WEEK 5
RANDOMISED CONTROLLED TRIAL (RCT)
what is RCT?
Experimental study
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.
Anatomy of the paper
Title: Provides info that it is RCT
Methods:
- 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
6 CRITERIA USED TO APPRAISE POTENTIAL RISK OF BIAS IN RCT
1. Is the assignment of groups randomised?
2. Is the allocation sequence concealed?
3. Groups similar at baseline and the end?
4. Participants and researchers blind to group allocation?
5. Is there a complete follow up and participants are properly accounted for?
6. Analyzed the randomised group using intention to treat analysis?
Randomisation design
Simple
Block
Cluster
Stratified
Hat/ flip coin
Randomised in group of 5
Divided into subcategories
using of % of patient by its population.
By race, gender
Intact clusters of individuals like schools/ town/ clinics
The person responsible for assignment is blinded
Minimise selection bias and measurement bias
*Look for baseline characteristics
Socio-demographic variable
Measures severity of condition
Key outcomes
Age
Gender
Pre-score tests of participants is a key prognostic factor for study outcome
Data about initial disease is important as it influence how participants response
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
Placeboeffect
How many left?
Why was there lost to follow up
Where did drop out occur?
Intervention group?
Control group?
Attrition bias
No outcome data available
Hawthorne effect
Not using the partiicipants as from treatment group when they forgot to take medications (as they are from interventio group).
Discussion:
- gives info on blinding too
Results:
- 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
Conclusion:
- If the results with help locally