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Types of Study in Epidemiology

Analytical Epidemiology

Analytical Epidemiology

It is primarily designed to establish the causes of disease by investigating the association between exposure to a risk factor and the occurrence of disease.

  • Objective of this study → Hypothesis testing.
  • Analytical epidemiology has 4 types:
    • Ecological study
    • Cross-sectional study
    • Case-control study
    • Cohort study

Ecological Study

  • Also known as correlational study.
  • Type of analytical epidemiological study, which provides the least satisfactory type of evidence on causality.
  • It is the least preferable analytical design.
  • Units of study → population.
  • Done in a small time frame, uses data which is already available.

Cross-Sectional Study

  • It is the simplest form of analytical study.
  • These studies are surveys that take place over a limited period.
  • Based on the single examination of a cross-section of a population ‘at one point of time’.
  • Results of the sample are projected to the whole population.
  • This study provides prevalence of disease.
  • It is a ‘snapshot’ of the population.
  • More useful for chronic disease.
  • Gives information about the distribution of disease, not its etiology.
  • Unit of study → Individual.
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Epidemiological Study Types

Epidemiological Study Types

Type of Epidemiological Study Unit of Study
1. Observational studies
a. Descriptive studies (Hypothesis formulation)
b. Analytical studies (Hypothesis testing)
     i. Cohort study Individual
     ii. Case-control study Individual
     iii. Cross-sectional study Individual
     iv. Ecological study Population
2. Experimental studies (Hypothesis confirmation)
a. Randomized controlled trial Patients
b. Field trial Healthy people
c. Community trial Community
d. Clinical trial Patients
Case Control Study

Case Control Study

Other Names:

  • Case reference study
  • Retrospective study
  • TROHOC study
  • Backward looking study
  • Effect to cause study
  • Outcome to exposure study
  • Disease to risk factor study

→ Unit of study → Individual.

→ This study is not expensive.

Advantages:

  • Useful to study rare disease.
  • Easy to carry out.
  • Rapid and inexpensive.
  • No loss to follow-up/ Attrition.
  • Requires few subjects.

→ This study gives information about many risk factors for a single disease.

Disadvantages:

  • Recall bias and selection bias are present.
  • Cannot measure incidence.

→ Strength of association in case control study → odds ratio (cross product ratio).

Cohort Studies

Cohort Studies

Other Names:

  • Prospective study
  • Forward-looking study
  • Causes to effect study
  • Exposure to outcome study
  • Risk factor to disease study
  • Incidence study
  • Follow-up study

→ This study ends with the disease.

→ It determines a single risk factor affecting many diseases.

→ Units of study → Individual.

Types of Cohort Study:

a) Prospective Cohort Study

  • Known as current cohort study or concurrent cohort study.
  • Only exposure has occurred when the study has begun.

Examples:

  • Framingham heart study.
  • Doll and Hill’s prospective study on smoking and lung cancer.

b) Retrospective Cohort Study

  • Known as historical cohort study or non-concurrent cohort study.
  • It has combined advantages of both cohort study and case-control study.
  • Both exposure as well as outcome have occurred when the study has begun.

Examples:

  • Effects of fetal monitoring on neonatal deaths.
  • PVC exposure and angiosarcoma of the liver.

c) Combined Prospective-Retrospective Cohort Study

  • Known as ‘mixed cohort study’.

Strength of Association in Cohort Study:

→ It is evaluated by:

  • Relative Risk (RR)
  • Attributable Risk (AR)
  • Population Attributable Risk (PAR)
Comparison of Study Designs

