MEDS 300: Statistical Methods for Biomedical Research Professors: Dr. Elahe Nezami E-mail: nezami@usc.edu Health Promotion & Disease Prevention Program: Angela Almer Turk 3375 S. Hoover St. University Village, Ste. E210 Los Angeles, CA 90089 almer@usc.edu; (213) 821-1601 Course Description and Goals Throughout this class, students pursuing pre-medical education will learn basic concepts in statistics and research methods. Students will be familiarized with various statistical tests (parametric and non-parametric), the underlying assumptions, and statistical analyses used in health fields. Upon completion of this course, students will appreciate the role and quality of statistical methods in published medical research, and will know how to appraise the evidence relevant to clinical decisions. Students will receive detailed instruction in each of the following areas: Basic concepts, uses and misuses of statistics Scientific method Research hypothesis development and testing Theories, constructs and variables (theoretical vs. operations definitions) Self-report measures (open vs. closed-ended, measurement scales, survey development) Research ethics Questionnaire development— reliability, validity (external and internal) and threats to validity Experimental studies (study designs, threats, causation) Sampling (random sampling, stratified sampling, convenience sampling) Study design (observational and experimental) Diagnostic tests Probability distribution Concepts of population and sample Descriptive statistics Importance of normal distribution, “normal ranges” for laboratory tests Confidence intervals and p-values The “art” of significance testing Parametric and non-parametric tests Interpreting statistical results Appraising the evidence Meta analysis and regression analysis Reading medical literature Textbooks Rosnow, R.L., & Rosenthal, R. (2008). Beginning Behavioral Research: A Conceptual Primer. 6th Edition. New Jersey: Prentice Hall. NOTE: A copy will be available on reserve at Leavey Library. The earlier 2005 5th Edition can also be used for this course. Kiess, H.O. & Green, B.A. (2008) Statistical Concepts for the Behavioral Sciences (4th ed.). Boston: Allyn and Bacon. Bock, David E. et al. Stats: Modeling the World. 3rd edition; Boston. Yates, Moore, & Starnes. The Practice of Statistics, 2008. Grade Components Homework/Lab Assignments Project : due the final exam day Mid-term Exam Final Exam Participation (class activities, in-class assignments, discussions) 10% 20% 30% 30% 10% Grade Scale A AB+ B B- 95-100% 90-94% 87-89% 83-86% 80-82% C+ C CD+ D DF 77-79% 73-76% 70-72% 67-69% 63-66% 60-62% 61%-0% Course Outline: Class Week General Topic Week 1 Part 1 – Sampling Distribution Models Week 2 Simulating a Sampling Distribution Model Sampling Variability Describing the Sampling Distribution Models for Sample Proportions in terms of Center, Spread, and Shape Assumptions and Conditions for the Sampling Distribution Model of Sample Proportions Calculating Probabilities Based on the Sampling Distribution Model of Sample Proportions Describing the Sampling Distribution Models for Sample Means in terms of Center, Spread, and Shape Central Limit Theorem Assumptions and Conditions for the Sampling Distribution Model of Sample Means Calculating Probabilities Based on the Sampling Distribution Model of Sample Means Law of Diminishing Returns Standard Error of the Sampling Distribution Model Part 2 – Confidence Intervals for Proportions and sample parameters Sampling Variability Estimating Population Parameters Point Estimates Margin of Error Interpreting Confidence Levels Critical Values of z* Creating a One-Proportion Z-Interval Interpreting Confidence Intervals Assumptions and Conditions for a One-Proportion Z-Interval Calculating Minimum Sample Size for a given Margin of Error Part 3 – Testing Hypotheses About Proportions Logic of a Hypothesis Test Null vs. Alternate Hypotheses Idea of Rejecting vs. Retaining the Null Hypothesis Conducting a One-Proportion Z-Test Calculating a Probability Value (P-Value) Assumptions and Conditions for a One-Proportion Z-Test One-sided vs. Two-sided Hypothesis Tests Drawing Conclusions from our Data Week 3 Week 4 How Hypothesis Tests and Confidence Intervals are Related Part-4 – More About Tests P-values as a Conditional Probability Making a Decision based on an Alpha Level Critical Values for a Hypothesis Test Comparing a Hypothesis Test to a Confidence Interval Type I and Type II Errors Power of the Test The Relationship between Alpha, Beta, and Power Effect Size Part-5 – Comparing Two Proportions Sampling Distribution Model for the Difference Between Two Independent Proportions Assumptions and Conditions for Two-Proportion Inference Creating a Two-Proportion Z-Interval Idea of Pooling Conducting a Two-Proportion Z-Test Relationship between an Interval and a Test Part-5 – Comparing Means Week 5 Sampling Distribution Model for the Difference Between