PH 311-Introduction to Clinical Epidemiology

Course Description:
This course addresses the function of epidemiology in clinical medicine. It looks at issues of normality and abnormality, frequency of events over time (probability), risk, cause, and uncertainties associated with diagnosis, prognosis, management and outcomes. Guidelines for the appraisal of medical literature related to causation, diagnostic tests, prognosis and case management are discussed.

• Prerequisite Courses: Eligible to enter 3rd Year CAPH

A. PROGRAM LEARNING OUTCOMES (PLOS):
The student will be able to:

1. Recognize, describe and discuss and research about the basic principles and practices of the specialty.
2. List, discuss and demonstrate the essential public health functions or the specialty and its interrelationships with the other specialties and health disciplines at community and national levels.
3. Describe, discuss and research adult, children and family health issues at community level.
4. Discuss and demonstrate an understanding and practice of the speciality public health competencies.
5. Demonstrate proper public health skills for its practice in the community as a national specialty practitioner.
6. Discuss and demonstrate community and cultural sensitivity in the health care environment.
7. Describe, discuss and research the health determinants and problems of adults, children and families.
8. Demonstrate proper cardio-pulmonary resuscitation (CPR) and first aid techniques and other healing and patient care abilities.
9. Demonstrate the ability and discuss how to conduct a community diagnosis and need assessment of the health determinants of the specialty in a community.
10. Identify and demonstrate good practice in the specialty.
11. Have had management, planning experience and leadership role at a public health specialty at community and national levels.

B. STUDENT LEARNING OUTCOMES (SLOS) - GENERAL
The student will be able to:

1. Explain the scientific basis for and the principles of clinical epidemiology and its uses in clinical practice.
2. Demonstrate a sound understanding on issues pertaining to clinical epidemiology.
3. Search for the best available information and to judge its validity in clinical practice.
4. Exhibit the capacity for critical thinking on how to conduct clinical research based on the principles of clinical epidemiology.

I = Introduced
D = Demonstrated
M = Mastered

C. STUDENT LEARNING OUTCOMES (SLOS) – SPECIFIC
The student will be able to:

General SLO 1: Explain the scientific basis for and the principles of clinical epidemiology and its uses in clinical practice.

General SLO 2: Demonstrate a sound understanding on issues pertaining to clinical epidemiology.

General SLO 3: Search for the best available information and to judge its validity in clinical practice.

General SLO 4: Exhibit the capacity for critical thinking on how to conduct clinical research based on the principles of clinical epidemiology.

D. COURSE CONTENT

1. Introduction
   
   1. The scientific basis for clinical medicine
   2. Basic principles of clinical medicine
      1. Clinical questions, variables and health outcomes
      2. Numerical values and probability
      3. Populations and samples
      4. Bias and chance
      5. Internal and external validity
2. Abnormality
   1. Types of data
   2. Performance of measurements: validity, reliability, interpretability
   3. Variation and distribution
   4. Criteria for abnormality
   5. Regression to the mean
3. Diagnosis
   
   1. Simplifying data
   2. The accuracy of a test result
   3. Sensitivity and specificity
   4. Establishing sensitivity and specificity: spectrum of patients, bias, and chance
   5. Predictive values
4. Frequency
   
   1. Prevalence and incidence
   2. Relationship among prevalence, incidence and duration of disease
   3. Studies of prevalence and incidence
   4. Value and limitations of prevalence studies
   5. Interpreting measures of frequency: concepts of case, population and sampling
   6. Distribution of disease by time, place and person
5. Risk
   
   1. Risk – looking to the future time
      
      1. Risk factors and recognizing risk
      2. Uses and studies of risk
      3. Ways to express and compare risk
   2. Risk – looking into the time past
      
      1. Case-control studies: design, odds ratio, controlling for extraneous variables
      2. Using case-control studies in disease outbreak investigations
      3. Scientific standards for case-control research
      4. Risk communication
6. Prognosis
   
   1. Differences in risk and prognostic factors
   2. Clinical course and natural history of disease
   3. Elements of prognostic studies and prediction rules
   4. Describing prognosis and identifying prognostic factors
   5. Bias in cohort studies: selection bias and confounding
7. Treatment
   
   1. Ideas and evidence
   2. Studies of treatment effects: Randomized controlled trials (RCT); their alternatives and limitations; tailoring the results of trials to individual patients
   3. Intention-to-treat and explanatory trials
   4. Efficacy and effectiveness
   5. Observational studies of interventions
   6. Phases of studies of treatment
8. Prevention
   
   1. Population and clinical prevention
      
      1. Types of clinical prevention: immunization, screening, behavioral counseling, chemoprophylaxis
      2. Levels of prevention
   2. Screening tests in preventive care
      
      1. Prevalence and incidence testing
      2. Special biases in screening
      3. Criteria for a good screening test
      4. Possible adverse effects of screening
   3. Effectiveness of treatment
9. Chance
   
   1. Approaches to chance - Hypothesis testing
   2. Point estimates and confidence intervals
   3. Estimating sample size requirements
   4. Equivalence trials and detecting rare events
   5. Multiple comparisons
   6. Subgroup and secondary analyses
   7. Describing associations; multivariable methods and Bayesian reasoning
10. Causation
    
    1. Concepts of causation: single versus multiple causes; proximity of cause to effect; interaction; effect modification
    2. Establishing causes: association and cause; hierarchy of research designs
    3. Ecological studies
    4. Evidence for and against cause
    5. Grading the quality of evidence
11. Systematic reviews
    
    1. Traditional reviews versus systematic reviews
       
       1. When are systematic reviews appropriate
       2. Finding all relevant studies
       3. Publication bias
       4. Summarizing results
    2. Combining studies in meta-analyses
       
       1. Justification for combining studies
       2. Summarizing the results and displaying the summary effect
       3. Cumulative meta-analysis
       4. Advantages and risks of combining studies

1. Lectures: in-class lectures
2. Group discussions and exercise on the critical review of the research methods, findings and evidence from selected samples of clinical studies.

F. REQUIRED TEXT AND COURSE MATERIALS
Fletcher RH., Fletcher SW. (2005). Clinical epidemiology – The essentials (4th ed.). Philadelphia, Pennsylvania: Lippincott Williams & Wilkins (or most recent edition).

G. REFERENCE MATERIALS
Haynes RB., et al. (2005). Clinical epidemiology – How to do clinical practice research (3rd ed.). Philadelphia, Pennsylvania: Lippincott Williams and Wilkins (or most recent edition)

Sackett DL., Straus SE., et al. (2005). Evidence-based medicine, how to practice and teach EBM (2nd ed.). Philadelphia, Pennsylvania: Churchill Livingstone (or most recent edition).

H. INSTRUCTIONAL COST
none

I. EVALUATION
None

J. CREDIT BY EXAMINATION
None