Leave a Comment / By David Tuller / 24 March 2024
By David Tuller, DrPH
Two weeks ago, I sent a letter to The BMJ on behalf of myself and 12 colleagues seeking a correction in a study published last month. The study, called Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial,” claimed that the intervention under investigation had been shown to be “clinically effective.” As our letter pointed out, this claim is untrue. In fact, the results for the primary outcome, health-related quality of life, fell below the threshold for what is considered to be a clinically important or minimally important difference on that measure. In other words, any measured benefits were so small as to be essentially meaningless even if they were statistically significant.
Last week, I received a response from Dr Nazrul Islam, an editor at The BMJ. He requested that we submit a rapid response to the article outlining our concerns. He indicated that The BMJ would ask the authors to respond, and that the journal would then act in accordance with its policies. After considering the invitation to submit a rapid response, our group has decided to decline it. I have sent Dr Islam a follow-up, explaining our position and again requesting that The BMJ take the necessary steps to correct the paper. Our response is below.
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Dear Dr Islam—
Thank you for the invitation to submit a rapid response regarding our concerns about a recent paper–“Clinical effectiveness of an online supervised group physical and mental health rehabilitation programme for adults with post-covid-19 condition (REGAIN study): multicentre randomised controlled trial,” from McGregor et al. As we noted in our letter, the paper’s methods section misstates the currently recommended minimally important difference for the primary outcome, as is evident from the reference cited by the authors. That factual error leads the authors to make the unwarranted assertion in the abstract that the intervention was found to be “clinically effective.”
After discussing The BMJ‘s invitation to submit a rapid response, my colleagues and I have decided to respectfully decline. Few people see rapid responses, especially since most are never formally published as correspondence and are not indexed in the medical literature. Moreover, as our letter noted, a rapid response making a similar point was already submitted on February 13th—in other words, more than a month ago. So far, it appears that the paper’s authors and The BMJ editorial team have ignored this rapid response.
In any event, it is unclear why The BMJ needs to receive another rapid response in order to perform its oversight function and take the necessary steps to correct the REGAIN paper; after all, the “BMJ policy and guidelines” you reference do not grant authors license to include factual errors in their papers. That the article was published in its present form represents a lapse in the editorial and peer review processes—especially because the authors themselves provide conflicting information in the methods and discussion sections about the minimally important difference for the primary outcome. It is incumbent upon The BMJ to address this glaring internal contradiction, with or without prompting from rapid responses.
This is not a question of interpretation that requires a debate. An intervention investigated in a clinical trial cannot honestly or legitimately be described as “clinically effective” if the results for the relevant outcome fall below the recommended threshold for the minimally important difference. That holds true even if that threshold has recently been adjusted, as seems to have happened with the primary outcome used in REGAIN. Beyond that, the authors’ apparent attempt in the discussion section to support an overall claim of clinical effectiveness by citing the results of a subset of the sample is not consistent with standard methods of scientific reporting.
Given the credibility and authority associated with publication in The BMJ, it is not surprising that McGregor et al’s misrepresentation of REGAIN’s core finding has been widely disseminated by news organizations. To continue to allow the paper to stand without immediate correction is a disservice to patients with Long Covid and the larger public, who rely on The BMJ to provide fully vetted and accurate medical information.
Once again, we urge The BMJ’s editorial team to take quick action on this matter. (I have cc’d my colleagues and Dr Abbasi.)
Best–David
David Tuller (corresponding author)
Center for Global Public Health
University of California, Berkeley
Berkeley, California, USA