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

MSEsperanza · Jul 30, 2019

Adam pwme said: ↑

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.
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Well, I was amazed at the video's succinctness...

Grigor · Jul 30, 2019

Andy said: ↑

I can recommend @Sly Saint, who has done great work with transcripts for recent Q&As of mine.
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Let me know. Otherwise I can ask on my page as well.

Adam pwme · Jul 30, 2019

Grigor said: ↑

Let me know. Otherwise I can ask on my page as well.
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Thanks Anil have asked SlySaint will let you know

Sly Saint · Jul 30, 2019

Adam pwme said: ↑

Thanks Anil have asked SlySaint will let you know
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have replied.
glad to help if I can.

Adam pwme · Jul 30, 2019

Thanks Sly

ME/CFS Skeptic · Jul 30, 2019

Sly Saint said: ↑

glad to help if I can.
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Thanks for doing all these transcripts.

Jonathan Edwards · Jul 30, 2019

Excellent piece.
All the key points.
No flannel.
Concise.
Visually spot on.

Jonathan Edwards · Jul 30, 2019

@Adam pwme

Can you do me a Power Point file for the screen at 1.38 for my NICE committee presentation - maybe even a few more of the static shots?

Barry · Jul 30, 2019

Adam pwme said: ↑

Unfortunately the PACE authors never seem to be worried about being embarrassed.
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Goes with the mindset. Arrogance and embarrassment tend to be mutually exclusive.

Adam pwme · Jul 30, 2019

Jonathan Edwards said: ↑

@Adam pwme

Can you do me a Power Point file for the screen at 1.38 for my NICE committee presentation - maybe even a few more of the static shots?
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Thanks Jonathan,

I don't have power point but I can export images and post them here. Is that OK?

Jonathan Edwards · Jul 30, 2019

Adam pwme said: ↑

Thanks Jonathan,

I don't have power point but I can export images and post them here. Is that OK?
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Sure, I can usually slide images across very simply.

Adam pwme · Jul 30, 2019

Adam pwme · Jul 30, 2019

Adam pwme · Jul 30, 2019

Here you go Jonathan, Let me know if you need anything else.

Sly Saint · Jul 30, 2019

Transcript

The PACE trial – Part 1 Moving the Goalposts

Slide 1 –

Half the research spending for ME in a 10 year period went on the widely discredited £5M PACE trial.

Gordon Brown 2008 – Ask the Prime Minister

The Medical Research Council has made it clear that research into M.E. is something that we are taking very seriously indeed. It’s a very big part of the research plan for the future, and I hope we will be able to report results in due course.

Slide 2 –

The PACE trial is taught in Universities and text books as an example of how not to conduct a clinical trial.

Slide 3 –

Over 100 experts and 80 charities want an independent review and 40 MPs want a public enquiry.

Carol Monaghan MP Glasgow North West SNP House of Commons debate 2019

When the full details of the trial become known this will be put down as one of the biggest medical scandals of the 21st Century.

Slide 4 -

The authors had a strict plan which had been approved and published.

But they decided to change that plan after the trial had started.

Dr Bruce Levin Professor of Biostatics

If you say you are going to do something, and you get funded to do it,

and approved by all kinds of review committees, then you ought to do it.

You are not allowed to wiggle out of it, it’s not good science, not good statistics.

Slide 5 –

The changes resulted in the publication of a study that was fundamentally flawed and uninterpretable.

Professor Brian Hughes National University of Ireland (Northern Ireland presentation)

Even if you know nothing more about the PACE trial except than it’s a non-blinded trial based on self report, you know enough to know that you cannot rely on that trial. That trial is not a good study. By definition, no matter what the researchers say, no matter what journals publish it, no matter how people defend it, it’s fundamentally flawed.

Slide 6 – “If you are reading a study that is un-blinded with subjective outcome measures then you may as well stop reading it” –

Students for Best Evidence, supported by Cochrane UK

Professor Brian Hughes National University of Ireland (Northern Ireland presentation)

Blinding is when in a therapy study for example you don’t tell the participant what the therapy is supposed to do. You don’t tell the participant that they are in the ‘good’ therapy group instead of the ‘bad’ therapy group. You come up with a way of hiding that information from the participant so that their self reports don’t become biased by expectation. Because if you’re told over and over again ‘you’re getting a fantastic therapy, this is wonderful’ when you fill out the questionnaire you’re going to say ‘the therapy was wonderful, I’m feeling a lot better now’.

