Discussion in 'PsychoSocial ME/CFS Research' started by Andy, Mar 16, 2019.
Open access at https://www.jmir.org/2019/3/e11276/
Such a large number of patients (363!) and complex trial (a three-arm, parallel, randomized, noninferiority trial with stepped care) simply to determine if CBT is equally "effective" with 25% less therapist time.
The PACE trial showed that CBT did not improve any objective outcomes (fitness, walking, work resumption, disability payment, doctor visits etc.) and that subjective improvements were not clinically significant and disappeared at follow-up. Yet Knoop is still doing these huge trials to determine how to make CBT cheaper.
It's quite remarkable that they spend enormous amounts of resources to determine whether a treatment can be delivered more effectively when there's still ongoing controversy whether this treatment is effective or not.
So, if I understand this correctly...
There is a treatment available which is not helpful. The same treatment is given over the internet. And the results from the internet version are not inferior to the non-internet version. Well... Err... Yes... That was useful.
Although the online versions with stepped care were not inferior, the trial seemed to have failed in several ways.
The control condition consisted of regular, face to face CBT (in group format). Yet a third of the patients did not start this therapy, which may have influenced the results for this group. The authors acknowledge that the improvements in fatigue for this group were smaller than in previous CBT studies, with lower proportions of nonstarters: "within-group effect size for fatigue severity in the TAU condition in our study fell outside the 95% CIs of 2 other CFS studies." So stepped care was non-inferior to something inferior.
There was another problem. Online CBT did not work that well. Of the 228 patients who started stepped care, 172 (75%) needed further treatment with regular, face to face CBT. As a result, the amount of therapist time saved by the complex procedure was rather small, approximately 27% (mean hours, starters only). So the whole point of beginning with the online version before starting with the full face to face version of CBT could be questioned.
Thirdly, a lot of patients did not seem to want CBT. Of the 172 patients to whom the therapists said that the online CBT wasn't enough, that they need further treatment with regular CBT, 85 (50%) refused the offer. So half of those patients did not 'step up'. The whole point of stepped care is that you start with the cheap version and only move on to the full version if that doesn't work out. Both elements did not seem to work out in this trial. The cheap version was insufficient for most patients and half of them did not want to proceed to the full version.
So what looks like a success in the abstract (stepped care was noninferior to regular CBT) was, in fact, a failure of the stepped care model.
I wanted to say: hope that those who provide funds for this trial start asking themselves some questions, but I can't find any statement on financial support.
In the appendix, a CONSORT EHEALTH checklist (V 1.6.1), one can read: "In the abstract it is stated that there was no specific funding for this study."
I can't find it in the paper. Weird. Such a large study needs funding no?
It's that darned silence again. They just can't publish anymore, except when they do. They just can't do any research anymore, except when they get huge funding and do just that.
But they're not taken seriously and that's unacceptable because they are top. researchers. who demand to be taken seriously and have their every little bit of research given a Nobel prize every time or else the whole world is against them.
I now feel "a little better", and it didn't cost a penny.
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