Denmark is wanting to buy California.
I'm all in!!!
Denmark is wanting to buy California.
"...
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic. This included those used in the UK National Institute for Health and Care Excellence (NICE)guidelines, the German Institute for Quality and Efficiency in Health Care (IQWiG) evidence review, and an updated systematic review prepared by the Center for Disease Control (CDC) in the USA.
Cochrane's response to the 2023 complaint said the following:
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic.
Has anybody looked at that document and what it says about harms? If so, would you mind sharing what you found?
Evidence in support of withdrawal
1. Withdrawal of the review is in line with Cochrane's editorial policy
Cochrane Reviews are withdrawn when serious issues with conduct or reporting are identified. The 2019 review meets the conditions for withdrawal of the review on the grounds, both that there are "factual errors in describing one or more included studies that risk misinforming implementation or investment decisions about an intervention" and that "Following the conclusions of the published review could result in harm to patients or populations of interest (other than known adverse effects)."
(Cochrane's editorial policy: Withdrawal of published articles)
2. Cochrane's guidance to reviewers has not been followed
The 2019 review places adverse events in a key position as one of two primary outcomes. However, the reviewers made the narrowest possible interpretation of this, including only data from one trial. This is contrary to the Cochrane handbook which specifies a more detailed analysis of adverse effects in cases such as this where the potential for harm has a major influence on treatment and policy decisions. In such cases it is expected that a bespoke search process will be undertaken that includes a wider selection of sources than that required to identify data on beneficial outcomes. (Cochrane Handbook for reviewers Chapter 19 - Adverse events)
my boldingKey Points:
- To achieve a balanced perspective, all reviews should try to consider adverse aspects of interventions.
- A detailed analysis of adverse effects is particularly relevant when evidence on the potential for harm has a major influence on treatment or policy decisions.
- There are major challenges in specifying relevant outcomes and study designs for systematic reviews evaluating adverse effects. This is due to high diversity in the number and type of possible adverse effects, as well as variation in their definition, methods of ascertainment, incidence and time-course.
- Review authors should pre-specify their approach to reviewing studies of adverse effects within the review protocol. The approach may be confirmatory (focused on particular adverse effects of interest), exploratory (opportunistic capture of any adverse effects that happen to be reported), or a hybrid (combination of both).
- Depending on the approach used and outcomes of interest to the review, identification of relevant adverse effects data may require a bespoke search process that includes a wider selection of sources than that required to identify data on beneficial outcomes.
- Because adverse effects data are often handled with less rigour than the primary beneficial outcomes of a study, review authors must recognize the possibility of poor case definition, inadequate monitoring and incomplete reporting when synthesizing data.
Cochrane’s assessments took account of the current guidance on harms from the Cochrane Handbook for Systematic Reviews of Interventions, Cochrane’s policy on withdrawal from the Cochrane Database of Systematic Reviews, and external quantitative and qualitative evidence syntheses on the topic. This included those used in the UK National Institute for Health and Care Excellence (NICE)guidelines, the German Institute for Quality and Efficiency in Health Care (IQWiG) evidence review, and an updated systematic review prepared by the Center for Disease Control (CDC) in the USA.
The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal. This process took several months to conclude, and we apologise for the delay in updating you on the status of your complaint.
We're currently preparing an appeal against this decision and the lack of information in the letter telling us the outcome.As well as not actually responding to any of our complaints, not even indicating any understanding of them, they do not actually give any actual reasons for rejecting withdrawal of Larun et al. They do give a list of documents that supposedly informed their decision making but provide no evidence that they actually looked at any of them.
Unfortunately their lack of any concrete detail means we have to look at all these documents in detail to counter their un argued assertion.
We're currently preparing an appeal against this decision and the lack of information in the letter telling us the outcome.
In my limited experience, if you actually work this way (informed reasoning), it’s pretty difficult to write such a lackluster response. Mostly because you’d have to make up new reasons instead of just writing down the ones you’ve already used.It is theoretically possible that they reached an informed reasoned conclusion based on actual evidence, but they have singularly failed to communicate that.
In my limited experience, if you actually work this way (informed reasoning), it’s pretty difficult to write such a lackluster response. Mostly because you’d have to make up new reasons instead of just writing down the ones you’ve already used.
That’s what they care about. Which is why their actions make perfect sense to me. That’s not to say that I agree with them.It may make life easier for individuals at Cochrane
I quoted from these in our letter to Cochrane about harms in March 2024:
https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-2#post-521800
This is the key points from the chapter in adverse events linked in the above quote
Excellent appeal. Especially this point.We note that we have been told that the time scale for appeals is the same or longer than that for complaints. Since we are still waiting for answers on some complaints over a year old, we do not consider it appropriate to wait for the response to this appeal before escalating our complaints to other bodies.