Slide 7 –

Subjective measures, like questionnaires, are not reliable, especially when the treatment encourages patients to think positively.

Faulkner 2016, Centre of Welfare Reform

Carol Monaghan MP Glasgow North West SNP House of Commons debate 2019, reading participant in PACE trial testimony

"I started to feel like I had to put a positive spin on my answers.

I could not be honest about just how bad it was, as that would tell them I wasn’t trying and I wasn’t being positive enough. When I was completing the questionnaires, I remember second guessing myself, thinking after every answer ‘ is it really that bad? Am I just not looking at things positively enough?’"

Slide 8 –

“In cases where blinding is not possible or feasible the outcome measures must be objective!”

Students for Best Evidence, supported by Cochrane UK

Dr Fred Friedberg PhD Research Associate Professor

We need more than just a self-report that is telling us they don’t feel limited. So if we have an actigraph to confirm what they’re doing we’ll have a sense of what changes there are objectively, more objectively than just a self-report where people are trying to put together what their functioning has been.

Slide 9 –

Actimeters which objectively measure activity were dropped at the end of the trial because a Dutch study reported negative results.

(PACE trial steering committee minutes. Info obtained by FOI request 2018)

John Peters ME patient and FOI requester

We looked at the minutes of the management committees and we saw that they dismissed the actimeters at the end of the trial because the readings didn’t confirm the subjective improvement. And I think that is a massive giveaway, because it reveals, straight off, that they’d become so convinced that they were right, that if any evidence didn’t fit, it was the evidence that was wrong.

Slide 10 –

They also lowered their definition of improvement and recovery.

Recovery was lowered to a level similar to patients with congestive heart failure.

(Agardy 2017 Journal of Health Psychology)

Carol Monaghan MP Glasgow North West SNP House of Commons debate 2019

It was discovered that the authors had altered the way in which they measured improvement and recovery to increase the apparent benefit of the therapies. Reanalysis shows that the improvement rate fell from 60% to just 21% and the recovery rate from 22 to just 7%.

Slide 11 –

“The claim that patients can recover is not justified by the data and is highly misleading to clinicians and patients”

(Wiltshire et al 2017 – Fatigue: Biomedicine, Health and Behavior)

Dr Bruce Levin Professor of Biostatics

This redefinition allowed the investigators to massively exaggerate the success of the trial results. The characterisation of the results and the spin that these investigators have applied to the results are not really justified.

Slide 12 –

Changes meant 13% of participants were already classed as recovered on a key measure before the trial had even started.

(Geraghty 2017 - Journal of Health Psychology)

Dr Bruce Levin Professor of Biostatics

So as a result of these changes, 13% of patients were already recovered at the start of the study. In other words ‘congratulations you are eligible, with your consent you are involved in the trial…oh, congratulations you’re now recovered’.

Slide 13 –

“I’m shocked that the Lancet published it…I don’t understand how it got through any kind of peer review”.

(Dr Ron Davis, Professor of Biochemistry and Genetics, Director of the Stanford Genome Technology Center)

David Tuller DrPh, Senior Fellow in Public Health

PACE is a major case of scientific misconduct and really needs to be investigated at the highest levels of the MRC and UK medical establishment. It is impossible to have a study in which participants meet outcome thresholds at baseline. If 13% of participants have met an outcome threshold at baseline and you do not reveal that in your study, that is research misconduct. It is very clear, it is not hard to figure out.
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Adam pwme · Jul 30, 2019

Thanks @Sly Saint you are a legend!

Sly Saint · Jul 30, 2019

Adam pwme said: ↑

Thanks @Sly Saint you are a legend!
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ah yes, they will sing many songs about my transcripts..........to use a quote by that well known ME/CFS researcher ......."'I always think that if I was involved in a car crash, and my femoral artery
was gushing blood and I knew I only had five minutes left, I
would hope I’d say “At least I made a difference to pwME needing transcripts”.’

Adam pwme · Jul 30, 2019

Sly Saint said: ↑

ah yes, they will sing many songs about my transcripts..........
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Ha! Yes they definitely should

Jonathan Edwards · Jul 30, 2019

Adam pwme said: ↑

Here you go Jonathan, Let me know if you need anything else.
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Brilliant. All set now!

JohnTheJack · Jul 30, 2019

Excellent work, @Adam pwme Thank you very much.

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