More PACE trial data released

@Brian Hughes

 

And maybe weakens future arguments against accessing more data.

 

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.

 

Ah ha! I got it wrong, thinking it down to the fact that people called John often get nicknamed Jack, though I've no idea why.

 

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.

 

Twas a mere triviality in comparison with the work you did to obtain it!

 

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.

 

Do we know what the inventory comprises, in order to assess what might be worth asking for? Or is it a catch-22 in that can only know once you have it?

ETA: @Lucibee answered in x-post.