PACE Trial and PACE Trial Protocol

[Dolphin]

Worse CGI scores in PACE Trial than Deale - CBT

Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Deale A, Chalder T, Marks I, Wessely S. Am J Psychiatry. 1997 Mar;154(3):408-14. http://ajp.psychiatryonline.org/cgi/reprint/154/3/408

Self-ratings at 6-month follow-up
CBT vs Relaxation:
27 100% 26 100%
Global improvement
Better or much better 19 70% 8 31%
Unchanged or worse 8 30% 18 69%

Compare with results in Table 5 of PACE

Note definition of a "Good Outcome"

Good Outcomea

aAn increase of 50 or more, from pretreatment to 6-month follow-up, or an end score of 83 or more on the physical functioning scale of the
Medical Outcomes Study Short-Form General Health Survey.

 

[oceanblue]

Sharpe: This was the RCT that "launched" CBT for CFS in a big way around the world:
It included some 6 minute walk data:
CGI results (compare to Table 5):

I seem to remember that the Sharpe cohort was pretty able-bodied which might explain the higher walking levels. One point about that study that sticks in my mind about that sutdy was that at baseline particpants spent an average of 3 days a week in bed, which given how well they did in other areas was odd. I also remember Charles Shepherd pointing out that the objective measure (some physiological measure, can't quite remember which) didn't change despite the self-rated improvement.

But interesting how these results, like the Fulcher one, appear substantially better than PACE. Much like the pilot FINE was based on being much better than FINE itself. But then smaller studies producing more promising results than larger more rigorous ones is hardly a new phenomena in medicine.

 

[Esther12]

Another SMC quote that stood out for me (I don't think it got posted before):

"This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits."

 

[Angela Kennedy]

Another SMC quote that stood out for me (I don't think it got posted before):

"This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits."

That is outrageous. Even more evidence as to why this trial needs to be properly challenged.

 

[urbantravels]

And of course we all realize that the "one commonly used intervention" that they found "not effective" was pacing - but they "identified" this by using an evil version of pacing. Anti-pacing. They apparently plan to use this to further browbeat patients out of "taking it easy".

Ugh.

 

[Snow Leopard]

Now I wonder if that particular doctor was talking about this research referenced above by Snow Leopard. And it makes me wonder what's *really* going on with those fatigued HIV patients. I'm not saying they have CFS or XMRV; I have no idea; but I now have a fundamental doubt about ANY physical manifestation of disease that can't be "objectively" measured being assigned to the "psychological factors" wastebasket. Perhaps someone ought to look a little harder into why those patients are fatigued when they "should" be well.

Yes, they would rather pass the buck than accept their own ignorance.

There is similar research on "cancer fatigue", chronic hepatitis etc. Apparently their fatigue is also entirely due to their behaviour and cognitions and nothing to do with any diseases they may coincidentally suffer from.
The arrogance of some medical practitioners is astounding!

But then smaller studies producing more promising results than larger more rigorous ones is hardly a new phenomena in medicine.

It's well known, they call it the "decline effect".
http://www.newyorker.com/reporting/2010/12/13/101213fa_fact_lehrer?currentPage=all

It presumably results from various publication biases.

 

[Dolphin]

In

Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. BMJ. 1997 Jun 7;314(7095):1647-52. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2126868/pdf/9180065.pdf

the results were better.

However they explicitly pointed out that the means were not back to normal (not done in the PACE Trial) and didn't try to claim any were within the normal range:

Both total and physical fatigue, total SF*36 score,
physical function, and general health were significantly
better after exercise than after flexibility treatment,
though none of these measures had returned to
normal (table 3).

 

[jace]

I was asked to engage more directly with the SMC press release about PACE. Ok, you asked for it, tis not much but tis my own...
Dr Alastair Miller:

... a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported. It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.

The PACE study might have been said to be carefully designed by some people, though there were plenty who disagreed even with that. Then, the team deviated from the original design in final outcomes assessment.

Initially (1) study design stated an SF-36 (2) score of 75 as a test of 'recovery'. In the final results, this has been reduced to 60, normative for 75 - 84 year olds (3). Entry criteria were adjusted up to an SF-36 score of <65, in order to get sufficient participants.

The definition of "safe and effective" as being attaining the fitness level of a septuagenarian is not exactly impressive, especially when one considers that that level might actually be lower than on entry.

In the current absence of a biomedical model for the causation and the absence of any pharmacological intervention, we have a pragmatic approach to therapy that works and we should use it.

There are therapies that work, at least for some, witness the treatments offered by Myhill and DeMerlier, not to mention Cheney and Ampligen. Then there's Klimas, doing good work for some.

