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The PACE Trial Psychiatrists Spinning Out of Control 4

The PACE Trial Psychiatrists Spinning Out of Control 4

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Published by Peter Kemp
The PACE Trial. Analysis and opinion in easy to read bullet-points.
The PACE Trial. Analysis and opinion in easy to read bullet-points.

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Published by: Peter Kemp on Oct 18, 2012
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03/22/2013

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The PACE Trial - Psychiatrists spinning out of control.
Some Background
In February 2011, the Science Media Centre (SMC) hosted a press conference for thepublication in The Lancet of the results of the PACE Trial research into treatments forM.E. and CFS.
The research took 6 years and cost UK tax payers £5 million. 640 Participants receivedeither Cognitive Behaviour Therapy (CBT); Graded Exercise Therapy (GET); AdaptivePacing Therapy (APT) or Specialist Medical Care (SMC – the Control Group).
CBT and GET were based on theories that M.E. and CFS are ‘deconditioning’ and ‘fearavoidance’. Treating these conditions is simple and effective. They represent the basicwork that any psychologist or occupational therapist might undertake.
The PACE Trial results (The Lancet, Feb 2011) for ‘improved’ show that Graded ExerciseTherapy (GET) had an effect for 16% and Cognitive Behaviour Therapy (CBT) for 14%compared to the control group. The results for ‘normal ranges’ show that GET had aneffect for 13% and CBT for 15%.
These results produce a ‘number needed to treat’ figure of 7. In other words, if 7people are treated with one of these therapies – one of them will improve but theremaining 6 will not get any significant benefit.
Some Concerns
Professor Hooper et al remarked, “The indisputable commitment of so many membersof the PACE team to the insurance industry (especially Professors White and Sharpe intheir roles as Chief Medical Officer to so many insurance companies) is a significantcause for concern, since their continued recommendation of CBT and GET and theirinsistence that ME/CFS is a functional (mental) disorder benefits the insurance industryfor which they work to the prejudice of patients.” 
(http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm)
Professor Peter White, the chief investigator of the PACE Trial, also does work for theDepartment of Work and Pensions (DWP) who co-funded the PACE Trial. The onlyclinical research that the DWP have ever funded.
The Science Media Centre which hosted the press conference declare: “The overall goalof the Centre is to help renew public trust in science by working to promote more
balanced, accurate and rational coverage of the controversial science stories
thatnow regularly hit the headlines”.
(http://www.sciencemediacentre.org/uploadDir/536adminconsultation_report.pdf)
The Science Media Centre ‘expert’ for M.E. and CFS news stories is Professor SimonWessely who was in the PACE Trial management group. For many years he has claimedthat M.E. and CFS are psychological illnesses. He stated:
“I will argue that ME issimply a belief, the belief that one has an illness called ME
” 
(Microbes, Mental Illness, TheMedia and ME: Institute of Psychiatry, London, 12 May 1994)
News Coverage of the PACE Trial – Mistaken or Misled?
The Science Media Centre press conference resulted in media statements that are notsupported by the research findings. Here are a few Headlines:1
 
The Daily Mail:Got ME? Fatigued patients who go out and exercise have besthope of recovery, finds studyThe Independent:Got ME? Just get out and exercise, say scientistsThe Guardian:Study finds therapy and exercise best for METhe Telegraph:
 
Exercise and therapy can help ME sufferers, study claimsThe Daily Express:TRIAL OFFERS HOPE FOR ME SUFFERERSThe Daily Record:Exercise and therapy can reverse effects of METhe Daily Star:TRIAL OFFERS HOPE FOR ME SUFFERERSReuters:Pushing limits can help chronic fatigue patients
IT IS IMPOSSIBLE to reconcile these headlines with the fact that the PACE Trial results aspublished in The Lancet showed that
GET and CBT only had an effect for around 15% ofparticipants
.
How could the press get it so wrong?
After all, they got their information direct from thePACE Trial researchers via the Science Media Centre; the centre for ‘
balanced, accurateand rational coverage
’ 
 
