actions on CDC empirical definition

Finch

Down With the Sickness
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There is an active petition to urge the CDC to stop using the "empirical" definition (also known as the Reeves 2005 definition) to define Chronic Fatigue Syndrome (CFS) patients in CFS research.

The petition is sponsored by Tom Kindlon, a patient with CFS for over 20 years. The petition currently has 1,687 signatures. You can sign your name and have the opportunity to leave a comment as well.

Following is the link: http://www.ipetitions.com/petition/empirical_defn_and_CFS_research/index.html


Here's another chance to show how many of us disagree with Dr. Reeves and the direction the CDC is headed. Tom Kindlon gives updates indicating when he uses the petition in his advocacy efforts. He has included it in emails to the CFSAC and in submissions to the CDC. Obviously, the more signatures he gets, the greater will be the impact of his efforts.

Please check it out and give consideration to signing if you haven't already done so!

Finch
 

Cort

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CAA on the CDC's Empirical Definition

The CFIDS Association has posted an article on the empirical definition. They came out strongly against it this past year. You can say they were a bit late but so was everybody else. The IACFS/ME - who should have been leading the charge on this - didn't do anything. (They did allow Dr. Jason to print an article on their website but refused to take a stand on the definition - a very odd thing given that their Pediatric definition was miles different from the empirical definition. I asked Dr. Jason about this he said fairly large segment of the research community was just not interested! The patients however are very interested!) The only one who did anything as the man featured in this article - Dr. Leonard Jason. Thank goodness for Lenny Jason.

Note how a stunningly high percentage of patients with major depression but not CFS were classified as having CFS in this study.

There's a bit at the end on Suzanne Vernon and her role in the definition.

http://www.cfids.org/cfidslink/2009/090203.asp


Defining CFS: The Debate Goes On

In 2005, the Centers for Disease Control and Prevention (CDC) CFS research group published a paper describing an empirical approach to defining CFS. (The full text can be accessed at http://www.biomedcentral.com/1741-7015/3/19.) This paper proposed that administering three questionnaires would provide standardized, reproducible criteria for defining CFS. The three questionnaires included the Short Form 36 (SF36), an instrument that assesses disability; the multidimensional fatigue inventory (MFI) for patients to report mental and physical fatigue levels; and the CDC symptom inventory, a checklist of 19 symptoms and symptom frequency experienced by patients.

Self-report responses to these three instruments from subjects participating in the two-day in-hospital Wichita Clinical study were analyzed and it was concluded that “the empirical definition includes all aspects of CFS specified in the 1994 case definition and identifies persons with CFS in a precise manner that can be readily reproduced by both investigators and clinicians.” Up until a recent publication by Leonard A. Jason and colleagues, there has been no application or reproduction of this empirical approach. In a paper published in the Journal of Disability Policy Studies this month, Dr. Jason documents serious flaws in the empiric CFS case definition for CFS and describes why it should not be used for further research on CFS.

Dr. Jason and his team recruited 27 subjects with CFS and 37 subjects with major depressive disorder (MDD) to participate in this study. All participants completed the three questionnaires described above. The data were then analyzed using the scoring criteria established by the CDC in the 2005 article. All 27 subjects diagnosed with CFS were classified as CFS using the empiric definition; however, 38% of those subjects who had a diagnosis of MDD being misclassified as having CFS. This resulted in 52% more subjects being classified as CFS by the empiric criteria compared to traditional means of determining the diagnosis.

The authors of this study determined that the empiric approach to defining CFS was overly inclusive because of the way the instruments are scored, capturing people who have only emotional and mental unwellness, without the necessary physical disability that is prominent in CFS.

This empiric CFS definition was used by CDC to estimate CFS prevalence in a community-based study of Georgia. Application of this criteria resulted in a quadrupling of the previous CDC CFS prevalence estimate, from one million Americans to four million Americans. This revision generated a great deal of concern from members of the medical and scientific community that these prevalence estimates were inaccurate and identified people with primary psychiatric disorders, rather than CFS. Many of the formal and informal comments submitted to CDC after its request for input on a draft strategic plan echoed these concerns. This new study by Jason and colleagues validates the many issues raised.

