Karina Hansen 6: THE HOMECOMING

My joy at this wonderful news is tainted with bitterness that this young woman was subjected to unspeakable arrogance and cruelty

valerieeliotsmith

KarinaHansenStockPicKARINA HANSEN, “PRISONER OF DENMARK”, IS HOME AT LAST.

On Monday 17 October 2016, after three and a half years of incarceration, Karina finally returned home to her family. The arrangement was on a trial basis but in the hope and expectation that she would be finally and permanently back where she belongs.

In recent weeks, Karina’s condition had improved slightly and her parents were able to visit her on a regular basis (more detail in my previous post). As a result, meetings took place between those in charge of the Clinic at Hammel where she had been an inmate since February 2013 (see Karina’s Story below for background) and representatives of Karina’s family. An arrangement for Karina’s return home was agreed whereby her parents would take her home within the next few days and she would remain there for a trial period. If all went well…

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The PACE Trial – ‘Illegal’ Participants skew the data

Changing the Protocol to admit less severely ill patients was rather desperate.  But then concocting the outcome measure ‘Normal Range’ which meant that some participants had recovered before they started, has made a laughing-stock of the PACE Trial.  But what did it do to the data?  Actually, it is not dreadful, but then again, it is not science.  Splitting the treatment groups into ‘legal’ and ‘illegal’ participants illustrates the difference between them.  Participants are ‘legal’ if their baseline score is BELOW the threshold of ‘Normal Range’ (60).  They are ‘illegal’ if their baseline is equal to or above that score – because, well, you just can’t do that!  It’s DUMB.

CBT group SF36PF

CBT group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=20:

i.e., already ‘Normal Range’

Legal Participants Illegal Participants
Baseline Average  = 36 Baseline Average  = 62
Outcome Average = 56 Outcome Average = 75

The ‘illegal’ CBT participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
80% scored 60 or more and were ‘Normal Range’
60% scored 75 or more and were ‘Improved’ as per the Protocol
45% scored 85 or more and were ‘Recovered’ as per the Protocol

 

 

SMC group SF36PF

SMC group SF36PF.

Baseline score 55 or less n=128

Baseline score 60 or more n=22:

i.e., already ‘Normal Range’

Baseline Average  = 34 Baseline Average  = 62
Outcome Average = 47 Outcome Average = 71

The ‘illegal’ SMC participants who joined the Trial already at ‘Normal Range’ had these SF36PF outcomes:
82% scored 60 or more and were Normal Range
50% scored 75 or more and were ‘Improved’ as per the Protocol
23% scored 85 or more and were ‘Recovered’ as per the Protocol

Conclusion

The incredible blunder of positioning an outcome threshold BELOW the level required for participation has had an effect on the outcome.  The overall influence has been limited due to the Control Group, but in a Trial where the researchers were evidently scrabbling for a few points here and there, the influence has significance.

PACE Trial CBT v. SMC

The PACE Trail Protocol states: “We propose that a clinically important difference would be between 2 and 3 times the improvement rate of SSMC.”

The chart below shows actual, individual CHANGES between baseline (start of the trial) and the 52 week Outcome for 148 participants in the CBT and SMC groups.  Added, are CHANGES in the SMC (Control Group) multiplied by 2 (blue) and 3 (green). These show the difference expected by the researchers.  If CBT had been effective, the red line would be between or above the blue and green lines at all points.

smcvcbtdifference

CBT failed in the PACE Trial – the data proves it. No torture was involved, I politely asked the data whether CBT lived-up to White et al’s expectations. It did not come close.  The only way to claim a treatment-effect from these outcomes is by denying the data.

PACE Trial Chalder Fatigue Questionnaire Data

In the charts below, each vertical blue line represents a PACE Trial participant’s BASELINE (before treatment) CFQ score.

The dark-red dot vertically aligned shows that same participant’s OUTCOME at 52 WEEKS.

A LOWER score means LESS fatigue. An effective treatment for fatigue would have the majority of red dots scoring 12 or lower.  It should also have many times more dots at this level than the Control Group (SMC).

cfq0and52smc

cfq0and52apt

cfq0and52cbt

cfq0and52get

The chart below shows the corresponding CFQ Baseline (yellow) CFQ Outcome (green) and SF36PF (red dots) for each participant in the CBT group.  There is little correlation between CFQ baseline and outcome or with the SF36PF.  The data is so random that no reliable or consistent influence could produce these results.  This is a NULL treatment-effect.

cfqbaseoutcomesf36pfoutcome

Do You Know About Action T4? The Erasure Of Disabled People From The Holocaust Narrative, And Why It Matters Today

Brilliant! From overview to detail and daily struggles to orchestrated vilification and eradication. Relevant for all disability campaigners.

Granite and Sunlight

“[£200,000] is what this person suffering from a hereditary defect costs the People’s community during his lifetime. Fellow citizen, that is your money too.”


