New Video - The PACE trial - Part 1: Moving the goalposts

https://www.youtube.com/watch?v=s0aN5MZ6u5w

Half the research spending for ME in a 10 year period in the UK went on the widely discredited £5M PACE trial [1]. The trial is taught in textbooks [2] and universities [3] as an example of how not to conduct a clinical trial. Over 100 experts and 80 charities want an independent review [4] and 40 MPs want a public inquiry [5].

The authors had a strict plan which had been approved and published, but they decided to change that plan after the trial had started. The changes resulted in the publication of a study that was fundamentally flawed and uninterpretable. The main flaw is that the trial is unblinded and primarily relies on the results of patient questionnaires [6]. Students for best evidence, supported by Cochrane, state" If you are reading a study that is un-blinded, with subjective outcome measures, then you may as well stop reading it" and if a trial is unblinded the measures "must be objective!" [7]. Subjective measures like questionnaires are not reliable especially when the treatment encourages patients to think positively [8]. A freedom of information request of the trial steering committee minutes found that actimeters which objectively measure activity were dropped at the end of the trial because a Dutch study reported negative results [9] [10].

They also lowered their definition of improvement and recovery. Recovery was lowered to a level similar to patients with congestive heart failure [11]. The claim that patients can recover is not justified by the data and is highly misleading to clinicians and patients [12] [13]. Changes meant that 13% of participants were already recovered on a key measure before the trial had even started [14]. Ron Davis stated "I'm shocked that the Lancet published it... I don't understand how it got through any kind of peer review" [15].

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@Adam pwme
lovely professional job.
Very good timing too!

 

@Adam pwme excellent video, thank you

 

Thanks Sly and Amy.

And thanks for sharing @Andy

 

Great video. Will share widely .
Thanks @Adam pwme

 

Thanks Amw66

 

This looks great @Adam pwme ! Must have been lots of hard work.

Just one minor remark. "Recovery was lowered to a level similar to patients with congestive heart failure" - this only refers to one of the recovery measures, physical functioning. In their response PACE defenders always emphasize this; that the recovery definition had multiple dimensions etc. Their argument doesn't really make sense IMHO because all of those dimensions had problems and such mistakes should be embarrassing anyway, even if it is only about a part of the recovery definition.

Anyway, I see that you formulated it correctly in the following sentence: "Changes meant that 13% of participants were already recovered on a key measure before the trial had even started ." So it's probably ok. Just wanted to emphasize it again, to be careful about this point.

Thanks for your hard work.

 

Very very good, thank you very much @Adam pwme

 

Thanks Michiel. Good point, yes that could have been clearer, will make a note. Unfortunately the PACE authors never seem to be worried about being embarrassed.

 

@Adam pwme

Wow!

Great video! Thank you for all your work on this.

Hope it's widely shared.

 

I get no sound on the third video, ditto when I view it on YouTube.

 

Thanks @DokaGirl

@MeSci The other videos are credits, I've deleted to avoid confusion.

 

good video watched and liked on you tube since likes really count . the music seems very like the haunting music in the mass effect game series . thanks for your hard work and all those involved with making this . damn have you seen the comment underneath on you tube it does no one any favours .

 

Thanks AlkTipping

And I'd not read it properly. have removed it now. Thanks for the heads up

 

Thanks Nellie it's the thought that counts

 

Thank you @Adam pwme .

As listening to and watching videos for me is a much more demanding activity than reading, I am particularly grateful that you provide a transcript here as well as on youtube.

Very much appreciated!

 

Thanks, I have done full transcripts for my other videos. But I haven't done it for this one as they keep causing me to crash. I think it's listening and typing at the same time. I tried a company for the last one but they were awful. So if anyone knows a more reliable service or has any ideas I would be grateful.

 

I can recommend @Sly Saint, who has done great work with transcripts for recent Q&As of mine.