Cochrane Exercise Review Withdrawn - Individual Patient Data

large donner said:
What is the current state of play over this so called withdrawn review that doesn't appear to be withdrawn.

Last we heard Cochrane were giving Larun yet another chance to rewrite the review or were they? No one really knows.

Almost two months later and we still have no progress. No statement from Cochrane no new review from Larun and yet no retraction.
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Yes, the lack of communication is quite disappointing.
 
While we wait, a comment by Larun about the individual patient data review - on an article by Helmfrid og Edsberg, in 2017. (google english - swedish)

Now gone - withdrawn before publishment by the editorial group: "This protocol has been withdrawn and it is no longer being progressed to a Cochrane review." ;)

Have there been any comment by her, or others of the authors, about this?


New overview on the way
2017-09-28 13:43

As the author of the Cochrane review criticized in the article above, we have been offered the opportunity to comment on the criticism in Läkartidningen. The arguments against our overview taken up in Läkartidningen are well known. We have previously responded to most in the debate department that accompanies our overview. We have also tried to argue against the criticism in more open forums, but have very bad experiences with this strategy.

A new Cochrane review based on individual patient data is published within a few months. In this, we will take into account the criticism and show the consequences of different methods of analysis. In view of our previous experience of public debates, we do not see ourselves served by participating in them before the IPD overview is published.

For the authors of the overview:

Lillebeth Larun, reseacher / assistant professor, Norwegian Institute of Public Health, Division for health services Nydalen, Oslo
 
We have also tried to argue against the criticism in more open forums, but have very bad experiences with this strategy.
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In view of our previous experience of public debates, we do not see ourselves served by participating in them before the IPD overview is published.
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So because they've been unable to defend their work they've consciously adopted a policy of avoiding debate?

How is this mentality seen as acceptable?
 
I missed @Caroline Struthers' comment from 2018 and Larun's response to that protocol. Seems that a link hasn't been posted yet?

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011040.pub2/read-comments

In October 2016 a FOI request was submitted to Queen Mary University London QMUL for additional data from the PACE trial which was an included study in the previous Cochrane Review on Exercise for CFS. (http://www.cochrane.org/CD003200/DEPRESSN_exercise‐treatment‐patients‐chronic‐fatigue‐syndrome). The PI of the PACE trial is now a co‐author on this IPD review.

The freedom of information request was rejected in November 2016 citing an exemption in the law that covers data which is part of ongoing research or scheduled to be included in future publications. Does this refer to the future publication of this review and the previous review update?

An internal appeal to QMUL was rejected, and the complainant appealed to the Information Commissioners Office (ICO) in March 2017. In the interim, the PI of the PACE trial retired from QMUL.

During this time, QMUL changed its rationale for not providing the data saying that they were not available because the PI had gone and they are not required to hire staff to access data in response to FOI requests.

The PI of the PACE Trial is both an author of the Cochrane review and the PI of the PACE trial. So he should be able to provide all the data needed for the new review. However, QMUL told the ICO that they are the holder and owner of the raw data and have lost the means to locate and extract it because that requires specialist knowledge. I would argue that the patients that gave their time and bodies to participate in the trial, and the people who paid taxes to fund the research are the owners of the data, and to deny access to them is unethical.

Does this mean the Cochrane reviewers will also be unable to access all the raw data from the PACE trial despite the PI being on the author team?
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L. Larun:
Your comment includes two specific questions in relation to availability of data from the PACE trial.

Your first question relates to the correspondence between QMUL and ICO, in which QMUL has cited an exemption in the law, which covers data in ongoing research or future publications. The authors of the Cochrane review have, however, not been involved in the correspondence between QMUL and ICO, and we have no knowledge of what QMUL has referred to in their response.

Your second question relates to the data availability for the Cochrane reviewers in relation to the data from the PACE trial. We can confirm that the Cochrane reviewers will have access to sufficient PACE trial data to perform the review in accordance with the Cochrane protocol (with it’s appendices).

