A cost effectiveness of the PACE trial

[Firestormm]

Simon. I am not feeling so good but this was the study to which I referred, and it carries references to prevalence data of the range 0.2-2.6% Hope this is useful sorry I can't do more at present

The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database

Simon M Collin1, Esther Crawley1*, Margaret T May2, Jonathan AC Sterne2, William Hollingworth2 and UK CFS/ME National Outcomes Database

In full: http://www.biomedcentral.com/1472-6963/11/217

CFS/ME is heterogeneous [4] and relatively common with an estimated prevalence from population surveys of between 0.2% and 2.6% [5-10].

1. Reeves WC, Jones JF, Maloney E, Heim C, Hoaglin DC, Boneva R, Morrissey M, Devlin R: Prevalence of chronic fatigue syndrome in metropolitan, urban, and rural Georgia.
   Popul Health Metr 2007., 5:
2. Evengard B, Jacks A, Pedersen NL, Sullivan PF: The epidemiology of chronic fatigue in the Swedish Twin Registry.
   Psychol Med 2005, 35:1317-1326. PubMed Abstract | Publisher Full Text
3. Buchwald D, Umali P, Umali J, Kith P, Pearlman T, Komaroff AL: Chronic Fatigue and the Chronic-Fatigue-Syndrome - Prevalence in A Pacific-Northwest Health-Care System.
   Annals of Internal Medicine 1995, 123:81-88. PubMed Abstract
4. Reyes M, Nisenbaum R, Hoaglin DC, Unger ER, Emmons C, Randall C, Stewart JA, Abbey S, Jones JF, Gantz N, et al.: Prevalence and incidence of chronic fatigue syndrome in Wichita, Kansas.
   Archives of Internal Medicine 2003, 163:1530-1536. PubMed Abstract | Publisher Full Text
5. Wessely S, Chalder T, Hirsch S, Wallace P, Wright D: The prevalence and morbidity of chronic fatigue and chronic fatigue syndrome: A prospective primary care study.
   American Journal of Public Health 1997, 87:1449-1455. PubMed Abstract | Publisher Full Text | PubMed Central Full Text
6. Skapinakis P, Lewis G, Mavreas V: Unexplained fatigue syndromes in a multinational primary care sample: specificity of definition and prevalence and distinctiveness from depression and generalized anxiety.
   Am J Psychiatry 2003, 160:785-787. PubMed Abstract | Publisher Full Text

 

[Simon]

Simon. I am not feeling so good but this was the study to which I referred, and it carries references to prevalence data of the range 0.2-2.6% Hope this is useful sorry I can't do more at present

The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database

Simon M Collin1, Esther Crawley1*, Margaret T May2, Jonathan AC Sterne2, William Hollingworth2 and UK CFS/ME National Outcomes Database
In full: http://www.biomedcentral.com/1472-6963/11/217

Hi Firestormm, sorry you are having a rough one (or maybe it was down to too much Olympic partying?). Looking at the Collins references you mention, the high prevalence rates come from these studies:

• Reeves 2007 @ 2.5% for Empirical criteria
• Wessely 97 @ 2.6% for CDC/Fukuda and 2.4% Oxford, flaws as above
• Evengard 2005 @ 2.4% for 'CFS-like' illness diagnosed by phone questionnaire

Which doesn't really help much. At the other end of the scale, the Buchwald 95 study @ 0.2% was based on 3 'CFS' cases who had an average SF36 PF score of 75, were all working part-time and were all college-decuated so these may not a) be representative cases of b) be cases at all. They do mention the Reyes study (0.24%) which together with the US Jason study (0.4%) and Nacul (0.2-0.4%) studies mentioned above are probably the best guides to prevalence.

 

[Dolphin]

Hi Firestormm, sorry you are having a rough one (or maybe it was down to too much Olympic partying?). Looking at the Collins references you mention, the high prevalence rates come from these studies:

• Reeves 2007 @ 2.5% for Empirical criteria
• Wessely 97 @ 2.6% for CDC/Fukuda and 2.4% Oxford, flaws as above
• Evengard 2005 @ 2.4% for 'CFS-like' illness diagnosed by phone questionnaire

Which doesn't really help much. At the other end of the scale, the Buchwald 95 study @ 0.2% was based on 3 'CFS' cases who had an average SF36 PF score of 75, were all working part-time and were all college-decuated so these may not a) be representative cases of b) be cases at all. They do mention the Reyes study (0.24%) which together with the US Jason study (0.4%) and Nacul (0.2-0.4%) studies mentioned above are probably the best guides to prevalence.

