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Bristol Uni should clean up its clinical trial registries by publishing 2 trials

D

Dolphin

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Orla

Orla

Senior Member
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Location
Ireland
This is great, my favourite quotes from Coyne:

On the Early Intervention in Fatigue study:

"Note that the primary outcomes are not patient clinical outcomes, i.e., whether patients benefited from being assigned to active treatment versus control. The study was explicitly described as a feasibility and acceptability study.

Psychotherapy studies are commonly described in the literature as pilot and feasibility studies, mainly to escape the criticism that the study was small and underpowered. But, if so, effect sizes for patient outcomes should be presented because they are likely to be exaggerated and not generalizable to what would occur in a larger, better controlled study or in routine practice.

I wonder if the consent forms provided to patients indicated that the investigators were not interested in whether they benefited from treatment."
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[about the SMILE trial - the Lightening Process trial]

"So, at a time when other evaluations of interventions for ME/CFS were undergoing coordinated switching of outrcomes because of null findings from the FINE trial with the original scoring, the SMILE trial seems to have switched outcomes as well."
Click to expand...

"This is an exceedingly weak rationale for inflicting a quack treatment on unsuspecting children. Ethically, there must be a scientific rationale for exposing children to an unproven treatment that might be ineffective or even harmful."
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"The Advertising Standards Authority (ASA) guidance has ruled that LP cannot be advertised as a treatment...
Yet, the information sheet for the trial is describing it as a treatment to patients.

The materials patients must read as part of participating in the trial reek of pseudoscientific misinformation."
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