Firestormm
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Happy to help with that old bean
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Technically, this is more or less accurate, but it does give a slightly skewed picture, which I will try to illustrate with an example. Let's say 60% of the SMC group improved and instead of GET/CBT, the trial was of NewWonderDrug. And let's say 95% of patients on NewWonderDrug improved, a pretty decent result. The approach in quotes would present that as "65% of patients did not benefit from NewWonderDrug/Only 35% improved. By contrast 60% of the SMC group showed a clinically useful outcome". I'm not sure that's a sound way of presenting the data.
Primary Results/Improvement rates:
I think the 'Number Needed to Treat' data is exactly the right way to present the key results of PACE, as it shows how many people have to be treated for just one patient to improve by a modest amount. Curiously, Michael Sharpe used these statistics when asked to explain the results of the PACE trial, giving a very different picture to that of the Official launch.
To simplify: I would just use NNT for those improving in both fatigue and function as this is probably the most important measure, and not bother with separate NNTs for fatigue, function.
I think it would also help if you first explain what a 'Clinically Useful Difference' is, either using the 0.5 SD definition or just saying the 'minimum useful improvement' in both fatigue and function. Then present the data.
Clinical Effectiveness /Therapeutic Effect Size:
It might help just to explain that while the 'primary' results above are categorical - i.e. what proportion of patients reach a threshold, these relate findings relate to continuous measures i.e. how much the average patient score improved.
Presenting the data in a neutral way
Maybe it's just me, but I find evidence far more persuasive when it's presented in a straightforward way, without pushing the data to appear truly dramatic.
The PACE results are very poor when viewed this way, which is why I'm not comfortable hyping the findings a little:
This means that approximately 87% of patients did not benefit from CBT or GET, the only treatments recommended for ME by NICE.
By contrast, 58% (physical function) and 65% (fatigue) of the SMC group achieved a clinically useful outcome.
Technically, this is more or less accurate, but it does give a slightly skewed picture, which I will try to illustrate with an example. Let's say 60% of the SMC group improved and instead of GET/CBT, the trial was of NewWonderDrug. And let's say 95% of patients on NewWonderDrug improved, a pretty decent result. The approach in quotes would present that as "65% of patients did not benefit from NewWonderDrug/Only 35% improved. By contrast 60% of the SMC group showed a clinically useful outcome". I'm not sure that's a sound way of presenting the data.
For similar reasons, I think describing fatigue as a 'self-reported subjective' symptom is over-egging things a bit. In contrast to physical function, there is no objective measure of fatigue, whoever is doing the experiment. I think it's appropriate to point out once that it is a self-reported measure and so liable to reporting bias, but to continually label a subjective phenomenom as subjective might irritate some people you want to influence. Again, I think the argument is strong enough without embelishment.
Note that SMC group was a 'control' group, so it is not legitimate to compare the results of CBT/GET with SMC, as if SMC was a normal therapy group. The SMC control group was designed for the PACE Trial to take account of natural fluctuations over time, and so any improvements seen in the SMC group might have taken place with no treatment.
edit: Bob: I possibly deserved a bit of a rant.
Sorry Bob, I could well have missed bits. My eyes started to glaze over once it got more mathematical, so I only properly read the start, and then saw someone else saying what I had thought to myself. (I'm afraid I've not fully taken in your reply either...
I should really step away from the PC and in to my bed
You seemed to begin with a strong emphasis on the 13% figure, but didn't explain at the start that this is very different from the figures being promoted by the PACE researchers because you had attempted to account for the impact of SMC.
Actually,I just had another quick look, and I'm not sure that this bit is right:
Note that SMC group was a 'control' group, so it is not legitimate to compare the results of CBT/GET with SMC, as if SMC was a normal therapy group. The SMC control group was designed for the PACE Trial to take account of natural fluctuations over time, and so any improvements seen in the SMC group might have taken place with no treatment.
It seems like there's some ambiguity over this, but I don't think we can really say the above. My memory could be off, but I also think that early on in the literature related to PACE, SMC was presented as more of a control group than it came to be in the final paper. It could be worth quoting from their description of SMC?