Small correction:
Nacul found:

The estimated minimum prevalence rate of ME/CFS was 0.2% for cases meeting any of the study case definitions, 0.19% for the CDC-1994 definition, 0.11% for the Canadian definition and 0.03% for the ECD*.

(ref: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3170215/)

ECD= Epidemiological Case Definitions that Pheby and others published in the JoCFS. It clearly didn't work.

 

[Dolphin]

Regarding costs, one person found out if somebody was referred from out of area to Barts, the cost was £4,228.

This covered the initial consultation, which is "free"; if the diagnosis is confirmed, Barts offer therapy over 16 sessions. If the patient has not responded, they keep going at no extra cost.

This figure is a lot higher than the costs (estimates) in the trial.

 

[user9876]

Regarding costs, one person found out if somebody was referred from out of area to Barts, the cost was £4,228.

This covered the initial consultation, which is "free"; if the diagnosis is confirmed, Barts offer therapy over 16 sessions. If the patient has not responded, they keep going at no extra cost.

This figure is a lot higher than the costs (estimates) in the trial.

I think the costs in the paper are based on labour rates having recorded the time people had in various sessions. So CBT works out at contact hours + 0.3 * contact hours + 46% overheads on all of that. So I recon that 16 1 hour sessions of CBT would cost 3340 at that rate ((16*110 + 16*0.3*110) * 1.46). SMC was charged at 169 hour per doctor so the diagnosis would push this up a bit.

That doesn't of course reflect the cost charged to the commissioning body. Barts are taking a risk on the number of sessions till they can convince someone they are better or until they are too ill to attend the clinic. So I would expect them to charge something to represent these costs.

 

[Dolphin]

I think the costs in the paper are based on labour rates having recorded the time people had in various sessions. So CBT works out at contact hours + 0.3 * contact hours + 46% overheads on all of that. So I recon that 16 1 hour sessions of CBT would cost 3340 at that rate ((16*110 + 16*0.3*110) * 1.46). SMC was charged at 169 hour per doctor so the diagnosis would push this up a bit..

I'm pretty sure that the £110 is the cost with these things factored in. For example, the cost of GET was £100 per session but if one looks at the Appendix, the cost of a physiotherapist is £42 per hour.

Similarly, the Appendix http://www.plosone.org/article/fetc...ri=info:doi/10.1371/journal.pone.0040808.s001 says:
Psychologist £81/hour
Community mental health nurse £56/hour

CBT was given by 7 clinical psychologists, 4 nurse therapists 2 counselling psychologists (Appendix to White et al, 2011)

Also, I don't know why they would mention:

"It was assumed that the ratio of time spent on patient-related versus support activities was 1:0.3 and that capital and administrative overheads were 46% [12]."

if they weren't adding on those extra bits (which they aren't if one goes from £110 and one works up to £3340 as the cost given is a lot less than £3340).

That doesn't of course reflect the cost charged to the commissioning body. Barts are taking a risk on the number of sessions till they can convince someone they are better or until they are too ill to attend the clinic. So I would expect them to charge something to represent these costs.

Technically what the letter said was "If the patient has not responded, they keep going at no extra cost" which may not have the same meaning as "better" depending how one uses it (i.e. if a person is improving, they might well have to pay more after 16 sessions). But if somebody hasn't responded at all after travelling in to Barts for 16 sessions, I'm not sure how many would keep going.

If Barts do regularly give more than 16 sessions and so it does work out at £4228/similar per person, this would affect value-for-money estimates. This annoys me a bit: nonpharmacological spending I don't think is watched as closely as spending on drugs.

 

[user9876]

I'm pretty sure that the £110 is the cost with these things factored in. For example, the cost of GET was £100 per session but if one looks at the Appendix, the cost of a physiotherapist is £42 per hour.

Similarly, the Appendix http://www.plosone.org/article/fetc...ri=info:doi/10.1371/journal.pone.0040808.s001 says:
Psychologist £81/hour
Community mental health nurse £56/hour

CBT was given by 7 clinical psychologists, 4 nurse therapists 2 counselling psychologists (Appendix to White et al, 2011)

Also, I don't know why the would mention:

if they weren't adding on those extra bits (which they aren't if one goes from £110 and one works up to £3340 as the cost given is a lot less than £3340).

