CDC Treatment Evidence Review - consultation period

Uh, odd framing, that opioids are ineffective. Of course they are, they just bring many other problems in. Like anti-depressants, and yet they are still handed out using those shirt cannons at sports events. So opioids are not a panacea, but of course they are still effective at reducing pain. Not inspiring, as the evidence for psychotherapy and exercise is lousy and unreliable for anything other than mild pain.

Problem is there is no way to categorize pain severity and rejecting the patient's assessment is common practice so the delivery is unlikely to be appropriate to need, instead based on what physicians determine despite having no way of assessing or confirming the assessment. That's guesswork, never good.

Though the bit about pain being a small part of the curriculum is telling considering it is one of the most impactful symptoms on quality of life, especially in chronic form. I don't think pain medicine can truly advance until medicine actually manages to gain an in-depth understanding of pain, that it's not some property, like hair color, and that, no, with time it does not magically goes away like with headaches and hitting your toe on a chair.

 

I realise that I belong to another generation when I hear someone say that everyone thought that opiates were the answer. When I trained we already knew from experience that they were a disaster. Nothing had changed in 2000 other than that money and politics had taken over medical educational I guess. And we went through this phase at UCH but I assumed nobody took it seriously. It did not change the way we taught students. Clearly in Canada some people did and it did.

 

Oh, we know it is a retrospective narrative. Politicians and administrators would rather firefight than do the right thing in the first place...

 

CDC gave an update on its systematic treatment review during today's (Aug 11) NIH interagency meeting. In a nutshell, their evidence review is ready for public review but they are working to finalize process and timeline. I don't have a date but would expect it would be soon. Prospero protocol record is here




They also discussed plans to develop treatment guidelines but that's new info and how that will work is unclear since the members need to be federal employees. No timeframes for the guidelines group together. Current focus is on the systematic review

Edited to add:
This is an update of the 2014 AHRQ review. Hopefully people will be up for providing feedback on the review when its released.

 

Can they go to content already? I need to know whether they will recommend group therapy, rehab, and mindfulness... the systematic review from Oregon is not going to bring any good i am Afraid. Garbage in, garbage out. There is no evidence.

 

I thought the CDC had removed GET as a treatment for ME/CFS?

yet here it says

https://www.medicalnewstoday.com/articles/8877#treatment

 

https://www.cdc.gov/me-cfs/treatment/index.html

 

Just a heads up -

During the CDC-NIH Interagency meeting today, CDC said that they will be releasing the draft of their systematic review of treatments shortly - the federal register notice is being prepared now. No link yet

 

Do we know what went in to that, if people were raising concerns about the sorts of issue that often get ignored, etc?

edit: I forgot to read the start of the thread, with others asking/saying similar things. Looks like there's little room for input prior to publication of their draft.

A google for the first author (and director of the centre doing the review), Roger Chou, found this:

https://www.nutritionaction.com/daily/exercise-for-health/can-exercise-treat-chronic-low-back-pain/

Without references it's difficult to fully assess what he's saying.

 

@Esther12 the systematic review in question has been prepared by university of Oregon, and usually they extract data from clinical trials- do not set your expectations real high on this one. The likelihood that this review includes CBt and GET is high. Other than that, low evidence everything.

 

Additional background - The group that conducted this systematic review for the CDC is the same one that did the systematic review for AHRQ before the P2P meeting in 2014.
https://effectivehealthcare.ahrq.gov/products/chronic-fatigue/research-protocol
https://effectivehealthcare.ahrq.gov/products/chronic-fatigue/research (note - this report is listed as being over 3 years old and should not be considered current)
This is a journal article about the 2014 stuff written by the group that did the review.
https://www.acpjournals.org/doi/10.7326/M15-0114

 

Merged thread

CDC: The Systematic Review Report for Diagnosis and Treatment of [ME/CFS]: Request for Comment, 2021

"SUMMARY: The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the opening of a docket to obtain comment on the systematic review draft report for Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).

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.

Access to pertinent scientific information from research and evidence-based clinical practice may be used to inform the final report. The anticipated CDC guideline would assist clinicians by outlining management practices for patients with ME/CFS.
...."

https://www.federalregister.gov/pub...t-of-myalgic-encephalomyelitischronic-fatigue

Deadline of 90 days after publication of document, which is scheduled for 17th May 2021.

