBT and GET was sufficiently
robust; that the process of collecting and analysing
other types of evidence from clinical trials,
stakeholders, experience of clinicians etc was
thorough and transparent; and that no evidence of
bias towards the psychosocial model had been shown
by individual members of the GDG.

Neither was there any bias in the way in which the
members of the GDG  were selected by nomination of
the relevant Royal Colleges or professional bodies,
and some of the accusations relating to bias, conflict
of interest, or disclosure of interest were based on
factual inaccuracies.

In other words, the procedures that were followed by
NICE were as robust and fair as could be achieved in
the circumstances and that the decision to only
recommend CBT and GET was not the result of any
bias on the part of individual members of the GDG,
or the group as a whole.  Legal arguments on behalf
of the defendants (ie NICE) went on till early
afternoon on Thursday.


Thursday afternoon produced a further legal
argument involving the cost effectiveness of both
treatments.  This was given by a barrister acting for
an 'interested party' in the case against NICE.
Evidence was put forward on behalf of this interested
party to show that the cost effective analysis for CBT
was seriously flawed and that no proper cost
effectiveness analysis for GET had even been
undertaken.  In other words, it was claimed that
NICE was recommending two forms of treatment that
had not yet been properly shown to be cost
effective.  Again, this position was vigorously
challenged by the barrister representing NICE.

A great deal of time was spent in discussing the
points that are summarised above, along with legal
technicalities.  However, some of the  other aspects
of the case against the NICE guideline, which have
surfaced in public discussion on the internet prior to
the case being heard in Court, were not referred to or
left very much out on the periphery (eg neurological
classification of the illness).

Legal arguments and discussion went on till almost
5pm on Thursday and there is still some unfinished
business for the Judge, Mr Justice Simon,  to deal
with.  So it looks as though the Judge's decision on
the case will be delayed for at least a week, possibly
even longer.


     * The ME Association has fully supported the case
for Judicial Review that has been made by the two
claimants - see here:
http://www.meassociation.org.uk/content/view/781/161/

     * A summary of press reports on the Judicial
Review can be found here:
http://www.meassociation.org.uk/content/view/789/161/


     * For anyone involved with insurance companies
referred to during the hearing - Exeter Friendly
Society and Liverpool Victoria - some interesting and
useful statements regarding their positions on
recognition and classification of ME/CFS were made
during the hearing.





Summary prepared by Dr Charles Shepherd

14 February 2009






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Friday, February 13, 2009

Open Letter to CDC's Bill Reeves

Dear Sir:

I am a long-standing ME patient from south Africa. I have been
following your research for a number of years but recently your
activities have begun to concern me.

Your empirical definition is too broad and includes too many
psychiatrically Ill patients. Furthermore, your collaboration with
several unpopular British psychiatrists Is worrying.

Recently your work has focused on vague notions of fatiguing illness
and, once again, your collaboration with Emory psychiatric
researchers is of grave concern to ME/CFS patients.
You are letting down a desperately ill and marginalised patient community.

Please either get your house in order or quit
your position so that a
suitable alternative candidate can take up the challenge of
researching this difficult illness, who does not collaborate with
mental health researchers, some of who's views on the treatment of
ME/CFS are deeply unpopular with ME patients, who hasn't designed a
deeply flawed empirical definition of ME/CFS and who will not waste
resources on studying vague notions of fatiguing illnesses.

Sincerely,

Jeremy Bearman
BSoc Sc PDM MBA

P.S. Co-cure forced me to censor this article because it contained
disparaging references to Wessely school psychiatrists
 






 


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MS vs. ME (CFS)

*please repost* *please repost* *please repost* *please repost*

M.E. vs MS: Similarities and differences, by Jodi Bassett February 2009

One of my most vivid memories of early childhood is of the day that a woman
with Multiple Sclerosis (MS) came to my primary school to give a talk to my
class. She spoke to my 9 year old classmates and me about MS and encouraged
us to help to raise funds for research into MS with the MS-read-a -thon. She
was somewhere between 30 and 35 at the time I think, perhaps a bit younger.


I don't recall if the woman with MS was in a wheelchair or just sitting, but
I remember how well she spoke. She was such a confident and engaging
speaker. She held our full attention for the entire time she spoke. I felt
that she knew what she was doing was important, and was proud to be able to
do it. I thought she was so brave and so strong and inspiring.


I remember that she told us that her first indication that something was
wrong with her was the day that she ended up with burns on her back because
she could no longer correctly feel the water temperature. She described this
burning so vividly. I felt so sorry for her, and for everyone with MS. It
seemed like an unbelievably terrible thing to happen to someone. Just
unimaginably awful, like your worst nightmare. I wished so much that people
with MS didn't have to go through such horrible experiences.


The talk on MS made a real impact on me at the time and stayed with me for a
long time afterward. For years I read as many books as I could during the
annual MS-read-a-thon.  I spent a lot of time thinking about the woman with
MS I'd met and I wondered how she was. I felt so sorry for her.


I could never have imagined back then that a mere 10 years later I'd be in
the terrible position of ENVYING this same woman with MS.


My story

What happened was that when I was 19 I suddenly became ill with Myalgic
Encephalomyelitis (M.E.). I was a normal, active and happy 19 year old when
suddenly everything changed.  I experienced severe brain damage from one
moment to the next. The first I knew of my illness was when my brain, my
heart, my balance and just my whole body just stopped working like they used
to and started doing all sorts of strange and terrible things. I couldn't
think anymore and I couldn't do anything anymore like I'd used to. I had
literally dozens of extreme and ever-changing symptoms and disabilities that
became so much worse whenever I did anything at all.


Unfortunately my illness worsened steadily over the next decade or so. 14
years later I'm completely housebound and about 99% bedbound. I'm very
disabled in many different ways, physically and cognitively.


Medical similarities between MS and M.E.

The reason I'm envious is not so much because of the type of illness MS is
medically compared to M.E. M.E. and MS are actually very similar medically
in many ways, as the following list demonstrates.



Table 1. Medical similarities between MS and M.E.*


MS is primarily a neurological disease, i.e. a disease of the central
nervous system (CNS).

            M.E. is primarily a neurological disease, i.e. a disease of the
central nervous system (CNS).



Demyelination (damage to the myelin sheath surrounding nerves) has been
documented in MS.

            Demyelination (damage to the myelin sheath surrounding nerves)
has been documented in M.E.



Evidence of oligoclonal bands in the cerebrospinal fluid has been documented
in MS.

            Evidence of oligoclonal bands in the cerebrospinal fluid has
been documented in M.E.



No single definitive laboratory test is yet available for MS but a series of
tests are available which can objectively confirm the diagnosis with some
certainty.

            No single definitive laboratory test is yet available for M.E.
but a series of tests are available which can objectively confirm the
diagnosis with a high degree of certainty.



MS can be severely disabling and cause significant numbers of patients to be
bedbound or wheelchair-reliant.

            M.E. can be severely disabling and cause significant numbers of
patients to be bedbound, wheelchair-reliant or housebound.



MS can be fatal (either from the disease itself or from complications
arising from the disease)

            M.E. can be fatal (either from the disease itself or from
complications arising from the disease)



MS significantly reduces life expectancy.

            M.E. significantly reduces life expectancy. (M.E. reduces life
expectancy by a greater period than MS: see Table 3.)



