CDC Treatment Evidence Review - consultation period

They did include the following study:

Stubhaug B, Lie SA, Ursin H, et al. Cognitive-behavioural therapy v. mirtazapine for chronic fatigue and neurasthenia: randomised placebo-controlled trial. Br J Psychiatry. 2008;192(3):217-23. doi: 10.1192/bjp.bp.106.031815. PMID: 18310583
​
This is weird because the trial selected patients using the ICD–10 research criteria for neurasthenia (code F48.0). The previous report excluded it because of code 5 'wrong population'. I think the inclusion is questionable. Here's the info the trial report gives:

Illness definition was operationalised by examining ICD–10 criteria. These diagnostic criteria are the presence of persistent and distressing feelings of exhaustion after minor mental effort or of fatigue after minor physical effort, accompanied by one or more of the following symptoms: muscular aches or pains; dizziness; tension headache; sleep disturbance; inability to relax; and irritability. There should be an inability to recover through rest, relaxation or enjoyment; the duration should exceed 3 months, and there should be no organic mental disorder, affective disorder, or panic or generalised anxiety disorder. The included patients satisfied these ICD–10 criteria, allowing for mild depressive or anxiety symptoms clinically evaluated to be independent of or secondary to fatigue symptoms. The criteria for chronic fatigue syndrome, specified by the Centers for Disease Control (CDC),4 and the Oxford group3 were also examined in this population: 65 of the 72 patients fulfilled case definition by the Oxford (British) criteria and 29 patients fulfilled the CDC (US) criteria.​
 
Andy said:
MEAction article about this review, includes historical timeline, https://www.meaction.net/2021/06/04...view-of-me-cfs-treatments-for-public-comment/
Click to expand...
I think that article by Ben Hsuborger is helpful in understanding the issues around this review, and I'm glad to see that MEAction is working effectively on providing feedback on the review.

Apologies if it has already been mentioned on the thread, but this was information that was new to me:
3. GOOD NEWS: CDC PUTS TREATMENT GUIDELINES ON HOLD
Some people have wondered whether this draft report means that CDC might reimplement CBT and GET as recommendations for ME/CFS treatments, but this systematic evidence review was only an initial step in CDC’s process of developing treatment guidelines. CDC has already announced that they will not pursue developing ME/CFS treatments guidelines at this time. #MEAction wrote to CDC Chronic Viral Disease Branch Chief, Dr. Beth Unger, and she stated:
“…the systematic review provided little new data and the process for guideline development would not be likely to provide an advance over what is currently available from the ME/CFS Clinician Coalition and IACFSME. We will be completing the Systematic Review and will not be proceeding with guideline development until clinical trial data becomes available.”
​
And of course, even if it does not contribute to new treatment guidelines, the review can still cause harm:
4. BAD NEWS: PUBLISHING FLAWED REVIEW WOULD HARM PEOPLE WITH ME
This report can still do harm to the ME community, even if the CDC doesn’t use it to develop its own treatment guidelines. If it is published in a peer-reviewed academic journal, as the 2014 review was, it could still be used by other entities to present an erroneous view of ME and promote the continued use of inappropriate CBT and GET “treatments.” There will be no opportunity for community review of the finalized evidence review, so it will be important that CDC hear from us how strongly we oppose any publication of this flawed report, which cannot be resolved through minor revisions.
 
dave30th said:
I've always found it very weird that they claimed it was Fukuda except for the four required additional symptom. WTF? I mean, it's mind-boggling. Take those away and it's Oxford, period. It was very bizarre.
Click to expand...

Convenient way to claim they used the important, authoritative CDC criteria, which stands out to casual readers & medics/researchers whose views were/are already fixed (most of them, let's be honest) and wouldn't read further. And wouldn't care if they did, because it's all the same to them. When cited I would think it'd be classified as defined by CDC Fukuda, which it seems to me would be more important to reviewers and editors than any modifications they made in selecting patients.

We're talking about an area where Crawley comes up with a prevalence based on a sample where a diagnosis wasn't mandatory; where the Cochrane review for CBT in CFS included unpublished data as well as studies where a formal diagnosis wasn't required, where peer reviewers don't read past the abstract & papers are published anyway. These wouldn't happen in any other illness, & nobody cared & most still don't. Try using the hashtag "MedTwitter" & see if anyone responds to a tweet about ME/CFS, ever. I've never seen one. They did it because they could, they knew they could, and it was a way of ensuring they'd get the results they wanted.

