Trial By Error: Some Good News on Cochrane

By David Tuller, DrPH

In what can only be characterized as a welcome surprise, Cochrane has rejected the revision of a 2014 review of exercise treatments for chronic fatigue syndrome, stating that the work does not meet the organization’s “quality standards.” Cochrane revealed the decision late Friday in a statement appended to the review, which itself was a revision of a review first published years earlier.

That review reported that exercise therapy, most often graded exercise therapy, was effective. Yet the review was a methodological mess. Two patients–Tom Kindlon and the late Robert Courtney—wrote extensive and cogent critiques after it was published. When the lead author of the review provided inadequate responses, Courtney filed a formal complaint with Cochrane.

Cochrane found merit in the complaint and had recently given the authors a chance to revise their work accordingly. This was the revision that Cochrane has now deemed unsatisfactory.

Why did Cochrane’s announcement surprise me? I had assumed the revision would be unsatisfactory. But Cochrane had initially decided to withdraw the review pending these revisions, and had backed down from doing so under what must have been enormous pressure from the CBT/GET ideological brigades and their defenders. So the review has not been withdrawn during this revision process.

Given that early retreat on Cochrane’s part, I was concerned the editorial team would require the authors to make only a few tweaks but no substantive changes to the review. Luckily, I was wrong. Here’s the statement Cochrane posted on Friday:

“The author team has re‐submitted a revised version of this review following the complaint by Robert Courtney. The Editor in Chief and colleagues recognise that the author team has sought to address the criticisms made by Mr Courtney but judge that further work is needed to ensure that the review meets the quality standards required, and as a result have not approved publication of the re‐submission. The review is also substantially out of date and in need of updating. 

Cochrane recognises the importance of this review and is committed to providing a high quality review that reflects the best current evidence to inform decisions. 

The Editor in Chief is currently holding discussions with colleagues and the author team to determine a series of steps that will lead to a full update of this review. These discussions will be concluded as soon as possible.”

The suggestion that the review is out of date is interesting. This could be referring to the fact that raw PACE trial data were released two years ago, and there are now published reanalyses of the findings. Perhaps Cochrane recognizes that these reanalyses, which refute the positive results reported by the PACE team, would need to be included in any credible “full update.”

The Cochrane statement does leave some questions unanswered. Given that a revision was deemed necessary in the first place, the current published version is obviously unsatisfactory as is. Will this published but unsatisfactory version be withdrawn? If not, why not? If so, when?

Moreover, the Cochrane statement seems conveniently ambiguous on a key point. Will the authors of the current review be asked to develop the “full update” themselves or will they just be participating in discussions of what steps should be taken going forward? Until given reason to think otherwise, I will interpret that ambiguity as deliberate and therefore as a positive sign.

Perhaps this is the moment when all, including the authors, will agree that the time has come to remove this illness from the Common Mental Disorders group. In conjunction with that, perhaps all will agree as well to withdraw the reviews conducted under the auspices of this group—the exercise review as well as an older review of cognitive behavior therapy for the illness.

In fact, the response to a comment posted on the review in October suggests that transferring the illness elsewhere could be a real possibility. A reader raised once again the concern about the illness being housed within the Common Mental Disorders group, citing the 2015 report from the Institute of Medicine and the WHO’s categorization of it as neurological. Cochrane’s response was not from the lead author of the review but from two representatives of the Common Mental Disorders group itself. Here’s part of what they wrote:

“In response to concerns raised by members of the CFS/ME community, Cochrane has been considering repositioning the editorial oversight of CFS/ME reviews. The Cochrane CMD Review Group currently sits within the Brain, Nerves and Mind (BNM) Network. In the future, reviews on this topic might sit with another Cochrane Review Group within the BNM Network, or they might transfer to another Network altogether…Please be reassured that this is currently under consideration and a decision is anticipated before the end of 2018.”

Given the source, perhaps this response is a signal that the Common Mental Health Disorders group has agreed to a collegial and imminent hand-off of responsibilities and that an acceptable biomedical home will be found for ME/CFS. That would indeed be an excellent development.

{ 16 comments… add one }
  • PACE Inspector 3 December 2018, 3:04 pm

    Thank you so much for this!

  • Erik Johnson 3 December 2018, 3:07 pm

    Could this be the beginning of restoration to common sense and sanity
    in the medical profession?
    Here is how we will know if that ever happens.
    It is when some brilliant mind finally thinks to ask,
    “How and where did this CFS syndrome begin, and why was it coined?”

    http://articles.latimes.com/1986-06-07/news/mn-9956_1_lake-tahoe
    ———————————————————————————-
    160 Victims at Lake Tahoe : Chronic Flu-Like Illness a Medical Mystery Story
    June 07, 1986|ROBERT STEINBROOK | Times Medical Writer

    INCLINE VILLAGE, Nev. — Sandy Schmidt, 42, came down with the mysterious illness soon after she ran a marathon in San Francisco last July. She got better before becoming sick again this spring, forcing her to quit her job as a business office manager. Running even one mile now would “put me in bed for a day and a half,” she said.

    Schmidt is among 160 residents of Lake Tahoe’s North Shore who have been diagnosed by two local physicians since the winter of 1985 as having a chronic flu-like illness in a medical puzzle that has assumed national proportions.

