Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial
BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1777 (Published 23 April 2010) Cite this as: BMJ 2010;340:c1777
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In the light of yet another study, which produced results that are
"disappointing but not surprising" (Failure of FINE trial comes as no
surprise, Dr Charles B Shepherd and Dr Ellen Goudsmit (BMJ 2010;340:c1777,
23 April 2010), may I suggest a long overdue, common sense, alternative to
"Peer Review", that is research which is picked over by people, judged to
be of at least equal academic qualification, for any flaws in experimental
design, subject selection and size, statistical errors and illogical
conclusions (AFTER you've spent a million quid of precious funding!).
I call it a "Preview Consultation Period", during which anyone (not
only those judged to be peers) and especially those directly involved in
the field of study, for example, in making a claim for the efficacy of a
particular treatment which is controversial, are invited to make any
comments, suggestions or criticisms BEFORE the million is spent and to
avoid any quibbling afterwards.
It is a principle that this Research Psychologist and veteran M.E.
sufferer since 1988 will employ in any study he initiates, whether working
alone or with others who wish to join him, for no reward other than the
outcome of the work itself.
Lest readers think I am so naive as to have given no consideration to
plagiarism (it has happened before and probably will again), anyone who
were to produce similar work, especially shortly afterwards and with no
previously documented intention of doing so, would appear dishonest or
foolish and probably end their career (that happens too). Anyone who
hadn't thought this far ahead should probably have considered alternative
employment anyway.
drjohngreensmith@mefreeforall.org
Dr John H Greensmith
ME Free For All.org
Competing interests:
None declared
Competing interests: No competing interests
I thought I'd point out that two of the authors (including the
corresponding author who was the Principal Investigator) should be well
aware of the problems of the ceiling effect of the Chalder Fatigue scale
for Chronic Fatigue Syndrome (CFS) patients as they devoted a whole paper
to analysing the use of the scale in CFS patients[1].
This study looked at the scores of 136 CFS patients, who were
attending an outpatient clinic, using the 14-item
Chalder Fatigue Scale with Likert scoring (i.e. 0, 1, 2, 3).
It found that "scores on ... six items "tiredness," "resting
more,""lacking energy,"
"feeling weak," "feeling sleepy or drowsy," and "starts things without
difficulty but gets weaker as goes on") were highly skewed with the
majority of patients reaching the maximum score." One item ("Starts
things without difficulty but gets weaker as goes on") is excluded from
the 11-item version of the Chalder Fatigue Scale but the
other 5 items remain.
They concluded: "Near-maximal scoring on six physical fatigue scale
items from the total of 14 items constituting the Chalder fatigue scale
supports the validity of scoring the physical fatigue scale on a two-point
scale (presence or absence) rather than the four-point Likert scoring.
Most of the variance in the total
fatigue scale is thus accounted for by the mental fatigue score."
To me, these results would have suggested using a different scale as,
in both scenarios (i.e. whether bimodal or Likert scoring is used),
patients can't be recorded as getting worse if they are already scoring
maximum at the start of the trial - an important issue that should be
investigated in rehabilitation trials in the CFS area given the high level
of adverse reactions that have been reported by patients from
rehabilitative interventions[2].
Another reason to use a different scale for the FINE trial in
particular is the fact that the trial, which was performed in patients'
homes, was designed to include severely affected patients who would have
difficulty attending an outpatient clinic[3] - the previous analysis found
high rates of maximal scoring in a group well enough to attend out-
patients so maximal scoring was certainly going to be an issue in a more
severely affected group.
Anyway, the authors concluded the bimodal scale was sufficient and
they then designed this trial using the bimodal scoring method[3]. I'm
sure many pharmacological and non-pharmacological studies could look
different if investigators decided to use a different scoring method or
scale at the end, if the results weren't as impressive as they'd hoped.
But that is not normally how medicine works. So, while it is interesting
that the researchers have shared this data, I think the data in the main
paper should be seen as the main data.
