Trial By Error: A Sneak Preview of Next Week’s Post

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.

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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

Comments on this entry are closed.

  • pinklil 27 December 2017, 2:58 pm

    Excellent! I’m sure the full exposition will make the start of 2018 pleasurable for people with ME who want to see an end to the charade that the BPS school are capable of making any sensible contribution to this disease whilst at the same time making it rather uncomfortable for BMJ Open, Crawley and not to mention COPE who need to make a response to this situation which bears some semblance of being in touch with the facts…

  • Sheila Campbell 27 December 2017, 4:18 pm

    Looking forward to reading the whole article exposing further failings/shenanigans in Professor Crawley’s “research”. Unfortunately the multiple problems with her “research” are not merely academic, this all seriously impacts the lives of children and their families.

  • Sleepyblondie 27 December 2017, 6:26 pm

    Thanks for the work you do. Shameful how researchers get away with such misleading statements and shoddy work. Crawley is quick to exploit BMJ’s weakness – BMJ Ethics Committee needs an overhaul if they swallow such twaddle.

  • Brenda Vreeswijk 28 December 2017, 2:35 am

    Excellent!! She just need to follow the ethic rules like everybody else. They are there for a reason.. It looks like she (and another group) live in their own world, have their own rules and discard everybody else.
    Thank you for getting (and staying) on top of this…
    ME patients are a vulnerable group…but the children she targets are even more so. She should be held accountable for every misstep she make’s and so should the people defending her and her work.

  • Joh 28 December 2017, 6:55 am

    Can’t wait to read the whole thing! Thank you for exposing this antiscience.

  • Barry 28 December 2017, 7:57 am

    This study went way beyond mere evaluation of an existing service. It compared the existing service to a newly modified service, the modification having not yet been applied or investigated. The study’s clear aim was to pilot and investigate this new service modification, compare the existing service to the new, and assess if the newly modified service should become standard.

    Children who would never have received specialist treatment under the existing service, would become subject to it under the newly modified service. Moreover, the first time this was ever done was when the study itself piloted this new service amendment – yet the study was not deemed liable to ethics approval.

    Even if the ethics approval exemption had been a simple oversight, it feels terribly negligent. But given it was validly pick up at peer review and then blatantly disregarded, that feels much more wilful. Even if a study seems borderline re ethics approval, it should always come down on the side of safety and due diligence. In this case it seems far from borderline.

    How many other paediatrics research studies would have been granted such a procedural shortcut as this? It seems crucial safety checks and balances were disregarded. What went wrong here?

    Many thanks David for exposing this.

  • pinklil 28 December 2017, 10:21 am

    I think it’s curious that the peer reviewer who flagged the lack of proper ethics approval was Matthew Hotopf working at KCL. Essentially we have two BPS model proponents at odds with each other regarding this matter. We don’t see that very often do we?

    http://bmjopen.bmj.com/content/bmjopen/1/2/e000252.reviewer-comments.pdf

  • Ellis 29 December 2017, 5:42 am

    This is great. I am just wondering if you are going to look at the Magenta trial? The trial protocol was reviewed by Suzanne Broadbent and the comments/recomendations largely ignored/side stepped. Parents are told to expect relapses and that their child may end up bed ridden- this is said to be part of the disease fluctuation and NOT due to over exertion!! This of course is at odds with science and patient experience in which symptom exacerbation is provoked by exertion (or triggers- physical, cognitive, food/chemical intolerances etc.)