High-Yield Core Concepts Checklist (10 Summary Cards)
USMLE Step 1 / Step 2 CK / IFOM StandardsSensitivity & Specificity
Fixed intrinsic properties of a screening test. Do NOT change with population prevalence.
- Sensitivity (TP Rate) A / (A + C)
- Specificity (TN Rate) D / (B + D)
PPV, NPV & Prevalence
Predictive values depend directly on disease Prevalence in the tested population.
- PPV (True Positive Test) A / (A + B)
- NPV (True Negative Test) D / (C + D)
Cut-Off Shift & ROC Curves
Shifting diagnostic cut-off points changes the trade-off between Sensitivity and Specificity.
Odds Ratio vs Relative Risk
Choose based on study design. Odds Ratio for retrospective, Relative Risk for prospective.
- Odds Ratio (Case-Control) (A×D) / (B×C)
- Relative Risk (Cohort) [A/(A+B)] / [C/(C+D)]
ARR, NNT & NNH
Quantifying therapeutic benefit or harm in clinical trials.
Precision, SD & Confidence Intervals
Distinguishing reliability (precision) vs validity (accuracy) and estimating population parameters.
Type I (α) & Type II (β) Errors
Errors in hypothesis decision-making and statistical power.
Study Designs Matrix
Choosing Statistical Tests
Confounding vs Effect Modification
Distinguish third variable distortions via Stratification Analysis.
Clinical Trial Phases
Trials occur after preclinical animal/in vitro testing and proceed through 5 phases before and after FDA approval.
- Phase 0: Microdosing PK/PD in a few volunteers. Often skipped.
- Phase 1: Small group, healthy or patients. Safety & max tolerated dose.
- Phase 2: Moderate group with disease. Does it Work? (efficacy + short-term AEs)
- Phase 3: Large group, RCT vs standard of care. Any Improvement?
- Phase 4: Postmarketing surveillance. Can it stay on the Market? (rare/long-term AEs)
Blinding & Crossover Trials
Trial quality improves with randomization and blinding of who knows the treatment assignment.
ITT vs As-Treated vs Per-Protocol
Bradford Hill Criteria for Causation
Necessary but not sufficient principles supporting a causal (not just associative) relationship.
Case Series, Twin, Adoption & Ecological Studies
Likelihood Ratios (LR+ / LR-)
Combine sensitivity and specificity into one number that updates pretest probability directly.
- LR+ Sens / (1 − Spec)
- LR− (1 − Sens) / Spec
Kaplan-Meier Curve & Hazard Ratio
Kaplan-Meier estimates survival probability over time ("time-to-event" data, often mortality).
Incidence vs Prevalence
- Incidence # new cases / at-risk pop, per time
- Prevalence Incidence × avg. duration
Mortality, Attack & Case Fatality Rate
- Mortality rate Deaths / population, per year
- Attack rate Ill people / people exposed
- Case fatality rate Deaths / cases × 100
Demographic Transition & Population Pyramids
As a country develops, birth and mortality rates decline to varying degrees, reshaping the population's age structure.
Mean, Median & Mode
Normal, Bimodal & Skewed Distributions
H0, H1 & the P-Value
Confidence Intervals
Range expected to contain the true population value, with a specified probability (CI = 1 − α).
- 95% CIMean ± 1.96×SE
- 99% CIMean ± 2.58×SE
Meta-Analysis
Pools summary data (means, RRs) from multiple studies for a more precise effect estimate, and estimates heterogeneity between studies.
Statistical vs Clinical Significance
Expanded Epidemiological Biases & How to Control Them
| Type of Bias | Definition & Clinical Vignette Pattern | Method to Reduce / Control |
|---|---|---|
| Selection / Berkson Bias | Non-random sampling or selecting hospitalized controls (Berkson bias) that don't represent the true target population. Convenience sampling (enrolling whoever is easiest to reach) is a common sub-type. | Randomization, high response rate, correct comparison group |
| Recall Bias | Subjects with negative outcome recall past exposures more accurately than healthy controls (common in retrospective case-control studies). | Decrease time from exposure to follow-up; use medical records as source |
| Measurement / Procedure Bias | Information is gathered in a systematically distorted way (e.g., a faulty automatic BP cuff), or subjects in different groups aren't treated/tested the same way (procedure bias). | Objective, standardized, pre-planned data collection; blinding |
| Hawthorne Effect | Study subjects alter their behavior because they know they are actively being observed ("Hawthorne watches you like a hawk"). | Placebo control, unobtrusive monitoring |
| Observer-Expectancy (Pygmalion) Bias | Researcher's belief in a treatment's efficacy changes the outcome of that treatment — e.g., an observer expecting improvement is more likely to document a positive outcome. | Blinding (masking) of researchers analyzing outcomes |
| Lead-Time Bias | Early detection by screening creates false impression of prolonged survival without altering true disease trajectory or outcome. | Measure "back-end" survival adjusted for severity at diagnosis |
| Length-Time Bias | Screening preferentially detects slowly progressive, less aggressive cases (long latency) over rapidly fatal ones, giving an illusion of improved survival. | Randomized controlled trial of the screening program itself |
| Confounding | An unmeasured factor is associated with BOTH the exposure and outcome, and is not on the causal pathway (e.g., coffee drinking appears linked to lung cancer, but smoking is the true cause). | Matching, randomization, stratified/regression analysis, crossover design |