Basic Concepts
Sample vs Population
Variables
- Random
- Independent
- Dependent
Analysis
- Univariable
- Bivariable
- Multivariable
Types of Data
- Non-parametric
- Parametric
Distributions
- Normal
- Bimodal
- Rectangular
- Skewed
- Positive Skew
- Negative Skew
- Kurtosis
Descriptive Statistics
Measures of Central Tendency
- Mean
- Median
- Mode
- Gaussian or Normally distributed data graph
- Positively skewed data graph
- Negatively skewed data graph
Measures of Variability
- Range
- Interquartile Range
- Variance
- Standard Deviation
- Coefficient of Variation
- Standard Error of the Mean (aka standard error)
- Confidence Intervals
- Interpretation of Superiority Traits
- Interpretation for Differences
- Interpretation for Ratios
- Interpretation of Equivalence Trials
- Interpretation of Non-Inferiority Trial
Sensitivity, Specificity, Predictive Value, and Hypothesis Testing
Sensitivity
Specificity
Positive Predictive Value
Negative Predictive Value
Prevalence
Incidence
Hypothesis Testing
- Null Hypothesis
- Alternative Hypothesis
- Type 1 or Alpha Error
- Type 2 or Beta Error
Sample size calculations
Correcting for estimated Drop-out Rate
Delta
One-tailed vs Two-tailed tests
Effect of change in Alpha
Effect of change in Beta
Effect of change in Delta
Effect of One-tailed vs Two-tailed design
Effect of change in expected incidence
Statistical Inference Techniques for Hypothesis Testing w/ Parametric Data
T-test
- Non-Paired
- Paired
- One-Tailed
- Two-Tailed
- Bonferroni
- Dunn-Sidak
ANOVA
- ANOVAs for Non-Paired samples
- 1-way ANOVA
- Multifactorial ANOVAs
- ANOVAs for Paired samples
- Repeated Measures ANOVA
- 2-way Repeated Measures ANOVA
- Repeated Measures Regression
- Multiple Comparison Methods (Post Hoc Analysis)
- Least Significant Difference
- Layer (aka stepwise) Methods
- Experiment-wise Methods
- Dunnett
- Dunn
- Tukey
- Scheffe
Statistical Inference Techniques for Hypothesis Testing w/ Non-Parametric Data
Non-Parametric Tests for Nominal Data
- Chi-Square Tests
- Test of Independence
- Goodness of Fit
- McNemar Chi-Square
- Mantel-Haenszel Chi-Square
- Log-Linear Analysis
- Post Hoc Analysis
- Fisher's Exact
- Rows by Columns Test
- Table Noting Proper Test to Use
Non-Parametric Tests for Ordinal Data
- Mann Whitney U and Wilcoxon Rank Sum
- Kolmogorov-Smirnov
- Wilcoxon Signed Rank
- Kruskal-Wallis
- Friedman
- Table Noting Proper Test to Use
Correlation and Regression
Correlation
- r-value
- population correlation coefficient
- coefficient of determination (r2)
- sample correlation coefficient
Regression
- Multiple regression
- Linear regression
- Logistic regression
- Cox Proportion Hazards
Error vs Bias
Bias in the Publication Process
- Funding Sources
- Publication
- Investigator
- Reviewer
- Small study
Compliance
Prevalence
Selection Bias
- Inclusion in study
- Participation in study
- Admission rate
- Nonresponse
- Membership
- Diagnostic or Detection
- Insensitive Measure
- Procedure
Bias that falsely identify or inflate risk factors
- Recall
- Observer
- Interviewer
- Misclassification
- Random Misclassification
- Channeling
Controlling for Bias
- Design of Trial
- Randomization
- Selection Criteria
- Blinding
- Matching
- Using Controls
- Analysis
Controlled vs Non-Controlled
Various Types of Controls
- Placebo
- Historical
- Crossover
- Standard or Active Treatment
- Within Patient Comparison
Blinding in Trial Design
Non-blinded
Single-blinded
Double-blinded
Double-dummy
Triple-blind
Total-blind
Note concerning trials that claim blinding, but may not be blinded.
Run-In-Phase
Confounding
Arrow Chart Examples
Co-linearity
Controlling for Confounding
- Design of Trial
- Randomization
- Selection Criteria
- Blinding
- Matching
- Analysis
- Stratification
- Multivariate Regression Analysis
- Note concerning various types of ANOVA used
Validity
Internal
External
Prospective vs Retrospective
General Considerations for Assessing Causality
- Relative strength of causal relationships
Retrospective Trials
- Case-Control
- Cohorts
- Retrospective Cohort
- Prospective Cohort (retrospective)
- True Prospective Cohort
- Benefits
- Problems
Odds Ratios, Relative Risks (aka Risk Ratios, Rate Ratio, or Incidence Rate Ratio)
Odds Ratio (see below for further explanation of examples)
Relative Risk (see below for further explanation of examples)
Hazard Ratio
Interpretation
Absolute Risk
Absolute Risk Reduction or Increase
Numbers Needed to Treat or Harm
Relative Risk Examples for RCTs and Cohort Trials
- Example 1: Relative Risk Reduction example w/ Calculations and Interpretations
- Absolute Risk
- Absolute Risk Reduction
- Numbers Needed to Treat
- Relative Risk
- Relative Risk Reduction
- Difference vs Cohort Trial
- Example 2: Relative Risk Increase example with Calculations and Interpretations
- Absolute Risk
- Absolute Risk Increase
- Numbers Needed to Harm
- Relative Risk
- Relative Risk Increase
- Difference vs Cohort Trial
Odds Ratio Examples for Case Control Trials
-
Example 1 w/ Calculations and Interpretation
-
Example 2 w/ Calculations and Interpretation
-
Note concerning change in Incidence's effect on estimation of Relative Risk
Randomized Controlled Trials
Parallel Design
Cross-over Design
Considerations
Disadvantages
Various Types of Analyses
Intention of Treat (ITT)
As Treated
Per Protocol
Post Hoc
Note concerning trials that claim to be ITT, but may not truly be ITT.
Run-In-Phase
Interim Analysis
Subgroup Analysis
Survival Analysis
-
Hazard
-
Life table
-
Actuarial Method
-
Kaplan-Meier
-
Statistical tests
-
Log-Rank
-
Wilcoxon-type
-
Cox Proportion Hazards
Meta-Analysis
Combined Endpoints
Miscellaneous
Breslow Day test
Rule of Four
Abbreviations
References
Index
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