this issue. It mixes calls for increased patient involvement in
medicine with some examples of what happens in ME/CFS
It's a bit long so, for anyone who doesn't make it, here's an extract
"... Unfortunately, such an enlightened approach has yet to reach
ME/CFS, as was shown by the world's largest CFS clinical trial, the £5
million PACE study, which defined success and failure without
Not everyone wants to collaborate with patients...
The PACE Trial's recent paper
http://www.qmul.ac.uk/media/news/items/smd/89978.html claimed that 22%
of patients 'recovered' with CBT or Graded Exercise (compared with 7%
without). However, they had abandoned their original protocol
definition of recovery and created a new version with much looser
criteria. To give an idea of how far-fetched some of the new
'recovery' criteria are, 11% of patients met the fatigue or function
'recovery' criteria at the start of the trial - while simultaneously
meeting criteria for 'severe and disabling fatigue'. And a quarter of
patients seen in wider clinical practice
http://qjmed.oxfordjournals.org/content/106/6/555 had physical
function scores that met PACE recovery criteria. Surely the prime
arbiters of what counts as recovery should be patients, who live the
real-world consequences of the illness, not researchers who might be
more concerned with making their study look good.
When it came to measuring treatment 'Harms', the PACE trial did go
further in collecting data than any previous study of CBT and graded
exercise. But they revised the original protocol definition of 'Harms'
, making it harder to for problems to count as 'harm', and made it
technically impossible for anyone to deteriorate seriously in the
second 6 months of the trial. They also published the proportion of
patients improving by a 'clinically useful difference' in their 2011
paper but failed to provide the corresponding proportion of patients
deteriorating by the same amount. Following a Freedom of Information
request http://bit.ly/11FOSfy i.e.
http://forums.phoenixrising.me/index.php?posts%2F360415%2F it appears
they will now be publishing the data - more than 2 years later.
As well as 'no decision about me without me', perhaps we also need a
firm commitment from the Government there should be 'no research about
me, without me'.
It's also worth noting that ME/CFS patient surveys - based on patients
receiving normal clinical services rather than the highly controlled
therapy of research trials - consistently find high levels of adverse
reactions with CBT and graded exercise. This information hasn't always
been taken very seriously by researchers and clinicians.