- Relationship to Diabetes
- Type 1
- Pronouns
- He/Him
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There was no "randomisation" of the support levels given to the participants though was there?
A surgery using the starvation method would have given huge encouragement to the trial participants where the "control groups" would have been left with the usual non-interference of standard care that we have all experienced because that was the point of the trial.
It's even outlined in the trial design.
I’ve not read the protocols, but that be important when evaluating something against ‘standard care’ though wouldn’t it? Otherwise you aren’t evaluating against standard care. You are evaluating against something else.
Ensuring consistency of delivery of the intervention that each participant experiences (as far as possible) between arms and across the different sites. But defining what each arm ‘means’, the levels of support, number of appointments, time spent, resources used, data collected etc.
I was involved as PPI lead on an RCT looking into T1 hypo awareness restoration, and significant trouble was taken in the protocols and study design to make sure the two different interventions being compared involved the same amount or level of input in each arm. But that wouldn’t work when comparing against ‘standard care’ as defined in current guidelines. For that you need to follow standard care, against the intervention.
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