(FINE Trial) Cost-effectiveness of supported self-management for CFS/ME patients in primary care

[Dolphin]

http://www.biomedcentral.com/1471-2296/14/12/abstract
Free: (Provisional) full text: http://www.biomedcentral.com/content/pdf/1471-2296-14-12.pdf

Research article

Cost-effectiveness of supported self-management for CFS/ME patients in primary care

Gerry Richardson, David Epstein, Carolyn Chew-Graham, Christopher Dowrick, Richard P Bentall, Richard K Morriss, Sarah Peters, Lisa Riste, Karina Lovell, Graham Dunn and Alison J Wearden

BMC Family Practice 2013, 14:12 doi:10.1186/1471-2296-14-12

Published: 18 January 2013

Abstract* (provisional)

Background

Nurse led self-help treatments for people with chronic fatigue syndrome/myalgic encephalitis (CFS/ME) have been shown to be effective in reducing fatigue but their cost-effectiveness is unknown.

Methods

Cost-effectiveness analysis conducted alongside a single blind randomised controlled trial comparing pragmatic rehabilitation (PR) and supportive listening (SL) delivered by primary care nurses, and treatment as usual (TAU) delivered by the general practitioner (GP) in North West England.

A within trial analysis was conducted comparing the costs and quality adjusted life years (QALYs) measured within the time frame of the trial. 296 patients aged 18 and over with CFS/ME diagnosed using the Oxford criteria were included in the cost-effectiveness analysis.

Results

Treatment as usual is less expensive and leads to better patient outcomes compared with Supportive Listening.

Treatment as usual is also less expensive than Pragmatic Rehabilitation. PR was effective at reducing fatigue in the short term, but the impact of the intervention on QALYs was uncertain.

However, based on the results of this trial, PR is unlikely to be cost-effective in this patient population.

Conclusions

This analysis does not support the introduction of SL.

Any benefits generated by PR are unlikely to be of sufficient magnitude to warrant recommending PR for this patient group on cost-effectiveness grounds alone.

However, dissatisfaction with current treatment options means simply continuing with 'treatment as usual' in primary care is unlikely to be acceptable to patients and practitioners.

Trial registration: The trial registration number is IRCTN74156610

*I've given each sentence its own paragraph

 

[Dolphin]

A reminder what pragmatic rehabilitation is:

Background:

[..]

A recent UK multicentre clinical study randomised primary care patients to one of three
treatments: pragmatic rehabilitation (PR) or supporting listening (SL), a non-directive
counselling approach, delivered over ten sessions by primary care nurses, or treatment as
usual (TAU) [7]. PR provides an explanation for patients’ symptoms, based on a model in
which CFS occurs as a consequence of physiological dysregulation associated with inactivity,
disturbance of sleep and circadian rhythms, and the somatic symptoms of arousal or anxiety.
The explanation provides the rationale for a rehabilitation program, developed collaboratively
with the patient, which includes a graded return to activity and normalisation of sleep
patterns. The model is presented to patients both verbally and in the form of a fully
referenced manual. The therapy aims to help patients understand the model and to support
them as they make the behavioural and lifestyle changes suggested by the model. PR was
effective after 18 weeks of treatment in reducing fatigue, depression and improving sleep, but
these effects had diminished one year later [7].

One can read the initial presentation to patients in this thread:

FINE Trial: Pragmatic Rehabilitation Presentation (initial presentation to patients)​

and the manual here:
http://forums.phoenixrising.me/index.php?threads/fine-trial-pragmatic-rehabilitation-manual.21415/

 

[Dolphin]

Minor:

chronic fatigue syndrome/myalgic encephalitis (CFS/ME)

I think "myalgic encephalitis" is incorrect - should be "encephalomyelitis".

-------
Table 2 is interesting:
"Cost of health care services and non-NHS expenditures related to CFS/ME at each follow up, by treatment group (mean, sd)*"

PR does well in the lost earnings category in the first 20 weeks:
Mean (SD): PR: 2601 (6460); Supportive listening: 4661 (15215); Treatment as usual: 3450 (7459).

However, PR does really bad over weeks 44 to 70 in follow-up period
Mean (SD): PR: 5562 (8776); Supportive listening: 3494 (8509); Treatment as usual: 3321 (5285).

They don't make any comment on how bad PR did.

