A cost effectiveness of the PACE trial

[Firestormm]

Dr Enlander left a comment on the MEA Website beneath the 'immediate response' from Dr Shepherd viz:

http://www.meassociation.org.uk/?p=12350

As usual Charles has given a penetrating assessment of the flawed study. Even the criteria of the study cohort are unacceptable, the Oxford criteria formulated by a psychiatric group are not accepted by most researchers in the field.

The Fukuda criteria, of which Prof Wessely was co author, were not used nor were the later Canadian Consensus which included Post Exercise Malaise . This is extraordinary in a study which is relating to improvement of ME/CFS patients after graded exercise in two arms of the research.

The thrust of financial gain perhaps to the insurance companies and the Government were priorities rather than improvement of the patient condition.

Little was mentioned about the relapse that we frequently see in ME/CFS patients after exercise. This was also illustrated by Dr Shepherd’s figures.

Presently we are studying pre and post exercise immunology , pathophysiology and genetics in a study at Mount Sinai Medical School, New York in a privately funded million dollar grant.

 

[alex3619]

I have yet to read it but how about this for a headline exemplifying what I was saying above:
New recommendations for treating fatigue could save economy millions

http://www.egovmonitor.com/node/53027

Total incomprehension and ignorance but, hell it makes a lovely headline...

Hi Firestormm, I have left a comment at that site though its waiting moderation. Bye, Alex

 

[Simon]

Morning,
I mean if they want to play fair then this 'cost-effectiveness' has to be realistically built in to the NICE model for costings of a service. The costing report is here (2007): http://www.nice.org.uk/nicemedia/live/11824/36203/36203.pdf

Thanks for this. Think you'd asked before about evidence for the '25%' severely affected rate - the NICE report you link to there has this: still no hard evidence but at least a published figure.

2.3.5 An estimated 90% of people with CFS/ME have mild to moderate levels of the condition. Estimates about the number of people with severe CFS/ME vary between 10% and 25%, but the weight of clinicians' opinion supports the 10% figure. Sensitivity analysis will look at the impact of varying the estimate.[/QUOTE]

 

[alex3619]

Snow Leopard, more than three trillion pounds? My gift basket idea is sound much better.

biophile, I agree with you on the reasoning in your last par in post 39, but so far public authorities/government have seemed oblivious to reason. The reasoning is good, but its not getting through. So what is at issue is whether or not it is blatantly obvious that we need biomedical research. It is to us, it should be to them, but for some reason it isn't, or at least not obviously. It is very likely that many are aware of the issues but they are not acting. That is part of what I am trying to understand. What influences/factors are preventing people from acting? The possibilities range from ideology to ideas about limitations of responsibility, to counter-forces that try to keep people in line with policy. As far as medicine is concerned the direction I am currently heading is that it is due to a combination of dogma and heavy compartmentalization of authority. Given that the UK has hamstrung control of the medical profession by medical professionals, and made it bureaucratic, I wonder if this is not in part why psychobabble has such a hold in the UK?

Another point of major concern is this: how many countries around the world are putting money into biomedical research on ME or CFS? There seem to be only a small number. Why is that?

I have been saying for years now that the lack of proper investment into biomedical resaerch is the equivalent of accumulating a huge debt, with interest, that will have to be paid some time in the future. The bad news is this debt will still have to be paid even in countries that go bankcrupt and so avoid current financial debt. These are not problems that are going to go away.

One of the concerns we have in the modern world is the rising cost of healthcare. We complain, we want to cost cut, but we are unwilling to put money into research to deal with the issues. Not dealing with real problems does not make them go away, it just accumulates issues so they become even more serious. This is head in the sand thinking leading to potential catastrophe.

Bye, Alex

 

[user9876]

What happens when you multiply 63 million people by a prevalence of 2.6% by twenty one thousand pounds? :wink:
Now there is a fact worthy of a media report!

From an economics perspective this is an interesting point. With a drug therapy you would expect as demand increases economies of scale to apply and unit costs to reduce. However with a labour intensive therapy as demand increases this will effect the cost of supply. I'm not an economist but I would expect pricing to depend on the elasticity of the supply. That is how easy is it to get and train suitable therapists. A lack of supply would be expected to push costs up. Ok this may not work with salaried employees in the NHS but if the treatments were effective then you would expect some movement towards the private sector thereby increasing cost.

There analysis suggests a cost increase of 22% for GET and 45% for CBT would push the treatments beyond the threshold.

Ok this assumes the treatments have some effect I notice they didn't do a sensitivity analysis around errors in estimates of the effectiveness of their treatment.