Technically what the letter said was "If the patient has not responded, they keep going at no extra cost" which may not have the same meaning as "better" depending how one uses it (i.e. if a person is improving, they might well have to pay more after 16 sessions). But if somebody hasn't responded at all after travelling in to Barts for 16 sessions, I'm not sure how many would keep going.

If Barts do regularly give more than 16 sessions and so it does work out at £4228/similar person, this would affect value-for-money estimates. This annoys me a bit: nonpharmacological spending I don't think is watched as closely as spending on drugs.

I had interpreted their statement differently but looking at the hourly rate figures I think you are right. I've possibly spent to long looking at hourly IT consultancy rates so these figures seemed reasonable. The other cost relating to time is utilisation (that is how much time are people spending with work/no work).Consultancies assume 80% generally I believe. It may be barts have lots of therapists and not enough patients hence high costs.

I imaging Barts are making a healthy profit on that they charge the PCT.

I assume costing pharmacological treatments is quite challenging since its not just the price of the drug but the time spent administering it and any stay in hospital. Maybe I'm just thinking of chemotherapy here.

 

[Firestormm]

Hi Firestormm, sorry you are having a rough one (or maybe it was down to too much Olympic partying?). Looking at the Collins references you mention, the high prevalence rates come from these studies:

• Reeves 2007 @ 2.5% for Empirical criteria
• Wessely 97 @ 2.6% for CDC/Fukuda and 2.4% Oxford, flaws as above
• Evengard 2005 @ 2.4% for 'CFS-like' illness diagnosed by phone questionnaire

Which doesn't really help much. At the other end of the scale, the Buchwald 95 study @ 0.2% was based on 3 'CFS' cases who had an average SF36 PF score of 75, were all working part-time and were all college-decuated so these may not a) be representative cases of b) be cases at all. They do mention the Reyes study (0.24%) which together with the US Jason study (0.4%) and NaculNICE Guidlines 2007/CMO 2002 (0.2-0.4%) studies mentioned above are probably the best guides to prevalence.

Thanks. Yes I was aware of the inadequacies of these studies, but the point was I suppose that they are used as prevalence data and indeed the 2.6% formed a key part of the Press Release accompanying this particular study. So much so that I get rather involved in debating this point with the MRC via AFME at the time.

I'm assuming that the PACE Trial itself or this cost-effectiveness assessment made no reference then to prevalence or what it might have been based upon?

Personally, I would still favour the Nacul study, which - as Dolphin mentions above - does indeed use CDC and CCC - but as NICE use the range 0.2-0.4% it is probably more reasonable to go with that as they themselves will do should they work up any model for additional healthcare based on these results.

 

[biophile]

Going through some older notes, out of coincidence I found this from the larger PACE Trial thread:

Or put another way you would need to treat 7 CFS patients to get just one patient up to a 'clinically useful difference' (the smallest worthwhile improvement). That's the equivalent of 105 CBT sessions. For GET it's 8 patients and 120 GET sessions. This probably doesn't look too clever in a cost effectiveness analysis.

More recently on this thread:

If Barts do regularly give more than 16 sessions and so it does work out at £4228/similar per person.

I imagine Barts are making a healthy profit on that they charge the PCT.

Peter White (Barts) assured us that "None of the psychiatrists are employed to provide any of these therapies. No researcher will make any personal financial gain from these trials." (https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0405C&L=co-cure&P=R579)

Richard Horton (Lancet) assured us that "[...] I think the criticisms about this study are a mirage. They obscure the fact that what the investigators did scrupulously was to look at chronic fatigue syndrome from an utterly impartial perspective." (http://www.abc.net.au/radionational...son-of-treatments-for-chronic-fatigue/2993296).

Obviously the issue is not that black and white as direct employment, but it would appear that the authors and their colleagues stood to indirectly gain much if the UK government rolled out CBT/GET. This is before considering the COI mentioned in the Lancet paper, and the fact that White and others have invested decades (30 years for White) of their careers on the rationale and practice of CBT and GET. PACE was the culmination of whole careers, but the results suggest the truth is wearing off for the cognitive behavioural model.

Facing the dreadful possibility that you helped to lead millions of people up a blind alley for 30 years, is a potentially powerful COI and motivator, especially when some of those people are already angrily blaming you and have been challenging your claims since the beginning. Also, imagine the embarrassment for White et al if they become historical figures for having abnormal illness beliefs about ME/CFS rather than the patients they were supposed to be correcting.

The sooner they just admit that the cognitive behavioural model and CBT/GET have over-reached, the better for patients. The closest statement I've ever seen from them is from the 2011 Lancet paper: "Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed. The effectiveness of behavioural treatments does not imply that the condition is psychological in nature." However, I think many patients/advocates will want a full admission and an apology as a bare minimum, others will want more.

