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Investigator bias and the PACE trial by Steve Lubet in Journal of Health Psychology

Yogi

Senior Member
Messages
1,132
Investigator bias and the PACE trial by Steve Lubet in Journal of Health Psychology
http://journals.sagepub.com/doi/full/10.1177/1359105317697324

Abstract
The PACE investigators reject Geraghty’s suggestion that the cognitive behavior therapy/graded exercise therapy trial could have been better left to researchers with no stake in the theories under study. The potential sources and standards for determining researcher bias are considered, concluding that the PACE investigators “impartiality might reasonably be questioned.”

http://me-pedia.org/wiki/Steven_Lubet
 

Tom Kindlon

Senior Member
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1,734
Lubet 2017.png


 

Tom Kindlon

Senior Member
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1,734
This doesn't surprise me. When I was seeing one of the PACE investigators long before PACE (in 1990) he actually said to me (after CBT and GET had landed me in hospital) 'I will be proved right, my career depends on it'.

https://www.facebook.com/TomKindlonMECFS/photos/a.657395361075259.1073741828.656049027876559/786813581466769/?type=3&comment_id=786816638133130&comment_tracking={"tn":"R0"}

She has now added that this was Michael Sharpe:
https://www.facebook.com/TomKindlon...d=786892678125526&comment_tracking={"tn":"R"}
 
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alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
[Satire]

"Oh, look" said the boy. "The Emperor has no clothes." He started giggling.

The bystanders at first averted their gaze, and refused to say anything, then they all started pointing. Some started giggling too.

The Emperor called for his guards. "Heads must roll, this is a plot against the Empire!"

He was right, but the plot was in his court, not in public.
 
Messages
2,391
Location
UK
Steven Lubet looks to be a bit of a legal eagle, and well placed to draw the conclusions he has.

Only one comment I would split hairs on:
The PACE investigators state that they have “always wanted the best” for their patients, of which I have no doubt at all
I think it warrants the corollary that they nonetheless wanted the best for themselves more.
 

Tom Kindlon

Senior Member
Messages
1,734
This doesn't surprise me. When I was seeing one of the PACE investigators long before PACE (in 1990) he actually said to me (after CBT and GET had landed me in hospital) 'I will be proved right, my career depends on it'.

https://www.facebook.com/TomKindlonMECFS/photos/a.657395361075259.1073741828.656049027876559/786813581466769/?type=3&comment_id=786816638133130&comment_tracking={"tn":"R0"}
She has now added that this was Michael Sharpe:
https://www.facebook.com/TomKindlon...d=786892678125526&comment_tracking={"tn":"R"}
 

Tom Kindlon

Senior Member
Messages
1,734
Somebody reminded me of the following quote today which they suggested would have been good for this piece:

Handoll and Hanchard argued that a cardinal rule for investigating whether a medical innovation truly works is “the need to separate the clinical evaluation of innovations from their innovators, who irrespective of any of their endeavours to be ‘neutral’ have a substantial investment, whether emotional, perhaps financial, or in terms of professional or international status, in the successful implementation of their idea.”7

Handoll, H and Hanchard, N.From observation to evidence of effectiveness: the haphazard route to finding out if a new intervention works.Cochrane Database Syst Rev.2014;5:ED000081
Sean B M Kirby quoted it in his letter on the PACE trial:
http://www.thelancet.com/journals/lanpsy/article/PIIS2215-0366(15)00110-8/fulltext
 
Messages
2,391
Location
UK
It is why in engineering you have independent testers, often part of the QA (quality assurance) department, who have independent veto if necessary. Designers are still responsible for doing their own testing, but they absolutely do not have the last word on whether their work fulfils requirements to the necessary quality. I find it somewhat mind boggling that in something so crucial as medical research, the complete opposite seems the norm.
 

Yogi

Senior Member
Messages
1,132
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Yogi

Senior Member
Messages
1,132
Steven Lubet looks to be a bit of a legal eagle, and well placed to draw the conclusions he has.

"The PACE investigators state that they have “always wanted the best” for their patients, of which I have no doubt at all"

Only one comment I would split hairs on: I think it warrants the corollary that they nonetheless wanted the best for themselves more.

Great article and nice to see the legal side of things. Big thanks to Prof Steven Lubet for writing this publication. I would agree that that part of the conclusion is not right. I am unsure as a lawyer if he was just being very charitable to the PACE team.

The article also stated "There are no comparably strict rules of recusal for clinical trials, nor could there be."

Agreed in the context of pharmaceutical and medical device company conflicts of interest. However having insurance/DWP conflicts of interests throughout their careers is highly unusual (if not unprecedented) and diametrically opposed to the interests of patients unlike pharma examples.

Corrected:
"The PACE investigators state that they have “always wanted the best” for their insurance paymasters, of which I have no doubt at all"

See:

http://www.virology.ws/2015/11/17/t...surance-companies-not-related-to-pace-really/

http://www.centreforwelfarereform.org/library/type/pdfs/in-the-expectation-of-recovery.html

http://www.margaretwilliams.me/2013/role-of-science-media-centre-and-insurance-industry.pdf

Good article overall!
 
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