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Randomised Controlled Trials

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Health & Medicine
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Randomised Controlled Trials (RCTs) Graeme MacLennan
James Lind ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Think about… ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The need to evaluate health care ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evaluation process ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Define research question and what is already known ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Definition of population, intervention and “outcomes” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Measuring “outcome” ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sources of systematic errors ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is a randomised controlled trial? ,[object Object],[object Object],[object Object]
Simple RCT model RANDOMLY allocated to experimental or CONTROL group CONTROL EXPERIMENT Trial participants
What is a randomised controlled trial? ,[object Object],[object Object],[object Object]
Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is a randomised controlled trial? ,[object Object],[object Object],[object Object]
Terminology ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
What is a randomised controlled trial ? ,[object Object],[object Object],[object Object],[object Object]
What is a randomised controlled trial? ,[object Object],[object Object]
Inclusion/exclusion criteria ,[object Object],[object Object],[object Object],[object Object]
What is randomisation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Pseudo-randomisation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Terminology ,[object Object],[object Object]
Why use randomisation? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Why do we need a control group? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regression to the mean ,[object Object],[object Object],[object Object],[object Object]
DISTRIBUTION OF RESULTS threshold measurement 1 measurement 2
Hawthorne Effect ,[object Object],[object Object]
Placebo Effect ,[object Object],[object Object],[object Object],[object Object],[object Object]
EFFECT OF AN INTERVENTION Effect size Experimental group Control group Hawthorne E. R. mean Placebo E. Therapeutic E. Real difference Noise Signal
Minimising bias in RCTs ,[object Object],[object Object],[object Object],[object Object]
Concealment of random allocation list ,[object Object],[object Object]
Blinding, placebos ,[object Object],[object Object],[object Object],[object Object]
Empirical evidence of bias
‘ Explanatory’ and ‘Pragmatic’ questions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Key differences between explanatory and pragmatic trials (1) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Key differences between explanatory and pragmatic trials (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Example of selection bias for PP in an open trial Exp Ctrl None None White(2005) E E Worse prognosis
Terminology: explanatory versus pragmatic ,[object Object],[object Object],[object Object],[object Object],[object Object]
RCT as the Gold Standard ,[object Object]
RCT strengths ,[object Object],[object Object],[object Object],[object Object],[object Object]
RCT limitations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other issues in RCTs (1) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other issues in RCTs (2) ,[object Object],[object Object]
Parallel group (simple) RCT design in practice Patient eligible for either treatment Patient gives informed consent Yes No Randomise Exclude from trial Experimental treatment Standard treatment Standard treatment
Summary ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Good study design ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Minimise sources of error ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Study designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Evaluation of health care interventions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Useful/interesting links ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
References ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

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Randomised Controlled Trials

  • 1. Randomised Controlled Trials (RCTs) Graeme MacLennan
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  • 11. Simple RCT model RANDOMLY allocated to experimental or CONTROL group CONTROL EXPERIMENT Trial participants
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  • 25. DISTRIBUTION OF RESULTS threshold measurement 1 measurement 2
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  • 28. EFFECT OF AN INTERVENTION Effect size Experimental group Control group Hawthorne E. R. mean Placebo E. Therapeutic E. Real difference Noise Signal
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  • 36. Example of selection bias for PP in an open trial Exp Ctrl None None White(2005) E E Worse prognosis
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  • 43. Parallel group (simple) RCT design in practice Patient eligible for either treatment Patient gives informed consent Yes No Randomise Exclude from trial Experimental treatment Standard treatment Standard treatment
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