 

I wonder if this is the closest thing the US has to the NICE Guideline.

I remember reading about this a couple of years ago. There was concern that the Pacific Northwest Evidence-Based Practice Center was being awarded the contract with no competitive bidding process. MEAction teamed up with the New York State Department of Health (NYSDOH) AIDS Institute to bid for the contract after successfully challenging the original process. I guess they were unsuccessful.
https://www.meaction.net/2018/10/18...part-of-health-and-meaction-bid-for-contract/

 

I wonder if non-US organisations can submit evidence?

 

Previous thread on this was here - https://www.s4me.info/threads/cdc-treatment-evidence-review.10243/

This is an updated treatment evidence review commissioned by CDC in 2019 using the Oregon group that did the 2014/2016 evidence review of treatments.

I can confirm but believe that it's open to comments from anyone.

 

The draft systematic evidence review has been released and can be downloaded from this page - https://www.regulations.gov/document/CDC-2021-0053-0001
There are two files for download but they appear to be the same file.

The deadline for comments is Due Aug 16, 2021. Details on how to submit are on this page - https://www.regulations.gov/docket/CDC-2021-0053/document

 

Structured Abstract

Objectives. Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) can have profound effects on function and quality of life. This report updates a 2014 Agency for Healthcare Research Quality (AHRQ)-funded review in order to synthesize the evidence on evaluation and management of ME/CFS. It also expands upon the prior AHRQ review by including children as well as adults, evaluating harms as well as benefits of diagnosis, and evaluating effects of treatment on depression, anxiety, sleep quality, pain, and other symptoms associated with ME/CFS in addition to fatigue, function, and quality of life.

Data Sources. MEDLINE (1988 to January 2019), PsycINFO (1988 to January 2019), Embase (through January 2019) and the Cochrane Library (through January 2019); supplemented by review of reference lists and the 2014 AHRQ review.

Review Methods. Articles were selected for review if they included: 1) evaluation of patients with fatigue, 2) diagnosis of ME/CFS, or 3) treatments (pharmacological, nonpharmacological, dietary, or complementary and alternative therapies) of ME/CFS. We abstracted data on the frequency of non-ME/CFS conditions in patients presenting with fatigue; benefits and harms of diagnosis of ME/CFS versus non-diagnosis; and benefits and harms of treatments. Two investigators reviewed abstracts and full-text articles for inclusion based on predefined criteria. Risk of bias was assessed using predefined criteria. Discrepancies were resolved through discussion and consensus, with a third investigator if needed. Random effects meta-analyses were conducted on trials of exercise and cognitive therapy; where evidence was unsuitable for combining, it was synthesized qualitatively. The strength of evidence was assessed using methods recommended by the AHRQ Methods Guide for Effectiveness and Comparative Effectiveness Reviews.

Results. We identified 4,951 potentially relevant articles, selected 636 for full-text review, and included 72 studies in 91 publications (1 systematic review and 5 observational studies on diagnosis and 66 trials of treatments). A systematic review of patients with fatigue or tiredness in primary care settings found that the most common non-ME/CFS conditions were depression (18.5%), serious somatic diseases (4.3%), anemia (2.8%), and malignancy (0.6%). In specialty settings of patients referred for evaluation of possible ME/CFS, the most common non-ME/CFS conditions were psychological (15% to 51%) and sleep disorders (6% to 30%). No study evaluated benefits or harms of ME/CFS diagnosis versus non-diagnosis.

Sixty-six trials evaluated treatments for ME/CFS. Thirty-three trials were included in the prior AHRQ report and 33 trials were new since the prior report. CBT and exercise therapy were associated with improved fatigue, function, and other outcomes versus inactive control therapies, but the magnitude of effects based on average benefits was small to moderate. These trials demonstrated unexplained statistical heterogeneity in pooled estimates and contained methodological limitations. Additionally, the applicability of findings to patients with severe ME/CFS diagnosed using more current, specific case definitions was uncertain. Other pharmacological, nonpharmacological, dietary, and complementary and alternative therapies were ineffective, or evidence of effectiveness was too limited to guide clinical practice. Reporting of harms across trials was suboptimal, with limited evidence that exercise and CBT were not associated with increased risk of serious adverse events or worsening of symptoms. In Management of ME/CFS DRAFT Systematic Review Pacific Northwest Evidence-based Practice Center iii adolescents with ME/CFS, limited evidence found CBT (family based or involving parents) associated with improved function and school attendance versus inactive therapies, but differences were not statistically significant.