In addition, your comment contains certain statements relating to the FOI request submitted to QMUL, and their responses on the current availability of raw data from the PACE trial. The Cochrane reviewers have no knowledge of these matters, and can neither confirm nor reject the statements made in your comment. If someone submits a request for data related to this Cochrane review, it should however be noted, that the reviewers have a duty of confidentiality on terms equal to those outlined in Appendix 4 in the protocol.
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Also, someone reminded me of the remarkable fact that the protocol was co-authored by, among others, some PACE PI and Paul Glasziou, one of the big figures at Cochrane and co-author of the Cochrane Handbook for Systematic Reviews of Interventions:

https://methods.cochrane.org/gradeing/resources
 
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From Flottorp's et al Lancet comment on the new NICE guideline:

Medfeb said:
This comment's author disclosure states:
  • KGB reports "he is currently involved in the work with a review based on individual patient data that is about CFS/ME and exercise therapy.
  • HK reports he "is currently preparing a review based on individual patient data of the outcomes of CBT for CFS/ME"
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Medfeb said:
Does anyone know what that's about? I knew there had been a review of individual patient data a few years ago but thought that had stopped. Is it still ongoing? And are there two different ones?
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Edit:
KGB = Kjetil G Brurberg
HK = Hans Knoop
 
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There's nothing added on the withdrawn protocol's page indicating a planned update.

But this was only on exercise, not on CBT. So there seem to be two reviews in the making, but not sure if they're still being edited by Cochrane.

However, I realized only now that Knoop is also a Cochrane author. I found two reviews co-authored by him:


Severe fatigue after treatment for childhood cancer (Cochrane Review), 2020
Sylvia van Deuren, Amilie Boonstra, Eline van Dulmen‐den Broeder, Nicole Blijlevens, Hans Knoop, Jacqueline Loonen

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012681.pub2/full


Psychosocial interventions for fatigue during cancer treatment with palliative intent (Cochrane Review), 2017
Hanneke Poort, Marlies Peters, Gijs Bleijenberg, Marieke FM Gielissen, Martine Margaretha Goedendorp, Paul Jacobsen, Stans Verhagen, Hans Knoop

https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012030.pub2/full

Forum thread here.
 
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I'm a little confused as to what the status is now?

The IPD review has recently been cited in the JNNP Anomalies paper in the last paragraph as thus:

The forthcoming individual patient data meta-analysis of exercise therapy trials for CFS/ME is a further step in the right direction.45

45 Larun L, Odgaard-Jensen J, Brurberg KG, et al. Exercise therapy for chronic fatigue syndrome (individual patient data).
PROSPERO 2018:CRD42018107473.
Available: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018107473
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So they seem to have a new protocol, but what does this actually mean in practice?

They also link to the Cochrane statement here: https://www.crd.york.ac.uk/PROSPEROFILES/107473_PROTOCOL_20211031.pdf

The main outcome measures are FS and FSS - but is FS (fatigue scale) Chalder's FS (CFQ), or something else? I mean, it has to be, doesn't it?
What has happened to all the evidence we sent in about the CFQ to the Cochrane IAG? Was it just thrown into a big black hole?
 
The forthcoming individual patient data meta-analysis of exercise therapy trials for CFS/ME is a further step in the right direction.45

45 Larun L, Odgaard-Jensen J, Brurberg KG, et al. Exercise therapy for chronic fatigue syndrome (individual patient data).
PROSPERO 2018:CRD42018107473.
Available: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018107473
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According to that page, they have only completed the preliminary searches.
 
It looks like the objection to the now withdrawn protocol was at least in part because the team doing it included White, Sharpe, Chalder, Weardon etc. ie people whose research was to be reviewed.

It seems that the Norwegian trio, Larun, Brurberg and Kristoffersen are now the author team for the new review and the have started work on it. The date of update is August 2022 and it says it's ongoing.
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=107473&VersionID=1771625
 
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