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Trial By Error: COPE to BMJ Open: More Details, Please!

Discussion in 'General ME/CFS News' started by Kalliope, Jan 3, 2018.

  1. Kalliope

    Kalliope Senior Member (Voting Rights)

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    Another blog post from David Tuller

    Trial By Error: COPE to BMJ Open: More Details, Please!

    - To sum up: The activities in the school absence study do not qualify as “service evaluation” by any standard. As this response from the COPE forum makes clear, the investigators should not have exempted the study from ethical review. Readers of the paper can see that for themselves. The editors at BMJ Open know it as well. Their efforts to pretend otherwise are unconvincing and will continue to damage the journal’s reputation.
     
    sea, Indigophoton, Inara and 23 others like this.
  2. Valentijn

    Valentijn Guest

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    My comment on the blog:

    This is really the crux: "The COPE forum has asked the journal editors to clarify the methodology
    used for the paper. Have they done that yet? All it would require is a review of the BMJ Open paper itself, which describes clearly how Professor Crawley and her team found those identified through the pilot intervention."

    Claiming that the 2007 ethics waiver somehow applies to trialing a new recruitment method really doesn't make sense unless the people involved didn't read the new recruitment method research and/or the application which resulted in an ethical waiver in 2007. The waiver very explicitly does not apply to anything except adding evaluation time points at 6 weeks and 6 months for an existing clinical service which already evaluated the same measures at other time points.

    The new research, on the other hand, is not about adding evaluations at 6 weeks and 6 months. It's about trawling through school absence records, contacting families of absentee children, and attempting to diagnose them to recruit them to the clinic. This is a completely different approach from usual recruitment practices for the clinic, and has numerous serious ethical implications, such as pressuring children and parents to cooperate with dodgy treatments out of fear of authorities taking action against non-compliant families.

    Presumably the BMJ has read the article which it published, and they're just talking crap. COPE needs to read both the 2007 waiver and the new research paper itself, and it will be blatantly obvious that the two documents have nothing to do with each other. COPE then needs to determine for itself that no other ethical oversight was involved with the new research paper, and let the BMJ know that these sorts of shenanigans are not acceptable. But mainly, COPE needs to read the documentation itself instead of trusting the BMJ - COPE's existence seems pretty pointless if they just believe what they're told by the "right" people.
     
    Indigophoton, Inara, Binkie4 and 28 others like this.
  3. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    When I was first aware that there were questions over the ethical oversight of Crawley's school absence study, I thought it was perhaps a purely technical point relating to probable woolly thinking and incompetence of Crawley's part, that it was only significant because of her and Bristol's subsequent attempts at a cover up.

    However the more Tuller and others analyse what happened the more worrying issues it raises. Crawley's failure to adequately address the issue of whether ethical aproval was or was not required means there was never any documented consideration of a number of complex ethical issues
    - given Crawley did not regard this as research what consents did she obtain prior to the process for use of individuals' data? As it is clearly a research project and not a service evaluation did she have consent of the participants to publish the results in a research paper?
    - is it acceptable to screen low school attenders for chronic fatigue, knowing a significant proportion will not have it? Is this effectively an unnecessary medical intervention and what are the implications of this?
    - can people give meaningful consent to participate in this screening process when parents/guardians may have reasonable fear of legal repercussions from the low school attendence? (This was further confused by the participation of both Crawley and the school attendence officer in the screening meeting.)
    - given it is unclear that participants were informed about whether or not any differential diagnosis would take place to distinguish between CFS/ME and other causes of chronic fatigue, were participants in a position to give informed consent for referral to Prof Crawley's clinic
    - given the ongoing issue of potential parental/guardian aniexity about repercussions of poor school attendence and the lack of clarity as to whether differential diagnosis between CFS/ME and other causes of chronic fatigue were ever made, could either free or informed consent to any recommended interventions be assumed? (That is over and above any concerns we might have about the interventions offered by the clinic and how Prof Crawley responds to those who refuse her treatments.)

    Then it raises concerns about Crawley's, the Unversity of Bristol's and the BMJ's obfuscation once the whole ethical aproval saga was raised. Are the oversight processes for protecting human research subjects, in this case vulnerable children fit for purpose in the UK? Certainly it would seem that the response so far from all three has been to protect the reputation of the researcher and the institutions rather than answer the question was there adequate ethical oversight protecting the interests of the children and families participating.
     
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  4. Seven

    Seven Senior Member (Voting Rights)

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    @Valentijn WAIT:
    "The new research, on the other hand, is not about adding evaluations at 6 weeks and 6 months. It's about trawling through school absence records, contacting families of absentee children, and attempting to diagnose them to recruit them to the clinic. "

    Who paid for this study??

    If tax payers did, and I got you to pay me to increase my own clientele, this is another Blog topic all together!!!!!
     
    Inara, ukxmrv, Valentijn and 14 others like this.
  5. Luther Blissett

    Luther Blissett Senior Member (Voting Rights)

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    Thanks @Valentijn and @Peter Trewhitt .

    The main question is a simple one, involving at most 3 sources of information and one choice. If these people cannot manage that, how the hell did they get their jobs?

