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The statistical plan also mentioned analysing the data based on zero cost for informal care. This is not mentioned.

Posted by tkindlon on 23 Dec 2013 at 12:11 GMT

SMcGrath has highlighted the results would look considerably different if informal care was calculated at minimum wage, a view the lead author has essentially agreed with[1,2].

Just to point out that the statistical plan mentioned another analysis, zero cost for informal care[3]:
"The main analyses will use an informal care unit cost based on the replacement method (where the cost of a homecare worker is used as a proxy for informal care). We will alternatively use a zero cost and a cost based on the national minimum wage for informal care."

Such a result would make a bigger difference again to the societal cost estimates.

This makes the authors' claim about sensitivity analyses seem particularly odd[4]:
"Fourth, we made assumptions regarding the value of unpaid care from family and friends and lost employment. However, sensitivity analyses revealed that the results were robust for alternative assumptions."

References:

[1]. SMcGrath. Can the authors show the Sensitivity Analysis results for Societal Benefits for CBT & GET? http://www.plosone.org/an...

[2] McCrone P. RE: Can the authors show the Sensitivity Analysis results for Societal Benefits for CBT & GET? http://www.plosone.org/an...

[3] Walwyn R, Potts L, McCrone P, Johnson AL, Decesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials. 2013 Nov 13;14:386. doi: 10.1186/1745-6215-14-386.

[4] McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One. 2012;7(8):e40808.

Competing interests declared: I work in a voluntary capacity for the Irish ME/CFS Association

RE: The statistical plan also mentioned analysing the data based on zero cost for informal care. This is not mentioned.

spjupmc replied to tkindlon on 01 Jan 2014 at 08:16 GMT

If a smaller unit cost for informal care is used, such as the minimum wage rate, then there would remain a saving in informal care costs in favour of CBT and GET but this would clearly be less than in the base case used in the paper. If a zero value for informal care is used then the costs are based entirely on health/social care (which were highest for CBT, GET and APT) and lost employment which was not much different between arms. In our opinion, the time spent by families caring for people with CFS/ME has a real value and so to give it a zero cost is controversial. Likewise, to assume it only has the value of the minimum wage is also very restrictive. In other studies we have costed informal care at the high rate of a home care worker. If we do this then this would show increased savings shown for CBT and GET.

Competing interests declared: I am the lead author of the paper.

It was the investigators themselves that chose the alternative assumptions (i.e. a zero cost rate or national minimum wage rate for informal care)

tkindlon replied to spjupmc on 15 Feb 2014 at 12:31 GMT

I would like to thank the lead author for replying. I imagine as a member of the team with technical expertise, there is a chance he may have been directed by others into how this trial was reported and what language was used.

To get back to the specifics: nothing he has said has justified what they claimed in the paper:
"However, sensitivity analyses revealed that the results were robust for alternative assumptions."
The two alternative assumptions mentioned in the statistical plan were "a zero cost and a cost based on the national minimum wage for informal care." The results are not robust for such scenarios.

Remember it was the investigators themselves that chose the alternative assumptions. If it's "controversial" now to value informal care at zero value, it was similarly "controversial" when they decided before the data was looked at, to analyse the data in this way.

There is not much point in publishing a statistical plan if inconvenient results are not reported on and/or findings for them misrepresented. If a drug company behaved in this way, it would be frowned on. Unfortunately, there is less scrutiny of the reporting of trials of non-pharmacological interventions, despite the fact that some of those involved in such trials can have their own competing interests. This may be particularly so in the field of ME/CFS where standards seem to be particularly lax e.g. [1].

Medicine is a serious business: people's health and lives depend on it. Some treatments will be offered, and others not offered, due to papers such as this. This will often involve the expenditure of considerable amounts of taxpayers' money. Investigators should not mislead readers.

Again, I thank this particular author for replying but I think it would have been better if the paper itself, which I imagine will be the main focus in future reviews and analyses, had not reported the results in such a way.

References:

1. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013 Oct;43(10):2227-35. doi: 10.1017/S0033291713000020.

Competing interests declared: I work in a voluntary capacity for the Irish ME/CFS Association

Another research group have published a cost-effectiveness paper, on chronic fatigue, which involved a sensitivity analysis valuing the cost of informal care as zero

tkindlon replied to tkindlon on 13 Dec 2014 at 12:45 GMT

I have just read a cost-effectiveness paper on a behavioural intervention for chronic fatigue[1]. That team performed a sensitivity analysis valuing the cost of informal care as zero, just like the PACE Trial authors said they would do in the statistical analysis plan but didn't report in the cost effectiveness paper itself [1-3].

References:

[1] Meng H, Friedberg F, Castora-Binkley M. Cost-effectiveness of chronic fatigue self-management versus usual care: a pilot randomized controlled trial. BMC Fam Pract. 2014 Nov 25;15(1):184.

[2] Walwyn R, Potts L, McCrone P, Johnson AL, Decesare JC, Baber H, Goldsmith K, Sharpe M, Chalder T, White PD. A randomised trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome (PACE): statistical analysis plan. Trials. 2013 Nov 13;14:386. doi: 10.1186/1745-6215-14-386.

[2] McCrone P, Sharpe M, Chalder T, Knapp M, Johnson AL, Goldsmith KA, White PD. Adaptive pacing, cognitive behaviour therapy, graded exercise, and specialist medical care for chronic fatigue syndrome: a cost-effectiveness analysis. PLoS One. 2012;7(8):e40808.

Competing interests declared: I work in a voluntary capacity for the Irish ME/CFS Association