CDC Treatment Evidence Review - consultation period

M

Medfeb

Senior Member (Voting Rights)
A thread announcing consultation on the draft document has been merged with this thread. Go to this post for the start of the merged thread. Consultation period 90 days from 17th May 2021.

See this thread for commentary on the finalised evidence review:
(CDC) Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 2023


The following update about the treatment evidence review being conducted by CDC was written by me (Mary Dimmock) and originally published in the summer edition of the ME Global Chronicle.

You may remember that in September 2018, the US Centers for Disease Control and Prevention (CDC) solicited bids to conduct a systematic evidence review of ME/CFS treatments as an update to the 2014-2016 systematic evidence review commissioned by the Agency for Healthcare Research and Quality (AHRQ). This new review, currently underway, could have a significant impact on treatment recommendations in clinical guidance for ME. I am a member of the key informants panel providing input on review questions and have agreed to hold those discussions and the names of the other members in confidence. In the meantime, the following summarizes what is known publicly about this important review, based on information provided by CDC and in the documentation for the bid solicitation.​

The Key Takeaways:
  • CDC is conducting this systematic evidence review as the first step in longer-term plans to develop treatment guidelines for ME/CFS
  • The timeline for completion has not yet been stated publicly but is estimated to be the first half of 2020
  • The handling of the disparate case definitions has not yet been specified. The 2016 Addendum to the 2014 AHRQ Evidence Review excluded Oxford studies from analysis
  • This review may consider other peer-reviewed literature that provides context for treatment of symptoms seen in ME/CFS (e.g. orthostatic intolerance, pain, etc)
  • The process for the review of the draft report has not yet been announced. During the 2014 evidence review, the public was given the opportunity to provide input
Further details are available here
 
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Thanks for the update, Mary.

One thing, "The solicitation stated this new review would include studies of treatments in “ME/CFS” but did specify what case definitions would be included or excluded or how Oxford studies would be handled", I think the "did" should be "didn't"?
 
I have lately been focusing more time and posts on developments in the UK than in the US. I guess that’s not too surprising. After all, this whole project began as an investigation of the PACE trial, conducted by British experts in British health care centers and published in British journals. And there’s so much crap besides PACE to pursue, given the strength of the CBT/GET ideological brigades.

I’m glad that Mary Dimmock and others are keeping up the pressure here. Mary got involved in the issue after her son fell ill several years ago. She has been especially active in prodding US health agencies, and in particular the Centers for Disease Control and Prevention, to do their jobs. The article below, about the agency’s new systematic review of the evidence base for ME/CFS treatments, appeared in last month’s issue of the ME Global Chronicle. I am re-posting it in full here with Mary’s permission.
Click to expand...
http://www.virology.ws/2019/07/10/trial-by-error-mary-dimmock-on-cdcs-new-evidence-review/
 
The protocol for the evidence review contracted by CDC has been published in Prospero
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=142805

A few notes from a first read of the protocol:
1) "ME/CFS in question 3 is defined as ""Persons diagnosed with ME, CFS, or both using standard criteria"

2) These are the key questions being asked: (my bolding added)
  • Q1: "In patients undergoing evaluation for possible ME/CFS, what is the frequency of non- ME/CFS conditions?"
  • Q2: "What are the benefits and harms of diagnosing ME/CFS, vs. non-diagnosis?
  • Q3: "What are the benefits and harms of therapeutic interventions for patients with ME/CFS, and how do they vary by patient subgroups?"
    • Q3a: "Interventions for treating ME/CFS"
    • Q3b: "Interventions for treating symptoms commonly present in persons with ME/CFS (poor sleep, orthostatic intolerance, pain, fatigue, cognitive problems, depression, multiple chemical sensitivity, gastrointestinal symptoms, urinary symptoms, etc.)"
NOTE: Subgroups in Q3 are include "those defined by age, sex, race/ethnicity, presence of biomarkers, ME/CFS severity (including homebound status) or duration, type of onset (e.g., acute vs. gradual), criteria used to diagnose ME/CFS, and co-morbidities."​

3) Study types to be included are listed as follows: (my bolding added). I have not read AMSTAR yet
"Systematic reviews of randomized controlled trials will be used as sources of evidence if they address a Key Question and are assessed as being at low risk of bias, according to the AMSTAR quality assessment tool. If multiple systematic reviews are relevant and low risk of bias, we will focus on the findings from the most recent reviews and evaluate areas of consistency across the reviews. If systematic reviews are included, we will update findings by adding primary studies identified in our searches. If systematic reviews are not included, we will include primary randomized controlled trials addressing the populations, interventions, comparators, outcomes, timings and settings (PICOTS) listed above. Large prospective cohort studies will be used to address Key Questions 1 and 2, and harms of interventions, if data are not available from randomized controlled trials.​
 
Thanks for the information. It is interesting to see this progressing in the US.