 

[Simon]

Direct cost of CFS to UK Government is around £1.5 billion (draft estimate)

I've already posted that the Societal cost of CFS is around £3.5 billion, but most of that is lost earnings and the cost of informal care valued at national earnings - neither of which cost the Government anything. Consequently it's not a very persuasive figure from its perspective. However, direct costs to it: healthcare costs, losts taxes and benefit payments will be of great interest. My intial estimate of these costs, working from the PACE trial CBT baseline data - is around £1.5 billion a year, a number that might make the government take more notice.

How this breaks down:

Lost Taxes= £875 million
Benefit Payed = £367m
Healthcare Costs = £236m

Total Government losses = £1.48 billion a year, for working age CFS patients

I'll write up more detail if people are interested in this approach, but main assumptions are:

1. Lost income tax @ 18.5% of lost earnings (average UK rate factoring in tax allowances)
2. Lost National Insurance @ 2/3 of lost income tax (based on Treasury data and net of pension contributions/reclaimed maternity pay, sick pay)
3. Lost VAT (sales tax). Harder to judge since people still spend when on a lower income. I used a loss of 50% of the average VAT paid, relative to lost earnings
4. Benefits. The hardest to gauge. 10% on income benefits assumed to be Income support for single person + £260 pcm for housing benefit and council tax relief. Illness/disability benefit assumed to all be Incapacity Benefit
5. Healthcare costs from the McCrone paper

WARNING: I haven't checked this work carefully yet, happy to supply spreadsheet or more details to anyone who is interseted.

 

[Firestormm]

Hi Simon,

The previous study from Crawley et al. based on the few patients they included prompted these headlines: http://forums.phoenixrising.me/index.php?threads/uk-impact-of-cfs-me.12243/#post-207785

I do recall now, that at the time other news sources were claiming even greater figures as a cost to the economy in lost earning etc. based on a 2.6% prevalence.

With regards to this PACE trail cost-effectiveness, I wonder if (assuming it would be possible) it might help to calculate what it would cost to implement on a large scale the proscribed therapies?

If the recommendation at next years NICE Guidlines Review is to - for example - roll these therapies out nationally, then it would make headlines if the total cost of care were to be estimated.

'All this cost and for how much gain?' That kind of thing. I dunno. What do you think?

Play them at their own game? If 100,000 people with moderate ME, underwent GET and CBT and e.g. only 30% improved and were able to return to work it would cost £X million to put 100,000 through therapy - and would result in £X gain to the economy assuming they all did return to work or even want to.

 

[Enid]

I was working 10 years ago - contributing to the income of the UK - no current resolution of the pathology findings will even consider. They just ignore real medical/scientific findings to really aid.

 

[Dolphin]

Hi Simon,

The previous study from Crawley et al. based on the few patients they included prompted these headlines: http://forums.phoenixrising.me/index.php?threads/uk-impact-of-cfs-me.12243/#post-207785

I do recall now, that at the time other news sources were claiming even greater figures as a cost to the economy in lost earning etc. based on a 2.6% prevalence.

With regards to this PACE trail cost-effectiveness, I wonder if (assuming it would be possible) it might help to calculate what it would cost to implement on a large scale the proscribed therapies?

If the recommendation at next years NICE Guidlines Review is to - for example - roll these therapies out nationally, then it would make headlines if the total cost of care were to be estimated.

'All this cost and for how much gain?' That kind of thing. I dunno. What do you think?

Play them at their own game? If 100,000 people with moderate ME, underwent GET and CBT and e.g. only 30% improved and were able to return to work it would cost £X million to put 100,000 through therapy - and would result in £X gain to the economy assuming they all did return to work or even want to.

Perhaps the idea would have a use. However, I'm not sure why one would make the point about 30% being able to return to work after CBT and GET when there was no difference in days lost between SMC, SMC+CBT, SMC+GET and SMC+APT (just highlighting this in case anyone missed it). And there was plenty of scope for improvement as the values were so high.

