The FINE Trial. BMJ ARTICLE. Nurse led, home based self help treatment for patients in primary care

[oceanblue]

Good letter, Tom. And it's weird that the paper itself mentions the London Criteria early on - then fails to report how the London Criteria patients performed.

 

[Dolphin]

Good letter, Tom. And it's weird that the paper itself mentions the London Criteria early on - then fails to report how the London Criteria patients performed.

Thanks oceanblue. I was a bit lazy and didn't write it in a tight manner - I'm not going for a letter that will be published, just putting it on the record that some things are missing (like not reporting how those with ME (London criteria) fared).

 

[oceanblue]

Oceanblue.
So did the therapist get you to increase what you were doing? How often?

Most of the advice was focused on balance and not going beyond limits. So there was a lot about getting a good mix of mental activity, physical activity and rest (ideally relaxation) throughout the day. And a lot about how to break up large activities into manageable smaller chunks to reduce the risk of overdoing things. It's also about not going wild on a good day, again to keep things in balance. Doing things this way I was able to increase my total activity levels quite a bit in a short time. We did also look at things I couldn't do now but would like to e.g. a short trip out somewhere. The approach again was to break things down into smaller chunks e.g. just making part of the journey at first, then coming back. The idea was to gradually increase activity towards the goal if possible. Sometimes it was possible, in other areas it wasn't. there was no timescale, no pressure and I was in charge. The advice from the therapist helped me maximise what I could do within my limits, and ultimately increase my limits is some areas. But it was no miracle cure, and didn't claim to be one either - just a helpful approach.

I saw the Magical medicine highlights, thanks. Should we continue that discussion in the PACE or Magical medicine threads? I'm new to this, and don't know how to do that.

 

[Dolphin]

BMJ Rapid Response: A valedictory dispatch from the Psychosocial School?

I don't know if this person is a member of PR, but well done to them anyway.

(from http://www.bmj.com/cgi/eletters/340/apr22_3/c1777)

A valedictory dispatch from the Psychosocial School?
5 May 2010

Sam Carter,
ME Patient
N/A

Does Pragmatic Rehabilitation (PR) reduce the "fatigue" experienced by people diagnosed with CFS/ME according to the Oxford criteria (1)? Wearden et al report in the Abstract of their paper that after 20 weeks of PR participants had "significantly improved fatigue" and, in their linked editorial, Moss-Morris and Hamilton state that participants receiving PR were "significantly less fatigued". However, in the body of the text, Wearden et al describe the improvement as being "small" and "clinically modest". Thus, in the same journal, we find that the effect of PR on fatigue is simultaneously "significant" and "small".

The effect cannot be both large and small, so which interpretation best matches the data?

A participant's fatigue was measured using the 11 item Chalder Fatigue Scale
(ChFS) "scored dichotomously on a four point scale (0, 0, 1, or 1)". The ChFS has been criticised because it "has a low ceiling, so patients with maximal scores at baseline will not be able to record an exacerbation after treatment." (2) The maximum one can score on the ChFS is 11, after which it cannot detect further deterioration. It can be seen from the published data that participants receiving PR had a mean baseline ChFS score of 10.49 from which it can be calculated that between 47 and 88 of the 95 participants started therapy with a ChFS score of 11. Therefore, at least half of the participants could not report that PR had worsened their fatigue, even if such were the case. PR involves graded exercise so one would expect this therapy more than "supportive listening" or normal GP treatment
(unspecified) to exacerbate fatigue but, had this occurred, the ChFS could not have detected it. Thus, the inability of the ChFS to measure deterioration in this patient cohort biases the trial in favour of finding "improvements" in fatigue and, in particular, favours PR because exercise-induced relapses cannot be recorded.

A genuine improvement in fatigue would, axiomatically, lead to increased physical capacity, but no statistically significant change in physical function was found in the PR group and, in fact, participants randomised to the control group (GP treatment as usual) experienced greater improvement in physical function.

Thus the conclusion that PR led to a real improvement in participants'
fatigue must be interpreted with caution.

The authors suggest that "treatment effects may have been enhanced had we been able to provide post-treatment booster sessions." However, it is instructive to note that the mean ChFS score fell from 10.49 at baseline to
8.39 after 20 weeks of therapy where, according to the text, "total scores of four or more on the fatigue scale designate clinically significant levels of fatigue." Therefore, even if extra sessions had trebled the efficacy of Pragmatic Rehabilitation, participants would still have "clinically significant levels of fatigue".

