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Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue - Sabes-Figura

Dolphin

Senior Member
Messages
17,567
Free full text: http://www.biomedcentral.com/1472-6963/12/264

Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care.

BMC Health Serv Res. 2012 Aug 20;12:264. doi: 10.1186/1472-6963-12-264.

Sabes-Figuera R, McCrone P, Hurley M, King M, Donaldson AN, Ridsdale L.

Source
Centre for the Economics of Mental and Physical Health (CEMPH), Institute of Psychiatry, King's College London, London, UK. ramon.sabes-figuera@kcl.ac.uk

Abstract*

BACKGROUND:

Fatigue is common and has been shown to result in high economic costs to society.

The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET) and counselling (COUN) with usual care plus a self-help booklet (BUC) for people presenting with chronic fatigue.

METHODS:

A randomised controlled trial was conducted with participants consulting for fatigue of over three months' duration recruited from 31 general practices in South East England and allocated to one of three arms.

Outcomes and use of services were assessed at 6-month follow-up.

The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale.

Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves.

RESULTS:

Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54.

Those receiving the active therapies (GET and COUN) had more contacts with care professionals and therefore higher costs, these differences being statistically significant.

COUN was more expensive and less effective than the other two therapies.

The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement.

However, there was much uncertainty around this result.

CONCLUSION:

This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue.

It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC.

Clinical Trial Registration number at ISRCTN register: 72136156.

PMID: 22906319 [PubMed - indexed for MEDLINE] PMCID: PMC3480915

*I gave each sentence its own paragraph
 

Dolphin

Senior Member
Messages
17,567
I just read this paper. I don't think I would recommend reading it as not sure how useful it is. For one thing, they don't give any separate data on the CFS group. (Aside: However, I suppose reading such papers and the reviewers' comments educates me in general).

Here's a major limitation:
Our analysis would also benefit from a wider perspective that includes informal care and productivity costs. It was not feasible to use quality-adjusted life years (QALYs) as an outcome measure, as planned in the trial protocol, and this is also a limitation. This was caused by unexpected unavailability of EQ-5D questionnaire data for the six months follow-up.

A reviewer http://www.biomedcentral.com/imedia/1517403697654935_comment.pdf had talked about this:


3. The paragraph beginning 'A more comprehensive analysis of outcomes trial
data...' needs to be revised as that more comprehensive analysis is now
published. Having read it, I was surprised to find that it was a 12 month trial
(although cost data only collected at 6 months?). Importantly it suggests that any
possible better effect of GET at 6 months had disappeared by 12 months. I think
the authors should have acknowledged that the wider trial had 12 month f/u in
the methods section and used this paragraph in the discussion to summarise the
12 month efficacy findings to put the 6 month cost effectiveness results in
context.

4. If EQ-5D and other economic outcomes are in the ISRCTN protocol, then it
would be appropriate for the authors to acknowledge this initial intention in the
limitations section and be explicit about why they are not reported here (were no
EQ-5D questionnaires sent out? were too few returned?).

They had also measured sickness absence but we don't get to see this data in either this paper or the main paper in Psychological Medicine.
 

Dolphin

Senior Member
Messages
17,567
The most interesting thing in this paper to me doesn't in fact really relate to this trial specifically, but more to trials in general that use the Chalder fatigue scale, particularly when they use a threshold to signify significant or important changes. For example, the PACE Trial claimed 2 points would be sufficient for a clinically useful difference with large percentages in all groups (incl. the SMC no therapy group) achieving this.

This paper says:

Outcomes

Assessments were made at baseline with follow-up at six and twelve months. The primary clinical outcome was the Chalder fatigue scale [9], which consists of 13 items assessed using Likert scales (0,1,2,3) producing a total score ranging between 0 and 33. For the purpose of the economic evaluation we calculated the amount of clinically significant change by the six-month follow-up given that use of services data was not available for the twelve months follow-up. This was obtained by dividing the actual change in the Chalder fatigue scale total score by four. Thus a value of one in the change in fatigue outcome corresponds to a difference of four in the original Chalder fatigue scale, assuming that a change of that magnitude was clinically significant (CSI)[6]. This was based in a consensus reached by clinicians in a previous trial [10].



6. McCrone P, Ridsdale L, Darbishire L, Seed P: Cost-effectiveness of cognitive behavioural therapy, graded exercise and usual care for patients with chronic fatigue in primary care.
Psychol Med 2004, 34(6):991-999.

10. Ridsdale L, Godfrey E, Seed P: Chronic Fatigue in general practice: authors reply.
Br J Gen Pract 2001, 51:317-318.

Here's the relevant part of their letter (reference 10):

Because the Chalder fatigue scale6 is relatively new, there is no published definition of equivalence. The researchers in this trial include several of those involved in developing and testing the instrument. Our consensus view was that a difference of less than four, using a Likert scale, is not important. We found that the apparent advantage six months after therapy of CBT over counselling was only 1.04 points with a 95% confidence interval from -1.7 to 3.7. Arriving at this estimate was always the main aim of the trial. Jones et al7 (on whom Underwood and Eldridge rely) state ‘If every point within this range (i.e. the confidence interval) corresponds to a difference of no clinical importance then the treatments may be considered to be equivalent.’ We conclude that the treatments are clinically equivalent.

A clinician that was concerned about differences of two or three points could legitimately claim that the question is still open.
 
Messages
13,774
Thanks for your notes. Had they originally failed to mention the 12 months data then? Looks like the reviewer actually did a good job on that one.
 

Dolphin

Senior Member
Messages
17,567
Thanks for your notes. Had they originally failed to mention the 12 months data then? Looks like the reviewer actually did a good job on that one.
I just had a quick look at the draft:
http://www.biomedcentral.com/imedia/9571941097543559_manuscript.pdf
and this is all they said:
Our analysis would also benefit from a wider perspective that includes informal care, productivity costs and measures of quality-adjusted life years (QALYs).
i.e. no mention that the EQ-5D data would have given them this info, if they had collected it.
I searched the draft for "eq" and no mention of EQ5D; similarly searching for "12" shows no mention that they originally had planned to do an economic analysis at this time.

Reviewers seemed to be fair and reasonably rigorous (on my fairly superficial read of it).