 

[user9876]

Another point of major concern is this: how many countries around the world are putting money into biomedical research on ME or CFS? There seem to be only a small number. Why is that?


Bye, Alex

There seems to be a fair bit of research on the immune systems, auto immune diseasases etc. A number of such papers have been discussed on other threads. My hope is that fundimental research into the immune system, viruses and autoimmunity will be applicable to ME.

 

[Esther12]

re the cost of treatment: They seem to want to use this as an argument for training more therapists - is the cost of this tr5aining included in the calculation of cost effectiveness? Pension costs of the staff involved? Anyone know what's normal?

 

[user9876]

re the cost of treatment: They seem to want to use this as an argument for training more therapists - is the cost of this tr5aining included in the calculation of cost effectiveness? Pension costs of the staff involved? Anyone know what's normal?

I know for research grants we include pension costs with wages but that is in the private sector. I'm not sure how the NHS accounts for pensions.

More generally, particularly with GET they need to make a business case that they can keep costs down. I beleive physios do a 3 year degree (funded by the NHS) and have a choice of areas to work in.

 

[user9876]

There's this from p95 of the CBT Patients Manual. (There might be more elsewhere, I've just had a skim.)

""""""
The "wrong" kind of social support

This may seem a contradiction in terms! The examples below illustrate how the wrong kind of support can make it more difficult for you to move forward for the following reasons:

• If you have a very supportive family member (partner, parent or child) who is used to doing everything for you, it may be difficult for you to increase your activity levels. Your relative may feel that they have your best interest at heart and discourage you from doing more. They may have difficulty accepting that in order to make progress, you need to do things at regular times even if you are feeling very fatigued. If family members have been your "carer" during your illness, they can sometimes feel that they no longer have a role when you are getting better which can sometimes lead them to be critical of your CBT programme or suggest that you are making yourself worse. This may then lead you to question the validity of the programme and deter you from persevering with it particularly when you have a lot of symptoms.
""""""

From p102 of the GET Patients Manual.

""""
What happens if I don't like exercise?

No problem. The important thing to know is that you can chose (sic) any form of activity - for
example DIY, household jobs, craft work or gardening.

""""
(ie. if you were being encouraged to count housework / chores as part or all of your 'exercise' routine this could affect how you report your need for 'informal care'.)

In the paper one of the advantages they talk of is in the reduction in social cost for CBT and GET but given

Informal care costs were substantial
for each group and significantly lower after receiving CBT and
GET when compared to APT and SMC. CFS affects patients in
many ways and can have a major effect on family members. This
study suggests that CBT and GET could ameliorate this effect..

It could be that there is reporting error as people don't like to admit that they have had more help or are subsitituting activity.

The findings we report
suggest that such investment would be justified in terms of
improved quality of life of patients and would actually be cost
saving if all costs including societal costs are considered.

Looks like they are trying to justify investment in training therapists based on a reduction in societal costs which given benefits increase must be the reduction in informal care and the reduction in working hours lost.

 

[Bob]

Think you'd asked before about evidence for the '25%' severely affected rate - the NICE report you link to there has this: still no hard evidence but at least a published figure.

2.3.5 An estimated 90% of people with CFS/ME have mild to moderate levels of the condition. Estimates about the number of people with severe CFS/ME vary between 10% and 25%, but the weight of clinicians' opinion supports the 10% figure. Sensitivity analysis will look at the impact of varying the estimate.

The (only) other official place that I've seen the 25% figure quoted, is as follows:

Department of Health.
A Report of the CFS/ME working Group: report to the chief Medical Officer of an Independent Working Group.
London: Department of Health; 2002.
http://www.dh.gov.uk/prod_consum_dh...@dh/@en/documents/digitalasset/dh_4064945.pdf

"Estimates suggest that up to 25% of people with CFS/ME are so seriously affected
that they are unable to perform most basic personal tasks and are confined to bed
or spend the majority of the day in bed. Such patients feel particularly alone and
isolated.The severity, complexity, and longevity of the illness are poorly understood."

And here's another quote from the NICE guidelines:

NICE Clinical Guidelines, No. 53

"No definitive studies have been carried out in the UK to determine the prevalence of severe CFS/ME in people with CFS/ME, but estimates range from 25% (population and setting not clear) to a lower figure experienced in general clinical practice. People who have severe CFS/ME may be unable to carry out activities of daily living and may spend a significant proportion, or all, of the day in bed."

http://www.ncbi.nlm.nih.gov/books/NBK53587/

 

[Firestormm]

Re: Increasing costs of therapy

Answer: I would expect to hear in the coming months a proposal to switch from face-to-face to internet based CBT/GET therapy

I won't go into the move in general that is occurring for telephone services, IT health check systems, and internet/email therapy. I think there's been more than enough coverage. But this is where I would expect them to go next. And that would see the massive savings whilst enabling them to say that they were 'doing something'.

