Clauses Noted: 1
Publication: The Lancet
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.
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.
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