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.