  • Anton Mayer 3 December 2018, 3:35 pm

    The only satisfactory response by Cochrane is to retract the review.

    Studies that encourage patients to take on a positive view of their symptoms and then assess the effectiveness of the intervention by measuring whether patients have a more positive view of their symptoms are worthless. Not to mention that CBT/GET studies fail to control for nonspecific effects. They also claim the treatment is safe but patients consistently report adverse effects in surveys.

    Cochrane must put the well being of patients before the careers of researchers.

  • Paul Fox 3 December 2018, 4:56 pm

    A positive move? Well, perhaps, but I won’t hold my breath. It seems more likely that this is a time-buy while time is spent working out what move best suits the vested interest. As Anton Mayer says, the only satisfactory action is to retract the review. Cochrane already know that, yet they choose to swathe the issue in more cotton wool.

  • Lisa 3 December 2018, 6:34 pm

    Anton Mayer’s cogent summary of the BPS studies, “that encourage patients to take on a positive view of their symptoms and then assess the effectiveness of the intervention by measuring whether patients have a more positive view of their symptoms,” reminds me of an acronym beloved by a high school coach. P.A.C.E. — positive attitudes change everything! No, they don’t and scientists should know better. Thanks, as always, for your work, David.

  • Seven 3 December 2018, 6:55 pm

    A good step, but I agree a total retraction is needed and definitely move it to the neuroimmune group ( and if they do not have one, should open one).

  • Margaret Laverick 3 December 2018, 7:16 pm

    Thank you, great to get some positive news, life is hard for the ME community, thank you, thank you

  • konijn 3 December 2018, 7:25 pm

    In Belgium they dis several years ago in flemisch universital hospitals an evaluation on the effectivniss of CBT and GET. Ofcourse there results failed. But since then, nothing has changed. It is here al CBT and GET or psychiatry allthough now even some psychiatry hospitals even do not want us also anymore. But the minister off health has changed nothing. And research is really almost zero and bad. I am severelly ill, bedridden for 98% and or a homefysician does not believe in cfs or they tell you that they will fix it. How, probebly CBT and GET and taking all the medication away (symptom medication for sleep). Allthough it is in the US and UK not good, in Belgium it is horrible! Acces to help services are denied because you have to go to a psychologist. If I could go outside the door, I had better things to do then that. I wished I lived in an other country. Where there is at least some real research, some awareness. Here they are all indoctrinated and the minister of health does not listen.

  • Incognito 3 December 2018, 8:39 pm

    Thanks for the latest excellent summary but please don’t interpret Cochrane’s ambiguity as positive. You’ve used the word perhaps – it’s with hope, I know, I can feel it but it’s giving false hopes to the masses who read your blog. If Cochrane had any integrity they’d be transparent. I have extensive experience with Cochrane and the way their autocratic editors behave. Their ambiguity is clandestine – and serves to protect their own interests. Stalling and time wasting on important decisions is a tactic to break your morale and your spirit when they can’t accept they’re in the wrong. It’s an abuse of power. I have no axe to grind, but my opinion through experience is that this organisation are clandestine, slow, and inept. How does a review this important get through editorial and peer review with the completely wrong risk of bias assessments applied to the PACE trial?

    Cochrane are also not collaborative, and good collaboration is required for accurate work. They’re not about patients and they’re worse than a corporation. At least corporations have ‘corporate responsibility’. Cochrane shouldn’t be giving the author’s four chances to correct the review. The review is not even required in the public domain is it? There’s already other reviews now published on the same topic. If they really need to get it corrected, they should give it to an independent team to carry out. The whole review really just needs to be withdrawn. It’s a total misuse of funds to be carrying on. But Cochrane knows it will lose face if they withdraw it, even though authors themselves withdraw protocols and reviews from Cochrane all the time. With this review, total retraction is all that is required, oh and an apology to patients. This review poses a real danger to the evidence based medicine fraternity. I hope I am wrong but I really feel this battle will go on for a long time. I really hope they’ll do the right thing and retract it.

  • Graham McPhee 3 December 2018, 9:08 pm

    If only Bob were here now to see how effective his analysis turned out to be.

  • Mike Dean 4 December 2018, 4:24 am

    @Lisa
    With “P.A.C.E. — positive attitudes change everything!” you’ve just revealed the origin of the PACE trial’s title. They needed a bit of work to get there starting with Pacing, GET, CBT and RCT, but hey, “Pacing, graded Activity, and Cognitive behaviour therapy; a randomised Evaluation” is near enough.

  • Gijs 4 December 2018, 6:42 am

    How naive can you be. Cochrane has no intention of withdrawing this article.
    It is a political game a tactical chess game not to suffer face loss.

  • Clyde 4 December 2018, 1:16 pm

    Considering ME/CFS is an immune mediated disease according to virtually all non fraudulent evidence it would seem thats what it should be classified as (as it is elsewhere that recognizes scientific evidence).

  • Justin Reilly 5 December 2018, 9:53 pm

    So they are attaching a statement that both the current “ME/CFS” review and the update submitted are out-of-date and do not meet Cochrane standards, they are refusing publication of the resubmission on these bases, yet they have not retracted or even temporarily withdrawn the original review?!!

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