05.07 · Cours 7 — Essais cliniques randomisés

Course 7 — Randomized clinical trials

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Randomized Clinical Trials

1Randomized Clinical Trials 2Review: Correlation 3Review: Simple Linear Regression 4Review: Regression Coefficients 5Review: Multiple Linear Regression 6Course Objectives

Why RCTs Are Needed

7Example: Pharyngitis 8Treatment Options for Pharyngitis 9Scenario: Friend's Advice 10Scenario: Dr Half Dex 11Evaluation Requires Comparison 12Scenario: Dr Kompar — Selection Bias 13Determinants of Health and Disease 14Scenario: Dr Historix — Historical Controls 15Selection Bias and Measurement Bias

16Definition: Systematic Error 17Bias vs Random Error 18Requirements for a Fair Comparison

19Matching vs Random Assignment 20Why Randomize 21How to Randomize 22When to Randomize 23Ethics of Randomization

Allocation Concealment

24Definition and Purpose 25Bad Concealment Methods

Building an RCT Step by Step

26Scenario: Dr Alea — Open-Label RCT 27Remaining Biases in Dr Alea's Trial

Placebo and Blinding

28Placebo Effect 29Components of Observed Treatment Effect 30Why Give Placebo 31When Not to Use Placebo 32Blinding: Definition and Levels 33Scenario: Dr Latotale — Double-Blind RCT

Statistical Significance and Sample Size

34Do Not Forget Chance 35Correlation vs Causation Cartoon

Pre-Specification of Outcomes

36Scenario: Dr Pick N. Choose 37Why Pre-Specify Primary Outcome 38Properties of a Good Outcome 39Choosing an Outcome for Pharyngitis

Analysis Population

40Intention-to-Treat vs Per-Protocol 41What Must Be Pre-Specified

42Basic Ingredients of an RCT 43PICO Applied to Pharyngitis

44Summary: PICO, Randomization, Blinding 45Summary: Placebo and Allocation Concealment 46Summary: Pre-Specification, ITT, Ethics

47Next Lecture Preview

05.07Page 1Randomized Clinical Trials

Cours 7 — Essais cliniques randomisés page 1

05.07Page 2Randomized Clinical TrialsReview: Correlation

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05.07Page 3Randomized Clinical TrialsReview: Simple Linear Regression

Cours 7 — Essais cliniques randomisés page 3

05.07Page 4Randomized Clinical TrialsReview: Regression Coefficients

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05.07Page 5Randomized Clinical TrialsReview: Multiple Linear Regression

Cours 7 — Essais cliniques randomisés page 5

05.07Page 6Randomized Clinical TrialsCourse Objectives

Cours 7 — Essais cliniques randomisés page 6

05.07Page 7Randomized Clinical TrialsWhy RCTs Are NeededExample: Pharyngitis

Cours 7 — Essais cliniques randomisés page 7

05.07Page 8Randomized Clinical TrialsWhy RCTs Are NeededTreatment Options for Pharyngitis

Cours 7 — Essais cliniques randomisés page 8

05.07Page 9Randomized Clinical TrialsWhy RCTs Are NeededScenario: Friend's Advice

Cours 7 — Essais cliniques randomisés page 9

05.07Page 10Randomized Clinical TrialsWhy RCTs Are NeededScenario: Dr Half Dex

Cours 7 — Essais cliniques randomisés page 10

05.07Page 11Randomized Clinical TrialsWhy RCTs Are NeededEvaluation Requires Comparison

Cours 7 — Essais cliniques randomisés page 11

05.07Page 12Randomized Clinical TrialsWhy RCTs Are NeededScenario: Dr Kompar — Selection Bias

Cours 7 — Essais cliniques randomisés page 12

05.07Page 13Randomized Clinical TrialsWhy RCTs Are NeededDeterminants of Health and Disease

Cours 7 — Essais cliniques randomisés page 13

05.07Page 14Randomized Clinical TrialsWhy RCTs Are NeededScenario: Dr Historix — Historical Controls

Cours 7 — Essais cliniques randomisés page 14

05.07Page 15Randomized Clinical TrialsWhy RCTs Are NeededSelection Bias and Measurement Bias

Cours 7 — Essais cliniques randomisés page 15

05.07Page 16Randomized Clinical TrialsBiasDefinition: Systematic Error

Cours 7 — Essais cliniques randomisés page 16

05.07Page 17Randomized Clinical TrialsBiasBias vs Random Error

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05.07Page 18Randomized Clinical TrialsBiasRequirements for a Fair Comparison

