Randomised Control Trials

Question 1

What requirements must be met in order to have valid consent?

Answer 1

Appropriate information provided by a knowledgable informant, allowed to ask questions, a cooling off period, fully understanding the procedures, no coercion or manipulation, no perception that coercion or manipulation has taken place

Question 2

What does pragmatic mean?

Answer 2

‘Intention to treat’ - includes everyone - preserves randomisation, representative of routine clinical practice, realistic size of effect.

Question 3

What does explanatory mean?

Answer 3

‘As treated’ - tests the physical potency - non-compliers are excluded

Question 4

What are the problems with explanatory trials?

Answer 4

Two groups are no longer randomly selected - survivor bias

Question 5

What is blinding?

Answer 5

Making participants unaware of the study details in order to avoid bias

Question 6

How are randomised control trials conducted?

Answer 6

Allocate one group to be given the new treatment and the other to be given standard treatment, follow up two groups equally, assess using the same criteria, compare the outcomes

Question 7

What are the advantages of randomised control trials?

Answer 7

Avoid allocation bias, can avoid unknown confounders

Question 8

What are the ethical considerations researchers need to be aware of?

Answer 8

Beneficence (do good), non-maleficence (do no harm), autonomy of the patient, justice, scientifically robust experimentation, ethical recruitment