Symptoms/problems which occur in MS include: impaired vision, nystagmus,
afferent pupillary defect, loss of balance and muscle coordination, cogwheel
movement of the legs, slurred speech, difficulty speaking (scanning speech
and slow hesitant speech), difficulty writing, difficulty swallowing,
proprioceptive dysfunction, abnormal sensations (numbness, pins and
needles), shortness of breath, headaches, itching, rashes, hair loss,
seizures, tremors, muscular twitching or fasciculation, abnormal gait,
stiffness, subnormal temperature, sensitivities to common chemicals,
sleeping disorders, facial pallor, bladder and bowel problems, difficulty
walking, pain, tachycardia, stroke-like episodes, food intolerances and
alcohol intolerance, and partial or complete paralysis.

            Symptoms/problems which occur in M.E. include: impaired vision,
nystagmus, afferent pupillary defect, loss of balance and muscle
coordination, cogwheel movement of the legs, slurred speech, difficulty
speaking (scanning speech and slow hesitant speech), difficulty writing,
difficulty swallowing, proprioceptive dysfunction, abnormal sensations
(numbness, pins and needles), shortness of breath, headaches, itching,
rashes, hair loss, seizures, tremors, muscular twitching or fasciculation,
abnormal gait, stiffness, subnormal temperature, sensitivities to common
chemicals, sleeping disorders, facial pallor, bladder and bowel problems,
difficulty walking, pain, tachycardia, stroke-like episodes, food
intolerances and alcohol intolerance, and partial or complete paralysis.



MS can cause orthostatic intolerance (dizziness or faintness on standing).

            M.E. commonly causes severe orthostatic intolerance (which often
worsens to become severe POTS and/or NMH).



Short-term memory loss, word finding difficulty, difficulty with
concentration and reasoning and other forms of cognitive impairment occur in
50% of MS patients. 10% of MS patients have cognitive impairments severe
enough to significantly affect daily life.

            Short-term memory loss, word finding difficulty, difficulty with
concentration and reasoning and other forms of cognitive impairment occur in
100% of M.E. patients. Almost all M.E. patients have cognitive impairments
severe enough to significantly affect daily life.



MS patients often become severely more ill in even mildly warm weather. Cold
weather can also cause significant problems.

            M.E. patients often become severely more ill in even mildly warm
weather. Cold weather can also cause significant problems.



MS can affect autonomic nervous system function (including involuntary
functions such as digestion and heart rhythms).

            M.E. can affect autonomic nervous system function (including
involuntary functions such as digestion and heart rhythms).



MS is thought to cause a breakdown of the blood brain barrier.

            M.E. is thought to cause a breakdown of the blood brain barrier.



A positive Babinski's reflex is consistent with several neurological
conditions, including MS. (Babinski's reflex or extensor plantar reflex is a
test for dysfunction of the corticospinal tract.)

            A positive Babinski's reflex (or extensor plantar reflex) is
consistent with M.E.



The Romberg test will often be abnormal in MS. (This test measures
neurological or inner ear dysfunction.)
              The Romberg test will be abnormal in 95% or more of M.E.
patients.



An abnormal neurological exam is usual in MS. Abnormalities are also
commonly seen in neuropsychological testing in MS.

            An abnormal neurological exam is usual in M.E. Abnormalities are
also commonly seen in neuropsychological testing in M.E.



MS causes a certain type of brain lesion detectable in MRI brain scans.
Abnormalities are also seen in EEG and QEEG brain maps and SPECT brain scans
in MS.

            M.E. causes a certain type of brain lesion detectable in MRI
brain scans. Abnormalities are also seen in EEG and QEEG brain maps and
SPECT brain scans in M.E.



Hypothyroidism is found in many MS patients.

            Hypothyroidism is found in almost all M.E. patients.



The glucose tolerance test is often abnormal in MS.

            The glucose tolerance test is often abnormal in M.E.



Low blood pressure readings (usually low-normal) are common in MS.

            Low blood pressure readings are extremely common in M.E.
Severely low blood pressure readings as low as, or lower than, 84/48 (or
75/35 according to many anecdotal accounts) are common in severe M.E. or
those having severe relapses. This can occur at rest or as a result of
orthostatic or physical overexertion. At times BP readings can be so low
that they cannot be measured by the machine and error messages appear.
Circulating blood volume measurements of only 50% to 75% of expected are
also commonly seen in M.E.



Patients with MS have an increased risk of dying from heart disease or
vascular diseases.

            Deaths from cardiac problems are one of the most common causes
of death in M.E.



Although MS is primarily neurological, it also has aspects of autoimmune
disease.

            Although M.E. is primarily neurological, it also has aspects of
autoimmune disease.



MS usually affects people between the ages of 20 and 40 years, and the
average age of onset is approximately 34 years. Onset occurs between the
ages of 20 to 40 years in 70% of patients.

            The average ages affected by M.E. are similar to those seen in
MS. However, the average age of onset may be significantly younger in M.E.



MS was once thought to be rare in children, but we know that around 5% of MS
sufferers are under 18.

            Around 10% of M.E. sufferers are under 18.



MS affects more than a million adults and children worldwide.

            M.E. affects more than a million adults and children worldwide.
(M.E. is at least as common as MS, and may be up to twice or three-times as
common.)

--


As well as there being many similarities in symptoms, the brain scans from
M.E. and MS patients are often very similar, as this chart illustrates. MS
and M.E. both cause a certain type of brain lesion detectable in brain
scans. Those with MS tend to have fewer brain lesions of a larger size,
while M.E. is associated with a greater number of these lesions of a
somewhat smaller size.


M.E. and MS are so similar medically that they are sometimes misdiagnosed as
one another.


The names used for M.E. and MS also indicate the similarities between the
two diseases. MS was first described in 1868, and MS has also been known as
'disseminated sclerosis' or 'encephalomyelitis disseminate.' Myalgic
Encephalomyelitis has existed for centuries but was first comprehensively
scientifically documented in 1934, when an outbreak of what at first seemed
to be poliomyelitis  (polio) occurred in Los Angeles (M.E. occurs in
outbreaks as well as sporadically). The term Myalgic Encephalomyelitis was
coined in 1956. Earlier names for M.E. include 'atypical polio' and atypical
multiple sclerosis.'


Both MS and M.E. have been correctly classified as organic diseases of the
central nervous system in the World Health Organization's International
Classification of Diseases for many decades. MS is classified at G 35 and
M.E. at G 93.3.


Why are people with M.E. often envious of people with MS?

MS and M.E. are distinct diseases, but they are in many ways very similar
medically. However, despite the medical similarities, the two diseases are
treated very differently politically and socially. The differences between
the political and social treatment of MS and M.E. are the reason for my envy
of MS sufferers......

--------

To read on please see:

http://www.ahummingbirdsguide.com/mevsms.htm

This page also includes a relevant quotes section, featuring comments from
other M.E. patinets about the similarities and differences between M.E. and
MS.

Permission is given for this unedited document to be freely redistributed,
**please redistribute this text widely**

Please link to the site version of  this text only as only this version will
be updated.

*Note: The table has been converted to plain text for the purposes of
redistribution here by plain text email. See the webpage or Word/PDF version
to see a more clearly formatted version of the chart!


