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FINE Trial team remove raw data file: pressure from PACE Trial team?

Dolphin

Senior Member
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17,567
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0156120

Correction: Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome
  • Lucy P. Goldsmith,
  • Graham Dunn,
  • Richard P. Bentall,
  • Shôn W. Lewis,
  • Alison J. Wearden
logo.plos.95.png




Notice of Republication
S1 Dataset was published in error. The error was corrected in the XML and PDF versions of this article on May 9, 2016. Please download this article again to view the correct version.

Reference
  1. 1. Goldsmith LP, Dunn G, Bentall RP, Lewis SW, Wearden AJ (2015) Therapist Effects and the Impact of Early Therapeutic Alliance on Symptomatic Outcome in Chronic Fatigue Syndrome. PLoS ONE 10(12): e0144623. doi: 10.1371/journal.pone.0144623. pmid:26657793

The file is available at: https://www.mediafire.com/?rvh3brmgoaznude
 
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13,774
They say:

Data Availability: Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn. Alison Wearden can be contacted at: Alison.wearden@manchester.ac.uk. Graham Dunn can be contacted at: Graham.dunn@manchester.ac.uk.

http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0144623
 
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Dolphin

Senior Member
Messages
17,567
I wonder could the PACE Trial team have pressurised the FINE Trial team to remove the file as it made them look bad as they wouldn't share or release similar data despite also publishing in Plos One.

This is another reason that the PACE Trial investigators don't like the data in that file:

http://www.ncbi.nlm.nih.gov/pubmed/23363640#cm23363640_14248

Recovery from chronic fatigue syndrome after treatments given in the PACE trial.
White PD.Psychol Med. 2013.8 commentsTom Kindlon and Lily Chu also commented

Sam Carter2016 Feb 15 5:23 p.m.edited 5 of 5 people found this helpful

Exploring changes to PACE trial outcome measures using anonymised data from the FINE trial.

When the results of the PACE trial were published (1, 2) it was noted that the primary outcome measures and the definition of "recovery" described in the trial's published protocol (3) had been abandoned and replaced with markedly less stringent criteria.

The fully anonymised data set from the FINE trial(4), considered to be the PACE trial's "sister" study, makes it possible to explore how these changes may have affected the reported efficacy of the PACE trial's interventions.

At week 20 (assessment 2), 18 FINE trial participants met PACE trial post-hoc recovery thresholds (SF36 PF ≥ 60 and CFQ Likert ≤ 18) compared to only 3 participants who met the stricter, protocol-defined recovery thresholds (SF36 PF ≥ 85 and CFQ bimodal ≤ 3). Therefore, at assessment 2, the post-hoc changes increased the "recovery" rate by a factor of 6.

By week 70 (assessment 3), between 10 and 12 of the original 18 had relapsed so that they no longer met the post-hoc recovery thresholds (data are missing for two participants). Such a high rate of relapse within a year shows that the post-hoc recovery thresholds, said to represent a "strict criterion for recovery" in a Comment (5) which accompanied the original publication of PACE trial results, are neither strict nor reliable indicators of sustained wellbeing.

Regarding the Chalder fatigue questionnaire, White et al wrote that "we changed the original bimodal scoring of the Chalder fatigue questionnaire (range 0–11) to Likert scoring to more sensitively test our hypotheses of effectiveness" (1). However, data from the FINE trial show that Likert and bimodal scores are often contradictory and thus call into question White et al's assumption that Likert scoring is necessarily more sensitive than bimodal scoring.

For example, of the 33 FINE trial participants who met the post-hoc PACE trial recovery threshold for fatigue at week 20 (Likert CFQ score ≤ 18), 10 had a bimodal CFQ score ≥ 6 so would still be fatigued enough to enter the PACE trial and 16 had a bimodal CFQ score ≥ 4 which is the accepted definition of abnormal fatigue.

Therefore, for this cohort, if a person met the PACE trial post-hoc recovery threshold for fatigue at week 20 they had approximately a 50% chance of still having abnormal levels of fatigue and a 30% chance of being fatigued enough to enter the PACE trial.