 

[Sasha]

Thanks for posting this, Dolphin. I must say I'm relieved to be spared the prospect of having some NHS-brainwashed nurse who has been profoundly and deliberately misinformed about ME 'supportively listen' to me or attempt to 'pragmatically rehabilitate' me.

Small mercies.

 

[Dolphin]

Thanks for posting this, Dolphin. I must say I'm relieved to be spared the prospect of having some NHS-brainwashed nurse who has been profoundly and deliberately misinformed about ME 'supportively listen' to me or attempt to 'pragmatically rehabilitate' me.

Small mercies.

Yes, although the form of CBT or GET generally offered by the NHS isn't a million miles away from pragmatic rehabilitation (a previous trial, Powell et al. 2001 has been included in systematic reviews for these) and CBT can be given by nurses.

 

[Dolphin]

They just focused on NHS healthcare costs, which seems to be the main one in NICE calculations.

The PACE Trial paper looked at healthcare costs but also separately did calculations for societal costs.

Though outside the strict perspective of the NHS and personal social services advocated by
NICE [9], the economic impact of CFE/ME on the patient and their family may be of interest
to decision makers (see web appendix).

9. National Institute for Health and Clinical Excellence: Guide to the methods of technology
appraisal. 2008.

Resource use and unit costs

Patients were asked to recall use of hospital services (inpatient, outpatient, A&E, day case surgery), day services (day centre, drop-in centre or social club), and contacts with health professionals over the time period of the trial. In addition, detailed costing of use of all prescribed medications was performed for each follow-up [10]. The cost of delivering the intervention, in terms of nurse time, travel and training was also included. Though ten sessions were scheduled for each PR was delivered over a mean of 9.5 sessions with SL delivered over a mean of 9.6 sessions (see web appendix).

Costs of CFS/ME borne by patient or family

The trial collected data from patient questionnaires on the economic impact of CFS/ME on patients and their families. These costs included help from informal carers, payments for prescription and over-the-counter medicines, payment for complementary therapies, major one off expenses, lost days and lost income from work and days lost from leisure. These costs are described in this paper but are not included in the estimation of the cost-per-QALY [9].

Explanation of how the figures are used:

Cost-effectiveness analysis
Cost-effectiveness analysis Regression analysis was used to estimate the mean difference in cost and mean difference in QALYs per patient for each treatment over 70 weeks, relative to treatment as usual. Incremental cost effectiveness ratios (ICERs) were calculated where appropriate; ICERs formally compare the incremental costs and effects associated with intervention(s) (see web appendix). Conventionally, NHS treatments in England are considered cost-effective by NICE if the incremental cost-effectiveness ratio is less than £20,000 per QALY [9]. For interventions that are associated with an ICER between £20-30,000 per QALY gained, there needs to be evidence that the intervention is innovative and/or that HRQoL is not captured adequately and/or that there is considerable uncertainty around the ICER. As the ICER goes above £30,000 per QALY gained, this evidence needs to be stronger [9].

----
They didn't compare the different methods directly with PACE: they first submitted the paper on August 16, 2012 while the McCrone PACE Trial paper was published on August 1, 2012 so perhaps this is excusable:

Comparison with existing literature
A recently published trial [22] suggests that graded exercise therapy leads to better patient
outcomes (in terms of reduced fatigue and better physical function) than standardised usual
specialist medical care. However, like the patients in the previous PR trial reported by Powell
et al. (2001) [8], these patients had been referred to secondary care and so were a selected
group, unlike the group in the FINE trial. In the White et al. (2011) report [22], the impact of
graded exercise therapy on overall health related quality of life was not stated and resource
use data were not reported.

 

[Dolphin]

There was a difference depending on whether they tried to impute missing values.
When they imputed missing values (main analysis), Treatment as usual had slightly better QALYs

Cost-effectiveness analysis
Table 4 shows mean incremental QALYs and mean incremental costs compared with
treatment as usual. Multiple imputation has been used to deal with missing data, and
confidence intervals have been estimated by bootstrapping the 15 imputed datasets. After
adjusting for baseline differences in EQ-5D, TAU delivered in primary care tends to be
slightly more effective than either PR or SL and at a lower cost.