 

[Dolphin]

http://www.bps.org.uk/news/behavioural-therapies-can-help-me

Behavioural therapies can help with ME

03/08/2012

It was demonstrated that no other treatments for the condition - symptoms of which include tiredness, poor memory and a lack of concentration - proved as successful and cost-effective as behavioural and exercise therapies.

It wasn't as if all the other posited treatments were tested!

Professor Michael Hyland, a Fellow of the British Psychological Society, comments:

"The PACE trial is a well-conducted study which has provided evidence, contrary to the assertion of patient groups, that adaptive pacing does not lead to benefit whereas cognitive behaviour therapy (CBT) and graded exercise therapy do.

"Nevertheless, even with the best designed studies there are several possible interpretations of the data. Adaptive pacing involved "living within physical and mental limitations imposed by the illness" as well as avoiding overexercising. In the CBT and graded exercise therapy treatment arms, patients were advised to avoid over-exercising, but, additionally, these therapies suggested procedures that the patient could perform into to achieve a gradual improvement in health.

"So although all treatment arms of this study recommended avoidance of over-activity (i.e. an element of pacing), they also differed in the amount of effort invested by the patient during treatment.

"My own research shows that the greatest non-specific predictor of therapeutic outcome is effort invested by the patient in the therapy. An important non-specific difference, therefore, between the treatment arms in this study is the extent to which the treatments provide hope and an effort-related plan of action for achieving recovery. We cannot tell whether it is the non-specific factors of hope and effort or the specific components of CBT and graded exercise therapy that are important for outcome. Perhaps the safest conclusion from this study is that therapy works – but just why therapy works remains as controversial for chronic fatigue syndrome as it is always has been for other conditions - see Wampold's The Great Psychotherapy Debate."

Perhaps the safest conclusion from this study is that therapy works

Having an effect is completely different from "working" which sounds like therapy is sufficient, which it wasn't.

I would look at what he says in a slightly different way and wonder whether the therapies and factors associated with them influence responses/have different effects on self-report measures. As people will recall, there was no difference between CBT, APT and SMC alone on the 6 minute walk test.

 

[Simon]

Thanks, Dolphin.

I was intrigued by some of Hyland's comments suggesting that the greater hope/recovery focus of CBT/GET may account for their greater 'effectiveness' than APT, a point that I think has been argued on the PACE thread before:

"So although all treatment arms of this study recommended avoidance of over-activity (i.e. an element of pacing), they also differed in the amount of effort invested by the patient during treatment.

"My own research shows that the greatest non-specific predictor of therapeutic outcome is effort invested by the patient in the therapy. An important non-specific difference, therefore, between the treatment arms in this study is the extent to which the treatments provide hope and an effort-related plan of action for achieving recovery. We cannot tell whether it is the non-specific factors of hope and effort or the specific components of CBT and graded exercise therapy that are important for outcome. Perhaps the safest conclusion from this study is that therapy works – but just why therapy works remains as controversial for chronic fatigue syndrome as it is always has been for other conditions - see Wampold's The Great Psychotherapy Debate."

Of course, the same factors could also lead to more positive reporting as opposed to more real-world effectiveness, as you suggest

 

[Esther12]

Of course, the same factors could also lead to more positive reporting as opposed to more real-world effectiveness, as you suggest

So much of the excitement over the wonderful positive power of placebo seems to require people fail to account for the fact that manipulating what people say about something isn't a terribly worthwhile thing for a doctor to do. If a patient feels that they have a good relationship with a therapist, they'll be more likely to say their treatment was helpful... people are more likely to give positive reports about the work of a plumber they like too! If people feel that they have been working towards an improvement in their health, and have invested their time and ego in to achieving this goal, they'll be more likely to report an improvement in health.... people want to feel pride in themselves and their actions... so what? If patients are still facing a reduced capacity, then the real problem remains, regardless of the positive delusions which have been instilled.

The evidence from actometers used to assess the impact of CBT would seem to indicate that it fails to have any impact upon the reduced capacity of patients. If that's the case, then it is not a medical treatment for CFS, it is just a political tool of manipulation.