Dr Derick Wade

The trial design in this study was very good, and means that the conclusions drawn can be drawn with confidence.

You might say the original design was good, but Professor Hooper and Invest in ME, among many others would disagree. If they'd stuck to the original outcome measures (SF36 score of 75, actometer readings...) they might have had some credibility, but they didn't, they moved the goalposts.

...it confirms the effectiveness of two treatments, and their safety.

I disagree. The ability to walk another 21 metres, to a total of 354m, when healthy elderly can do 631 mtrs, is not at all impressive. Regarding safety, what happened to the 189 that dropped out of the study? There was no assessment of the effect of participation on those individuals.

No-one is denying that GET and CBT can be helpful in patients with depression. Some 50% of the participants were on anti-depressants, and the entry criteria mitigated against people with true ME getting accepted into the study.

Dr Fergus Macbeth

We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild or moderate CFS/ME.

See above

We will now analyse the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline. Until then, healthcare professionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS

.
For depression, perhaps. Not for the organic disease Myalgic Encephalomyelitis.

Dr Esther Crawley:

All children with chronic fatigue syndrome and their parents are desperate for new research to understand how to treat this condition. The next step is to do a study like this for children to find out if these treatments work.

And so to SMILE. Or not. Most informed opinion would much rather not, Esther.

Prof Willie Hamilton::

At least half of patients improved with CBT or GET. The study also allays fears that CBT or GET may be harmful.

See the measures of "improvement" that they gave in my answers above. And I'm still wondering about the almost one third of the participants that didn't stay with it until the end.

We didn’t know if pacing worked. This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing, or to refer for CBT or GET. Worse still, not all GPs have access to CBT or GET, so ended up suggesting pacing almost by default. This study should solve that dilemma.

The pacing they are referring to here is not what ME patients know is essential to their survival, that is to listen to your body and not overdo things to avoid precipitating Post Exertional Malaise (or Meltdown, as I prefer to call it) which is the cardinal symptom of ME.

They used APT, Adaptive pacing therapy. The aim is to achieve 'optimum adaption" by means of fixed rest times, and an activity diary. Interestingly the booklet used for this arm of the study, referenced 18 and by Action for ME, is no longer available online.

Action for ME's home page has an article headed "PACE: surprising and disappointing" where they say among other things "Action for M.E. is surprised and disappointed by the results of the PACE trial – and by some of the exaggerated claims being made about the effectiveness of two of the therapies: cognitive behaviour therapy and graded exercise, and by the unqualified assertion about the general safety of graded exercise." Gosh!

Dr Brian John Angus:

The study should reassure patients that there is an evidence based treatment that can help them to get better and there is no need to worry about harm from the treatment.

Hmm. Well you are wrong there.

looking at different ways of classifying the condition through different diagnostic criteria do not make any difference to the effect of treatments.

So, studying a cohort made up of 15% tigers and 85% rabbits, to see if vegetarianism is good for their health, will give a useful outcome? Sorry, this stuff is making me silly....

It was extremely rigorous. It was large and it was randomised....stringent efforts were made to ensure the ‘purity’ of each treatment and to rapidly report any adverse effects. As a trial this involved a huge amount of checking and cross checking.

It was not rigorous. Study design was changed mid trial to massage the results that were in any case inconclusive. It was not a pure cohort, it was not truly randomized, as each participant surely knew which treatment they were getting, and no-where can I find a reference to unblinding the results, so I would like proof if indeed it was a blinded trial.

The trial was conducted to a high ethical standard. Patients were fully informed and randomised to the different treatments. It was rigorously performed. The study has definitively shown that there is no harm associated with GET.

Not if your participants haven't got ME. Yet these disappointing results are being applied to our treatment, and we have got ME. Oh darn.

1) http://www.ncbi.nlm.nih.gov/pubmed/17397525
2) http://www.ncbi.nlm.nih.gov/pmc/arti...00022-0017.pdf
3) http://www.thelancet.com/journals/la...096-2/abstract

 

[Dolphin]

Only started reading it.
Agree with points thus far.

Initially (1) study design stated an SF-36 (2) score of 75 as a test of 'recovery'. In the final results, this has been reduced to 60, normative for 75 - 84 year olds (3). Entry criteria were adjusted up to an SF-36 score of <65, in order to get sufficient participants.

Actually the score for recovery was higher again:

"Recovery" will be defined by meeting all four of the following criteria: (i) a Chalder Fatigue Questionnaire score of 3 or less [27], (ii) SF-36 physical Function score of 85 or above [47,48], (iii) a CGI score of 1 [45], and (iv) the participant no longer meets Oxford criteria for CFS [2], CDC criteria for CFS [1] or the London criteria for ME [40].

