Petition: S4ME 2023 - Cochrane: Withdraw the harmful 2019 Exercise therapy for CFS review

Just found a potentially relevant article:

Use of inactive Cochrane reviews in academia: A citation analysis
  • Open access
  • Published: 12 April 2023 Volume 128, pages 2923–2934, (2023)
see https://link.springer.com/article/10.1007/s11192-023-04691-9

From Abstract

In 2020, 41% of all citations of Cochrane reviews, were of reviews that had not been updated for more than 5.5. years. 5 years after last update, Cochrane reviews were on average cited 8.6 times per year. Twenty-five percent of Cochrane reviews were still cited 10 years after last update and were on average cited 4.3 times in the 10th year. None of the most recent citations of the 20 most outdated reviews indicated directly that the review was out of date. Cochrane reviews continued to be cited even though they were not being updated. This could pose a problem if they do not represent the most up-to-date evidence, as it may lead to the distribution of outdated evidence or misinformation.
 
Also from 2021:

Most Cochrane reviews have not been updated for more than 5 years.
Hoffmeyer BD, Andersen MZ, Fonnes S, Rosenberg J

See https://europepmc.org/article/med/34427395

From Abstract

The study included 7931 reviews from the CDSR. The median age of all reviews in the CDSR was 5.3 years. Fifty-five percent were published for the first time between 1996 and February 2015 and 88% of these had been inactive for 5.5 years or more. Among these, 89% were first publication of the review that had never been updated afterward.
 
I have been pondering Cochrane’s latest response to our communication posted on the 2023 Open Letter to Cochrane thread (https://www.s4me.info/threads/s4me-...e-me-cfs-exercise-therapy-review.34973/page-2)

The following response has been received from Cochrane:

Dear Trish Davis and the Committee of Science for ME international forum,

Thank you for your correspondence. We will include the additional points and references to studies in our review of the issues raised by S4ME in previous correspondence. This thorough process will take some time, and we will get back to you about this in due course.

In the short term, some of the questions will be addressed on the Cochrane project website. We will keep you informed of progress.

Kind regards,

Cochrane Support

Yet again it has no one individually identified as a signatory, and yet again it commits to no clearly specified action and no specified time scale. Obviously the intent to ‘review the issues raised’ as part of a ‘thorough process’ is commendable, but what will that process involve and at what level will it be undertaken/overseen? When can we reasonably object if nothing happens? The promise of updating the Project Website ‘in the short term’ remains very vague as to timescale, especially given we were informed some months ago that such update was already imminent.

I have from this no idea whether Cochrane intend to take our concerns and formal complaints seriously or if this represents yet further attempt to avoid the substantive issues by prevarication and delay tactics. What is most worrying is that, though there have been some expression of regret about ongoing delays, as far as I have seen there has been no acknowledgment of the vital importance of addressing the potential/likely significant harms arising from any interventions based on the 2019 Exercise Review either directly from Cochrane or via Hilda Bastian.
 
I think the latest reply from Cochrane is little more than an acknowledgement of receipt of our letter, sent simply because their standard automated response to all emails includes a promise of a reply within 3 weeks, so they had to send something now the 3 weeks are up.

Basically it says there will be updates when they get around to it, and there is no timescale for their investigation into our complaints, but it will be long.

It's shameful. You'd think we were complaining our cup if tea wasn't hot enough or a button fell off our jacket, for all the urgency they are showing.

This is about people's health and lives.

We might as well not have bothered.
 
We might as well not have bothered.
:hug:
I suspect the people at Cochrane wished you hadn't bothered either... because their pathetic non-reponses seem to suggest they actually are very much bothered (and are hoping that by delaying long enough they can make it all go away; looks like this will be a contest of who is going to be the most stubborn)
 
I think the latest reply from Cochrane is little more than an acknowledgement of receipt of our letter, sent simply because their standard automated response to all emails includes a promise of a reply within 3 weeks, so they had to send something now the 3 weeks are up.

Basically it says there will be updates when they get around to it, and there is no timescale for their investigation into our complaints, but it will be long.

It's shameful. You'd think we were complaining our cup if tea wasn't hot enough or a button fell off our jacket, for all the urgency they are showing.

This is about people's health and lives.

We might as well not have bothered.

I wonder, at least in relation to the Project Website, if somethings is happening soon, given Hilda Bastian is holding back at least some comments on her blog awaiting moderation (at least two, @Trish’s for over three week and mine for some two weeks). Normally she is fairly prompt at responding to comments, so wonder if she is expecting an update to the website soon to allow her to give her responses a more positive spin.
 
