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The P2P Draft Systematic Review Is Up

WillowJ

คภภเє ɠรค๓թєl
Messages
4,940
Location
WA, USA
I'm working my way through this. I think they have missed some employment data. The PACE Trial has been mentioned but I believe O'Dowd et al. had some too. It would be good if all such data was checked - not sure I'll get to do it myself.

I was thinking that it would be good for all the references to be checked, after seeing a blog complain how some were mis-cited, but I don't think I can do much myself, either.

I have made my way through some of it, making notes on the hard copy, but some of them are [check this], and my notes haven't made it to electronic form yet (I like to read the physical pages so I can readily flip back and forth, and read the title/authors of the citations, and so on)
 

Dolphin

Senior Member
Messages
17,567
I've just finished reading it. I don't recall any mention of the results from actigraphy/actometers/pedometers.

Also, don't recall much talk of the six-minute walking test data in some studies.

Given there were some studies where various employment data hasn't been reported, if people are looking up full papers, probably a good idea to note any objective data.
 
Messages
18
Location
Kansas, USA
Thank you for all your hard work. This is a very labor intensive project and I'm grateful you were up to the challenge. One point I would like to offer for consideration regards the harms associated with a diagnosis of CFS. I read the entire proposal and I don't remember seeing this point made. If I've missed it, please accept my apologies.

Once a patient receives a CFS diagnosis all future attempts to seek other possible diagnoses seem to stop. This approach causes harm when the patient may actually be suffering from undiagnosed M.S. or A.D.E.M. disease (http://myelitis.org/symptoms-conditions/acute-disseminated-encephalomyelitis/). Both can be tricky to diagnose.

How likely is it that a physician will continue hunting for another diagnosis regardless of their belief about CFS. I see you have included research from Dr. Montoya and Dr. Komaroff. Have you seen the presentation on the Biology of Chronic Fatigue Syndrome?
.

Obviously, this statement can be said about any difficult to diagnose illness, but without a protocol for physicians it's much more difficult for patients. Doctors can only treat illnesses they actually believe in when medicine is available.

Peace,
Mia
 
Messages
18
Location
Kansas, USA
I was thinking that it would be good for all the references to be checked, after seeing a blog complain how some were mis-cited, but I don't think I can do much myself, either.

I have made my way through some of it, making notes on the hard copy, but some of them are [check this], and my notes haven't made it to electronic form yet (I like to read the physical pages so I can readily flip back and forth, and read the title/authors of the citations, and so on)

Hi WillowJ,

I can help with this if you would like. Let me know.

Peace,
Mia
 

WillowJ

คภภเє ɠรค๓թєl
Messages
4,940
Location
WA, USA
Hi WillowJ,

I can help with this if you would like. Let me know.

Peace,
Mia

Thanks so much. :thumbsup: I don't think I'm working in an organized enough way to work with someone else this time around; maybe another time we can work together.

They will take comments from anyone, though, and possibly change the draft (if they think the comment has merit) but they should at least publish the comment and make a reply.

I love your avatar photo by they way. :)
 
Messages
18
Location
Kansas, USA
Thanks so much. :thumbsup: I don't think I'm working in an organized enough way to work with someone else this time around; maybe another time we can work together.

They will take comments from anyone, though, and possibly change the draft (if they think the comment has merit) but they should at least publish the comment and make a reply.

I love your avatar photo by they way. :)

Your most welcome. I submitted a suggestion for review, so we'll see. Thanks for noticing my avatar. I think Friesian horses with all that wavy hair are gorgeous.
 

Nielk

Senior Member
Messages
6,970
This was posted by Mary Dimmock on Jennie Spotila's blog: http://www.occupycfs.com/2014/10/06/they-know-what-theyre-doing-not/

This post comes via Mary Dimmock, with assistance from Claudia Goodell, Denise Lopez-Majano, and myself. You are welcome to publish it on your site with attribution to Mary Dimmock.



Last week, Jennie Spotila and Erica Verillo posted summaries of just some of the issues withAHRQ’s Draft Systematic Evidence Review, conducted for P2P.

Jennie and Erica highlighted serious and sometimes insurmountable flaws with this Review, including:

  • The failure to be clear and specific about what disease was being studied.
  • The acceptance of 8 disparate ME or CFS definitions as equivalent in spite of dramatic differences in inclusion and exclusion criteria.
  • The bad science reflected in citing Oxford’s flaws and then using Oxford studies anyway.
  • The well-known problems with the PACE trial.
  • The flawed process that used non-experts on such a controversial and conflicted area.
  • Flawed search methods that focused on fatigue.
  • Outright errors in some of the basic information in the report and apparent inconsistencies in how inclusion criteria were applied.
  • Poorly designed and imprecise review questions.
  • Misinterpretation of cited literature.
In this post, I will describe several additional key problems with the AHRQ Evidence Review.