I'm just over-tired.
It is widely stated, even among patients that 30% improved on CBT/GET.
Every time we see this figure wrongly quoted, we now can correct it.
Bob said:I'm just over-tired.
Me too. I think a couple of nights of interrupted sleep (it's too hot!) had more of an impact than I realised.
Heads up, you 'orrible little dedicated overworking grunts!
Step away from the computer.
Leave the room. Do Not Look Back.
Make a nice cup of your favourite beverage.
Go outside, and be with the sky/sea/trees/birds etc for an hour. Or longer.
Squad – wait for it, wait for it... – diiiiiiiismissed!
Ah, that makes sense, though given how helpful your piece is I suspect it will reach a far wider audience.Thanks again for your comments Simon.
Something to keep in mind is that this was all intended purely for a forum audience...
I'm pretty sure all CUD thresholds are secondary, even those in Table 3:I think I will leave these results as presented. I've clearly laid out all of the primary results so people can use them if helpful. I disagree that the analysis for both fatigue and physical function is the most important measure. It is a "secondary" and "post-hoc" analysis, and to my mind it adds confusion to the results. (The secondary post-hoc analysis places CBT and GET in a slightly more favourable light, so I can't imagine why they decided to include it!) And the primary results have the advantage of differentiating fatigue and physical function, which I think is helpful.
The 0.5 SD was used to assess if there was a clinically useful difference between the means of the primary outcomes.A secondary post-hoc analysis compared the
proportions of participants who had improved between
baseline and 52 weeks by 2 or more points of the Chalder
fatigue questionnaire, 8 or more points of the short
form-36, and improved on both.
Agreed that 95% would be misleading, but I think saying 65% do not respond could be misleading too. With 60% of the control group improving, the maximum improvement that is mathematically possible, even for "PerfectDrug", is 40% - less than for the control group. Giving both figures - in this case 95% vs 60% gives the full picture. For PACE it's 45% for the SMC/control group vs 60% for CBT, which I think gives a fair view of the results, and they are unimpressive.95% of patients did not respond to the NewWonderDrug, as far as we know, and it would be misleading to say so. Only 35% improved as a result of the drug, as far as the data tells us, and 60% in the control group improved.
Unlerlined and highlighted by me. I don't undertstand that part of the sentence. Did all or most of the subjects have a dx of depression? I was under the impression they did. For what we used to call endogenous depression, which was a severe organic based depression without psychoses, fatigue was/is a major symptom. Those patients with EnD did not respond well to any talking therepies because their depression was caused by the way their brains were not taking up seretonim and something to do with dopermine (can't remember, it's been a long time since I was a psychi nurse).
Even with reactive depression CBT was not a one-size-fits-all approach. We used different councelling methods depending on patient need (old fashioned view isn't it?)
It was understood that exercise and relaxation therepies could help people with lots of different kinds of depression as it helped boost seretonim. Even so, the results were mixed.
All this was known and documented back before I was training (started 1986).
So Wessley n White should have KNOWN the outcomes wouldn't be that good.
Who were these fatigued people without depression? And if they had depression in what way was their fatigue different? And how did they differentiate the symptoms if ME wasn't in the mix?
Ah, yes, I was so tired last night that I couldn't remember that's why I felt it is so important to give such prominence to the "13%" figure.
An now the MRC has started saying that 60% improved as a result of CBT and GET.
willow - yes, you're right. It's a personal bug-bare of mine that depression gets treated so badly and with so little understanding. The DSM seems to get worse with each new publication. I've seen it used to prop up a broken table once- excellent use, should be the only one allowed.
The standard of psychiatrists is appalling imho. I worked with two excellent ones in 16 years of psychi nursing, the rest were on a scale of bad to dangerous.
I believe that the "it's all in yer 'ead" and "yuppie flu" reporting on ME has damaged the care of people with all kinds of depression as well as our care.
Sorry, I'm getting off topic.