It was starting to look like things had changed; but now this. They do what they want no matter the reasons not to & they don't care. For the first time I am hopeful they won't get away with this sort of thing, especially with something as big as this, as more people are paying attention, but I don't know what would stop them choosing to publish.
 
It seems that this trial by Cleare and Wessely on hydrocortisone reported in the Lancet was excluded (I suppose because the treatment duration of 1 month was too short)

Cleare AJ, Heap E, Malhi GS, et al. Low-dose hydrocortisone in chronic fatigue syndrome: a randomised crossover trial. Lancet. 1999;353(9151):455-8. PMID: 9989716. Excluded: inadequate duration​
 
Seems that they have also excluded this Belgian RCT on methylphenidate because of "inadequate duration". Given the many flaws the studies that were included, have I think it would be best if they included studies with inadequate duration and simply highlight their limitation and shortcoming (rather than exclude them which might be confusing).

Blockmans D, Persoons P, Van Houdenhove B, et al. Does methylphenidate reduce the symptoms of chronic fatigue syndrome? Am J Med. 2006;119(2):167.e23-30. PMID: 16443425. Excluded: inadequate duration​
 


Summary of the CDC evidence review
The Centers for Disease Control and Prevention (CDC) have commissioned a systematic review on the management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The review is conducted by the Pacific Northwest Evidence-Based Practice Center (EPC) at Oregon Health and Science University. A draft report was released on 17 May 2021 and interested individuals or organizations are invited to submit comments and feedback.

Much like the draft report by the National Institute for Health and Care Excellence (NICE) in the United Kingdom, the CDC review rated the strength of evidence for graded exercise therapy (GET) and cognitive-behavioral therapy (CBT) as ‘low’. The evidence for drug therapies fared no better. This blog post summarizes the main findings of the 419-pages-long document.

Full text: https://mecfsskeptic.com/summary-of-the-cdc-evidence-review/
 
Michiel Tack said:
I don't understand why in Appendix F. Risk of Bias for Randomized Controlled Trials (starting on page 228) all trials received the label "Yes" for the question "Outcomes Pre-specified"

Does anyone understand what they mean?
Click to expand...
I understand it as: before beginning, all RCTs were registered in a clinical trials database or had published their respective protocols, but I do not think that would be the case.
 


Comments on the CDC evidence review on ME/CFS
In a previous blog post, we summarized the draft report of a systematic review on the management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The review was commissioned by the Centers for Disease Control and Prevention (CDC) in the United States.

Unfortunately, the draft report suffers from multiple flaws such as failure to include objective measurements and reports of harms from observational studies. The report also underestimates the risk of bias in non-blinded trials where subjective questionnaires are used, where the intervention influences how patients view their symptoms and where the control group receives no intervention at all. Such trials are at high risk of bias but this is not reflected in the draft report.

In this blog post, we present our comments and feedback to the report. We identified major shortcomings and included recommendations on how the review could be improved. Our comments are also available in pdf format below.

Full text at: https://mecfsskeptic.com/comments-on-the-cdc-evidence-review-on-me-cfs/
 
Michiel Tack said:
I don't understand why in Appendix F. Risk of Bias for Randomized Controlled Trials (starting on page 228) all trials received the label "Yes" for the question "Outcomes Pre-specified"

Does anyone understand what they mean?
Click to expand...
cassava7 said:
I understand it as: before beginning, all RCTs were registered in a clinical trials database or had published their respective protocols, but I do not think that would be the case.
Click to expand...

Having pre-specified outcome is one thing reporting them in the main research is a different thing entirely. I think PACE only reported their pre-specified outcomes after they were forced to release data.
 
By email from Solve.
CDC Releases First Look at
ME/CFS Interim Report
In 2019, The Centers for Disease Control (CDC) contracted with the Pacific Northwest Evidence-based Practice Center (EPC) to conduct a systematic review of the scientific literature of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). Solve M.E. applauded this timely contract for two important reasons:


1. The resulting report would meet recommendation #3 of the 2015 [1] National Academy of Medicine, which states “A multidisciplinary group should reexamine the diagnostic criteria set forth in this report when firm evidence supports modification to improve the identification or care of affected individuals. Such a group should consider, in no more than 5 years [2020], whether modification of the criteria is necessary.”*

* "7 Recommendations." Institute of Medicine. 2015. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington, DC: The National Academies Press. doi: 10.17226/19012.)

2. The field of ME/CFS has moved forward so quickly that a new definitive government evidence review is desperately needed.