Keep in mind that comments must be submitted by October 20, 2014. Directions for doing so are at the end of this post.

We Don’t Need No Stinking Diagnostic Gold Standard

Best practices for diagnostic method reviews state that a diagnostic gold standard is required as the benchmark. But there is no agreed upon diagnostic gold standard for this disease, and the Review acknowledges this. So what did the Evidence Review do? The Review allowed any of 8 disparate CFS or ME definitions to be used as the gold standard and then evaluated diagnostic methods against and across the 8 definitions. But when a definition does not accurately reflect the disease being studied, that definition cannot be used as the standard. And when the 8 disparate definitions do not describe the same disease, you cannot draw conclusions about diagnostic methods across them.

What makes this worse is that the reviewers recognized the importance of PEM but failed to consider the implications of Fukuda’s and Oxford’s failure to require it. The reviewers also excluded, ignored or downplayed substantial evidence demonstrating that some of these definitions could not be applied consistently, as CDC’s Dr. Reeves demonstrated about Fukuda.

Beyond this, some diagnostic studies were excluded because they did not use the “right” statistics or because the reviewer judged the studies to be “etiological” studies, not diagnostic methods studies. Was NK-Cell function eliminated because it was an etiological study? Was Dr. Snell’s study on the discriminative value of CPET excluded because it used the wrong statistics? And all studies before 1988 were excluded. These inclusion/exclusion choices shaped what evidence was considered and what conclusions were drawn.

Erica pointed out that the Review misinterpreted some of the papers expressing harms associated with a diagnosis. The Review failed to acknowledge the relief and value of finally getting a diagnosis, particularly from a supportive doctor. The harm is not from receiving the diagnostic label, but rather from the subsequent reactions of most healthcare providers. At the same time, the Review did not consider other harms like Dr. Newton’s study of patients with other diseases being diagnosed with “CFS” or another study finding many MS patients were first misdiagnosed with CFS. The Review also failed to acknowledge the harm that patients face if they are given harmful treatments out of a belief that CFS is really a psychological or behavioral problem.

The Review is rife with problems: Failing to ask whether all definitions represent the same disease. Using any definition as the diagnostic gold standard against which to assess any diagnostic method. Excluding some of the most important ME studies. It is no surprise, then, that the Review concluded that no definition had proven superior and that there are no accepted diagnostic methods.

But remarkably, reviewers felt that there was sufficient evidence to state that those patients who meet CCC and ME-ICC criteria were not a separate group but rather a subgroup with more severe symptoms and functional limitations. By starting with the assumption that all 8 definitions encompass the same disease, this characterization of CCC and ICC patients was a foregone conclusion.

But Don’t Worry, These Treatment Trials Look Fine

You would think that at this point in the process, someone would stand up and ask about the scientific validity of comparing treatments across these definitions. After all, the Review acknowledged that Oxford can include patients with other causes of the symptom of chronic fatigue. But no, the Evidence Review continued on to compare treatments across definitions regardless of the patient population selected. Would we ever evaluate treatments for cancer patients by first throwing in studies with fatigued patients? The assessment of treatments was flawed from the start.

But the problems were then compounded by how the Review was conducted. The Review focused on subjective measures like general function, quality of life and fatigue, not objective measures like physical performance or activity levels. In addition, the Review explicitly decided to focus on changes in the symptom of fatigue, not PEM, pain or any other symptom. Quality issues with individual studies were either not considered or ignored. Counseling and CBT studies were all lumped into one treatment group, without consideration of the dramatic difference in therapeutic intent of the two. Some important studies like Rituxan were not considered because the treatment duration was considered too short, regardless of whether it was therapeutically appropriate.

And finally, the Review never questioned whether the disease theories underlying these treatments were applicable across all definitions. Is it really reasonable to expect that a disease that responds to Rituxan or Ampligen is going to also respond to therapies that reverse the patient’s “false illness beliefs” and deconditioning? Of course not.

If their own conclusions on the diagnostic methods and the problems with the Oxford definition were not enough to make them stop, the vast differences in disease theories and therapeutic mechanism of action should have made the reviewers step back and raise red flags.

At the Root of It All

This Review brings into sharp relief the widespread confusion on the nature of ME and the inappropriateness of having non-experts attempt to unravel a controversial and conflicting evidence base about which they know nothing.

But just as importantly, this Review speaks volumes about the paltry funding and institutional neglect of ME reflected in the fact that the study could find only 28 diagnostic studies and 9 medication studies to consider from the last 26 years. This Review speaks volumes about the institutional mishandling that fostered the proliferation of disparate and sometimes overly broad definitions, all branded with the same “CFS” label. The Review speaks volumes about the institutional bias that resulted in the biggest, most expensive and greatest number of treatment trials being those that studied behavioral and psychological pathology for a disease long proven to be the result of organic pathology.