The score of 75 was involved in the definition of improvement - the primary outcome measures which one is really not supposed to touch:

Primary outcome measures – Primary efficacy measures

Since we are interested in changes in both symptoms and disability we have chosen to designate both the symptoms of fatigue and physical function as primary outcomes. This is because it is possible that a specific treatment may relieve symptoms without reducing disability, or vice versa. Both these measures will be self-rated.

The 11 item Chalder Fatigue Questionnaire measures the severity of symptomatic fatigue [27], and has been the most frequently used measure of fatigue in most previous trials of these interventions. We will use the 0,0,1,1 item scores to allow a possible score of between 0 and 11. A positive outcome will be a 50% reduction in fatigue score, or a score of 3 or less, this threshold having been previously shown to indicate normal fatigue [27].

The SF-36 physical function sub-scale [29] measures physical function, and has often been used as a primary outcome measure in trials of CBT and GET. We will count a score of 75 (out of a maximum of 100) or more, or a 50% increase from baseline in SF-36 sub-scale score as a positive outcome. A score of 70 is about one standard deviation below the mean score (about 85, depending on the study) for the UK adult population [51,52].

Those participants who improve in both primary outcome measures will be regarded as overall improvers.

Regarding safety, what happened to the 189 that dropped out of the study? There was no assessment of the effect of participation on those individuals.

Where did you get that figure from?

2) http://www.ncbi.nlm.nih.gov/pmc/arti...00022-0017.pdf
3) http://www.thelancet.com/journals/la...096-2/abstract

Links don't work.

 

[Esther12]

I've not paid much attention to the step test results so far, but I was just wondering, what % (or number) of patients would need to have returned to the average for healthy controls in order to entirely explain the increase in the step test for GET?

One thing I've struggled to understand with Pace, is how minor the improvements were for treatments that White etc claimed should be promoted as leading to full recovery. Surely they must have been able to 'cure' some of the patients who fitted within the broad criteria they used for inclusion?! If just a few patients did move from the average patient score to the average 'healthy' score, that could have a big impact on the relatively minor changes in mean results pre and post treatment.

(I couldn't find the data needed to work this out after a cursory look, and now have to get off the PC, so that's my excuse for not doing any of the maths needed to work this out).

 

[Dolphin]

I've not paid much attention to the step test results so far, but I was just wondering, what % (or number) of patients would need to have returned to the average for healthy controls in order to entirely explain the increase in the step test for GET?

Firstly, the 2-minute step test is a different test from the six minute walk test (6MWT).
They never gave us the results of the 2 minute step test.
For the 6 minute walk, the following results are nearly correct:

I'm not sure what a normal score is.
Let's say it'd be an average of 650m.
Imagine that some just went up by 22m to 335m, the same amount the average the SMC went up and very similar to the amount CBT (21m) and APT (20m).
Unfortunately the SD is too wide if one just picks those two sets of numbers.
So let's throw in a few in between:
If 82 (75%) scored 335m, 12 (11%) scored 379m (final average), 3 (3%) reached 500m and 11 (10%) reached 650 one could get the final result.

So one could have 13% who truly responded/improved their results (the 379m ones could be due to natural variation) and one would get the final figure.

One thing I've struggled to understand with Pace, is how minor the improvements were for treatments that White etc claimed should be promoted as leading to full recovery. Surely they must have been able to 'cure' some of the patients who fitted within the broad criteria they used for inclusion?! If just a few patients did move from the average patient score to the average 'healthy' score, that could have a big impact on the relatively minor changes in mean results pre and post treatment.

(I couldn't find the data needed to work this out after a cursory look, and now have to get off the PC, so that's my excuse for not doing any of the maths needed to work this out).

Yes, but taking the SF-36 PF "normal" threshold is 60, an individual has to score that - it doesn't matter if lots of people scored 100, when they were calculating how many got 60 or more, it's about counting the individuals. But it is relevant for averages as I have tried to point out with the 6MWT.

 

[Dolphin]

Prof. Richard Bentall (psychologist) on PACE Trial on Daily Mail website

http://www.dailymail.co.uk/health/a...-hope-recovery-finds-study.html#ixzz1F64Oald1

(I've made each line a paragraph to make it easier to read)

As a researcher who has conducted two RCTs on CFS, I find the comments on this site pretty sad.

The only way of finding whether a treatment works is to carry out a randomized controlled trial in which outcomes (including adverse reactions) are objectively measured.

In the latest and largest trial to date the findings are unequivocal and consistent with previous studies showing that GET and CBT are effective.

