More PACE trial data released

Robert 1973 said:
Many, many thanks, @JohnTheJack . Great result.

For anyone reading this who is not aware, this has involved a huge amount of work – many, many hours of complex legal arguments against senior academics and highly paid lawyers over many months. For John to have achieved this result on his own, with all the limitations imposed on him by his ill-health, is a remarkable achievement. Thanks also, once again, to Alem Matthees, for helping to pave the way.

I wonder if it might be possible to get some press coverage, especially with it being ME Awareness week.
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Thanks, Rob. That's kind of you.

I would say that I did have some help in the latter stages of the appeal and thank all those who did.

I'll update Tom Whipple who has been kept in the loop all along.
 
So now the question really has to be put to those involved: what was the point of it all? Besides revealing the clear fraud of claiming to have a simple magical cure for a disease as disabling as MS affecting millions, what justification is there in hiding anonymous data from a publicly-funded trial that is mired in controversy and riddled with more flaws than Swiss cheese has holes?

The only plausible explanation is that it reveals their claims were hollow and misleading, that keeping the data secret was strictly and wholly out of self-interest, to protect professional reputations and evade basic accountability. Which is, of course, highly unethical and unprofessional. The Lancet and PLOS come out looking particularly shady and/or incompetent out of this. As does QMUL.

This is especially important to the institutions who enabled this, as they had no valid reasons to provide cover for the researchers' self-interest. They simply failed in their most basic academic obligations and enabled the PACE researchers' self-interest for reasons that need a serious investigation.
 
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JohnTheJack said:
Here are all the trial data so far released, thanks to @sTeamTraen who has combined everything in the one file.
'File is ready to be saved as CSV and then opened in pretty much any statistics program.'


In fact Nick has done a csv file.

Both Excel and CSV file and a consolidated readme file now in this folder.

https://www.dropbox.com/sh/f3nfolkh1hlw9kg/AACb78M_jA3Q_NoBbnbQsWvXa?dl=0
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I'm sure @sTeamTraen has done a fine job - but can I just check what the procedure was for merging the files, and what the common variables were - just so I don't go making any assumptions about the data that I shouldn't be making... ?
 
Here's a summary of the new measures added:

EQ_index is EuroQol-5D-3L (EQ_index in dataset).
The questionnaire asks about 5 items of health (Mobility, Pain/discomfort, Self-care, Anxiety/depression, Usual activities) scored on 3 levels (score 1, 2, 3) + a VAS of current health state (scored 0-100). EQ asks about your health today. The questionnaire used in PACE has also added a question about comparing how you feel now with 1 year ago.
The data in the dataset is the summary index score, and not the health state score (which replicates the individual item scores - eg 12132). The summary index score is normally used for cost-utility analyses. Euroqol summary index scores [in this dataset] appear to be <1.0 (although some are negative) - each country requires its own method of calculation based on age and sex.
The Euroqol user guide (section 4, page 11) provides more info on its calculation from health states obtained from the questionnaire itself: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
I assume higher scores on the index indicate better quality of life.

Hospital Anxiety and Depression Scale is a 14-item scale and asks how you feel over the past week.
Each item scores 0-3. Overall scores between 0 and 21 - presumably because anxiety and depression qs are split (7 questions each).
(HAANT and HADET in dataset).

Work and Social Adjustment Scale (WSAT). 5 items scored on 0-8 scale.
Scores between 0 and 40. No time specified - about how you feel now.

Borg scale is scored between 6 and 20. On the laminated sheet given to pts, 7 is scored "Very, very light", 11="Fairly light", 13="Somewhat hard", 19="Very, very hard".
Measures effort perception after the step test.
(STBOR in dataset)
[ETA: This webpage provides more context: https://www.hsph.harvard.edu/nutritionsource/borg-scale/]

Patient Health Questionnaire records physical (somatic) symptoms in past 4 weeks.
15-item scale. Each item scores 0-2. Scored out of 30.
(PSTOT in dataset)

PACE trial protocol has copies of the questionnaires used, but provides no info on how the scores are calculated.
 
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Lucibee said:
Here's a summary of the new measures added:

EQ_index is EuroQol-5D-3L (EQ_index in dataset).
The questionnaire asks about 5 items of health (Mobility, Pain/discomfort, Self-care, Anxiety/depression, Usual activities) scored on 3 levels (score 1, 2, 3) + a VAS of current health state (scored 0-100). EQ asks about your health today. The questionnaire used in PACE has also added a question about comparing how you feel now with 1 year ago.
The data in the dataset is the summary index score, and not the health state score (which replicates the individual item scores - eg 12132). The summary index score is normally used for cost-utility analyses. Euroqol summary index scores [in this dataset] appear to be <1.0 (although some are negative) - each country requires its own method of calculation based on age and sex.
The Euroqol user guide (section 4, page 11) provides more info on its calculation from health states obtained from the questionnaire itself: https://euroqol.org/wp-content/uploads/2016/09/EQ-5D-3L_UserGuide_2015.pdf
I assume higher scores on the index indicate better quality of life.

Hospital Anxiety and Depression Scale is a 14-item scale and asks how you feel over the past week.
Each item scores 0-3. Overall scores between 0 and 21 - presumably because anxiety and depression qs are split (7 questions each).
(HAANT and HADET in dataset).

Work and Social Adjustment Scale (WSAT). 5 items scored on 0-8 scale.
Scores between 0 and 40. No time specified - about how you feel now.

Borg scale is scored between 6 and 20. On the laminated sheet given to pts, 7 is scored "Very, very light", 11="Fairly light", 13="Somewhat hard", 19="Very, very hard".
Measures effort perception after the step test.
(STBOR in dataset)

Patient Health Questionnaire records physical (somatic) symptoms in past 4 weeks.
15-item scale. Each item scores 0-2. Scored out of 30.
(PSTOT in dataset)

PACE trial protocol has copies of the questionnaires used, but provides no info on how the scores are calculated.
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Thanks for all your work on this @Lucibee
 
I also asked for the Client Service Receipt Inventory scores.

Their response was:

In relation to part 7 – Client Service Receipt Inventory, or CSRI, scores – having considered your request afresh as part of this response, I advise that the CSRI is not a standardised instrument or a variable in its own right; it was a tool used in the PACE trial to collect a very large amount of information (the inventory) which was used to generate healthcare and societal costs. There are several hundred variables of CSRI information in the PACE dataset and Queen Mary would need to receive a more specific request concerning which variables or pieces of information are of interest to you in order to be able to respond to you.
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Anyone have any ideas as to it's worth asking for anything?
 
JohnTheJack said:
I also asked for the Client Service Receipt Inventory scores.

Anyone have any ideas as to it's worth asking for anything?
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This is what the Protocol says about the Client Service Receipt Inventory:

"The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME, [42] will
measure hours of employment/study, wages and benefits received, allowing
another more objective measure of function."

It appears in the Protocol in Appendix 6 item 11 (pages 165-176). I'll put together a summary of the questions asked - it might well be useful.
 
Lucibee said:
This is what the Protocol says about the Client Service Receipt Inventory:

"The Client Service Receipt Inventory (CSRI), adapted for use in CFS/ME, [42] will
measure hours of employment/study, wages and benefits received, allowing
another more objective measure of function."

It appears in the Protocol in Appendix 6 item 11 (pages 165-176). I'll put together a summary of the questions asked - it might well be useful.
Click to expand...

Thanks.
 
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