This institutional neglect, mishandling and bias have brought us to where we are today. That the Evidence Review failed to recognize and acknowledge those issues is stunning.

Shout Out Your Protest!

This Evidence Review is due to be published in final format before the P2P workshop and it will affect our lives for years to come. Make your concerns known now.

  1. Submit public comments on the Evidence Review to the AHRQ website by October 20.
  2. Contact HHS and Congressional leaders with your concerns about the Evidence Review, the P2P Workshop and HHS’ overall handling of this disease. Erica Verillo’s recent post provides ideas and links for how to do this.
The following information provides additional background to prepare your comments:

However you choose to protest, make your concerns known!



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Dolphin

Senior Member
Messages
17,567
I'm working my way through this. I think they have missed some employment data. The PACE Trial has been mentioned but I believe O'Dowd et al. had some too. It would be good if all such data was checked - not sure I'll get to do it myself.

This paper was referenced, but the following data wasn't used

Health Technol Assess. 2006 Oct;10(37):iii-iv, ix-x, 1-121.

Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme.

O'Dowd H, Gladwell P, Rogers CA, Hollinghurst S, Gregory A.

http://www.journalslibrary.nihr.ac.uk/hta/volume-10/issue-37

----

Employment status - referred to a different stages:

"Group CBT did not significantly improve cognitive function, quality of life, employment status or healthcare utility measures"

"Group CBT did not significantly improve cognitive function, quality of life (as measured by the physical subscale of the SF-36), employment status or healthcare utility measures."

Details:

Baseline pp87 (page 99 of pdf)

At 6 months: pp 99 (page 110 of pdf)

At 12 months: pp 106 (page 117 of pdf)

----

6 minute incremental shuttle walking test:

Physical performance – shuttles walked

Similar trends were seen with the number of
shuttles walked, as was seen for the GHQ scores,
with more shuttles walked in the CBT treatment
cohort and fewer in the SMC treatment cohort,
with the EAS cohort showing results similar to the
SMC group. Patients in the CBT cohort completed
an average of 22 shuttles (200 m) compared with
an average of 19 shuttles in the EAS treatment
cohort and 18.3 in the SMC group (Table 7).
Again, overall across the three groups the
differences were not statistically significant
(p= 0.16), but the difference between CBT and
SMC was nearing statistical significance
(p= 0.060). On average, patients in the CBT
group completed 20% more shuttles than those
randomised to SMC (odds ratio 1.20, 95% CI 0.99
to 1.45). As was seen for the other quality of life
measures, the mean scores reported at 6 months
were similar to those reported at 12 months
(p= 0.80) and the trend across the groups was
unchanged between the 6- and 12-month
assessments (p= 0.99).

Five clear outlying observations were omitted from
the analysis of shuttles walked. Three were very
low values (0 or 2) and two were amongst the
highest values (60 and 75), but were from a
patient with a low baseline score (9). If these
outliers were retained, the SEs increased and
difference between CBT and SMC was no longer
statistically significant (p= 0.17).

The number of shuttles walked is illustrated in
Figure 3. The distribution was positively skewed in
each group, hence median scores are presented.
The increase in the median number of shuttles
walked in the CBT treatment condition from 20.5
(205 m) at baseline to 30 (300 m) at 12 months
suggests an improvement, which did not reach
statistical significance. The change from a median
of 20.5 shuttles at baseline to 30 shuttles at 12 months in the CBT cohort represents an
increase in walking speed at the end of the test
from 2.64 to 3.02 miles per hour. The median
increase is composed of an additional 4.5 shuttles
at 2.64 miles per hour (level 5) and five shuttles at
3.02 miles per hour (level 6).

[My comment: I don't believe some or all of the outliers should be excluded. Scores of 60 and 75 are normal scores for healthy people - the paper says: "The ISWT, used as a physical performance measure, has normative reference data described by Taylor and colleagues. Their sample of 122 healthy subjects (mixed gender and age) walked a mean of 67 ×10-m shuttles" There is no reason that some people with CFS can't become healthy during a trial. Note that they appear not to have excluded other similar scores as they say "were among the highest" in "two were amongst the highest values (60 and 75)". These scores were only excluded because this person had a low score at baseline. But as I said, there is no reason why somebody couldn't improve during a trial.]
 
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Dolphin

Senior Member
Messages
17,567
As was mentioned previously, this paper looked at employment outcome measures in the PACE Trial:

PLoS One. 2012;7(8):e40808. doi: 10.1371/journal.pone.0040808. Epub 2012 Aug 1.
Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis.
McCrone P1, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD.
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0040808

There are tables with various pieces of data. The authors summarise it as:
There was no clear difference between treatments in terms of lost employment.
 

