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Targeting the therapies to "overall improvers" could significantly improve cost-effectiveness

Posted by AndrewK on 04 Aug 2012 at 08:17 GMT

The development of therapies to reduce the economic costs and increase the quality of life of patients with this illness is certainly welcome.

However the improvement in QALYs was quite small compared to the overall disability burden of these patients and despite the five or so percent lower costs of CBT compared to SMC, these therapies are clearly not enough if we are to seriously tackle this illness. More efficacious treatments are urgently required and the lack of interest by the research community must end.

The previously released results suggested that only a proportion of patients had substantial improvements after therapy [1]. I find it disappointing that there is no mention by the authors of how cost effectiveness could be improved by targeting it to only those who are likely to make substantial improvements. Perhaps by utilising all of the measures specified by the original protocol [2] and seeing which variables were able to predict "overall improvement" as described by meeting both of the primary outcomes of the study:
"A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less" [2] on the Chalder fatigue scale utilising bimodal scoring. In addition to "a score of 75 (out of a maximum of 100) or more, or a 50% increase from baseline in SF-36 sub-scale score as a positive outcome." [2]

I hope that the authors are able to respond with some analysis on this point.

Secondly, I am still waiting for the authors to release the data on recovery as defined by the protocol:
""Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less, (ii) SF-36 physical Function score of 85 or above, (iii) a CGI score of 1, and (iv) the participant no longer meets Oxford criteria for CFS, CDC criteria for CFS, or the London criteria for ME."

This study also revealed another interesting effect, a significant increase in costs due to lost unemployment and or welfare utilisation. Now this increase in welfare utilisation has been noted in previous studies of similar treatments, between baseline and a follow-up interval of at least 6 months post-intervention. For example, the audit of the Belgian ME/CFS reference centre, which delivered a rehabilitation programme based on the principles of CBT and GET noted that "Physical capacity did not
change; employment status decreased at the end of the therapy." [3]
Do the authors of this study have any comments which may explain this effect?


[1] White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377: 823–836.

[2] White PD, Sharpe MC, Chalder T, DeCesare JC, Walwyn R; on behalf of the PACE trial group. Protocol for the PACE trial: a randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise, as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy. BioMed Cent Neurol 2007; 7: 6.

[3] [Fatigue Syndrome: diagnosis, treatment and organisation of care]
KCE Reports 88. (with summary in English). Accessed: 4th August, 2012.

No competing interests declared.

RE: Targeting the therapies to "overall improvers" could significantly improve cost-effectiveness

spjupmc replied to AndrewK on 04 Aug 2012 at 13:01 GMT

Thanks for your comments Andrew. I can't address them all at this stage but I agree with you that it is important to identify for whom these therapies are particularly cost-effective. We used the net benefit approach in the study which allows us to use regression analysis to identify predictors of cost-effectiveness. This is something we will be doing. (I actually think it should be done in RCTs in general given that the average effect shown in trials while informative does not tell us all we need to know.)

Competing interests declared: Author of paper