WEEK 5 RANDOMISED CONTROLLED TRIAL (RCT)
RANDOMISED CONTROLLED TRIAL (RCT)
6 CRITERIA USED TO APPRAISE POTENTIAL RISK OF BIAS IN RCT
1. Is the assignment of groups randomised?
Hat/ flip coin
Randomised in group of 5
Intact clusters of individuals like schools/ town/ clinics
Divided into subcategories
By race, gender
using of % of patient by its population.
2. Is the allocation sequence concealed?
The person responsible for assignment is blinded
Minimise selection bias and measurement bias
3. Groups similar at baseline and the end?
*Look for baseline characteristics
Measures severity of condition
Data about initial disease is important as it influence how participants response
Pre-score tests of participants is a key prognostic factor for study outcome
4. Participants and researchers blind to group allocation?
Prevent participants and study personnel from knowing which group the participants assigned to so that there is not influences
So that the researcher cannot distort the measurement of treatment outcome
5. Is there a complete follow up and participants are properly accounted for?
How many left?
Why was there lost to follow up
Where did drop out occur?
No outcome data available
6. Analyzed the randomised group using intention to treat analysis?
Not using the partiicipants as from treatment group when they forgot to take medications (as they are from interventio group).
Anatomy of the paper
Title: Provides info that it is RCT
Will provide info that it is RCT
Will show that participants randomised into 2 groups (control and experimental)- DETAILS OF RANDOMISATION USED.
INFORMATION ON BLINDING
Description of interventions gives assessment and follow up
Flow of people through the study
gives info on blinding too
To check for similar assessment and follow up
Table that shows BASELINE CHARACTERISTICS = If process worked, means there is similar baseline
Contain figure which show the flow of people though the study
If the results with help locally
what is RCT?
Participants randomised into 2 groups
Each group have different intervention
At the end, the effect of the trials are measured and compared
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific (often medical) experiment which
aims to reduce bias
when testing a new treatment. ... The RCT is often considered the
gold standard for a clinical trial.
As the study is conducted, the only expected difference between the control and experimental groups in a randomized controlled trial (RCT) is the
outcome variable being studied.