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Epidemiology
Study Designs (T Pierce)
39
Health Care
Graduate
10/15/2010

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Cards

Term
types of epidemiologic study designs
Definition
  • observational
    • analytic- hypothesis testing
    • descriptive- only describes
  • experimental
    • analytic- always hypothesis testing
Term
describe descriptive studies
Definition

Are not hypothesis-testing, but generate hypotheses
Focus on patterns of disease by person, place, and time
Usually have no comparison group
Term
Describe analytic studies
Definition

Test a hypothesis
Usually include a control or comparison group
Use a more complex design
Term
Describe observational study designs
Definition

 

  • Are “observing” what has occurred naturally
  • Investigator does not manipulate exposure status of study participants
  • Most epidemiologic studies are observational
Term
Describe experimental study designs
Definition

Investigator manipulates the exposure
Equivalent to a laboratory experiment
Considered to be the “gold standard” for establishing causality
Term
Different kinds of cohort studies
Definition
  • retrospective cohort
  • prospective cohort
  • nested case control
  • case cohort
Term
Factors that influence choice of study design
Definition

The nature of the research question
Ethical issues
Resources available (cost, personnel, time)
How much is known about the topic
Frequency of disease or exposure
Available information
Nature of the disease (induction period)
Term
Different types of descriptive study designs
Definition
  • case series
  • case reports
  • surveillance
  • ecological
  • descriptive survey
    • cross sectional
Term
Describe ecological studies
Definition

Studies of group characteristics.  The “units of analysis are populations or groups of people, rather than individuals.”  (Last, 1995)
Correlation between disease rates and exposures are based upon average exposure levels and average disease rates.
Ecological studies do have comparison groups.  However:  NO data on individual exposures!
Term
Advantages of ecological studies
Definition

  • Availability of data on exposures and disease
  • Can be done quickly and with limited resources
  • Exposures may differ substantially between cities, states, and countries
  • Analysis is fairly simple
Term
Limitations of ecological studies
Definition

  • Are subject to numerous biases and limitations
  • Are more subject to confounding (the mixing of effects of other risk factors with the exposures of interest) than individual risk studies
  • Time trend studies are limited in that you can’t determine whether exposure preceded the outcome
  • Are subject to the “ecological fallacy”
Term
What is the ecological fallacy
Definition
  • Results from correlations found on a group level do not hold true for the individual members of these groups.
  • We don’t know the link between exposure and disease among individuals within each group
Term
Describe a cross sectional study design
Definition

Begins with a population base but does not follow individuals over time
Looks at prevalence of disease and/or exposure at one point in time (a population “snapshot”)
Persons in the snapshot are classified as diseased or non-diseased, exposed or unexposed
Term
How can a cross sectional study be either descriptive or analytical
Definition
  • Depends on the purpose
    • to simply describe the health status of the population (descriptive), or
    • to conduct comparative analyses, relate exposure to disease (analytical)
Term
How are cross sectional studies good at IDing target populations?
Definition

Useful following reports of disease, when you want to identify risk factors.
Or, useful when you know your population has some risk factors, and you would like to explore associations with disease.
Usually, you don’t know the exposure and disease status of individuals in population until you collect the data.
Term
What values are used to analyze or conceptualize cross sectional studies?
Definition

odds of exposure among diseased compared to non-diseased (exposure-odds ratio); or
odds of disease among exposed compared to unexposed (disease-odds ratio)
either yields the same OR, which is a prevalence odds ratio
Term
Compare and contrast prevalence ratios and prevalence odds ratios
Definition
  • prevalence odds ratio 
    • Estimates the Incidence Rate Ratio (IRR)
    • Best for X-sectional studies of chronic diseases
  • prevalence ratio
    • Estimates the CIR
    • Best for X-sectional studies of acute diseases
Term
Advantages of cross sectional studies
Definition

Relatively quick and cheap
Useful to study morbidity, or pre-clinical markers
Can collect detailed data on exposures and confounders
Do not have to know disease/exposure status ahead of time
Term
Limitations of cross sectional studies
Definition

  • Selection bias is major problem
    • Diseases of long duration (e.g., diabetes) are often over-represented (“survival” bias)
    • Many individuals have left “cohort”
    • Representativeness of volunteers
  • Time sequence between exposure and disease inferred only through history
  • Often reply on subjective information
Term
When is it desirable to do a case control study?
Definition

 

When exposure data are expensive or difficult to obtain

  Ex: Women exposed to pesticides in a study of breast cancer

When disease has long induction and latent period

   Ex: Cancer, cardiovascular disease

 

