USMLE Content

2016 USMLE Content Outline


  • Ecology of Health and Medicine (EHM)
  • Research Methods (RM)
  • Foundations of Clinical Medicine (FCM)

Biostatistics, Epidemiology/Population Health, & Interpretation of the Medical Literature

Epidemiology/population health

Measures of disease frequency: incidence/prevalence

(EHM)  Measures of health status: rates, crude and adjusted; reproductive rates (eg, maternal mortality, neonatal/infant/under-5 mortality); mortality, morbidity; standardization; life expectancy, health-adjusted life expectancy; population attributable risk (PAR), population attributable risk percent (PAR%); risk factors

Survival analysis interpretation (eg, Kaplan-Meier curve)

(EHM)  Composite health status indicators, measures of population impact: years of potential life lost; quality-adjusted life years; disability-adjusted life years; standardized mortality ratio

(EHM)  Population pyramids and impact of demographic changes

(EHM)  Disease surveillance and outbreak investigation: disease reporting; response to public health advisory, health promotion; recognition of clusters

Communicable disease transmission: attack rate; herd immunity; reportable diseases

(EHM)  Points of intervention: primary, secondary; community level (eg, cigarette taxes, soda taxes, smoke-free cities, buildings: restaurants, public buildings); school policies; access, healthy food, transportation, clean air, safe environments

Study design, types and selection of studies (includes dependent/independent variables)

Descriptive studies (case report [one person]/case series [more than one])

Analytical studies: observational: community surveys; cross-sectional (individuals); ecological (populations); case control; retrospective and prospective cohort

Analytical studies: interventional: clinical trial (randomized controlled trial; double-blind; placebo-controlled; noninferiority/equivalence trials); community intervention

Systematic reviews and meta-analysis: potential uses; estimation of effect sizes; heterogeneity; publication bias; forest plots, funnel diagrams; risk of bias, bias risk scale

Obtaining and describing samples: matching, inclusion/exclusion criteria, selecting appropriate controls for studies, lack of controls, concealed allocation, randomization, stratification

Methods to handle noncompliance: loss to follow-up; intention-to-treat analysis

Qualitative analysis

Measures of association

Relative risk

Odds ratio, hazard ratio

Other measures of association: number needed to treat/harm; absolute risk (AR), absolute risk percent (AR%); population attributable risk (PAR), population attributable risk percent (PAR%)

Distributions of data:  measures of central tendency; measures of variability; regression to mean; normal distribution; nominal measurement

Correlation and regression, uses and interpretation: correlation coefficients; multiple regression

Principles of testing and screening

Properties of a screening test: validity, accuracy, reliability; criteria for a screening test; confirmatory testing; appropriateness; lead-time bias, length bias; screening vs diagnostic tests

Sensitivity and specificity; predictive value, positive and negative ROC curves

Probability: theory (independence, product, addition rules); decision trees; likelihood ratios (application of Bayes theorem); posttest, pretest

Study interpretation, drawing conclusions from data

Causation: hypothesis-generating vs hypothesis-driven testing; causal criteria, temporality, temporal sequence, dose-response relationship; reverse causality


  • null hypothesis, Type I error and alpha level (multiple comparisons, random error/chance)
  • sample size and Type II error, beta, power
  • selection and interpretation of basic tests of statistical significance: chi-square; confidence intervals; p-values; t-test
  • a priori vs. post hoc analysis: subgroup analysis; error rate; affect types

Interpretation of graphs/tables and text

Bias, confounding, and threats to validity (includes methods to address)

  • selection, sampling bias
  • information bias: recall; ascertainment, ecologic fallacy, lack of blinding; loss to follow up
  • confounding variables, Hawthorne effect (includes methods to address)
  • other threats to validity (eg, placebo effect)

Internal vs. external validity: generalizability (external validity); efficacy vs effectiveness

Statistical vs. clinical significance; clinical and surrogate outcome/end point

(EHM)  Clinical decision making, interpretation and use of evidence-based data and recommendations:  application of study results to patient care and practice, including patient preferences and individualization of risk profiles; risk/benefit analysis; synthesis of concepts with real data

Research ethics

(EHM)  Informed consent for research

(EHM)  Privacy of patient data (HIPAA)

Roles of institutional review boards (IRBs)

Intervention analysis: interim analysis; stopping analysis; safety monitoring

Regulatory issues: drug development, phases of approval; appropriateness of placebo; appropriateness of randomized clinical trial; components of studies; ethics; scheduling; off-label use

(EHM)  Other issues related to research ethics

Social Sciences

Communication and interpersonal skills, including health literacy and numeracy, cultural competence

(EHM)  Patient interviewing, consultation, and interactions with the family (patient centered communication skills)

  • fostering the relationship (eg, expressing interest)
  • information gathering (eg, exploring patient’s reaction to illness)
  • information provision (eg, providing information about working diagnosis)
  • making decisions (eg, eliciting patient’s perspectives)
  • supporting emotions (eg, effective discussion with difficult patients)
  • enabling patient behaviors (eg, education and counseling)

(EHM)  Use of an interpreter

Medical ethics and jurisprudence, include issues related to death and dying and palliative care

(EHM)  Consent/informed consent to treatment, permission to treat (full disclosure, risks and benefits, placebos, alternative therapies, conflict of interest, and vulnerable populations)

(EHM)  Determination of medical decision-making capacity/informed refusal

(EHM)  Involuntary admission

(EHM)  Legal issues related to abuse (child, elder, and intimate partner) child protective services, foster care, immunizations legal requirements for reporting abuse or neglect/obligation to warn