Thanks @Peter Trewhitt that's even better.

Prevarication definitely. Either way this thread is now evidence of Cochrane's contribution towards causation of harm. This is from something I've already prepared:

1. Human rights (who.int) For those unfamiliar with this, my I introduce you to the Right to Health. The AIDs campaigners had to make themselves very familiar with this among rights. Right on the landing page you will find:

"This means that countries have legal obligations, while acknowledging that time and resources are required to fully achieve them. Some immediate obligations for countries include the guarantees of non-discrimination and equal treatment in health. The right to health includes entitlements, such as the right to control one’s health, informed consent, bodily integrity, and participation in health-related decision-making. It also includes freedoms, like freedom from torture, ill-treatment and harmful practices.​

The right to health is closely related to and dependent on the realization of other human rights, including the rights to life, food, housing, work, education, privacy, access to information, freedom from torture and the freedoms of association, assembly and movement. It includes both non discriminatory access to quality, timely and appropriate health services and systems and to the underlying determinants of health. "​

2. Cumberlege Report "Do No Harm" (2020) From the Recommended actions for Improvement

not make comfortable reading for many who have dedicated their lives with the best of intentions to delivering high-quality and compassionate treatment and care…'Most people do excellent work most of the time in the health service.’

Innovation in medical care has done many wonderful things and saved many lives’. But – and it is a very big but – ‘innovation without comprehensive pre-market testing and post-market surveillance and long-term monitoring of outcomes is, quite simply, dangerous…Without such information it is not possible for doctors and patients to understand risks, and patients cannot make informed choices.".​

3. Montgomery v. Lanarkshire Healthboard 2015 reminded the medical profession of the autonomy of the patient 'consumer' is of primary importance. It makes it very clear that the patient is the decision maker, where there is capacity.

4.
Also from 2021:

Most Cochrane reviews have not been updated for more than 5 years.
Hoffmeyer BD, Andersen MZ, Fonnes S, Rosenberg J

See https://europepmc.org/article/med/34427395
"If these inactive Cochrane reviews are still used to guide treatment and research, it may contribute to the distribution of outdated evidence to other research articles, guidelines and decision-makers (Higgins 2022)"

"It can therefore affect patients negatively if Cochrane reviews are not kept up to date (Murad 2017)"​

The Petition evidences testimony of the level of harm caused. (Literally thousands)

To simplify all this, if this were a card game, it's at this point I'd say something like: I see your maleficence and non-maleficence and raise you with the autonomous patient and the right to health and to life.

Oh by the way, here's a link to a discussion of the Consumer Rights Act 2015 What are my statutory rights, and when do they apply? - Which?

"Everything you buy must conform to the Consumer Rights Act, which says all goods and services must be of satisfactory quality, fit for purpose and as described.

If your goods don’t conform to this, then they are classed as a faulty good and can be returned for a refund, repair or replacement depending on the length of time you’ve owned them for.

This statutory right applies regardless of whether you purchased the goods online or in store.
Everything you buy must conform to the Consumer Rights Act, which says all goods and services must be of satisfactory quality, fit for purpose and as described.

If your goods don’t conform to this, then they are classed as a faulty good and can be returned for a refund, repair or replacement depending on the length of time you’ve owned them for.

This statutory right applies regardless of whether you purchased the goods online or in store."​


That's me done for today. Thanks to the Committee for all your hard work on this. :asleep:
 
Just found a potentially relevant article:

Use of inactive Cochrane reviews in academia: A citation analysis
  • Open access
  • Published: 12 April 2023 Volume 128, pages 2923–2934, (2023)
see https://link.springer.com/article/10.1007/s11192-023-04691-9
Another problem that has long been solved in software development. In most library packaging systems (basically ways to use code written by someone else) there is a versioning system that will throw warnings or errors when using deprecated versions of a library, even sometimes email the authors of a code repository to make sure they know that they are using unsafe or unsupported code.

It's absurd that medical academia is still stuck at the pen and paper level even though they have access to the best tools and resources available. There is an entire freaking industry that has solved most of those problems and they just... don't care? Can't be bothered? Refuse to use tools built by others? It's baffling.
 
Another problem that has long been solved in software development. In most library packaging systems (basically ways to use code written by someone else) there is a versioning system that will throw warnings or errors when using deprecated versions of a library, even sometimes email the authors of a code repository to make sure they know that they are using unsafe or unsupported code.