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05.07Page 19Randomized Clinical TrialsRandomizationMatching vs Random Assignment

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05.07Page 20Randomized Clinical TrialsRandomizationWhy Randomize

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05.07Page 21Randomized Clinical TrialsRandomizationHow to Randomize

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05.07Page 22Randomized Clinical TrialsRandomizationWhen to Randomize

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05.07Page 23Randomized Clinical TrialsRandomizationEthics of Randomization

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05.07Page 24Randomized Clinical TrialsAllocation ConcealmentDefinition and Purpose

Cours 7 — Essais cliniques randomisés page 24

05.07Page 25Randomized Clinical TrialsAllocation ConcealmentBad Concealment Methods

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05.07Page 26Randomized Clinical TrialsBuilding an RCT Step by StepScenario: Dr Alea — Open-Label RCT

Cours 7 — Essais cliniques randomisés page 26

05.07Page 27Randomized Clinical TrialsBuilding an RCT Step by StepRemaining Biases in Dr Alea's Trial

Cours 7 — Essais cliniques randomisés page 27

05.07Page 28Randomized Clinical TrialsPlacebo and BlindingPlacebo Effect

Cours 7 — Essais cliniques randomisés page 28

05.07Page 29Randomized Clinical TrialsPlacebo and BlindingComponents of Observed Treatment Effect

Cours 7 — Essais cliniques randomisés page 29

05.07Page 30Randomized Clinical TrialsPlacebo and BlindingWhy Give Placebo

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05.07Page 31Randomized Clinical TrialsPlacebo and BlindingWhen Not to Use Placebo

Cours 7 — Essais cliniques randomisés page 31

05.07Page 32Randomized Clinical TrialsPlacebo and BlindingBlinding: Definition and Levels

Cours 7 — Essais cliniques randomisés page 32

05.07Page 33Randomized Clinical TrialsPlacebo and BlindingScenario: Dr Latotale — Double-Blind RCT

Cours 7 — Essais cliniques randomisés page 33

05.07Page 34Randomized Clinical TrialsStatistical Significance and Sample SizeDo Not Forget Chance

Cours 7 — Essais cliniques randomisés page 34

05.07Page 35Randomized Clinical TrialsStatistical Significance and Sample SizeCorrelation vs Causation Cartoon

Cours 7 — Essais cliniques randomisés page 35

05.07Page 36Randomized Clinical TrialsPre-Specification of OutcomesScenario: Dr Pick N. Choose

Cours 7 — Essais cliniques randomisés page 36

05.07Page 37Randomized Clinical TrialsPre-Specification of OutcomesWhy Pre-Specify Primary Outcome

Cours 7 — Essais cliniques randomisés page 37

05.07Page 38Randomized Clinical TrialsPre-Specification of OutcomesProperties of a Good Outcome

Cours 7 — Essais cliniques randomisés page 38

05.07Page 39Randomized Clinical TrialsPre-Specification of OutcomesChoosing an Outcome for Pharyngitis

Cours 7 — Essais cliniques randomisés page 39

05.07Page 40Randomized Clinical TrialsAnalysis PopulationIntention-to-Treat vs Per-Protocol

Cours 7 — Essais cliniques randomisés page 40

05.07Page 41Randomized Clinical TrialsAnalysis PopulationWhat Must Be Pre-Specified

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05.07Page 42Randomized Clinical TrialsPICO FrameworkBasic Ingredients of an RCT

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05.07Page 43Randomized Clinical TrialsPICO FrameworkPICO Applied to Pharyngitis

Cours 7 — Essais cliniques randomisés page 43

05.07Page 44Randomized Clinical TrialsSummarySummary: PICO, Randomization, Blinding

Cours 7 — Essais cliniques randomisés page 44

05.07Page 45Randomized Clinical TrialsSummarySummary: Placebo and Allocation Concealment

Cours 7 — Essais cliniques randomisés page 45

05.07Page 46Randomized Clinical TrialsSummarySummary: Pre-Specification, ITT, Ethics

Cours 7 — Essais cliniques randomisés page 46

05.07Page 47Randomized Clinical TrialsNext Lecture Preview

Cours 7 — Essais cliniques randomisés page 47