It does not appear that the CDC CFS empiric case definition has been or will be adopted by others studying CFS and this paper should give CDC sufficient reason to reexamine its own use of this empiric case definition. A brief survey of CDC’s own web site (www.cdc.gov/cfs) finds inconsistent prevalence estimates, suggesting that CDC may be wavering on scientific support for the higher estimates it published in June 2007.

As stated in the conclusion of Jason’s paper, “…the erroneous inclusion of people with primary psychiatric conditions in CFS samples will have detrimental consequences for the interpretation of epidemiologic, etiologic, and treatment efficacy findings for people with CFS.” With so much left to discover about the origins, treatment and prevention of CFS, conflict over the definition of the condition stalls progress.

Jason LA, Najar N, Porter N, Reh C. Evaluating the Centers for Disease Control’s empirical chronic fatigue syndrome case Definition. Journal of Disability Policy Studies, volume 20, pages 93-100, September 2009.

Note: Suzanne D. Vernon, one of 10 authors listed on the 2005 paper, is no longer employed by CDC. Like many other scientists and advocates, she has expressed concerns about the CDC’s continued application of the empiric criteria which have shown not to serve the original intended purpose of providing standardized, reproducible criteria for CFS.
Fortunately the definition appears to have been a complete flop for the CDC; not outside groups that I know of have used it in their research.

________
 

Dolphin

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Message is going in to CFSAC in next 48 hours so any signatures before then particularly welcome.
 

Chris

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us Canadians...

Koan, is it OK to sign as a Canadian? I ask not as accusation but in search of support--I live in Canada too! But I am a little hesitant to sign on a petition to a specifically US body. Help me to feel comfortable!
Best, Chris
 

Dolphin

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Koan, is it OK to sign as a Canadian? I ask not as accusation but in search of support--I live in Canada too! But I am a little hesitant to sign on a petition to a specifically US body. Help me to feel comfortable!
Best, Chris
A large fraction (maybe half?) of the names are not from the US. Sometimes this is quite visible (e.g. a batch of Scandinavian names together).

Research crosses borders.

But the big thing is the person who set it up is from Ireland!
 

Dolphin

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CDC research - chararcteristics of CFS patients as selected by their empirical defn

The following paper uses the empirical criteria (Reeves, 2005) to define
CFS:

An evaluation of exclusionary medical/psychiatric conditions in the
definition of chronic fatigue syndrome.
Jones JF, Lin JM, Maloney EM, Boneva RS, Nater UM, Unger ER, Reeves WC.
BMC Med. 2009 Oct 12;7(1):57. http://www.biomedcentral.com/1741-7015/7/57

---------

If one goes to Table 6, and look at the "No" column (as in "no exclusionary
conditions") one can see the characteristics of the patients the definition
is selecting.


One that stands out to me is SF-36 "Role emotional" 30.93 (SD: 39.03).


This is a much worse score that scores for role emotional in CFS patients
generally.


-----------
The SF-36 "Role emotional" subscale has three questions:

(the underlinings are in the questionnaire):

6. During the past 4 weeks, have you had any of the following problems with your work or other regular daily activities as a result of any emotional problems (such as feeling depressed or anxious)?

(circle one on each line)

a. Cut down on the amount of time you spent on work or other activities
Yes No

b. Accomplished less than you would like deleted
Yes No

c. Didn't do work or other activities as carefully as usual deleted
Yes No
-----------

Remember that this asks about impairments "as a result of any emotional problems" (other questions ask about impairments but in other ways).


If you answer Yes to two of these three questions, you would score 33.


So an average of 30.93 means people with the CFS (empirical criteria) answer
"Yes" to more than 2 out of these 3 questions on average.