After two years, the CDC has finally made the draft report from this contract available for review and comment. The systematic review draft report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) published by the Pacific Northwest Evidence-based Practice Center, housed at Oregon Health & Science University reviewed nearly 5,000 articles and 66 trials.

The draft report describes inclusion and exclusion criteria to identify relevant literature, outlines the approach for evaluating study quality, and summarizes the systematic review results. The report, once finalized, is intended to support the anticipated development of future clinical practice guidelines, which would guide physicians in managing and providing care for patients with ME/CFS.

Currently there are no federal guidelines for management of ME/CFS. CDC has commissioned the Pacific Northwest Evidence-based Practice Center at Oregon Health & Science University to conduct a systematic review of the publicly available scientific literature and now seeks public comment to inform the final report. In particular, CDC seeks data and information, including reports and manuscripts that are pending publications or are not available through indexed bibliographic databases.

Read the CDC’s draft report in its entirety here.

Submit Your Comments to Inform
CDC ME/CFS Interim Report

Take action online today!

Pertinent scientific information from research, evidence-based clinical practice, and your real-world experiences may be used to inform the final report.

Click here to learn more.

Individuals are encouraged to submit their comments. The name and contact information of all who submit comments will be public and part of the federal record.

Solve M.E. especially encourages comments addressing the dangers of Graded Exercise Therapy (GET) as a treatment for ME/CFS.

Submit your comments to the CDC by August 16, 2021 here.

Solve M.E. will be submitting our own organizational comments, which will include anonymous comments on behalf of our community members. If you would like us to include your comments with our own, please send your comments to solvecfs@solvecfs.org by August 1, 2021.
Click to expand...
 
CDC's original plan had been to use this review as the first step in developing treatment guidelines. But in
MEAction's initial communication about this draft review, posted by @Hutan above, they shared an email from CDC's Dr. Unger saying CDC will not be using this review to develop treatment guidelines.

"...the systematic review provided little new data and the process for guideline development would not be likely to provide an advance over what is currently available from the ME/CFS Clinician Coalition and IACFSME. We will be completing the Systematic Review and will not be proceeding with guideline development until clinical trial data becomes available."​
 
Medfeb said:
CDC's original plan had been to use this review as the first step in developing treatment guidelines. But in
MEAction's initial communication about this draft review, posted by @Hutan above, they shared an email from CDC's Dr. Unger saying CDC will not be using this review to develop treatment guidelines.

"...the systematic review provided little new data and the process for guideline development would not be likely to provide an advance over what is currently available from the ME/CFS Clinician Coalition and IACFSME. We will be completing the Systematic Review and will not be proceeding with guideline development until clinical trial data becomes available."​
Click to expand...
Well then it's a cursed blessing that Covid came along or that would have taken us all the way to the 2050's and beyond.

What do clinical trials have anything to do with this anyway? A trial means trying something. There is nothing to try. So why would a trial be of any use in telling us anything?

This all sounds like running out the clock. Hey, it's just millions of lives no big deal take all the time you want it doesn't even affect you.
 
aamirin said:
MEAction has written a draft response to the CDC Evidence Review. Please see https://www.meaction.net/wp-content...tion-Draft-Response-CDC-Systematic-Review.pdf. Please feel free to submit suggestions and/or add your signature. Relevant information is at the beginning of the aforementioned link. Thank you.
Click to expand...
I realize that there's information in this thread saying that this CDC evidence review will not be used to develop a treatment guideline.

Good news, but there's a part of me that's cynical (gee, I wonder why?) and worries that decisions like these could be reversed.

So although it may be a bit paranoid I still think it's a good idea to get details on the record, from as many ME patients and ME advocacy groups as possible, about why this CDC evidence review is flawed.
 
The S4ME Management Committee has decided, with regret, that we will not be making an S4ME submission to the CDC Evidence Review consultation. There has not been a lot of discussion about the content of the evidence review here, and we do not have the capacity to undertake the work by the closing date, 17th August.

If individuals wish to submit a comment, the details of how to do so are here: https://www.regulations.gov/docket/CDC-2021-0053/document
 
Science For ME said:
The S4ME Management Committee has decided, with regret, that we will not be making an S4ME submission to the CDC Evidence Review consultation. There has not been a lot of discussion about the content of the evidence review here, and we do not have the capacity to undertake the work by the closing date, 17th August.

If individuals wish to submit a comment, the details of how to do so are here: https://www.regulations.gov/docket/CDC-2021-0053/document
Click to expand...

You can’t do everything! This work is definitely a community effort, with the baton often being shared around.
 
You must log in or register to reply here.
Back
Top Bottom