A further problem with the Chalder fatigue questionnaire is illustrated by the observation that the bimodal score and Likert score of 10 participants moved in opposite directions at consecutive assessments i.e. one scoring system showed improvement whilst the other showed deterioration.

Moreover, it can be seen that some FINE trial participants were confused by the wording of the questionnaire itself. For example, a healthy person should have a Likert score of 11 out of 33, yet 17 participants recorded a Likert CFQ score of 10 or less at some point (i.e. they reported less fatigue than a healthy person), and 5 participants recorded a Likert CFQ score of 0.

The discordance between Likert and bimodal scores and the marked increase in those meeting post-hoc recovery thresholds suggest that White et al's deviation from their protocol-specified analysis is likely to have profoundly affected the reported efficacy of the PACE trial interventions.

An independent re-analysis of anonymised PACE trial data as described in its published protocol is urgently required to quantify the effects of the revised outcome and recovery criteria.

References

(1) White PD et al (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet Mar 5;377(9768):823-36.
(2) White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M (2013) Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. Oct;43(10):2227-35.
(3) White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R (2007) Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BMC Neurol Mar 8;7:6.
(4) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4685991/bin/pone.0144623.s002.dta
(5) Bleijenberg G, Knoop H. (2011) Chronic fatigue syndrome: where to PACE from here? Lancet. Mar 5;377(9768):786-8.
 
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JaimeS

Senior Member
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3,408
Location
Silicon Valley, CA
This is another reason that the PACE Trial investigators don't like the data in that file:

http://www.ncbi.nlm.nih.gov/pubmed/23363640#cm23363640_14248

Wowww. Nice write-up!

Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn.

Bona fide researchers... defined as "those who agree with us", presumably.

How do they get to decide who counts as a 'real' researcher? This in and of itself is offensive. Either information is available to everyone or we're just "taking their word for it".

New meme because I can't believe I found this:

a22579b8a63e04dbc5fc8e0687fae503.jpg
 
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Messages
2,087
Wowww. Nice write-up!
Yes that letter alone is so telling.

How can data be treated seriously when patients quite clearly were confused

[ETA Thanks @Dolphin for pointing out i had incorrect author, sorry I saw Toms name and got confused]
 
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snowathlete

Senior Member
Messages
5,374
Location
UK
You don't publish raw data in error and then take months to correct it. If such a genuine error were to be made it would be an extremely serious breach requiring serious questions about researcher and journal procedures, and in such a case would be corrected very promptly, as in hours, or at worst, days.

I am being asked to believe the data was published in error and not noticed for eons and that the current political pressure on FINE's sister study (PACE) to publish their comparable data is a coincidence and nothing to do with this. I do not buy it. Who would? In today's modern world where you cannot publish anything on the internet and then take it back and bury it, there would be no logic in publishing a correction where the data is absent. The more obvious logic is that FINE having released their data made it incredibly difficult for it's sister trial PACE to refuse to publish comparable data when they have been asked to do so and this move gives PACE an answer when presented with that question: FINE published their data. Why can't you?
 

Yogi

Senior Member
Messages
1,132
Received: December 18, 2014; Accepted: November 19, 2015; Published:December 14, 2015

Data Availability: Our ethical permission did not expressly permit us to share patient data, even anonymised patient data, in a public forum. Data will be made available to bona fide researchers on application to the principal investigator, Alison Wearden or the trial statistician, Graham Dunn. Alison Wearden can be contacted at: Alison.wearden@manchester.ac.uk. Graham Dunn can be contacted at: Graham.dunn@manchester.ac.uk.

It took them 17 months to notice this ethical breach after submitting?

It took them 5 months to notice this ethical breach after it being in the public domain where "motivated intruders" and "vexatious ME activists" had access to it and risked "de-anonomysing the data" ?

Someone should alert there ethics and governance of Manchester university. Surely the University of Manchester should launch an urgent investigation and these investigators should be suspended with immediate effect whilst this investigation takes place.


The FINE And PACE PIs really do think we are fools.
 
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