Study protocol for POSITIF, ... feasibility trial of a brief cognitive-behavioural intervention ... for post-stroke fatigue, 2020, Gillespie, Chalder

Study protocol for POSITIF, a randomised multicentre feasibility trial of a brief cognitive-behavioural intervention plus information versus information alone for the treatment of post-stroke fatigue

https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-020-00622-0

 

POSITIF. Are these people capable of conducting a study without a catchy name. It's all about the marketing with them, think of a catchy title then build a study around it.

 

It's CBT for ME applied to post stroke fatigue. With a no treatment control group compared to a placebo and expectation setting pseudotreatment. And a study name that could be a caricature.

 

I think they need a spelling intervention

 

The people who approved this are a complete joke. Chalder is a lost cause, that's not an issue, many people are. But there are people who oversee her work and give approval for doing the exact same things in loops despite never delivering anything and that's just wrong. It makes a mockery of not only the system of medicine but the entire system of science.

And the obsession with fatigue despite Chalder being totally clueless about what it even means. You can't teach something you don't understand. Evidence-based medicine needs to be dismantled entirely, it has clearly failed while appearing to serve no specific purpose that cannot be served otherwise.

 

https://twitter.com/user/status/1282918562399649797

 

POSITIF

hmm no chance of any bias with a name like that

 

Apparently this would be the "feasibility" study: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0183286. Quoted because those things are always performative, with the conclusion written far in advance.

1/3 dropped out.

Everything is feasible if you just don't bother when it's not. What a total waste. The people overseeing this have failed completely in their duties.

That is, unless this is an unrelated feasibility study for the exact same thing. Chalder does have a habit of doing the same things over and over without there being any connection between those.

 

Lmao

 

Post stroke intervention trial in fatigue (POSITIF): Randomised multicentre feasibility trial

Abstract

Objective: To test the feasibility of a telephone delivered intervention, informed by cognitive behavioural principles, for post-stroke fatigue, and estimated its effect on fatigue and other outcomes.

Design: Randomised controlled parallel group trial.

Setting: Three Scottish stroke services.

Subjects: Stroke survivors with fatigue three months to two years post-stroke onset.

Interventions: Seven telephone calls (fortnightly then a 'booster session' at 16 weeks) of a manualised intervention, plus information about fatigue, versus information only.

Main measures: Feasibility of trial methods, and collected outcome measures (fatigue, mood, anxiety, social participation, quality of life, return to work) just before randomisation, at the end of treatment (four months after randomisation) and at six months after randomisation.

Results: Between October 2018 and January 2020, we invited 886 stroke survivors to participate in postal screening: 188/886 (21%) returned questionnaires and consented, of whom 76/188 (40%) were eligible and returned baseline forms; 64/76 (84%) returned six month follow-up questionnaires. Of the 39 allocated the intervention, 23 (59%) attended at least four sessions. At six months, there were no significant differences between the groups (adjusted mean differences in Fatigue Assessment Scale -0.619 (95% CI -4.9631, 3.694; p = 0.768), the Generalised Anxiety Disorder 7 -0.178 (95% CI -3.823, 3.467, p = 0.92), and the Patient Health Questionnaire -0.247 (95% CI -2.935, 2.442, p = 0.851). There were no between-group differences in quality of life, social participation or return to work.

Conclusion: Patients can be recruited to a trial of this design. These data will inform the design of further trials in post-stroke fatigue.

https://pubmed.ncbi.nlm.nih.gov/35866206/

 

886 > 188 > 76 > 64 > 39 > 23 ! Yes you can get 2.6% of a patient population to partially participate in a trial - but exactly what does that self selecting 2.6% represent ? The most well ? The most desperate ? The most bored ?

886 people and only 23 thought this was worth pursuing should be key evidence that there is something profoundly lacking in what is on offer, not "patients can be recruited to a trial of this design".