This is all just brilliantI have now submitted an appeal to Cochrane to the decision we received on 14th February 2024.
The decision refers to our complaint submitted on 26th January 2025 which was about the lack of response to our letters and complaints dating back to October 2023 and March 2024.
Formal appeal to decision regarding complaint #COMP00192844
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Appeal part 1: Complaints submitted 30th October 2023.
We submitted a set of 5 complaints to Cochrane on 30th October 2023, listed and linked in #COMP00192844.
As we outlined in #COMP00192844, there followed over a year of attempts on our part to find out whether any of the complaints were considered, if so which ones, and the outcomes.
We received a brief outcome letter on 14th February 2025.
We assume the first part of this letter refers to these five 2023 complaints:
"We acknowledge that our previous approach to managing complaints in Cochrane led to delays and, in the case of your complaints, frustration on your part. We apologise for this and recognise that our previous process could be difficult to navigate, which is why we overhauled our complaints process last year."
In this appeal we are asking you to provide us with answers to questions we have been asking for over a year and which the outcome letter fails to address.
Appeal 1a.
We appeal the decision not to inform us which of the complaints submitted in October 2023 were investigated, why were some not investigated, and what were the outcomes of each complaint.
To be clear, we ask that you provide a specific response for each complaint with enough detail for us to understand why no action is being taken.
Appeal 1b.
We appeal the decision, unstated, but from recent actions clearly made, to renege on editors' promises to address critical comments about the review in the Cochrane Library, including that by Michiel Tack in 2020 that we highlighted in October 2023 (Complaint B).
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Appeal part 2: Appeal of decision not to withdraw the review on the grounds of harm.
As we outlined in #COMP00192844 submitted on 26th January 2025, we provided Cochrane with detailed evidence on harms from exercise therapy for ME/CFS in March 2024. We explained why we consider that there is sufficient evidence that Larun et al had not fulfilled Cochrane's guidance on searching for wider sources of harms evidence. We explained why we consider that the level of evidence meets Cochrane's policy on withdrawal of reviews on the grounds of harms.
Combining the harms evidence with the critiques that show any beneficial effects to be minimal and such findings to be uncertain and unsound, and evidence evaluations such as that of NICE, we cannot understand why the investigation reached the outcome stated in your letter of 14th February 2025.
"The outcome of this assessment was that no grounds for withdrawal could be established by any of the requests for withdrawal."
We find this evident lack of understanding of the degree and scale of harms experienced by people with ME/CFS shocking.
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Appeal 2a Lack of explanation
We appeal the decision to provide no explanation of the decision not to withdraw the review. We do not consider it appropriate for a body that regards itself as the gold standard in reviews to simply dismiss without explanation serious criticisms of a review that continues to be used to promote ineffective and harmful treatments. We ask you to provide us with more detail of what led to the decision. Specifically we ask for a copy of any report produced by those who carried out the investigation, and minutes of any meetings at which the decision was made.
Appeal 2b Lack of ownership of decisions
As a professional body employing experts to review scientific materials, we would expect those involved to put their names to their work, just as authors of Cochrane reviews and those whose comments on reviews you publish are expected to sign their work. We do not consider it acceptable for a professional body making decisions affecting people's health to do so anonymously.
An unsigned letter is not an appropriate way to deliver the outcome of investigation of a complaint, especially in circumstances where we have alerted you to the conflicts of interests of advisors to the review.
Please provide us with the names and roles in the organisation of the individuals who contributed to, influenced and signed off on this decision.
Appeals 2c Lack of impartiality
Since we have not been provided with the names or views of those who made this decision, we are left assuming bias. We have already highlighted the inappropriate involvement of two people credited as advisors to the review who have professional and financial conflicts of interest. We are not reassured that others in the Cochrane organisation are able to approach this subject impartially. We therefore appeal the decision on the grounds of lack of impartiality.
We ask that impartial reviewers acceptable to S4ME be appointed to review the decision on withdrawal.
__________________
We note that we have been told that the time scale for appeals is the same or longer than that for complaints. Since we are still waiting for answers on some complaints over a year old, we do not consider it appropriate to wait for the response to this appeal before escalating our complaints to other bodies.
Signed, Trish Davis on behalf of the committee of the Science for ME international forum.
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https://www.s4me.info/threads/s4me-...rcise-therapy-review.34973/page-3#post-582680
anti-effort-preference champion
Wouldn’t Trish be an anti-effort-champion if we go by Parker’s logic?