Dear All
Is the following reasoning correct?
When evaluting the validity of trial about a therapy, ensuring that all
patients are analysed in an intention to treat manner is important since
the percentage of compliers versus non-compliers may be different in the
placebo and intervention groups. In this way we are testing whether the
offering of a specific treatment is more beneficial than offering placebo.
Now when analysing whether patients would benefit from a series of services
organised in a certain manner (e.g. stroke unit treatment) compared to
routine care, how do you analyse patients who only at the end of (or
during) the trial are found not to meet the inclusion criteria (e.g. not a
stroke but a cerebral metastasis)?
Surely because the entry criteria are not met, the patients should be
excluded BEFORE the analysis. This is not the same as someone being
allocated to the stroke unit and decides not to be admitted for any reason
(e.g. the unit may be at another hospital). The latter would be analysed
including the patient as "a patient who the trial intended to treat".
Is my reasoning correct?
Dr Nilesh Patel
Director: Clinical Services
The Brenthurst Centre for Rehabilitation Medicine
Johannesburg
South Africa
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