Best wishes everyone,
Jodi Bassett
--
A Hummingbirds Guide to Myalgic Encephalomyelitis:
www.ahummingbirdsguide.com
--
M.E. is a systemic disease (initiated by a virus infection) with multi
system involvement characterised by central nervous system dysfunction which
causes a breakdown in bodily homoeostasis (The brain can no longer receive,
store or act upon information which enables it to control vital body
functions, cognitive, hormonal, cardiovascular, autonomic and sensory nerve
communication, digestive, visual auditory balance, appreciation of space,
shape etc). It has an UNIQUE Neuro-hormonal profile" Dr Elizabeth Dowsett
 
 
* * *
I'll quibble with one point.  Jodi says that ME patients are affected by heat.  According to Dr. Bell, the way to tell MS from ME is by the patient's reaction to heat, because MS patients will feel worse and ME patients will feel better.  I live in an area with extreme heat, and, in fact, I do feel much better in summer than in winter.







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Thursday, February 12, 2009

GET/CBT helpful only for a few

 
The following findings support my analysis of CBT as detailed on Co-Cure during the past few years. Please note the modest effect sizes, also found by others. Alternative programmes which are not based on the CBT model and which allow patients to discuss their frustrations appear as effective, if not more so, than CBT (cf. Jason et al, 2007, Taylor et al, 2006, full references on url below).  However, given the negative effects of stress on the immune system, for example, the inflammation, delayed wound healing etc (cf interview with Prof. Glaser, HPU March 2009), it is  wise to seek some kind of psychological support when the burden of the illness and frustrations of having a contested illness, lead to emotional distress. The first line of treatment for most, in my view, remains counselling. I advocate finding a professional with experience of physical disability.

Friedberg, F and Sohl, S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? Journal of Clinical Psychology, 2009, 65, 4, 1-20.

This multiple case study of cognitive-behavioral treatment (CBT) for CFS compared self-report and behavioral outcomes. Eleven relatively high-functioning participants (out of a group of 17) with CFS (CDC criteria '94) received 6-32 sessions of outpatient graded-activity oriented CBT. Self-report outcomes included measures of fatigue impact, physical function, depression, anxiety, and global change. Behavioral outcomes included actigraphy and the 6-minute walking test.

Global change ratings were very much improved (n=2), much improved (n=2), improved (n=5), and no change (n=2). Of those reporting improvement, clinically significant actigraphy increases (n=3) and decreases (n=4) were found, as well as no significant change (n=2). Effect sizes (Cohen's d) were moderate for fatigue impact (-.78), small for physical functioning as measured by the MOS (.35), anxiety and depression and near zero for the 6-minute walking test. It was also small for activity levels as measured by actigraphy (-.13)*. The number of visits did not significantly predict any outcome variable.

The nature of clinical improvement in CBT trials for high-functioning CFS patients may be more ambiguous than that postulated by the cognitive-behavioral model.

Extracts from discussion: "Furthermore, if clinically significant improvement is defined by achieving normal population values (Jacobsen & Truax, 1991), then no participant reached this level on the fatigue severity scale (Krupp et al., 1989) and only two participants met population values on the SF-36PF subscale (Ware, Snow, Kosinski, & Gandek, 2000). This is consistent with successful CBT studies that, despite clinical improvements, have not yielded outcomes equivalent to recovery or cure in both short- (e.g., Prins et al., 2001) and long-term (e.g., Deale, Husain, Chalder, & Wessely, 2001) follow-ups... Although cognitive-behavioral theory predicts improved well-being and functioning via cognitively-mediated increases in activity (e.g., Bleijenberg, Prins, & Bazelmans, 2003; Butler et al., 1991; Prins & Bleijenberg, 1999; Surawy et al., 1995), the clinical trial outcomes in support of the theory were conducted on largely low-functioning, unemployed participants, many of whom were receiving disability benefits (Ross et al., 2004). The current study, conducted on mostly employed participants, calls into question whether real-time behavioral change is associated with such improvement in this subgroup...  Given that 7 of 11 participants were employed at baseline and performed many non-work activities, it may be unrealistic to expect that CBT will substantially increase physical and role functioning and, by implication, real-time physical activity and exercise tolerance in these high-functioning individuals (Friedberg & Krupp, 1994). By comparison, the lower functioning participants in previous clinical trials may have been more likely to show measurable increases in physical and role activity as a result of CBT (Friedberg, 1999)... Although our participants may have been mobilized by their graded activity assignments in the initial phase of treatment, the effect of this low-level activity (sometimes in combination with other CBT strategies, e.g., relaxation, sleep scheduling) may have been to facilitate a healthier balance among activity, rest, and leisure (Friedberg, 2006) that in only some cases yielded greater overall activity levels. Thus, assigned increases in physical activity may be important to the process of therapeutic behavioral change, but improved outcomes may not require net increases in overall physical activity especially in already high-functioning participants... This uncontrolled small sample CBT study in individuals with CFS found that improvements were strongest for self-report fatigue impact. However, treatment gains may be attributable to nonspecific effects such as therapist attention or passage of time, rather than the targeted intervention. Although conclusions about cause and effect cannot be made, this study revealed an ambiguous picture of clinical outcomes in relatively high-functioning CFS patients than has not been previously reported.

[Ed. Note: For other d values related to CBT and graded activity, see Malouff et al 2008 and Nezu et al 2001. The drop-out rate in the above study was 35.3%.]

http://www3.interscience.wiley.com/journal/122197496/abstract
  ----------------------------------------------------------------------
Ellen M. Goudsmit PhD CPsychol AFBPsS
Chartered Health Psychologist
Visiting Research Fellow, School  of Psychology
University of East London
 




 


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Tuesday, February 10, 2009

NFA's response to AP article on Fibro

NFA's Response to AP article (February 8, 2009, "AP Impact: Drugmakers'
push boosts 'murky' ailment")

Click the link below to read the article:
http://hosted.ap.org/dynamic/stories/F/FIBROMYALGIA_DRUG_COMPANIES?SITE=RIPRJ&SECTION=HOME&TEMPLATE=DEFAULT 


To the editors:

The recent Associated Press story on fibromyalgia hardly qualifies as
news; it merely regurgitates the same arguments that have been published
in the past and offers the opinions of the same two men who have built
careers out of drawing attention away from the hundreds of scientists
who continue to make amazing scientific strides toward understanding the
underlying cause(s) and pathophysiology of what fibromyalgia patients
experience. By perpetuating this message, the article implies that it is
more acceptable to debate names or labels for this "set of symptoms" and
to point fingers at the usual "villains" (i.e.: pharma and the
nonprofits who accept money from them), than to focus on the millions of
desperate patients who deserve to have a voice in the discussion. The
fact is that credible medical institutions and organizations recognize
fibromyalgia as a life-altering disease
; the fact is that patients who
suffer with FM depend on the medical system (including pharmaceutical
companies) to help them inform the public that this is a very real
illness and that they need treatments, including pharmaceutical agents,
to help them get through each day-and to look forward to some sort of
quality of life in the future.

This article misinforms readers in a way that undermines and victimizes
innocent people. By telling only selective parts of the story the author
is perpetuating misperceptions and making it difficult, if not
impossible, for readers to grasp what is truly important: that we need
to stop debating and pointing fingers and start asking why it is
perceived as acceptable to stigmatize a patient population just because
medical research hasn't yet provided us with all the information needed
to understand that particular illness.
Every illness seems to go through
a stage of having to prove its legitimacy, but why should the patients
be suspect during that phase of research?

