Should not be used ?If the review doesn't recommend for or against exercise they should be willing to attach an editorial note saying the review should be used as evidence for clinical care.
Thanks.Should not be used ?
Yes indeedthis seems like sophistry or just semantics to me. You don't need to use the phrase "We recommend" in a sentence for a positive assessment of an intervention to be considered a recommendation. The review "recommends" exercise therapy in the common-sense meaning of the word, which is understandable to all native speakers of English. ADD: Maybe "semanticism"? Is there such a word? Using semantics or linguistic hair-splitting to deny reality?
I wonder if this isM. Warshaw
In my response above, I should have added that I’m a biostatistician with decades of experience doing medical research including clinical trials. My comments on the poor quality of the study is not due to dogmatism, but due to violation of accepted research standards. Once a study has a protocol in place defining the endpoints, it is not acceptable to change them. It is especially not acceptable to change them so that a participant who gets worse over the course of the study meets the new definition of remission. I read the study protocol and resulting paper years ago and was appalled that it had passed peer review at a prominent journal.
She fits the bill.I wonder if this is
Meredith Warshaw
Center for Biostatistics in AIDS Research, Harvard School of Public Health
Meredith Warshaw - Google Scholar
This is her previous comment:On the Retraction Watch article on the Cochrane review, I noticed this comment:
I found this based on her LinkedIn, she has done some work in psychiatry and special needs education before getting into HIV/AIDS. She might be sympathetic to ME/CFS?
I read the the major study out of England of graded exercise therapy and it was appallingly bad.
I was thinking this - that it doesn’t mean they think the methodology was a problemI'm not surprised. They have superficially gone along with the NICE guideline. Note that they say we "find overexertion to be detrimental" in this statement, yet in their position paper published in 2020 and updated in 2022 after the NICE guideline was published they say:
https://bacme.info/wp-content/uploa...-on-the-Management-of-ME-CFS-October-2020.pdf
And their representative on the Cochrane IAG, Peter Gladwell, supports pacing up, as seen in his materials shared via AfME.
BACME speak with forked tongues. They want to be seen to be on our side but at the same time want to maintain their jobs running rehab clinics with CBT and watered down GET.
I'm thinking they probably see some value in separating PEM vs non-PEM to preserve their industry and income streams. Even though it makes zero difference, which is actually the main takeaway. But by emphasizing that it's the problem, they keep the problem afloat with a distinction that no one can reliably identify.I was thinking this - that it doesn’t mean they think the methodology was a problem
and their latest stuff has simply rebranded with the same old assumptions underlying things
but I can see why they’d want that rebrand included
It’s not the same as hearing them talk about seeing the light on method and information issues , and indeed on respect when pwme submit proper feedback and it being heard as intended etc
I think if we started seeing proper changes along those lines I’d feel it was more about hearing the issue with harm and outcomes and wanting to ‘get things’ better
I am interested however in it seeming the approach of the IAG might have been to agree a message they could all cooerdinate on?
Yes I’ve seen in other places that certain clinic’s have used their fatigue clinic model to eg get grants from cancer charities or maybe nhs to offer courses for fatigue post cancerI'm thinking they probably see some value in separating PEM vs non-PEM to preserve their industry and income streams. Even though it makes zero difference, which is actually the main takeaway. But by emphasizing that it's the problem, they keep the problem afloat with a distinction that no one can reliably identify.
So if the issue is only that PEM is different, they can continue 'duing' the same ritual crap while claiming that if it doesn't work, it's because of PEM and, my guess again, you need CBT, not GET. They simply insist that it works for 'fatigue'.
Or something like it. I can't ever see good intentions out of this industry. It's built to be parasitic and can't change. Its only valuable future is to fold and stop the grift, but these people made their career out of it so they can't let go. Especially so because their skills are entirely worthless anywhere else.
To: Dr. Susan Phillips, Chair, Cochrane Governing Board
CC: Dr. Karla Soares-Weiser, Cochrane Editor in Chief
Dr. Hilda Bastian, IAG chair
Date: March 11, 2025
Subject: Cochrane’s decision to terminate the ME/CFS exercise review update
Dear Dr. Phillips,
We are ME/CFS consumer and researcher members of the ME/CFS exercise review author panel, convened by Cochrane to produce a full update to the Larun et al review of Exercise Therapy for Chronic Fatigue Syndrome (1,2). We are shocked by Cochrane’s unilateral decision in December 2024 to disband this initiative while continuing to leave the controversial Larun et al review in place (3,4). This creates a significant risk of harm to people with ME/CFS and also to those with Long COVID who experience post-exertional malaise (PEM), the adverse response to even small amounts of exertion that is the hallmark of ME/CFS.