I have seen many studies where authors have given the percentage who
scored the maximum scores as the problem of floor and ceiling effects is a
well-recognised issue. In the spirit of full disclosure, it would be good
if the authors of this trial would now share that data for the bimodal
scoring (the scoring method used in the published paper) and also for the
Likert scoring system (0-3), now that they have presented other data using
that scoring method. Dr. Bart Stouten has already pointed out the problems
that exist with the bimodal scoring system for the group in this study but
we do not have the exact figures[4]:
"Reviewing the mean and standard deviation data in this study, I
calculated that between 62 (65%) and 78 (82%) patients in the Pragmatic
Rehabilitation (PR) group must have recorded the maximum score of 11 at
baseline (see
separate response). This indicates that a substantial proportion of
participants would not have been able to record an exacerbation of fatigue
following PR. Similarly, between 21 (26%) and 57 (70%) patients must have
recorded the maximum score at 70 weeks."
Given that the initial scores in the Pragmatic Rehabilitation (PR)
group on the Likert scoring scale were 29.39 (SD: 3.46), one can clearly
see that there was a large amount of maximal scoring on many or all of the
11-items in the Likert scale also.
References:
[1] Morriss RK, Wearden AJ, Mullis R. Exploring the validity of the
Chalder Fatigue scale in chronic fatigue syndrome. J Psychosom Res. 1998
Nov;45(5):411-7.
[2] Kindlon T, Goudsmit EM. Graded exercise for chronic fatigue
syndrome: too soon to dismiss reports of adverse reactions. J Rehabil Med.
2010 Feb;42(2):184; author reply 184-6.
http://jrm.medicaljournals.se/article/full/10.2340/16501977-0493
[3] Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP,
Morriss RK, Peters S, Dunn G, Richardson G, Lovell K, Powell P. Fatigue
Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled
trial of nurse
led self-help treatment for patients in primary care with chronic fatigue
syndrome: study protocol. [ISRCTN74156610]. BMC Med. 2006 Apr 7;4:9.
http://www.biomedcentral.com/1741-7015/4/9
[4] Stouten B. Fatigue scale.
http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235631
Competing interests:
None declared
Competing interests: No competing interests
I write this as a patient with ME.
One of the major problems which patients face is the 'incomplete'
information available on the internet. For example, after reading the
Oxford criteria for CFS, I mentioned to someone that they might exclude
people with ME by virtue of the many neurological symptoms associated with
the disease. This was included in a lay article and unfortunately, has
been uncritically repeated in online publications ever since. The truth is
that we don't know. Those who use the Oxford criteria generally do not
recognise ME as a neurological disease (G 93.3) and in my experience,
symptoms such as vertigo and blurred vision tend to be ignored, considered
as separate, or classified as a sign of stress. I therefore suspect that
the proportion of ME patients in studies using the Oxford and CDC criteria
is probably small simply because the illness is less common than CFS (.1%
versus 2.6%)[1].
The FINE trial also used the 1994 CDC criteria. These changed the
concept of CFS, from a disorder similar to ME (described by Ramsay) to one
more closely related to neurasthenia [1,2]. The CDC criteria do not
exclude the severely ill; researchers do. As for the Canadian criteria,
there has only been one study examining the selected population and the
results revealed a higher prevalence of co-morbid psychiatric disorders
compared to a group with ME. It is unclear whether this is due to the
large number of qualifying symptoms (over 90), or because of a flaw in the
criteria used to diagnose ME.
Writers on the internet sometimes support the Canadian criteria
because of the recommendation to conduct certain tests. They then
interpret abnormalities in natural killer cell (NK) activity and other
results as evidence of 'physical disease', unaware that these findings are
not unique to CFS and that abnormal NK cell cytotoxicity is also
associated with stress [3]. And just as some psychologists do not believe
patients with ME, some patients do not believe psychologists with ME.
While unrefereed articles on the net have led to confusion, so have
articles on CFS in our best known journals. Indeed, I would go so far as
to suggest that the online articles have flourished largely because of the
narrow range of opinions on CFS published in the medical literature [4].
These have disempowered doctors, leaving most unaware of the growing
evidence for a subset of patients with ongoing infection and neurological
disease. It's a lose-lose situation for all and that includes the tax
payers who are spending millions of pounds on suboptimal treatment.
1. Goudsmit EM, Shepherd C, Dancey CP,Howes, S. (2009) ME: Chronic
fatigue syndrome or a distinct clinical entity? Health Psych Update 18;1:
26-33.
http://www.bpsshop.org.uk/Health-Psychology-Update-Vol-18-No-1-2009-
P797.aspx
2. Farmer A, Jones I, Hillier J, Llewelyn M, Borysiewicz L, Smith A.
(1995) Neurasthenia revisited: ICD-10 and DSM-III-R psychiatric syndromes
in chronic fatigue patients and comparison subjects. Br J Psychiatry 167;
503-6.