Tom K

========================================================
Don't support the Reeves/empirical definition/criteria for CFS?
Sign the petition at: http://CFSdefinitionpetition.notlong.com
========================================================
 

Dolphin

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Reeves' Criteria Petition update: Marly Silverman (Pandora) to bring petition print-out to CFSAC meeting

Marly "Marla" C. Silverman, Founder of P.A.N.D.O.R.A. (Patient Alliance for
Neuroendocrineimmune Disorders Organization for Research & Advocacy, Inc
http://www.pandoranet.info) has been in touch to say that she will be
bringing a print-out of the "entire petition" (i.e. the visible signatures
and comments) to the CFSAC meeting at the end of October.


Please use whatever resources you have access to (e.g. blogs, Twitter,
Facebook, other social networking sites, newsletters, E-mail
lists/discussion forums, etc) to highlight the existence of the petition.
The petition also links to some critiques of the definition. Many people
have also written interesting comments.


Note: I have no intention of closing the petition site until the CDC stop
using this flawed definition.


I'm appending the text of the petition below with a link.


Tom Kindlon



http://CFSdefinitionpetition.notlong.com
i.e.
http://www.ipetitions.com/petition/empirical_defn_and_CFS_research


The petition

We call on the Centers for Disease Control and Prevention (CDC) to stop
using the "empirical" definition[1] (also known as the Reeves 2005
definition) to define Chronic Fatigue Syndrome (CFS) patients in CFS
research.

The CDC claim it is simply a way of operationalizing the Fukuda (1994)
definition[2]. However the prevalence rates suggest otherwise: the
"empirical" definition gives a prevalence rate of 2.54% of the adult
population[3] compared to 0.235% (95% confidence interval, 0.142%-0.327%) and 0.422% (95% confidence interval, 0.29%-0.56%) when the Fukuda definition was used in previous population studies in the US[4,5].

The definition lacks specificity. For example, one research study[6] found
that 38% of those with a diagnosis of a Major Depressive Disorder were
misclassified as having CFS using the empirical/Reeves definition.

References

[1] Reeves WC, Wagner D, Nisenbaum R, Jones JF, Gurbaxani B, Solomon L,
Papanicolaou DA, Unger ER, Vernon SD, Heim C. Chronic fatigue syndrome--a
clinically empirical approach to its definition and study. BMC Med. 2005 Dec
15;3:19. Link: http://www.biomedcentral.com/1741-7015/3/19

[2] Fukuda K, Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff A. The
chronic fatigue syndrome; a comprehensive approach to its definition and
study. Ann Int Med 1994, 121:953-959.

[3] Reeves WC, Jones JF, Maloney E, Heim C, Hoaglin DC, Boneva RS, Morrissey M, Devlin R. Prevalence of chronic fatigue syndrome in metropolitan, urban, and rural Georgia. Popul Health Metr. 2007 Jun 8;5:5.

[4] Reyes M, Nisenbaum R, Hoaglin DC, Unger ER, Emmons C, Randall B, Stewart JA, Abbey S, Jones JF, Gantz N, Minden S, Reeves WC: Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas. Arch Int Med 2003, 163:1530-1536.

[5] Jason LA, Richman JA, Rademaker AW, Jordan KM, Plioplys AV, Taylor RR,
McCready W, Huang CF, Plioplys S. A community-based study of chronic fatigue syndrome. Arch Intern Med. 1999 Oct 11;159(18):2129-37.

[6] Jason, LA, Najar N, Porter N, Reh C. Evaluating the Centers for Disease
Control's empirical chronic fatigue syndrome case definition. Journal of
Disability Policy Studies 2008, doi:10.1177/1044207308325995.

Further reading:
Problems with the New CDC CFS Prevalence Estimates
Leonard Jason, Ph.D., DePaul University
http://tinyurl.com/2qdgu4 i.e.
http://www.iacfsme.org/IssueswithCDCEmpiricalCaseDefinitionandPrev/tabid/105/Default.aspx
 

MEG

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Petition

Tomk;
I signed it, wrote a comment and donated money. Feel like writing any more petitions? We cannot let CDC, NIH, Reeves off the hook.
 

Dolphin

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Tomk;
I signed it, wrote a comment and donated money.
That's very good of you.

Note to others: you shouldn't feel you have to donate money. I donated a little (US$10) when I set it up.

Feel like writing any more petitions? We cannot let CDC, NIH, Reeves off the hook.
I agree to the latter point.