Why would AP print information that is simply not true-i.e.: people with
fibromyalgia are "more likely to have a history of mental illness and
are economically disadvantaged?" That is totally false
, as is the
writer's statement that the National Fibromyalgia Research Association
received pharma money to fund Dr. Clauw's functional MRI study. The
money for all of the NFRA's funded research came from the founder (the
husband of a fibromyalgia patient), general donations, and revenue
generated from a nonprofit bingo game. (Yes, the FM community has had to
rely on bingo games to fund our research!)

How can we allow the system to fail millions of people whose only "fault" is to have developed a devastating illness? Along with the rest
of the fibromyalgia patient community, I look forward to the day when
society (including the medical community, the media, and our government
agencies) accepts the responsibility of treating fibromyalgia patients
like any other group of chronically ill patients; when it is a given
that fibromyalgia will be further studied, that treatments will be
developed and made accessible to patients, that the media presents the
facts rather than perpetuating threadbare controversies. 

Now that would be news worth printing.

Sincerely,
Lynne Matallana
President, National Fibromyalgia Association


 


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Jason on CDC's CURRENT Definition for CFS

Source: Journal of Disability Policy Studies Online
        Preprint
Date:   October 21, 2008
URL:    http://jdps.sagepub.com
        http://dps.sagepub.com/cgi/content/abstract/1044207308325995v1


Evaluating the Centers for Disease Control's Empirical Chronic Fatigue
Syndrome Case Definition
----------------------------------------------------------------------
Leonard A. Jason(*), Natasha Najar, Nicole Porter, Christy Reh,
DePaul University, Chicago, Illinois
* Address correspondence to Leonard A. Jason, PhD, Director, Center for
  Community Research, DePaul University, 990 W. Fullerton Avenue, Suite 3100,
  Chicago, IL 60614; e-mail: Ljason@depaul.edu .


Abstract

The Centers for Disease Control and Prevention (CDC) recently developed an
empirical case definition that specifies criteria and instruments to diagnose
chronic fatigue syndrome (CFS) in order to bring more methodological rigor to
the current CFS case definition. The present study investigated this new
definition with 27 participants with a diagnosis of CFS and 37 participants
with a diagnosis of a Major Depressive Disorder. Participants completed
questionnaires measuring disability, fatigue, and symptoms. Findings
indicated that 38% of those with a diagnosis of a Major Depressive Disorder
were misclassified as having CFS using the new CDC definition
. Given the
CDC's stature and respect in the scientific world, this new definition might
be widely used by investigators and clinicians. This might result in the
erroneous inclusion of people with primary psychiatric conditions in CFS
samples, with detrimental consequences for the interpretation of
epidemiologic, etiologic, and treatment efficacy findings for people with
CFS.

Keywords: chronic fatigue syndrome; empirical case definition; Centers for
Disease Control and Prevention; Fukuda criteria; Major Depressive Disorders


Chronic fatigue syndrome (CFS) is a disabling chronic illness that has been
defined by a consensus-based approach by Fukuda et al. (1994). This case
definition specifies that individuals with this illness must have 6 or more
months of chronic fatigue of new or definite onset, which is not
substantially alleviated by rest, is not the result of ongoing exertion, and
results in substantial reductions in occupational, social, and personal
activities. In addition, to be diagnosed with this illness, individuals must
have four or more symptoms (i.e., sore throat, lymph node pain, muscle pain,
joint pain, postexertional malaise, headaches of a new or different type,
memory and concentration difficulties, and unrefreshing sleep) that persist 6
or more months since onset. Although the Fukuda et al. case definition
continues to be widely used, several articles have identified difficulties
that this case definition continues to pose to clinicians and researchers
(Jason, King, et al., 1999; Reeves et al., 2003). For example, the Fukuda et
al. case definition did not specify which instruments to use and did not
provide empirically derived cutoff points and scoring guidelines to diagnose
CFS.

The Centers for Disease Control and Prevention (CDC) has now developed an
empirical case definition for CFS that involves assessment of symptoms,
disability, and fatigue (Reeves et al., 2005). The new CDC empirical case
definition assesses disability using the Medical Outcomes Survey
Short-Form-36 (Ware, Snow, & Kosinski, 2000), assesses symptoms using the
Symptom Inventory (Wagner et al., 2005), and assesses fatigue using the
Multidimensional Fatigue Inventory (Smets, Garssen, Bonke, & DeHaes, 1995).
The authors of this empirical case definition feel that the specification of
instruments and cutoff points would result in a more reliable and valid
approach for the assessment of CFS. Using these new criteria, the estimated
rate of CFS has increased to 2.54% (Reeves et al., 2007), a rate that is
about 10 times higher than prior CDC estimates (Reyes et al., 2003) and
prevalence estimates of other investigators (Jason, Richman, et al., 1999).
It is of interest that the new CFS rates are within the range of several mood
disorders. Mood disorders are the most prevalent psychiatric disorders after
anxiety disorders: For a major depressive episode, the 1-month prevalence is
2.2%, and lifetime prevalence is 5.8% (Regier, Boyd, & Burke, 1988). It is at
least possible that the increases in the United States are due to a
broadening of the case definition and possible inclusion of cases with
primary psychiatric conditions. CFS and depression are two distinct disorders, however, even if they share a number of common symptoms.
Including
patients with a primary psychiatric illness in the current CFS case
definition could confound the interpretation of epidemiologic and treatment
studies. Major Depressive Disorder (MDD) is an example of a primary
psychiatric disorder that has some overlapping symptoms with CFS.

Fatigue, sleep disturbances, and poor concentration occur in both depression and CFS. It is important to differentiate those with a principal diagnosis of MDD from those with CFS only. This is particularly important because it is
possible that some patients with MDD also have chronic fatigue and four minor
symptoms that can occur with depression (e.g., unrefreshing sleep, joint
pain, muscle pain, and impairment in concentration). Fatigue and these four
minor symptoms are also defining criteria for CFS. It is possible that using
this broadened new CFS empirical case definition (Reeves et al., 2005), some
patients with a primary affective disorder could be misdiagnosed as having
CFS. Some CFS investigators would not see this as a problem because they
believe that CFS is mainly a psychiatric disorder and that distinctions
between the two phenomena are superficial and merely a matter of
nomenclature. However, several CFS symptoms, including prolonged fatigue after physical exertion, night sweats, sore throats, and swollen lymph nodes, are not commonly found in depression. In addition, although fatigue is the
principal feature of CFS, fatigue does not assume equal prominence in
depression (Friedberg & Jason, 1998; Komaroff et al., 1996). Moreover,
illness onset with CFS is often sudden, occurring over a few hours or days,
whereas primary depression generally shows a more gradual onset. Individuals
with CFS can also be differentiated from those with depression by recordings
of skin temperature levels and electrodermal activity (Pazderka-Robinson,
Morrison, & Flor-Henry, 2004). Hawk, Jason, and Torres-Harding (2006) used
discriminant function analyses to identify variables that successfully
differentiated patients with CFS, MDD, and controls. Using percentage of time
fatigue was reported, postexertional malaise severity, unrefreshing sleep
severity, confusion/disorientation severity, shortness of breath severity,
and self-reproach to predict group membership, 100% were classified
correctly. In summary, CFS and depression are two distinct disorders,
although they share a number of common symptoms. It is possible to
appropriately differentiate MDD from CFS if one uses appropriate measures.