However, if do a separate analysis when don't impute missing values:

Sensitivity analysis
A complete case analysis (N=254) (excluding patients who did not complete questionnaires at
baseline, 20 weeks or 70 weeks), suggested that PR tended to be associated with slightly
higher QALYs than TAU though again with wide confidence intervals that crossed zero
(Table 4)

The underlined part means the difference was not statistically significant.

 

[Dolphin]

Implications for future research and clinical practice
There is a body of evidence that suggests that patients with CFS/ME are not satisfied with the care they currently receive from primary care, and that GPs find management of these patients difficult [5,21]. Thus the suggestion that the cost-effective solution should be implemented is of limited use if patients feel that this option is not acceptable. Thus further research into effective management options for patients with CFS/ME is needed. In addition, the skills of GPs in making the diagnosis of CFS/ME and offering acceptable treatment, or referral to specialist CFS/ME services, need to improve. The team are currently developing and evaluating resources to support GPs and patients with CFS/ME.

If somebody had the time, I think it'd be good if one or more people responded to this with a comment.
Basically, I think lots of patients would prefer other options to this one and also that their GPs weren't educated that this was a good approach.

 

[Dolphin]

There is some data in the Appendix people could easily miss:

There is an Appendix file at: http://www.biomedcentral.com/imedia/9227522608966898/supp1.docx

The first eight pages of it look like they would not be of interest to the average patient - I haven't read them but they appear to be about how to deal with missing data.
However, after that, the data is much more basic and comprehensible.

Table A3. Therapy time (minutes of therapy and cost in total during first 20 weeks)

Table A4. Number of patients using each type of healthcare resource during each follow up period

We had some information on those topics from Table 2 in the main paper.

However,

Table A5. Costs of CFS/ME borne by patient and family, by treatment group, in 5 months up to Week 20 interview

and

Table A6. Costs of CFS/ME borne by patient and family, by treatment group, in 6 months up to Week 70 interview

contain items "Time off work (days)" and "Leisure time lost (hours)".
However, unfortunately they don't also include mean figures for these which would have made them more interesting I think.

Table A7. Mean EQ5D index at baseline and follow up

contains the exact EQ5D scores (so one doesn't have to estimate them from the figure)

The appendix also has this little discussion:

Comparison of the results with other studies The results of this analysis can be compared with a previous study that estimated the economic burden of CFS in a UK primary care setting 2003.(McCrone et al., 2003). This study found service costs (hospital, primary care etc) to be £202 (SD 170), the costs of informal care were £2903 (SD4227) and costs of lost employment were £410 (SD 759) over three months in CFS patients. The present study found service costs were £710 (SD 814), informal care was £3102 (SD 4221) and lost employment was £3221 (SD 5285) over six months (measured in the usual care group at 70 weeks after the start of the trial). The costs of health services seem slightly higher in the current study, though one must take account of cost inflation and the uncertainty induced by different periods of recall (3 versus 6 months). The costs of informal care (costed at home help wages) appear considerably lower in the current study. This may be partly due to the design of the questionnaires. The current study asked if the respondent had used any informal help, with two examples (tasks around the home, shopping). McCrone et al asked about broader categories of specific tasks (personal support, child care, help in/around the house, help outside the home and other tasks). This may have prompted better recall. The costs of lost employment seem considerably higher than estimated by the previous study. Again this could be partly due to the design of the questionnaire. McCrone et al asked respondents to recall the number of hours or weeks lost to work, and multiplied this by the weekly wage. The current study asked respondents directly to estimate their total lost earnings as a result of CFS over the previous 6 months. This wording may have prompted some respondents to include potential offers of employment that they could not take up because of their disease, as well as sick days from their actual contracted employment.

£3221 doesn't match £3321 in the main table 2.

Those are my comments for the moment.

 

[Sean]

However, dissatisfaction with current treatment options means simply continuing with 'treatment as usual' in primary care is unlikely to be acceptable to patients and practitioners.

If no current treatment option is satisfactory and acceptable, then why single out 'treatment as usual' in primary care?

It should be:

'However, dissatisfaction with current treatment options means simply continuing on with any of these options is unlikely to be acceptable to patients and practitioners.'

 

[Dolphin]

New David Tuller article today:
"Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?"

http://www.virology.ws/2015/11/09/t...-sister-trial-been-disappeared-and-forgotten/

Phoenix Rising thread on it:
http://forums.phoenixrising.me/inde...rial”-been-“disappeared”-and-forgotten.41104/