Use of self-reported outcome measures whether by patients or clinicians would be a limitation of any study, as they do not represent scientific evidence and are open to cognitive bias by all involved. To continue to use these anecdotal reports is not helpful in elucidating the pathophysiology of any disease or in developing effective treatments.

Although you are now placing emphasis on the reduction in time family members spend providing care, it was not a primary outcome or primary objective for the PACE trial. The study was meant to assess the effectiveness of CBT, GET, and your own invention of graded activity, called APT, in reducing fatigue and or disability, and the costs-effectiveness of these approaches. On all counts the study failed.

Considering that you were trying to persuade patients and their families that CBT would reverse cognitive and behavioural responses you believe cause a fear avoidance, and GET was used to support your belief that patients are deconditioned and avoid activity, then it is reasonable to suspect that family members were persuaded to no longer provide the assistance necessary, not that patients needed less care. This could have been avoided if you had not told patients and their families during the trial that improvement and recovery were possible using CBT and GET.

Patients in the CBT arm actually displayed no objective improvement of any kind, and hence the hypothesis that disability stemmed from a fear based avoidance of exercise was disproven.

The PACE trial has been criticised for numerous reasons, these include, not admitting ME patients into the study, for not using any objective measure, for failing to provide evidence that CBT and GET are clinically effective treatments and for failing to report primary outcome measures. Further legitimate criticisms can be found in Professor Malcolm Hooper's report, ‘Magical Medicine: How to Make a Disease Disappear’, and subsequent correspondence regarding a legitimate official complaint with the Department of Health.

Magical Medicine
Professor Malcolm Hooper
February 2010
http://www.meactionuk.org...

UPDATE ON THE PACE TRIAL
Professor Malcolm Hooper
11th July 2012
http://www.meactionuk.org...

The lack of clinical benefit demonstrated by even a cursory examination of the data means that from a patient treatment perspective the PACE study protocols were an abject failure. Suggesting that you needed more time to get patients back to work is also not supported by the evidence, as you were given a whole 52 weeks in which to attempt to have your beliefs fit your preconceived ideological position.

It is particularly noteworthy that the data on practical significance and clinical importance has been withheld. NICE would not approve a treatment without such data. Another major omission is the data demonstrating the numbers needed to harm (NNH) for these interventions. How long do you intend to keep this data from being publicly scrutinised?

Paul McCrone states that: "While clinician-administered measures have a definite place in research many are of the opinion that it is those who experience conditions such as CFS/ME who are the best judges of the severity of these conditions".

It would follow that in order to measure severity, those who have experience of CFS/ME would need to be, at the very least, equally involved in the design of measuring instruments, to ensure that instruments being used are not simply mechanisms that inadvertently tend to confirm the ideas of researchers.

Kindlon has discussed another aspect of the subject where the "best judges" are those with relevant experience.

"However, exercise-related physiological abnormalities have been documented in recent studies and high rates of adverse reactions to exercise have been recorded in a number of patient surveys. Fifty-one percent of survey respondents (range 28-82%, n=4338, 8 surveys) reported that GET worsened their health while 20% of respondents (range 7-38%, n=1808, 5 surveys) reported similar results for CBT".

Despite certain reservations, Kindlon concludes the section by pointing out that: "the consistently high rates and absolute numbers of adverse reactions coupled with the potentially disabling effects of GET and CBT reported in these surveys are concerning and need to be investigated more thoroughly".

Paul McCrone asks: "Is it really being suggested that gaining employment should be the primary aim of a successful intervention?".

Yes.

The Department of Work and Pensions who partly funded this trial have stated:

"We believe that the findings of the trial will contribute to the continuingly growing evidence base, which informs the development of health and work related policy, policy based on the large body of evidence showing that work is good for physical and mental wellbeing and that being out of work can lead to poor health and other negative outcomes".


1) Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Tom Kindlon Bulletin of the IACFS/ME. 2011;19(2): 59-111.
http://www.iacfsme.org/BU...

2) http://www.whatdotheyknow...

"many are of the opinion that it is those who experience conditions such as CFS/ME who are the best judges of the severity of these conditions."

Personally, I would agree with this. However, the Research Protocol clearly shows that the premise for treatments is that patients misjudge or misinterpret symptoms. e.g.: "CBT will be based on the illness model of fear avoidance".

If this were correct it would make participants an unreliable source of information about their illness and incapacity. Objective measurements were therefore an obvious requirement. Without them, the research could simply be reporting what participants say about their symptoms - when such subjective opinions were originally considered erroneous.

This is not science.