I guess we now start to wonder why a Cochrane scoring system is being used when the uselessness of these scores has become apparent (but maybe only since the ROB2 Paper). I am intrigued as to why there is reference to a Cochrane Back Review Group, described on their site as :

The Cochrane Back Review Group is one of 50 Review Groups that produces and maintains systematic reviews on the effects of healthcare. The goal is to provide the most up-to-date information to inform clinical decisions at the individual, institutional and policy level. The scope of the Back Review Group is primary and secondary prevention and treatment of neck and back pain and other spinal disorders, excluding inflammatory diseases and fractures. It is hosted by the Institute for Work & Health (http://www.iwh.on.ca), an independent, not-for-profit research organization whose mission is to conduct and share research with workers, labour, employers, clinicians and policy-makers to promote, protect and improve the health of working people. The Back Review Group also has funding from the Canadian Institutes of Health Research and the Canadian Agency for Drugs and Technologies in Health.

This looks slanted towards work placement. I find it hard to see what ME and back pain have in common - other than the usual implication that they are reasons for not going to work.
 
Medfeb said:
Good question and why is that more relevant than any of the other 49 review groups
Click to expand...

Possible explanation...

This Cochrane site lists the review groups - https://www.cochranelibrary.com/about/cochrane-review-groups

One review group is the Back and Neck review group under the Musculoskeletal, Oral, Skin and Sensory group.

The coordinating editors of the Back and Neck review group are Dr Roger Chou of Oregon Health & Science University, USA and Andrea D Furlan of the Institute for Work and Health, Canada

Dr. Roger Chou is the first author for this protocol
 
I am wondering how they intend to assess:
""What are the benefits and harms of diagnosing ME/CFS, vs. non-diagnosis?"

By using randomized controlled trials, or if those aren't available, cohort studies.

Even though they have changed "harms" to "beneifts and harms", it's still a slanted question. For example, labeling is only a problem when there is stigma, and that is a societal problem, not a diagnosis problem.

I am also concerned that there is probably not enough evidence to address their questions from stuff you could put in a meta-analysis like this, especially from large RCT/cohort studies that don't have a low risk of bias.

Unless they muck the bias question and use mostly Oxford subgroup, but that still won't answer a lot of questions and would mostly look like: we shouldn't try to diagnose patients with ME/CFS because there's a high risk of misdiagnosis and no treatments. Which is a really wild and unhelpful conclusion. But I am concerned that this will be the result of this protocol.

Why can't they ask about this stuff before they start a thing?
 
Judging by this quote from a systematic review by Chou this is not a good place to start:

New evidence indicates that tai chi (strength of evidence [SOE], low) and mindfulness-based stress reduction (SOE, moderate) are effective for chronic low back pain and strengthens previous findings regarding the effectiveness of yoga (SOE, moderate). Evidence continues to support the effectiveness of exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage, and acupuncture for chronic low back pain (SOE, low to moderate). Limited evidence shows that acupuncture is modestly effective for acute low back pain (SOE, low). The magnitude of pain benefits was small to moderate and generally short term; effects on function generally were smaller than effects on pain. Limitation: Qualitatively synthesized new trials with prior meta-analyses, restricted to English-language studies; heterogeneity in treatment techniques; and inability to exclude placebo effects.
 
And from an interview with Chou:

Has OHSU revamped the curriculum to include pain management? There is a whole section on pain. In the past, pain was a small part of the curriculum for medical students and oftentimes, it was a very biomedical approach, when we know now pain is very complex and there are lots of psycho-social contributions — mood, depression and substance use. The goal at OHSU is to not just focus on biomedical, but understand the psychosocial and public health implications and use all that to address the issue in a more effective way. It was a big gap in the training.

Presumably the Cochrane Back group is about as bad as it gets.
 
From the article that includes the interview (from 2016):

Snow Leopard said:
On Roger Chou:
"Meet the Portland man who helped shape the CDC’s new painkiller guidelines"
https://www.bizjournals.com/portlan...-portland-man-who-helped-shape-the-cdc-s.html
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Dr. Roger Chou [...] has written extensively on the safety and efficacy of opioid painkillers for treating chronic pain. He's concluded that drugs like Vicodin and OxyContin aren't all that effective [...].
Click to expand...
The guidelines call for interventions such as physical and cognitive behavior therapy, over-the-counter painkillers and exercise as the first line of defense.
Click to expand...
Also, from the interview:
Was there anything in the final recommendations you had to fight for?
[...] In the past, the tendency was to jump to opioids, because that’s what we were taught 15 years ago — they’re safe and effective and underused. This is a shift in thinking. Even for the short term, opioids are not effective compared with a placebo.
Click to expand...

(My bolding added).

Chou's claims quoted in this and the previous post seem to me to be overgeneralizing (at least)?

Apologies for repeated editing for clarity.
 
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MSEsperanza said:
From the article that includes the interview (from 2016):




Also from the interview:


(My bolding added).

Chou's claims quoted in this and the previous post seem to me to be overgeneralizing (at least)?

Apologies for repeated editing for clarity.
Click to expand...

"Even for the short term, opioids are not effective compared with a placebo."

WHAT? Has this scam artist ever had a wisdom tooth hammered out? Has s/he/it ever heard of surgery?
Are adults actually expected to believe this, or is this another case of O'Brien requiring us Smiths to swallow the Current Truth?
 
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