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PACE Trial team won't release data they've already published in graph form

Dolphin

Senior Member
Messages
17,567
I came across this while doing a search of the whatdotheyknow.com website where UK Freedom of Information requests can be made:

https://www.whatdotheyknow.com/request/fitness_data_for_pace_trial

From: Graham McPhee

29 June 2015

Dear Queen Mary, University of London,

I am writing to request the fitness data for the PACE Trial (on Chronic Fatigue Syndrome).

That is to say the
(i) mean
and
(ii) standard deviation

for each of the four arms of the trial
i.e. (a) CBT (b) GET (c) APT and (d) SMC-alone
at
(I) baseline
(II) 12 weeks
(III) 24 weeks
(IV) 52 weeks.

This data was presented in Figure 2 in the following paper that was published earlier this year:
Chalder T, Goldsmith KA, White PD, Sharpe M, Pickles A. Rehabilitative therapies for chronic fatigue syndrome: a secondary mediation analysis of the PACE trial. Lancet Psychiatry 2015; published online Jan 14.
http://dx.doi.org/10.1016/S2215-0366(14)00069-8

However, the figure is too small to extract the exact data.

Yours faithfully,

Graham McPhee

Queen Mary, University of London claim it is a vexatious request.
 

Dolphin

Senior Member
Messages
17,567
This relates to this graph. CBT and GET had the lowest (i.e. worst) fitness scores at 52 weeks
Chalder2015 fitness and legend.jpg


Time points are baseline, 12 weeks, 24 weeks and 52 weeks.
 
Last edited:

MeSci

ME/CFS since 1995; activity level 6?
Messages
8,231
Location
Cornwall, UK
Maybe if someone stretched the graph to show the differences more clearly, the approximate improvements and deteriorations could be roughly estimated. The graphical form and the scales of the axes are badly chosen.
 

Daisymay

Senior Member
Messages
754
Excellent reply from Graham to the Queen Mary rejection of his FOI request on the grounds that it was vexatious:

https://www.whatdotheyknow.com/request/fitness_data_for_pace_trial

From: Graham McPhee

28 July 2015

Dear Queen Mary, University of London,

Please pass this on to the person who conducts Freedom of
Information reviews.

I am writing to request an internal review of Queen Mary,
University of London's handling of my FOI request 'Fitness data for
PACE trial'.

I was very surprised to find that my request has been turned down
on the basis that it was "vexatious". I looked at the guidelines
and found: "The key question to ask yourself is whether the request
is likely to cause a disproportionate or unjustifiable level of
distress, disruption or irritation. Bear in mind that it is the
request that is considered vexatious, not the requester." The data
in question has already been calculated and is a fundamental part
of the analysis: it has been used as the basis of a low-resolution
diagram in the study. If publishing such a diagram is acceptable,
how can requesting publication of the actual numbers on which it is
based be vexatious?

As a mathematician with ME, I take a keen interest in research into
the illness, and, to me, data speaks much more convincingly than
words. I am on record
(http://www.bmj.com/content/342/bmj.d3780...) as
recognising the importance of the PACE trial, but not accepting the
validity of its analysis and conclusions. There is no logic in
turning down my request according to the guidelines: I can only
assume that my scepticism of the conclusions of the PACE trial, and
my wish to analyse the data for myself has played a part here. Such
a reason is explicitly denied in the guidelines: a refusal must
relate to the information required, not the person making the
request. In the scientific world it is considered important for
data to be available and to be analysed by supporters and sceptics
alike, in order to arrive at the truth. Sadly that does not seem to
be the situation here. As such I believe the refusal more closely
fits a description of "vexatious".

A full history of my FOI request and all correspondence is
available on the Internet at this address:
https://www.whatdotheyknow.com/request/f...

Yours faithfully,

Graham McPhee
 

A.B.

Senior Member
Messages
3,780
@Graham the approximate real values of the data points:

Code:
Baseline:

  SMC: 1.84375  (1.640625 - 2.078125)
  GET: 1.75     (1.46875  - 2.046875)
  CBT: 1.78125  (1.5625   - 2       )
  APT: 1.609375 (1.46875  - 1.765625)

At 52 weeks:

  SMC: 2.03125  (1.6875   - 2.375   )
  GET: 1.859375 (1.671875 - 2.046875)
  CBT: 1.875    (1.59375  - 2.140625)
  APT: 2.015625 (1.640625 - 2.375   )

I used the GIMP graphics program with guides and the measurement tool. Any of these values is at most off by a pixel which would be 1/64 (unless I messed up positioning of the guides). I hope the formatting works for everyone.
 
