David Tuller: Trial By Error: My Letter to LP's Study's Senior Author

Kalliope

Kalliope

Senior Member (Voting Rights)
My Letter to LP Study's Senior Author

I e-mailed the following letter to Professor Montgomery on Sunday evening (California time), with the subject heading “Retrospective Registration and Outcome-Swapping in Lightning Process Trial.” I cc’d Dr Nick Brown, editor-in-chief of Archives of Disease in Childhood, and Dr Fiona Godlee, editorial director of BMJ. In addition, I cc’d three members of Parliament who have expressed dismay about the poor quality of research in this field and are seeking a parliamentary debate on the issue: Carol Monaghan MP, Darren Jones MP and Nicky Morgan MP. Finally, I cc’d Adom Lowe, Sally Burch and Dr Charles Shepherd, three members of the committee that is developing the ME/CFS guidance for the National Institute for Health and Care Excellence.
 
Thank you @dave30th for pursuing this.

Just spotted this typo:
Kalliope said:
I cc’d Adom Lowe.
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(it's Adam)

And perhaps, given that three of the study's co-authors are still at Bristol, it might be worthwhile to forward the letter also to Prof Munafo at Bristol? see:

https://www.s4me.info/threads/bristol-new-network-prof-munafo.5802/

@Graham 's letter:
https://www.s4me.info/threads/bristol-new-network-prof-munafo.5802/page-3#post-106472

Prof Munafo's first reply:
https://www.s4me.info/threads/bristol-new-network-prof-munafo.5802/page-4#post-107448

Graham's reply:
https://www.s4me.info/threads/bristol-new-network-prof-munafo.5802/page-5#post-107586

Prof Munafo's second reply:
https://www.s4me.info/threads/bristol-new-network-prof-munafo.5802/page-6#post-107738
 
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Thank you @dave30th. I am pleased to see you spelling out the dodgy background of LP and its creator as well as the faults with the trial. And a forceful request that the senior author take responsiblity, that the paper should be retracted and an apology made to those who have wasted money on LP on the back of a flawed trial.

I am a bit confused about how authors of papers are listed. I've just looked and Alan Montgomery is listed last on the author list, which I understand often means that person is the senior author, but Esther Crawley, listed first, is stated as the one to whom correspondence should be sent. I would have assumed from this that Crawley was the senior author. But what do I know! Will a copy of the letter be sent to Esther Crawley?
 
Trish said:
I am a bit confused about how authors of papers are listed. I've just looked and Alan Montgomery is listed last on the author list, which I understand often means that person is the senior author, but Esther Crawley, listed first, is stated as the one to whom correspondence should be sent. I would have assumed from this that Crawley was the senior author. But what do I know! Will a copy of the letter be sent to Esther Crawley?
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My understanding is that in the social sciences the principal author is listed first and in medicine, they're listed last, so when you get a psychological medicine paper, it's very confusing! But this paper was published in Archives of Disease in Childhood, so I'd expect the principal author to come last. But then, as you say, Crawley is the corresponding author.
 
In this particular case I do not think Montgomery can be regarded as senior author, although the name does not matter and no interpretation of it will let him off a hook of sorts.

There is no consensus about author order because academic conventions came into conflict with research assessments for promotion about twenty years ago and since then nobody has known quite what orders mean. As a result papers now indicate individual contributions in appendices.

A first author is either the p son with th big idea OR the stooge who did the spadework. Generous bosses make their stooges first authors, less generous take th slot for themselves. But for trials like this the first author is likely to be th person with the Ida to do the trial and also the one who got it done. In that situation the lat author is either a head of department given courtesy authorship, which is not so likely, or simply then l east important contributor , who goes last. So in all probability Montgom ry is just the last important author.

But he still has a particular responsibility here because he is supposed to be th person who knows about trial methodology. So sending a message to him specifically is bang on the nail.
 
Now I also had a look at the list of authors* which reminded me that Crawley is doing all this nonsense in collaboration with a seemingly very busy and well funded club called "Bristol Randomised Trials Collaboration" (BRTC), http://www.bristol.ac.uk/population-health-sciences/centres/brtc/

(ETA: This collaboration has nothing to do with the above mentioned Prof Munafo's network.)

So it might be worthwhile to distribute the letter even more generously, also among those people in charge of the BRTC, as well as of collaborating and funding institutions?
We are part of the Bristol Academic Clinical Trials within the University of Bristol, along with our sister unit Clinical Trials and Evaluation Unit (CTEU).