It is still unclear whether the new empirical case definition of CFS (Reeves
et al., 2005) has inappropriately included cases of purely affective
disorders, such as MDD. This study evaluated whether the CDC empirical case
definition distinguished between persons with MDD and persons with CFS. By
assessing samples with MDD and CFS, we hoped to clarify whether the CDC
empirical case definition has been able to successfully differentiate those
with MDD from those with CFS.


Method

Participants

We recruited a total of 64 individuals, 27 with CFS and 37 with MDD. We
obtained our sample of participants with CFS from two sources: local CFS
support groups in Chicago and a previous research study conducted at DePaul
University. To be included in the study, participants were required to have
been diagnosed with CFS, using the Fukuda et al. (1994) diagnostic criteria,
by a certified physician and were required to currently meet CFS criteria
using the Fukuda et al. criteria. We excluded individuals who had other
current psychiatric conditions in addition to major depression or who
reported having untreated medical illnesses (e.g., diabetes, anemia).

We solicited 37 participants with a diagnosis of MDD to participate in this
study. We found participants from three sources: local chapters of the
Depression and Bipolar Support Alliance group in Chicago; Craigslist, a free
local classified ads forum that is community moderated; and online depression
support groups. To be included in the study, all participants were required
to have been diagnosed with MDD by a licensed psychologist or psychiatrist.
We excluded individuals who had other current psychiatric conditions in
addition to MDD (e.g., bipolar, schizophrenia) and those who reported having
untreated medical illnesses.

Participants who met criteria completed questionnaires that are described
below. Participants reported any previous physical and mental illnesses and
the date of diagnosis as well as current medications being taken to ensure
that no other illness could account for the fatigue. We carefully screened
participants to ensure that participants from the MDD group did not have CFS
as defined by the Fukuda et al. (1994) criteria.


Measures

Demographic variables.
We collected basic demographic variables that included age, ethnicity,
marital status, occupation, gender, work status, and educational level.

The Medical Outcomes Survey Short-Form-36.
This 36-item instrument is composed of multi-item scales that assess
functional impairment in eight areas: limits in physical activities (Physical
Function), limits in one's usual role activities due to physical health (Role
Physical), limits in one's usual role activities due to emotional health
(Role Emotional), Bodily Pain, general health perceptions (General Health),
vitality (Energy and Fatigue), Social Function, and General Mental Health
(Ware et al., 2000). Scores in each area reflect ability to function, and
higher values indicate better functioning. Reliability and validity studies
have demonstrated high reliability and validity in a wide variety of patient
populations for this instrument (Stewart, Greenfield, Hays, et al., 1989).
Based on the CDC empirical case definition (Reeves et al., 2005), the Medical
Outcomes Survey Short-Form-36 was used to assess disability (Wagner et al.,
2005). According to Reeves et al. (2005), significant reductions in occupa-
tional, educational, social, or recreational activities were defined as
scores lower than the 25th percentile on Physical Function (less than or
equal to 70), or Role Physical function (less than or equal to 50), or Social
Function (less than or equal to 75), or Role Emotional function (less than or
equal to 66.7). A person would meet the disability criterion for the
empirical CFS case definition by showing impairment in only one or more of
these four areas (Reeves et al., 2005).

The CDC Symptom Inventory.
The CDC Symptom Inventory assesses information about the presence, frequency,
and intensity of 19 fatigue-related symptoms during the past 1 month (Wagner
et al., 2005). All 8 of the critical Fukuda et al. (1994) symptoms were
included as well as 11 other symptoms (e.g., diarrhea, fever, sleeping
problems, and nausea). For each of the 8 Fukuda et al. symptoms,
participants were asked to report the frequency (1 = a little of the time, 2
= some of the time, 3 = most of the time, 4 = all of the time) and severity
(the ratings were transformed to the following scale: .08 = very mild, 1.6 =
mild, 2.4 = moderate, 3.2 = severe, 4 = very severe; see Note 1). The
frequency and severity scores were multiplied for each of the 8 critical
Fukuda et al. symptoms and were then summed. Participants having 4 or more
symptoms and scoring greater than or equal to 25 would meet symptom criteria
on this instrument according to the CDC empirical case definition (Reeves et
al., 2005).

The Multidimensional Fatigue Inventory.
This instrument is a 20-item self-report instrument consisting of five
scales: General Fatigue, Physical Fatigue, Reduced Activity, Reduced
Motivation, and Mental Fatigue (Smets et al., 1995). Each scale contains four
items rated from 1 to 5, with the scale score of 1 meaning yes, that is true
and the scale score of 5 meaning no, that is not true. Reeves et al. (2005)
used the Multidimensional Fatigue Inventory to measure severe fatigue, and to
do this, they used only two of the five subscales: General Fatigue and
Reduced Activity. Using the CDC empirical case definition standards, severe
fatigue was defined as greater than or equal to 13 on General Fatigue or less
than or equal to 10 on Reduced Activity.


Results

Classification by CDC Empirical Case Definition Criteria

When using the CDC empirical case definition to classify people with CFS, all
27 participants in the CFS-recruited group met criteria for CFS. However, 14
additional individuals from the MDD group also met the new CDC criteria for
CFS. That is, 38% of those with a professional diagnosis of major depression
were misclassified as having CFS using the CDC empirical case definition.


Sociodemographic Variables

Participants were separated into three groups: Those 27 diagnosed with CFS
prior to this study and who met the new empirical CDC case definition of CFS,
those 14 from the group with MDD meeting the new empirical CDC case
definition of CFS criteria (MDD/CFS), and those 23 from the group with MDD
not meeting the new empirical CDC criteria for CFS (MDD). Sociodemographic
data were compared across all three groups of participants using Pearson's
chi^2 and analysis of variance (ANOVA; see Table 1). Findings indicated a
significant age effect, F(2,63)=3.25, p<.05. The average age for the CFS
group was significantly older than the MDD/CFS group. Furthermore, there were
also significant differences in regard to work status between groups,
chi^2(6,N=64)=13.92, p<.05. More individuals in the CFS group were on
disability as compared to the MDD/CFS group, chi^2(1,N=41)=4.11, p<.05.


Illness Classification by Standardized Clinically Empirical Criteria

Medical Outcomes Survey Short-Form-36.
According to the CDC empirical case definition, participants are required to
demonstrate functional impairment within one of the four areas: Physical
Function, Role Physical, Role Emotional, and Social Function. One-way ANOVA
was used to assess the effect of physical impairment within four subscales of
the Medical Outcomes Survey Short-Form-36 for the three groups (CFS, MDD, and
MDD/CFS). As seen in Table 2, there were significant effects for three of the
subscales, but not social functioning. Using Tukey's honestly significant
difference (HSD) post hoc test, significant differences were found for Role
Physical; participants with CFS had significantly lower scores compared to
both the MDD group (p<.001) and the MDD/CFS group (p<.001). In regard to
physical functioning, the participants with CFS had significantly worse
Physical Function impairment scores in compari- son to participants with MDD
(p>.001) and participants with MDD/CFS (p<.001). Finally, for role emotional
functioning, the MDD/CFS group scored significantly lower on the Role
Emotional scale than both the CFS (p<.001) and the MDD groups (p<.001).

