randomisation, blinding and bias Flashcards
randomisation
based on chance alone by which study participant is assigned to either treatment or control group
randomisation minimises
the difference among groups by equally distributing people with particular characteristics among all trial arms
–> reducing confounding effect
randomisation prevents
bias associated with patients and investigators expectations
blinding
refers to keeping study participants, those involved with their management, and those collecting and analysing data unaware of the assigned treatment
–> therefore researchers cant be influenced by known if participant had drug or not
bias
a process where scientists performing the research influence the results, in order to portray a certain outcome
Explain Intention to treat analysis
treatment group are analysed as they were intended to be i.e. even if they completed the protocol or not
how would a participant be treated if they crossed over to the other arm
analysed as they were intended to be
why is ITT important
maintains composition of treatment groups - reducing the potential for confounding results from an imbalance in baseline characteristics