 

[Dolphin]

I've never studied economics (or indeed any business subject) so don't know much about the area but I see that the CDC calculated what they called household productivity:

Reynolds KJ, Vernon SD, Bouchery E, Reeves WC. The economic impact of chronic fatigue syndrome. Cost Eff Resour Alloc. 2004 Jun 21;2(1):4. Free full text: http://www.resource-allocation.com/content/2/1/4

This was based on lost earnings not just of the patient but also other family members, which could be affected by either care needed directly for the patient and also the patient not doing "their fair share" around the house and so other people having to spend more time on such things. (Although probably again, a lot of the time this wouldn't cause healthy people to reduce hours at work and instead free time would be reduced). (That's my recollection from the paper - it's years since I read it). We can't calculate such information from the data given in the McCrone paper.

 

[Dolphin]

A couple of other papers looking at the economic impact, for what they are worth:

Collin SM, Crawley E, May MT, Sterne JA, Hollingworth W; UK CFS/ME National Outcomes Database. The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database. BMC Health Serv Res. 2011 Sep 15;11:217. Free full text (with a comment) http://www.biomedcentral.com/1472-6963/11/217

Lin JM, Resch SC, Brimmer DJ, Johnson A, Kennedy S, Burstein N, Simon CJ. The economic impact of chronic fatigue syndrome in Georgia: direct and indirect costs. Cost Eff Resour Alloc. 2011 Jan 21;9(1):1. Free full text (with a comment) http://www.resource-allocation.com/content/9/1/1

Lin et al. uses (so-called) "empiric" criteria so I imagine the individual figures are too low, but then the prevalence is way too high.

 

[Firestormm]

Perhaps the idea would have a use. However, I'm not sure why one would make the point about 30% being able to return to work after CBT and GET when there was no difference in days lost between SMC, SMC+CBT, SMC+GET and SMC+APT (just highlighting this in case anyone missed it). And there was plenty of scope for improvement as the values were so high.

You're right. It was just a figure I grasped out of thin air

Infact that would make a better headline/article.

'Despite claiming moderate improvements of X, this resulted in no increase in employment but economic cost of £X millions in delivering the healthcare and in lost productive capacity, not to mention continued dependence on benefits'

Of course you can't put a price on improved quality of life - assuming there was any - or in any other less measurable effects that interventions might have.

 

[Simon]

A couple of other papers looking at the economic impact, for what they are worth:

Collin SM, Crawley E, May MT, Sterne JA, Hollingworth W; UK CFS/ME National Outcomes Database. The impact of CFS/ME on employment and productivity in the UK: a cross-sectional study based on the CFS/ME national outcomes database. BMC Health Serv Res. 2011 Sep 15;11:217. Free full text (with a comment) http://www.biomedcentral.com/1472-6963/11/217

Lin et al. uses (so-called) "empiric" criteria so I imagine the individual figures are too low, but then the prevalence is way too high.

Agree with you re Lin. The main difference between the Collin study and the estimates I've made above isn't on cost per patient (which are not so dissimilar, and PACE data is more detailed) but on the relevant number of patients to count. Collin et al based their calculation on the number of people accessing specialist services (a small number):

Our sample was equivalent to 4,424 UK adults accessing specialist services each year, representing productivity costs to the UK economy of £102.2 million.

while I assumed that PACE patients are typical of all CFS patients. However, a Nacul paper found that CFS patients in its population study (miniumum Fukuda prevalence 0.19%) had a mean SF-36 Physical Function score of 26, well below the PACE baseline average of around 37, and on that basis the assumption that PACE patients are typical of the wider patient population looks reasonable, and possible even conservative.

 

[Dolphin]

However, a Nacul paper found that CFS patients in its population study (miniumum Fukuda prevalence 0.19%) had a mean SF-36 Physical Function score of 26, well below the PACE baseline average of around 37, and on that basis the assumption that PACE patients are typical of the wider patient population looks reasonable, and possible even conservative.

FWIW: The Nacul study used the SF-36v2 health survey. That means normalised scoring.

 

[Simon]

FWIW: The Nacul study used the SF-36v2 health survey. That means normalised scoring.

Doh! Table 2 gives both normalised and standardised scores (specifically for comparison with other studies) and I quoted the wrong one. Correction:

SF-36 Physical Function scores: PACE = 37-ish; Nacul population study = 30

So it still looks like the PACE results are similar (or slightly higher) than the population study, indicating that it is probably reasonable to assume that PACE patients are broadly representative of the wider patient population - at least as far as physical functioning goes.

 

[biophile]

"But Andrew Lloyd, who runs the fatigue section of the Lifestyle Clinic at the University of NSW, believes that PACE is representative of at least three-quarters of ME-CFS patients in Australia, namely young or middle-aged adults who are not housebound."

http://sacfs.asn.au/news/2011/03/03_28_putting_exercise_through_its_paces.htm