By David Tuller, DrPH
Last week, I wrote about the correction made to the “Highlights” section of the paper reporting the long-term follow-up results for the GETSET trial. (The trial was conducted by Professor Peter White, one of the three lead PACE investigators, and colleagues.) I noted that this correction was not indicated or identifiedâ€”a fact I attributed to the ambiguous status of â€œHighlightsâ€ sections, which could be viewed as more like news headlines than part of a paper’s core text.
But I was wrongâ€”the official notice of a correction, called a corrigendum, has now appeared. For whatever reason, the correction itself was made before the corrigendum was posted. And unlike corrigendi that just state what was corrected, this one provided something of an explanation. Here is the full text:
The authors regret that they did not submit a revised highlights statement, when resubmitting their paper, in the light of revisions made to the final article. The revised highlights include a new statement, which reads: â€œThere were no differences between interventions in primary outcomes at long-term follow upâ€. This is a substitute for: â€œGuided graded exercise self-help (GES) may lead to sustained improvement in fatigue.â€ The authors also made a minor correction to another highlight, which now reads: â€œThe study showed that GES probably was cost-effectiveâ€.
The revised highlights are as follows:
â€¢ There were no differences between interventions in primary outcomes at long-term follow up.
â€¢ There was no evidence of greater harm after GES compared to specialist medical care at long-term follow-up.
â€¢ The study showed that GES probably was cost-effective.
â€¢ Most patients remained unwell at follow up; more effective treatments are required.
The authors would like to apologise for any inconvenience caused.
First, I want to thank the Journal of Psychosomatic Research and its editorial team for pursuing this important issue. Professor White, who is on the journalâ€™s advisory board, could not have been pleased at having to make such a correctionâ€”especially based on a complaint coming from me, given my active role in discrediting the PACE trial. Even so, the journal obviously decided that the concerns I raised were valid and well-founded. For Professor White, that must have stung.
No one wants to correct a paperâ€”just like no one likes to have to correct a news article. In many or most cases, however, corrections do not undermine the entire message the authors hoped to convey. In this case, that is precisely the impact. The first sentence of the new â€œHighlightsâ€ section now clearly states that the study had null results. The previous first sentence ignored the bad news and falsely presented the results as positive.
One telling aspect of the corrigendum was the suggestion that the deceptive framing in the published â€œHighlightsâ€ section was meant for an earlier draft of the paper. Professor White and his colleagues thus presented their mistake as having failed to revise that section at the same time they revised the paper itself. The problem with this explanation is that an initial draft of the paper that portrayed the results along the lines of the now-disappeared â€œHighlightsâ€ sentence would have involved serious misrepresentation of the trialâ€™s findings. Given the null results, it is troubling that anyone involved believed it was responsible or ethical to submit a draft–or “Highlights” section–that downplayed them to such a degree.
The corrigendum also acknowledged a minor edit in the “Highlights” section sentence about cost-effectiveness. (I hadnâ€™t noticed this change previously, and Iâ€™m not completely sure what the change is, since the corrigendum unfortunately didn’t include this detail.) In any event, the current version of the statement appears nonsensical, given the null results. In what way can a treatment be said to be â€œcost-effectiveâ€ if it does not produce beneficial impacts? Cost-effective at what, exactly?
Professor White and his colleagues need to come up with some better logic on that one. As it is, the assertion that the treatment “probably was cost-effective” is essentially meaningless. and makes the investigators look ridiculous.
As for the Journal of Psychosomatic Research, it has not disclosed whether or not the â€œHighlightsâ€ section was peer-reviewed. It goes without saying that the initial version of the â€œHighlightsâ€ section should never have been allowed to pass through the editorial process unchallenged by editors and peer-reviewersâ€”especially if the paper itself had been revised to address related inadequacies, as the corrigendum indicates.
The journal should make clear whether it normally subjects â€œHighlightsâ€ sections to peer review. If so, what went wrong in this instance, and what will the journal do to ensure this sort of lapse does not recur? And if not, will the journal now insist that â€œHighlightsâ€ sections be subjected to peer review like other parts of the manuscript? I assume soâ€”but full transparency would be welcome.