BMJ Archives of Diseases in Childhood: ''Editor’s note on correction to Crawley et al. (2018)'', 2019, Nick Brown. (SMILE LP Trial)

[Tilly]

I would say all respect and trust from parents but mostly mothers (as they are the ones who have to witness the carnage that unfolds in these trials and get blamed for that carnage) in the system has now evaporated.

 

[Amw66]

For a population group who are supposed to benefit from higher levels of protection, when it comes to paediatrics, careers seem to trump the health and wellbeing of children.

Has there been a precedent in English law along the lines of Montgomery v South Lanarkshire Council?

In light of both GET and LP, it could be worth highlighting it.

 

[Lucibee]

From the editor's note;

Would be interesting to see these reviews as well as the "further unpublished work" that "suggests [school attendance using school records] highly correlated with the self report measure we used" and "could have provided an objective outcome" if only we had the "capacity to check" this. (EC & et al 2018)

(Edited to remove some muddled thoughts).

It would. I suspect that they do correlate well at baseline, but there may be an "intervention effect" that makes it divert from objectivity, as with all these subjective measures.

This change in the webappendix is interesting:

Feedback from participants and their parents, as well as the publication of the PACE trial, has informed a decision to use fatigue and SF36 as the primary outcomes from the full study. This is instead of school attendance (which we proposed may be the primary outcome in the feasibility study). School attendance will continue to be collected as a secondary outcome. The reason for this is that many of the participants are transitioning from GCSEs to A levels in this study and therefore % of school attendance does not necessarily reflect illness severity. For example, a teenager may have decided to take 2 A levels and be attending school for 2-3 hours a day. This would be recorded as 100% school attendance but this does not equate to 6.5 hours a day of normal school attendance.

As long as the groups are balanced, this really shouldn't make that much of a difference.

 

[feeb]

"The process has additionally involved seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase."

lol. so that's alright then.

The following paragraph was removed: ‘Lightning Process practitioners have completed a Diploma through the Phil Parker Training Institute in Neurolinguistic Programming, Life Coaching and Clinical Hypnotherapy. This diploma is examined through written and practical exams and is accredited by the British Institute of Hypnotherapy and NLP. Following the Diploma, Lightning Process practitioners undertake a further course to learn the tools and delivery required for the Lightning Process after which they must pass both a practical and written exam. Practitioners undertake supervision and CPD in order to further develop their skills and knowledge. They are regulated by the Register of Lightning Process practitioners, adhere to a Code of Conduct, and there is a Professional Conduct Committee that oversees complaints and professional practice issues.’

lol, so they got rid of the stuff that immediately makes it look like Obvious Woo at the very first glance to anyone with functioning critical facilities!

 

[Lucibee]

The following paragraph was removed:

This is incorrect, or rather, incomplete. The paragraph was moved to an appendix, not deleted.

 

[Adrian]

It shouldn't matter whether or not the editor believes it was all an innocent mistake, what matters is that the BMJ should never have published it.

"The process has additionally involved seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase."

Would a pharmaceutical company be allowed to offer such a gentlemanly assurance?

I guess a phama company may demand equal treatment to academics and point to how journals and editors have backed the bad practices of Crawley and PACE at every opportunity.

Also if it was an innocent mistake when David Tuller pointed it out then the authors would, I assume, rush to correct the paper so it is accurate. Just their unwillingness to correct is unethical.

 

[MEMarge]

Not enough "capacity to check"!

What about all those PhD students watching people carrying shopping bags. Did it not occur to them to ensure they had enough people to look into this when they put forward their proposal? Sounds like the level of preparation re PACE, when someone used the excuse of the clinic corridors being too short for participants to do the 6 minute walking test accurately, as they would have to turn round too often.

Surely someone in the paediatric team knew that youngsters doing A levels do not usually have a full timetable. Is working out the percentage of lessons thy did attend divided by the total per their timetable too complex?

 

[large donner]

Not enough "capacity to check"!

What about all those PhD students watching people carrying shopping bags. Did it not occur to them to ensure they had enough people to look into this when they put forward their proposal? Sounds like the level of preparation re PACE, when someone used the excuse of the clinic corridors being too short for participants to do the 6 minute walking test accurately, as they would have to turn round too often.

Surely someone in the paediatric team knew that youngsters doing A levels do not usually have a full timetable. Is working out the percentage of lessons thy did attend divided by the total per their timetable too complex?

If they used the excuse that subjective school attendance reporting was sufficient instead of school records and then went on to claim some students transferred to a less demanding attendance regime halfway through, so they changed the primary outcomes measure, why couldn't they have used subjective reporting on extra curricular activities, like sports and social events or home study for A level courses outside of school time etc.

Surely they could have worked out an average weekly activities schedule for 17 and 18 year olds including social schooling and activities of daily living.

For all we know the attendance requirement dropping to 2 to 3 hours a day in sixth form could have accounted for the "drop in fatigue" reported. How did they control for that bias and secondly do we even know if any of these students passed their exams or not?

Attendance requirement being lowered because of transition from high school to sixth form doesn't tell us that the home study requirement and revision timetable was kept up to the normal amounts.