Thanks for asking but personally I have a lot on my plate and should concentrate more on what happens in Ireland. Also I want to write more letters to the editor which are time consuming (I've started one on a CDC paper). And I've an incomplete article on CFS I want to finish and submit to a journal (I last looked at it last Christmas).

So although there are lots of petitions I might like to set up, I don't think I will be doing one anytime soon.

It might be good if people could suggest another petition site. For some reason, with this one, quite a lot of people's comments never came up (they were grey boxes). As well as frustrating in itself, I reckon this might have put these people off promoting the petition.
 

MEKoan

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Tom,

You do so much! I hope something lovely happens. I hope you find out you are loved more than you could have imagined or that you have a bank account you'd forgotten all about or that your dog comes over and lays his head on your hand in a way that makes everything feel so much easier.

Thank you for being Tom.

Koan
 

Dolphin

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Tom,

You do so much! I hope something lovely happens. I hope you find out you are loved more than you could have imagined or that you have a bank account you'd forgotten all about or that your dog comes over and lays his head on your hand in a way that makes everything feel so much easier.

Thank you for being Tom.

Koan
Thank you for those very kind wishes. :)

Of course, with regard to a couple of those things I mentioned (letter, article), they haven't been published yet so I don't want any credit for them just yet (in fact, if I hear that lots of other people are writing letters in reply to a CDC letter and it means that if I send in a letter, theirs get in instead of mine, I won't be sad at all). Unfortunately, few people are writing letters in reply to CFS articles these days and I think some researchers know this and are taking advantage of it to write some rubbish.
 

MEKoan

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Very heartfelt wishes, Tom.

I think we will hear a great deal of rubbish from those who feel they have been unseated by WPI and XMRV.

Didn't I read somewhere here that 8 EU countries signed a document in support of the WPI research?! I hope Ireland was a part of that but we are awful slow to sign anything!

The rubbish writers days are numbered.

Take care of Tom.

Koan
 

Dolphin

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Thanks Koan.

Didn't I read somewhere here that 8 EU countries signed a document in support of the WPI research?! I hope Ireland was a part of that but we are awful slow to sign anything!
I'm guessing you are referring to:

The European ME Alliance (EMEA) wish to congratulate the
Whittemore-Peterson Institute for the painstaking, professional and groundbreaking work which its staff have performed, along with the National Cancer Institute and the Cleveland Clinic, which has resulted in the publication of the findings of a novel virus XMRV in causing or influencing ME.

The members of EMEA recognise that the staff at WPI are performing
research of the highest quality.

The publication of this research in Science magazine is itself an
amazing achievement.

This work has been achieved in an amazingly short period of time and
the tenacity, dedication and sheer excellence of the WPI has brought hope to millions of people, patients, carers and friends, in Europe and further afield.

EMEA announces its continued full support for WPI and hopes to be able
to become a stronger partner in the future

Signed by all members of the European ME Alliance

Belgium - ME/CFS Association (Nieuwrode, Belgium)
Denmark - ME-NetDK
Ireland - Irish ME Trust
Germany - Fatigatio e.V.
Norway - Norges ME-forening
Spain - Liga SFC
Sweden - Riksfreningen fr ME-patienter
UK - Invest in ME

The European ME Alliance
www.europeanmealliance.org


This has one ME group from each of 8 countries. The Irish ME Trust are most likely the biggest financial supporters of it (as they have spare cash from a government grant they get as the sell scratch cards - and when the National Lottery scratch cards were set up here, a fund was set up for charities who lose out). So the group I help run wasn't invited to be involved and so couldn't sign.
 

Dolphin

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Fortunately the definition appears to have been a complete flop for the CDC; not outside groups that I know of have used it in their research.
Yes it is good news, but when they publish population studies in our underfunded field, they can be influential. And the two studies using the definition have also be associated with a large quantity of papers - maybe 50 (?) papers between the Wichita 2-day study and the Georgia study. Certainly 30.

There is a petition against the definition at:
http://www.ipetitions.com/petition/empirical_defn_and_CFS_research