The discovery of a treatment that works should be good news so why all the anger?

Part of the problem is the misperception that the researchers think the condition is psychological.

In fact, GET/CBT researchers generally assume that CFS is a physical condition caused by severe deconditioning and disruption of the circadian rhythms (sometimes triggered by a viral infection).

Exercise often makes people feel worse in the short term (try going to the gym after a long break) but in the long run corrects these physical problems.

CBT is a way of encouraging exercise, hence the result.

- Richard Bentall, Merseyside, 18/2/2011 22:20

Here is one of those trials. Cost 1.3m of taxpayers' money but he didn't mention the results - wonder does he consider it a waste of money?

Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial.

BMJ. 2010 Apr 23;340:c1777. doi: 10.1136/bmj.c1777.

Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group.

Collaborators (23)Bennett C, Bentall R, Booth L, Brocki J, Cahill G, Chapman A, Chew-Graham C, Connell S, Dowrick C, Dunn G, Fleetwood D, Ibbotson L, Jerman D, Lovell K, Mann J, Morriss R, Peters S, Powell P, Quarmby D, Richardson G, Riste L, Wearden A, Williams J.

School of Psychological Sciences, University of Manchester, Manchester. alison.wearden@manchester.ac.uk

Abstract

OBJECTIVE: To evaluate the effectiveness of home delivered pragmatic rehabilitation-a programme of gradually increasing activity designed collaboratively by the patient and the therapist-and supportive listening-an approach based on non-directive counselling-for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME).

DESIGN: Single blind, randomised, controlled trial.

SETTING: 186 general practices across the north west of England between February 2005 and May 2007.

PARTICIPANTS: 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria.

INTERVENTIONS: Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months' training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period. Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes.

RESULTS: A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome.

CONCLUSIONS: For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME. Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.

Notes: RPB and RKM participated in the training and supervision of therapists.

 

[Dolphin]

Free - PACE Trial paper now available (again!) for free (with tables, graphs, etc.)

[One may have to go through free registration]


http://bit.ly/f6W1TI i.e.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext

------

Also, there's a pdf link that would have all the tables and graphs neatly in it.

-----------

Don't forget to pick up the Web Appendix down the bottom (I don't think I'll give a link as it looks particular to me)

----

Comparison of adaptive pacing therapy, cognitive behaviour therapy,
graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial Prof PD White MD, KA Goldsmith MPH, AL Johnson PhD, L Potts MSc, R Walwyn MSc, JC DeCesare BSc HL Baber BSc, M Burgess PhD, LV Clark PhD, DL Cox PhD, J Bavinton BSc, BJ Angus MD, G Murphy MSc, M Murphy FRCP, H O'Dowd PhD, D Wilks FRCP[Ed], Prof P McCrone PhD, Prof T Chalder PhD, Prof M Sharpe MD, on behalf of the PACE trial management group The Lancet, Vol. 377 No. 9768 pp 823-836

 

[oceanblue]

the results were better.

However they explicitly pointed out that the means were not back to normal (not done in the PACE Trial) and didn't try to claim any were within the normal range:

From your posts it sounds like PACE is consistently worse than previous trials of CBT/GET on comparable measures? Is that right?

 

[Dolphin]

From your posts it sounds like PACE is consistently worse than previous trials of CBT/GET on comparable measures? Is that right?

The results definitely looked worse than Fulcher & White (that's the one I currently know most about having read the PhD thesis). I just looked at the CGI for the other two ones in the last page or two.

One point to keep an eye out for is the version of the Chalder Fatigue Scale used. In the Fulcher & White paper, the 14 version questionnaire was used. The fatigue score of 20.5 (8.9) in that study is better than the 20.6 (7.5) (GET) and 20.3 (8.0) (CBT) in the PACE Trial which was based on 11 questions.

Interestingly, the figure of 20.5 (8.9) in Fulcher & White is still a long way from what the sedentary controls were.
In:

Fulcher KY, White PD. Strength and physiological response to exercise in patients with chronic fatigue syndrome. J Neurol Neurosurg Psychiatry. 2000 Sep;69(3):302-7. Free at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1737090/pdf/v069p00302.pdf

we see that the sedentary controls had a median score of an even 14 i.e. the equivalent of all "no more than usual" or put another way 11 on the 11 question version used in the PACE Trial. The PhD thesis gives the mean for controls: 15.3 (4.8) which would translate as a mean of 12.0 on a 11 question chalder fatigue scale. The PACE Trial were claiming 18 or less indicated normal fatigue.

