Biostatistics II with SPSS and R Master of Science in Clinical Investigation Program Date: M- F, February 1 – 28, 2006 Time: 1:30 PM – 4:30 PM Class Room: Room 412 Light Hall Instructor: Ayumi Shintani, PhD, MPH Department of Biostatistics Office: MCN S-2323 Phone: (615) 936-1954 Fax: (615) 343-4924 E-mail: Ayumi.shintani@vanderbilt.edu Class Website: http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/MsciBiostat2 Course Objectives: 1. Able to analyze data from a complex clinical research project and interpret and review/critique statistical methods used in published papers. 2. Know when to use, be able to define and conduct the 30 most commonly used inferential statistical methods and be able to interpret the statistical software outputs for those tests. 3. Understand the fundamental bio-statistical concepts related to univariate analysis and especially multivariate analysis with a firm understanding between individual univariate test and corresponding multivariate analysis. 4. Understand concept of confounding and interaction and how to detect using subgroup analysis and multivariable modeling techniques. 5. Understand purpose of conducting multivariable models and master proper strategies for developing reliable multivariable models from complex data and how to check model assumptions. 6. Introduce students to a modern area of biostatistics such as non-linear spines for fitting continuous data, model validation using bootstrap method. 7. Master the statistical software package SPSS version 13 and develop complementary skill using R- software. 8. Able to create publication-quality and statistically meaningful medical graphs. 9. Able to perform and understand fundamental concept related to sample size and power computation. Text Books: Main text books: (1) Kirkwood BR, Sterne JAC. Essentials of Medical Statistics. $49.95. Blackwell Sciences, 2nd ed. (2001). ISBN: 0865428719. (2) Katz MH. Multivariable Analysis: A Practical Guide for Clinicians. $35.00. Cambridge University Press. (1999). ISBN: 0521596939. Supplemental text books: (1) Bernard Rosner. Fundamentals of Biostatistics, Sixth Edition, Duxburry Press, ISBN: 0534418201. List Price (USD) $119.95 (2) Douglas G. Altman. Statistics with Confidence: Confidence Intervals and Statistical Guidelines. B M J Books. ($31.45) ISBN: 0727913751; 2nd edition. (3) SPSS 13.0 Advanced statistical Procedures Companion. Marija J. Norusis ISBN 0-13186540-4 (4) SPSS 13.0 Guide to Data Analysis, Marija J. Norusis ISBN 0-13-186535-8 Hardware: Students are advised to bring a laptop to all sessions. Software: 1. SPSS software version 13 (or latest) 2. R – statistical software. Free download from: http://www.r-project.org 3. PS sample size software. Free download from: http://www.mc.vanderbilt.edu/prevmed/ps/index.htm 4. nQuery Advisor 4.0 (recommended but not required) Examination and Grading: Homework Class attendance Midterm Exam Final Exam 40% 10% 10% 40% Course organization (subject to change): 50 min. Lecture + SPSS tutorials 10 min. Break 50 min. Lecture + SPSS tutorials 10 min. Break 60 min. Homework Presentation Note: Students will form study groups (each consisting 2-3 members) at the 1st day, all homework projects are recommended to be discussed in groups before presentation. Course Schedule Week 1 Wednesday Feb 1 Thursday Feb 2 Friday Feb 3 Week 2 Wednesday Feb 6 Thursday Feb 7 Wednesday Feb 8 Thursday Feb 9 Friday Feb 10 Week 3 Monday Feb 13 Tuesday Feb 14 Wednesday Feb 15 Thursday Feb 16 Friday Feb 17 Week 4 Monday Feb 20 Tuesday Feb 21 Wednesday Feb 22 Thursday Feb 23 Friday Feb 24 Course Introduction (30 min.) Chapter 3: Comparing 2 means: Paired t-test, Student’s ttest Chapter 4: Comparing 3+means: One-way Analysis of Variances, issues of multiple comparisons Chapter 5: 2 way ANOVA, Concept of effect modification (interaction) using means Book Chapters Kirkwood Sterne 7 Rosner 8 Kirkwood Sterne 9 Rosner 12 Kirkwood Sterne 9 Rosner 12 Chapter 6: Simple Linear Regression Pearson Correlation / Spearman Correlation Chapter 7: Relation between Student’s t-test, One-way ANOVA, Two-way ANOVA with Linear regressions Chapter 8: Simple Linear Regression: Transformation, non-linear association in R Chapter 9: Multiple Linear Regression: Detecting confounding and interaction Chapter 10: Multivariable Regression Strategies: Kirkwood Sterne 10, 12 Rosner 11 Kirkwood Sterne 11 Rosner 11 Kirkwood Sterne 11.5, 12,13 Kirkwood Sterne 11, 18, 29 Katz (entire book) Kirkwood Sterne 29 Mid-term Exam Chapter 10: Multivariable Regression Strategies: Chapter 11: Comparing Two proportions: Measures of Association in 2 x 2 tables, Relative risk, Odds ratio, Test for association: Chi-squares / fisher’s exact test Comparing 3 + proportions: Test for association for R x C tables, Chi-squares test for linear trend Chapter 12: Binary Logistic Regression Katz (entire book) Kirkwood Sterne 29 Kirkwood Sterne 14, 15, 16, 17, 21, 36 Rosner 10 Chapter 13: Multivariable Binary Logistic Regression Multiple 2 x 2 tables: Confounding, Effect modification, Testing for homogeneity of odds ratios, Mantel-Haenszel tests Chapter 14: Analysis of two related categorical variables: Mcnemar test, Conditional logistic regression Analysis of categorical variable with more than 2 levels: Proportional Odds Logistic regression Kirkwood Sterne 18, 20, 29 Rosner 10 Chapter 15: Survival Analysis (1-1): Introduction to Survival Analysis Chapter 16: Survival Analysis (1-2): Kaplan-Meier estimates, Log-rank test model Chapter 16: Survival Analysis (2): Cox Proportional Hazard model Chapter 17: Analysis of Continuous Repeated measures (1): Paired t-test, ANCOVA, Response Feature Analysis Chapter 18: Analysis of Continuous Repeated measures (2): Linear Mixed model Kirkwood Sterne 26 Rosner 14 Kirkwood Sterne 26 Rosner 14 Kirkwood Sterne 27 Rosner 14 Kirkwood Sterne 31 Kirkwood Sterne 19 Kirkwood Sterne 21 Kirkwood Sterne 31 Week 5 Monday Feb 27 Tuesday Feb 28 Review Final Exam