research & funding

Moderator: talkhealth

To the moderators of this forum. Misleading information.

Postby Jon Denberry on Tue Aug 20, 2013 2:37 pm

To the moderators of this forum.

I am very concerned about the amount of inexact, ambiguous or misleading information that is being promoted by some of the 'experts' on the forum, and that has been posted on the forum by the principal investigators of the PACE trial.

The principal investigators of the PACE trial suggested that about 60% of patients improved after treatment with CBT/GET in the PACE trial. In fact, the best results achieved in the PACE trial were that up to 15% of participants improved in either self-reported fatigue of function when CBT or GET were added to SMC. (SMC being the control.) The 60% figure relates to participants who received the treatment (CBT or GET) plus SMC, so it includes the proportion of participants who improved in the SMC control group, as a result of treatment with SMC or because of natural fluctuations.

Also, the principal investigators talked about 'recovery', but the PACE trial did not report on recovery in lay terms, but defined a 'recovery' in very specific terms. The trial's definition of 'recovery' did not reflect what patients or clinicians would recognise as a recovery. (i.e. participants reported as 'recovered' could have severe disability, or could even have had physical function that deteriorated after treatment with CBT/GET.) Based on the results of the PACE trial it is unfair and medically inappropriate to tell patients to expect a recovery after CBT or GET, when a 'recovery' can indicate severe disability or even deterioration.

CBT and GET will only help a minority of patients feel better about their illness.
In the PACE trial, only up to an additional 15% of patients felt at least minimally better (self-reported fatigue and physical function) when CBT or GET were added to SMC.
But for objectively measured disability, the improvements were non-existent, except for a small (clinically insignificant) improvement when GET was added to SMC.
The evidence in other trials which investigated CBT/GET have had very similar results.
There is no evidence that demonstrates effective sustainable overall improvement in the actual illness, or in actual disability, when objectively measured, after treatment with either CBT or GET.
The PACE trial found that CBT and GET were moderately effective for self-reported outcomes.

Also, there is not a good evidence basis for CBT or GET to be recommended to house-bound or bed-bound patients. The PACE trial, for example, did not investigate house-bound patients.

Comments and recommendations about CBT and GET need to be put into context, so that patients understand what to expect, especially as there are many reports of patients being harmed by CBT and GET.
Because of the nature of CFS/ME, and the symptom of post-exertional malaise, exposure to unsafe levels of exertion can be harmful.
There is plenty of research evidence to support this.
Some research suggests that harm as a result of CBT or GET may depend on the quality of the therapy and therapist.
However, the PACE trial investigators have so far refused to release the deterioration data (as an equivalent measure to the improvement data), so patients and clinicians cannot know whether to expect deterioration from CBT or GET.

I ask that the moderators of the forum correct or delete the misleading information, and also ask the 'experts' to qualify their information, rather than recommending CBT or GET to all patients, without explaining that only very modest improvements should be expected, by only a small minority of patients, and that there is no evidence basis for severely affected CFS/ME patients.
Jon Denberry
 
Posts: 3
Joined: Mon Aug 19, 2013 5:29 pm

Re: To the moderators of this forum. Misleading information.

Postby Laurellen on Tue Aug 20, 2013 4:13 pm

Rather than correcting or deleting the claims of others, I think that it would be better for moderators to leave threads open, so that others could explain why some of the claims being made are misleading.

What is really dangerous, is for the moderators to close topics once misleading information has been posted, and the thread is then locked before any discussion of the claims being made can occur.

An example of this is this thread:

viewtopic.php?f=490&t=4557

I had responded to some of the claims made by Bavinton, only to have my response deleted and the thread closed.

I then had to repost my reply in a new thread, which was locked and moved:

viewtopic.php?f=494&t=4729

The locking of the thread started by the PACE trial researchers also leaves misleading information unchallenged. If these threads are to be archived, and linked to for patients to view in the future, it is important that all challenges to the claims being made in posts are also linked to, and ideally, added to the bottom of the relevant thread.

The attempts by some to hide from any real discussion or debate reflects just how tenuous the claims of expertise are for some who make their money from CFS.
Laurellen
 
Posts: 18
Joined: Wed Aug 14, 2013 3:25 pm

Re: To the moderators of this forum. Misleading information.

Postby Laurellen on Tue Aug 20, 2013 4:19 pm

Also, with regards to the most seriously ill patients, we should mention the FINE trial.

Much attention has been devoted to PACE, but the FAQ on the PACE website reports:

Is PACE the only major trial for CFS/ME being carried out in the UK?
The MRC announced funding in May 2003 for two trials looking at the effectiveness of various treatments for CFS/ME. The other trial is FINE, (Fatigue Intervention by Nurses Evaluation) which will test two different treatments that are particularly suited to those who are too ill to attend a specialist clinic. The FINE research is being carried out in NW England.


The FINE trial did include house bound patients, and also published results in the manner laid out in it's protocol, so we can be more confident that data was not spun to serve the interests of those who wish to promote their treatments.

The primary outcome for the FINE trial was reported by those who have built their careers on developing these treatments thus:

At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435).


http://www.bmj.com/content/340/bmj.c1777

It is important that people are not misled about the interventions available to them, and do not waste time and effort on interventions that are very unlikely to be of any real benefit, and carry a serious risk of being applied in a harmful way.
Laurellen
 
Posts: 18
Joined: Wed Aug 14, 2013 3:25 pm

Who is online
Users browsing this forum: No registered users and 1 guest