Research Curriculum

Course Outline

SECTION 1 – BIOSTATISTICS

The Basics of Data

1. Data Scales

2. Normal vs. Non-normal Distribution

3. Parametric vs. Non-parametric Data

Descriptive Statistics

1. Measures of Central Tendency: Mean, Median and Mode

2. Measures of Variability: Standard Deviation, Standard Error of the Mean, Interquartile Range, and Range

Sampling and Estimation

1. Confidence Intervals

Measuring Performance of Diagnostic Tests

1. Sensitivity and Specificity

2. Positive and Negative Predictive Value

3. Receiver Operating Characteristic Curves

4. Likelihood Ratio and Bayesian Theory

Measures of Risk and Odds

1. Relative Risk and Absolute Risk

2. Odds Ratio

Measuring Performance of Therapies

1. Absolute Risk Reduction and Absolute Benefit Increase

2. Number Needed to Treat and Number Needed to Harm

Hypothesis Testing

1. The Null Hypothesis

2. Type I and Type II error

3. Statistical Power and Sample Size Estimates

4. Parametric Statistical Inference Tests: t-test and ANOVA

5. Non-parametric Statistical Inference Tests: Chi-Square test and Variants, Rank Tests of Non-parametric Data

6. "Statistically Significant" vs. "Biologically Meaningful"

Measuring the Relationships between Variables

1. Correlation

2. Regression

Measures of Validity/Reliability

1. Inter-rater Reliability (Kappa)

Measures of Safety

1. Upper limit of the 95% Confidence Interval

Sample Size Determinations

SECTION 2 – STUDY DESIGN

The “Skeleton” of a Research Paper

1. Proper Organization of a Research Paper

2. The Relationship Between Definitions and Conclusions

Sources of Bias, Confounding, and Error

Study Types

1. Prospective vs. Retrospective Studies

2. Descriptive Studies: Case Reports, Case Series, Cross-Sectional Studies

3. Evaluative/Analytical Studies: Cohort Studies, Case Control Studies

4. Experimental Studies: Randomized Controlled Trials, Non-randomized Controlled Trials

5. Synthesis Studies: Reviews, Systematic Reviews, Meta-Analyses

6. Intention-to-Treat Analysis

7. Paired/Matched Study Design

Methodology: The “Rosetta Stones”

1. The Randomized Controlled Trial – CONSORT

2. The Chart Review –Gilbert

SECTION 3 - PRESENTATION OF RESULTS

1. Patient Flow Diagrams

2. Tables

3. Graphs

4. Figures

SECTION 4 - THE CONDUCT OF RESEARCH

1. Informed Consent

2. Human and Animal Rights

3. The Role of the IRB

4. HIPAA

5. Forms of Scientific Misconduct

6. Conflicts of Interest

7. Investigator/Co-Investigator Responsibilities

8. Responsibilities of a Valid Author