MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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• Consider a 24‐hour on‐call service for dealing with trial queries
• Consider a launch meeting for collaborators
• Consider a dedicated trial website, it could include all trial materials, information leaflets etc
“To maintain recruitment:
• Circulate regular newsletters with updates on progress
• Use posters or letters of congratulation to acknowledge good progress
• Consider offering incentives for achieving targets, such as T‐shirts, mugs or pens etc
• Use opportunities to ‘piggy‐back’ small meetings onto national or international conferences.
The choice of the acronym “PACE” seems particularly misleading because some participants may have
thought the trial was about “pacing” when it seems not to be – it is about restructuring participants’
cognitions by means of CBT and about reversing “deconditioning” by means of GET and even by APT
(which, in the PACE Trial, requires participants to plan and practise activity and relaxation according to a
timetable), all of which are referred to in the trial literature as forms of “pacing” when they clearly have little
in common with “pacing” that is defined as “listen to your body” (see below). The use of acronyms that
mislead people is a tactic that may be considered a form of coercion (Chest 2002:121:2023‐2028).
It is notable that there is considerable effort being invested in ensuring that trial participants remain
engaged with and do not withdraw from the trial; a recent paper co‐authored by Alison Wearden (FINE
Trial Investigator) highlights the net‐working that is employed by those using CBT in particular:
“Orne and Wender (1968) first suggested that an important factor in the success or failure of therapy is the degree to
which patients understand what they called ‘the rules of the game’. They suggested that ‘anticipatory
socialisation’ would increase the benefit from therapeutic input…(and that it) would be an important
condition for success in any type of psychotherapy…Walitzer et al (1999) suggest that cognitive behavioural
therapists would benefit from the systematic use of these strategies to enhance engagement and promote
positive outcome (see below for how reinforcement of “positive outcome” is utilised in the PACE Trial). Beck
(1995) recognised the importance of socialisation in maintaining…patient engagement, outlining that therapists need
to ‘sharpen their skills at socialisation’. Beck offered a 27‐point checklist of how to socialise the patient to cognitive
therapy (and) the therapist can use the checklist to determine whether the patient is sufficiently socialised. Wells
(1997) referred to socialisation as ‘selling the cognitive model’…The present operational definition can be used to
clarify a concept in frequent use in clinical psychology (and) may influence clinical practice by defining the main
components that can guide clinicians to socialising the patient adequately …to cognitive therapy” (Jo Roos and
Alison Wearden. Behavioural and Cognitive Psychotherapy 2009:37:341‐345).
This background seems to provide the rationale for the emphasis on “empathy” with participants (for
example, the sending of birthday cards to them and encouraging them to provide positive contributions to
the PACE Trial Newsletters, thus ensuring their “involvement”) and the emphasis on “positive
reinforcement” that permeate the PACE Trial literature, all of which are designed to achieve the desired
outcome of the trial and may thus be deemed to be misleading participants.
Despite claims that the PACE Trial is “the largest trial of treatments for CFS/ME to date”
(http://www.iop.kcl.ac.uk/departments/?locator=355&project=10068), the PACE Trial Investigators struggled
to meet the target quota to the extent that they changed the eligibility criteria once the trial was underway.
The companion MRC FINE trial (Fatigue Intervention by Nurses Evaluation) ended recruitment in
November 2007, with just 296 participants recruited (449 patients having been referred).
According to the PACE Participants’ Newsletter Issue 1 (June 2006), after two years of recruiting, “By May
there were 92 people receiving treatments as part of PACE”. Issue 2 (March 2007) states: “The number of CFS/ME
patients recruited to PACE rose steadily to 180 by the end of November 2006”, which was no‐where near the target