In its 2019 announcement of this initiative, Cochrane acknowledged that even with the changes done in the 2019 update to address concerns with the methods and evidence, that review didn’t “resolve all the ongoing questions” and that a “new approach” was needed (1). Cochrane committed to a full review using a new author panel and an Independent Advisory Group (IAG), both of which included people with ME/CFS lived experience. Cochrane stated it expected this approach would improve the review.
Between October 2020 and February 2023, the author panel drafted four successive versions of the new protocol, each of which was submitted to Cochrane Central Editorial Service for their review and revised based on that feedback. The fourth and final version was submitted to Cochrane Central Editorial Service in February 2023 with the understanding that Cochrane would submit this for peer and IAG review and for public consultation.
As required by the project’s remit, the February 2023 draft protocol addressed the concerns and issues documented by the IAG and acknowledged by Cochrane in its 2019 announcement. For instance, the draft protocol specified both objective and subjective outcomes, specified an outcome to evaluate harms associated with PEM, required evaluation of the long term effects, called for separately evaluating studies that required PEM from those that did not, and required sensitivity and subgroup analyses to detect high levels of bias in any domain and evaluate the impact of outcome switching.
In its decision to disband this initiative, Cochrane cited a lack of resources and insufficient new research. But the original decision to undertake this review was never predicated solely on the emergence of new studies. Further, Cochrane never raised the concern about lack of resources with the author panel; in fact, Cochrane’s Central Editorial Service was actively involved for two years in shaping the successive drafts.
The most disturbing aspect of Cochrane’s decision to abandon the planned update is the parallel decision to leave the current Larun et al review in place and re-endorse it (4). As the IAG documented and as Cochrane’s own statements and actions acknowledge, Larun et al has serious methodological deficiencies in assessing the efficacy and safety of exercise in ME/CFS. This includes the review’s failure to adequately address PEM and the harms that can result from exercise in people with ME/CFS and those with Long COVID who experience PEM and develop ME/CFS.
This failure creates a significant risk of harm from inappropriate clinical recommendations. This risk is compounded by Cochrane’s decision to change the date of Larun et al from October 2019 to December 2024, despite the only difference between the two versions being an editorial note about the cancellation of the update (2,4). This misleadingly suggests to the public that Larun et al is a carefully updated work. However, this simple date change does not address the significant methodological concerns with the previous review. Neither the new publication date nor the included editorial note were based on a formal, documented, and repeatable search of the scientific literature, consistent with Cochrane best practices.
We understand that Cochrane revised its withdrawal policy in 2019 and that being outdated is no longer sufficient reason to withdraw a review. We also understand that Cochrane has rejected calls from members of the ME/CFS community to withdraw Larun et al (5). But Cochrane’s withdrawal policy still provides for withdrawal when “following the conclusions of the published review could result in harm to patients or populations of interest (other than known adverse effects) (6).” Further, Cochrane’s Handbook for Systematic Reviews of Interventions calls for caution in evaluating adverse effects that, if followed, would have highlighted the risks of harm (7). The deficiencies in Larun et al, especially in its failure to require PEM in patient selection or adequately consider PEM as a significant adverse effect of exercise in ME/CFS, rises to the level of serious error. Under the circumstances, withdrawal is necessary to best protect people with ME/CFS from harm.
Accordingly, we call on Cochrane to immediately withdraw the Larun et al ME/CFS exercise review.
We look forward to your response.
Signed
Dr. Todd E. Davenport, Researcher author
Mary Dimmock, Consumer author
References
1. Cochrane announcement of the planned full update to the ME/CFS Exercise Review
a. Publication of Cochrane Review: ‘Exercise therapy for chronic fatigue syndrome.’ Cochrane. October 2019 https://web.archive.org/.../publication-cochrane-review...
b. Also see Stakeholder engagement in high-profile reviews pilot. Cochrane. March 2020. Discusses the approach to be taken in the review, including the IAG and new author panel https://web.archive.org/.../stakeholder-engagement-high...
2. Larun et al. Exercise therapy for chronic fatigue syndrome. Cochrane. October 2019 https://www.cochranelibrary.com/.../14651858.../full
3. Update on ‘Exercise therapy for chronic fatigue syndrome.’ Cochrane. December 16, 2024. https://www.cochrane.org/.../update-exercise-therapy...