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Messages
15,786
Approximated change from baseline to 52 weeks:
SMC = +0.1875
GET = +0.109375
CBT = +0.09375
APT = +0.40625

That seems like a pretty big increase in the pacing group, compared to the GET and CBT groups. Any chance it's statistically significant? That might explain their strong opposition to providing the actual figures, and making the differences look miniscule by using a crappy graph.
 

A.B.

Senior Member
Messages
3,780
Approximated change from baseline to 52 weeks:
SMC = +0.1875
GET = +0.109375
CBT = +0.09375
APT = +0.40625

That seems like a pretty big increase in the pacing group, compared to the GET and CBT groups. Any chance it's statistically significant? That might explain their strong opposition to providing the actual figures, and making the differences look miniscule by using a crappy graph.

There also seems to be a curious ceiling effect in the GET group. The high end of the range at baseline is exactly the same as the high end of the range at 52 weeks (both 2.046875). At least that is the final outcome, at 12 and 24 weeks GET fares a bit better. But maybe I'm trying to read too much into it.
 

user9876

Senior Member
Messages
4,556
Approximated change from baseline to 52 weeks:
SMC = +0.1875
GET = +0.109375
CBT = +0.09375
APT = +0.40625

That seems like a pretty big increase in the pacing group, compared to the GET and CBT groups. Any chance it's statistically significant? That might explain their strong opposition to providing the actual figures, and making the differences look miniscule by using a crappy graph.

The other interesting thing about the APT group is there starting position is quite a bit lower with the higher bound (is that 1SD?) being around the level of the other groups. Obviously they didn't control for this.
 

anciendaze

Senior Member
Messages
1,841
Oh, by the way, has anyone noticed the obvious about the hypothesis that false illness beliefs and deconditioning produce chronic fatigue syndrome? There were changes in subjective measures, but this had essentially no effect on objective measures of physical condition, except for the questionable 6-minute walk test where about 1/3 of participants declined the test. (This leaves the result open to the criticism that they are measuring stratification of the cohort, so that those who are in worse condition are more likely to decline the test.)

Bottom line: the original "false illness belief" hypothesis has been falsified by this study.
 

Kyla

ᴀɴɴɪᴇ ɢꜱᴀᴍᴩᴇʟ
Messages
721
Location
Canada
How was 'fitness' defined?

Looking at the trial protocol it is a "step test"
Secondary outcome measures – Secondary efficacy measures
1. The Chalder Fatigue Questionnaire Likert scoring (0,1,2,3) will be used to compare responses to treatment [27].

2. The self-rated Clinical Global Impression (CGI) change score (range 1 – 7) provides a self-rated global measure of change, and has been used in previous trials [45]. As in previous trials, we will consider scores of 1 or 2 as a positive outcome ("very much better" and "much better") and the rest as non-improvement [23].

3. The CGI change scale will also be rated by the treating therapist at the end of session number 14, and by the SSMC doctor at the 52-week review.

4. "Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47,48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].

5. The Hospital Anxiety and Depression Scale scores in both anxiety and depression sub-scales [38].

6. The Work and Social Adjustment scale provides a more comprehensive measure of participation in occupational and domestic activities [33].

7. The EuroQOL (EQ-5D) provides a global measure of the quality of life [39].

8. The six-minute walking test will give an objective outcome measure of physical capacity [31].

9. The self-paced step test of fitness [43].

10. The Borg Scale of perceived physical exertion [44], to measure effort with exercise and completed immediately after the step test.

11. The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME [31], will measure hours of employment/study, wages and benefits received, allowing another more objective measure of function.

12. An operationalised Likert scale of the nine CDC symptoms of CFS [1].

13. The Physical Symptoms (Physical Health Questionnaire 15 items(PHQ15)) [35].

14. A measurement of participant satisfaction with the trial will also be taken at 52 weeks [53].

The reference linked there goes to this:
http://www.ncbi.nlm.nih.gov/pubmed/11380757/

So it appears to be...a VO2 max test!

No wonder they are hiding the results from this.
 

Kyla

ᴀɴɴɪᴇ ɢꜱᴀᴍᴩᴇʟ
Messages
721
Location
Canada
Time to start demanding a published retraction of their dubious conclusions?
 

user9876

Senior Member
Messages
4,556
Looking at the trial protocol it is a "step test"


The reference linked there goes to this:
http://www.ncbi.nlm.nih.gov/pubmed/11380757/

So it appears to be...a VO2 max test!

No wonder they are hiding the results from this.

Its not a Vo2 max test but its a test that someone developed to give roughly the same results but which is easier to do and hence more appropriate for people with chronic illness or as people age.

I believe it involves repeatedly climbing on a step (i think for a fixed number of times) and then the results are modified by body mass (weight) and final heart rate.