Notwithstanding, Wearden et al comment: "it is likely that our trial gives an accurate indication of the effectiveness of nurse delivered pragmatic rehabilitation and supportive listening for CFS/ME in primary care." Indeed it does: the data provide strong evidence that the anxiety and deconditioning model of CFS/ME on which the trial is predicated is either wrong or, at best, incomplete. These results are immensely important because they demonstrate that if a cure for CFS/ME is to be found, one must look beyond the psycho-behavioural paradigm.

(1) Sharpe MC, Archard LC, Banatvala JE, et al. (February 1991). "A report--chronic fatigue syndrome: guidelines for research". J R Soc Med 84
(2): 118-21

(2) http://www.biomedcentral.com/1471-2377/7/6/comments

Competing interests: None declared

 

[Jerry S]

Good letter, Mr Carter!

 

[V99]

Very good letter. Doesn't just say the method doesn't work, also addresses how the assessment measures are not fit for purpose.

 

[Sam Carter]

Thanks, folks! (*blushes*)

I tried to follow the example of TomK's (many) excellent letters and focus on methodological and statistical issues.

The UK psychosocial school are so wedded to their beliefs that they have become "blind" to any empirical data that does not accord with their own patho-aetiological theory. If the results of a study are at variance with their "model" of ME/CFS they don't question the model, they question the validity of the study.

To quote the physicist Wolfgang Pauli, they are "not even wrong."

 

[Dolphin]

Thanks, folks! (*blushes*)

I tried to follow the example of TomK's (many) excellent letters and focus on methodological and statistical issues.

Thanks Sam.
I find it hard to keep track of names now so don't know if you've made comments on papers before but hope you will in the future.

And welcome to Phoenix Rising!

P.S. I posted it to a couple of yahoogroups and I see that somebody posted it to Co-Cure http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1005A&L=CO-CURE&P=R5897&I=-3&X=50C9907C60EA6661E4 with the heading, "[CO-CURE] NOT:Very good BMJ rapid response to the FINE Trial Paper".
Co-Cure is probably the place for ME/CFS news (Phoenix Rising may be better in a way but is much higher volume).

 

[Dolphin]

(Not important)
AfME pay for a media monitoring service.
So these were presumably in the print edition.

http://www.afme.org.uk/news.asp?newsid=828

FINE Trial
The article on the FINE Trial results was amongst the most commented on at www.bmj.com
British Medical Journal, p9
08/05/10

Pragmatic rehabilitation
The article Pragmatic rehabilitation for chronic fatigue syndrome was amongst the most read at www.bmj.com
British Medical Journal, p9
08/05/10

 

[PoetInSF]

The authorities will not be dropping GET or CBT anytime soon,...

Note that FINE was a trial for a delivery vehicle of CBT/GET, not CBT/GET itself. The failure of FINE does not provide impetus for dropping CBT/GET as it does not say anything about CBT/GET. PACE, on the other hand, is a trial of CBT/GET itself along with adaptive pacing. The failure of PACE, if that happens, will forcethe policy makers to at least reconsider CBT/GET as it is an extensive study and therefore carry a heavy weight.

 

[fds66]

Just found this reponse from AFME on their news section of the website (my bold and added some extra spaces)

http://www.afme.org.uk/news.asp?newsid=822

Action for M.E. Response to FINE Trial

On April 23 2010 the British Medical Journal published the findings of the FINE (Fatigue Intervention by Nurses Evaluation) Trial
The study compared three treatment approaches for people with CFS/ME:

1) Pragmatic rehabilitation: Devising a programme of gradually increasing activity in collaboration with a therapist

2) Supportive Listening: Non-directive counselling at home

3) “Usual” General Practitioner Treatment

Fatigue and physical functioning were tested at the end of treatment (20 weeks) and 70 weeks.

At 20 weeks, patients on pragmatic rehabilitation had significantly improved fatigue but not physical functioning compared with patients on treatment as usual. At 70 weeks, there were no statistically significant differences in fatigue or physical functioning between patients on pragmatic rehabilitation and those on treatment as usual.