3. Webster Marketon JI, Glaser R. (2008) Stress hormones and immune
function. Cellular Immunol 252; 16-26.
4. Goudsmit E, Stouten B. (2004) Chronic fatigue syndrome: editorial
bias in the British Medical Journal. Journal of Chronic Fatigue Syndrome
12; 4: 47-59.
http://freespace.virgin.net/david.axford/JCFS.pdf
Competing interests:
None declared
Competing interests: No competing interests
Goudsmit's statement :".. the FINE Trial was designed just
after the publication of the Canadian criteria and it's
therefore rather unfair to criticise Wearden et al for not
using what were at the time little known clinical criteria
which had not yet been evaluated for use in research" cannot
be allowed to go unchallenged.
The Oxford criteria upon which the FINE trial was based ,
were drawn up by psychiatrists in 1990 and broaden the
1988 Holmes et al CFS criteria to include all those with
psychiatric “chronic fatigue" , while specifically excluding
those with neurological disorders. ( Sharpe et al 1991)
Used only by a small group of English psychiatrists (the
Wessely-school) and by the university of Nijmegen,
Netherlands (Neilson 2002), the Oxford criteria , by
definition, exclude all those with authentic Ramsay-defined
ME from study .
By the time the MRC announced that the Oxford criteria
were to be used as the criteria for the PACE/FINE trial,
in May 2003, they had been well and truly superseded :
Research, for example, published in 2002 found that in
terms of 'who has ICD ME/CFS' ? :
CDC1998 criteria 80% plus may have ME/ICD-CFS
CDC1994 criteria 40% may have ME/ICD-CFS
'Oxford' criteria 10% may have ME/ICD-CFS
(Neilson 2002)
Additionally , it is particularly significant how
US researchers noted in 1999 that : “ "neither the 1988
nor the 1994 case definition identifies the sickest patients
because information about symptom severity is not required
to make a diagnosis of CFS” ( Hill et al 1999)
The FINE trail was supposed to be about those most severely
affected.
In 2004 Lord Warner, confirmed that the UK accepted that
ME/CFS is a neurological disease , listed as such by the
World Health Organisation (WHO) under ICD-10 G93.3, yet the
PACE/FINE trials still set out to study only psychosocial
management regimes and treatments using as a set of criteria
"ICD10: 48.0" : "Mental and Behavioural Disorders";
subtitled "Other Neurotic Disorders" (Neilson 2002)
Patients wrote to the MRC in 2004 pointing out how the
Canadian Clinical Case Definition , "was produced by an
Expert Medical Consensus Panel of eleven physicians who
between them treated/diagnosed over 20,000 ME/CFS sufferers
worldwide, enabling medical practitioners to more easily
distinguish ME/CFS, with its pathological fatigue, from
ordinary fatigue and other fatiguing illnesses." (Kennedy
2004)
Given that they specifically exclude people with ME from
study, there was no compelling reason, whatsoever, to have
based the FINE trial upon the Oxford criteria; apart from a
serious case of discrimination.(cf Neilson 2002)
As Hooper (2010) points out the MRC's PACE/FINE trials:
".. seemingly inhabits a unique and unenviable position in t
he history of medicine. It is believed to be the first and o
nly clinical trial that patients and the charities that supp
ort them have tried to stop before a single patient could be
recruited and is the only clinical trial that the Departmen
t for Work and Pensions (DWP) has ever funded."
Goudsmit states : “ the emphasis on fatigue in research
into CFS and CFS/ME is unfortunate. “ The FINE trial results
,at least, have proved how true that is.
References ;
Hill et al 1999 Natural History of Severe Chronic Fatigue
Syndrome. Arch Phys Med Rehab 1999:80:1090-1094).
Hooper (2010) Magical Medicine : How to Make a Disease
Disappear
http://www.investinme.org/Article400%20Magical%20Medicine.ht
m
Kennedy A (2004) ME/CFS, complaint letter template
http://www.prohealth.com/fibromyalgia/blog/boardDetail.cfm?
id=370090
Neilson L(2002) New Canadian clinical definition - ME/CFS
http://www.cfids-cab.org/cfs-
inform/CFS.case.def/me.cfs.canadian.def03.txt
Sharpe et al (1991) A report – chronic fatigue syndrome:
guidelines for research. JRSM 1991:84:118-121).