This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials. The BRTC is a UK Clinical Research Collaboration registered CTU and in the NCRI Cancer Clinical Trials Group.
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http://www.bristol.ac.uk/population-health-sciences/centres/brtc/

*https://www.ncbi.nlm.nih.gov/pubmed/28931531#
 
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MSEsperanza said:
Now I also had a look at the list of authors* which reminded me that Crawley is doing all this nonsense in collaboration with a seemingly very busy and well funded club called "Bristol Randomised Trials Collaboration" (BRTC), http://www.bristol.ac.uk/population-health-sciences/centres/brtc/

(ETA: This collaboration has nothing to do with the above mentioned Prof Munafo's network.)

So it might be worthwhile to distribute the letter even more generously, also among those people in charge of the BRTC, as well as of collaborating and funding institutions?

http://www.bristol.ac.uk/population-health-sciences/centres/brtc/

*https://www.ncbi.nlm.nih.gov/pubmed/28931531#
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thread here:
https://www.s4me.info/threads/bristol-randomised-trials-collaboration.5731/
 
As pointed out in the thread that @Sly Saint links to in the above post, the Bristol Randomised Trials Collaberation includes Crawley's MAGENTA and FITNET-NHS trials as current examples of good research practice.

So the Bristol Collaberation has a lot of questions about Prof Crawley's previous research malpractice and whether these issues are being dealt with in relation to the current trials. However the signs are not looking promising given such as Red Whale's advertising FITNET- NHS (see https://www.s4me.info/threads/david-tuller-trial-by-error-my-letter-to-red-whale-gp-update.5457/ ) that is likely to bias potential participants even before enrolling in the trial.

[edited to correct the name of the Bristol Collaberation]
 
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Jonathan Edwards said:
But he still has a particular responsibility here because he is supposed to be th person who knows about trial methodology. So sending a message to him specifically is bang on the nail.
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I think if people are authors they have some responsibility for the conduct of the research particularly senior authors (as in senior academics attaching their names to the paper). So it seems worth pointing out to him that there are issues. Perhaps he will realize the issues and that being associated with a misleading paper isn't good and push for a correction. But he may just hope that if people publish work criticizing the paper then that will increase his citation count.
 
Jonathan Edwards said:
There is no consensus about author order because academic conventions came into conflict with research assessments for promotion about twenty years ago and since then nobody has known quite what orders mean. As a result papers now indicate individual contributions in appendices.
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Maybe this differs by discipline. I consider first and senior (last) author to both be exalted positions--as least that's how it's been in my experience in US public health academia. Montgomery is the senior author by virtue of being the last one listed. Traditionally, as Jonathan suggested, this might be the head of the research group that did the study or someone else in a position of oversight, while the first author--in this case Crawley--is the main driver of the study. I don't know what specifically it means in this case. The corresponding author is usually the first author but sometimes the senior author--again, in my experience.

In any event, whether or not he is the "senior author" or just the last one listed, his prior position at Bristol and his credentials suggest that he had some responsibility for making sure this was a well-designed study--or should have, if he didn't. So writing him seemed very appropriate. In terms of sending this to Professor Crawley, I have not sent her anything since last year and will not start now. She considers e-mail from me to be a form of harassment, as I understand it, so no need to scratch that itch. I presume she will see it whether or not I sent it to her directly, or to Bristol.
 
Trial By Error: A Second Letter to LP Study’s Senior Author
Alan Montgomery is a professor of medical statistics and clinical trials at the University of Nottingham’s School of Medicine. He is also the senior author of the Lightning Process study, which was published in 2017 in Archives of Disease in Childhood, a BMJ journal. I wrote him a letter in January of this year, alerting him to my concerns about the study, but did not hear back. Because a recent review cited this problematic trial in highlighting the Lightning Process as an “effective” treatment for children, I decided it was time to send Professor Montgomery a second letter reminding him about my first.

I sent the following earlier today.
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http://www.virology.ws/2019/06/05/trial-by-error-a-second-letter-to-lp-studys-senior-author/
 
Jonathan Edwards said:
A first author is either the p son with th big idea OR the stooge who did the spadework. Generous bosses make their stooges first authors, less generous take th slot for themselves.
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I remember the first paper I wrote as the ‘stooge’. I constructed a new experimental design to explore new aspects of some previous research carried out by my mentor. I did all the work and the thinking, wrote the paper, presented interim results to sponsors (which was one of those panelled amphitheater type affairs). I was pretty much a one man band doing a 2 year government and industry funded research project with just courtesy updates to my mentor.

When I submitted a draft to my mentor, he made one edit, which was to put his name after mine. He was very old school. His perspective was ...I secured the original funding, I started the “big idea”, I’m technically your mentor so I’ll pop my name on your follow up work. It didn’t matter that my work was a better design and furthered our knowledge more than the initial exploratory work he did. The thing that really grated though is that he made absolutely no contribution to the work I did or the paper. It was quite the hierarchy in that place.

I’m not sure there was any convention he was using other than one of collecting papers with his name on it.
 
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