Examining Table 3, it is apparent that all three illness groups met criteria
for at least one of the four subscales and thus would meet the disability
criteria for the empirical case definition of CFS. It is clear that
significantly more participants from the MDD and MDD/CFS groups met Role
Emotional criteria than the CFS group. However, if Role Physical or Physical
Functioning criteria were used as the sole criterion for disability, sig-
nificantly more participants within the CFS group would meet the disability
criteria than those in the MDD/CFS and MDD groups.


Symptom Inventory analysis.
There was a significant effect of the total CFS symptom scores,
F(2,61)=34.184, p<.001. The MDD group had the lowest mean score, indicating
that this group did not likely meet criteria for CFS. The CFS group mean
score was directionally but not significantly higher than the MDD/CFS group
score. Tukey post hoc tests indicated that the CFS and MDD/CFS groups scored
significantly higher than the MDD group (p<.001). Examining Table 3, both the
CFS and MDD/CFS groups had higher percentages of participants meeting CFS
symptom criteria than those in the MDD group. The fact that 100% of
participants in the CFS and MDD/CFS groups met criteria for this index
suggests that many individuals without CFS will meet these cutoff criteria
for symptom frequency and severity.


The Multidimensional Fatigue Inventory.

The CDC empirical case definition used the Multidimensional Fatigue Inventory
to measure fatigue. There was a significant effect for General Fatigue,
F(2,61)=4.89, p<.05, but no significant effect was found for Reduced
Activity. Post hoc analysis using the Tukey HSD test revealed significant
differences for General Fatigue. The MDD group scored significantly lower on
the General Fatigue scale than both the CFS (p<.01) and MDD/CFS groups
(p<.01). Inspecting Table 3, all participants within the CFS and MDD/CFS
groups met one of the fatigue criteria. In addition, 87% of those in the MDD
group also met one of the fatigue criteria. This again suggests that for the
domain of fatigue, the empirical case criteria will select many individuals
without CFS who will meet fatigue criteria for the empirical case definition.


Discussion

Reeves et al. (2005) claim that the empirical definition identifies people
with CFS in a more precise manner than can occur in the more traditional way
of diagnosis. Analyses from this study reveal that the new empirical case
definition identified 38% of the MDD group as meeting CFS criteria. Cantwell
(1996) argues that diagnostic criteria should specify which diagnostic
instrument to use, what type of informants to interview, and how to determine
the presence and severity of the criteria. The effort by Reeves et al. to
specify a certain number and type of symptoms that should be present in order
to make a particular diagnosis appears to be overinclusive, particularly for
those having a primarily depressive disorder.

An analysis of the Medical Outcomes Survey Short-Form-36 illustrates the
problems with the cutoff criteria. When using the Reeves et al. (2005) cutoff
points to classify functional impairment, all three groups (100%) met
criteria for this instrument in Table 3. However, had Reeves et al. selected
either Physical Function or Role Physical, better differentiation would have
occurred, as there is a significant difference between the CFS group and the
other two groups for these domains. Because individuals need only to score
lower than the 25th percentile in one of these four areas in order to meet
the CFS criteria, individuals might not have any reductions in key areas of
physical functioning and only impairment in role emotional areas (e.g.,
problems with work or other daily activities as a result of emotional
problems).

For Role Emotional, 93% of the MDD/CFS group and 78% of the MDD group met
criteria, a percentage much higher than the CFS group (44%). Ware et al.
(2000) found that the mean for Role Emotional for a clinical depression
group was 38.9, indicating that almost all those with clinical depression
would meet criteria for being within the lower 25th percentile on this scale
(which was a score of less than or equal to 66.7). In addition, King and
Jason (2005) compared a group diagnosed with CFS and a group diagnosed with
MDD, and the latter group had lower scores than the group with CFS (37.8 vs.
48.9), but both groups would have met the CDC criteria as they both scored
below 66.7. In contrast, if the criterion was a score lower than the 25th
percentile on just Physical Function (less than or equal to 70), the
participants with CFS would have met this criterion as their average score
was 44, whereas many within the MDD group would have not met this criterion
as their average score was 70.3.

Regarding the Symptom Inventory, 100% of both the CFS and MDD/CFS groups met
criteria, indicating this instrument did not distinguish the individuals with
CFS from individuals with major depression. It is probable that the Symptom
Inventory misclassified the MDD/CFS group for several reasons. For example,
the Symptom Inventory asks about the symptom occurrences within the past
month rather than the past 6 months, as required by the Fukuda et al. (1994)
case definition. The requirement for a participant to report a symptom for 1
month might include more individuals within the CFS category (e.g., a person
who has experienced a physical illness such as influenza or a head cold could
very well have experienced a severe sore throat for the past month). Even
with summed scores for the empirical case definition needing to be greater
than or equal to 25 (Reeves et al., 2005), the overall level of symptoms
might be relatively low for patients with classic CFS symptoms (the criterion
would be met if an individual rated only two symptoms as occurring all the
time, and one was of moderate and the other of severe severity). Similarly, a
person with MDD could endorse symptoms that would easily meet criteria for
this scale, such as unrefreshing sleep, impaired memory, and headaches, and
muscle pain at a moderate to severe level. However, the most important factor
is that the Symptom Inventory does not distinguish critical symptoms for CFS
such as postexertional malaise, unrefreshing sleep, and cognitive
difficulties. Each symptom is given the same value, which means that a
participant reporting severe and frequent headaches is given the same value
as a participant reporting severe and frequent postexertional malaise.
Overall, 14 individuals diagnosed with MDD scored 25 or higher on the Symptom
Inventory and reported four or more symptoms. This demonstrates that
individuals with primary psychiatric illnesses are not always excluded using the CDC Symptom Inventory.

The Multidimensional Fatigue Inventory was used to measure severe fatigue,
yet 93% of both the CFS and MDD/CFS groups met criteria for General Fatigue,
while 74% of the MDD group did as well. As for the criteria that Reeves et
al. (2005) used, the primary developer of the Multidimensional Fatigue
Inventory had this to say: "Regarding the criteria suggested by Reeves, we
have no paper to back up their decision, but scanning their paper it appears
that they used the median of their own data" (E. M. Smets, personal
communication, June 29, 2006). In one study of three groups with CFS, the
mean Multidimensional Fatigue Inventory General Fatigue scores were 18.3 to
18.8 (Tiersky, Matheis, DeLuca, Lange, & Nateson, 2003). When assessing
Reduced Activity, 85% and 86% of both the CFS and MDD/CFS groups
(respectively) met criteria, as did 78% of the MDD group. Therefore, 100% of
the CFS and 100% of the MDD/CFS group met the CDC fatigue criteria. The
problem with this instrument is that it is relatively easy to meet criteria
for one of the two categories. In other words, a depressed person could
easily respond positively to questions such as "I get little done" or "I do
very little in a day" and answer negatively to "I feel very active" or "I
think I do a lot in a day." Consequently, a depressed person would meet CFS
criteria by answering "entirely true" to these types of items.

