They're writing a paper... about having done a study? Which is already published? Which they recognize was not statistically significant? But still speculate that it could work?
The finding that avoidance behaviour mediated change in several outcomes supported our theoretical fear-avoidance model on which DS-CBT was partly based,
3 8 9 and indicated that therapists were for, the most part, addressing avoidance behaviour during therapy. However, our analyses indicated that the mediated effects were relatively small; perhaps targeting beliefs about emotions and emotional avoidance more directly may be helpful in influencing outcomes.
But it failed, did not even reach statistical significance. And this reasoning is entirely circular, it doesn't confirm anything at all. "Perhaps" it "may be helpful" to just quit doing this nonsense.
We chose monthly DS frequency as our trial primary outcome partly because the funder had identified seizure frequency as an important outcome
It is worth noting, however, that recording seizure diary data over a protracted period is challenging for patients. It can lead to variable amounts of missing data and measurement error, which requires careful consideration of how the outcome should be constructed from the weekly counts available.
Moreover, DS frequency was a highly skewed outcome.
But they have no issues claiming that their secondary subjective improvements are significant, even though they literally aren't. Those must be trusted. Reports of seizures? Who can really tell if they're real? Feeling better? Now that's real space age medicine!
Our qualitative work with trial participants
36 supports the suggestion that changes in perceptions of the debilitating effects of DS may be much more important than the exact number of seizures participants have.
What nonsense.
After claiming that their trial is "fully powered", they argue that it actually isn't:
Could the comparison group have been given a different psychological intervention? Even more psychodynamically-oriented treatments
40 may contain some CBT-based elements targeting seizure control. It seems likely, based on other data, that the sample size needed to demonstrate a difference between two active psychotherapies would be so large as to not be feasible for this kind of design.
It is interesting that the primary outcome of seizure frequency was negative at 12 months. Simple frequency of seizures may not be as important to people with DS as their impact or ‘bothersomeness’. Given the importance of the primary outcome in determining treatment effectiveness, researchers should be very clear about their choice.
They had been arguing for years about this primary outcome. They claim to have integrated patient input in the study, which agreed to this objective primary outcome. Even though they should have expected that it would be null. Probably confident that even if it were, they could just pull it off anyway, argue for whatever nonsense they feel like. Just like they're doing here.
Lessons learned:
Many aspects of the trial went well. The trial recruited the expected numbers at the correct time. This sends an important message for those considering developing or funding clinical trials in FND, that is, that recruitment is feasible.
Trial experts can do a trial, on time. Groundbreaking stuff.
We showed that therapists without a background in DS could be trained to deliver treatment with acceptable fidelity. Perhaps most strikingly, the formation of a large national clinical network with interdisciplinary collaboration between psychology, psychiatry and neurology was, in itself, an achievement in a disorder in which care has traditionally been historically ignored and fragmented between specialties.
They can even, with funding, get professionals to do something as instructed, which I guess comes as a surprise? It ended up being useless, so it's feasible to do something useless. As long as the money keeps flowing they'll pull off doing useless things.
What is the point of this paper?! All they do is basically narrate what they did, admit it didn't work, but they could do it, and it can be done again, therapists can consider applying the same concepts, or do whatever they feel like, it's all good.
Trial experts doing trials for the sake of doing trials and claiming that all they can do with it is do trials, on time. It's truly a wonder why biopsychosocial medicine has exactly zero breakthroughs to its name. But, hey, they can keep doing it as long as the money comes in and they can publish useless papers about useless studies.