Sioux Blair-Jordan outside the conference, from the East Anglia Daily Times.

In the midst of the most controversial Labour Conference in recent times, the speeches were pored over for things to be outraged about. The country needed to show that the Party had been taken over by ‘lefty loonies’ and, while the big names got front page headlines, other speakers became easy targets. One of these was Sioux Blair-Jordan, a Labour disability rights campaigner, who gave a powerful speech about the dehumanising narrative regarding sickness and disability emanating from the government, and the risks disabled people face if the Conservative Government follows through on their campaign pledge to dissolve the power of the European Court of Human Rights in the UK. The media and commentariat exploded with…

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Coercion of Participants in the PACE Trial

This follows on from my blogs:
The Science Media Centre and the PACE Trial – a deceptive partnership (https://wordpress.com/post/peterkempblog.wordpress.com/318) and
PACE Trial Participants – were they exploited?(https://wordpress.com/post/peterkempblog.wordpress.com/91)

One could be forgiven for wondering if M.E. patients and PACE Trial participants have any right to respect for their autonomy.  The PACE authors seem to have no such respect.  Collecting information about people then publicly misrepresenting them is not showing respect.

Reading the PACE Trial documents, from the Protocol to the Lancet publication, disregard for participant autonomy seems pervasive and could even be considered inevitable considering espoused theories of the PACE researchers.  To whit: ‘participants are so incompetent that they cannot even judge their own health or tell whether they are ill or not, if they could, then a bit of exercise and positive thinking would cure them’.  So working from this view of participants as incompetent, it is no surprise that the researchers attitude towards participants was one of condescension verging on abuse.

Just one instance of this disrespect occurred in a Participant Newsletter and is neatly analysed by Hooper and Williams in Magical Medicine.  The dubious tactic of employing participants as recruitment officers for the Trial, is not only coercive of the participants, but also risks skewing the data of what was supposed to be a scientific experiment.  The PACE researchers stopped short of offering a set of steak-knives for each new recruit introduced, or a skiing holiday for the one that got the most new participants, but the principal is not dissimilar.

 From Magical Medicine, How to make a disease disappear, by Professor Malcolm Hooper (http://www.meactionuk.org.uk/magical-medicine.pdf):

The PACE Participants’ Newsletter (Issue 2, March 2007) was openly soliciting for more participants: “If you know of any friends or family who suffer from CFS/ME and who might be eligible and interested in taking part in the study and live close enough to one of these centres, please suggest they approach their GP for a referral to a PACE centre”. The problems with using existing participants to recruit new participants are obvious.

First, the existing participant might no longer feel inclined to report negative effects and might exaggerate any positive effects because (i) they may feel they have become part of the PACE research team and thus feel a loyalty that could influence how they report their experience and (ii) participants who recruit others are asking them to join in their own experience and thus they assume a burden of responsibility, as a result of which they may be less likely to report ‘it was awful’ or ‘ it did not help’.  This could render their own subjective data invalid.  Furthermore, if a participant knows s/he has persuaded someone else to join the trial, the recruiting participant might no longer feel s/he had the right to drop out or withdraw consent at any time of their choice.

Secondly, a participant who was recruited by a friend or family might also feel similar obligations of loyalty to their friend or family member, so their own data might also be unreliable.

Thirdly, only participants who are enjoying or benefiting from their participation are likely to have recruited others, with the result that a potential participant is exposed to a positive viewpoint that might not adequately reflect the risks and burdens of participation, as well as arousing fears that they are missing out on something helpful.  This could be viewed as making unjustifiable claims about the therapies on trial (which could be in breach of the GMC’s Guidelines for Good Medical Practice (section 61) that states: “You must not make unjustifiable claims about the quality or outcomes of your services in any information you provide to patients.  It must not…exploit patients’ vulnerability or lack of medical knowledge”).

Fourthly, participants who do not recruit anyone might be influenced by the suggestion that they should recruit and may feel guilty if they are unable to recruit more participants, with the result that they may compensate by being ‘better’ (ie. more positive and less critical) participants.  This could affect they way they report their experience and thus invalidate their data.

Other institutions concerned with research integrity require approval for all methods of advertisement prior to use and they consider “advertising or soliciting for study participants to be the start of the informed consent process…Advertisements must be reviewed and approved…When advertising is to be used, the information contained in the advertisement and the mode of its communication (must be reviewed) to determine that the procedure for recruiting participants is not coercive and does not state or imply a certainty of favourable outcome” (http://orip.syr.edu/sop/sop036.php ).

The tactics used for recruitment to the PACE trial seem to indicate the difficulties encountered by the Investigators, a fact that is believed by many people ought to have raised concern with the various ethics bodies.

It is believed that the difficulty in recruitment may have resulted in coercion of sick people.