Inspecting the scores of a person with MDD who was inappropriately classified
as having CFS highlights the problems with the CDC empirical criteria. A
26-year-old female with MDD met criteria for CFS using the CDC empirical case
criteria (Reeves et al., 2005). For the Medical Outcomes Survey
Short-Form-36, she met cutoff points for Social Function (scoring 37.5 when
needing to score 75) and Role Emotional (scoring 0 when needing to score
66.7). With a clinical diagnosis of MDD, she demonstrated impairment with
social and emotional functioning, two important traits of depression. This
person scored 100 on Physical Function, which is the highest possible score
on this measure, indicating that she had no difficulties with physical
functioning, which would be a clear indicator that she did not have CFS. On
the CDC Symptom Inventory, she reported that postexertional malaise was mild
only some of the time, indicating that she did not have this cardinal symptom
of CFS. For this individual and others within the MDD/CFS group, the
instruments used to identify cases of CFS did not adequately exclude persons
with primary psychiatric disorders.


Study Limitations

There were biases in using a convenience sample, and recruitment from a
population-based referral source would have been preferable, but such samples
are expensive to recruit. Also, the sample sizes overall were relatively
small, but even though power was low to detect differences, we were able to
find a number of significant outcomes, as represented in Tables 2 and 3. In
addition, we focused on only one psychiatric disorder, and future studies
might include anxiety disorders, which might also be misclassified. In
addition, there is probably a redundancy in some of our findings, as some of
the scales are correlated.

There are other ways that might be used to develop improvements in the CFS
case definition. As an example, Jason, Corradi, and Torres-Harding (2007)
factor analyzed the core symptoms as defined by the Fukuda et al. (1994)
criteria, but this did not result in interpretable factors. However, when
they included a larger group of theoretically defined symptoms in the factor
analyses, an interpretable set of factors did emerge. The following factors
were found: neurocognitive (e.g., slowness of thought), vascular (e.g., dizzy
after standing), inflammation (e.g., chemical sensitivities), muscle/joint
(e.g., pain in multiple joints), infectious (e.g., sore throat), and
sleep/postexertional (e.g., unrefreshing sleep).
These findings suggest that
theoretical and empirical approaches to determining critical symptoms of CFS
have considerable merit. The field of CFS studies needs to be grounded in
empirical methods for determining a case definition versus more
consensus-based efforts.

In conclusion, this study suggests that the Reeves et al. (2005) empirical case definition has broadened the criteria such that some individuals with a purely psychiatric illness will be inappropriately diagnosed as having CFS. The Reeves et al. empirical case definition used specific instruments (such
as the Medical Outcomes Survey Short-Form-36) to make diagnostic decisions
but included dimensions within them such as role emotional functioning that
were not specific for this illness. Green, Romei, and Natelson (1999) found
that 95% of individuals seeking medical treatment for CFS reported feelings
of estrangement, and 70% believed that others uniformly attributed their CFS
symptoms to psychological causes. Inappropriate inclusion of pure
psychiatric disorders into the CFS samples may further contribute to the
diagnostic skepticism and stigma that individuals with this illness
encounter. Several researchers continue to believe that CFS should be
considered a functional somatic syndrome (Barsky & Borus, 1999),
characterized by diffuse, poorly defined symptoms that cause significant
subjective distress and disability and that cannot be corroborated by
consistent documentation of organic pathology. Taylor, Jason, and Schoeny
(2001) have challenged this position, but ultimately assessment and criteria
that fail to capture the unique characteristics of these illnesses might
inaccurately conclude that only distress and unwellness characterize CFS,
thus inappropriately supporting a unitary hypothetical construct called
"functional somatic syndrome." Such blurring of diagnostic categories will
make it even more difficult to identify biological markers for this illness,
and if they are not identified, many scientists will be persuaded that this
illness is psychogenic (Jason & Richman, 2008). Ultimately, using a broad or
narrow definition of CFS will have important influences on CFS epidemiologic
findings, on rates of psychiatric comorbidity, on how patients are treated,
and ultimately on the likelihood of finding biological markers for this
illness.


Note

1. The scale we used had five choices, and we needed to convert the ratings
   to a 4-point scale. We divided the five items by 4, which came to .8. We
   then made each increment in value .8.


About the Authors

Leonard A. Jason, PhD, is a professor of psychology at DePaul University and
the Director of the Center for Community Research. His current interests
include myalgic encephalomyelitis/chronic fatigue syndrome, recovery homes,
and tobacco control.

Natasha Najar, BA, currently conducts research at Northwestern University.
She has particular interests in cultural issues.

Nicole Porter, PhD, currently is the project director of a chronic fatigue
syndrome (CFS) epidemiologic grant at the Center for Community Research,
DePaul University. Her interests are in myal- gic encephalomyelitis/CFS,
meditation, and dynamic systems.

Christy Reh, BA, currently is a graduate student at the Alder School of
Professional Psychology in Chicago, Illinois.


Tables

Table 1. Sociodemographic Characteristics Between the CFS, MDD/CFS, and MDD Groups
-------------------------------------------------------------------------------------------------------------
Characteristic                 CFS                   MDD/CFS               MDD                   Significance
                               --------------------  --------------------  --------------------
                               n    %    M   (SD)    n    %    M   (SD)    n    %    M   (SD)
-------------------------------------------------------------------------------------------------------------
Age                            27        49  (13.2)  14        37  (12.3)  23        44  (15.5)
Gender
   Male                         2    7                1    7                3   13
   Female                      25   93               13   93               20   87
Race
   White                       19   70               11   79               17   74
   Black                        5   19                2   14                0    0
   Other                        3   11                1    7                6   26
Marital status
   Married                      7   26                3   21                4   17
   Never married               11   41                8   57               15   65
   Separated/widowed/divorced   9   33                3   21                4   17
Children
   Yes                         17   63                5   36                8   35
   No                          10   37                9   64               15   65
Education
   High school degree or less   2    7                2   14                4   17
   Partial training             9   33                8   57                6   26
   College degree               8   30                3   21                7   30
   Grad/profession              8   30                1    7                6   26
Work status
   On disability               13   48                3   21                3   13               *
   Unemployed                   4   15                2   14                7   31
   Work part-time               5   18                2   14                1    4
   Work full-time               5   18                7   50               12   52
-------------------------------------------------------------------------------------------------------------
Note: CFS=chronic fatigue syndrome; MDD=major depressive disorder.
*Difference is statistically significant at the p=<.05 level.


Table 2. Mean Differences Between the CFS, MDD/CFS, and MDD Groups on Criteria Variables
-------------------------------------------------------------------------------------------------------------
Variable                           CFS                  MDD/CFS               MDD                Significance
                                   -------------------  -------------------  -------------------
                                   M       (SD)         M       (SD)         M       (SD)
-------------------------------------------------------------------------------------------------------------
Medical Outcomes Survey Short-Form-36
   Role Physical                    5.56   (16.01)^a,b  51.79   (40.98)^b    58.7    (45.61)a    ***
   Social Function                 30.09   (28.43)      41.96   (23.31)      40.22   (25.27)
   Physical Function               37.41   (23.43)^a,b  70.36   (32.90)^b    76.74   (21.25)a    ***
   Role Emotional                  69.14   (40.22)^a,b  19.05   (31.25)^a    30.43   (40.09)b    ***
CDC Symptom Inventory
   CDC scores                      43.97   (14.28)^b    37.56   (10.54)^a    17.05   (8.62)a,b   ***
Multidimensional Fatigue Inventory
   General Fatigue                 16.74   (2.90)^b     16.86   (2.80)^a     14.3    (3.42)a,b   **
   Reduced Activity                14.44   (3.79)       13.64   (3.95)       13.17   (4.77)
-------------------------------------------------------------------------------------------------------------
Note: Similar letter subscripts across rows indicate significant differences in means.
CFS=chronic fatigue syndrome; MDD=major depressive disorder.
**Difference is statistically significant at the p=<.01 level.
***Difference is statistically significant at the p=<.001 level.


