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Randomised Controlled Trials (General Features (Regression to the mean…
Randomised Controlled Trials
Blinding
Placebo
Clinical Trials
P2: Early outcome and efficacy
P3: Compare w/ standard
Phase 1: Pharmo and Toxicity
P4: Post-market surveillance
General Features
Control group vs. intervention group
Regression to the mean
Proving it works
Requires contemporaneous control group
Random Allocation
Non-random (Concurrent Control Group)
Many cases have led to deaths due to lack of RCTs.
Well designed RCT can give conclusion about Best Use of one intervention over another
Randomisation
Ensure balance for baseline factors
Followed up over same time
Decreased systematic bias in allocation
Stratification
Important factors affecting outcome balanced (Grade of Cancer)
Bias Types
Detection Bias
Result of knowledge of the group assignment, investigator or ppt.
Performance Bias
Systematic difference in care provided to ppts in comparison groups other than intervention
Selection Bias
Allocation concealment : RNG, Coin toss. Reduces selection bias
Hierarchy of Evidence
Cohort Study
Case-control study.
RCTs
Case report, expert opinion
Systematic review of RCTs with homogeneous results