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 indefensible; the results for the primary outcome, health-related quality of life, fell below the threshold for what is considered a minimally important or clinically important difference.
Last week, The BMJ responded by asking us to submit a rapid response. We declined, as I reported earlier this week. Today I sent the following letter directly to Dr Gordon McGregor, a clinical exercise physiologist at the University of Warwick, who was the lead trial investigator as well as the lead author of the published report.
**********
Dear Professor McGregor—
As you know, several colleagues and I wrote to The BMJ more than two weeks ago seeking a correction to your 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.” (I cc’d you on the initial letter; I have cc’d my colleagues and The BMJ‘s Dr Islam on this letter.) The journal advised us to submit a rapid response, which we declined to do. After all, one rapid response already made the same point more than a month ago, and the journal has apparently ignored it.
To recap: The paper’s methods section contradicts both the discussion section and a key reference in describing the recommended threshold for the minimally important difference for the primary outcome, health-related quality of life. It is irrelevant that this recommended threshold seems to have been updated after the start of the trial. Given that the results for the main analysis fell below the current threshold, it is perplexing that the abstract declared the intervention to be “clinically effective.” It is also perplexing that this blanket assertion survived editorial scrutiny and peer review.
So far, The BMJ does not appear eager to address what is clearly a misrepresentation of the findings. Long Covid patients and readers of the journal deserve better. On behalf of myself and the dozen colleagues who signed the letter to The BMJ, I am urging you, as the lead author, to take responsibility for this substantive error and ensure that the needed correction is made.
Best–David
David Tuller
Senior Fellow in Public Health and Journalism
Center for Global Public Health
University of California, Berkeley
Berkeley, California, USA
Well put. Errors in the literature need to be corrected. Thanks to all who signed the letter to the journal..
As a medical practitioner and sometime researcher, published, with Long Covid (LC) it seems to me that, given that LC can improve unpredictably, beneficial effects of an experimental treatment need to be highly significant before claims of efficacy should be made.
Thanks David for calling out these charlatans yet again. For us sufferers from chronic post viral illness it feels like these guys are constantly out to suffocate us and hide the truth simply in order to chase government and insurance money.