By David Tuller, DrPH
I wanted to post something this week, but not a whole long thing. So I thought I’d just post the top of what I’ll post in full next week.
This week ends the first half–six months!–of my crowdfunded project. Sometime soon I’ll post something or other looking backward and forward a bit. But not today.
In August, I posted a critical analysis of a 2011 study by Professor Esther Crawley. The article, published in BMJ Open, was called “Unidentified Chronic Fatigue Syndrome/myalgic encephalomyelitis (CFS/ME) is a major cause of school absence: surveillance outcomes from school-based clinics.”
The BMJ Open paper included an “article summary,” a sort of layperson’s abstract next to the actual abstract. This summary explained the study’s “hypothesis” and “research question”:
“Hypothesis: many children with CFS/ME remain undiagnosed and untreated, despite evidence that treatment is effective in children.”
“Research question: are school-based clinics a feasible way to identify children with CFS/ME and offer treatment?”
The methods section described the intervention as “a pilot clinical service” created “to try and improve school attendance.” In other words, this initiative did not assess or evaluate the actual care already being provided in either school-based clinics or in a specialized CFS/ME clinic.
The title itself highlighted a key finding–that CFS/ME is “a major cause” of school absence. The abstract presented the official “conclusions”: “Children diagnosed through school-based clinics are less severely affected than those referred to specialist services and appear to make rapid progress when they access treatment.” In the text of the paper, the authors wrote that the intervention had “the potential to identify children with CFS/ME, which may reduce school absence and its harmful consequences.”
Appropriately, BMJ Open published this study under the following slug: “Research.”
Studies that involve human subjects and draw broad conclusions normally need approval from an ethics review committee. Remarkably, Professor Crawley exempted this school absence research from the required ethical review. Instead, the paper included the creative claim that the study did not need such a review because it qualified as “service evaluation.”
Professor Crawley is correct that service evaluation studies are exempt from ethical review. She is wrong to claim that this piece of research could in any way qualify as service evaluation.
Why am I reprising the issue now? After my post about the school absence paper, BMJ Open presented the case to the Committee on Publication Ethics in a misleading light. *The journal’s version of the issue was published as part of the agenda for the November meeting of the COPE forum. This accounting from BMJ Open is at odds with the facts and sidesteps the key issues.
[*Same-day correction: This sentence initially stated that the BMJ Open version was published in the November issue of the COPE newsletter.]
In this post, I will recap the study itself. Then I will explain the official guidelines on the differences between “research” and “service evaluation” and how these relate to the study. Finally, I will respond to the BMJ Open’s statement to COPE…
Next week: The whole thing