It's absurd that medical academia is still stuck at the pen and paper level even though they have access to the best tools and resources available. There is an entire freaking industry that has solved most of those problems and they just... don't care? Can't be bothered? Refuse to use tools built by others? It's baffling.
On the other hand it is very useful for those of us who do know code to get instant positive feedback for «amazing» figures and tables just because they are not from Word, excel and other known and standard programs :whistle:
 
On the other hand it is very useful for those of us who do know code to get instant positive feedback for «amazing» figures and tables just because they are not from Word, excel and other known and standard programs :whistle:

To be fair, I got quite a bit for assuming Excel must be able to calculate time, because it'd be ridiculous if it didn't.

"I'd never have thought of scheduling on a spreadsheet!"—former boss, who still hadn't quite got over there not being a typing pool any more.
 
innovation without comprehensive pre-market testing and post-market surveillance and long-term monitoring of outcomes is, quite simply, dangerous…

For example, in another context, the fate of the Titan submersible.
 
We haven't done an update on signatories by country for a while.

We now have signatories from 74 Change.org recognised countries (77 if we count UK as 4 countries), with the addition of 2 signatories from Bangladesh, 1 from Uganda and 1 from Qatar. I note that we have no signatories from Russia or China yet. I know it's quite a niche and complex subject, but I think there are a lot of countries where we could be doing better to get awareness out.

The ten countries with the biggest number of signatories are
UK, Australia, Canada, US, New Zealand, Norway, France, Germany, Netherlands, Sweden

The countries with more than 20 signatories per 1 million of population have the 'per million' number shown in red:
New Zealand, Norway, Isle of Man, Gibraltar, UK, Australia, Sweden, Denmark, Netherlands, Canada

Countries where we have seen substantial increases since the last update are
Australia, Canada, France, New Zealand, UK and USA

Country __ total __ total per million population
Argentina __ 8 __ 0.2
Australia __ 1048 __ 39.6
Austria __ 41 __ 4.6
Azerbaijan __ 1 __ 0.1
Bangladesh __ 2 __ 0.0
Barbados __ 1 __ 3.6
Belgium __ 146 __ 12.5
Belize __ 1 __ 2.4
Bermuda __ 1 __ 15.7
Brazil __ 35 __ 0.2
Bulgaria __ 2 __ 0.3
Canada __ 986 __ 25.4
Colombia __ 3 __ 0.1
Costa Rica __ 1 __ 0.2
Croatia __ 7 __ 1.8
Cyprus __ 3 __ 2.4
Czech Republic __ 5 __ 0.5
Denmark __ 213 __ 36.0
Egypt __ 2 __ 0.0
Estonia __ 2 __ 1.5
Finland __ 32 __ 5.8
France __ 538 __ 8.3
French Polynesia __ 1 __3.3
Germany __ 531 __6.4
Gibraltar __ 2 __ 61.2
Greece __ 7 __ 0.7
Grenada __ 1 __ 7.9
Guadeloupe __ 2 __ 5.1
Guernsey __ 1 __ 15.5
Hong Kong __ 3 __ 0.4
Hungary __ 15 __ 1.48
Iceland __ 2 __ 5.33
India __ 6 __ 0.00
Ireland __ 56 __ 11.1
Isle of Man __ 8 __ 94.4
Israel __ 63 __ 6.9
Italy __ 64 __ 1.1
Japan __ 2 __ 0.0
Jersey __ 2 __ 19.4
Kenya __ 1 __ 0.0
Latvia __ 1 __ 0.5
Lithuania __ 1 __ 0.4
Luxembourg __ 4 __ 6.1
Malaysia __ 2 __ 0.1
Mexico __ 10 __ 0.1
Montenegro __ 2 __ 3.2
Morocco __ 1 __ 0.0
Netherlands __ 500 __ 28.4
New Zealand __ 736 __ 140.8
Norway __ 564 __ 103.0

Palestine __ 1 __ 0.2
Philippines __ 2 __ 0.0
Poland __ 13 __ 0.3
Portugal __ 9 __0.9
Qatar __ 1 __ 0.4
Réunion __ 1 __ 1.0
Saudi Arabia __ 2 __ 0.1
Senegal __ 1 __ 0.1
Serbia __ 4 __ 0.6
Singapore __ 1 __ 0.2
Slovakia __ 1 __ 0.2
Slovenia __ 3 __ 1.4
South Africa __ 18 __ 0.3
South Korea __ 1 __ 0.0
Spain __ 102 __ 2.2
St. Vincent & Grenadines __ 1 __ 9.9
Sweden __ 397 __ 37.4
Switzerland __ 124 __ 14.1
Thailand __ 1 __ 0.0
Trinidad & Tobago __ 3 __ 2.0
Turkey __ 2 __ 0.0
Uganda __ 1 __ 0.0
UK __ 3290 __ 48.6
US __ 981 __ 2.9

Total: 10626
 
Cochrane updates

Since Cochrane has not posted any update from Hilda and the IAG or anyone else this year, here's my update on what we're still waiting to hear from them.