Comparison of Study Designs

Characteristic Cross-sectional studies Case-control studies Cohort studies
Time One time point Retrospective Prospective
Other names Prevalence study Case reference study
  • Longitudinal study
  • Forward looking study
  • Follow up study
  • Incidence study
Incidence No No Allows the study of incidence
Prevalence Allows the study of prevalence No No
Causality No Yes Yes
Role of disease Measures disease Begin with disease End with disease
Assesses Association of risk factor and disease Many risk factors for a single disease Single risk factor affecting many diseases
Data analysis Chi-square to assess association Odds ratio to estimate risk Provides direct estimate of relative risk (COMEDK – 2013)
Advantages
  • Used to calculate prevalence
  • Faster
  • Quick and inexpensive
  • Useful to study rare diseases
  • Require few subjects
  • Easy to conduct
  • Incidence can be calculated
  • Provides direct estimate of relative risk
Disadvantages
  • Unusable for acute diseases
  • Over-represents certain conditions
  • Recall bias and selection bias are present
  • Misses undiagnosed or asymptomatic cases
  • Expensive
  • Time-consuming
  • Involves a large number of subjects
Epidemiological Studies

Epidemiological Studies Summary

Ecological Study Cross Sectional Study Case Control Study Cohort Study
  • Correlational study
  • Unit of study – population
  • Used for very large population
  • Very weak study
  • Prevalence study
  • Gives snapshot of population study
  • Unit of study – Individual
  • This is a one-point study
  • Measures disease
  • Associates risk factor & disease (not causative factor)
  • More useful for chronic diseases
  • Does not establish time sequence
  • Also known as:
    • Retrospective study
    • Backward looking study
    • Case reference study
    • Effect to cause study
    • Disease to risk factor study
    • Outcome to exposure study
    • TROHOC study
  • Unit of study – Individual
  • Study begins with disease
  • Assesses many risk factors for a single disease
  • Uses Odds Ratio for risk estimation
  • Suitable for rare diseases
  • Casual association
  • Risk factors can be identified
  • Inexpensive
  • Recall & selection bias present
  • Also known as:
    • Prospective study
    • Forward-looking study
    • Cause to effect study
    • Exposure to outcome study
    • Risk factor to disease study
    • Incidence study
  • Follow-up study
  • Unit of study – Individual
  • Study ends with disease
  • Assesses single risk factor for many diseases
  • Involves large number of subjects
  • Suitable for community diseases
  • Yields:
    • Incidence
    • Attributable risk
    • Relative risk
  • Expensive

Experimental Epidemiology

Randomized Controlled Trials (RCTs)

Randomized Controlled Trials (RCTs)

→ RCT is of two types:

Concurrent Parallel Design:

→ Comparisons are made between 2 groups:

  • Experimental group: Is exposed to specific medication or intervention.
  • Reference group: Is not exposed to specific medication or intervention.

Crossover Design:

→ Comparisons are made between 2 groups:

  • Experimental group: Is exposed to specific medication or intervention.
  • Reference group: Is not exposed to specific medication or intervention.

→ Then the groups are crossed-over (Exposed group now becomes non-exposed and vice-versa).

→ Crossover design RCT helps removing ethical concerns.

Intention to Treat Trial:

→ Implies that the results of an RCT are unaffected by attrition (Loss to follow-up) or changeover of study subjects from one group to another.

Randomization in RCT:

→ It is a statistical procedure, by which participants are allocated into either of two groups:

  • Experimental group: In which intervention is given.
  • Reference group: In which intervention is not given.

→ Randomization is best done by ‘Random number tables’.

Pre-Clinical & Clinical Trials

Pre-Clinical & Clinical Trials

Phase Unit of Study Purpose
PRECLINICAL PHASE
Lab experiments Animals Pretesting
CLINICAL PHASES
Phase 0 Healthy human volunteers Micro-dosing
Phase I Healthy human volunteers Safety and non-toxicity profile
Phase II Patients Effectiveness
Phase III Patients Comparison with existing drug
Phase IV Patients Long-term side effects
  • Phase III is an RCT: Comparison of a new drug with an existing old drug.
  • New drug is launched in market after: Phase III.
  • Longest phase of a trial: Phase IV.
  • Post-marketing surveillance: Phase IV.
  • Maximum tolerated dose (MTD) of a drug: Phase I.

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