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Screening for carbon monoxide exposure in selected patient groups attending rural and urban emergency departments in England: a prospective observational study
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  • Published on:
    False and misleading claims in reply of Clarke et al

    I am writing to correct false and misleading claims in the reply of Dr. Clarke, two of his co-authors, and Ms. Zamani to my letter of 25 August 2018 documenting evidence of scientific misconduct in their 2012 study of carbon monoxide (CO) poisoning (1).

    For the record, my original letter did not accuse them of “committing research fraud” as they claim. I was open to the possibility that all their misconduct—including not fully reporting their ethics committee approvals, methods, and results—may have been inadvertent or unwitting.

    But this seems less likely in light of their reply, which does not address any of my specific concerns while making new false and misleading claims. They say I allege that they “incorrectly used both arterial and venous COHb,” but my complaint was that they incorrectly used one to validate the other. I assumed this was because they mistook the arterial Rad57 measure for venous. However from their reply it appears they recognized the difference but simply ignored it, based on their mistaken belief that “there is no significant clinical difference [emphasis added] between arterial and venous COHb levels after 10-15 minutes of exposure due to admixture [2-12].”

    In fact, 8 of the 11 studies they cite for this reported just the opposite, finding both clinically and statistically significant differences, including the only study that, like Clarke et al, compared Rad57 measures with venous COHb (12). Only three reported...

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    Conflict of Interest:
    None declared.
  • Published on:
    Editor's Note

    This is a note to indicate that BMJ Open is still looking into the disagreement between Albert Donnay and the authors of the paper.

    We will post further updates on the article in due course.

    Conflict of Interest:
    None declared.
  • Published on:
    Unpublished methods and results in "Screening for carbon monoxide exposure..."
    • Simon Clarke, Consultant Emergency Physician Musgrove Park Hospital
    • Other Contributors:
      • Patricia Ward, Consultant Emergency Physician
      • Stephen Bush, Consultant Emergency Physician
      • Joanne Zamani, Deputy Manager Research and Development

    ****Please note that BMJ Open received this response on 10 September 2018, but it was not published until 14 January 2019***

    We note the letter from Mr Donnay accusing us of committing research fraud in our 2012 paper [1].
    First, Mr Donnay states that we incorrectly used both arterial and venous COHb. It is clear from the published human literature that there is no significant clinical difference between arterial and venous COHb levels after 10-15 minutes of exposure due to admixture [2-12], although I acknowledge that this message has not got through to some front-line clinicians [13].
    His second point is more pertinent. We became aware of some discrepancies between the non-invasive and venous results. We subsequently became aware of concerns raised by other researchers about the Rad-57 device [14] so we did analyse the data separately in the report to the Department of Health. However, the separate analyses did not alter the fundamental conclusion of our study that a proportion of patients do present to Emergency Departments with higher than expected COHb levels and our hope to raise awareness of possible CO exposure in these people. We stressed that the figures obtained should not be extrapolated more widely and we were careful to avoid confusing higher than expected COHb levels with exposure to non-smoking exogenous sources of CO. We also discussed in depth the limitations of COHb as a biomarker.
    On the note of patient safety our definition of...

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    Conflict of Interest:
    None declared.
  • Published on:
    Editor's Note

    The Editor of BMJ Open has received the comments from Albert Donnay on this paper. The authors of the paper have been contacted and have been asked to provide a response.

    Conflict of Interest:
    None declared.
  • Published on:
    Unpublished methods and results in "Screening for carbon monoxide exposure..."

    In “Screening for carbon monoxide poisoning…in England: a prospective observational study,”(1) Clarke et al mischaracterize Masimo's Rad57 pulse CO-oximeter as a measure of venous carboxyhaemoglobin. As noted in one of their references(2) and the Rad57 Operator’s Manual,(3) Masimo’s trademarked “SpCO” measures arterial carboxyhaemoglobin. Based on this misunderstanding, the authors checked their [arterial] Rad57 ([a]Rad57) results against [venous] carboxyhaemoglobin ([v]COHb) measured by unspecified “point-of-care blood analyzers.”(4)

    Instead of publishing these results separately, however, the authors simply combined them—by which 76 of 1758 patients were “positive” for CO poisoning (COp).(1) Only in an unpublished report to their funder did they disclose the R2 correlation among 608 paired [a]Rad57 and [v]COHb measurements was just 0.03.(4) Without any other testing, they assumed [v]COHb was more accurate and used this whenever available, even when [a]Rad57 was higher. By this method, they classified 293 with high [a]Rad57 but normal [v]COHb as false positives—and discharged them without the COp treatment and home inspection given 60 cases confirmed by high [v]COHb.(4)

    Also disclosed only to the funder: the authors’ original protocol was “non-invasive” with a nested case-control design.(4) Blood CO-oximetry was only added after the controls—three per case—were dropped because “a number [unspecified] had high COHb readings [unspecified] on the...

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    Conflict of Interest:
    None declared.