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).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.
So did the therapist get you to increase what you were doing? How often?
A valedictory dispatch from the Psychosocial School?
5 May 2010
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
Competing interests: None declared
Thanks Sam.Thanks, folks! (*blushes*)
I tried to follow the example of TomK's (many) excellent letters and focus on methodological and statistical issues.
The article on the FINE Trial results was amongst the most commented on at www.bmj.com
British Medical Journal, p9
The article Pragmatic rehabilitation for chronic fatigue syndrome was amongst the most read at www.bmj.com
British Medical Journal, p9
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.The authorities will not be dropping GET or CBT anytime soon,...
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.
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.
That is a bit rich of AfME they backed and gave their full support to both the FINE & PACE Trials in the first place!!
At 20 weeks, patients on pragmatic rehabilitation had significantly improved fatigue but not physical functioning
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.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.
No problem - it's not very exciting - it's here if anyone wants it: http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235156Thanks tomk... sorry, i didn't get round to reading your rapid response...
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.Do we assume that the results from the objective step test were even worse than the self-reported physical functioning?
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