Table 3. Percentages of the CFS, MDD/CFS, and MDD Groups Meeting
         Specific CFS Criteria
------------------------------------------------------------------------
Criteria                       %CFS     %MDD/CFS   %MDD     Significance
------------------------------------------------------------------------
Medical Outcomes Survey Short-Form-36
   Role Physical  50.0          96^a,b   50^a       44^b    ***
   Social Function  75.0        96      100         91
   Physical Function  70.0      93^a,b   43^a       35^b    ***
   Role Emotional  66.7         44^a,b   93^a       78^b    ***
   Meets at least 1            100       100       100
CDC Symptom Inventory
   CDC scores  25.0            100^a     100^b       9^a,b  ***
Multidimensional Fatigue Inventory
   General Fatigue  13.0        93        93        74
   Reduced Activity  10.0       85        86        78
   Meets at least 1            100       100        87
------------------------------------------------------------------------
Note: Similar letter subscripts across rows indicate significant differ-
ences in means. CFS=chronic fatigue syndrome; MDD=major depressive
disorder.
***Difference is statistically significant at the p=<.001 level.


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--------
(c) 2008 Hammill Institute on Disabilities
(c) 2008 SAGE Journals


* * *
My chiropractor gave me a similar computer-scored diagnostic test, which indicated that one of my problems was depression.  However, when we went beyond the numbers to the actual responses I'd given, every Yes in the Depression section of the questionnaire was for some non-emotional component, like pain, questions also asked in other sections of the questionnaire.  Fortunately, he was astute enough to realize that my demeanor in interacting with him was not that of a depressed person, and looked past the numbers to see what the score was based on.
Unfortunately, there are far too many people who hear "fatigue" and immediately jump to a depression diagnosis.  When you add in those non-depression symptoms, like fever and sore throat and severe digestive problems, some of them will, as one of my doctors did, file it under "nothing you say makes sense" instead of looking for an alternative diagnosis where it does make sense.  In 1987, I was evaluated by a professor of counseling, who pointed out that, while I answered Yes to 3-of-8 on the ultra-basic depression quiz, the things I said yes to were also symptoms of physical illness (someone with a fever will sleep a lot, feel lethargic, and have trouble concentrating, but those symptoms are caused by the fever, not by depression), and therefore, I did not have depression because there was no emotional component present.  The doctor refused to accept this evaluation.  And again, in 2000-2001, the doctor who was convinced I was depressed disregarded the statements of two psych evaluators that I was not depressed.  To him, it was just more input that didn't make sense, because it didn't support what he wanted to diagnose.
 
I am closely monitored by a good friend who worked as a psych nurse and still volunteers at the free psych clinic.  If she ever tells me "hie thee to a shrink", I'll go without argument.  But she's never said it, because I'm not depressed.  I do have post-viral CFS, which can be differentiated from depression by someone who asks the right questions instead of making a diagnosis based on the single word "fatigue".

If you're trying to get a diagnosis, tell the doctor everything else before you finally get around to mentioning fatigue.  Get him thinking down a different path -- most of the symptoms of CFS are also symptoms of MS -- before you finally bring up fatigue.  If he's already thinking along the lines of a physical illness, you're more likely to get a correct diagnosis than if you start with fatigue and he gets depression in his mind before you say another word.
 
And if you're reading research on "CFS", be sure to read the selection criteria carefully.  Tom Kindlon is pretty good at pulling out those studies which say they're investigating CFS but are actually looking at people with psychiatric problems.
 
 
 
 
 


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Monday, February 9, 2009

9 Years Off For Good Behavior

This is the 9th anniversary of the day I lost my job for being too sick to work, and next week is the 22d anniversary of getting the virus.
 
Due to spending the past 9 years taking care of myself, getting plenty of rest, I am in better shape than the day I lost my job.  However, I have no delusions that I could go back to work, because every time I try to do a little more, I make myself sicker.
 
Life these days is a tenuous balance between doing what needs to be done and doing too much, then ending up back in bed for days or weeks.  With proper medical treatment (which I didn't get the first few years), I'm now able to do some normal things, like a quick trip to the mall or a short walk, which is a long way from the days I was only out of bed a total of an hour a day.  But that's still far from good enough to be able to work 8 hours a day.
 
I got a new client who, the last couple of weeks, has had me working consistently and I've seen the results of working a couple hours every day, rather than 6-10 hours a week.  It didn't make me as sick as it did in the past, but nonetheless caused enough downturn that I had to take days off.  So, I know I can't walk into VocRehab and commit to a job that requires 2-3 hours 5 days a week, and VocRehab won't place you if you can't make that commitment and keep "regular attendance" (i.e., use a normal number of sick days).

Things are improving, but not as fast as some people would like to see.  I'm working, but I'm still not "employable".
 
The one thing that is difficult for some people to understand is that I feel as good as I do because I am not working in an office.  I would not feel this good if I did not have the opportunity throughout the day to lie down, and maybe take a nap.
 
With continued rest and proper medication, I hope that I can celebrate the 10th anniversary of losing my job by telling VocRehab that I am well enough to be employable, but we'll take that one small step at a time.

Despite the claims of some of my detractors, the goal has ALWAYS been to get back to the career I loved. That's why, at the very first appointment, I told the doctor what he needed to prescribe to get me back to work as quickly as possible.  And continued to make the request at every subsequent appointment, "fine, since what you wanted to prescribe didn't work, now can I have what I asked for originally?"  That's not the behavior of someone who doesn't want to work.  The doctor's behavior, however, is inexplicable; he disregarded an expert diagnosis and expert advice on what to prescribe, and then blamed the patient when his misdiagnosis and mistreatment didn't cure a condition that I don't even have.
 
 
 


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ME/CFS JUDICIAL REVIEW

CFS/ME NICE Guidelines Judicial Review
11 & 12 February 2009
The One Click Group

www.theoneclickgroup.co.uk

mail@theoneclickgroup.co.uk
 
INFORMATION RELEASE
9 February 2009


JUDICIAL REVIEW
CFS/ME NICE GUIDELINES

IN THE HIGH COURT OF JUSTICE
QUEENS BENCH DIVISION
ADMINISTRATIVE COURT

BETWEEN:


Claimants: Douglas Frazer, Kevin Short

Interested Party: Benjamin Bryant/The Pledgers

Defendant:
The Defendant is the National Institute for Health and Clinical Excellence (NICE). This case concerns a challenge made to the legality of a clinical guideline published by NICE on recommended treatments for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis.
 
JUDICIAL REVIEW
CFS/ME NICE GUIDELINES

11 & 12 February 2009
Court Room 76
Royal Courts of Justice
Strand
London
England
WC2A 2LL
Tel: 0207 947 6000

*************
Related Links:
* The One Click Group Response - CFS/ME NICE Guidelines
The One Click Group
*************
 
 


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