(EHM)  Birth-related issues

(EHM)  Death and dying and palliative care

  • life support
  • advance directive, health care proxy, advance care planning
  • euthanasia and physician-assisted suicide
  • brain death/diagnosing brain death/diagnosing death
  • pronouncing death
  • organ donation
  • hospice
  • pain management, including ethical issues related to death and dying
  • information sharing, counseling families
  • psychosocial and spiritual counseling, fear and loneliness

(EHM)  Physician-patient relationship (boundaries, confidentiality including HIPAA, privacy, truth-telling, other principles of medical ethics, eg, autonomy, justice, beneficence)

(EHM)  Impaired physician, including duty to report impaired physician

(EHM)  Negligence/malpractice, including duty to report negligence and malpractice

(EHM)  Physician misconduct, including duty to report physician misconduct

(EHM)  Referrals

(EHM)  Cultural issues not otherwise coded

Systems-based practice (including health systems, public health, community, schools) and patient safety (including basic concepts and terminology)

Complexity/systems thinking

(EHM)  Characteristics of a complex system and factors leading to complexity: how complexity leads to error

(EHM)  Health care/organizational behavior and culture: environmental factors, workplace design and process; staffing; overcommitment, space, people, time, scheduling; standardization, reducing variance, simplification, metrics; safety culture; integration of care across settings; overutilization of resources (imaging studies, antibiotics, opioids); economic factors

Quality improvement

(EHM)  Improvement science principles

  • Variation and standardization: variation in process, practice; checklists, guidelines, and clinical pathways
  • Reliability

(EHM)  Specific models of quality improvement: model for improvement: plan-do-study-act (PDSA), plan-do-check-act (PDCA)

(EHM)  Quality measurement

  • Structure, process, outcome, and balancing measures
  • Measurement tools: run and control charts
  • Development and application of system and individual quality measures: core measures; physician quality report system (PQRS); event reporting system

(EHM)  Strategies to improve quality

  • Role of leadership
  • Principles of change management in quality improvement: specific strategies

(EHM)  Attributes of high-quality health care

  • High-value/cost-conscious care: overutilization of resources, including diagnostic testing, medications
  • Equitable care: access
  • Patient-centered care
  • Timely care

Patient Safety

(EHM)  Patient safety principles

  • Epidemiology of medical error
  • Error categorization/definition: active vs latent errors; Swiss cheese model of error; preventable vs non-preventable; near miss events/safety hazards
  • Causes of error
    • Patient factors: understanding of medication use; health literacy; economic status; cultural factors (eg, religion); failure to make appointments; socioeconomic status
    • Physician factors: deficiency of knowledge; judgment errors; diagnostic errors; fatigue, sleep deprivation; bias – cognitive, availability, heuristic, anchoring, framing
    • Human factors (eg, cognitive, physical, environmental)
  • High reliability of organization (HRO) principles: change management and improvement science; conceptual models of improvement
  • Reporting and monitoring for errors: event reporting systems
  • Communication with patients after adverse events (disclosure/transparency)

(EHM)  Specific types of error

  • Transitions of care errors (eg, handoff communication including shift-to-shift, transfer, and discharge): handoffs and related communication; discontinuities; gaps; discharge; transfers
  • Medication errors
    • Ordering, transcribing, dispensing, administration (wrong quantity, wrong route, wrong drug)
    • Medication reconciliation
    • Mathematical error
  • Procedural errors
    • Universal protocol (time out); wrong patient; wrong site; wrong procedure
    • Retained foreign bodies
    • Injury to structures: paracentesis; bowel perforation; thoracentesis; pneumothorax; central venous/arterial line injuries; arterial puncture and bleeding and venous thrombosis; lumbar puncture bleeding; paralysis
    • Other errors: anesthesia-related errors; mathematical errors
  • Health care-associated infections: nosocomial infection – eg, surgical site, ventilator associated, catheter-related; handwashing procedures or inadequate number of handwashing stations; central line-associated blood stream infections; surgical site infections; catheter-associated urinary tract infections; ventilator-associated pneumonia
  • Documentation errors: electronic medical record (including voice-recognition software errors); record keeping; incorrect documentation (eg, wrong patient, wrong date, copying and pasting, pre-labeling)
  • Patient identification errors
    • Mislabeling: transfusion errors related to mislabeling
    • Verification/two identifiers: lack of dual validation, including verbal verification of lab results
  • Diagnostic errors: errors in diagnostic studies; misinterpretation
  • Monitoring errors
    • Cardiac monitoring/telemetry
    • Drug monitoring (warfarin, antibiotics)
  • Device-related errors
    • malfunction
    • programming error
    • incorrect use

(EHM)  Strategies to reduce error

  • Human factors engineering
    • Situational awareness
    • Hierarchy of effective interventions: forcing function; visual cues
  • Error analysis tools: error/near miss analysis; failure modes and effect analysis; morbidity and mortality review; root cause analysis
  • Safety behavior and culture at the individual level: hierarchy of health care, flattening hierarchy, speak up to power; afraid to report, fear; psychological safety; closed-loop communication
  • Teamwork: principles of highly effective teams; case management; physician teams, physician-physician communication; interprofessional/intraprofessional teams; strategies for communication among teams, including system-provider communication, physician-physician communication (eg, consultations), interprofessional communication, provider-patient communication

Health care policy and economics

(EHM)  Health care policy

  • Health care disparities: race/ethnicity; numeracy/literacy; socioeconomic status
  • Access to care: critical access systems or hospitals
  • Social justice

(EHM)  Health care economics/Health care financing

  • Types of insurance: Medicare, Medicaid, private insurance, self-pay
  • Navigating the insurance system: deductibles/co-pays; in-/out-of-network; preferred providers
  • Reimbursement issues affecting safety and quality: emergency services – EMTALA; pay-for-performance