All the 5 updates, 3 in mid 2021 and 2 in late 2023, are listed and linked here
Stakeholder engagement in high-profile reviews pilot
It includes FAQ's last updated on 10th November 2023

The two updates from the IAG in late 2023 were posted by Cochrane on
10th November 2023
20th December 2023

My update today:

1. Resumption of monthly updates
From the November 2023 update:
Now that reporting has resumed, we are planning on reporting regularly – usually about once a month.
No monthly updates since December 2023

2. New editorial note to be attached to the 2019 review
From the FAQ's November 2023
Can Cochrane do anything else to address concerns while waiting for the update?
Finalising the update of the review will take time. So a new editorial note is being developed to attach to the current, 2019 version, of the review. The note will address some concerns about use of that review by clarifying its limitations and the need for an update.
From the November update
As completing the review will take time, the joint Cochrane/IAG meeting discussed a proposal from a member of the IAG for adding a revised editorial note. Some uses of the Cochrane review do not reflect critical nuance and limitations in its conclusions, and the goal of a note would be to try to reduce such misinterpretation. There was unanimous agreement to this step, and the IAG has begun drafting a proposal for the editors’ consideration.
From the December 2023 update
As discussed in my last report, the editorial note on the current review on exercise and ME/CFS will be revised. The IAG has been considering the practice of editorial notes on Cochrane reviews, and discussing possible contents for the revised editorial note. We have also been discussing potential peer reviewers to recommend to Cochrane.
No news

3. New IAG member Appointment of a doctor who treats pwME to join the IAG
From the December update:
There is one final vacant position on the IAG. A primary consideration in filling this position will be addressing concerns expressed about a perception of bias in the makeup of the IAG.
...
Stakeholder gaps will also be taken into account in this final appointment – in particular, for a medical practitioner working with patients with ME/CFS.

Since this IAG was announced, there have been multiple nominations of potential candidates for the group. If anyone else would like to be considered themselves, or would like to suggest someone else, they could email me at Cochrane.IAG@gmail.com by the end of January 2024.
No news

4. Public consultation on problems with previous reviews written by the IAG to help with the new review

From the November 2023 update
Two consultations are currently planned for this project. The first will be for feedback on a paper summarising the criticisms made of the current and previous versions of the Cochrane review.

That paper on criticisms was prepared early in the project. The first draft was provided to the author team, so that the issues people have raised in the past could inform their discussions about the development of the protocol – the roadmap for how the updated review will be done. The final version of this criticisms paper after the consultation will be part of the public historical record for this review.

The original review has been through some updates. So some of the original critiques will be redundant. However, many of the comments made about the old versions of the review will still be relevant for consideration in the development of the new review. In addition, the consultation will be a test run of our processes for collecting, analysing, and reporting on the feedback we receive.
From the December update:
We also plan to get the IAG’s first consultation underway in the early weeks of the new year. That is a consultation on a paper summarising past critiques of the Cochrane review – see my last report for more details.
No news

5. Update on progress with the draft protocol for the new review, with timetable for public consultation

From the November update
The first draft of the protocol is currently with the Cochrane Editorial Unit, and the editors are planning the next steps for the project. Once they sign off on a protocol, the IAG will be reviewing it. Then it will go to peer reviewers, some of whom will be proposed by the IAG. Responses to peer review will also be considered by the IAG.

It will be the version after all that review that will be released as a preprint. We will use our experience with the first consultation to seek, analyse, and report on feedback to the protocol. The consultation period is currently planned to be six weeks after the preprint of the protocol is released. Providing written comments won’t be the only mechanism for discussing the protocol, and we’ll let you know about other opportunities.
No news

6. Results of complaints submitted to Cochrane from S4ME, and possibly others
From the December 2023 update:
Complaints and communication
As a result of the complex internal restructuring Cochrane began in 2021, the organisation had a new communications team. Early in December I asked for a meeting with the people involved with managing complaints, to discuss issues with recent complaints and how responsiveness could be improved.

Complaints and questions are being sent to multiple individuals and addresses across Cochrane and the IAG, so coordination is critical to ensure that issues and concerns don’t fall through the cracks. Our meeting was very useful for clarifying our respective roles and expectations.