 

[user9876]

So much of the excitement over the wonderful positive power of placebo seems to require people fail to account for the fact that manipulating what people say about something isn't a terribly worthwhile thing for a doctor to do. If a patient feels that they have a good relationship with a therapist, they'll be more likely to say their treatment was helpful... people are more likely to give positive reports about the work of a plumber they like too! If people feel that they have been working towards an improvement in their health, and have invested their time and ego in to achieving this goal, they'll be more likely to report an improvement in health.... people want to feel pride in themselves and their actions... so what? If patients are still facing a reduced capacity, then the real problem remains, regardless of the positive delusions which have been instilled.

The evidence from actometers used to assess the impact of CBT would seem to indicate that it fails to have any impact upon the reduced capacity of patients. If that's the case, then it is not a medical treatment for CFS, it is just a political tool of manipulation.

Even believing their figures in this paper the EQ-5D shows about a 6% improvement which is very small. I would have thought at best they could argue that CBT helps people cope and manage better. It makes it very hard for them to claim their hypothesis that ME is a behavioral disorder. In this paper they are clear about this hyposthesis:

CBT, delivered by clinical psychologists or nurse
therapists, aimed to change behavioural and cognitive factors
assumed to be responsible for perpetuating symptoms and
disability.

I don't see how they can argue that a therapy involving multiple different aspects with such poor results can back their theory. The same goes for the deconditioning theory and GET.

If they really believed in their hypothesis they would have tested their version of CBT against a more standard version helping people cope.

 

[Esther12]

Quite a few comments up on the PLOS site:

http://www.plosone.org/article/fetc...icleURI=info:doi/10.1371/journal.pone.0040808

No replies from the authors. The top three (TKindlon, Peter Kemp and JohnM) all looked like good and solid points.

 

[Esther12]

Even believing their figures in this paper the EQ-5D shows about a 6% improvement which is very small. I would have thought at best they could argue that CBT helps people cope and manage better. It makes it very hard for them to claim their hypothesis that ME is a behavioral disorder. In this paper they are clear about this hyposthesis:



I don't see how they can argue that a therapy involving multiple different aspects with such poor results can back their theory. The same goes for the deconditioning theory and GET.

If they really believed in their hypothesis they would have tested their version of CBT against a more standard version helping people cope.

At this point, I find it hard not to believe that they're actively corrupt, or else believe that the therapy just wasn't delivered properly as part of the RCT so they're justified in spinning the results (which is, I guess, just another way of being actively corrupt).

They're results just look too much like homoeopathy to me.

 

[Dolphin]

Looks like they are trying to justify investment in training therapists based on a reduction in societal costs which given benefits increase must be the reduction in informal care and the reduction in working hours lost.

Except they didn't include benefits increases in the societal costs. I don't know how these things are normally calculated to know if benefits costs are usually included in societal cost calculations.

 

[alex3619]

Another thing that has to be taken into account is lost productivity. If benefit claims went up, is it hard to suspect that productivity went down? Of course there is a delay in getting benefits, its also possible that the productivity of patients went down prior to getting benefits and the changes in benefits simply reflect this.

So the main benefit is improved productivity in support workers, including family? You get the same benefit by simply abandoning the disabled. Were any measures taken to ensure that quality of care was not compromised? Or do they simply rely on patients ticking boxes that imply they are happier? Every time I increase my control over my circumstances I am happer. That is independent of my actual capacity to function.

Bye, Alex

 

[Dolphin]

Nice post, biophile.

Extract:

For treating CFS, there is no such thing as high quality candy (reasonably effective treatment). We do however have very cheap candy (CBT/GET) which a small proportion of patients find tastes slightly more pleasant (small improvement in subjective measures) than plain chalk bread (SMC). Therefore, enough very cheap candy for enough people will generate the same amount of taste goodness as high quality candy and at a reasonable cost too, therefore, very cheap candy is "cost-effective" at producing pleasant taste even if most patients do not like the taste better than plain chalk bread. Studies by candy proponents invested in promoting or selling candy report that patients do not dislike the taste (adverse effects), although external surveys of candy eaters suggest that many indeed dislike the taste. Candy proponents claim that there is nothing wrong with the candy and the people that don't like it aren't eating it properly.

To put some figures on this: they estimated the healthcare cost of CBT as £904 and the healthcare cost of GET as £810. Given such low costs, one could see that it would not be hard to be cost-effective with self-report measures, especially in a mixed cohort (these are Oxford criteria patients).

Of course, as has been said, there are also "costs", mainly in terms of their time and energy, for the participant in doing such courses. Loads of healthy people don't do regular exercise because it involves sacrifices; for people with M.E. or CFS who are already struggling, doing such a course, with all the homework, involves bigger sacrifices/is a serious commitment, especially for people with other responsibilities.