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PACE Trial and Press Complaints Commission

Discussion in 'General ME/CFS News' started by Yogi, Jun 24, 2013.

  1. Yogi

    Yogi

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    In the recent Forward ME meeting it was stated:

    http://www.forward-me.org.uk/14th May 2013.htm

    "5.2. The Chairman announced that her formal complaint to the Press Complaints Commission about the Commentary to the PACE Trial reported in the Lancet had been accepted"

    I could not find any any mention of this decision on here, specifically of the Press Complaints Commission and the PACE trial.

    I looked around and found it on the PCC website from 2 May 2013:

    http://www.pcc.org.uk/news/index.html?article=ODQwOQ==


    COMPLAINANT NAME:
    The Countess of Mar
    CLAUSES NOTED: 1
    PUBLICATION: The Lancet
    COMPLAINT:
    The Countess of Mar complained to the Press Complaints Commission that an article headlined "Chronic fatigue syndrome: where to PACE from here?", published in The Lancet on 5 March 2011, was inaccurate in breach of Clause 1 (Accuracy) of the Editors' Code of Practice.
    The journal had failed to take care not to publish inaccurate or misleading information in breach of Clause 1 (i), but had offered sufficient action to remedy the initial breach.
    The article was a comment piece on a paper - published in the same issue of The Lancet - reporting on the findings of the PACE clinical trial, which studied four treatments for adults with chronic fatigue syndrome (CFS), including cognitive behaviour therapy (CBT) and graded exercise therapy (GET). The commentators stated that in evaluating outcomes, the study had used a "strict criterion" for recovery: "a score for both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person's score". They went on to say that "in accordance with this criterion", the "recovery rate" for CBT and GET observed in the trial was about 30 per cent. Because the complaint was delayed, the Commission formally considered the matter in relation to the online version of the article only.
    The complainant said that, while an earlier paper which set out the protocol for the PACE trial had included criterion for recovery, the paper on which the comment piece was based had not included any analysis of "recovery rates". It had provided figures (around 30 per cent, in the case of CBT and GET) for the percentages of trial participants who were within "normal range" for fatigue and physical function following treatment, but the complainant argued that the difference between "recovery" and "normal" in this context was highly significant. For example, she noted that a minimum "normal" score for physical function was 60, whereas a patient could enrol in the trial with a score for physical function of up to 65.
    The journal had published a series of letters from readers in response to the publication of the trial paper and the comment piece, which were accompanied by a "reply" from the researchers. One reader, whose letter was linked on the journal's website to the article under complaint, had pointed out that "although the trial protocol does give a strict definition for recovery, this information was omitted from the published paper, which instead refers to physical function and fatigue in the ‘normal range'". The researchers' reply, published alongside this letter, stated: "it is important to clarify that our paper did not report on recovery; we will address this in a future publication".
    The journal noted that clinical research is complex in execution and interpretation. It argued that the item, an opinion piece, had to be considered in the context of the other information published about the trial, which included the full trial protocol containing the quoted definition of recovery. The comment, which had been discussed with the authors of the PACE trial prior to publication, defined "recovery" in a particular way and discussed data from the trial appropriately in that context. The commentators considered that "one way of defining recovery is to say that a patient is no longer fatigued and disabled" and "one could further operationalise recovery as scoring within normal range". The journal did not accept that any clarification was necessary and noted the letters it had published on the subject, but offered to publish a further letter from the complainant.

    DECISION:
    Sufficient remedial action offered
    ADJUDICATION:
    This complaint presented a useful example of the Commission's role in considering complaints about the reporting of scientific research. The authors of the comment piece were clearly entitled to take a view on how "recovery" should be defined among the patients in the trial, notwithstanding the complainant's strong view to the contrary. The Commission did not take a view on whether their position on this underlying issue was significantly inaccurate, as that was a matter of interpretation and continuing debate.
    Under the terms of Clause 1 of the Code, however, "the press, whilst free to be partisan, must distinguish clearly between comment, conjecture and fact". The authors of the comment had failed to make clear that the 30 per cent figure for "recovery" reflected their view that function within "normal range" was an appropriate way of "operationalising" recovery - rather than statistical analysis by the researchers based on the definition for recovery provided. This was a distinction of significance, particularly in the context of a comment on a clinical trial published in a medical journal. The comment was misleading on this point and raised a breach of Clause 1 (Accuracy) of the Code.
    The journal had therefore been required under the terms of Clause 1 (ii) to take steps to clarify the reference. It had published a reader's letter which addressed the point under complaint, in addition to the reply from the trial authors, which had confirmed the trial paper "did not report on recovery". While the Commission formally considered only the complaint regarding the journal's website, it noted that the correspondence section in the journal was a prominent forum for detailed, fully referenced responses, which allowed correspondents to address the issue under complaint while continuing and developing the complex scientific debate on the subject. It was also appropriate that the comment piece on the journal's website included prominent links to the responses. In the full circumstances of the complaint - including the nature of the breach - the responses published by the journal, along with its offer to publish a further letter from the complainant, were sufficient to remedy the initial breach of Clause 1.
    Relevant ruling
    Ward v The Sunday Telegraph (2009)

    DATE PUBLISHED:
    02/05/2013
  2. Esther12

    Esther12 Senior Member

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    Their claim that the PACE paper used a healthy population to calculate the mean-1sd was a clearly false factual claim, rather than an opinion.