At 20 weeks, patients on supportive listening had poorer physical functioning than those on treatment as usual and no difference in fatigue. At 70 weeks, they did not differ significantly from those on treatment as usual on either primary outcome, ie. supportive listening is not an effective treatment for CFS/M.E.

Action for M.E. is disappointed that the FINE trial found the treatments studied are not as effective as earlier studies had indicated. As such we share the disappointment expressed by many patients that the trial has made such a limited contribution to advancing our knowledge about M.E./CFS. This outcome strengthens our view that the priority for future research funding should be given to studies that will lead to an improved understanding of the fundamental biology of the illness and to setting up the infrastructure facilities necessary to support biomedical research.

 

[ukxmrv]

And the infrastructure may be a reference to their support of the tissue bank for research

 

[bananaman]

That is a bit rich of AfME they backed and gave their full support to both the FINE & PACE Trials in the first place!!

 

[Bob]

Note that FINE was a trial for a delivery vehicle of CBT/GET, not CBT/GET itself. The failure of FINE does not provide impetus for dropping CBT/GET as it does not say anything about CBT/GET. PACE, on the other hand, is a trial of CBT/GET itself along with adaptive pacing. The failure of PACE, if that happens, will forcethe policy makers to at least reconsider CBT/GET as it is an extensive study and therefore carry a heavy weight.

Which is why the FINE trial was allowed, or designed, to fail... The PACE trial won't fail... we can all be absolutely sure of that!

 

[Min]

That is a bit rich of AfME they backed and gave their full support to both the FINE & PACE Trials in the first place!!

They do seem to speak with forked tongues - they had a page on their website listing the reasons for their support of these expensive flim flam trials, but the page has now been removed.

 

[Bob]

At 20 weeks, patients on pragmatic rehabilitation had significantly improved fatigue but not physical functioning

So the subjective experience of fatigue had 'significantly' (but actually, only slightly) improved in patients at 20 weeks, but the objectively tested physical functioning hadn't (i.e. there was absolutely no improvement in physical ability after all of that million pound 'therapy' to reduce "learned illness beliefs")...

If they can't learn from this that ME is a real, physical, non-psychological illness, then they never will!

 

[Dolphin]

So the subjective experience of fatigue had 'significantly' (but actually, only slightly) improved in patients at 20 weeks, but the objectively tested physical functioning hadn't (i.e. there was absolutely no improvement in physical ability after all of that million pound 'therapy' to reduce "learned illness beliefs")...

If they can't learn from this that ME is a real, physical, non-psychological illness, then they never will!

Technically, they didn't report any objective testing of physical functioning. What they reported was the results of a questionnaire. The results from the step test were never reported as I mentioned in my rapid response.

 

[Bob]

Technically, they didn't report any objective testing of physical functioning. What they reported was the results of a questionnaire. The results from the step test were never reported as I mentioned in my rapid response.

Thanks tomk... sorry, i hadn't got round to reading your rapid response... (I've read it now)...
So, do we assume that the results from the objective step test were even worse than the self-reported physical functioning?
And do we assume that the results for the non-oxford diagnosed patients were even worse then the overall results?
(I'm assuming that they have tried to put the best gloss on the results as possible, so they can avoid total ridicule and embarrassment.)

Basically the trial was a catastrophic failure, but they are only giving us selective results, and not all of the results... they appear to be covering up the worst results.

 

[Dolphin]

Thanks tomk... sorry, i didn't get round to reading your rapid response...

No problem - it's not very exciting - it's here if anyone wants it: http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235156

Do we assume that the results from the objective step test were even worse than the self-reported physical functioning?

I didn't want to say that in case they have some other evidence. I think the evidence is bad enough with this trial - they said in the original paper on the protocol that the primary outcome point would be at 70 weeks and there's no difference from the control group at that point for the five measures.

 

[Bob]

No problem - it's not very exciting - it's here if anyone wants it: http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235156

Well, maybe it's not very 'exciting', but it's very useful, so thanku. (I've read it now.)

Yes, at 70 weeks, all measures show no improvement in the patients...
But it would be extremely valuable for our community if we had the stats for the different patient cohorts (patients diagnosed using different diagnostic criteria).
If 'pragmatic rehabilitation' (in other words: CBT/GET) was shown to make patients with a CDC diagnosis worse, in a one-million-pound medical trial, then this would be a very useful weapon against the psychological establishment for us.