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Efficacy of therapist-delivered transdiagnostic CBT for patients with persistent physical symptoms in secondary care: an RCT, 2021, Chalder et al

Discussion in 'PsychoSocial ME/CFS Research' started by Joan Crawford, Jun 7, 2021.

  1. Joan Crawford

    Joan Crawford Senior Member (Voting Rights)

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    The spin on this is quite shocking:

    https://www.cambridge.org/core/jour...rolled-trial/CEDD9B7597902C283BBB7CA7B43A81C7

    Efficacy of therapist-delivered transdiagnostic CBT for patients with persistent physical symptoms in secondary care: a randomised controlled trial
    Published online by Cambridge University Press: 31 May 2021

    Trudie Chalder
    Open the ORCID record for Trudie Chalder [Opens in a new window]
    ,
    Meenal Patel
    ,
    Matthew Hotopf
    ,
    Rona Moss-Morris
    ,
    Mark Ashworth
    ,
    Katie Watts
    ,
    Anthony S. David
    ,
    Paul McCrone
    ,
    Mujtaba Husain
    ,
    Toby Garrood
    ,
    Kirsty James
    and
    Sabine Landau

    Abstract
    Background
    Medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS) are debilitating to patients. As many specific PPS syndromes share common behavioural, cognitive, and affective influences, transdiagnostic treatments might be effective for this patient group. We evaluated the clinical efficacy and cost-effectiveness of a therapist-delivered, transdiagnostic cognitive behavioural intervention (TDT-CBT) plus (+) standard medical care (SMC) v. SMC alone for the treatment of patients with PPS in secondary medical care.

    Methods
    A two-arm randomised controlled trial, with measurements taken at baseline and at 9, 20, 40- and 52-weeks post randomisation. The primary outcome measure was the Work and Social Adjustment Scale (WSAS) at 52 weeks. Secondary outcomes included mood (PHQ-9 and GAD-7), symptom severity (PHQ-15), global measure of change (CGI), and the Persistent Physical Symptoms Questionnaire (PPSQ).

    Results
    We randomised 324 patients and 74% were followed up at 52 weeks. The difference between groups was not statistically significant for the primary outcome (WSAS at 52 weeks: estimated difference −1.48 points, 95% confidence interval from −3.44 to 0.48, p = 0.139). However, the results indicated that some secondary outcomes had a treatment effect in favour of TDT-CBT + SMC with three outcomes showing a statistically significant difference between groups. These were WSAS at 20 weeks (p = 0.016) at the end of treatment and the PHQ-15 (p = 0.013) and CGI at 52 weeks (p = 0.011).

    Conclusion
    We have preliminary evidence that TDT-CBT + SMC may be helpful for people with a range of PPS. However, further study is required to maximise or maintain effects seen at end of treatment.

    Keywords
    Cognitive behavioural therapy (CBT)
    medically unexplained symptoms
    persistent physical symptoms
    randomised controlled trial (RCT)
    secondary medical care
    transdiagnostic

    Open access paper.
     
  2. Adrian

    Adrian Administrator Staff Member

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    I assume they have not adjusted their significance tests for the number of secondary outcomes they are looking at - they don't mention that they do. Not sure what is normal but if they are claiming results based on it it looks dodgy.


    I
     
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  3. Esther12

    Esther12 Senior Member (Voting Rights)

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  4. Sam Carter

    Sam Carter Established Member

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  5. Esther12

    Esther12 Senior Member (Voting Rights)

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    That makes sense - I just read it as meaning a 'secondary' part of the PRINCE trial.
     
  6. Adrian

    Adrian Administrator Staff Member

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    As you would expect they don't seem to take too much notice of the protocol as they write the paper and claim what are secondary outomes.

    The secondary outcomes for PRINCE secondary were (according to the trial registration https://clinicaltrials.gov/ct2/show/study/NCT02426788) tha last two were added late on.
    The ones in bold are what they report.

    In the paper they claim:
    But I don't see this in the list of secondary outcomes.