Competing interests:
None declared
Competing interests: No competing interests
The following sentence should have read "One can use both clinical
and research criteria as one or two recent studies have done, but there is
no published study where the Canadian criteria have been used on their
own."
My apologies.
Competing interests:
Hon Advisor (Psychology), ME Association
Competing interests: No competing interests
I note some confusion in a previous response. The Canadian criteria
for CFS/ME were designed for clinical use. One can use both as one or two
recent studies have done, but there is no published study where the
Canadian criteria have been used on their own. Moreover, the FINE Trial
was designed just after the publication of the Canadian criteria and it's
therefore rather unfair to criticise Wearden et al for not using what were
at the time little known clinical criteria which had not yet been
evaluated for use in research.
There is also some confusion about the nature of ME. Post-exertional
malaise is a minor criterion for the diagnosis of CFS, and various studies
have reported a high prevalence of this symptom in the patients with the
latter. It is also reported in ME but the cardinal feature of this disease
is not 'post-exertional fatigue' but muscle fatiguability following
minimal exertion and a delay in recovery of muscle power [1].
The two conditions also differ in another way. The symptoms of ME
show a marked variability, both from day to day and hour to hour [2]. The
fluctuation in symptoms is a major criterion for ME but not CFS.
However, I agree that the emphasis on fatigue in research into CFS
and CFS/ME is unfortunate. Fatigue is a ubiquitous symptom also prevalent
in other patient groups. A recurring question which is rarely addressed is
whether the interventions that alleviate fatigue are as effective for the
frequently more disabling symptoms of CFS and ME, including muscle
weakness and vertigo. It's rather like testing a drug for breast cancer by
focusing on the size of the primary and ignoring its effects on the
metastases.
E Goudsmit FBPsS
1. Dowsett EG & Welsby PD. (1992). Conversation Piece. Postgrad
Med J 68; 63-65.
2. Ramsay, A.M. (1988). Myalgic encephalomyelitis and postviral
fatigue states. 2nd ed. London: Gower Medical Publishing.
Competing interests:
Advisor on Psychological Issues, ME Association
Competing interests: No competing interests
Stouten's comments are concerning because he is quoting
fatigue as a cardinal symptom of CFS, which is fine if you
separate CFS from ME and admit that you are really just
looking at people who just have fatigue conditions rather
than a neurological disease.
However people with ME do not even have to have a diagnosis
of Fatigue, to have ME ; it is a glaring mistake to not use
the Canadian criteria to define the group of people used in
the research , which would much more clearly identify ME
patients.
Looking at the percentages, quoted in Stouten, he points out
that 86% of people still had significant fatigue at 70 weeks
and 26% were made worse, which seems to suggest that these
people probably had ME and the other 14% did not.
ME is an exhausting illness , however the fatigue the study
should have been looking at is post exertional fatigue,
which has nothing to do with "illness beliefs", or the
fatigue the study was looking at, but with well documented
(5000 + published papers)multi-system physical dysfunction.
It is a travesty to claim that this poorly identified
group of participants represents ME only and more
worryingly that Wearden et al are now scrabbling about
with a fine tooth comb just to find any measurable change
in fatigue at all.
Interestingly Wearden et al haven't even identified what
percentage they have now arrived at.
The Chalder scale will, by definition, represent non-ME
Fatigue, rather than the post exertional fatigue which is
the hallmark of ME , because it is based upon illness
beliefs and not physical illness. This is presumably why it
only comes up with at best a "clinically modest " result.
When is it time to admit that this is not the way to go to
help people with ME ?
More than enough time and money have spent on looking at
wrong illness beliefs; a ridiculous issue to be focusing on,
for such a severely physically and disabled group of people,
who need biomedical input.
When will it be acknowledged that the biopsychosocial
pathway has never been appropriate for
ME, because it denies the physical truth ?