Two Independent Means When to Use the Z-distribution vs. the T-distribution Assumptions and Conditions for Two-Sample Inference for Unpaired Means Creating a Two-Sample T-Interval for Unpaired Means Idea of Pooling Conducting a Two-Sample T-Test for Unpaired Means Relationship between an Interval and a Test TI: Calculating a Two-Sample T-Interval for Unpaired Means, Calculating a Two-Sample T-Test for Unpaired Means Part- 6 – Paired Samples and Blocks Paired Data vs. Independent Samples Assumptions and Conditions for Inference for Paired Means Creating a Matched-Pairs T-Interval for Means Conducting a Matched-Pairs T-Test for Means Part-7 – Comparing Counts Intro to ANOVA One-Factor ANOVA Multiple Comparison Tests Intro to Linear Models Two-Factor ANOVA Week 6 Week 7 Week 8 Weeks 8 & 9 Part-8 – Comparing Counts Chi-Square Distribution Chi-Square Test of Goodness of Fit Assumptions and Conditions for Chi-Square Tests Expected Counts vs. Observed Counts Chi-Square Test of Homogeneity Chi-Square Test of Independence Part-9 –Non parametric tests and Inferences for Regression Idealized Regression Model Assumptions and Conditions for Inference for Regression Sampling Distribution Model for the Slope of the Regression Line Single & multiple linear regression Polynomial regression Pearson, Spearman correlation Midterm Part-10-Clinical Trials Week 10 Weeks 11 and 12 Basic concepts and designs: Different types of designs (Experimental, qualitative, and quantitative). Controlled and uncontrolled clinical trials; historical controls; protocol; placebo; randomization; blind and double blind trials; ethical issues; protocol deviations. Size of trials. Multiplicity and meta-analysis: interim analyses; multi-centre trials; combining trials. Cross-over trials. Binary response data: logistic regression modelling; McNemar's test, relative risks, odds ratios. Part-11-Survival Data Analysis Basic concepts: survivor function; hazard function; censoring. Single sample methods: lifetables; Kaplan-Meier survival curve; parametric models. Two sample methods: log-rank test; parametric comparisons. Regression models: inclusion of covariates; Cox's proportional hazards model; parametric and accelerated failure time models. Part-11-Design of Experiments Notation:Design region. Variation and blocking. Stages in experimental research. Randomisation. Criteria for a good experiment: Optimality criteria. General theory of block designs Factorial designs: Estimability. Blocking. Confounding. Screening. Optimum Design theory: General Equivalence Theorem. Experiments with constraints. Design construction. Weeks 12, 13 and 14 (project is due the final exam day) Part-12-Final Project will demonstrate students understanding of the statistical and design concepts Choose a question of interest. Design an appropriate study or experiment. Collect data and describe the data using graphical displays, and summery statistics. Make inference about the population and test the results. Justify methods and state conclusions Make a presentation for the class, and submit a report. Week 15 Final exam Academic Dishonesty Academic dishonesty on exams, assignments, and other aspects of the course is grounds for failure on the assignment, failure in the course, or expulsion from the university. This is another strict policy. Students are expected to understand what constitutes plagiarism and other forms of cheating, as well as the consequences. For information, see http://www.usc.edu/dept/publications/SCAMPUS/gov/. Click on University Governance and then Behavior Violating University Standards and Appropriate Sanctions to find definitions of cheating. Sanctions are listed under 11.80. The minimum official consequence for cheating is course failure. Students with Disabilities Any student requesting academic accommodations based on a disability is required to register with Disability Services and Programs (DSP) each semester. A letter of verification for approved accommodations can be obtained from DSP. Please be certain the letter is delivered to the Instructor as early in the semester as possible. DSP is located on the University Park campus in STU 301 and is open 8:30 a.m. – 5:00 p.m., Monday through Friday. The phone number is (213) 740-0776. Student Athletes Student athletes are expected to keep the Professor or Teaching Assistant informed of any necessary situations which might lead to a missed class. Emergency Preparedness/Course Continuity: In case of emergency, and travel to campus is difficult, USC executive leadership will announce an electronic way for instructors to teach students in their residence halls or homes using a combination of Blackboard, teleconferencing, and other technologies. Instructors should be prepared to assign students a "Plan B" project that can be completed at a distance. For additional information about maintaining your classes in an emergency please access: http://cst.usc.edu/services/emergencyprep.html