On SF-36 PF, the exercise group in Fulcher & White ended at 69.5 (18.5) and the flexibility group 55 (21.8). In the PACE Trial, the GET group ended at 57.7 (26.5) and the CBT group at 58.2 (24.1).

It is my impression from memory that the end scores to me in the PACE Trial seem towards the lower end of other GET and CBT trials (and indeed some other treatments also achieve them) although the initial scores in the PACE Trial were also relatively low.
However the starting values shouldn't affected the CGI scores which were worse for the 3 studies I gave.

 

[oceanblue]

Thanks for all that, you've clearly been poring over a lot of papers (and a PhD Thesis).

Presumably it's the net gain (as a %age or absolute amount), relative to controls, that is key. I was surprised how low the baseline scores were for PACE, given that particpants had to be able to travel to the centres and undertake an hour of therapy, and they'd had to raise the recruitment threshold to SF36 65 to get enough participants.

 

[Dolphin]

Peter White/Barts "can't" complain the PACE Trial was too short

Thanks for all that, you've clearly been poring over a lot of papers (and a PhD Thesis).

Presumably it's the net gain (as a %age or absolute amount), relative to controls, that is key. I was surprised how low the baseline scores were for PACE, given that particpants had to be able to travel to the centres and undertake an hour of therapy, and they'd had to raise the recruitment threshold to SF36 65 to get enough participants.

Thanks. However, another point to remember is that the other trials the main figures were from a shorter time-frame e.g. the figure I gave of SF-36 PF of 69 was after 12 weeks or an increase of 22. In the PACE Trial, for GET at that stage, the figure had gone up 11.4 or only a little more than half.

Peter White/Barts said the following in their submission on the draft NICE guidelines:

These goals should include recovery,
not just exercise and activity goals.
If it takes "years" to achieve goals, then
either the goals are wrong or the
therapy is wrong. What other treatment
in medicine would take years to work?

http://www.nice.org.uk/nicemedia/live/11630/36186/36186.pdf
"page 308 of 383"

-------- Full Exchange ---------

Draft text:
6.3.6.16 When planning a programme of GET the healthcare professional
should:
. discuss with the patient ultimate goals with the patient that are important and relevant to them. This may be, for example a 2 x 15 minutes daily brisk walk to the shop, a return to previous active hobby such as cycling or gardening, or, if more severely affected, sitting up in bed to eat a meal.
. recognise that it may take weeks, months, or even years to achieve goals, and it is essential that the therapy structure takes this pace of progress into account.

SH St Bartholomew's Hospital Chronic Fatigue Services 75 FULL 188
6.3.6.16
These goals should include recovery, not just exercise and activity goals.
If it takes "years" to achieve goals, then either the goals are wrong or the therapy is wrong. What other treatment in medicine would take years to work?
We suggest "or even years" is deleted. If a therapy is not helping within a few months, either the therapy or the diagnosis or both should be reviewed and changes considered. We suggest that this advice is pertinent to all treatment approaches, not just for GET.

GDG response:
The statistics indicate that total recovery is relatively rare and the GDG felt that to include recovery as a goal may lead to disappointment. As the goals are patient derived they may be long term. Interim goals would be developed.

 

[oceanblue]

Peter White/Barts said the following in their submission on the draft NICE guidelines:
These goals should include recovery,
not just exercise and activity goals.
If it takes "years" to achieve goals, then
either the goals are wrong or the
therapy is wrong. What other treatment
in medicine would take years to work?

You've unearthed a gem there! Hope it can get used publicly somewhere. Was this from the same time as the bullish protocol measures of recovery and improvement?

Your point about shorter timescales for those earlier trials does support the conclusion that PACE has underperformed.

 

[Orla]

Originally Posted by Dolphin

Peter White/Barts said the following in their submission on the draft NICE guidelines:
These goals should include recovery,
not just exercise and activity goals.
If it takes "years" to achieve goals, then
either the goals are wrong or the
therapy is wrong. What other treatment
in medicine would take years to work?

This is particularly hilarious considering that some people attend their clinic for years, and are not recovered. So does that mean they think their treatment is rubbish for these patients????

 

[Dolphin]

You've unearthed a gem there! Hope it can get used publicly somewhere. Was this from the same time as the bullish protocol measures of recovery and improvement?

Your point about shorter timescales for those earlier trials does support the conclusion that PACE has underperformed.

Yes, probably around the same time. I think comments had to go in around Nov 2006. The submission talks about the Dutch full recovery paper that was in press (one of the many give-aways that Peter White must have written/co-written it. Although. to be more accurate, the protocol paper was published in early 2007, but I'm not sure how long it was in the pipeline.