Sensitivity - Definition & Calculation
Proportion of patients with a condition who have a positive test result.
TP/(TP + FN)
Specificity - Definition & Calculation
Proportion of patients without a condition who have a negative test result.
TN / (TN + FP)
Positive Predictive Value - Definition & Calculation
Chance that a patient actually has the condition given a positive test.
TP / (TP + FP)
Negative Predictive Value - Definition & Calculation
Chance that a patient does not have the condition given a negative test
TN / (TN + FN)
Likelihood Ratio (Positive) - Definition & Calculation
How much the odds of a disease increase when a test is positive.
Sensitivity/(1-Specificity)
Likelihood Ratio (Negative) - Definition & Calculation
How much the odds of a disease decrease when a test is negative.
(1 - Sensitivity) / Specificity
Numbers Needed to Treat (NNT) - Definition & Calculation
Measure indicative of how many patients would require an intervention to reduce the number of outcomes by one - 1 / Absolute Risk Reduction) - Expressed as a whole #
Absolute Risk Reduction - Calculation
Control Event Rate - Experimental Event Rate
Relative Risk (Risk Ratio) - Calculation
Experimental Event Rate / Control Event Rate
Relative Risk Reduction / Increase (RRR/RRI) - Calculation
RRR = (EER - CER) / CER
Odds / Odds Ratio - Definition and Calculation
Odds - A ratio of people who incur an outcome to the number who do not incur e.g. 80/20 (80 out of 100).
Odds Ratio - Ratio of the odds of a particular outcome with that of a control (Used in Case-control studies).
Stages of Clinical Trials
Stage 0 - Exploratory Studies - Small Numbers of participants assessing pharmacokinetics/dynamics.
Stage 1 - Safety Assessment - Determines side effects prior to larger studies (Healthy Volunteers)
Stage 2 - Efficacy Assessment - Small # of patients w/ a disease.
- Stage IIA - Assesses optimal dosing.
- Stage IIB - Assesses Efficacy
Stage 3 - Effectiveness Assessment - thousands of patients in RCT trials comparing the novel treatment to a placebo.
Stage 4 - Postmarketing Surveillance - Monitors for long-term side effects.
Randomised Control Trial (RCT)
Random Allocation to a control or intervention group. (Can have practical and ethical problems)
Cohort Study
Observational and Prospective
Groups selected based on exposures and are followed up to determine relative risks of outcomes.
Case-Control Study
Observational & Retrospective
Patients are selected based on outcomes and are surveyed to determine exposure (Prone to confounding.
Outcome measure is usually odds ratio
What is Categorical Data
Data w/ Names & no logical order
What is Ordinal Data
Data with a logical order but unequal gaps between values
What is Continuous Data
Data on a scale with equal gaps between values.
Features of a “Perfect” Normal (Gaussian) Distribution
Mean = Mode = Median
68.3 % of Values lie within 1 SD of Mean
95.4 % of Values lie within 2 SD of Mean
99.7 % of Values lie within 3 SD of Mean
95 % of Values lie within 1.96 SD of the Mean
Characteristics of Skewed Gaussian Distribution
Positive Skew Mean> Median > Mode
Negative Skew Mean < Median < Mode
What is the Null Hypothesis (H0)
Two treatments are equally effective (Significance tests assess how likely H0 is to be true)
What is the Alternative Hypothesis (H1)
The opposite of H0 - there is a difference between the two treatments
What is the P-Value
The probability of obtaining a result that is at least as extreme as the observed (Chance of making a Type I Error)
What is a Type I Error
The null hypothesis is rejected when it is true