4. Larun et al. Exercise therapy for chronic fatigue syndrome. Cochrane. December 19, 2024. https://www.cochranelibrary.com/.../14651858.../full
5. March 17, 2024 letter from Science for ME to Cochrane calling for the withdrawal of Larun et al review because of the risk of harms https://www.s4me.info/.../s4me-2023-open-letter.../page-2...
a. Cochrane’s response February 14, 2025 https://www.s4me.info/.../s4me-2023-open-letter.../page-3...
6. Cochrane Database of Systematic Reviews: editorial policies: Withdrawal of published articles. https://www.cochranelibrary.com/cdsr/editorial-policies...
7. Cochrane Handbook for Systematic Reviews of Interventions: Chapter 19: Adverse Effects. Version 6.5, 2024 https://training.cochrane.org/handbook/current/chapter-19
**********
Thank you for sharing this, and kudos to Mary and Todd for going public!Mary Dimmock and Todd Davenport have sent a letter to Cochrane and also wrote one for the ME/CFS community, with a link to the draft protocol. I posted the letters on Facebook but VB is being screwy and I can't sign in at the moment...Hopefully that will be figured out soon.
https://www.facebook.com/david.tull...ZSh2J5XZA4gvqRGBgAd2yjbZpGW9J6CUYBeE3WCxhxyel
To: The ME/CFS Community
Subject: Cochrane ME/CFS Exercise Review
Date: March 11, 2025
We are writing this letter to the ME/CFS community as two of the original eight members of the author panel convened by Cochrane in 2020 to produce a full update of their review of Exercise Therapy for Chronic Fatigue Syndrome by Larun et al (1,2). When Cochrane disbanded this initiative in December 2024, they told the authors they retained the rights to use the contents of the draft protocol elsewhere. The other authors have relinquished their rights and moved on. As the remaining authors, we have decided to release the final draft protocol, as submitted to Cochrane in February 2023, and to solicit public comment. We have also sent an open letter to Cochrane calling on them to withdraw the review by Larun et al (3).
As background, in October 2019, Cochrane committed to a full update of this review. They did this because of continued serious concerns, despite amendments made by the authors to the last update in 2019 (1, 2). To that end, Cochrane established an Independent Advisory Group (IAG) and a new author panel (4). Both groups included individuals with lived experience of ME/CFS; the author panel also included two ME/CFS clinician/researchers.
The author panel met regularly from October 2020 until February 2023. During that time, we analyzed the documentation of concerns with Larun et al provided by the IAG (5), considered the findings of UK’s NICE review of ME/CFS exercise studies, and drafted four successive draft protocols for review and feedback by Cochrane Central Editorial Services. We incorporated their feedback, which played a critical role in improving the draft protocol. The fourth and final version was submitted in February 2023, with the expectation that it would be distributed to peer reviewers and IAG members and then for public consultation (4). In May 2023, the Executive Director of Cochrane Central Editorial Services informed the authors by email that they were awaiting clarity on next steps in that process (6).
Cochrane did not communicate with the author panel again until December 16, 2024, when the Office of the Editor in Chief emailed all of us that the initiative had been disbanded. Cochrane’s brief explanation was that “producing a meaningful update of this review is not a priority based on insufficient new research in the field and the available organizational resources to oversee this work (7).” But Cochrane’s original decision to undertake this review was never predicated solely on the emergence of new studies; it was to address concerns with Larun et al (1, 4). The explanation about resources was also confusing as Cochrane Central Editorial Service had been actively involved for two years in shaping the successive drafts of the protocol. And a change in priority at Cochrane would be equally befuddling, given the dramatic increase in the prevalence of ME/CFS in the wake of the coronavirus pandemic (8).
When Cochrane Central Editorial Service informed the authors that they retained the rights to use the content of the withdrawn protocol elsewhere, they also noted that Cochrane retained the rights to the elements developed by Cochrane, such as the search strategy, as well as the right to publish a new Cochrane ME/CFS exercise review, using “potentially, an entirely new author team” (9). Cochrane did not provide further explanation on their future intent.
The most disturbing aspect of Cochrane’s decision to abandon the planned update is that it simultaneously decided to leave Larun et al in place (10,11,12). As the IAG had documented and as Cochrane’s own statements and actions had acknowledged, Larun et al has serious methodological deficiencies in how it assessed both the efficacy and safety of exercise in ME/CFS (1,4,5). This includes Larun et al’s failure to adequately address the harms associated with post-exertional malaise (PEM), an adverse reaction to exercise and other forms of exertion that is the hallmark of ME/CFS (13).