We agreed on pathways for referring complaints, along with continuing liaison. This should improve responsiveness in future. The Cochrane team had been working on several system improvements for some time, too, so there will be more to report on this soon.
No news

7. Timetable for production of the new review

From the December 2023 update:
The revised editorial structure to support this review has taken shape. I expect details will be finalised by my next report, including a preliminary timetable.
No news.
 
Cochrane updates

Since Cochrane has not posted any update from Hilda and the IAG or anyone else this year, here's my update on what we're still waiting to hear from them.

All the 5 updates, 3 in mid 2021 and 2 in late 2023, are listed and linked here
Stakeholder engagement in high-profile reviews pilot
It includes FAQ's last updated on 10th November 2023

The two updates from the IAG in late 2023 were posted by Cochrane on
10th November 2023
20th December 2023

My update today:

1. Resumption of monthly updates
From the November 2023 update:

No monthly updates since December 2023

2. New editorial note to be attached to the 2019 review
From the FAQ's November 2023

From the November update

From the December 2023 update

No news

3. New IAG member Appointment of a doctor who treats pwME to join the IAG
From the December update:

No news

4. Public consultation on problems with previous reviews written by the IAG to help with the new review

From the November 2023 update

From the December update:

No news

5. Update on progress with the draft protocol for the new review, with timetable for public consultation

From the November update

No news

6. Results of complaints submitted to Cochrane from S4ME, and possibly others
From the December 2023 update:

No news

7. Timetable for production of the new review

From the December 2023 update:

No news.
The thing is all this makes even me confused to remember the original date they got sent the petition

it would be good to have ‘what anniversary it is’ of that date in particular (eg six months, 7 months and so on) added to eg any things we might circulate to remind people / highlight exactly how long they’ve been playing the blanking game for (yes after having played that game before that leading to said petition)
 
As well as including the petition submission date as suggested by @bobbler, is it relevant to record here the promise made by Cochrane to us to overhaul their complaints process, after much prevarication in response to our questions and then formal complaints, and their stated intent to investigate aspects of our complaints on an unspecified time scale.

Though they did not specify which aspects would be covered, there was, if I remember correctly, intimation that the now overdue update to their website would address some of our issues.

At best Cochrane are incompetent and totally immune to embarrassment and at worse this ongoing prevarication is a deliberate attempt to retain their deeply flawed and harmful Exercise Review in the literature as long as possible.
 
I don't think it's just incompetence, I think Cochrane's leaders have been persuaded to stall this new review process indefinitely and keep the 2019 review.

The fact that the current editor in chief published the 2019 review demonstrates a lack of understanding of evidence. The fact that she continues to ignore our letters and petition and the evidence we and others have provided to Cochrane about harms indicates to me a greater concern for keeping her colleagues like Garmer and Glasziou happy than for the welfare of pwME.

And if we ever get a new review, I think we will be disappointed. I wouldn’t be surprised if the whole process was closed down, and we and others who have made complaints will be cast publicly as to blame on the grounds of creating work for overstretched editors. Though we have no evidence that the editor in chief has even read any of our letters.
 
And if we ever get a new review, I think we will be disappointed.

Certainly, I have no faith that the current Cochrane set up is capable of producing an objective account of e exercise in relation to ME/CFS.

At present any process looking at exercise intervention in relation ME/CFS is a waste of time. The current evidence base in relation to any activity based intervention is deeply flawed and is not worth any further examination, beyond the existing NICE guidelines evidence review. The evidence of harm is such that the only medically sane advice is that any attempt at using activity/exercise as a treatment for ME/CFS is contra indicated and unethical.

There is potentially new research that could be done trying to distinguish between the few that spontaneously improve and can increase their activity levels and the majority who do not. Also we need better understanding of how activity levels trigger PEM. But there is no existing evidence worth the effort of a Cochrane review.
 
I agree there is no useful evidence of efficacy for GET in ME/CFS. However, as has been demonstrated time after time by surveys, there is credible evidence of serious harm.

Cochrane reviews, according to their own handbook for reviewers, are supposed to include harms evidence investigation.

The protocol for the old reviews includes harms.

So a valid review on the old protocol should have concluded that the evidence for GET is very weak, and far outweighed by the evidence of harm. And therefore that exercise therapy should not be offered to people with ME/CFS.

If Cochrane editors had the courage to stand up to the psychosomatic supporters among them, they could have done that long ago. The evidence was all there if they bothered to look.

A Cochrane review that stated categorically that GET is harmful, and that there is no evidence supporting the claims that specialist therapists can do GET safely, would be very helpful.
 
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