When the disease is rare

Ex: Studying risk factors for birth defects

When little is known about the disease

Ex. Early studies of AIDS

When the population is dynamic

Ex. Residence in a city

Term
Different types of case control studies
Definition

  • Community-Based (Population-Based)
    • Prevalence case-control study
    • Incidence case-control study
  • Cohort-Based (Nested)
  • Case-Crossover Study
Term
How do you choose cases in case control study
Definition

 

Identify newly diagnosed (incident) cases of disease (preferably)
Choose prevalence cases, that have existed for a longer time period. May include deceased cases if the disease has a high case fatality rate
Sources include death certificates, disease registries, hospital discharge records, insurance records, medical lab records, records of physicians/other medical providers
Importance of case-definition
Term
Definition and purpose of controls
Definition

 

Definition:  A sample of the source population that gave rise to the cases.
Purpose: To estimate the exposure distribution in the source population that produced the cases.
Term
Define the "would" criterion of selecting controls in a case control study
Definition

 

Would” criterion: a member of the control group who gets the disease being studied “would” end up as a case in the study.
Exposed and unexposed controls should have the same probability of selection.
Term
Case control studies: selecting general population controls, example
Definition

Most often used when cases are selected from a defined geographic population

 

Sources: random digit dialing, residence lists, drivers’ license records 

 

  Ex: Study of Hepatitis A in Hispanic Children; controls were chosen from same neighborhood and schools as cases

Term
Case control studies: Advantage and disadvantages of using general population controls 
Definition
  • Disadvantage 
    • Advantage
      • Because of selection process, investigator is usually assured that they come from the same base population as the cases.

  time consuming

  expensive

  hard to contact and get cooperation

  may remember exposures differently than cases (recall bias)

Term
Case control studies: hospital controls
Definition
  • Used most often when cases are selected from a hospital population
  • Study of cigarette smoking and myocardial infarction among women. Cases identified from admissions to hospital coronary care units. Controls drawn from surgical, orthopedic, and medical unit of same hospital. Controls included patients with non-coronary conditions
Term
Advantages of using hospital controls
Definition

 

Same selection factors that led cases to hospital led controls to hospital

Easily identifiable and accessible (so less expensive than population-based controls)
Accuracy of exposure recall comparable to that of cases since controls are also sick
More willing to participate than population-based controls
Term
Disadvantage of using hospital controls
Definition

 

Since hospital based controls are ill, they may not accurately represent the exposure history in the population that produced the cases

Hospital catchment areas may be different for different diseases  
Term
What illnesses make good hospital controls?
Definition
those illnesses with no relation to risk factor under study
Term
What are some issues that can come up during control selection?
Definition

control groups differ in their potential biases; may want to use more than one control group
desirable to control confounding factors (unless you want to estimate their effect)
address confounding through matching or during analysis (stratification, regression, analysis)
Term
Describe nested case control studies
Definition

 

Usually more efficient than cohort studies
Don’t have to calculate exposures on entire cohort, just on cases and selected controls
Controls come from same population as cases, thereby minimizing control selection biases
Term
How do you conduct a nested case control study
Definition

performed after cohort study

choose all cases of disease among cohort

identify sample of controls from among cohort members without the disease

obtain detailed data on exposures and potential confounders

compare prevalence of exposure between cases and controls

Term
case cross over studies
Definition

 

Useful when brief exposure causes a change in risk of a rare acute onset disease
The increased risk following the exposure is termed the “hazard period”
Cases serve as their own controls
Exposure frequency during hazard period is compared to that from a control period
Term
example of case cross over studies
Definition

Acute myocardial infarction after heavy physical exertion
Motor vehicle collision while using a cell phone
Unsafe sex after drinking alcohol
Term
When is OR a good estimate of RR?
Definition

 

(1) controls are representative of individual in the base population

(2) cases are representative of all individuals with the disease of interest in the base population

(3) the disease is relatively rare rare

Term
Advantages of case control studies
Definition

 

  • Useful for rare diseases
  • Can assess multiple exposure & confounders
  • Can assess exposures which are not detailed in records
  • Smaller study population
  • Quicker and cheaper
Term
limitations of case control studies
Definition

 

Relies on participation
Data on exposure and confounders obtained by interview or survey (subjective)
Can look at only one disease
Selection of controls is challenging
Incidence cannot be estimated
Term
Potential biasis of case conrol studies
Definition

 

Selection biases (many types)

Recall bias

Interview bias

Exposure misclassification
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