Dolphin

Senior Member
Messages
17,567
Regarding:
79. Deale A, Husain K, Chalder T, et al. Long-term outcome of cognitive
behavior therapy versus relaxation therapy for chronic fatigue syndrome: a 5-year follow-up study. Am J Psychiatry. 2001;158(12): 2038-42. PMID: 11729022.
Draft has:

Three trials reported the number of hours, either per week or per
24-hours, individuals were working, with one trial reporting significantly more hours worked per
week for the CBT group compared with relaxation (mean hours of 35.57 vs. 24.00 at 5 years;
p<0.04),79

Hours worked per week at 5 years was higher in CBT group, mean (SD):35.57 (8.11) vs. 24.00 (4.97); p<0.04
% With full-or part-time employment at 5 year followup: NS

Correction: the hours worked figure only apply to a sub-group. See Table 2 of Deale et al. (2001):
"Hours worked per week (employed patients only)"
 

Gingergrrl

Senior Member
Messages
16,171
@jimells, I meant someone at the level of a US President or their spouse or child actually getting ME/CFS for anything to be done about it. I agree that anyone can mouth empty words during a political question & answer session and never follow through. But if someone at that level or their loved one actually got the disease, only then do I think something might get done. Not that I wish it on anyone, but I think that is what it will take.
 

Dolphin

Senior Member
Messages
17,567
@jimells, I meant someone at the level of a US President or their spouse or child actually getting ME/CFS for anything to be done about it. I agree that anyone can mouth empty words during a political question & answer session and never follow through. But if someone at that level or their loved one actually got the disease, only then do I think something might get done. Not that I wish it on anyone, but I think that is what it will take.
I heard it said that Tony Blair's daughter had M.E. when he was Prime Minister. Although I'm not sure whether this was confirmed (to my satisfaction anyway)
 

caledonia

Senior Member
Obama mouthed some empty words of support a while back, and look what we got: P2P and IOM. We don't need more of that kind of help.

I've thought the same thing. What happened? Obama said "I'll look into it". He assigned a person to look into it for him. IOM and P2P reviews were set off in response. So therefore "something was done about it" as the President asked. It just wasn't what we want or need. Heck they didn't even do anything about Ampligen, which was what Bob Miller who started that whole thing wanted. What a mess...
 

caledonia

Senior Member
@jimells, I meant someone at the level of a US President or their spouse or child actually getting ME/CFS for anything to be done about it. I agree that anyone can mouth empty words during a political question & answer session and never follow through. But if someone at that level or their loved one actually got the disease, only then do I think something might get done. Not that I wish it on anyone, but I think that is what it will take.

Assuming ME/CFS is based on methylation issues, African Americans have the lowest amount of MTHFR mutations out of any ethnic group. So the chances of Obama and his family having issues is smaller than, say, the Clintons or Bushes having issues.
 

Gingergrrl

Senior Member
Messages
16,171
@caledonia I didn't mean Obama per se but that in the future, it seems like it would take someone at the highest level of govt or their loved one to be stricken by the illness to actually take it seriously.
 

Dolphin

Senior Member
Messages
17,567
However, one trial also measured functioning using a
walking speed test and found improved walking speed in the CBT group compared with controls
(difference from baseline to 12 months for CBT vs. support: 1.77; 95% CI, 0.025 to 3.51;
p=0.0055 and difference from baseline to 12 months for CBT vs. no intervention: 2.83; 95% CI,
1.12 to 5.53; p=0.0055).88
88=O'Dowd et al.

They don't mention the PACE Trial which used the 6-minute walking test and found no difference between CBT and the control group:

White PD, Goldsmith KA, Johnson
AL, et al. Comparison of adaptive
pacing therapy, cognitive behaviour
therapy, graded exercise therapy, and
specialist medical care for chronic
fatigue syndrome (PACE): a
randomised trial. Lancet.
2011;377(9768): 823-36. PMID:
21334061.
 

Dolphin

Senior Member
Messages
17,567
Here's the questions on the WSAS so that people could quote it compared to the real employment measures reported in McCrone et al. (2012):

Please read each of the following questions and tick the appropriate box to indicate

No impairment Severe impairment
0 1 2 3 4 5 6 7 8

Because of my CFS/ME, my ability to work is
Impaired.

Because of my CFS/ME, my social leisure
activities (with other people, such as parties,
bars, clubs, outings. visits, dating, home
entertainment) are impaired.

Because of my CFS/ME, my home
management (cleaning, tidying, shopping,
cooking, looking after home or children,
paying bills) is impaired.

Because of my CFS/ME, my private leisure
activities (done alone, such as reading,
gardening. collecting, sewing, walking alone)
are impaired.

Because of my CFS/ME, my ability to form
and maintain close relationshipswith others,
including those I live with, is impaired.
I'd encourage people to make this point. Points have to be replied to. I think there should be quite a good chance this could be changed i.e. not be reported as an employment measure.