This failure creates a significant risk of harm for people with ME/CFS, including the millions who have developed ME/CFS following COVID (8). This risk of harm is compounded by Cochrane’s decision to revise the date of Larun et al from October 2019 (2) to December 2024 (14), despite the only change being the addition of an editorial note announcing the cancellation of the update. Many, if not most, readers will undoubtedly make the unwarranted assumption that the review itself has been substantially updated and that any criticisms raised in the posted comments relate to previous versions. This risk of harm can only be rectified by Cochrane fully withdrawing Larun et al, as we and others have requested (3,10).
As the remaining two authors, we are considering next steps. In the meantime, we are releasing the final version of the draft protocol submitted to Cochrane to provide transparency about its contents and to provide the opportunity for public consultation as originally promised (4).
Links to the final version of the draft protocol, to a survey for comments on the protocol, and an FAQ on both are provided below. Please provide your comments by May 15, 2025. We will review those comments and provide a summary.
If you have any questions, you can submit them to mecfsexercisereview@proton.me. We may not be able to reply directly to each individual email, but we will add the answers to the FAQ.
We recognize there are opportunities to improve this draft protocol. We look forward to your feedback.
Dr. Todd E. Davenport, Researcher author
Mary Dimmock, Consumer author
Links to the draft protocol, survey, and FAQs:
● The draft protocol: https://drive.google.com/.../1bJzQ7C6Gr2sCFQ37vZ0.../view...
● The survey to provide comments: https://pacific.qualtrics.com/jfe/form/SV_0wRPgjuYlVVZa6i
● FAQs on the draft protocol and survey: https://drive.google.com/.../1Njn0o98LMoU9nyJmd.../view...
References
1) Cochrane announcement regarding its plans for a full update of its review of Exercise Therapy for Chronic Fatigue Syndrome by Larun et al. October 2019. https://community.cochrane.org/.../publication-cochrane...
2) Larun et al. Exercise therapy for chronic fatigue syndrome. Cochrane. October 2019 https://www.cochranelibrary.com/.../14651858.../full
3) Davenport, T, Dimmock, M. Open letter to Cochrane. March 11, 2025. https://drive.google.com/.../12.../view...
4) Cochrane announcement on stakeholder engagement in the update to the ME/CFS exercise review. March 2020. Discusses the approach to be taken in the review, including the IAG and new author panel https://web.archive.org/.../stakeholder-engagement-high...
5) Bastian, Hilda. Cochrane Exercise and ME/CFS Review Update: May 2021. https://web.archive.org/.../stakeholder-engagement-high...
6) Email to the authors from Helen Wakeford, Executive Editor, Cochrane Central Editorial Service. May 26, 2023
7) Unsigned email to the authors from the Office of the Editor in Chief, December 16, 2024.
8) COVID-19 Infection Associated With Nearly Eightfold Increase in Chronic Fatigue Syndrome. University of Utah. January 14, 2025. https://healthcare.utah.edu/.../covid-19-infection...
9) Unsigned email to the authors from Cochrane Central Editorial Service, December 16, 2024
10) March 17, 2024 letter from Science for ME to Cochrane calling for withdrawal of Larun et al because of risk of harms https://www.s4me.info/.../s4me-2023-open-letter.../page-2...
a) Cochrane’s response, February 14, 2025 https://www.s4me.info/.../s4me-2023-open-letter.../page-3...
11) Thousands demand withdrawal of review article recommending exercise therapy for chronic fatigue syndrome. Retraction Watch. January 23, 2025. https://retractionwatch.com/.../thousands-demand.../
12) Rücker, M. ME/CFS: New dispute over potentially harmful activation therapy shakes Cochrane network. January 30, 2025. https://www.riffreporter.de/.../mecfs-cochrane...
a) Cochrane told Rücker "Cochrane stands by its decision to have published this review in 2019" and that the decision was made at the Governing Board, the highest group in Cochrane in September 2024.
13) Vink M, Vink-Niese F. Graded exercise therapy does not restore the ability to work in ME/CFS – Rethinking of a Cochrane review. Mooney A, ed. WOR. 2020;66(2):283-308. doi:10.3233/WOR-203174 https://pubmed.ncbi.nlm.nih.gov/32568149/
14) Larun et al. Exercise therapy for chronic fatigue syndrome. Cochrane. December 2024 https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub9/full