    In the published protocol https://bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-019-2297-y they have a similar list though not the ones they added later in the registration info.


     
  7. DokaGirl

    DokaGirl Senior Member (Voting Rights)

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    Still lumping different groups together. "It's all one condition, eh?" By what definition?
     
  8. rvallee

    rvallee Senior Member (Voting Rights)

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    Defined by symptoms, symptoms aren't even the primary outcome and are only asked generically. What a bunch of crap. Any process that approves such ridiculous studies needs to be rebuilt from scratch, is completely unfit for purpose and frankly everyone involved has no business working in such roles.
     
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  9. dave30th

    dave30th Senior Member (Voting Rights)

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    good catch. classic outcome-switching
     
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  10. Peter Trewhitt

    Peter Trewhitt Senior Member (Voting Rights)

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    Started looking to see what the Journal’s policy on after the fact deviations from the original protocol is, but not up to reading the full text of their publication ethics policy and the COPE policies which they claim to be bound by ( https://www.cambridge.org/core/journals/psychological-medicine/information/publishing-ethics ), though I am assuming that the failure of peer review to pick up the outcome swapping resulted in the editors breaching their own publication ethics policy by publishing the article as it stands.
     
  11. Adrian

    Adrian Administrator Staff Member

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    I wonder if its just a lack of competance they have no advantage to doing that so feels like a lack of rigour and showing they don't believe in (or read) their own protocols.
     
  12. Snowdrop

    Snowdrop Senior Member (Voting Rights)

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    I agree. They are savvy and competent enough to know what needs to be in a proposal for it to be accepted. So they write something acceptable and then go off and do the work (not sure at this stage if they do the protocol and ignore parts for the write up or do half the protocol).

    Either way what makes it to the report stage is what was 'meant' to be there all along.
     
  13. Andy

    Andy Committee Member (& Outreach when energy allows)

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  14. dave30th

    dave30th Senior Member (Voting Rights)

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    I don't know. but it is certainly worth a letter bringing it to the journal's attention. These people seem incapable of doing studies without outcome-switching, made up end. points, and the like. Or claiming success based on failed primary outcomes but marginal secondary outcome measures. It really is mind-blowing.
     
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  15. dave30th

    dave30th Senior Member (Voting Rights)

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    absolutely.
     
  16. Michiel Tack

    Michiel Tack Senior Member (Voting Rights)

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    Waw, this is really a textbook example of how to misrepresent results: highlight a couple in a long list of secondary outcomes that reached statistical significance, even although differences were very minor and not clinically significant.

    Also: this study had an A versus A + B design. Patients in the control got no intervention, therapists were not blinded and subjective outcomes were used and still, there was no meaningful difference between groups.
     
  17. Sean

    Sean Senior Member (Voting Rights)

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    Failed
    Research
    Allows
    Undesirable
    Developments
     
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  18. dave30th

    dave30th Senior Member (Voting Rights)

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    And the WSAS is a 40-point scale. So even if the 1.5 difference for the primary outcome were statistically significant, it would be unlikely to beclinically significant. This is just trash. I'm going to write to the journal after I finish my post about Peter White's most recent GET defense in the Journal of Psychosomatic Research.
     
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  19. dave30th

    dave30th Senior Member (Voting Rights)

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    And yet more research is needed because they have some indications of improvement in vague secondary outcomes.
     
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  20. Michiel Tack

    Michiel Tack Senior Member (Voting Rights)

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    The authors themselves have defined a minimum clinically important difference for the WSAS at 3.6 points. So 1.5 isn't even close. They measured the WSAS at 9 weeks (difference of 0.19), at 20 weeks (difference of 2.41), at 40 weeks (difference of 1.32), and at 52 weeks (difference of 1.48).

    At no point was the difference close to what they defined as the minimum clinically important difference (a difference of 3.6 points). Yet the authors were allowed to highlight the difference of 2.41 at 20 weeks because it reached statistical significance. I don't understand why the peer reviewers allowed this.
     
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