of science. Professors Wessely, White, Sharpe and Chalder musthave had complete control over the information given to the press.
Some Points that did Not Make Headlines
Professor White the chief investigator stated in contradiction of the Trial Protocol andThe Lancet publication, that
the PACE Trial was not studying “CFS/ME”.
He claimsthey were only studying people with fatigue as a main symptom.
The criteria of ‘fatigue’ does not define M.E. or CFS according to the NICE Guidelines(2007), the CMO Report (2002) and all other authorities on these illnesses.
The PACE Trial researchers were aware that using lax criteria for CFS could improve theoutcome of their therapies. They reference Joyce, Hotopf and Wessely who stated: “Asthe definition becomes more stringent the prognosis appears to worsen.” 
(PACE Protocolreference 9).
Severely ill patients were excluded from participation – these make up around 25% of patients. The PACE Trial researchers were aware that excluding severely ill patientscould improve the outcome of their therapies. They reference Effective Health Carewhich states: “The prognosis tends to be worse for severely ill patients than for lessseverely ill patients”.
(PACE Protocol reference 5).
The FINE Trial published a year earlier, established that rehabilitation therapies do notbenefit severely ill patients. Therefore if the PACE Trial had included 25% of severely illpatients to reflect the general patient population it is reasonable to project that theapparent treatment-effect in the PACE Trial would only have occurred in 12%, insteadof 15%; and given the limitations of RCTs, a realistic ‘need to treat’ figure in generalmedical practice would probably be at least 10.
The PACE Trial has not demonstrated any significant benefit with GET or CBT. Leadresearcher Professor Michael Sharpe told ABC Australia: “What this trial isn't able toanswer is how much better are these treatments than really not having very muchtreatment at all?” 
(http://www.abc.net.au/radionational/programs/healthreport/comparison-of-treatments-for-chronic-fatigue/2993296)
2
 
Which is incredible given that this research cost UK Tax-payers £5 million and the TrialProtocol claimed: ‘
The main aim of this trial is to provide high qualityevidence to inform choices
made by patients, patient organisations, health servicesand health professionals about the relative benefits, cost-effectiveness, and cost-utility,as well as adverse effects, of the most widely advocated treatments for CFS/ME.’ 
Hooper observed: “…adverse event deemed by trial scrutinisers to be “non-serious” were CBT Group 89%; SMC and GET groups 93%; and APT Group 96%.” And: “… wehave no idea how many of the 3,002 adverse events that were deemed “non serious” may have been reactions to the trial interventions.” 
(http://www.meactionuk.org.uk/COMPLAINT-to-Lancet-re-PACE.htm)
Sir Michael Rawlins (as Chair of NICE) stated that, “we need a new approach toanalysing clinical evidence”. He observed that Randomised Controlled Trials, “are oftencarried out on specific types of patients for a relatively short period of time [snip]. Thereis a presumption that, in general, the benefits shown in an RCT can be extrapolated to awide population; but there is abundant evidence to show that the harmfulness of anintervention is often missed in RCTs.” 
(http://pressrelease.rcplondon.ac.uk/Archive/2008/Attack-on-traditional-ways-of-assessing-the-evidence-of-therapeutic-interventions)
The PACE Trial relied almost entirely on subjective measures (questionnaires). This is acontradiction. The Trial treatments GET and CBT were based on theories thatparticipants are not physically ill but are incapable of accurately interpreting their ownsymptoms because of phobia and hysteria. Yet the opinions of these supposedlydelusional participants are considered reliable to provide data for a clinical trial.
More Concerns
The PACE Trial researchers modified benchmarks and entry criteria, cancelled or misappliedmeasures and changed scoring methods during the Trial. These changes had the effect of damaging generalizability, favoured the treatments being tested, eliminated objectivemeasurements and created ludicrous anomalies:
People originally disqualified from participation were later allowed to join the Trial.Patients with a completely different illness from the target group were allowed to join(fibromyalgia).
Because of moveable benchmarks, it was possible for a participant to join thetrial, deteriorate, yet still fall within the modified definition of ‘normal range’.
Improvements from GET and CBT were so small that many patients that met theresearcher’s chosen definition of ‘normal functioning’ were still more disabled thanpeople with other serious diseases.
The Trial Protocol stated that actigraphy measurement would be used at the start andend of treatment. The investigators cancelled this objective test as an outcomemeasure, claiming it was too much of an imposition even though all the participantswore the monitor at the start of their testing.
 A 6 Minute Walk Test was the
only
objective measure used at the start and end of thetreatment. However,
the researchers did not follow the protocol for the 6 Minute
3

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