    I thought I'd post the editorial Horton used to introduce the letters which helped point out the basic errors that had been made in his magazine. If Liz Jones can get past the PCC, maybe Horton should try raising his standards a bit.

  3. user9876

    user9876 Senior Member

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    I believe the data they used to derive their theshold for the sf36 physical function scale was for the bowling data and included all age groups. It also included 22% of people with long term health issues and a number with short term issues. If they had used just the healthy population (of any age) they would have got a mean - 1 std value of around 80. Removing those over 65 would have increased the threshold to 85. However it is wrong to use the mean and standard deviation due to the shape of the distribution, this is perhaps show by the median being 95 for the complete data set, 100 for the healthy population and 100 for the healthy working age population. The 5th percentile for the healthy working age population is 77 - that is just 5% of the healthy working population fell on or below a theshold of 77.
  4. WillowJ

    WillowJ Senior Member

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    that seems rather peculiar for an official correction to take the form of publishing a letter to the editor, since this doesn't usually imply official endorsement from the publisher of the content
    biophile, snowathlete and Valentijn like this.
  5. Tom Kindlon

    Tom Kindlon Senior Member

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    Some background info I posted elsewhere:

    Background: What is being referred to is the following:

    The criteria were SF36 physical functioning >= 60 and Chalder Fatigue Questionnaire (likert scoring) <=18, both possible at baseline.

    Profs. Bleijenberg and Knoop said
    The wording of the PCC ruling (below) notes, which has been mentioned before, that the commentary had been shown to the PACE Trial investigators before it was published. It is disappointing they didn't disagree with such a wording in a commentary published alongside their paper.

    The PACE Trial PIs refuse ( https://www.whatdotheyknow.com/request/pace_trial_recovery_rates_and_po )
    to release the data for the secondary outcome measure, recovery, from their own protocol:

    The recovery definition on which they published data in Psychological Medicine

    is not that dissimilar to what the Press Complaints Commission has ruled against.
    Valentijn and Esther12 like this.
  6. Esther12

    Esther12 Senior Member

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    Right.... and I'm sure Horton would have ensured all of that had been checked, in order to avoid misleading his readers. Ho-ho-ho, *sob*.
    Valentijn likes this.
  7. user9876

    user9876 Senior Member

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    I thought corrections were meant to have the same prominence as the original mistake.
    WillowJ likes this.
  8. biophile

    biophile Places I'd rather be.

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    The same PCC which ruled that it was OK for Max Pemberton to claim that 30% were recovered in the PACE Trial (and subsequently allow him to hold his nose high in the air about it when people challenged his absurd claim)?

    [deleted quote]

    Now they are admitting that there was indeed an error, but claim that it was already adequately corrected? I hope it demonstrates to themselves and smug Pemberton that they were wrong over something so basic while those they probably viewed as stupid irrational plebeians were correct.

    Malcolm Hooper said that in (June/July?) 2011 Zoe Mullan of the Lancet had promised a formal correction, but it never happened. Yet the Lancet have since issued a minor formal correction about how the Chalder fatigue questionnaire was used. So at some stage Mullan initially agreed that a formal correction was required. Peer-review is a sort of a joke and apparently involves the same politics of whatever controversy the published papers involve.

    [​IMG]
    http://niceguidelines.blogspot.com.au/2011/08/max-pemberton-has-got-it-all-wrong-on.html
    Shell and Valentijn like this.
  9. Snow Leopard

    Snow Leopard Senior Member

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    Exactly. Some of that was pointed out in a letter to the Lancet, but they still ignored it wholesale.
  10. Bob

    Bob

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    Have I mis-read this? The wording is a bit ambiguous, but it seems that the Lancet is suggesting that that PACE protocol includes the definition of recovery that was defined in the commentary?
  11. biophile

    biophile Places I'd rather be.

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    I think it refers to the previous paragraph:

  12. Bob

    Bob

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    Thanks bio, but I'm not entirely convinced. It doesn't seem clear what it means.
  13. Bob

    Bob

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    I don't know if the PCC usually gets involved in this sort of scientific debate. If it's unusual, I wonder if this decision notice will catch the eye of a wider audience.

    It seems that the essence of the adjudication is captured by this short extract:

    The authors of the comment had failed to make clear that the 30 per cent figure for "recovery" reflected their view that function within "normal range" was an appropriate way of "operationalising" recovery - rather than statistical analysis by the researchers based on the definition for recovery provided. This was a distinction of significance, particularly in the context of a comment on a clinical trial published in a medical journal. The comment was misleading on this point and raised a breach of Clause 1 (Accuracy) of the Code.
    biophile likes this.

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