Prev SAQs: consider adding

· Objectives of an ethics review

· Pros and cons of multi-centre trials

· What is the value of case reports

I |
Systematic review |

II |
Proper RCT |

III-1 |
Pseudo RCT |

III-2 |
Comparative study with concurrent control -Cohort study -Case-control study |

III-3 |
Comparative study without concurrent control |

IV |
Case series |

V |
Case report |

A |
Excellent |
· Many good trials · Guides practice |

B |
Good |
· Couple of good trials · Guides practice in most situations |

C |
Satisfactory |
· Couple of ok trials · Careful with application |

D |
Poor |
· Low quality trials · Beware application |

Phase |
Numbers |
Purpose |

0 |
10-20 |
Kinetics |

1 |
20-100 |
Safety + dose finding |

2 |
100-300 |
Safety + efficacy |

3 |
1k-2k |
Safety + efficacy |

4 |
Many |
Safety + efficacy |

Definitions |
· Systematic review: combined analysis of multiple studies ·
Meta-analysis: combined |

Stages |
· Define inclusion and exclusion criteria · Search for trials · Assess heterogeneity · Perform meta-analysis · Assess whether result makes sense |

Forest plot |
= what’s the outcome? · X axis: odds ratio · Y axis: individual studies · Dot size: weight · Line width: confidence intervals · Diamond centre: point estimate · Diamond width: confidence interval |

Funnel plot |
= is there publication bias? · Large studies should cluster around the true effect · Publication bias is suspected if results cluster on one side of the plot |

Pros |
· Get an answer |

Cons |
· Combining apples and oranges |

Interpretation |
· Negative result -> probably accept · Positive result -> probably do a large RCT to confirm |

Introduction |
· Appropriate question · Appropriate study design · Appropriate endpoint |

Research methods |
· Measurement techniques · Who, where, when, how many, how long for · Control group, randomization, blinding · Inclusion and exclusion criteria |

Result |
· Answers the question? · Statistically significant? · Presented clearly? · Missing data and why? |

Discussion & conclusion |
· Logical? · Biased? |

Summary |
· Quality? · Relevance? · Changes my practice? |

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