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