Limitations. Treatment trials had methodological limitations. Most interventions and comparisons were evaluated in few trials, most trials used older ME/CFS case definitions, and there was limited information on how key characteristics and subgroups of patients impacted outcomes. There was unexplained statistical heterogeneity in meta-analyses, study inclusion was restricted to English language publications and formal methods for determining small sample effects were not performed due to small numbers of studies.

Conclusions. Evidence on effective treatments for ME/CFS remains limited. Although graded exercise and CBT were more effective than inactive control therapies (usual care, usual specialist care, or an attention control) in improving fatigue, function, and other outcomes, the magnitude of effects was small to moderate and methodological and other limitations (imprecision, inconsistency, uncertain generalizability) precluded strong conclusions. Other therapies were not shown to be effective or require additional evidence to verify effectiveness. Non-ME/CFS conditions were common in patients presenting with fatigue.

 

Yes, non-US organizations can submit comments and evidence.

 

As usual, this is a review of interventions using the Oxford and Fukuda criteria, and it does not consider post-exertional malaise as the primary symptom of ME/CFS as the NICE review does.

The authors note that the findings may not be applicable to people diagnosed with "more recent" criteria and severe "post-exertional fatigue" (only one trial required PEF), but despite the fact that these criteria are outdated, they still put CBT and exercise therapy forward.

The review reads very similarly to Cochrane's, as the authors note (Discussion, p. 152 / p. 159 of the PDF):

Our findings are generally consistent with a recent systematic review on exercise therapy for ME/CFS that concluded that exercise probably has a positive effect on fatigue in adults compared to usual care or passive therapies, but noted uncertain applicability to patient diagnosed with case definitions other than the Oxford and Fukuda criteria.​

I have concerns with how the evidence was assessed (in-paragraph bolding mine).

Data Synthesis
[...]
Although some trials reported results at long-term, post-trial follow-up, we restricted meta-analyses to outcomes assessed during the trial, due to potential crossover and contamination following trial completion.
[...]
We did not evaluate for potential publication bias using graphical or statistical methods for small sample effects, because no analysis had at least 10 trials (41)

Assessing Research Applicability

(...) To interpret the magnitude of benefits, we defined a minimum clinically important difference for fatigue as 2.3 points on the 11-item 0 to 33 Chalder scale, 0.6 points on the 1 to 7 Fatigue Severity Scale, or 11.5 points on the 1 to 50 Multidimensional Assessment of Fatigue; (30) for function as 10 points on the 0 to 100 Short Form (SF)-36 physical function subscale; (31) and for psychiatric outcomes as 1.7 points on the 0 to 21 Hospital Anxiety and Depression Scale (HADS) depression or anxiety scales. (32) For pooled standardized mean difference (SMD) estimates for outcomes reported using different scales, we defined an SMD of 0.2 to <0.5 as small, 0.5 to <0.8 as moderate, and ≥0.8 as large. (33)
​

In the synthesis for key question 2 (benefits and harms of symptomatic treatments), pages 17 to 19, the whole evidence base for CBT, exercise therapy and medications is rated as "low quality", defined as:

A “low” grade indicates low confidence that the estimate of effect lies close to the true effect for this outcome. The body of evidence has major or numerous deficiencies (or both) and additional evidence is needed to determine that the findings are stable or that the estimate of effect is close to the true effect.
​

Strangely, 8 of the 10 included trials of exercise therapy were rated to be at "moderate" risk of bias, including PACE, GETSET, FINE, Powell 2001 and 2007, Moss-Morris 2005:

Eight trials were rated medium risk of bias and two trials (54, 57) were rated high risk of bias (Risk of Bias Table Appendix F). In all trials, blinding of patients and care providers to the exercise intervention was not feasible. Other methodological limitations included high attrition, failure to report attrition, inadequate description of randomization or allocation concealment methods, and failure to blind or unclear blinding status of outcomes assessors and data analysts.
​

@Michiel Tack