How do we know that the reported drop in fatigue self reports wasn't due to pacing on transition from a 7 hour day to a 2 to 3 hour day?

How did they account for the transition from high school to sixth form having a six week summer holiday in the middle with zero attendance requirement followed by a two thirds drop in school day hours and make objective causal claims about the reasons for reported lowering of fatigue?

Wouldn't the most obvious conclusion be that lowered timetable requirement accounted for lowered fatigue scores.

Isn't this supporting evidence of pacing, at least for those transitioning to reduced attendance requirement?

 

[rvallee]

O. M. G. This is a car crash. A mega-wreck. Just look at it! LOOK AT IT!!!!

They've been allowed to correct it to admit to all sorts of shenanigans. And still keep the same Conclusions. Flippin 'eck!

Cross-linking with my analysis on the other thread.

I'm going to look at this in more detail, and judging by the timeline from the editor's note, they only released the data once re-publication was assured. It should have "expressions of concern" all over it. Like my face at the moment.



lol

It's still clearly a button soup. Nevermind the meat, and the veggies, and the broth, and the spices, and the herbs. Which we initially did not report in the ingredients' list and denied were ever present. The main ingredient is clearly the button. You can't deny there is a button in this soup and it is called button soup therefore all the taste, all the nutrients, everything that makes this soup come together is all button and nothing else.

 

[rvallee]

Feedback from participants and their parents

This is seriously insulting. Dismissing feedback from the patient community is the main reason why this psychosocial research is so lousy. They basically admit to cherry-pick what feedback they want and only want feedback that curiously happens to align with claims that they have made for years with strong objections from advocates and actual experts.

It's the equivalent of "people are saying". This has no place in academic discourse and makes a mockery of ME advocates' decades-long efforts to engage with this group of ideologues only to be met with, and I quote verbatim from Michael Sharpe upon being told the devastating consequences of his work: "Well if that were true it would be horrible. But it is not".



Well, the claim that it was feedback from participants that made them choose the very thing they happened to have bizarrely been promoting for decades is just that: not true.

The reason for this is that many of the participants are transitioning from GCSEs to A levels in this study and therefore % of school attendance does not necessarily reflect illness severity. For example, a teenager may have decided to take 2 A levels and be attending school for 2-3 hours a day. This would be recorded as 100% school attendance but this does not equate to 6.5 hours a day of normal school attendance.

This is complete throw-mud-in-your-face bullshit!

 

[rvallee]

The process has additionally involved seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase.

Ah, yes, the well-known "pinky promise" process of validating bias in scientific research. Thoroughly validated and a seal of integrity that everyone knows to trust and respect.

 

[Amw66]

The heart of the matter

 

[dreampop]

Also worth noting, Brown says

We are now satisfied that the paper is a robust account of events and that it can be consid-ered as a contribution to the field of CFS research

He admits it's a flawed paper whose author was decietful to the point of making them rewrite portions of the study, but without irony supports its contribution to the field of research, i.e. it's conclusions.

BMJ policy requires prospective registration of randomised trials but we do not consider a failure to enforce that policy grounds for retraction. The corrections to the article are mainly clarifications and we do not believe the article meets any of the Committee on Publication Ethics’ criteria for retraction

The original Editor's note is gone as far as I can tell. This looks like the lowest possible respose above doing nothing, not equivalent to an expression of concern.

 

[dreampop]

I think we have a new precedent from BMJ. Personal reassurances after the fact are an acceptable way to get around core research guidlines. That's what I just read.

 

[Peter T]

Why bother to do actual research, why not just make up the results?

If questioned you can say, but it really is my belief that my made up results are very accurate and represent what we would have found anyway. This is a very powerful approach as it enables you to do double blind studies on behavioural interventions and to have exactly matched controls groups on multiple variables, given you don’t need real people.

It must be valid approach, because the BMJ have confirmed that the researcher’s opinion, at least if they are a professor or are important, matters more than proper scientific method.

 

[Sean]

The process has additionally involved seeking assurance from the authors that the change in primary outcome was not influenced by (positive) findings in the feasibility phase.

As usual, the comedians were there first (relevant bit is from 20:40-21:58, but the whole episode is good):

 

[chrisb]

Why bother to do actual research, why not just make up the results?

That would clearly never do. First one has to make up the conclusion.

 

[Adrian]

We did not have capacity to check school attendance using school records, but this could have provided an objective outcome.

I seem to remember that in an interview Crawley claimed that they had validated the school attendance figures using the school records (it may be a bbc one but can't remember)

 

[Peter T]

I seem to remember that in an interview Crawley claimed that they had validated the school attendance figures using the school records (it may be a bbc one but can't remember)

My fallible memory is that using the school attendance figures was part of the design protocol, and that up to now they had not ‘explained’ why no results were ever published.

 

[chrisb]

My reading of this thread has been rather perfunctory, for the usual reasons. Has it been made clear what she means by "capacity"? It could be that they lacked the resources. It could be that they lacked the authority, permission or status to have the records made available. In either case this should have been predictable when setting up the study.