## Statistical design of experiments 2020-2021

**University of Modena and Reggio Emilia**

**Department of Biomedical, Metabolic and Neural Sciences**

**PhD modul: Clinical an Experimental Medicine – CEM – Medicina Clinica e Sperimentale**

**Course: Statistical design of experiments**

**Academic year 2020 – 2021**

Director of the course: Prof. Giuseppe Biagini

Course coordinator: Olivera Djuric, MD PhD

Course Programme:

Day | Topic | Hours |

Monday 31/5/2021 | Part I Lecture: Principles of causation: causal inference, directed acyclic graphs, relation between variables (bias, confounding, effect modification)
Group assignment - problem solving |
16:00-18:00
18:00-19:00 |

Tuesday 01/6/2021 | Part I Lecture: Principles of statistical inference Group assignment - statistical vs. clinical inference
Part II Lecture: Sample size and power calculation Practical exercise on calculating power and sample size for experimental study
Part III Lecture: Choice of adequate statistical test Group assignment - problem solving |
16:00-17:15
17:15-18:15
18:15-19:00 |

Thursday 03/06/2021 | Part I Lecture: Overview of epidemiological study designs Part II Lecture: Basics of experimental studies Theoretical exercise on types of experimental studies and types of clinical trials
Part III Lecture: Statistical analysis in experimental design |
16:00-16:45 16:45-18:15
18:15-19:00 |

Friday 04/6/2021 | Part I Lecture: Basics of correlation – use and misuse
Part II Lecture: Regression – basic principles Lecture: Linear regression and multiple linear regression
Part III Practical exercise in SPSS or STATA | 16:00-16:45
16:45-18:30
18:30-19:00 |

Monday 07/6/2021 | Part I Lecture: Logistic regression – basic concepts Lecture: Single and multiple logistic regression
Part II Practical exercises in SPSS or STATA |
16:00-17:00 17:00-18:15
18:15-19:00 |

Tuesday 08/6/2021 | Part I Lecture: Logistic regression – variable selection and model building Lecture: Logistic regression – statistical adjustment – interaction and confounding Lecture: Regression – diagnostics
Part II Practical exercises in SPSS or STATA |
16:00-18:00
18:00-19:00 |

Thursday 10/6/2021 | Part I Lecture: Analysis of variance (ANOVA), multivariate analysis of variance (MANOVA), analysis of covariance (ANCOVA), and multivariate analysis of covariance (MANCOVA)
Part II Lecture: Repeated measures analysis
Part III Practical exercise in SPSS or STATA |
16:00-17:15
17:15-18:15
18:15-19:00 |

Friday 11/6/2021 | Part I Lecture: Basic concepts of time-to-event data Lecture: Testing for equivalency of time distributions (comparing survival curves) Lecture: Regression models for time-to-event data (Cox regression)
Part II Practical exercise in SPSS or STATA |
16:00-18:15
18:15-19:00 |

Monday 14/06/2021
| Presentation and discussion of a protocol for the experimental study assigned in day one | 16:00-19:00 |

Work in groups | General group assignment: write and present a protocol for a randomized controlled study, emphasis on statistical analysis plan and sample size calculation | ≥4h |

Theoretical (homework) exercises | - Regression
- Time-to-event analysis
| 1.5h 1.5h |