    If this is the incompetent standard applied to compliance, then the rules are not there for the safety of subjects, but institutions.
     
    Inara, Binkie4, Valentijn and 15 others like this.
  6. Seven

    Seven Senior Member (Voting Rights)

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    The point at this stage of the game, ALL THESE people are not incompetent, Some are being misled (COPE), others KNOW what they are doing, the question is why the support from the Journals and institutions. The university group got exposed so we know they support the BPS model and why.

    We need to dig on the journals and this people involved monetary gains. NOBODY at this stage can claim IS not un purpose (maybe the new involved COPE people) But Plus on, EC, White, Oxford, BMJ editor, PLos one Editor....
    About how they got the jobs, At this point, who are they working for is the most appropriate question!!!!
     
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  7. Esther12

    Esther12 Senior Member (Voting Rights)

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    I wonder if there's any mechanism to complain to COPE about the misrepresentation of a complaint to COPE?

    From what I've seen of COPE, they don't seem big on holding people to account.
     
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  8. Alvin

    Alvin Senior Member (Voting Rights)

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    I sincerely hope so
     
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  9. BurnA

    BurnA Senior Member (Voting Rights)

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    Performing scientific research on children without ethical approval must be one of the worst offences a researcher can make.

    I can't see anyone defending this.

    I think university of Bristol needs to make a clear statement where they stand on this.
     
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  10. BurnA

    BurnA Senior Member (Voting Rights)

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    Did anyone else find this odd?

    Is it within COPEs remit to advise specific action on communication?

    And what does "problematic" imply?

    That they know it stinks and want to avoid drawing attention to it?


     
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  11. Liv aka Mrs Sowester

    Liv aka Mrs Sowester Senior Member (Voting Rights)

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    Inara, Valentijn, Allele and 10 others like this.
  12. guest001

    guest001 Guest

    Very neatly condensed :)
     
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  13. guest001

    guest001 Guest

    I think you have pretty much done COPE's job for them. I hope they're reading this thread as they're clearly in need of direction. Oops.. oh no.. by their own (new) rules they can't possibly use your very useful analysis because it's part of a social media / blog. Oh dear.
     
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  14. guest001

    guest001 Guest

  15. Invisible Woman

    Invisible Woman Senior Member (Voting Rights)

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    So, Prof Crawley was allowed to trawl through school records and invite kids for a "screening " for referral to her clinic.

    Given that Prof Crawley has a history of conflating chronic fatigue, or even just some transient fatigue, with chronic fatigue syndrome it is very possible that she referred healthy kids who had experienced some fatigue to her clinic. No oversight either for the protection of her own reputation, or to safe guard the children.

    In addition the presence of a school official during screening may, for some kids, have biased their answers. Let's say they had been staying up late playing games or surfing or whatever. They may not want to admit that and may think it more acceptable (to the school) if it looks like they were ill rather than stay up too late on a school night. I'm not saying this happened, just raising the possibility.

    Having been allowed to cast her net so far and wide these kids will presumably attend the clinic and will provide further fodder for Prof Crawley's papers and research. So you could say it is in her interests to draft in kids who do not have chronic fatigue syndrome or any actual health problems. This could seriously improve how effective her clinic appears. Again, I'm not saying this happened, but I am questioning whether it could have.

    In terms of harms this could be significant. Research carried out on children who are not ill or are simply fatigued, means development of further treatments that are inappropriate or even harmful to ME patients. It could also be used to dilute the number of severely affected children in the patient population this making it easier to claim they are a tiny minority or even justify an additional/alternative mental health diagnosis.

    Children who are incorrectly diagnosed may face harms as this diagnosis will be on their medical records and follow them for the rest of their lives. As many adult patients can tell you, having ME or CFS written in your notes can have a huge impact on whether or how you are treated by doctors in the future.

    The more I think or read about this, the worse it gets....
     
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  16. Barry

    Barry Senior Member (Voting Rights)

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    Back to COI issues again, which has ethical connotations.
     
  17. large donner

    large donner Guest

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    Why the hell does COPE need to ask the BMJ to provide info that is freely available. Having said that its fascinating that the BMJ will keep going on record supplying utter delusion in their responses when the information is freely accessible and contradicts their support of the publication.

    There is something very bizzare in the fact that the BMJ just wont throw Crawley under the bus even at this point when the evidence seems so clear. Surely they must realise they could claim she mislead them instead of continuing to pretend they cant see any flaws in the claims.
     
    Stuart, MEMarge, Inara and 16 others like this.
  18. Seven

    Seven Senior Member (Voting Rights)

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    Just wondering, is it the editor only or we know the head and top of BMJ is informed???
     
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  19. Jonathan Edwards

    Jonathan Edwards Senior Member (Voting Rights)

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    I think the editor is the highest up person that matters. Beyond that you have shareholders of faceless companies if anything. I would expect the editor, Fiona Godlee, to be well aware of what is going on.
     
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  20. large donner

    large donner Guest

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    Yes she is probably in conversation as we speak with the SMC to churn out some more of the usual deaths threat, militant patient etc claims in the general media whilst simultaneously totally whitewashing the COPE BMJ response.
     
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