Competing interests:
None declared
Competing interests: No competing interests
Following Bart Stouten’s suggestion that scoring the Chalder fatigue
scale(1) 0123 might more reliably demonstrate the effects of pragmatic
rehabilitation, we recalculated our fatigue scale scores. Calculated this
way, the reduction in fatigue seen at post treatment (20 weeks) in
patients allocated to pragmatic rehabilitation (PR), when compared to
those allocated to general practitioner treatment as usual (GPTAU)(2), is
maintained at one year follow up (70 weeks), our primary outcome point.
Supportive listening (SL) is still ineffective when compared with GPTAU
(Table 1 and Figure 1). Effect estimates [95% confidence intervals] for 20
week comparisons are: PR versus GPTAU -3.84 [-6.17, -1.52], SE 1.18,
P=0.001; SL versus GPTAU +0.30 [-1.73, +2.33], SE 1.03, P=0.772. Effect
estimates [95% confidence intervals] for 70 week comparisons are: PR
versus GPTAU -2.55 [-4.99,-0.11], SE 1.24, P=0.040; SL versus GPTAU +0.36
[-1.90, 2.63], SE 1.15, P=0.752.
We agree with Sam Carter and other correspondents that the fatigue scale
suffers from a ceiling effect, but this is more of a problem at baseline
(before treatment started) than at the follow up assessments. With the
fatigue scale re-scored 0123, we are able to demonstrate a clinically
modest, but statistically significant effect of PR compared with GPTAU at
both outcome points. Given the chronicity of CFS/ME in our sample, we
believe that this on average small improvement in fatigue is important to
these individuals.
Tom Kindlon points out that we have not analysed all the outcomes which we
measured(3). We reported our primary outcomes and the related secondary
clinical outcome data which we thought would be of interest in judging the
clinical effectiveness of our intervention. We did not report the step
test as an outcome due to a significant amount of missing data. Further
papers will examine exercise capacity and illness beliefs as potential
mediators of the effects of pragmatic rehabilitation. We will also be
reporting on predictors or moderators of treatment response; among the
variables we will examine will be criteria fulfilled (CDC, London ME),
ambulatory status and co-morbidities. Other papers will examine economic
outcomes and barriers to delivering these treatments. All papers will use
the acronym FINE and have the same ISRCT number, so can be linked to the
BMJ paper.
References
1. Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D,
et al. Development of a fatigue scale. Journal of Psychosomatic Research
1993;37(2):147-153.
2. Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S,
et al. Nurse led, home based self help treatment for patients in primary
care with chronic fatigue syndrome: randomised controlled trial. British
Medical Journal;340.
3. Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK,
et al. Fatigue Intervention by Nurses Evaluation - The FINE Trial. A
randomised controlled trial of nurse led self-help treatment for patients
in primary care with chronic fatigue syndrome: study protocol.
[ISRCTN74156610]. Bmc Medicine 2006;4.
Competing interests:
None declared
Table 1
Figure 1 Mean scores on the Chalder et al fatigue scale, scored 0123, at baseline(week 0), after treatment (week 20), and at one year follow-up (week 70) for patients allocated to the three treatment arms. *Significant difference between PR and GPTAU. GPTAU, general practitioner treatment as usual; PR, pragmatic rehabilitation; SL, supportive listening.
Competing interests: No competing interests
Tom Marshall says, "There is evidence that exercise is effective for
fatigue in cancer, improves quality of life in multiple sclerosis and it
is suggested that exercise may be beneficial in HIV/AIDS. Nobody suggests
that this means cancer, multiple sclerosis or HIV/AIDS are not taken
seriously. Surely anything that might help deserves investigation?"
This is disingenuous. Suppose that a programme of research into the
benefits of exercise to MS patients were being carried out. Sounds
sensible. Then suppose that the entire research budget for MS were being
spent on this investigation. And then suppose further that there were an
influential body of opinion suggesting that MS is mostly a question of de-
conditioning and negative thinking.
Add to that a suspicion that the point of this particular research
programme was to provide evidence to support that particular medico-
political stance, and deny any further funds for support of patients or
research into any other factors causing, maintaining or exacerbating MS.
And then add one other ingredient to this witches' brew: the selection of
patients by a set of criteria which probably includes lots of patients who
do not have MS at all, but who might benefit from a regime of exercise.
Does the proposition still sound so sensible?
Let me add one more point, and two predictions. There is evidence
that a diet rich in fruit and nuts is beneficial to general health.
However, nobody suggests that it is sensible for people with a nut
allergy. Most of the definitions of ME/CFS include "exercise intolerance"
as one of it prime characteristics.
The predictions?
#1: That there will those who say that the this trial failed because
the patients were not trying hard enough.
#2: That no funds will be found for other research into ME/CFS since,
in the words of one NHS Chief Executive, "We will have to ensure that we
prioritise care for those who need it most.”
Would they say that to those with cancer, MS or HIV/AIDS?
Competing interests:
None declared
Competing interests: No competing interests
FINE trial authors fail to follow CONSORT Guidelines
The FINE trial authors have been contacted several times regarding
requests that copies of the nurse and patient training manuals, reading
lists, etc., which were used in preparation of and during the FINE trial,
be made publicly available. Indeed, the recent CONSORT guidelines for
randomized trials of nonpharmacologic treatments explicitly recommend that
study authors allow access to these materials. From the relevant CONSORT
guidelines- "Explanation-Authors should describe each intervention
thoroughly, including control interventions. The description should allow
a clinician wanting to use the intervention to know exactly how to
administer the intervention that was evaluated in the trial"(1) and "The
description of any standardization methods is essential to allow adequate
replication of the nonpharmacologic treatment. We recommend that authors
allow interested readers to access the materials they used to standardize
the interventions, either by including a Web appendix with their article
or a link to a stable Web site. Such materials include written manuals,
specific guidelines, and materials used to train care providers to
uniformly deliver the intervention."(2)
The BMJ, which published the FINE trial results, also recommends
authors publishing therein to follow the CONSORT Guidelines- "For research
articles we ask you to ensure that they include all the information
recommended in the relevant reporting statement, for example CONSORT. We
do not use reporting guidelines as critical appraisal tools to evaluate
study quality or filter out articles. We're simply aiming to make research
articles so clear that peer reviewers, editors, clinicians, educators,
ethicists, policy makers, systematic reviewers, guideline writers,
journalists, patients, and the general public can tell what really
happened during a study."(3)
Given that a) a potentially related document (although one cannot be
sure of this as the FINE trial authors refuse to release the relevant
materials) authored by Pauline Powell, a member of the FINE trial group,
entitled 'Chronic Fatigue Syndrome: What you need to know to get better',
aka the 'Liverpool CFS Clinic Patient Handout', clearly and explicitly
states that patients are told that there is absolutely no underlying
pathophysiology present whatsoever in CFS patients and that any
abnormalities which may be found are solely the result of deconditioning,
both of which statements are clearly at odds with the preponderance of
biomedical research into the condition, which is summarized quite nicely
by Dr. Anthony Komaroff of Harvard Medical School(4) and b) the FINE trial
itself cost well over 1 million pounds of taxpayer monies with the total
end result being a 'clinically modest' reduction in fatigue (but with no
increase in physical functioning, the other primary outcome measure), and
thus could be described as being more or less a failure, it is deeply
troubling that the FINE trial authors refuse to follow relevant guidelines
such as CONSORT and fail to make available the 'written manuals, specific
guidelines, and materials used to train care providers to uniformly
deliver the intervention' so that 'peer reviewers, editors, clinicians,
educators, ethicists, policy makers, systematic reviewers, guideline
writers, journalists, patients, and the general public can tell what
really happened during a study'. This failure is all the more troubling
given that the authors' final conclusion is that 'More studies are needed
to determine the optimal conditions under which pragmatic rehabilitation
can be delivered to patients in the community with CFS/ME'.
1. Moher D, Hopewell S, Schulz KF, Montori V, G?tzsche PC, Devereaux
PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and
elaboration: updated guidelines for reporting parallel group randomised
trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869
http://www.bmj.com/cgi/content/full/340/mar23_1/c869
2. Boutron I, Moher D, Altman DG, Schulz K, Ravaud P, for the CONSORT
group. Extending the CONSORT Statement to randomized trials of
nonpharmacologic treatment: explanation and elaboration. Ann Intern Med.
2008:295-309. http://www.consort-statement.org/index.aspx?o=1415
3. Overview of requirements for BMJ manuscripts-
http://resources.bmj.com/bmj/authors/article-submission/article-
requirements
4. The Latest Research on CFS- presentation by Anthony Komaroff, MD,
given to Mass CFIDS Association, April 24, 2010-
http://www.masscfids.org/videofiles/Komaroff/Komaroff.html
Competing interests: CFS patient